[Federal Register Volume 73, Number 62 (Monday, March 31, 2008)]
[Rules and Regulations]
[Pages 16966-17235]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-4998]
[[Page 16965]]
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Part II
Nuclear Regulatory Commission
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10 CFR Part 26
Fitness for Duty Programs; Final Rule
Federal Register / Vol. 73, No. 62 / Monday, March 31, 2008 / Rules
and Regulations
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NUCLEAR REGULATORY COMMISSION
10 CFR Part 26
RIN 3150-AF12
Fitness for Duty Programs
AGENCY: Nuclear Regulatory Commission.
ACTION: Final rule.
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SUMMARY: The Nuclear Regulatory Commission (NRC) is amending its
regulations for Fitness for Duty (FFD) programs to update these
requirements and enhance consistency with advances in other relevant
Federal rules and guidelines, including the U.S. Department of Health
and Human Services (HHS) Mandatory Guidelines for Federal Workplace
Drug Testing Programs, and other Federal drug and alcohol testing
programs that impose similar requirements on the private sector. The
amendments require nuclear power plant licensees and other entities,
including facilities possessing Category 1A material, to strengthen the
effectiveness of their FFD programs. In addition, the amendments
require nuclear power plant licensees and other entities to enhance
consistency between with the FFD programs with NRC's access
authorization requirements for nuclear power plants. The amendments
also require nuclear power plant licensees to ensure against worker
fatigue adversely affecting public health and safety and the common
defense and security by establishing clear and enforceable requirements
for the management of worker fatigue. The final rule ensures that
individuals who are subject to these regulations are trustworthy and
reliable, as demonstrated by avoiding substance abuse; are not under
the influence of drugs or alcohol while performing their duties; and
are not mentally or physically impaired from any other cause that would
in any way adversely affect their ability to perform their duties
safely and competently.
This final rule also grants, in part, a petition for rulemaking
(PRM-26-1) submitted by Virginia Electric and Power Company (now
Dominion Virginia Power) on December 30, 1993, by relaxing several
required FFD program audit frequencies, and partially grants a petition
for rulemaking (PRM-26-2) submitted by Barry Quigley on December 28,
1999.
DATES: This final rule is effective April 30, 2008. However, licensees
and other applicable entities may defer implementation of this rule,
except for Subparts I and K, until March 31, 2009. Subpart I must be
implemented by licensees and other applicable entities no later than
October 1, 2009. Licensees and other applicable entities shall comply
with the requirements of Subpart K as of April 30, 2008.
FOR FURTHER INFORMATION CONTACT: David Diec, Office of Nuclear Reactor
Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-
0001, telephone (301) 415-2834, Timothy McCune, Office of Nuclear
Security and Incident Response, telephone (301) 415-6474, Dr. David R.
Desaulniers, Office of New Reactors, telephone (301) 415-1043, or Dr.
Valerie Barnes, Office of Nuclear Regulatory Research, telephone (301)
415-5944. All of the above contacts may also be reached by e-mail to
[email protected].
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
A. Drug and Alcohol Testing Provisions, and General Fitness-for-
Duty Program Provisions
B. Worker Fatigue Provisions
C. Combined Part 26 Rulemaking
D. Public Input Accepted Since 2000 ``Affirmed Rule''
II. Petitions and Request for Exemption
A. Petition for Rulemaking PRM-26-1
B. Petition for Rulemaking PRM-26-2
C. Request for Exemption under 10 CFR 26.6
III. Abbreviations
IV. Discussion of Final Action
A. Overview
B. Goals of the Rulemaking Activity
C. Overview of Final Rule
D. Inclusion of Worker Fatigue Provisions in 10 CFR Part 26
V. Summary of Public Comments Submitted on Proposed Rule
VI. Section-by-Section Analysis of Substantive Changes
VII. Availability of Documents
VIII. Criminal Penalties
IX. Agreement State Compatibility
X. Plain Language
XI. Voluntary Consensus Standards
XII. Finding of No Significant Environmental Impact: Environmental
Assessment
XIII. Paperwork Reduction Act Statement
XIV. Regulatory Analysis
A. Aggregate Analysis
B. Screening Review for Disaggregation
C. Disaggregation of Worker Fatigue Provisions
XV. Regulatory Flexibility Act Certification
XVI. Backfit Analysis
A. Consideration of Fuel Fabrication Facilities and Gaseous
Diffusion Plants
B. Aggregate Backfit Analysis
C. Screening Review for Disaggregation
XVII. References
List of Subjects in 10 CFR Part 26
I. Background
A. Drug and Alcohol Testing Provisions, and General Fitness-for-Duty
Program Provisions
On June 7, 1989, the Commission announced the adoption of a new
rule, 10 CFR Part 26, Fitness for Duty Programs (54 FR 24468), that
required each licensee authorized to operate or construct a nuclear
power reactor to implement an FFD program for all personnel having
unescorted access to the protected area of its plant. A subsequent
final rule published in the Federal Register on June 3, 1993 (58 FR
31467), expanded the scope of Part 26 to include licensees authorized
to possess, use, or transport formula quantities of Strategic Special
Nuclear Materials (SSNM).
At the time the FFD rule was published in 1989, the Commission
directed the NRC staff to continue to analyze licensee programs, assess
the effectiveness of the rule, and recommend appropriate improvements
or changes. The NRC staff reviewed information from several sources
including inspections, periodic reports by licensees on FFD program
performance, reports of significant FFD events, industry-sponsored
meetings, and current research literature, as well as initiatives by
industry, the Substance Abuse and Mental Health Services Administration
of the Department of HHS (SAMHSA, formerly the National Institute on
Drug Abuse), and SAMHSA's Drug Testing Advisory Board, and recommended
improvements and changes.
As a result, the NRC published proposed amendments to the FFD rule
in the Federal Register on May 9, 1996 (61 FR 21105). The 90-day public
comment period for the proposed rule closed on August 7, 1996. The NRC
staff reviewed and considered public comments on the proposed rule, and
submitted a final rule to the Commission in a Commission paper (SECY-
00-0159), dated July 26, 2000. The Commission affirmed the rule in a
Staff Requirements Memorandum (SRM-M001204A) dated December 4, 2000.
The affirmed rule was sent to the Office of Management and Budget (OMB)
to obtain a clearance under the Paperwork Reduction Act. The request
for comments on the clearance was published in the Federal Register on
February 2, 2001 (66 FR 8812). OMB and NRC received public comments
that objected to some aspects of the rule. In SECY-01-0134, dated July
23, 2001, the NRC staff recommended withdrawing the request for
clearance and preparing a new proposed rule. In a Staff
[[Page 16967]]
Requirements Memorandum (SRM-SECY-01-0134) dated October 3, 2001, the
Commission approved the staff's recommendation to withdraw the request
for clearance and prepare a new proposed rule.
B. Worker Fatigue Provisions
The NRC's ``Policy on Factors Causing Fatigue of Operating
Personnel at Nuclear Reactors'' (referred to in this document as NRC's
Policy on Worker Fatigue) was first published in the Federal Register
on February 18, 1982 (47 FR 7352), and later issued through Generic
Letter (GL) 82-12, ``Nuclear Power Plant Staff Working Hours,'' on June
15, 1982 (referred to in this document as GL 82-12). In GL 82-12, the
NRC requested licensees to revise the administrative section of their
technical specifications to ensure that plant administrative procedures
were consistent with the work-hour guidelines. Those guidelines were:
(1) An individual should not be permitted to work more than 16
consecutive hours (excluding shift turnover time);
(2) An individual should not be permitted to work more than 16
hours in any 24-hour period, nor more than 24 hours in any 48-hour
period, nor more than 72 hours in any 7-day period (all excluding shift
turnover time);
(3) A break of at least 8 hours should be allowed between work
periods (including shift turnover time); and
(4) Except during extended shutdown periods, the use of overtime
should be considered on an individual basis and not for the entire
staff on a shift.
Further, the guidelines permitted deviations from these limits in
very unusual circumstances if authorized by the plant manager, his
deputy, or higher levels of management in some cases. The NRC's Policy
on Worker Fatigue was incorporated, directly or by reference, and with
variations in wording and detail, into the technical specifications of
all but three nuclear power plant sites who implemented the concept
using other administrative controls.
When 10 CFR Part 26 was issued on June 7, 1989 (54 FR 24468), it
focused on establishing requirements for preventing and detecting
personnel impairment from drugs and alcohol. However, consistent with
SRM-SECY-88-129, dated July 18, 1988, several requirements addressed
other causes of impairment, including fatigue. Those requirements
included general performance objectives [Sec. 26.10(a) and (b)] that
provided for ``reasonable assurance that nuclear power plant personnel
* * * are not under the influence of any substance, legal or illegal,
or mentally or physically impaired from any cause'' and ``early
detection of persons who are not fit to perform activities within the
scope of this part.'' A requirement was also included in Sec. 26.20(a)
for licensee policies to ``address other factors that could affect
fitness for duty such as mental stress, fatigue and illness.''
In a letter dated February 25, 1999, Congressmen Dingell, Klink,
and Markey expressed concerns to former NRC Chairman Shirley Ann
Jackson that low staffing levels and excessive overtime may present a
serious safety hazard at some commercial nuclear power plants. The
Union of Concerned Scientists (UCS) expressed similar concerns on March
18, 1999, in a letter from David Lochbaum to Chairman Jackson, and in
the UCS report ``Overtime and Staffing Problems in the Commercial
Nuclear Power Industry,'' dated March 1999. In a letter dated May 18,
1999, to the Congressmen, the Chairman stated that the NRC staff would
assess the need to revise the policy.
On September 28, 1999, the Commission received a petition for
rulemaking (PRM-26-2) from Barry Quigley. (The petition is discussed in
greater detail in Section II.B of this document.) The petition
requested that the NRC amend 10 CFR Parts 26 and 55 to establish clear
and enforceable work-hour limits to mitigate the effects of fatigue for
nuclear power plant personnel performing safety-related work.
The UCS petitioned the NRC on April 24, 2001, under 10 CFR 2.206,
to issue a Demand for Information (DFI) to specified licensees. The
petition asserted that Wackenhut Corporation has the contractual right
to fire security guards who refuse to report for mandatory overtime,
and that this contractual right conflicts with 10 CFR Part 26. The NRC
denied the DFI request (ADAMS Accession No. ML013230169), but addressed
the concerns of the petition through the NRC's generic communication
process. On May 10, 2002, the NRC issued NRC Regulatory Issue Summary
(RIS) 2002-07, ``Clarification of NRC Requirements Applicable to Worker
Fatigue and Self-Declarations of Fitness-for-Duty.'' The RIS addressed
the applicability of 10 CFR Part 26 to worker fatigue, the potential
for sanctions related to worker FFD concerns to have adverse
implications for maintaining a work environment conducive to reporting
FFD concerns, and the protections afforded workers by 10 CFR 50.7,
``Employee Protection.''
On January 10, 2002, in SRM-SECY-01-0113, the Commission approved a
rulemaking plan, ``Fatigue of Workers at Nuclear Power Plants,'' dated
June 22, 2001 (referred to in this document as SECY-01-0113). Under the
approved plan, the NRC initiated a rulemaking to incorporate fatigue
management into 10 CFR Part 26 in order to strengthen the effectiveness
of FFD programs at nuclear power plants in ensuring against worker
fatigue adversely affecting public health and safety and the common
defense and security by establishing clear and enforceable requirements
for the management of worker fatigue.
During the development of the fatigue management requirements, the
NRC observed an increase in concerns (e.g., allegations, media and
public stakeholder reports) related to the workload and fatigue of
security personnel following the terrorist attacks of September 11,
2001. Subsequent to an NRC review of the control of work hours for
security force personnel, and public interactions with stakeholders,
the Commission issued Order EA-03-038 on April 29, 2003, requiring
compensatory measures related to fitness-for-duty enhancements for
security personnel at nuclear power plants, including work hour limits.
The compensatory measures imposed by Order EA-03-038 were similar
to the guidelines of the NRC's Policy on Worker Fatigue. The
compensatory measures differed from the Policy guidelines in a few
areas in which the NRC believed it was necessary to address previously
identified deficiencies in the guidelines, including the need to
address cumulative fatigue from prolonged periods of extended work
hours, matters unique to security personnel and stakeholder input
obtained through public meetings concerning the worker fatigue
rulemaking and the order. The NRC imposed the requirements in the order
to provide the Commission with reasonable assurance that the public
health and safety and common defense and security continue to be
adequately protected. The provisions specified in 10 CFR Part 26,
Subpart I, Managing Fatigue, for security force personnel replace the
requirements imposed by the order. Differences between the requirements
in Subpart I and the requirements imposed by the order, and the
rationale for those differences, are discussed in Section IV.D of this
document.
C. Combined Part 26 Rulemaking
On March 29, 2004, in COMSECY-04-0014, the NRC staff informed the
Commission of the status of both
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rulemaking activities. The NRC staff also noted that because both
rulemaking activities were being completed in parallel, the draft
proposed fatigue rule language was based on the draft language in the
proposed overall revision to Part 26, rather than on the former
language in Part 26. Therefore, meaningful public comment could be
confounded by the simultaneous promulgation of two draft rules which
are somewhat interdependent, and staff action to address a comment on
one proposed rule could easily impact the other proposed rule, creating
a high potential for the need to issue one or both proposed rules. In
SRM-COMSECY-04-0014, dated May 25, 2004, the Commission directed the
staff to combine the rulemaking related to nuclear power plant worker
fatigue with the ongoing Part 26 rulemaking activity. This combined
final rule withdraws the proposed rule published on May 9, 1996.
D. Public Input Accepted Since 2000 ``Affirmed Rule''
In preparing this rule, the NRC considered comments received by OMB
on the prior Part 26 final rule affirmed by the Commission in an SRM
dated December 4, 2000. The NRC also considered feedback received from
industry, as well as other interested parties and members of the
public. The NRC held 11 stakeholder meetings on the drug and alcohol
testing portions of the rule during 2001-2004, and 13 stakeholder
meetings on the fatigue portions of the rule during 2002-2003.
Following the Commission's decision to combine the two rulemaking
efforts, the NRC held one stakeholder meeting on the combined rule in
July, 2004, and two subsequent meetings on the fatigue provisions of
the combined rule in August and September 2004.
Throughout the time the meetings were being held, drafts of
proposed rule language, regulatory and backfit analysis data, and other
pertinent information were made available to the public on the
Internet, as announced in the Federal Register on February 15, 2002 (67
FR 7093). The NRC received feedback from stakeholders both through the
public meetings and the NRC's Web site. Address questions about our
rulemaking Web site to Carol Gallagher (301) 415-5905; e-mail
[email protected].
These interactions with stakeholders were a significant benefit to
the NRC in developing the language for the final rule in a manner to
ensure it is clearly understandable, will be consistently interpreted,
and does not result in unintended consequences. Many of the
stakeholders' comments directly resulted in changes. When a comment was
included in a provision, the comment is discussed in Section VI of this
document.
Many comments were received during the years the meetings were
held. The draft proposed rule language was changed and re-posted to the
Web numerous times.
Following the publication of the August 25, 2005 (70 FR 50442)
proposed rule, the NRC proposed a 4-month period to accept public
comment submissions. However, the NRC accepted comments for several
months after the proposed deadline for the submission of public
comments. These comments are discussed in Section V of this document.
The NRC also held several public meetings after the proposed rule
was published to increase stakeholder involvement in the rulemaking.
These meetings were held on September 21, 2005 (ADAMS Accession No.
ML052420363), November 7 and 9, 2005 (ADAMS Accession No. ML052990048),
December 15, 2005 (ADAMS Accession No. ML053400002), and March 29-30,
2006 (ADAMS Accession No. ML060650535).
II. Petitions and Request for Exemption
A. Petition for Rulemaking PRM-26-1
On December 30, 1993, Virginia Electric and Power Company (now
Dominion Virginia Power) submitted a Petition for Rulemaking (PRM-26-1)
requesting relaxation of the required 1-year audit frequency of
licensee FFD programs and the program elements of contractors and
vendors (C/Vs) that are relied upon by licensees. The petition
requested that the first sentence of former 10 CFR 26.80(a) be amended
to read:
Each licensee subject to this Part shall audit the fitness-for-
duty program nominally every 24 months * * *. In addition, audits
must be conducted, nominally every 24 months, of those portions of
fitness-for-duty programs implemented by contractors and vendors.
In a letter dated March 14, 1994, the NRC informed the petitioner
that the petition would be addressed in a proposed rulemaking that was
under development. The NRC has periodically communicated with the
petitioner regarding the status of this rulemaking since that time.
Section 26.41(b) of the final rule partially grants two aspects of
the petition. The required audit frequency for licensees and other
entities who are subject to 10 CFR Part 26 has been reduced from the
nominal 1-year frequency in the former rule to a nominal 2-year
frequency. Further, audits of C/V services that are performed on site
and under the direct daily supervision or observation of licensee
personnel will be conducted as part of the 2-year audits of the
licensee or other entity's FFD program, under Sec. 26.41(b).
Section 26.41(c)(1) of the final rule partially denies two aspects
of the petition. The nominal annual audit requirement for HHS-certified
laboratories has been retained. In addition, the annual audit
requirement has been retained for FFD program elements provided by C/Vs
whose personnel ``are off site or are not under the direct daily
supervision or observation of licensee personnel.''
The bases for these changes to the audit requirements in the rule
are addressed in the subsequent sections of this supplementary
information.
B. Petition for Rulemaking PRM-26-2
On September 28, 1999, Barry Quigley submitted a Petition for
Rulemaking (PRM-26-2) requesting that the NRC amend 10 CFR Parts 26 and
55 to establish clear and enforceable work hour limits to mitigate the
effects of fatigue for nuclear power plant personnel performing safety-
related work. The PRM was published for public comment on December 1,
1999, (64 FR 67202). As described in detail in Attachment 3 to SECY-01-
0113, the petition requested the NRC to:
(1) Add enforceable working hour limits to 10 CFR Part 26;
(2) Add a criterion to 10 CFR 55.33(a)(1) to require evaluation of
known sleeping disorders;
(3) Revise the NRC Enforcement Policy to include examples of
working hour violations that warrant various NRC sanctions; and
(4) Revise NRC Form 396 to include self-disclosure of sleeping
disorders by licensed operators.
The NRC received 176 comment letters in response to the petition.
The majority of the comments (157) were in favor of a rule. These
comments were principally from individuals and public interest groups.
Comments received from licensees, the Nuclear Energy Institute (NEI)
and Winston and Strawn, a law firm representing several utilities, were
opposed to PRM-26-2. A summary of the comments and responses is
available in SECY-01-0113 as Attachment 2. This document may be
obtained from the NRC's Web site, http://www.nrc.gov, by selecting the
electronic reading room and then collections of documents by type. It
is also available in the NRC's Agencywide Documentation and Management
[[Page 16969]]
System (ADAMS) under Package Accession Number ML010180224.
Although the NRC received many comments concerning the specific
requirements proposed in PRM-26-2, in general, letters in support of
the rulemaking--
(1) Cited the importance of ensuring that personnel who perform
safety-related functions are not impaired by fatigue;
(2) Expressed concern that the NRC does not have a regulation
limiting working hours and the perception that the NRC lacks the
authority to enforce the guidelines in the NRC's Policy on Worker
Fatigue;
(3) Asserted that the guidelines are ambiguous and that licensees
interpret the guidelines as not applicable when the plant is in an
outage;
(4) Asserted that ``the NRC appears to look the other way'' when
licensee work scheduling practices appear inconsistent with the
guidelines; and
(5) Expressed the concern that utility restructuring and cost
competition will cause reductions in staffing levels and increased
working hours and fatigue.
Further, several commenters noted that the Federal Government has
established work-hour limits for personnel in other industries and
suggested that similar limits should apply to nuclear power plant
workers.
In general, comments that opposed the petition expressed the
opinion that existing regulatory requirements (i.e., technical
specifications and 10 CFR Part 26) are adequate to ensure that
personnel are not impaired by fatigue, that the requirements would
impose an unnecessary and excessive burden that could not be justified
through a backfit analysis, and that industry performance data refute
the petitioner's argument that a rule is necessary to prevent fatigued
personnel from performing safety-related work.
The NRC evaluated the merits of PRM-26-2, the comments received in
response to the PRM, and assessed the Policy on Worker Fatigue. The NRC
concluded that the petitioner proposed a comprehensive set of
requirements that could reasonably be expected to effectively address
fatigue from individual and programmatic causes. However, the NRC
concluded that it is possible to achieve these objectives through
alternative requirements that are more flexible, more directly focused
on risk, and more aligned and integrated with current regulatory
requirements. Therefore, the final rule grants, PRM-26-2, in part. A
detailed discussion of the principal findings that led to the decision
to grant, in part, PRM-26-2 through rulemaking are included in Section
IV.D of this document. In addition, for item 3 of PRM-26-2, the NRC
revised Inspection Procedure (IP) 71130.08, ``Fitness For Duty
Programs'' on February 19, 2004, to reflect the requirements of Order
EA-03-038, dated April 29, 2003, which required compensatory measures
related to fitness-for-duty enhancements for security personnel at
nuclear power plants, including work hour limits. The NRC will
similarly revise this inspection procedure following issuance of the
final rule. The self-disclosure of sleeping disorders by licensed
operators (item 4) is being addressed by the NRC as a separate effort
from this rule through changes to Regulatory Guide 1.134, ``Medical
Evaluation of Licensed Personnel at Nuclear Power Plants.''
C. Request for Exemption Under 10 CFR 26.6
The former rule required random drug and alcohol testing for
personnel with unescorted access to the protected area of a nuclear
power plant. By letter dated March 13, 1990, the International
Brotherhood of Electrical Workers (IBEW) Local 1245 requested an
exemption from random testing for clerical, warehouse, and maintenance
workers at the Diablo Canyon Nuclear Power Plant (Diablo Canyon) under
the provisions of 10 CFR 26.6. The NRC denied the request and IBEW
Local 1245 sought judicial review. In 1992, the Ninth Circuit Court of
Appeals affirmed the NRC's denial of the request (IBEW, Local 1245 v.
NRC, No. 90-70647, 9th Cir., June 11, 1992). In its opinion, the court
said that random testing may well be impermissible for clerical workers
at Diablo Canyon who perform no safety-sensitive work and have no
access to vital areas. However, in the record before the court at that
time, IBEW Local 1245 had not established that such a group existed. On
January 26 and December 6, 1993, IBEW Local 1245 renewed its request
for exemption, specifically asking that the NRC exempt from 10 CFR Part
26 requirements for random drug testing, clerical employees at Diablo
Canyon who are members of Local 1245 of the IBEW and who have
unescorted access to the protected area (PA) only, but not to the
radiologically controlled areas (RCAs) or vital areas (VAs) and who are
not required to staff the plant's emergency response center (ERC). The
PA is the area inside the security fence of a nuclear power plant,
which surrounds the entire plant, and the immediately surrounding area,
whereas the VAs enclose key safety systems and are located within the
PA. The RCAs contain elevated levels of radiation or contamination and
are generally located within the PA. The ERC is located off site and is
where the licensee evaluates and coordinates licensee activities
related to an emergency, and communicates to Federal, State and local
authorities responding to radiological emergencies. The NRC requested
public comment on the issue in the Federal Register of May 11, 1994 (59
FR 24373). Comments were received from the nuclear industry, which
largely opposed a reduction in the scope of random testing, and from
elements of the IBEW, including Local 1245, which favored it. In SRM-
SECY-04-0229, dated January 10, 2005 (available on the NRC Web site at
http://www.nrc.gov/reading-rm/doc-collections/commission/srm/), the
Commission denied the IBEW exemption request because it--
(1) Would endanger the common defense and security (as a result of
increasing the likelihood of an insider threat); and
(2) Was not in the public interest (because reducing the scope of
random drug testing could increase the risk to public health and safety
due to a greater risk of both sabotage (insider threat due to
vulnerability to coercion) and of an accident (impaired worker)).
Consequently, this final rule maintains the former requirement for
random drug and alcohol testing for all personnel with unescorted
access to the PA at a nuclear power plant.
III. Abbreviations
The following abbreviations and acronyms are used in this Statement
of Considerations.
AEA Atomic Energy Act
ASDs Alcohol screening devices
BAC Blood alcohol concentration
CPL Conforming products list
C/V Contractor/vendor
DOT Department of Transportation
EAP Employee assistance program
EBT Evidential breath testing device
EPRI Electric Power Research Institute
FFD Fitness for duty
GC/MS Gas chromatography/mass spectrometry
HHS Department of Health and Human Services
IBEW International Brotherhood of Electrical Workers
ITAAC Inspections, Tests, Analyses, and Acceptance Criteria
KAs Knowledge and abilities
LOD Limit of detection
LOQ Limit of quantitation
mg/dL Milligrams per deciliter
MRO Medical Review Officer
NEI Nuclear Energy Institute
ng/dL Nanograms per deciliter
NHTSA National Highway Transportation Safety Administration
[[Page 16970]]
NRC Nuclear Regulatory Commission
NSF National Sleep Foundation
OMB Office of Management and Budget
PDFFDI Potentially disqualifying fitness-for-duty information
pH potential of hydrogen
POGO Project on Government Oversight
PROS Professional Reactor Operator Society
QA/QC Quality assurance/quality control
SAE Substance Abuse Expert
SAMHSA Substance Abuse and Mental Health Services Administration
SSNM Strategic special nuclear material
THC Tetrahydrocannabinol, delta-9-tetrahydrocannabinol-9-carboxylic
acid
UCS Union of Concerned Scientists
6-AM 6-acetylmorphine
IV. Discussion of Final Action
A. Overview
A review of FFD program experience confirms that the former
regulatory approach of 10 CFR Part 26 was fundamentally sound and
provided a means of deterrence and detection of substance abuse at
licensee facilities. FFD Program Performance Reports through 2005 are
published on the NRC's Web site, http://www.nrc.gov/reactors/operating/ops-experience/fitness-for-duty-programs/performance-reports.html.
Nonetheless, the NRC believes that revisions were needed to improve
the effectiveness and efficiency of FFD programs; enhance consistency
with advances in similar rules and guidelines, including HHS' Mandatory
Guidelines for Federal Workplace Drug Testing Programs (herein called
the HHS Guidelines) and other Federal drug and alcohol testing programs
that place similar requirements on the private sector; strengthen the
effectiveness of FFD programs at nuclear power plants in ensuring
against worker fatigue adversely affecting public health and safety and
the common defense and security by establishing clear and enforceable
requirements for the management of worker fatigue; enhance consistency
with the NRC's access authorization requirements; improve clarity in
the organization and language of the rule; and improve Part 26 by
eliminating or modifying unnecessary requirements.
B. Goals of the Rulemaking Activity
The NRC is amending 10 CFR Part 26, Fitness For Duty Programs. The
goals are to:
(1) Update and enhance the consistency of 10 CFR Part 26 with
advances in other relevant Federal rules and guidelines, including the
HHS Guidelines and other Federal drug and alcohol testing programs
(e.g., those required by the U.S. Department of Transportation [DOT])
that impose similar requirements on the private sector;
(2) Strengthen the effectiveness of FFD programs at nuclear power
plants in ensuring against worker fatigue adversely affecting public
health and safety and the common defense and security by establishing
clear and enforceable requirements for the management of worker
fatigue;
(3) Improve the effectiveness and efficiency of FFD programs;
(4) Improve consistency between FFD requirements and access
authorization requirements established in 10 CFR 73.56, as supplemented
by orders to nuclear power plant licensees dated January 7, 2003;
(5) Improve Part 26 by eliminating or modifying unnecessary
requirements;
(6) Improve clarity in the organization and language of the rule;
and
(7) Protect the privacy and other rights (including due process) of
individuals who are subject to Part 26.
Each of these goals is expected to result in substantial
improvements in FFD programs. Many changes in the final rule relate to
each goal. The major changes for each subpart and the reasons for those
changes are described in Section IV.C of this document. For each of the
many specific changes, detailed discussions are included in Section VI.
However, the following discussion provides a description of each goal,
a basis for the need to accomplish that goal, and several examples of
changes to the former rule that will contribute to meeting the goal.
Goal 1--Update and enhance the consistency of 10 CFR Part 26 with
advances in other relevant Federal rules and guidelines, including HHS
Guidelines and other Federal drug and alcohol testing programs (e.g.,
those required by the DOT that impose similar requirements on the
private sector.) Goal 1 is central to this rulemaking activity. Many
changes are included in the final rule to maintain consistency with
advances in the conduct of FFD programs, including changes in the HHS
Guidelines. The 1994, 1998, and 2004 revisions to the HHS Guidelines
differ substantially from the 1988 version of the HHS Guidelines, upon
which the former rule was based.
The President of the United States designated HHS as the agency
responsible for the Federal workplace drug testing program. HHS' SAMHSA
is responsible for maintaining the HHS drug testing guidelines based on
the most recent research and the accumulation of lessons learned from
the Federal drug testing program, as well as others who are regulated.
The NRC has historically relied on HHS to establish the technical
requirements for urine specimen collection, testing, and evaluation,
and has only deviated from HHS' guidelines for considerations that are
specific to the nuclear industry. Updating Part 26 to be consistent
with the most recent HHS Guidelines ensures that NRC regulations
continue to be scientifically and technically sound.
Further, the HHS-certified laboratories that Part 26 requires
licensees to use for drug testing are required by HHS to follow the HHS
Guidelines in order to retain their certification. Basing Part 26 on
older versions of the HHS Guidelines, or deviating from those
Guidelines, increases the cost of drug testing for the nuclear
industry. Therefore, updating Part 26 to increase consistency with the
HHS Guidelines not only ensures that Part 26 is based on the best
scientific and technical information available, but also avoids
imposing an unnecessary and costly regulatory burden on the nuclear
industry.
One example of an improvement from enhancing consistency with the
HHS Guidelines is that several cutoff levels for detection of various
drugs have been updated, including a revised lower cutoff level for the
marijuana metabolite THC. The lower cutoff level will provide greater
assurance that individuals who use marijuana are identified.
Additionally, a revision to the HHS Guidelines, published in the
Federal Register on April 13, 2004 (69 FR 19643) as a final rule,
includes requirements for specimen validity tests to determine whether
a urine specimen has been adulterated, diluted, or substituted. This
final rule adopts significant portions of the final HHS specimen
validity testing provisions. The new validity testing requirements will
substantially improve the effectiveness of the measures to guard
against subversion of the testing process that are contained in former
Part 26.
Several other provisions for drug testing are under consideration
by HHS and were published as a proposed rule for public comment in the
Federal Register on April 13, 2004 (69 FR 19672). One change to 10 CFR
Part 26 that is included from the proposed HHS Guidelines is permission
for licensees to use validity screening tests to determine whether a
urine specimen must be
[[Page 16971]]
subject to further testing at an HHS-certified laboratory because it
may have been adulterated, diluted, or substituted, in lieu of the
instrumented validity testing required in the April 13, 2004, final
version of the HHS Guidelines. Although the HHS Guidelines that would
permit Federal drug testing programs to use validity screening tests
for initial testing of urine specimens are not yet final, some NRC
licensees desired the flexibility to use these testing methods. A
technical basis for use of those methods is included in section VI.
However, the NRC is not including other provisions in the proposed HHS
Guidelines at this time. Those provisions include permitting the drug
testing of specimens other than urine (e.g., hair, saliva, sweat),
requirements for split specimen procedures for all specimens, and HHS
certification of instrumented initial test facilities, which would be
analogous to licensee testing facilities. Should such provisions be
included in final HHS Guidelines in the future, the NRC will consider
incorporating them into 10 CFR Part 26 at that time.
In addition to the changes to 10 CFR Part 26 that incorporate the
recent revisions to the HHS Guidelines, the DOT revised its Procedures
for Transportation Workplace Drug and Alcohol Testing Programs (49 CFR
Part 40, 65 FR 41944; August 9, 2001) to include the use of oral fluids
(i.e., saliva) as acceptable specimens for initial alcohol screening
tests. This final rule also reflects the new oral fluids testing
technology to provide FFD programs with increased flexibility in
administering initial alcohol tests.
Because the HHS Guidelines do not establish requirements for
alcohol testing, NRC relies on the DOT regulations, in part, to ensure
that the alcohol testing provisions of Part 26 remain scientifically
sound and legally defensible. Because the DOT programs test a much
larger number of individuals in comparison to the number of alcohol
tests that are conducted under Part 26, basing the NRC's alcohol
testing regulations on portions of the DOT regulations reflects the
lessons learned from that larger population.
Goal 2--Strengthen the effectiveness of FFD programs at nuclear
power plants in ensuring against worker fatigue adversely affecting
public health and safety and the common defense and security by
establishing clear and enforceable requirements for the management of
worker fatigue. This goal is central to this rulemaking activity.
Subpart I, Managing Fatigue, adds clear and enforceable requirements
for licensee management of worker fatigue to 10 CFR Part 26. The
requirements reduce the potential for worker fatigue and therefore,
strengthen the effectiveness of FFD programs at nuclear power plants
and substantially increase the protection of public health and safety
and the common defense and security. Section VI of this document
discusses the specific reasons for each worker fatigue provision.
Section IV.D provides a detailed discussion of the overall basis for
establishing fatigue management requirements for FFD programs, and the
benefits expected to result.
Goal 3--Improve the effectiveness and efficiency of FFD programs.
The NRC has gained experience in the actual implementation of FFD
programs since Part 26 was originally promulgated. The NRC is making
many changes throughout Part 26 based on that experience in order to
improve the industry's programs, specifically to increase both the
effectiveness of the programs in achieving the goals of Part 26 and the
efficiency of program operations. Increasing the effectiveness and
efficiency of FFD programs will enhance the protection of public health
and safety and the common defense and security.
One example of a change related to Goal 3 is the reduction in the
period within which pre-access testing must be performed from 60 days,
in former Sec. 26.24(a)(1), to 30 days or less, in Subpart C [Granting
and Maintaining Authorization]. This change improves the effectiveness
of the pre-access test in detecting drug and alcohol use by individuals
who are applying for authorization to have the types of access or
perform the duties that require them to be subject to Part 26. Reducing
the number of breath specimens required for alcohol testing from two
each for initial and confirmatory testing, in former Section 2.4(g)(18)
in Appendix A to Part 26, to one specimen for the initial test and one
for the confirmatory test also increases the efficiency of FFD programs
without compromising the accuracy and validity of alcohol test results.
Another example of rule changes related to Goal 3 is establishing a
regulatory framework for the management of worker fatigue that
appropriately balances the need for flexibility to manage plant
exigencies with the need for more readily enforceable requirements and
efficient NRC oversight of licensee compliance with the requirements
and performance objectives of the rule.
Goal 4--Improve consistency between FFD requirements and the access
authorization requirements established in 10 CFR 73.56, as supplemented
by orders to nuclear power plant licensees dated January 7, 2003. Part
26 and the access authorization requirements each contain provisions
that require establishing the trustworthiness and reliability of
personnel before granting unescorted access to the protected areas of
nuclear power plants. The NRC determined that, because both sets of
requirements share this same goal, revising Part 26 was necessary to
clarify the relationship between these requirements, particularly for
licensee access authorization decisions regarding personnel who move
between sites with some interruption in their status of having
unescorted access to a nuclear power plant. In addition, some
requirements in former Part 26 addressed the granting of temporary
unescorted access. In response to the terrorist attacks of September
11, 2001, on the World Trade Center and the Pentagon, and the current
threat environment, the Commission took action to curtail the use of
temporary unescorted access at commercial nuclear power plants.
Temporary unescorted access was eliminated by orders issued January 7,
2003, which imposed enhancements to existing access authorization
programs. Therefore, it was necessary to revise the related provisions
in Part 26.
Goal 5--Improve 10 CFR Part 26 by eliminating or modifying
unnecessary requirements. The final rule incorporates a number of
changes to eliminate or modify unnecessary requirements. The experience
NRC has gained over the years since Part 26 was promulgated has
enhanced the agency's understanding of implementation issues
experienced by the industry, and the NRC is now eliminating or
modifying some provisions, while at the same time maintaining
protection of public health and safety and the common defense and
security.
For example, because of inconsistencies in how licensees
interpreted the FFD and access authorization requirements for
conducting employment inquiries, many licensees contacted an
individual's previous employers twice--once to obtain the information
required under Part 26 and once to obtain the information required for
access authorization. The revisions to Part 26 clarify that licensees
may obtain information to satisfy FFD suitable inquiry requirements and
related access authorization requirements at the same time when
conducting an employment inquiry.
[[Page 16972]]
Goal 6--Improve clarity in the organization and language of the
rule. The final rule is organized to facilitate implementation, as
compared to the former rule, which has generated many questions from
licensees. Therefore, in the final rule, the NRC has substantially
reorganized the requirements to eliminate redundancies, to group
related requirements, and to present requirements in the order in which
they apply to licensees' FFD processes. In addition, the NRC has made
many language changes to improve clarity. This substantial
reorganization, which substantially reduces the likelihood of
variations in FFD programs across the industry through differing
interpretations of the rule, improves the protection of public health
and safety and the common defense and security. The final rule is
clearer in both organization and language, and is expected to result in
more uniform implementation, and, consequently, more consistency in
achieving the Part 26 goals.
In contrast to certain NRC regulations, Part 26 includes a
considerable number of detailed requirements. In the public meetings
held during the development of the final rule, industry representatives
indicated that they consider this level of detail necessary to help
protect individual privacy and ensure consistency in implementing the
requirements. Additionally, industry representatives indicated that
this high level of detail can help to avoid unnecessary litigation
between licensees and individual personnel regarding worker non-
compliance with specific drug and alcohol testing performance steps.
Such litigation would be more likely if those specific performance
steps were not required by NRC rule. The level of detail and the
enhanced clarity in the new language and organization included in Part
26 have eliminated the need for a guidance document for provisions
pertaining to drug and alcohol testing. Industry representatives
commented that a guidance document would not have the same weight as a
rule, and that both licensees and individuals should be protected fully
with rigor and specificity in a rule. Therefore, industry desired the
rule to be more specific and detailed, in lieu of a guidance document.
Goal 7--Protect the privacy rights and other rights (including due
process) of individuals who are subject to 10 CFR Part 26. This goal
was an implicit objective of the former rule, and the final rule
continues to protect the privacy and other rights of individuals
(including due process) who are subject to 10 CFR Part 26. The NRC,
DOT, and HHS have all gained experience in implementing workplace drug
and alcohol testing programs. This experience has led the DOT and HHS
to modify many of their requirements for such testing to more clearly
protect privacy and other rights of individuals. Many of the changes to
Part 26 related to this goal are based on either DOT or HHS
requirements. The NRC believes the protection of individual rights to
be of the highest importance and is making changes to Part 26 to ensure
that those rights are protected through rule language developed using
the best available information. One example of such a change is that
the final rule prohibits any testing of ``Bottle B, the second portion
of a split urine specimen, or retesting an aliquot of a specimen''
without the donor's permission.
C. Overview of Final Rule
The final rule is divided into subparts that contain related
requirements. Each subpart is assigned a descriptive title to aid users
in locating rule provisions and to simplify cross-referencing within
the final rule. By grouping related requirements and presenting them
generally in the order in which they apply to licensees' and other
entities' FFD processes, the final rule improves the ease of
implementing the rule. For example, the final rule adds Subpart K [FFD
Programs for Construction] to consolidate FFD requirements for new
reactor construction. Also, the provisions that were contained in
Subparts J [Recordkeeping and Reporting Requirements] and K
[Inspections, Violations, and Penalties] of the proposed rule are now
contained in Subparts N and O, respectively, of the final rule.
The major topics addressed in each subpart and the reasons that the
NRC made major changes to the former rule are described below. A
detailed cross-reference table between the former and final Part 26
provisions is included at the end of this notice.
Subpart A Administrative Provisions
The first subpart, Subpart A, replaces the General Provisions
portion of the former rule, but continues to address the same subject
matter. Thus, Subpart A addresses the purpose and scope of the rule,
provides definitions of important terms used in the final rule, and
updates former provisions related to requests for specific exemptions,
interpretations of the rule, and communications with the NRC. The final
rule also adds a section to Subpart A that consolidates FFD program
applicability requirements for categories of individuals.
Subpart B Program Elements
Subpart B of the final rule reorganizes and amends former
Sec. Sec. 26.10 through 26.29. These sections of the former rule
specified the performance objectives that FFD programs were required to
meet and the FFD program elements that licensees and other entities
were required to implement to meet the performance objectives. However,
the final rule does not include former Sec. 26.27 [Management actions
and sanctions to be imposed] in Subpart B for two reasons. First, the
final rule is reorganized to be consistent with the order in which
licensees and other entities implement their programs. Because Subpart
B is focused on establishing the framework of FFD programs, it would be
premature to present requirements related to implementing the FFD
program (i.e., imposing sanctions on an individual for violating the
FFD policy) at this point in the rule. Second, the subject matter of
former Sec. 26.27 is sufficiently important and complex that a
separate subpart is warranted. Therefore, the final rule presents
requirements related to management actions and sanctions in Subpart D
[Management Actions and Sanctions to be Imposed].
Subpart C Granting and Maintaining Authorization
Subpart C of the final rule substantially amends former FFD
requirements related to the process that licensees and other entities
must follow in determining whether an individual is trustworthy and
reliable, as demonstrated by avoiding substance abuse, and can be
expected to perform his or her job duties safely and competently. The
final rule introduces the concept of (authorization( to Part 26 to
refer to the status of an individual who the licensee or other entity
has determined can be trusted to avoid substance abuse, and, therefore,
may be permitted to have the types of access or perform the duties
described in Sec. 26.4 [FFD program applicability to categories of
individuals], as a result of the process described in this subpart. For
example, in the case of nuclear power plant personnel, a licensee may
permit an individual who is ``authorized'' under Part 26 to have
unescorted access to protected areas in nuclear power plants if the
individual's job requires such access.
The NRC has published other requirements, such as 10 CFR 73.56,
that establish additional steps that licensees and other entities must
take as part of the process of determining whether to grant unescorted
access to an
[[Page 16973]]
individual or permit an individual to maintain unescorted access to
protected areas. These additional requirements focus on aspects of an
individual's character and reputation other than substance abuse, and,
among other steps, require the licensee or other entities who are
subject to the rule to conduct a psychological assessment of the
individual, perform a credit and criminal history check, and interview
individuals who have knowledge of the applicant for authorization.
However, historically there have been some inconsistencies and
redundancies between the Part 26 requirements related to granting and
maintaining unescorted access and the other related regulations,
particularly the NRC's access authorization requirements for nuclear
power plant personnel. The inconsistencies have led to many
implementation questions from licensees, as well as inconsistencies in
how licensees have implemented the requirements. The redundancies have
imposed an unnecessary burden on licensees in other cases. Therefore, a
central goal of adding Subpart C to the final rule is to eliminate
those inconsistencies and redundancies to ensure that licensees and the
other entities who are subject to the rule have clear and easily
interpretable requirements to follow when determining whether to grant
or maintain an individual's unescorted access under Part 26 and also
under other, related requirements, including, but not limited to, the
January 7, 2003 access authorization orders issued by the NRC to
nuclear power plant licensees.
The requirements in Subpart C are based on several fundamental
changes to the NRC's approach to the authorization requirements in
former Part 26. The primary concern, which Subpart C is designed to
address, is the necessity of increasing the rigor of the authorization
process to provide reasonable assurance that any individual who is
granted and maintains authorization is trustworthy and reliable, as
demonstrated by avoiding substance abuse. The necessity for increased
rigor in the authorization process is discussed in Section VI of this
document with respect to Sec. 26.23(a) in terms of the increased
insider threat since the terrorist attacks of September 11, 2001. One
change to former Part 26 authorization requirements that reflects this
concern is the elimination of temporary access authorization
requirements in the second sentence of former Sec. 26.27(a)(4). Other
changes are discussed in Section VI with respect to the specific
provisions that incorporate them.
A second, related change to the NRC's approach to authorization
requirements, which has informed Subpart C, is an increased concern
with the sharing of information about individuals between licensees and
other entities. At the time the former Part 26 was developed, the
industry structure was different and personnel transfers between
licensees (i.e., leaving the employment of one licensee to work for
another licensee) with interruptions in authorization were less common.
Most licensees operated plants at a single site and maintained an FFD
program that applied only to that site. When an individual left
employment at one site and began working for another licensee, the
individual was subject to a different FFD program that often had
different requirements. Because some licensees were reluctant to share
information about previous employees with the new employer, licensees
often did not have access to the information the previous licensee had
gathered about the individual and were required to gather the necessary
information again. The additional effort to collect information that
another licensee held created an unnecessary burden on both licensees.
But, because few individuals transferred, the burden was not excessive.
However, since 1989, the industry has undergone significant
consolidation and developed new business practices to use its workforce
more efficiently. Industry efforts to better use expertise and staffing
resources have resulted in the development of a large transient
workforce within the nuclear industry that travels from site to site as
needed, such as roving outage crews. Although the industry has always
relied on C/Vs for special expertise and staff for outages, the number
of transient personnel who work solely in the nuclear industry has
increased and the length of time they are on site has decreased.
Because the former FFD regulations were written on the basis that
individual licensees would maintain independent, site-specific FFD
programs and shared limited information, and that the majority of
nuclear personnel would remain at one site for years, the former
regulations did not adequately address the transfer of personnel
between sites.
These changes in the industry have increased the need for
information sharing among licensees and C/Vs. The increased insider
threat since September 11, 2001, has also heightened the need for
information sharing among licensees and C/Vs to ensure that licensees
and other entities have information that is as complete as possible
about an individual when making an authorization decision. To address
this need, the access authorization orders issued by the NRC to nuclear
power plant licensees on January 7, 2003, mandated increased sharing of
information. In addition, Subpart C requires licensees and other
entities to collect and share greater amounts of information than under
the former rule, subject to the protections of individuals' privacy
that are specified in Sec. 26.37 [Protection of information]. As a
result, individuals who are subject to the rule will establish a
detailed ``track record'' within the industry that will follow them if
they change jobs and move to a new position that requires them to be
granted authorization by another licensee or entity who is subject to
the rule. This increased information sharing contributes to providing
reasonable assurance that individuals who are granted and maintain
authorization under Part 26 are trustworthy and reliable when
individuals move between FFD programs.
However, a consequence of increased information sharing is that one
violation of any licensee's FFD policy has greater potential to end an
individual's career. Although an individual who has an active substance
abuse problem cannot be permitted to have unescorted access to
protected areas, the NRC continues to affirm that individuals who
pursue treatment, stop abusing drugs or alcohol, and maintain sobriety
for an extended period of time should regain the public's trust. The
length of time that an individual must maintain sobriety in order to
demonstrate that he or she can again be trusted with the public's
health and safety and the common defense and security has been a matter
of debate since Part 26 was originally under development. However, the
research literature continues to indicate that individuals who maintain
sobriety past the first 3 years following treatment have substantially
reduced recidivism rates (i.e., relapsing into substance abuse) than
during the first 3 years after treatment. There is also a further drop
in recidivism rates after 5 years of sobriety.
Despite these research findings, some individuals who have had one
confirmed positive test result have been prevented from working in
operating nuclear power plants. The increased information sharing
required under Subpart C has the potential to result in a greater
number of these individuals being banned from working in the industry.
Therefore, the NRC has added several requirements to Subpart C to
[[Page 16974]]
minimize these consequences for individuals who are able to demonstrate
that they are effectively coping with a substance abuse problem.
Additional requirements for protecting information to be gathered about
individuals under Part 26 are specified in Sec. 26.37. The detailed
changes to former requirements are discussed in Section VI with respect
to the specific provisions that incorporate these requirements.
In general, the authorization requirements in Subpart C are
structured according to whether an individual who has applied for
authorization has previously held authorization under Part 26. If an
individual has not established a ``track record'' in the industry, the
final rule requires licensees and other entities to meet an extensive
set of requirements before granting authorization to the individual. If
an individual has established a favorable track record in the industry,
the amount of original information gathering that the final rule
requires licensees and other entities to complete before granting
authorization to the individual is reduced. The need for original
information gathering in these instances is reduced because licensees
and other entities will have access to all of the information that
previous FFD programs have collected about the individual under the
final rule.
For individuals who have established a favorable track record in
the industry, the steps that licensees and other entities are required
to complete in order to grant authorization to an individual also
depends upon the length of time that has elapsed since the individual's
last period of authorization was terminated and the amount of
supervision to which the individual was subject during the
interruption. (The term ``interruption'' refers to the interval of time
between periods during which an individual holds authorization under
Part 26.) In general, the more time that has elapsed since an
individual's last period of authorization ended, the more steps that
the final rule requires licensees and other entities to complete before
granting authorization to the individual. However, if the individual
was subject to behavioral observation under a Part 26 program or
continued to be subject to random drug and alcohol testing during the
interruption, the final rule requires licensees and other entities to
complete fewer steps in order to grant authorization to the individual.
There are several reasons that the final rule requires fewer steps in
the authorization process for these individuals.
First, individuals who have established a favorable work history in
the industry have demonstrated their trustworthiness and reliability
from previous periods of authorization, so they pose less potential
risk to public health and safety and the common defense and security
than individuals who are new to the industry. Much is known about these
individuals. Not only were they subject to the initial background
screening requirements before they were initially granted
authorization; but, while they were working under a Part 26 program,
they were watched carefully through on-going behavioral observation,
repeatedly attained negative results from random drug and alcohol
tests, and demonstrated the ability to consistently comply with the
many procedural requirements that are necessary to perform work safely
at operating power reactor facilities.
Second, individuals who have established a favorable work history
in the industry and whose authorization has been interrupted for only a
short period are unlikely to develop an active substance abuse problem
during the interruption. The shorter the period of time since the
individual's last period of authorization ended, the less likely it is
that the individual has developed an active substance abuse problem or
undergone other significant changes in lifestyle or character that
would diminish his or her trustworthiness, reliability, and ability to
perform work safely and competently.
Further, if the individual was also subject to supervision under
some elements of a Part 26 program (e.g., behavioral observation, a
requirement to report any arrests, random drug and alcohol testing)
during the period that his or her authorization was interrupted, the
higher the assurance that the individual does not have an active
substance problem. And, it is less likely that the individual could
have undergone significant changes in lifestyle or character that would
be undetected.
Therefore, the final rule establishes categories of requirements
for granting authorization to an individual that vary, based upon
whether the individual has previously held authorization under Part 26;
whether the individual's last period of authorization was terminated
favorably or unfavorably; how long it has been since the individual
last held authorization under Part 26; and whether the individual was
subject to any elements of a Part 26 program during the interruption
period. Section 26.55 [Initial authorization] establishes authorization
requirements for individuals who have not previously held authorization
under Part 26 and individuals who have not held authorization within
the past 3 years. Section 26.57 [Authorization update] establishes
authorization requirements for individuals who previously held
authorization under Part 26, whose last period of authorization was
terminated favorably more than 1 year ago but less than 3 years ago.
Section 26.59 [Authorization reinstatement] establishes authorization
requirements for individuals who previously held authorization under
Part 26 and whose last period of authorization was terminated favorably
within the past year. Section 26.69 [Authorization with potentially
disqualifying fitness-for-duty information] defines the steps that
licensees and other entities must take in granting authorization to an
individual about whom potentially disqualifying FFD information has
been disclosed or discovered.
The time periods used to establish these categories of
authorization requirements are consistent with the categories
established in the access authorization orders issued by the NRC to
nuclear power plant licensees on January 7, 2003. Basing the
requirements on elapsed time is consistent with the programs of other
Federal agencies who have similar needs to control access to sensitive
information and protected areas. In addition, these time periods have
been used successfully within nuclear power plant access authorization
programs since 1989 and have met the NRC's goal of ensuring that
individuals who are granted unescorted access are trustworthy and
reliable. Therefore, the final rule incorporates these time periods
within Part 26.
In general, the steps that are required under this part to grant
authorization to an individual who has recently held authorization and
whose most recent period of authorization was terminated favorably are
less extensive than the steps required for applicants for authorization
who are new to the industry or those who have not recently held
authorization. In addition, the NRC has strengthened the requirements
for a rigorous evaluation process contained in the former Sec.
26.27(e) that licensees and other entities are required to meet before
granting authorization to an individual about whom potentially
disqualifying FFD information has been disclosed or discovered (see
Sec. 26.69). The final rule requires licensees and other entities to
obtain and review a written self-disclosure from the applicant and an
employment history, and ensure that a suitable inquiry and pre-access
drug and alcohol testing are completed before granting authorization to
an individual,
[[Page 16975]]
with certain exceptions. The exceptions to the self-disclosure and
employment history, suitable inquiry, and pre-access testing
requirements are specified in Sec. Sec. 26.61 [Self-disclosure and
employment history], 26.63 [Suitable inquiry], and 26.65 [Pre-access
drug and alcohol testing], respectively. The final rule also requires
licensees and other entities to ensure that applicants are subject to
random testing, as specified in Sec. 26.67 [Random drug and alcohol
testing of individuals who have applied for authorization].
Subpart D Management Actions and Sanctions
Subpart D of the final rule replaces former Sec. 26.27(b) and (c)
and divides the former provisions into two separate sections that
specify requirements for responding to FFD policy violations in Sec.
26.75 [Sanctions], and indications of impairment in Sec. 26.77
[Management actions regarding possible impairment]. The final rule adds
a new Sec. 26.73 [Applicability] to specify the entities and
individuals to whom the requirements of the subpart apply. The former
rule has been reorganized to generally reflect the order in which the
requirements apply to licensees' and other entities' FFD processes, and
to group related requirements into separate sections. Therefore, the
NRC has made these changes to meet Goal 6 of this rulemaking to improve
clarity in the organization and language of the rule.
In general, subpart D includes three significant changes from the
related provisions in the former rule that are each intended to provide
a stronger deterrent to engaging in the unwanted actions specified in
the subpart. First, the final rule increases the severity of the
minimum sanctions that are required if an individual violates a
licensee's or other entity's FFD policy. The more stringent sanctions
are necessary in order to strengthen the effectiveness of the rule in
providing reasonable assurance that individuals who are subject to this
part are trustworthy and reliable, as demonstrated by avoiding
substance abuse, and by increasing the assurance that only individuals
who are fit for duty are permitted to have the types of access or
perform the duties listed in Sec. 26.4.
Second, the final rule requires licensees and other entities who
are subject to the rule to impose the same sanctions for an FFD
violation involving the abuse of alcohol as required for the abuse of
illegal drugs. Impairment caused by alcohol abuse creates a risk to
public health and safety that is fundamentally similar to the risk
posed by the use of illegal drugs. However, some licensees have imposed
lesser sanctions for alcohol violations, an approach that is
inconsistent with the NRC's intent. Therefore, the final rule rectifies
this situation by explicitly requiring the same minimum sanctions for
abuse of alcohol as formerly required for the use of illegal drugs.
Third, the final rule adds the sanction of permanent denial of
authorization for any individuals who subvert or attempt to subvert the
testing process. The former rule permitted licensees and other entities
to have flexibility in establishing sanctions for actions such as
refusing to submit to testing and attempting to subvert the testing
process by submitting an adulterated or substitute specimen. As a
result, different FFD programs imposed different sanctions and some
individuals were granted authorization or permitted to maintain
authorization when they committed such acts. However, acts to defeat
the testing process indicate that an individual is not trustworthy and
reliable, and suggest that the individual may be engaging in substance
abuse that could pose a risk to public health and safety and the common
defense and security. Therefore, the final rule establishes a minimum
sanction that all FFD programs must impose to deter attempts to subvert
the testing process, as well as provide reasonable assurance that
individuals who are granted and maintain authorization can be trusted
to comply with the rules and regulations to which they are subject.
These three changes have been made to meet Goal 3 of this
rulemaking to improve the effectiveness of FFD programs. The NRC has
made other changes to former Sec. 26.27(b) and (c) in subpart D
primarily to eliminate or modify unnecessary requirements and clarify
the intent of former provisions.
Subpart E Collecting for Testing
Subpart E of the final rule reorganizes and amends the requirements
related to collecting specimens for drug and alcohol testing that were
contained in former Sec. 26.24 [Chemical and alcohol testing] and
interspersed throughout former Appendix A to Part 26. The subpart
groups the related requirements and presents them in the order in which
they would be implemented by FFD programs. The final rule also
eliminates some redundancies in the provisions of the former rule that
were related to specimen collections. The NRC has made these changes to
meet Goal 6 of the rulemaking to improve clarity in the organization
and language of the rule.
In general, the procedures in this subpart are more detailed than
those in Appendix A to the former rule and NRC regulations that are
based on a risk-informed, performance-based approach, for several
reasons. First, the more detailed procedures in subpart E will increase
the consistency of Part 26 drug and alcohol specimen collection
procedures with those of other Federal agencies and therefore, take
advantage of the scientific and technical advances that have been made
in workplace drug and alcohol testing programs since the former Part 26
was promulgated, as discussed in Section IV.B of this document. Second,
the final rule permits FFD programs to accept and rely upon other FFD
programs that are implemented under this part, as well as the programs
of other Federal and State agencies, to a much greater extent than is
permitted under the former rule. The permission to rely on other
programs improves the effectiveness and efficiency of FFD programs
(Goal 3 of the rulemaking) and improves the rule by eliminating or
modifying unnecessary requirements (Goal 5 of the rulemaking). For
example, under Sec. 26.69(b)(6), the final rule permits licensees and
other entities to rely on another Part 26 program's drug and alcohol
followup testing of an individual who has violated an FFD policy and is
consequently required to have at least 15 followup tests within the 3-
year period following the violation, and is transferring from one
licensee's site to another.
The final rule requires the receiving licensee or entity to
continue the followup testing program. However, the final rule permits
the licensee or other entity to accept the followup testing that was
completed by the previous FFD program when determining the remaining
number of followup tests to which the individual must be subject and
the period of time during which the individual must continue to be
subject to followup testing. Therefore, because the final rule permits
this reliance on other programs, more detailed requirements for
conducting the activities on which other FFD programs may rely,
including drug and alcohol testing, are necessary to provide greater
assurance that all Part 26 programs meet minimum standards. Third, the
final rule incorporates a greater level of detail in the specimen
collection procedures of the final rule for the reasons discussed in
Section IV.B.
The NRC has made other major changes to the former rule's
requirements for collecting specimens for drug and alcohol testing to
incorporate specimen validity testing
[[Page 16976]]
requirements from the HHS Guidelines into Part 26 (Goal 1 of this
rulemaking) and modify former alcohol testing requirements to improve
the efficiency of FFD programs (Goal 3 of the rulemaking), while
continuing to protect or enhance individuals' rights to privacy and due
process under the rule (Goal 7 of the rulemaking).
Subpart F Licensee Testing Facilities
Subpart F of the final rule presents detailed requirements for
conducting initial urine specimen validity and drug tests at licensee
testing facilities, as permitted in Sec. 26.24(d)(1) of the former
rule and Sec. 26.31(d)(3)(ii) of the final rule. The subpart is
entitled, ``Licensee Testing Facilities,'' for brevity, but permits
other entities who are subject to the rule to establish and operate
drug testing facilities under the final rule.
The NRC has added this subpart to the final rule to group together
in a single subpart the rule's requirements that are related to
licensee testing facilities, which were intermixed with requirements
related to drug testing at HHS-certified laboratories in Appendix A to
Part 26 in the former rule. The final rule presents the requirements
that are applicable to licensee testing facilities and HHS-certified
laboratories in two separate subparts because the provisions of the
former rule were not always clear with respect to which requirements
applied to which type of testing facility. Also, the final rule
includes the requirements that apply to both types of facilities in
both subparts so that it is unnecessary for licensees and other
entities who do not operate licensee testing facilities to be concerned
with any provisions in subpart F. Although many of the requirements in
this subpart are redundant with similar requirements in subpart G
[Laboratories Certified by HHS], these changes meet Goal 6 of this
rulemaking to improve clarity in the organization and language of the
rule.
The most important change in subpart F to the former requirements
for licensee testing facilities is the addition of new requirements for
licensee testing facilities to conduct initial urine specimen validity
testing, based on similar provisions contained in the most recent
revision to the HHS Guidelines (69 FR 19643; April 13, 2004). The
reasons for requiring initial urine specimen validity testing are
discussed with respect to Sec. 26.31(d)(3)(ii). The NRC believes that
it is necessary for licensee testing facilities to conduct specimen
validity testing because Part 26 permits licensees and other entities
to make authorization decisions based on initial drug test results from
such facilities. Thus, the rule permits licensees and other entities to
grant authorization to an individual who has negative initial test
results from pre-access testing without further analysis of the urine
specimen by an HHS-certified laboratory. If the initial test results
from the licensee testing facility are inaccurate because the urine
specimen was adulterated or substituted, the licensee or other entity
could grant authorization to an individual who poses a risk to public
health and safety and the common defense and security. Similarly, if an
individual who has been selected for random testing submits an
adulterated or substituted specimen that is not detected by initial
tests at the licensee testing facility, the individual would be
permitted to maintain authorization if the results of drug testing are
negative. Therefore, in order to increase the likelihood that
individuals who may be using drugs and attempting to defeat the testing
process are detected, and to ensure that they are not permitted to be
granted or maintain authorization, the NRC has concluded that it is
necessary to require licensee testing facilities to conduct urine
specimen validity tests.
However, in consideration of the increased costs and burden that
are associated with instrumented initial validity testing, subpart F
permits licensee testing facilities to use commercially available
validity screening tests of urine specimens, which may be a less
expensive alternative than the instrumented initial validity tests
required in the current HHS Guidelines. As discussed in Section VI with
respect to Sec. 26.5 [Definitions], the final rule uses the term
``validity screening test'' to refer to these commercially available
tests. The term ``initial validity test'' refers to instrumented
validity testing.
At the same time that the HHS published its regulations to require
specimen validity testing, which have been incorporated in the final
rule, HHS also published a proposed revision to the Guidelines (69 FR
19673; April 13, 2004) that would permit the use of validity screening
devices for the detection of substitution and the presence of
adulterants in urine specimens. These devices include non-instrumented
devices with visually-read endpoints as well as semi-automated or
automated instrumented testing devices with machine-read end points.
Specimen validity tests conducted with these devices use colorimetric
assays, which is the same scientific principle as the initial tests
conducted at HHS-certified laboratories. Non-instrumented specimen
validity devices for urine testing have been shown to detect
adulterants in urine specimens and creatinine concentrations on tests
that were conducted on specimens that were spiked with drug analytes.
However, the results from the preliminary studies are variable.
Therefore, the proposed HHS Guidelines include extensive performance
testing requirements for these devices, which subpart F also
incorporates. Such performance testing is necessary to ensure that
validity test results based on using these devices are accurate.
Subpart G Laboratories Certified by the Department of Health and Human
Services
Subpart G presents together in a single subpart requirements
related to the HHS-certified laboratories that are used by licensees
and other entities who are subject to Part 26 for validity and drug
testing. The requirements in this subpart group together the former
requirements in Appendix A to Part 26 as they relate to HHS-certified
laboratories. However, the final rule updates the former requirements
to be consistent with the HHS Guidelines that were published in the
Federal Register on April 13, 2004 (69 FR 19643). The most important
changes to the former rule's requirements for HHS-certified
laboratories are the incorporation of extensive requirements for urine
specimen validity testing.
Subpart H Determining Fitness-for-Duty Policy Violations and
Determining Fitness
Subpart H in the final rule reorganizes, clarifies, and enhances
former requirements related to the decisions that medical review
officers (MROs) and other healthcare professionals must make under Part
26 to provide input to licensees' and other entities' management
decisions with respect to granting and permitting an individual to
maintain authorization under Subpart C and also with respect to
imposing sanctions and taking actions to prevent an individual from
performing duties that require an individual to be subject to this part
under Subpart D. The former requirements, which were interspersed
throughout the rule, are grouped together in Subpart H to make them
easier to locate within the final rule, consistent with Goal 6 of this
rulemaking to improve clarity in the organization and language of the
rule. The subpart also makes several significant changes to the former
requirements.
In general, Subpart H includes more detailed requirements for
determining
[[Page 16977]]
FFD policy violations and conducting determinations of fitness than
were included in the former rule. The NRC has added these more detailed
requirements in response to implementation questions that the NRC has
received from licensees since Part 26 was first promulgated, lessons
learned from NRC inspections of FFD programs, and the experience of
other Federal agencies that similarly require workplace drug and
alcohol testing. However, the NRC's primary concern in establishing
more detailed requirements is to enhance the consistency in how FFD
policy violations and fitness are determined among Part 26 programs.
The final rule permits licensees and other entities to rely on the
determinations made by other Part 26 programs to a greater extent than
the former rule. For example, Sec. 26.63(b) of the final rule permits
licensees and other entities to rely upon a previous licensee's or
other entity's determinations of fitness, as well as their reviews and
resolutions of potentially disqualifying FFD information, from previous
periods of authorization. The reasons for adding these permissions were
discussed previously in this section, with respect to Subpart C.
However, to ensure that all licensees' and other entities'
determinations of FFD policy violations and fitness can be relied upon
by other FFD programs, it is necessary to enhance the former
requirements and establish clear minimum standards for those processes.
Therefore, the subpart includes greater detail to meet Goal 3 of this
rulemaking to improve the effectiveness and efficiency of FFD programs.
Under the final rule, licensees and other entities continue to be
prohibited from imposing sanctions on an individual who has a positive
confirmatory drug test result from testing at the HHS-certified
laboratory until the MRO has had an opportunity to discuss the result
with the individual and determines that there is no legitimate medical
explanation for the positive result(s). The final rule extends this
requirement to the review of positive confirmatory validity test
results, consistent with the addition of requirements to conduct
validity testing throughout the final rule, as discussed in Section VI
with respect to Sec. 26.31(d)(3)(I). An MRO review of adulterated or
substituted validity test results from an HHS-certified laboratory
before a licensee or other entity imposes sanctions on an individual is
necessary for the same reasons that an MRO review is required of
positive drug test results. That is, there may be legitimate medical
reasons for the adulterated or substituted test result and the test
result may not indicate that the donor has violated the FFD policy,
which in this case would mean that he or she has not attempted to
subvert the testing process. The NRC added a requirement for the MRO to
review adulterated or substituted validity test results to meet Goal 7
of this rulemaking to protect the privacy and other rights (including
due process) of individuals who are subject to Part 26 and ensure that
the individuals are afforded accurate and consistent testing. The HHS
Guidelines also require the MRO to review adulterated and substituted
validity test results. Therefore, adding this requirement to the final
rule also meets Goal 1 of this rulemaking to update and enhance the
consistency of Part 26 with advances in other relevant Federal rules
and guidelines.
Another significant change that the final rule makes to former
requirements is the establishment of a new position within FFD
programs--the ``substance abuse expert'' (SAE). The SAE is responsible
for performing a determination of fitness, which is determining whether
there are indications that an individual may be in violation of the
licensee's or other entity's FFD policy or is otherwise unable to
safely and competently perform his or her duties, in those instances in
which an individual may not be fit for duty for reasons related to drug
or alcohol abuse. The NRC has added the SAE position for several
reasons.
First, some MROs who provide services under Part 26 have indicated
that they do not feel qualified to assess the presence and severity of
substance abuse disorders, make treatment recommendations, and
determine when an individual who has had a substance abuse disorder may
again be able to safely and competently perform duties under this part.
The focus of MRO responsibilities under Part 26 and other Federal
workplace drug testing programs is on the medical evaluation of
positive, adulterated, substituted, or invalid test results, which
requires a knowledge of substance abuse. However, some MROs do not have
the extensive knowledge of substance abuse disorders that is necessary
to make determinations of fitness and treatment recommendations as
required under this part. Therefore, the final rule permits MROs to
serve as SAEs if they meet the qualifications for this role that are
established in this subpart. But, the rule requires licensees and other
entities to rely on other healthcare professionals who have the
necessary qualifications to conduct determinations of fitness if the
MRO does not meet the SAE qualification requirements.
Second, the NRC believes that healthcare professionals other than
licensed physicians may have the requisite knowledge and skills to
serve as SAEs under the rule. Therefore, the final rule defines the
position of SAE in terms of the knowledge and skills required, and
permits healthcare professionals other than licensed physicians to
serve in this role.
Third, under the final rule, FFD programs are permitted to accept
determinations of fitness and treatment plans from other Part 26
programs, if an individual who has had a substance abuse problem will
be granted authorization by another licensee or entity. Consequently,
detailed requirements for the qualifications and responsibilities of
the SAE are necessary to ensure consistency among FFD programs.
Detailed requirements for the qualifications and responsibilities of
the SAE are necessary because of the key role the SAE plays in assuring
the common defense and security and public health and safety when
making a determination of fitness on which licensees and other entities
will rely when making authorization decisions. It is critical that SAEs
understand the potential impact on the common defense and security and
public health and safety when determining that an individual who has
had an active substance abuse problem has resolved the problem and is
again worthy of the public's trust. A sophisticated understanding of
substance abuse problems and the types of adverse behaviors they may
involve, including knowledge of the research literature and clinical
experience, is necessary to inform the SAE's clinical judgments in
these circumstances.
The NRC has adapted many of the provisions in the subpart from
related DOT requirements regarding the ``substance abuse professional''
[49 CFR Part 40, subpart O; 65 FR 41944; August 9, 2001]. The SAE role
is not defined in former Part 26.
Subpart I Managing Fatigue
Subpart I of the final rule strengthens the effectiveness of FFD
programs at nuclear power plants in ensuring against worker fatigue
adversely affecting public health and safety and the common defense and
security by establishing clear and enforceable requirements for the
management of worker fatigue. Because the overall rationale for
including Subpart I, Managing Fatigue, in Part 26, is detailed
[[Page 16978]]
and extensive, this discussion is presented separately in Section IV.D.
Subpart J [Reserved]
As a result of adding Subpart K [FFD Programs for Construction] to
the final rule, several subparts of the proposed rule have been
renumbered. The provisions contained in Subpart J of the proposed rule
have been moved to Subpart N of the final rule.
Subpart K FFD Programs for Construction
As a result of reorganizating the final rule, the NRC has moved the
provisions contained in Subpart K of the proposed rule [Inspections,
Violations, and Penalties] to Subpart O of the final rule.
The final rule adds a new Subpart K to revise and increase the
level of detail of FFD requirements contained in Sec. 26.3(e) of the
proposed rule pertaining to FFD programs for new reactor construction.
The NRC has added this subpart to the final rule to clarify the
requirements applicable to entities conducting construction activities
in response to public comments that raised concerns with the proposed
requirements. A detailed description of these public comments, as well
as a summary of the features and objectives of Subpart K can be found
in Section V of this document. A detailed section-by-section analysis
of the provisions of Subpart K can be found in Section VI of this
document.
Subpart L [Reserved]
Subpart M [Reserved]
Subpart N Recordkeeping and Reporting Requirements
As a result of reorganizing the proposed rule, the NRC has moved
the provisions contained in Subpart J of the proposed rule
[Recordkeeping and Reporting Requirements] to this subpart of the final
rule. The NRC has added Subpart N to the final rule to reorganize the
former rule's requirements for maintaining records and submitting
reports to the NRC. The subpart combines and amends two sections of the
former rule: Section 26.71 [Recordkeeping requirements] and Sec. 26.73
[Reporting requirements], and incorporates the record retention
requirements of former Sec. Sec. 26.21(b), 26.22(c), and 26.80(c). The
final rule adds a new Sec. 26.709 [Applicability]. The NRC has made
these changes to meet Goal 6 of this rulemaking to improve clarity in
the organization and language of the rule, by grouping related
requirements together in the subpart.
Major changes to the former rule's requirements for recordkeeping
and reporting reflect the addition of requirements for specimen
validity testing to the final rule, the addition of requirements for
managing worker fatigue at nuclear power plants, and a relaxation of
the required frequency with which Part 26 programs must submit FFD
program performance reports to the NRC from bi-annually to annually.
Subpart O Inspections, Violations, and Penalties
As a result of reorganizing the proposed rule, the NRC has moved
the provisions contained in Subpart K of the proposed rule
[Inspections, Violations, and Penalties] to this subpart of the final
rule. The NRC added Subpart O to the final rule to combine into one
subpart former Sec. Sec. 26.70 [Inspections], 26.90 [Violations], and
26.91 [Criminal penalties]. The NRC has grouped these sections together
in one subpart because they each establish requirements related to the
NRC's oversight of the implementation of FFD programs. Section 26.821
[Inspections] retains the requirements in former Sec. 26.70. Section
26.823 [Violations] retains the requirements in former Sec. 26.90
[Violations]. Section 26.825 [Criminal penalties] retains the
requirements in former Sec. 26.91 [Criminal penalties].
D. Inclusion of Worker Fatigue Provisions in 10 CFR Part 26
The NRC has determined that the effectiveness of FFD programs in
ensuring against worker fatigue adversely affecting public health and
safety and the common defense and security should be strengthened by
establishing clear and enforceable requirements for the management of
worker fatigue at nuclear power plants. Subpart I, Managing Fatigue, of
the final rule includes these requirements and establishes an
integrated approach to fatigue management for nuclear power plant
workers, with fatigue prevention, detection, and mitigation as the
fundamental components. The requirements in Subpart I provide a
substantial increase in the protection of public health and safety and
common defense and security. In establishing the provisions of this
final rule, the NRC has taken into consideration the effects of
fatigue; the specific work practices of the nuclear power industry that
contribute to and mitigate fatigue; the inadequacy of the former
regulatory framework; the excessive hours formerly worked by many
nuclear power workers; and the practices of other industries and
countries for regulating work hours. In addition, the NRC held many
public meetings with the nuclear industry and the public to discuss
provisions for the final rule.
The NRC has determined that an integrated approach is necessary to
effectively manage worker fatigue because individuals experience
fatigue for many reasons, including long work hours, inadequate rest,
and stressful or strenuous working conditions. Shiftwork, home-life
demands, and sleep disorders can all contribute to inadequate sleep and
excessive fatigue. Individual differences in workers' tolerance of
these conditions also influence worker fitness for duty. As a
consequence, fatigue is a complex phenomenon that requires an
integrated approach to manage effectively. The requirements in Subpart
I were developed on the premise that fatigue management requires the
collaboration of individual workers and licensees.
Each of the requirements in Subpart I is discussed in detail in
Section VI. However, because Subpart I presents an integrated fatigue
management approach, this section discusses the principal findings that
led to the NRC's decision to include fatigue management provisions in
Part 26, as well as supporting information on the causes and problems
with worker fatigue in the nuclear power industry.
The Commission approved a rulemaking plan to include worker fatigue
provisions for nuclear power plants in 10 CFR Part 26 on January 10,
2002, (SRM-SECY-01-0113), as described in Section I. Since that time,
the NRC has continued to analyze the need for work-hour provisions in
the final rule. The considerations listed in the numbered paragraphs
that follow summarize the NRC's considerations concerning the
appropriate regulatory action to address the potential for worker
fatigue to affect public health and safety and the common defense and
security. These considerations include:
(1) The research literature demonstrating the substantive effects
of fatigue and decreased alertness on an individual's ability to safely
and competently perform his or her duties;
(2) The conditions that contribute to worker fatigue in the U.S.
nuclear power industry;
(3) With the exception of orders limiting the work hours of
security personnel, the NRC's former regulatory framework did not
include consistent or readily enforceable requirements to address
worker fatigue;
(4) Reviews of industry control of work hours have repeatedly
identified practices that were inconsistent with the NRC's Policy on
Worker Fatigue, including excessive use of extended
[[Page 16979]]
work weeks and the overuse of work-hour limit deviations;
(5) The former regulatory framework included requirements that were
inadequate and incomplete for effective fatigue management;
(6) Ensuring effective management of worker fatigue through
rulemaking substantially enhances the effectiveness of FFD programs,
but additional orders are not presently warranted to ensure adequate
protection of public health and safety or the common defense and
security; and
(7) Addressing the fatigue of workers in safety-critical positions
through regulation is consistent with practices in foreign countries
and other industries in the U.S.
Each of these considerations is discussed in greater detail below.
(1) Fatigue and decreased alertness can substantively degrade an
individual's ability to safely and competently perform his or her
duties.
The NRC previously noted in its ``Policy Statement on the Conduct
of Nuclear Power Plant Operations,'' dated January 24, 1989 (54 FR
3424), that ``nuclear power plant operators on each shift must have
knowledge of those aspects of plant status relevant to their
responsibilities to maintain their working environment free of
distractions, and using all their senses, be alert to prevent or
mitigate any operational problems.'' The degradation in an individual's
cognitive functioning resulting from inadequate rest includes, but is
not limited to, a reduced ability to sustain attention; maintain
situational awareness; make timely and conservative decisions;
communicate; and work effectively as a team member. These degradations
in performance, if exhibited by individuals performing risk-significant
functions, can adversely affect the safety and security of a nuclear
power plant.
The NRC evaluated the research available on the degradation of
worker abilities that are important to safe plant operation. The
research supports the fatigue management provisions in subpart I. Many
of the specific research citations are listed in detail in section VI.
The following is a discussion of the fundamental concerns associated
with worker fatigue, and some of the overall research that forms the
basis for the integrated fatigue management approach in Subpart I.
Many studies have shown that fatigue impairs human alertness and
performance (e.g., Alluisi and Morgan, 1982; Rosa, 1991; Scott, 1990;
Dinges, 1992; Dinges, 1995; Dawson and Reid, 1997; Bobko, et al., 1998;
Harrison and Horne, 2000; Williamson and Feyer, 2000). The lack of
adequate days off and extended workdays (overtime) can result in a
cumulative sleep debt (i.e., the difference between the amount of sleep
an individual needs and the amount of sleep that individual actually
obtains) and performance impairment (Webb and Agnew, 1974; Baker, et
al., 1994; Colquhoun, et al., 1996; Tucker, et al., 1999; Williamson
and Feyer, 2000; Department of Transportation (DOT), May 2, 2000, 65 FR
25546). Across a broad range of industries, studies concerning extended
work hours suggest that fatigue-induced personnel impairment can
increase human error probabilities by a factor of more than 2 to 3
times (Hanecke, et al., 1998; Colquhoun, et al., 1996; Akerstedt, 1995;
U.S. DOT, 49 CFR parts 350, et al., Final Rule, May 2, 2000; 65 FR
25544).
Studies of the nuclear power industry indicate that normal daily
variations in alertness associated with human circadian rhythms (i.e.,
physiological processes that vary on an approximate 24-hour cycle) may
be responsible for daily variations in the incidence of personnel
errors at nuclear power plants (Bobko, et al., 1998; Dorel, 1996;
Maloney, 1992). The findings of these studies are consistent with the
results of a survey of more than 100 nuclear power plant shift
supervisors--over 90 percent stated that they notice times of day, and
days in the schedule, during which control room operators are less
alert, less vigilant, or make more mistakes (Baker, et al., 1990 [EPRI
NP-6748]). These studies suggest that despite controls, such as
standardized work practices and independent verification, to ensure
correct and reliable human performance, factors that influence
alertness may increase the incidence of human errors in nuclear power
plants.
Fatigue has generalized effects on human performance capabilities,
and is associated with performance decrements at a base level, across a
variety of tasks (Dinges, 1995). Fatigue can impair both physical and
cognitive (i.e., mental) functioning.
Generally, cognitive task performance is affected more readily by
fatigue than physical or psychomotor tracking performance (Krueger,
1989; 1991). General cognitive fatigue decreases an individual's
ability to remain alert, process complex information, and correctly
grasp a complex set of circumstances. Fatigue has been shown to cause
memory problems, slowed responses, lapses and false responses
(Williams, et al., 1959; Morgan, et al., 1974; Dinges, 1992; Dinges,
1995). Many of the cognitive tasks performed by nuclear power plant
personnel that are important to the protection of public health and
safety and the common defense and security rely on their ability to
sustain attention, analyze problems, make rapid, accurate decisions,
and communicate and work as a team. The following effects of fatigue on
cognitive abilities are the primary focus of the fatigue management
requirements:
(a) Sustaining attention--Vigilance and attention to detail are
fundamental for plant safety, whether an individual is operating or
maintaining equipment important to plant safety, performing
surveillance procedures in the plant, monitoring system status in the
control room, or monitoring plant security systems or barriers. Tasks
requiring sustained attention (e.g., vigilance tasks) are among the
most susceptible to fatigue-induced degradation (Monk and Carrier,
2003). The sensitivity to fatigue of vigilance tasks is one of the
primary reasons that tests, such as the psychomotor vigilance task
(Dinges, et al., 1997; Doran, et al., 2001), are standard measurement
tools used in studies of the effects of sleep deprivation and fatigue.
Of particular note are research findings showing that, in operational
settings, individuals may experience periods of sleep up to a few
seconds (called microsleeps), during which they fail to respond to
external stimuli, and are completely unaware that these episodes have
occurred (Cabon, et al., 2003; Priest, et al., 2001; Summala, et al.,
1999).
(b) Decision-making--Conservative decision-making is central to
safe nuclear power plant operations. Fatigue is associated with more
risky strategies and decreases in the effort individuals exert in
decision-making (Schellekens, et al., 2000). Furthermore, Harrison and
Horne (2000) reviewed the impact of sleep deprivation on decision-
making and reported that, contrary to popular belief, sleep deprivation
impairs decision-making even if individuals try to compensate for lack
of sleep when responding to heightened stimulation. As noted by Cabon,
et al. (2003), studies have shown reductions in aircrew alertness, even
during the critical descent phase. These findings suggest that the
alerting stimuli of off-normal conditions (e.g., landing an airplane,
acknowledging control room annunciators) may not fully negate the
effects of fatigue on performance. The National Transportation Safety
Board (NTSB) reviewed the performance of flight crews involved in 37
major accidents and found that those crew members who had been awake
longer than 12 hours before their accidents made more errors overall,
and specifically more tactical decision
[[Page 16980]]
errors, than did crew members who had been awake for less time (NTSB,
1994).
(c) Problem solving--Perseveration is a term used to describe poor
problem solving performance, characterized by an individual or group of
individuals maintaining a faulty diagnosis or mitigation plan despite
contrary information. An example of perseveration from the nuclear
power industry was the initial response by plant operators to events at
Three Mile Island Unit 2 in 1979. The operators' initial response was
based on a faulty diagnosis of the plant condition (the operators
failed to recognize they were dealing with a loss of coolant accident),
which the operators maintained throughout the first 2 hours of the
event in the face of numerous conflicting indications. Many factors
contributed to human performance problems during the Three Mile Island
accident and the NRC is not suggesting that operator fatigue was a
contributing factor. However, fatigue is one factor that has been found
to contribute to this type of performance degradation (Harrison and
Horne, 2000), which may have serious consequences for public health and
safety. Sleep-deprived workers fail to appropriately allocate
attention, set task priorities, or sample for sources of potentially
faulty information (Hockey, 1970; Krueger, 1989). Mental fatigue also
contributes to decreased originality and flexibility in problem solving
and sub-optimal planning (Van der Linden, et al., 2003; Lorist, et al.,
2000; Horne, 1988).
(d) Communication and teamwork--Fatigue affects skills important to
written and oral communication and teamwork. Fatigue degrades speech
articulation, verbal fluency, grammatical reasoning (the ability to
process oral and written instructions), and memory (Harrison and Horne,
1997; 1998). Studies of individuals in simulated combat and command and
control conditions have shown that fatigue slows the encoding,
decoding, and transcription of information (Banderet, 1981; Angus and
Heslegrave, 1985). Fatigued individuals also tend to be less
communicative and have greater difficulty performing multiple tasks
concurrently, as demonstrated in simulated aircraft cockpit tasks
requiring monitoring and communications (Pascoe, et al., 1995; Harrison
and Horne, 2000). These effects have been found in the analysis of
incidents and accidents. In a study of major aircraft accidents, crews
that had been awake longer (an average of 13.8 hours for captains and
13.4 hours for first officers) made significantly more procedural and
tactical decision errors than crews that had been awake for a shorter
period (an average of 5.3 hours for captains and 5.2 hours for first
officers) (NTSB, 1994). Similar to control room personnel in nuclear
power plants, aircraft cockpit crews make extensive use of secondary
checks to verify that decisions and performance are correct, and to
mitigate the consequences of errors. Although the difference was not
statistically significant, analysis of the crew errors indicated that
crews that had been awake longer made nearly 50 percent more errors in
failing to challenge a faulty action or inaction by another crew
member. These studies highlight how fatigue cannot only degrade the
fitness of an individual, but also the overall performance of a crew.
Although fatigue has long been widely recognized as causing
degraded performance, recent research has helped characterize the
magnitude of these effects relative to a historical FFD concern:
impairment from alcohol intoxication. Part 26 prohibited the use of
alcohol on site and within several hours before a tour of duty, and
established alcohol testing requirements for personnel on duty. The NRC
established these requirements based on the recognition that alcohol
can have significant adverse effects on a worker's ability to safely
and competently perform his or her duties. Recent studies have shown
that fatigue can cause performance degradations that are comparable to
the levels observed from blood alcohol concentrations (BACs) in excess
of those that would result in a positive breath alcohol test under the
provisions of Part 26. In those studies, individuals who were awake for
17-19 hours had cognitive and psychomotor performance comparable to
individuals with a BAC of 0.05 percent (Dawson and Reid, 1997;
Williamson and Feyer, 2000). Part 26 establishes breath alcohol cutoff
level below 0.05 percent. The NRC considers the insight that fatigue
can impair a worker at levels comparable to those prohibited for
alcohol to be particularly significant.
(2) Conditions that contribute to worker fatigue are prevalent in
the U.S. nuclear power industry.
Fatigue may result from an individual remaining awake continuously
for an excessive period of time, or from the individual obtaining an
inadequate amount or quality of sleep, or both. Conditions that
contribute to worker fatigue include:
(a) Extended work shifts with five or more consecutive work days--
Although the effects of shift length on worker performance are
influenced by the nature of the task, various studies have shown that
task performance declines after 12 hours on a task (Rosa, 1991;
Folkard, 1997; Dawson and Reid, 1997). Other studies have shown that
the relative risk of having an accident increases dramatically after 9
consecutive hours on the job (Colquhoun, et al., 1996; Hanecke, et al.,
1998; U.S. DOT, 49 CFR parts 350, et al., Final Rule; 65 FR 25544; May
2, 2000). The effects of extended working hours on worker performance
can be exacerbated when many extended shifts are scheduled in
succession. The National Institute for Occupational safety and Health
published a report in 2004 (Caruso et al., 2004) that reviewed 52
recent reports examining the association between long work hours and
illness, injuries, health behaviors, and performance. NIOSH reported
that ``a pattern of deteriorating performance on psychophysiolgical
tests as well as injuries while working long hours was observed across
study findings, particularly when 12-hour shifts combined with more
than 40 hours of work a week.''
The use of 12-hour shifts has become increasingly common at U.S.
nuclear power plants. Schedules that include 5 or more 12-hour shifts
in succession during routine operations are sometimes popular with
workers because they allow a long sequence of days off. However,
scheduling more than 4 consecutive 12-hour shifts is not a recommended
means of managing fatigue (Baker, et al., 1990 [EPRI NP-6748]; NUREG/
CR-4248, ``Recommendations for NRC Policy on Shift Scheduling and
Overtime at Nuclear Power Plants''). As noted in the 2000 Sleep in
America Poll, ``waking up unrefreshed'' was more likely to be reported
by individuals working more than 60 hours per week (58 percent vs. 42
percent of those working 41-60 hours per week and 39 percent of those
working 31-40 hours) (National Sleep Foundation, 2000).
During the public meetings described in the preamble to the
proposed rule, industry stakeholders noted that the use of 6 or more
consecutive 12-hour shifts is now standard practice during plant
outages. In SECY-01-0113, the NRC staff reported that more than 80
percent of the authorizations written by licensees to exceed the
technical specification work-hour limits during outages were for
exceeding 72 hours (e.g., six 12-hour shifts) in a 7-day period. The
NRC's more recent review of deviations authorized at six plants for
refueling outages during 2003 and 2004 also indicated that deviations
from the limit of 72 hours in 7 days continue to account for more than
80 percent of the
[[Page 16981]]
deviations authorized. During the public meetings, industry
stakeholders also reported that, during outages, some licensees have
scheduled personnel for three or more weeks of consecutive 12-hour
shifts without intervening days off.
(b) Extensive Overtime--Many research studies report that excessive
working hours cause worker fatigue (Akerstedt, 1995b; Rosa, 1995;
Buxton, et al., 2002). The U.S. nuclear power industry makes extensive
use of overtime, creating a combined effect of long work hours with
reduced break periods. As noted in SECY-01-0113, at approximately one-
fourth of the sites, more than 20 percent of the personnel covered by
working hour limits work more than 600 hours of overtime annually. This
amount of overtime is more than two to three times the level permitted
for personnel at some foreign nuclear power plants and more than twice
the level recommended by an expert panel Commissioned by the NRC in
1985 (NUREG/CR-4248). In SECY-01-0113, the NRC also noted that some
licensees authorized hundreds to several thousand deviations from the
limits of 16 hours of work in any 24-hour period, 24 hours of work in
any 48-hour period, 72 hours of work in a 7-day period, and from the
minimum break requirement of 8 hours between work periods. The NRC also
noted the continued excessive use of such deviations in its survey of
six plants in 2004.
(c) Shiftwork--The nuclear power industry is a round-the-clock
operation requiring individuals to be awake and working at times when
they would normally be asleep. Although individuals can function in
these circumstances, human alertness and task performance are
cyclically affected by a daily biological clock, which runs on about a
24-hour (circadian) cycle, as it assists in timing numerous
physiological and psychological phenomena (such as core body
temperature, the daily release of various hormones, mood swings, and
wake-sleep cycle) (Liskowsky, et al., 1991). The circadian trough, or
lowest levels of function reflected in, for example, alertness,
performance, subjective mood, and body temperature, occurs around 3
a.m. to 5 a.m., with many human functions showing reduced levels
between 12 a.m. and 6 a.m. Sleepiness is most severe between 3 and 5
a.m., with a less marked but significant expression again between 3 and
5 p.m.
There is substantial scientific literature on circadian variations
in alertness that clearly demonstrates the significant roles that
worker fatigue, sleep loss, and circadian rhythms play in contributing
to errors and accidents (Kryger, et al., 1994; Akerstedt, 1995a;
Dinges, 1995; Folkard, 1997; Comperatore and Krueger, 1990; Miller and
Mitler, 1997). These findings range from reduced response speed on a
variety of tasks, to missing warning signals, to minor hospital
incidents and accidents (Krueger, 1994). In addition, as previously
described in this section, circadian variations have also been noted in
studies of the incidence of personnel errors at nuclear power plants
(Bobko, et al., 1998; Dorel, 1996; Maloney, 1992) and noted in
observations by a large number of nuclear power plant shift supervisors
(Baker, et al., 1990 [EPRI NP-6748]).
In addition to causing individuals to perform work at periods of
depressed alertness, shiftwork also conflicts with circadian variations
in alertness by requiring individuals to sleep during naturally
occurring periods of increased cognitive arousal. Circadian rhythms,
and naturally occurring tendencies for sleep and wakefulness, do not
fully adapt to shiftwork schedules. In addition, daylight, noise and
the ``regular day'' schedules of other family members challenge the
ability of shiftworkers to obtain adequate rest. As a result,
shiftworkers generally obtain less sleep, and report a higher incidence
of sleepiness and sleep-related complaints. For example, in a survey of
1,154 U.S. adults, the National Sleep Foundation (NSF) found that
shiftworkers, on average, get less sleep (6 hours, 30 minutes) than
regular day workers (6 hours, 54 minutes). Almost half of the
shiftworkers they surveyed obtained less than 6.5 hours of sleep per
``night'' during the work-week, 30-90 minutes less than recommended by
most sleep experts. In comparison to regular day workers, shiftworkers
were more likely to be sleepy at work 2 or more days per week (34
percent vs. 23 percent) (National Sleep Foundation, 2000). Many studies
have demonstrated that decreased performance and increased errors and
accidents are associated with night work and are affected by varying
sleep schedules and durations of sleep periods (e.g., Balkin, et al.,
2000).
The challenge for shiftworkers to remain alert during the early
morning hours of a shift can be exacerbated by extended shift lengths,
overtime, and the inability of many shiftworkers to obtain adequate
sleep during the day (Hanecke, 1998). The powerful drive for sleep that
is associated with circadian factors, and the fact that shiftwork is a
daily influence on the alertness of all shiftworkers at nuclear power
plants, has been demonstrated by a number of recent events. For
example, there have been instances of operators falling asleep in the
control rooms at the Pilgrim nuclear power station (2004) and the test
and research reactor at the Massachusetts Institute of Technology
(2003), as well as a security officer falling asleep at the Braidwood
nuclear power plant while driving a patrol vehicle (2004), despite
these individuals recognizing the potential safety and disciplinary
consequences.
(d) Early start times and extended commutes --Although many plant
personnel do not work rotating shifts, start times before 7 a.m. can
interfere with a worker's ability to obtain adequate rest if the
schedule is not aligned with his or her circadian cycle and naturally
occurring tendency for sleep and wakefulness. Such start times
typically cause workers to wake before 6 a.m., thereby reducing the
amount of sleep that can be obtained between midnight and 6 a.m., the
most effective time period for most people to sleep. In addition, long
commutes to remote work sites such as nuclear power plants, which are
frequently located in rural areas and distanced from major population
centers, contribute to the potential for fatigue associated with early
start times.
(e) Sleep disorders--Sleep disorders, such as sleep apnea,
insomnia, and restless leg syndrome (i.e., a condition that is
characterized by uncomfortable or unpleasant sensations in the legs,
causing an overwhelming urge to move them, often contributing to
difficulty in staying or falling asleep), are conditions that can
significantly reduce the quantity and quality of sleep that individuals
are able to obtain, affect an individual's ability to remain alert, and
ultimately degrade an individual's ability to safely and competently
perform his or her duties (Kryger, et al., 1994; Lewis and Wessely,
1992). These factors are not effectively addressed by limits on working
hours in the absence of other fatigue management practices. Although
the NRC does not have data for the incidence of sleep disorders that
are specific to U.S. nuclear power plant workers, in the general U.S.
population, these conditions are not uncommon. For example, the
prevalence of sleep apnea is estimated to be 4 percent for adult males
and 2 percent for adult females (Strollo and Rogers, 1996). The
incidence of sleep apnea may in fact be higher for shiftworkers at
power plants, as this condition is more common in middle-age adult
males than in the general population. A survey by the NSF of 1,154
adults living in households in the continental U.S.
[[Page 16982]]
found self-reports of sleep apnea were more common from shiftworkers
than regular day workers (15 percent vs. 9 percent) (National Sleep
Foundation, 2000). Similarly, the NSF found that shiftworkers reported
a higher incidence of insomnia (66 percent vs. 55 percent) than regular
day workers.
Although worker motivation can mitigate to a limited degree the
effects of fatigue, fatigue has a physiological basis, including
changes in glucose metabolism in the brain (Wu, et al., 1991; Thomas,
et al., 2000). These changes are beyond the individual's control. In
addition, several studies have suggested caution with regard to the
abilities of individuals to self-monitor their capacity to safely and
competently perform their duties when fatigued (Dinges, et al., 1997;
Belenky, et al., 2003; Akerstedt, 2003). These studies note that
individuals experience microsleeps without being aware of their lapses
in attention and underestimate their propensity for uncontrolled sleep
episodes. As a consequence, a worker's motivation to remain alert does
not provide reasonable assurance that an individual will be able to
safely and competently perform his or her duties.
Considering the above factors, fatigue can have a significant
adverse effect on worker abilities. Further, the likelihood of a
nuclear power plant worker being impaired from fatigue is not trivial,
and potentially greater than the likelihood of impairment from drugs
and alcohol, which the NRC requires licensees to address through their
FFD programs. Therefore, the NRC believes that regulatory action is
warranted to ensure that fatigue is adequately addressed through
licensee FFD programs. Further, the NRC asserts that rulemaking is the
appropriate regulatory action for the following reasons:
(3) With the exception of orders limiting the work hours of
security personnel, the NRC's former regulatory framework did not
include consistent or readily enforceable requirements to address
worker fatigue.
The principal components of the former regulatory framework for
matters pertaining to working hours and fatigue for non-security
personnel were (a) NRC's Policy on Worker Fatigue, as issued on June
15, 1982, in GL 82-12, and (b) plant technical specifications related
to this policy statement, and (c) certain limited requirements of 10
CFR Part 26.
As part of the assessment of PRM-26-2, in which Barry Quigley
petitioned for rulemaking to establish enforceable requirements
addressing fatigue of workers at nuclear power plants, the NRC reviewed
and assessed the implementation and enforceability of the NRC's former
regulatory framework applicable to worker fatigue, including licensee
technical specifications for the administrative control of work hours.
This review was documented in detail in Attachment 1 to SECY-01-0113.
The NRC continued this evaluation during development of this final
rule, and the principal findings include:
(a) NRC's Policy on Worker Fatigue--NRC guidance documents do not
prescribe requirements. Guidance documents establish policy or provide
advice on meeting a regulatory requirement. As a result, a policy is
enforceable only to the extent that the guidelines have been
incorporated into a license condition or technical specifications. For
the three nuclear power plant sites that have not incorporated the
guidelines from the NRC's Policy on Worker Fatigue into a license
condition or technical specification, the guidelines are unenforceable.
These plant sites have implemented the concept using other
administrative controls that the NRC has determined to be adequate.
However, had the NRC determined that the controls were inadequate, it
would have had no basis for taking enforcement action.
(b) Technical Specifications--For those licensees who have
incorporated the NRC's Policy on Worker Fatigue into a license
condition or technical specifications, consistent enforcement has been
complicated by the following factors:
--The language in plant technical specifications is largely advisory
(e.g., an individual should not be permitted to work more than 16 hours
straight) and key terms have not been defined. This deficiency has
resulted in inconsistent interpretation and implementation of technical
specifications by licensees, as well as difficulty for the NRC in
enforcing the requirements. For example, many technical specifications
use the terms, ``routine heavy use of overtime,'' ``unforeseen
problems,'' and ``temporary basis.'' The NRC has not defined any of
these terms and has not consistently pursued enforcement on the basis
of the amount or frequency of overtime authorized.
--The technical specifications have inconsistent levels of detail from
one nuclear power plant licensee to another. Only three-quarters of the
licensees' technical specifications include the quantitative work-hour
limit guidelines of the NRC's Policy on Worker Fatigue.
--The technical specifications contain varying scopes of requirements.
Some plant technical specifications require periodic reviews of
overtime approvals to ensure that excessive hours have not been
assigned, while other technical specifications contain no equivalent
requirements. Although the observed variability in the controls does
not by itself present a safety concern, such variability is
inconsistent with establishing a uniform level of assurance that
personnel are not in a fatigued condition that could significantly
reduce their mental alertness and decision-making capabilities.
--Licensees have inconsistently interpreted the scope of personnel who
must be subject to the technical specification work-hour limits. The
NRC's Policy on Worker Fatigue applies to personnel who are performing
safety-related functions. The NRC's review of work-hour data gathered
by NEI regarding the work hours of personnel subject to the technical
specifications (Nuclear Energy Institute, 2000) identified variation in
the numbers and types of personnel covered by these controls. A limited
number of sites may not have been applying work-hour controls to all
personnel performing safety-related functions. At least two nuclear
plant sites do not apply the work hour controls to any maintenance
personnel even though GL 83-14, ``Definition of `Key Maintenance
Personnel' (Clarification of GL 82-12),'' issued March 7, 1983, defined
key maintenance personnel to include individuals who work on safety-
related equipment.
--The basic measure used to determine whether an individual's work
hours are within or above the technical specification limits has not
been implemented consistently from one nuclear power plant to another.
Work hours included within the limits at some nuclear power plants have
not been included at others, effectively creating substantively
different work-hour limits among plants.
(c) 10 CFR Part 26, ``Fitness for Duty Programs''--The general
performance objectives of former Sec. 26.10 required that licensees
provide ``reasonable assurance that nuclear power plant personnel * * *
are not * * * mentally or physically impaired from any cause, which in
any way adversely affects their ability to perform their duties.''
Although former 10 CFR Part 26 contained specific requirements
pertaining to alcohol and drug usage, it did not include prescriptive
[[Page 16983]]
requirements regarding fatigue. Rather, former Sec. 26.20 used
general, non-mandatory language to state that the FFD policy ``should''
address other factors that can affect a worker's ability to safely and
competently perform his or her duties, ``such as mental stress,
fatigue, and illness.'' As a result, it has been difficult for the NRC
to justify a violation of the regulation based on a licensee's failure
to limit overtime hours. In addition, without a numerical limit on
overtime hours, or a provision limiting overtime, a range of overtime
practices could be viewed as ``reasonable,'' and therefore in
compliance with the regulation.
In summary, the broad and non-prescriptive provisions of Part 26,
and the technical specifications and license conditions pertaining to
fatigue, in the absence of clearly defined terms or measures of
fatigue, have made it difficult for the NRC to enforce worker fatigue
requirements and work-hours limits in an effective, efficient, and
uniform manner that ensures that all licensees provide reasonable
assurance that workers are able to safely and competently perform their
duties. The NRC believes that a consistent fatigue management program
and its uniform implementation across the industry is essential, and
the most effective regulatory mechanism is to incorporate worker
fatigue requirements into 10 CFR Part 26.
(4) Reviews of industry control of work hours have repeatedly
identified practices that were inconsistent with the NRC's Policy on
Worker Fatigue, including excessive use of work hours and work hour
limit deviations.
The policy states, in part, ``Enough plant operating personnel
should be employed to maintain adequate shift coverage without routine
heavy use of overtime.'' Surveys and expert panels have suggested that
tolerance for overtime is generally limited to 300-400 hours of
overtime per year (ADAMS Accession No. ML05270310; NUREG/CR-4248).
Baker, et al. (1994) reviewed the hours worked by nuclear power plant
operations, technical, and maintenance personnel during 1986, four
years after the NRC issued its policy. Based on a sample of 63 percent
of U.S. nuclear power plants operating at that time, Baker and
colleagues found that operations personnel averaged more than 500 hours
of overtime annually at 20 percent of the plants, and more than 700
hours of overtime at 9 percent of the plants. Technical personnel
averaged more than 500 hours of overtime annually at 30 percent of the
plants, and more than 700 hours of overtime at 18 percent of the
plants. Maintenance personnel averaged more than 500 hours of overtime
annually at 80 percent of the plants and more than 700 hours of
overtime at 14 percent of the plants.
The NRC's Policy on Worker Fatigue included provisions for
licensees to authorize deviations from the NRC's work and rest
guidelines for individual workers in ``very unusual circumstances.'' On
June 10, 1991, following several NRC inspections noting concerns
related to licensee work hour control, the NRC issued Information
Notice (IN) 91-36, Nuclear Power Plant Staff Working Hours, to alert
licensees of potential problems resulting from inadequate controls to
prevent excessive working hours. The conditions cited in the notice
included an event attributed to fatigue, excessive use of deviations
and overtime, and overtime deviations authorized after the fact.
Subsequent NRC reviews completed in 1999 and 2001 identified continued
problems with industry control of work hours. In 1999, the NRC reviewed
licensee event reports and NRC inspection reports from January 1994
through April 1999. The NRC found that only a few events of limited
risk significance had been attributed to fatigue. However, the staff
found several instances each year in which licensee use of overtime
appeared to be inconsistent with the general objectives or specific
guidelines of the NRC's Policy on Worker Fatigue.
NEI conducted a survey in the summer of 2000 concerning industry
control of work hours for personnel subject to the technical
specifications (letter dated August 29, 2000, from J. W. Davis, NEI, to
G. M. Tracy, NRC, ADAMS Accession No. ML003746495). Forty-seven sites
responded to the survey, providing data from 1997-1999. The NRC staff's
review of the data is documented in Attachment 1 to SECY-01-0113. The
NRC evaluated the results of the survey concerning overtime and found
that 8 of 36 sites providing data had more than 20 percent of the
personnel covered by the policy working in excess of 600 hours of
overtime per year. Considering all plants that provided data, the
percentage of personnel working in excess of 600 hours of overtime per
year increased from 7 percent in 1997 to 11 percent in 1999. The
percentage of licensed operators working in excess of 600 hours of
overtime per year increased from 13 percent in 1997 to more than 16
percent in 1999. The NRC considers these percentages to represent
excessive use of overtime in the nuclear industry.
The NRC also reviewed the data collected by NEI concerning
deviations, which showed that approximately one-third of the
respondents were authorizing more than a thousand, to as many as 7,500,
deviations in a year to exceed the policy guidelines. The frequency of
deviations did not appear to be consistent with either the specific
guidelines or the general objective of the policy. As previously
described in this section, the policy permits deviations from the
guidelines in ``very unusual circumstances.''
Subsequent to the Commission's decision to initiate rulemaking for
worker fatigue, the NRC staff also obtained data from six sites in
2004. Those data indicated that between 95 and 603 deviations, with an
average of 311 deviations, were issued for individuals. The data were
provided by the six sites for each plant's most recent refueling outage
and one month of power operation, and therefore do not reflect the
total number of deviations issued for individuals during all of 2004,
except for one of the six sites that provided its deviation data (101
deviations) for all of 2004. Data on the deviations from 2004 in this
sample are reported in detail in Appendix 3 of the Regulatory Analysis.
The NRC believes that licensee use of deviations and overtime at some
sites has been excessive, and has been inconsistent with the intent of
the NRC's Policy on Worker Fatigue.
In addition to excessive work hours and work-hour guidelines
deviations, the NRC has recently identified other concerns related to
licensee policies and practices applicable to worker fatigue. On May
10, 2002, the NRC issued Regulatory Issue Summary (RIS) 2002-007,
``Clarification of NRC Requirements Applicable to Worker Fatigue and
Self-Declaration of Fitness-for-Duty.'' The NRC issued the RIS
following several allegations made to the NRC regarding the
appropriateness of licensee actions or policies related to individuals
declaring they are not fit due to fatigue. These concerns indicate a
need to ensure that individuals and licensees clearly understand their
responsibilities with respect to self-declarations of worker fatigue.
The final rule establishes requirements to address this need.
(5) The former regulatory framework included requirements that were
inadequate and incomplete for effective fatigue management.
(a) The NRC's Policy on Worker Fatigue did not establish clear
expectations for the control of work hours. As previously noted in this
section, the NRC did not define key terms of the policy, and, as a
[[Page 16984]]
consequence, implementation has been varied across the industry.
(b) Certain policy guidelines and technical specifications were
inadequate to provide reasonable assurance that individuals remain
capable of safely and competently performing their duties. For example,
the requirement for an 8-hour break between work periods has been
revised to a 10-hour break. The basis for this revision to increase the
length of this break period is described in detail in Section VI with
respect to Sec. 26.205(d)(2)(i).
In addition, although the policy established an objective of a
nominal 40-hour work week, the specific work hour guidelines of the
policy and most technical specifications for the administrative control
of work hours have principally focused on acute fatigue. These
guidelines did not adequately address the longer term control of work
hours and the cumulative fatigue that can result from prolonged periods
of extended work hours. Acute fatigue results from restricted sleep,
sustained wakefulness, or continuous task demands over the past 24
hours or more. Cumulative fatigue results from inadequate rest over
consecutive sleep-wake periods when the worker obtains less sleep than
he or she requires. An individual incurs a sleep debt for each day
during which the worker obtains insufficient sleep. If the individual
continues to obtain insufficient sleep, this debt accumulates over
successive days, resulting in increasing fatigue and impairment
(Belenky, et al., 2003).
The inadequacy of the former regulatory framework for addressing
cumulative fatigue became particularly apparent in the months following
the terrorist attacks of September 11, 2001. The NRC received numerous
allegations from nuclear security officers that certain licensees
required them to work excessive amounts of overtime over long periods
due to the post-September 11, 2001, threat environment. These
individuals questioned their readiness and ability to perform their
required job duties due to the adverse effects of cumulative fatigue.
The NRC reviewed the actual hours worked by security personnel and
determined that, in the majority of cases, individual work hours did
not exceed the guidelines specified in the NRC's Policy on Worker
Fatigue, but the review confirmed that individuals had been working up
to 60 hours per week for extended periods. The concerns expressed by
individuals regarding their FFD, in light of work schedules that did
not exceed the specific guidelines of the policy, as well as relevant
technical research supporting the basis for cumulative fatigue, led the
NRC to conclude that the work hour guidelines of the policy were
inadequate for addressing cumulative fatigue. The NRC obtained
additional worker feedback supporting this conclusion through a review
of worker fatigue concerns and work hours during a long-term outage at
the Davis Besse nuclear plant (NRC Inspection Report 05000346/2004003,
dated March 31, 2004, ADAMS Accession No. ML040910335).
The comprehensive fatigue management approach in Subpart I,
Managing Fatigue, establishes controls to address cumulative fatigue.
Limits to mitigate cumulative fatigue for nuclear power plant security
personnel were implemented by Order EA-03-038. The final rule codifies,
with changes, these requirements. Changes to those limits that have
been imposed by this rule are discussed in detail in Section VI, which
also includes a detailed discussion of the limits and other controls to
mitigate cumulative fatigue for other personnel who perform safety-
related duties at nuclear power plants.
(c) The former regulatory framework did not effectively ensure that
fatigue from causes other than work hours was addressed. Work hour
controls are necessary, but not sufficient, to effectively manage
worker fatigue. As a consequence, training and fatigue assessments are
essential. Worker fatigue, and its effects on worker alertness and
performance, can result from many causes in addition to work hours
(e.g., stress, sleep disorders, daily living obligations) (Rosa, 1995;
Presser, 2000). In addition, there are substantial individual
differences in the abilities of individuals to work for extended
periods without performance degradation from fatigue (Gander, 1998; Van
Dongen, et al., 2004a; Van Dongen, et al., 2004b; Jansen, et al.,
2003). Subpart I, Managing Fatigue, requires a comprehensive fatigue
management program. One example is the strengthening of FFD training
requirements concerning worker fatigue. The training requirements will
improve the effectiveness of behavioral observation and the assessment
of worker fatigue, self-declaration as a means for early detection of
fatigue, worker self-management of fatigue, the ability of workers to
obtain adequate rest on a shiftwork schedule, and licensee use of
effective fatigue counter-measures.
(6) Ensuring effective management of worker fatigue through
rulemaking will substantially enhance the effectiveness of FFD
programs, but additional orders are not presently warranted to ensure
adequate protection of public health and safety or the common defense
and security.
Adequate protection of public health and safety and the common
defense and security were ensured under the former regulatory
framework, including Order EA-03-038 (for security personnel), the
NRC's Policy on Worker Fatigue, and licensee technical specifications.
Licensee FFD programs included behavioral observation programs to
identify individuals whose behavior indicates they may not be fit to
safely and competently perform their duties, and ensure that those
individuals are removed from duty until any question regarding their
fitness has been resolved. The former work-hour controls, in
conjunction with licensee behavioral observation programs, automatic
reactor protection systems and other administrative controls on worker
activities (e.g., post-maintenance testing, peer checks, independent
verifications) ensured adequate protection of public health and safety
and the common defense and security. However, there were substantial
limitations to the former regulatory framework, as detailed in this
section. Therefore, although the previous regulatory framework provided
adequate protection, including work-hour controls in 10 CFR Part 26
provides a substantial increase in public health and safety and the
common defense and security. The NRC has incorporated worker fatigue
provisions in Part 26 in light of the substantial increase in safety
and security that is expected to result.
(7) Addressing fatigue of workers in safety-critical positions
through regulation is consistent with practices in foreign countries
and other industries in the U.S.
The NRC reviewed the limits on work hours for nuclear plant workers
in eight other countries, as well as six other industries in the United
States and Canada. These are summarized in Attachment 1 of SECY-01-
0113. Although many factors influence specific regulatory limits, and
requirements for other industries should be considered in context, the
NRC found that the NRC's former guidelines are the least restrictive
among those reviewed.
The work hours of nuclear power plant personnel in other countries
are largely based on labor laws or union agreements that apply to
multiple industries. With the exception of Spain, which has limits
consistent with the NRC's Policy on Worker Fatigue, each of the other
eight countries has more stringent requirements. The more stringent
requirements have largely
[[Page 16985]]
preempted the need in those countries for regulation of work hours
based on nuclear safety concerns.
The Department of Transportation (DOT) has established regulatory
limits on the work hours of pilots, air traffic controllers, and
maintenance personnel in the commercial aviation industry (14 CFR parts
121 and 135); in the maritime industry (46 U.S.C. 8104; 46 CFR parts
15.705, 15.710 and 15.111); in the rail industry (49 U.S.C. 211; 49 CFR
Part 228); and for drivers of heavy trucks in the commercial trucking
industry (49 CFR Part 395). The DOT recognized that fatigue can
substantively degrade the ability of individuals to perform these
duties and, therefore, promulgated regulatory requirements for each of
these modes of transportation in keeping with the department's mission
to protect public safety. In the late 1980s and early 1990s, the
National Transportation Safety Board (NTSB) identified equipment
operator fatigue as a significant issue affecting all transportation
modes (Beal and Rosekind, 1995). As a result, DOT classified operator
fatigue management as a DOT ``Flagship Initiative'' and several
proactive fatigue management activities ensued across the
transportation industries (e.g. U.S. DOT, 1995; Rogers, 1996, 1997;
Hartley, 1998; Carroll, 1999).
In 1999, the NTSB evaluated DOT's decade of efforts on operator
fatigue (NTSB, 1999). Not satisfied that enough was being done, NTSB
subsequently offered DOT three recommendations: (1) expedite a
coordinated research program on the effects of fatigue, sleepiness,
sleep disorders, and circadian factors on transportation safety; (2)
develop and disseminate educational materials for transportation
industry personnel and management regarding shift work, work rest
schedules, and proper regimens of health, diet, and rest; and (3)
review and upgrade regulations governing hours of service for all
transportation modes to assure they are consistent and incorporate the
results of the latest research on fatigue and sleep issues (NTSB,
1999).
On April 28, 2003, the DOT issued revised hours-of-service
regulations to require motor carriers to provide drivers with better
opportunities to obtain sleep. Among other provisions, the regulations
(1) increase the required off-duty time from 8 to 10 consecutive hours;
(2) limit driving time to 11 cumulative hours following 10 consecutive
hours off duty; (3) prohibit work after the end of the fourteenth hour
after the driver began work; and (4) require long break recovery
periods to prevent cumulative fatigue (68 FR 22456-22517; April 28,
2003, as amended by 70 FR 50071; August 25, 2005).
Nuclear power plant licensees in the U.S. have sometimes asserted
that the characteristics of the work tasks in nuclear power plants
differ from other occupations that have work hour controls (e.g.
transportation equipment operators); therefore information from other
occupations may not be applicable. In addition, licensees have
suggested that the level of automation in nuclear power plants provides
an important barrier to human errors resulting from fatigue, and that
the amount of control room crew interaction and oversight of operators'
actions assures that fatigue-induced errors will be detected and
corrected before they have an opportunity to impact plant operations.
The NRC concurs that requirements for other industries should be
considered in context. Nevertheless, the fact that other Federal
agencies with a safety mission have established regulations to address
fatigue is relevant for several reasons.
First, the human need for sleep and the deleterious effects of
sleep deprivation have a physiological basis (e.g., changes in brain
glucose metabolism) that is independent of the nature of the work being
performed (Wu, et al., 1991). Second, circadian variations in alertness
and performance, and the underlying changes in physiological processes,
have been observed in individuals performing a wide range of tasks
across many industries (Kecklund, et al., 1997). For all individuals,
time since awakening, the time of day, and the amount of prior sleep
that an individual obtains relative to his or her sleep needs are
primary determinants of fatigue and the need for sleep.
The NRC acknowledges that task characteristics and time on task may
exacerbate the effects of fatigue on the ability of individuals to
remain alert. For example, a concern for task-specific effects is
reflected in the DOT hours-of-service regulations for commercial truck
drivers, which establish a daily limit on driving time of 11 hours per
day. This limit is in addition to the requirements prohibiting driving
after 14 hours on duty and mandating minimum 10-hour break periods,
which reflect the human physiological need for rest that is necessary
to maintain performance (68 FR 22456-22517; April 28, 2003).
By comparison to driving a truck, the characteristics of some jobs
in nuclear power plants (e.g., reactor operator) permit greater freedom
of movement and social interaction, which may serve to temporarily
mitigate the effects of fatigue on alertness. However, there is no
evidence to indicate that worker motivation or the stimulating effects
of the job or environment alter the underlying physiological processes.
Although crew interactions and other job characteristics may serve to
bolster worker alertness temporarily, environmental stimulation only
masks individuals' physiological need for sleep. Removing the
stimulation (e.g., transitioning from the activity of shift turnover to
monitoring steady state plant operations during a night shift) will
increase the potential for lapses in attention and uncontrolled sleep
episodes among individuals who may be partially sleep deprived or
otherwise fatigued.
Another consideration regarding the relevance of other regulations
limiting work hours is that adverse fatigue effects are observed across
a broad range of cognitive functions in addition to alertness. Whereas
crew interactions may help sustain alertness, sleep deprivation and
sustained periods of wakefulness continue to degrade other cognitive
functions (e.g., memory and decision making) and elements of
performance that are important to safe nuclear plant operations, such
as communications and following written and oral instructions. For
example, as discussed earlier in this section, studies of crew
performance in critical phases of commercial aircraft flight (e.g.,
take-off and landings) and in simulated battle command station
operations have shown fatigue-related degradations in performance
despite the stimulation of the interactions, the intense level of
activity, and the implications of degraded performance for the loss of
human life. Regulations limiting work hours in other industries that
use operating crews (e.g., aviation) and allow greater freedom of
movement than trucking (e.g. maritime) are consistent with this
understanding of the broad effects of fatigue on cognitive performance.
There is no reason to believe that nuclear power plant workers'
physiological processes and the adverse effects of fatigue on their
abilities to perform their tasks would differ. In addition, the notion
that human performance practices in the nuclear industry prevent
fatigue-related performance decrements from resulting in human errors
is not supported by studies that have shown circadian variations in
performance at nuclear power plants (Bobko, et al., 1998; Dorel, 1996;
Maloney, 1992).
The NRC acknowledges that the nuclear power industry is perhaps
unique, relative to many other
[[Page 16986]]
industries, in its use of automated safety systems to protect against
the consequences of equipment failure and human error. Nevertheless,
reliable human performance remains an essential element in the
protection of public health and safety and the common defense and
security. NRC requirements, such as the minimum onsite staffing
requirements of 10 CFR 50.54(m) and minimum security staffing
requirements in site security plans, are predicated on the expectation
that all personnel in these positions are fit for duty and are able to
safely and competently perform their duties. As a consequence, the NRC
does not consider the use of automated safety systems to be an
appropriate basis for permitting conditions that could allow fatigue to
degrade the important line of defense of reliable human performance.
Further, despite automated systems, the contribution of human error to
risk in operating events continues to be notable (NUREG/CR-6753,
``Review of Findings for Human Error Contribution to Risk in Operating
Events'').
Because the NRC concurs that task characteristics are an
appropriate consideration, the final rule differs from other Federal
agencies' requirements with respect to specific work hour requirements
and requires licensees to consider task characteristics when
authorizing any waiver from the work hour controls. Nevertheless, the
NRC believes that it remains relevant that other Federal agencies with
public safety missions have chosen to address worker fatigue through
regulation.
In summary, the NRC believes that the requirements in Subpart I
will provide a substantial increase in the protection of public health
and safety and common defense and security. In determining the
provisions of this final rule, the NRC has taken into consideration the
effects of fatigue on human performance, the specific work practices of
the nuclear power industry that both mitigate and contribute to
fatigue, the inadequacy of the former regulatory framework, the
excessive hours formerly worked by many nuclear power plant personnel,
and the relevant research and practices of other industries and
countries for regulating work hour limits. In addition, many public
meetings were held with the nuclear industry and the public to discuss
draft provisions for the final rule. The specific basis for each
provision of the fatigue management portions of the final rule are
discussed in Section VI.
The requirements for managing fatigue will provide a substantial
increase in the protection of public health and safety and common
defense and security by:
(1) Establishing specific, integrated, comprehensive, and
enforceable requirements for the effective prevention, detection, and
mitigation of worker fatigue;
(2) Ensuring that personnel who perform functions that are
significant to the protection of public health and safety or the common
defense and security are subject to appropriate work hour controls,
including: individuals performing risk significant operations or
maintenance duties; health physics, chemistry, and fire brigade duties
important to emergency response; and individuals performing security
duties important to maintaining the security of the plant;
(3) Establishing work hour controls that provide increased
assurance that workers will have adequate opportunity for rest and that
deviations from the work hour limits will only be authorized as
necessary for plant safety or security and following appropriate
assessment of the worker's ability to safely and competently perform
his or her duties;
(4) Ensuring that work hour deviations are only permitted when
necessary for plant safety or security, and following assessment of the
worker's ability to safely and competently perform his or her duties;
(5) Establishing controls to prevent cumulative fatigue that can
result from consecutive weeks of extended work hours;
(6) Ensuring workers are provided with sufficient break periods to
provide for adequate opportunity for sleep to mitigate acute and
cumulative fatigue;
(7) Ensuring that, in addition to work hours, other factors that
can affect worker fatigue and the ability of workers to remain alert
are adequately addressed through licensee FFD programs;
(8) Encouraging effective fatigue management by permitting
licensees to use alternate measures for prevention and mitigation of
fatigue; and
(9) Strengthening FFD training requirements concerning worker
fatigue. This will improve behavioral observation and assessment of
worker fatigue; self-declaration as a means for early detection of
fatigue; worker self-management of fatigue; the ability of workers to
obtain adequate rest on a shiftwork schedule; and licensee use of
effective fatigue counter-measures.
E. Subsequent Rulemakings
On August 28, 2007 (72 FR 49352), the Commission issued a final
rule amending its regulations by revising the provisions, particularly
10 CFR Part 52, applicable to the licensing and approval processes for
future nuclear power plants. The Part 52 final rule also clarified
portions of the former Part 26 to explicitly extend the applicability
of sections of the former Part 26 to a combined license holder after
the date that the NRC makes the finding under Sec. 52.103(g), a
combined license holder before the date that the NRC makes the finding
under Sec. 52.103(g), a manufacturing license holder under Subpart F
of 10 CFR Part 52, and a person authorized to conduct the construction
activities under Sec. 50.10(e)(3). The Part 52 final rule accomplished
this by:
(1) Revising the former Sec. 26.2(a) to refer to combined license
holders after the date that the NRC makes the finding under Sec.
52.103(g);
(2) Revising the former Sec. 26.2(c) to refer to a holder of a
combined license before the date that the NRC makes the finding under
Sec. 52.103(g), a holder of a manufacturing license under Subpart F of
Part 52, and a person authorized to conduct the activities under Sec.
50.10(e)(3);
(3) Revising the former Sec. 26.10(a) to refer to the personnel of
a holder of a manufacturing license and those authorized to conduct the
activities under Sec. 50.10(e)(3); and
(4) Revising the former Appendix A to Part 26, paragraph 1.1(1) to
include a reference to a holder of a combined license after the date
that the NRC makes the finding under Sec. 52.103(g).
The Part 52 final rule changes to Part 26 went into effect on
September 27, 2007. Each of the Part 26 provisions revised by the Part
52 final rule has been modified by this final rule, as discussed in
section VI of this document.
On October 9, 2007 (72 FR 57416), the Commission issued a final
rule amending its regulations applicable to limited work authorizations
(LWAs), which allow certain construction activities on production and
utilization facilities to commence before a construction permit or
combined license is issued. The LWA final rule modified the scope of
activities that are considered construction for which a construction
permit, combined license or LWA is necessary, specified the scope of
construction activities that may be performed under a LWA, and changed
the review and approval process for LWA requests. By making these
changes in the LWA final rule, the Commission also revised the scope of
Part 26 by clarifying which entities could be subject to Part 26. The
extent to which the LWA final rule impacted
[[Page 16987]]
Part 26 is discussed in section VI in this document.
V. Summary of Public Comments Submitted on Proposed Rule
Description of Public Comments and Public Meetings
The NRC received 81 written public comments on the proposed Part 26
published on August 26, 2005. The NRC also considered six comments
submitted on a previous working draft of the proposed rule that NRC
posted on its Web site on May 19, 2005, but which were received too
late to consider at that time. These 87 written comments contained more
than 350 pages of material. The stakeholders who submitted these 87
comments are as follows: 25 (29 percent) from nuclear energy industry
representatives, including several substantive comments from NEI; five
(6 percent) from other organizations; seven (8 percent) from unions; 21
(24 percent) from individuals who work in the nuclear energy industry
(i.e. operators, maintenance workers); 15 (17 percent) from other
individuals; and 14 (16 percent) from anonymous commenters.
The NRC considered comments contained in the transcript of a public
meeting held on September 21, 2005, in which 28 individuals, including
NRC staff, spoke. Four written comments were submitted anonymously at
this meeting. The NRC also considered comments from several other
public meetings: November 7 and 9, 2005 (ADAMS Accession No.
ML052990048) to provide clarification on the proposed rule; and
December 15, 2005 (ADAMS Accession No. ML053400002) regarding NEI's
proposed alternative approach to the work-hour portions of the proposed
rule.
The written comments received on the proposed rule addressed many
issues that were of stakeholder concern. The NRC analyzed all of these
comments as part of the process for developing this final rule. In
particular, commenters raised several important concerns relating to
fatigue management, the application of FFD requirements to entities
involved in new plant construction and manufacturing activities, and
validity testing of urine specimens. These concerns are discussed in
some detail below. As discussed in Section VI, commenters also raised
numerous other smaller issues that led the NRC to modify many final
rule provisions. Finally, many comments resulted in minor changes to
the proposed rule to improve clarity in the rule's organization and
language, consistent with Goal 6 of this rulemaking. Virtually all of
the comments supported the objectives of the proposed rule.
Public Comment on Subpart I
The NRC has reorganized the overall structure of the proposed rule
and renumbered several subparts. This necessitated renumbering the
affected sections of Subpart I [Managing Fatigue].
Subpart I contains requirements for the management of worker
fatigue at nuclear power plants. Most comments recommended
modifications to Subpart I to address specific concerns with the
proposed rule language or certain provisions of the rule. However, the
vast majority of the stakeholders commenting on Subpart I expressed
their general support for the NRC's objective of establishing a set of
clear and enforceable requirements to address the management of worker
fatigue at nuclear power plants. Commenters supported the fatigue
provisions for various reasons. In particular, commenters expected that
the rule would increase the clarity of work hour requirements, reduce
forced overtime, provide reasonable assurance that the risk of fatigue-
related events is managed, increase staffing levels, and prevent worker
injuries. Those who opposed the rule asserted that it would place an
unnecessary burden on licensees, reduce worker income, and make it more
difficult for licensees to attract supplemental workers during outages.
The NRC received several substantive comments that addressed
specific provisions in proposed Sec. 26.199 [Work hour controls]. This
section would have established requirements for the control of work
hours for a limited scope of personnel at a nuclear power plant. In
general, the individuals who would have been subject to these
requirements perform functions that most directly affect the protection
of public health and safety and common defense and security. The
provisions that were the subject of these comments were proposed Sec.
26.199(d)(2)(ii), which would have required a minimum 24-hour break in
any 7-day period; proposed Sec. 26.199(d)(2)(iii), which would have
required a minimum 48-hour break in any 14-day period; and proposed
Sec. 26.199(f) [Collective work hour limits], which would have
required licensees to control the average work hours of specified duty
groups (e.g., operations, security). The NRC also received substantive
comments on the reporting requirements in Subpart I of the proposed
rule. Specifically, the comments concerned the proposed Sec. 26.197(e)
[Reporting] which would have required licensees to provide information
concerning the implementation of certain work hour requirements as part
of an annual FFD program report.
Proposed Requirements for a Minimum 24-Hour Break in Any 7-Day Period
Section 26.199(d)(2)(ii) of the proposed rule would have required a
minimum 24-hour break in any 7-day period. Commenters noted that
licensees who currently use 8-hour schedules often include periods of 7
consecutive work days in their schedules. These schedules limit the
frequency of shift rotations and enable licensees to conduct training
on a Monday-through-Friday schedule. The commenters also asserted that
the requirement for a minimum 24-hour break in any 7-day period would
substantially reduce licensee flexibility in scheduling 8-hour shifts
and would cause them to switch to 12-hour shifts. The NRC agrees that
the proposed requirement for a minimum 24-hour break in any 7-day
period would have adversely affected licensee scheduling of 8-hour
shifts as described in the comments and has revised the maximum number
of work days that the rule permits between breaks.
Section 26.205(d)(2)(ii) of the final rule replaces proposed Sec.
26.199(d)(2)(ii) and requires a minimum 34-hour break in any 9-day
period. In revising the requirement, the NRC considered that, although
the final rule permits more consecutive work shifts for 8-hour and 10-
hour shift schedules, the additional flexibility allows licensees to
more readily optimize their 8-hour shift schedules to minimize the
transitions between day, evening, and night shifts that can lead to
worker fatigue. Although this relaxation also allows more consecutive
shifts for individuals on 10-hour shifts, these individuals typically
do not work a rotating schedule and therefore do not experience the
disruption of their circadian cycle that exacerbates the cumulative
fatigue effects of consecutive work shifts. The rule also establishes
minimum day of requirements in Sec. 26.205(d)(3) that effectively
limit within each shift cycle the number of times individuals can work
the 8 consecutive work days allowed by Sec. 26.205(d)(2)(ii). The
scheduling of 12-hour shifts is unaffected by this requirement because
Sec. 26.205(d)(1)(iii) effectively limits the scheduling of 12-hour
shifts to not more than 6 consecutive days. The final rule also
provides the licensee with sufficient flexibility to accommodate other
[[Page 16988]]
practical considerations, such as scheduling training on a Monday-
through-Friday basis, and allows a contingency day for 8-hour shift
schedules that include a series of seven consecutive 8-hour shifts.
The final rule also revises the minimum duration of the break
period from 24 hours, as specified in Sec. 26.199(d)(2)(ii) of the
proposed rule, to a minimum of 34 hours. The revision more clearly
reflects the NRC's intent to require a periodic ``day off'' in which
individuals have the opportunity for two consecutive sleep periods
without an intervening work period. The 34-hour break duration provides
this opportunity, supports use of forward rotating and fixed shifts,
and allows for the possibility that individuals may work 26 hours in a
48-hour period contiguous to the break.
Proposed Requirement for a Minimum 48-Hour Break in Any 14-Day Period
and Collective Work Hour Limits
Section 26.199(d)(2)(iii) of the proposed rule would have required
a minimum 48-hour break in any 14-day period. This requirement would
have provided periodic breaks to prevent and mitigate cumulative
fatigue. Although this requirement would have also been applicable when
a reactor was operating, the NRC considered it particularly important
for the control of work hours during outages. During these periods,
successive weeks of extended work hours (i.e., up to 72 hours per week)
are common. However, the NRC received substantive comments regarding
this provision.
Several commenters expressed concern that a mandatory 48-hour break
would limit the ability of licensees to provide adequate coverage for
unplanned maintenance (e.g., to quickly restore inoperable equipment).
Several commenters also stated that the break requirements would
encourage supplemental workers to seek jobs in other industries that
offer more overtime. Therefore, commenters were concerned that this
unintended consequence of the break requirements would harm the
licensees' ability to attract and retain qualified workers. Other
commenters stated that, although the recovery concept is scientifically
supported, the approach used to prevent cumulative fatigue should
consider existing work schedules and scheduling practices. Commenters
also asserted that a 48-hour break during a series of night shifts
would adversely affect the circadian cycle of those workers who had
adjusted to the night shift. These commenters stated that for workers
on the night shift, having 1 day off provides an additional rest period
and allows the worker to maintain a consistent pattern of work and
sleep habits, thus reducing the risk of accidents on the job. However,
two days off may interfere with a worker's sleep cycle, requiring the
individual to readjust to the night shift after a 2-day break.
Commenters also asserted that a 1-day break in any 7-day period is more
than adequate when combined with other rule provisions to address
cumulative fatigue.
The NRC considered public comments on the proposed 48-hour break
requirement in conjunction with public comments on the collective work
hour limits of the proposed rule. The collective work hour limits in
proposed Sec. 26.199(f) would have required licensees to control the
average work hours of specified groups of personnel that perform the
same job function. In general, this provision would have required
licensees to ensure that the collective work hours of individuals
within each group did not average more than 48 hours per week, when
averaged over a period of up to 13 weeks. The objective of the
collective work hour limits, like the 48-hour break requirement, was to
prevent cumulative fatigue. In contrast to the 48-hour break
requirement, the collective work hour limits would typically have been
applicable only when a reactor was operating. Thus, the 48-hour break
requirement in conjunction with the 24-hour break requirement of
proposed Sec. 26.199(d)(2)(i) would have been the principal mechanism
to address cumulative fatigue during outages, and collective work hour
limits would have been the principal means of preventing cumulative
fatigue while a plant was operating.
Some commenters stated that the collective work hour limits would
be an ineffective means for addressing fatigue because it is
experienced on an individual basis. That is, the collective work hour
limits could not ensure that each individual would be protected from
cumulative fatigue. One commenter stated that the collective work hour
controls would allow licensees to force individuals to work overtime.
Other commenters stated that licensees may be able to manipulate the
collective work hour calculations. Still other commenters asserted that
the collective work hour controls were unnecessary to mitigate the
effects of cumulative fatigue and that they would limit licensee
flexibility to increase work hours for a job-duty group based on
operational needs. These commenters stated that other rule provisions,
such as the work scheduling requirement, individual work hour limits,
individual break requirements, and the provisions concerning fatigue
assessments and the self-declaration process, adequately address the
possibility of cumulative fatigue.
The NRC agrees, in part, with certain comments on the proposed 48-
hour break requirement and the collective work hour limits of the
proposed rule, and has revised the final rule accordingly. To address
cumulative fatigue during periods when a plant is operating, the NRC
replaced the proposed rule requirement for a minimum 48-hour break in
Sec. 26.199(d)(2)(iii) and the collective work hour limits in Sec.
26.199(f) with the requirements in Sec. 26.205(d)(3) of the final
rule. This section requires that each individual subject to the work
hour requirements has a minimum average number of days off per week
while the plant is operating. This provision addresses comments on the
proposed 48-hour break requirement and collective work hour limits as
follows:
The minimum day-off requirements of Sec. 26.205(d)(3)
address cumulative fatigue on an individual basis. In contrast to the
proposed collective work hour limits, the final rule provides more
uniform assurance of worker FFD and addresses the concern that,
although duty groups could have met the collective work hour
requirements, individuals in those groups may have worked excessive
hours.
The minimum day-off requirements of Sec. 26.205(d)(3)
establish limits that in most circumstances are tailored to the
duration of the shifts that individuals work (e.g., individuals on 8-
hour shifts must average at least 1 day off per week; individuals on
10-hour shifts must average 2 days off per week). As a consequence, in
contrast to the single set of break requirements in the proposed rule,
the final rule provides a better correlation between the number of
hours an individual works and the amount of restorative rest required
by the rule.
The minimum day-off requirements of Sec. 26.205(d)(3)
establish a flexible approach to addressing cumulative fatigue. This
provision requires a minimum average number of days off per week,
averaged over a shift cycle of up to 6 weeks. Accordingly, the rule
does not require that individuals meet the average each week, but does
ensure that individuals receive a minimum number of days off over the
course of the shift cycle. As a consequence, the NRC has established a
requirement that accommodates a wide range of scheduling practices and
short-term fluctuations in workload. The
[[Page 16989]]
requirement also allows licensees considerable flexibility in
accommodating individual worker preferences concerning the timing and
distribution of days off.
The minimum day-off requirements of Sec. 26.205(d)(3)
establish limits that are practical and likely to impose less
administrative burden on licensees than would have been required by the
collective work hour limits in the proposed rule.\1\ By establishing
limits that require the control of work hours on an individual basis,
licensees need not define and track membership in duty groups. In
addition, the requirements in the final rule largely adopt an approach
proposed by NEI as an industry-recommended alternative to the group
work hour controls. Thus, the NRC expects that licensees will consider
the administrative requirements of this work hour control method to be
less burdensome.
---------------------------------------------------------------------------
\1\ Although the NRC believes that the minimum day off
requirements of Sec. 26.205(d)(3) will impose less administrative
burden on licensees than the collective work hour limits of the
proposed rule, the NRC has conservatively retained the
administrative burden estimate of the collective work hour limits
for Sec. 26.205(d)(3) of the final rule.
---------------------------------------------------------------------------
To address cumulative fatigue during periods when a plant is in a
unit or planned security system outage, the NRC has replaced the
proposed rule requirements for a minimum 48-hour break (Sec.
26.199(d)(2)(iii)) and the collective work hour limits applicable to
security personnel during outages (Sec. 26.199(f)(2)(i)) with the
requirements in Sec. 26.205(d)(4) and (d)(5) of the final rule.
Section 26.205(d)(4) requires that licensees provide individuals who
perform the operations, health physics or chemistry, and fire brigade
duties described in Sec. 26.4(a)(1) through (a)(3) of the final rule a
minimum of 3 days off in each successive 15-day period of a unit
outage. Section 26.205(d)(4) also requires that licensees provide
individuals who perform the maintenance duties described in Sec.
26.4(a)(4) at least 1 day off in any 7-day period. Section 26.205(d)(5)
applies to individuals who perform the security duties described in
Sec. 26.4(a)(5) of the final rule and requires a minimum of 4 days off
in each successive 15-day period of a unit outage or planned security
system outage. These final rule provisions address those comments on
the 48-hour break and collective work hour requirements applicable to
outage periods as follows:
The minimum day-off requirements of Sec. 26.205(d)(4) do
not mandate that licensees schedule 2 consecutive days off as would
have been required by the 48-hour break requirement. As a result,
licensees are better able to establish schedules that minimize the
potential for disrupting the circadian cycle of individuals who are on
fixed night shifts.
The minimum day-off requirements of Sec. 26.205(d)(4)
allow licensees substantial flexibility in scheduling the required days
off within the 15-day outage periods. As a result, licensees are able
to implement a range of scheduling options to meet known outage
schedule demands and have the flexibility to revise schedules as
necessary to address emergent needs.
The minimum day-off requirements of Sec. 26.205(d)(4)
allow licensees to use a predictable, repeating schedule. The
requirements permit a schedule of four consecutive 12-hour shifts
followed by 1 day off. This 5-day sequence can repeat three times in
each 15-day period creating a schedule that is predictable and
repeatable, characteristics typically desired by workers and
schedulers. This schedule limits the number of consecutive work shifts
to prevent cumulative fatigue and includes sufficient periodic days off
to mitigate fatigue. For individuals performing the maintenance duties
described in Sec. 26.4(a)(4) the requirement permits a predictable,
repeating schedule of 6 consecutive work days followed by 1 day off.
The minimum day-off requirements of Sec. 26.205(d)(4), in
conjunction with the other requirements in Sec. 26.205 [Work hours],
allow a maximum workweek of 72 hours and an average workweek of 67.2 to
72 hours for a period of up to 60 days. As a result, the requirements
allow licensees to offer substantial amounts of overtime within these
limits to attract supplemental workers for outage activities. The NRC
acknowledges that some individuals may want to work more than 72 hours,
or even more than 84 hours, per week. However, the NRC notes that the
work hour limits of Sec. 26.205 apply only to those duties that the
agency believes have the most direct impact on the protection of public
health and safety and common defense and security. As a result, the
requirements do not prevent individuals from working more than 72 hours
per week, unless those individuals are performing (1) duties on
structures, systems, and components (SSCs) that a risk-informed
evaluation process has shown to be significant to public health and
safety, (2) critical emergency or fire response duties, or (3) duties
as members of the site security force that are necessary for the
execution of the site security plan.
Several commenters recommended that the 8-week exclusion
period be extended to 10 weeks to accommodate extended outages for
activities such as reactor vessel head and steam generator
replacements. In conjunction with these comments, industry stakeholders
asserted at public meetings held for this rulemaking that cumulative
fatigue was not a concern during these extended outages because
individuals often had periods when they were not required to work the
extended work hours typically associated with outages. In response to
this comment, the NRC includes a provision in Sec. 26.205(d)(6) of the
final rule which allows licensees to extend the 60-day exception for
individuals by 1 week for each 7-day period the individual worked not
more than 48 hours during the outage. Thus, the rule allows the outage
exception to be extended when directly justified by an individual's
actual work history. In light of the significant work hours allowed by
the requirements, as discussed in the preceding paragraph, the NRC
considers this approach to be better justified for the management of
worker fatigue than the proposal for a blanket extension of the outage
exclusion to 10 weeks.
Section 26.205(d)(5) of the final rule applies to individuals who
perform the security duties described in Sec. 26.4(a)(5) and requires
a minimum of 4 days off in each successive 15-day period of a unit
outage or planned security system outage. This minimum days-off
requirement is comparable to the work hour limits imposed for security
personnel by order EA-03-038 and the 60-hour collective work hour
average that the proposed rule would have required. The NRC replaced
the collective work hour limits for security personnel with the
requirements in Sec. 26.205(d)(5) of the final rule for the following
three reasons:
(1) In addition to other commenters, security personnel expressed
concerns about the effectiveness of the collective work hour controls
to fully protect against impairment from fatigue for all personnel in a
group.
(2) Elimination of the 48-hour break requirement sets aside a key
requirement for preventing an excessive number of consecutive work days
that would have otherwise been allowed under the collective work hour
limits. As a result, the NRC concluded that the collective work hour
limits, absent the 48-hour break requirement, would not provide
reasonable assurance that nuclear power plant security personnel would
be protected from cumulative fatigue from excessive work hours.
(3) Revision of the outage requirements to a minimum of 4 days off
in a 15-day period avoids the potential confusion and additional
[[Page 16990]]
burden of two different approaches and accounting systems (i.e.,
minimum day off requirements and collective work hour limits) for the
control of personnel work hours at a site.
The NRC believes that the minimum day-off requirements of Sec.
26.205(d)(3) through (d)(6) of the final rule address the range of
comments on the rule, several of which expressed opposing views
regarding the need to relax the requirements or to make them more
restrictive.
The NRC does not agree with the comments that asserted that the
proposed requirements to address cumulative fatigue were unnecessary
and that a 1-day break in any 7-day period is more than adequate when
combined with the other rule provisions (e.g., self-declaration and
training) to address cumulative fatigue. The NRC has concluded that,
given a broad range of considerations, a 1-day break in any 7-day
period is an appropriate requirement for individuals performing the
maintenance duties described in Sec. 26.4(a)(4) for a limited time
period during unit outages. The NRC has also concluded that additional
days off are necessary for individuals performing other duties
described in Sec. 26.4(a) to ensure that those individuals are not
impaired by the cumulative fatigue that would result if they routinely
worked the maximum work hours that would otherwise be allowed by the
requirements in Sec. 26.205(d)(1) and (d)(2). Accordingly, the final
rule requires more than a 1-day break in any 7-day period for
individuals performing the duties described in Sec. 26.4(a)(1) through
(a)(3) and (a)(5) during unit outages. For periods when the plant is
operating, the final rule requires that all individuals working 10 or
12-hour shifts receive on average more than one day off per week. The
rule requires only one day off per week on average for individuals
working 8-hour shifts because individuals on 8-hour shifts could not be
practically scheduled at the maximum work hours allowed by the
requirements in Sec. 26.205(d)(1) and (d)(2).
The NRC acknowledges the important role of self-declaration and
training in fatigue management, as noted by some commenters, but also
recognizes the inherent limitations of these provisions to effectively
address fatigue, particularly during periods of outage schedule
conditions. As noted by Michael T. Coyle, NEI, comment letter
49, and supported by several other commenters, ``for many
supplemental workers the availability of overtime is a key factor in
where they decide to work.'' The NRC also recognizes that outages are
periods when individuals may perceive increased schedule pressure and
is aware that at least one site offered bonuses for perfect attendance
during outages. Self-declaration would likely cause individuals to
forfeit a portion of that overtime and possibly a bonus. As a result,
despite the best efforts of licensees to emphasize safety and worker
FFD, the NRC anticipates that self-declaration and training in methods
to obtain adequate rest may not be implemented as effectively or
consistently during outage periods as during periods of routine plant
operation, and therefore, they are not a substitute for work hour
controls that effectively prevent cumulative fatigue.
In asserting that a 1-day break is more than adequate to address
cumulative fatigue, industry stakeholders have cited the basis for the
Federal Motor Carrier Safety Administration's (FMCSA) minimum 34-hour
break provision for commercial motor vehicle (CMV) operators. The NRC
reviewed the FMCSA regulations (49 CFR Part 395), associated statements
of considerations (65 FR 25540 (May 2, 2000); 70 FR 49978 (Aug 25,
2005), the findings of an expert panel commissioned by the FMCSA
(Belenky et al., 1998), a petition for review of the final rule (Brief
of Public Citizen, et al., Owner-Operator Independent Drivers Ass'n,
Inc. v. Federal Motor Carrier Safety Admin., 494 F.3d 188 (D.C. Cir.
July 24, 2007) (No. 06-1035) (``FMCSA'')), and the decision of the
court with regard to the petition. FMCSA. The NRC concluded that, for a
limited range of conditions, the studies cited by FMCSA support a 34-
hour break as an appropriate minimum rest period. However, the NRC
staff does not agree that the basis cited by the FMCSA supports a
requirement that would routinely allow 72 hours of work for all nuclear
power plant workers performing functions important to the protection of
public health and safety before such a break is required. The NRC notes
that:
(1) The FMCSA regulations for CMV operators include requirements
that prohibit driving after 60 hours of duty in 7 days. By contrast the
NEI proposal would allow 72 hours of work in a 7-day period, excluding
turnover.
(2) The statement of considerations for the FMCSA regulation
establishes that long work weeks with minimum break periods are the
exception for CMV operators. The FMCSA sets forth this information as a
premise for the adequacy of the 34-hour break. By contrast, application
of the industry proposed requirement to the control of work hours
during unit outages would allow licensed operators \2\ and other plant
personnel to work regularly occurring periods of multiple consecutive
72-hour work weeks with minimum break periods. The NRC notes that a
federal appeals court vacated the 2005 provision of the FMCSA
requirements that would have permitted a 34-hour break to restart the
weekly limits. Among the reasons cited by the court was that FMCSA's
operator-fatigue model did not ``account for cumulative fatigue due to
the increased weekly driving and working hours permitted by the 34-hour
restart provision.'' FMCSA at 206.
---------------------------------------------------------------------------
\2\ At multi-unit sites with common control rooms, all licensed
operators would be subject to the limits applicable to unit outages,
including operators responsible for operating units.
---------------------------------------------------------------------------
(3) Contrary to the NEI assertion that a 34-hour break is ``more
than adequate'' the expert panel commissioned by the FMCSA described
the 34-hour break as ``absolutely minimal.'' Further, the expert panel
noted that a fundamental assumption for the adequacy of the 34-hour
break is that it will provide two consecutive nights of uninterrupted
sleep between midnight and 6 a.m. Given common outage scheduling
practices, the NRC believes that no workers on night shifts and few
workers on day shifts would meet this assumption.
In addition, the NRC does not agree with industry stakeholder
comments that an opportunity for 8 hours of sleep between shifts
prevents cumulative fatigue. This argument is contrary to common
experience in that it implies workers should be able to work 12 hours
per day, without degradation in their performance, for an unlimited
number of days. To the contrary, the National Institute for
Occupational Safety and Health (NIOSH) found that ``up to five
consecutive 12/14-hour shifts * * * creates the potential for excessive
fatigue, even when 8 hours of sleep per day are obtained'' (2000 NIOSH
3). Similarly, the NRC notes that it has received increased reports of
excessive fatigue following extended periods of 12-hour shifts, such as
in the months following the terrorist attacks of September 11, 2001,
and during the extended head replacement outage at Davis Besse (NRC
Inspection Report 05000346/2004003, dated March 31, 2004, ADAMS
Accession No. ML040910335). The NRC found that workers typically did
not average more than 60 work hours per week during these periods. As a
result, even if a 34-hour break was adequate to mitigate cumulative
fatigue from 72 or more hours of work, the 1 day off in a 7-day
[[Page 16991]]
period that the industry's proposed would not ensure that breaks would
be provided on a sufficient frequency to prevent weekly occurrences of
cumulative fatigue. A NIOSH review (Caruso, et al., 2004) of 52 recent
reports examining the association between long work hours and illness,
injuries, health behaviors, and performance, reported ``a pattern of
deteriorating performance on psychophysiological tests as well as
injuries while working long hours was observed across study findings,
particularly when 12-hour shifts combined with more than 40 hours of
work a week.''
Considering the limitations of the technical basis cited by the
industry and its applicability to outage scheduling practices and
operating experience and technical literature indicating that 1 day off
in 7 days is not adequate for recovery when individuals are working in
excess of 60 hours per week, the NRC concluded that the industry
proposal would not effectively prevent cumulative fatigue for
individuals performing the operations, health physics, chemistry, fire
brigade and security duties described in Sec. 26.4(a)(1) through
(a)(3) and (a)(5) for multiple consecutive weeks of extended work
hours. The NRC considers the minimum day off requirements of the final
rule provide adequate flexibility to accommodate emergent work and a
range of scheduling practices while supporting reasonable assurance of
worker FFD. By limiting the use of the maximum work hours and minimum
break guidelines to a ``temporary basis,'' the requirements of Sec.
26.205(d)(3) through (d)(6) are consistent with the NRC's long-standing
``Policy on Factors Causing Fatigue of Operating Personnel at Nuclear
Reactors.''
Proposed Reporting Requirements
Many comments addressed the reporting requirements for the fatigue
provisions. Section 26.197(e) of the proposed rule would have required
licensees to submit, as part of the annual FFD program report required
under Sec. 26.717 [Fitness-for-duty program performance data] of the
final rule, information concerning the licensee's implementation of the
work hour controls and management of worker fatigue. The proposed rule
would have required the annual report to include a summary of the
waivers the licensee approved during the calendar year, information
pertaining to instances of job duty groups exceeding a collective work
hour average of 48 hours in any averaging period during the calendar
year, and information pertaining to instances of fatigue assessments
conducted during the calendar year.
Several commenters from industry asserted that the reporting
requirements in the proposed Sec. 26.197(e) should be deleted from the
rule because they would not provide new or unique information to the
NRC, would be unnecessary to protect public health and safety, would be
unnecessary to facilitate NRC oversight of the revised rule, and would
be unduly burdensome. One commenter further stated that the NRC's
proposed FFD rule and supporting materials did not demonstrate that the
industry would fail to comply with the requirements of the revised rule
without the imposition of these reporting requirements. The commenter
asserted that the existing regulatory process is adequate to ensure
compliance with the rule. Some commenters believed that the reporting
requirement would create a significant duplication in licensee efforts,
noting that proposed Sec. 26.199(j) required periodic reviews by
licensees to assess the effectiveness of the work hour controls, and
that these reviews are documented and trended under the licensee's
corrective action program which is periodically inspected by the NRC.
Some commenters stated that the reports the rule would require
would not be a meaningful indicator of licensee performance in managing
work hours because a number of valid conditions may warrant waivers of
work hour controls. Two commenters suggested that the rule require
licensees to report the number of workers covered under Sec. 26.199(a)
[Individuals subject to work hour controls] of the proposed rule to
provide appropriate context for the annual reporting of waivers.
Several commenters from industry also stated that the NRC did not
meet its obligation under the Paperwork Reduction Act with respect to
the information collection requirements proposed in Sec. 26.197(e).
They argued that the NRC failed to adequately justify the need for
these provisions to achieve the objectives of the proposed FFD rule and
failed to objectively support its estimate of the burden placed on
affected licensees. The commenters asserted that the annual report
would require at least 30 clerical hours to develop and 20 management
hours to review.
In response to public comments on the reporting requirements, the
NRC revised certain requirements for the inclusion of fatigue
management information in the annual FFD program report. The NRC also
made conforming changes to the reporting requirements as part of
changes to other provisions of the rule.
Section 26.203(e) [Reporting] of the final rule presents the
reporting requirements associated with licensee implementation of
Subpart I. This section does not retain the requirements in proposed
Sec. 26.197(e)(2) for the reporting of information pertaining to the
control of collective work hours because the final rule does not
include collective work hour controls. In addition, the agency revised
the requirements in proposed Sec. 26.197(e)(1) and (e)(2) in response
to comments that the required information would not provide a
meaningful indication of licensee performance in managing work hours
because a number of valid conditions may warrant waivers of work hour
controls. Through its review of authorized waivers from the work hour
limits in plant technical specifications, the NRC has found that
waivers are most frequently associated with outage activities.
Accordingly, the NRC has revised the final rule to require licensees to
report whether a waiver of the work hour requirements in Sec. 26.205
was associated with an outage activity.
As a result of these revisions, the NRC will be better able to
interpret a licensee's changes in waiver use over time and understand
why certain annual reports for a given licensee may indicate a
heightened level of waiver use relative to the licensee's previous
reports. The NRC recognizes that outages are not the only cause of
waivers; however, the agency expects that most other causes of waiver
use will be for substantially shorter periods of time or involve
smaller groups of workers and that these other conditions would not
have a substantive effect on overall waiver use. For unique causes that
may have more substantive effects (e.g., licensee response to
hurricanes), the NRC is likely to be aware of or able to identify these
conditions if they were to significantly affect waiver use. The NRC
notes that the frequency of waiver use (i.e., how often individuals
exceed the work hour limits while performing functions important to
safety and security) indicates the potential for worker fatigue to
affect the performance of these functions, regardless of whether a
waiver is the result of an activity associated with an outage or a
cause that is beyond the licensee's control.
In addition to requiring an indication of whether a waiver was
associated with an outage activity, the NRC revised the annual report
requirement to require a frequency distribution of waivers for each of
the five duty groups described in Sec. 26.4(a) of the final rule. As a
result, the annual report would include, for
[[Page 16992]]
example, a table that shows the number of operators who received just
one waiver during the year, the number of operators who received two
waivers during the year, and so on. The NRC incorporated this
requirement in the final rule in response to comments that the rule
should also require licensees to report the number of workers covered
under Sec. 26.199(a) of the proposed rule to provide an appropriate
context for the annual reporting of waivers. The NRC understood that
the intent of this comment was to provide a basis for evaluating the
number of waivers from the work hour controls relative to the number of
individuals subject to those controls. The NRC chose not to require
licensees to report the number of individuals covered under Sec.
26.4(a) of the final rule because that number will vary throughout the
course of the reporting period, particularly when the reporting period
includes a unit outage. In addition, the NRC believes that the required
distribution of waivers more effectively provides context to the waiver
use information by indicating whether the waivers were concentrated
among individuals performing a certain duty and whether the waiver use
in a duty group was associated with relatively few individuals or
distributed among many individuals.
The NRC does not agree with comments that the requirements for
including fatigue management information should be deleted from the
rule because they would not provide new or unique information to the
NRC, would be unnecessary to protect public health and safety, would be
unnecessary to facilitate NRC oversight of the revised rule, and would
be unduly burdensome. In choosing to retain reporting requirements for
waiver use, the NRC considered several aspects of the work hour
requirements in the final rule. First, the NRC established the work
hour limits in the final rule at levels such that the potential for
fatigue is substantive for individuals working in excess of those
limits. Second, the rule permits licensees to authorize waivers of the
limits only for circumstances in which the additional work hours are
necessary to prevent or mitigate a condition adverse to safety or
security. Finally, the rule only requires a waiver if the individual is
operating or maintaining an SSC that a risk-informed evaluation process
has shown to be important to the protection of public health and safety
or if the individual is performing specified functions that are
essential to an effective response to a fire, plant emergency, or
implementation of the site security plan. As a result, information
concerning licensee use of waivers indicates (1) the number of hours
worked on risk-significant activities by individuals who are at
increased potential for impairment, and (2) how often a licensee must
mitigate or prevent a condition adverse to safety while relying on
individuals who are at increased potential for impairment. The NRC
considers this unique information, not otherwise reported, to be
relevant to the agency's mission.
The NRC similarly considered the need to retain reporting
requirements regarding fatigue assessments and any management actions
in response to the fatigue assessments. The NRC concluded that the
fatigue assessment information that would have been reported under the
requirements of the proposed rule is more the purview of a licensee's
corrective action program, and would have been more detailed than the
program performance data for drug and alcohol testing required under
Sec. 26.717(c) of the final rule. Accordingly, the final rule requires
licensees to report a summary of corrective actions, if any, resulting
from the licensee's analysis of waiver and fatigue assessment data. As
a consequence, the required reports will provide information that will
focus more on licensee performance in managing worker fatigue and will
enable NRC to review licensee reporting of waivers in the context of
associated corrective actions.
The NRC expects that the information provided by licensees in
response to the annual reporting requirements in Subpart I will
facilitate NRC oversight of the implementation of the requirements
through the following means:
Consistency, efficiency, and continuity of NRC oversight--
Information provided through the annual FFD program performance reports
concerning fatigue management will enable the NRC to achieve a higher
level of consistency and efficiency in the oversight of the
implementation of the requirements in Subpart I and in the enforcement
of those requirements. Without the reporting requirements, the NRC's
inspection of licensee FFD programs would likely be limited to
individual inspectors evaluating licensee fatigue management for a
sample of workers at a site for a limited time period. These
assessments would necessarily be conducted without the benefit of
broader contextual information from the site or the industry normative
information that would be available through the annual reports. In
contrast, the annual reports will help ensure a common perspective and
maintain consistency among inspectors conducting the oversight process.
In addition, the annual reports can enhance the efficiency of the NRC
inspection process by providing information necessary to allow the
agency to focus inspection resources on duty groups (e.g., security or
maintenance) that may warrant review. The reports will enable the NRC
to be better focused in preparing for the inspection, reduce the burden
of onsite inspection hours, and potentially reduce the total number of
hours required for a baseline inspection. Further, the annual reporting
will also help to achieve a more complete and continuous assessment of
licensee performance because the NRC intends to conduct the baseline
inspection of FFD programs only once every 2 years.
Evaluation of rule implementation for lessons learned--
Although the NRC and stakeholders have made extensive efforts to ensure
clear and enforceable requirements that are effective and practical for
the management of worker fatigue, the rule introduces the potential for
unintended consequences and lessons learned. In addition, changes in
the size and composition of the nuclear industry may have unforeseen
implications for site staffing and fatigue management. The NRC expects
that the site-specific and normative information obtained through the
annual reports can provide important insights regarding opportunities
to amend the rule to improve its effectiveness or reduce unnecessary
burden. The NRC notes that information provided by the FFD program
performance reports was the basis for reducing the random testing rate
for drugs and alcohol required in a previous amendment to Part 26.
Consistent interpretation of waiver criterion--The final
rule provides licensees the discretion to use waivers to exceed the
work hour limits, thereby allowing levels of work hours that could
adversely affect worker FFD. The principal basis for allowing waivers
is to reduce the additional staffing burden that licensees would
otherwise incur if waivers were not available to address exigent
circumstances. The annual reporting of waiver use in conjunction with
the corrective action summaries will enable the NRC to ensure that
licensees use this discretion in a manner consistent with the
objectives of the rule and not as a means to compensate for a lack of
adequate staffing. Further, although the use of waivers is limited to
conditions when the work hours are ``necessary to prevent or mitigate a
condition adverse to safety or security,'' the NRC recognizes the
potential for licensees to develop different
[[Page 16993]]
interpretations regarding this criterion. Some industry commenters on
the proposed rule took exception to the NRC's characterization of high
levels of waiver use at some sites as abuse. These commenters suggested
that differences in licensee waiver practices could be attributed to
the policy being subject to a number of interpretations during the many
years that it has been in effect. Regardless of the cause of the
differences in licensee use of work hour control waivers, the NRC
considers it prudent to address, through rulemaking, the lessons
learned from past implementation of the policy and provide a level of
oversight through the annual reporting requirement that will ensure
consistent implementation of the waiver criteria in the future.
In addition to the reasons cited in the preceding paragraphs
explaining the need for reporting requirements to ensure the effective
and efficient oversight of the implementation of the rule, the NRC
considers the reporting requirements to be justified and beneficial for
the following additional reasons:
Consistency with other Part 26 requirements and
performance objective--The final rule retains the requirement of the
former rule that licensees must report the results of drug and alcohol
testing and the performance objective for reasonable assurance that
individuals are not impaired from any cause (Sec. Sec. 26.719
[Reporting requirements] and 26.23(b) of the final rule). In addition,
several studies discussed in detail in Section IV.D of this document
have demonstrated that worker fatigue can produce levels of impairment
that are comparable to blood alcohol concentrations above the levels
permitted by this rule. Further, given the frequency of worker concerns
regarding fatigue and the work scheduling practices that are common
during outages, the incidence of impairment from fatigue is likely to
be greater than the very low incidence of drug and alcohol use that is
detected through testing. Therefore, the NRC considers the reporting of
information pertaining to licensee management of worker fatigue to be
consistent with the requirements for reporting information pertaining
to drug and alcohol testing, the performance objective of this
rulemaking for licensees to implement a comprehensive FFD program, and
the NRC's belief that the management of worker fatigue is no less
important to worker FFD than the effective detection and deterrence of
drug and alcohol use.
Public confidence--Public interest groups such as the UCS
and the Project on Government Oversight have commented at public
meetings that relevant information regarding worker fatigue is withheld
to either protect alleger identity or, in the case of security
personnel, plant security. In addition, several public media articles
have been published during the past 2 years reporting instances of
guards sleeping and guards fearing repercussions for refusing forced
and excessive overtime. Information submitted by licensees in the
annual reports will be publicly available and will reassure public
stakeholders that the NRC is appropriately cognizant of licensee
actions regarding fatigue management and that the NRC's oversight of
these activities is transparent to all stakeholders.
The burden is limited and justified--Section 26.203(e) of
the final rule requires licensees to report information concerning
fatigue management as part of the annual FFD program report. As a
result, the burden associated with this reporting requirement is an
incremental change to the reporting requirement for drug and alcohol
testing. In addition, the fatigue management information required by
Sec. 26.203(e) of the final rule is largely information that licensees
will have already generated to demonstrate compliance with other
provisions of Subpart I. As a result, the burden associated with the
report will be largely associated with compiling the information in an
appropriate form and reviewing that compilation. The NRC has reviewed
the public comments suggesting that the agency underestimated the
number of clerical and management hours associated with this
requirement and has taken these comments into consideration in
estimating the burden of the reporting requirements in Sec. 26.203(e)
of the final rule. Nevertheless, the NRC considers the burden
associated with the annual reporting requirements to be justified for
the reasons described in this and the preceding paragraphs.
The NRC also considered comments that the reporting requirement
ignores significant duplication in licensee efforts. The NRC agrees
that Sec. 26.205(e) of the final rule requires licensees to
periodically review and assess the effectiveness of the work hour
controls and that the licensee's corrective action program, which is
routinely inspected by the NRC, will document and trend these reviews.
However, as noted previously, the NRC considers the annual reports to
be a limited burden that will enable the NRC to provide more effective
and consistent oversight and achieve other objectives for the effective
implementation of the requirements in Subpart I.
Public Comments on FFD Programs for Construction and Manufacturing
In response to substantive public comments and industry efforts to
develop guidance on the subject, the NRC has added Subpart K to the
final rule to clarify Sec. 26.3(e) of the proposed rule, which
contained requirements for combined license holders, combined license
applicants, construction permit holders, construction permit
applicants, as well as manufacturing license holders under Part 52.
Subpart K's FFD program is intended to provide reasonable assurance
that individuals involved in the construction of a nuclear power plant
who perform specified duties at the site are fit for duty, trustworthy,
and reliable, commensurate with the potential risks to public health
and safety and the common defense and security that their activities
and access to certain information would pose.
Proposed Sec. 26.3(e) would have retained and updated the
requirements of Sec. 26.2(c) of the former rule. However, proposed
Sec. 26.3(e) would not have revised the basic approach taken in former
Sec. 26.2(c). The former rule specified the regulations in Part 26
that applied to licensees holding permits to construct a nuclear power
plant. Section 26.2(c) of the former rule required each construction
permit holder with a plant under active construction to comply with
Sec. Sec. 26.10 [General performance objectives], 26.20 [Written
policy and procedures], 26.23 [Contractors and vendors], 26.70
[Inspections], and 26.73 [Reporting requirements] of the former rule.
This provision also explained that permit holders with plants under
active construction were required to implement a chemical testing
program, including random tests, and make provisions for employee
assistance programs (EAPs), imposition of sanctions, appeals
procedures, the protection of information, and recordkeeping.
Proposed Sec. 26.3(e) would have explicitly reflected the NRC's
combined licensing procedure for nuclear power plants under 10 CFR Part
52, ``Early Site Permits; Standard Design Certifications; and Combined
Licenses for Nuclear Power Plants.'' It would have specified the
entities that are regulated by the NRC (specifically, combined license
holders before the Commission has made the finding under Sec. 52.103
[Operation under a combined license], combined license applicants who
have received authorization to construct under Sec. 50.10(e)(3),
construction permit
[[Page 16994]]
holders under Part 50, ``Domestic Licensing of Production and
Utilization Facilities,'' construction permit applicants who have
received authorization to construct under Sec. 50.10(e)(3), and
holders of manufacturing licenses under Part 52) who would be
responsible for meeting certain Part 26 requirements. (The Part 52
final rule amended Sec. 26.2(c) of the former rule to include in Sec.
26.2(c) combined license holders before the date that the Commission
makes the finding under Sec. 52.103(g), holders of manufacturing
licenses, and persons authorized to conduct the activities under Sec.
50.10(e)(3).)
The proposed rule would have replaced the cross-references to other
sections of the former rule with updated cross-references to the
related sections in the proposed rule (i.e., Sec. Sec. 26.23
[Performance objectives], 26.41 [Audits and corrective action], and
26.189 [Determination of fitness]). The proposed rule would also have
stipulated that the specified entities should implement a drug and
alcohol testing program, including random testing, and make provisions
for EAPs, imposition of sanctions, procedures for the objective and
impartial review of authorization decisions, protection of information,
and recordkeeping. However, the proposed rule did not specify in detail
how the FFD programs of the entities listed in proposed Sec. 26.3(e)
were to address these topics or the categories of workers who would be
subject to the programs.
Some comments received during the public comment period stated that
the proposed rule did not clearly describe the type of FFD programs the
NRC expected under proposed Sec. 26.3(e). Commenters stated that
because the proposed rule required FFD programs for construction to
comply with a few specific sections of the rule, it would have imposed
virtually all of the rule's requirements on FFD programs for
construction, because it would be difficult to ensure compliance with
the referenced sections of the rule without applying the entire rule.
Other comments received from industry representatives during the public
comment period indicated that the NRC should not require FFD programs
for construction that are more rigorous than industrial safety programs
implemented during construction of other large, commercial facilities
because construction activities do not pose risks to public health and
safety or the common defense and security until nuclear fuel arrives on
site. In response to these comments, the NRC staff gathered additional
information about FFD programs for construction in other industries,
developed a new Subpart K, ``FFD Programs for Construction,'' and
revised other sections of the rule to clarify the scope of requirements
for construction activities.
The results of the NRC staff's benchmarking activities indicated
that, as a result of the higher incidence of substance problems among
construction workers than other occupational groups, pre-employment,
for-cause, and post-accident drug and alcohol testing are increasingly
common at large, commercial construction projects and some labor union
coalitions have implemented drug and alcohol testing and substance
abuse treatment-referral programs for their members. In addition, the
staff also identified several private-sector entities in the
petrochemical and steel manufacturing industries that require drug and
alcohol testing, including random testing, for construction workers on
large projects, as well as employment history evaluations and other
background checks. Where safety and/or security during construction are
critical, large construction projects initiated by some Federal
agencies (e.g., the Department of Energy) require drug and alcohol
testing, including random testing, extensive background checks, and
continuous behavioral observation for the most sensitive construction
tasks. The NRC concluded that (1) implementing FFD requirements for new
nuclear power plant construction activities is consistent with the
practices of other industries, and (2) taking a graded approach to FFD
requirements, by imposing requirements that are commensurate with the
potential risks to public health and safety and the common defense and
security that the results of construction activities may pose when a
plant begins operations, is consistent with the approach implemented by
other government agencies when constructing facilities that have the
potential to affect public health and safety or the common defense and
security.
The NRC also determined that some of the requirements in proposed
Sec. 26.3(e) would be difficult to implement. For example, much of the
nuclear power plant construction workforce will likely be transient and
rapidly changing. As a result, it may be challenging to conduct random
drug and alcohol testing in a manner that would meet all of the random
testing requirements Part 26 includes for operating plants. In
addition, some new reactors will be constructed near an operating plant
that has readily accessible FFD program resources, such as a specimen
collection and alcohol testing site, a licensee testing facility, an
FFD training program, and expert staff (e.g., a substance abuse expert,
MRO, or EAP representative). However, other new reactors may be
constructed at locations that are distant from the FFD program
resources of an operating plant. Therefore, the NRC concluded that
applying some of the requirements in the proposed rule would be overly
burdensome, such as requiring random testing of all construction
workers, the requirement for all nuclear power plant construction
workers to have access to an EAP, and the proposed requirement for a
determination of fitness process performed by a substance abuse expert
under Sec. 26.189 of the final rule.
To streamline administration of the FFD program for construction,
add flexibility, and implement an approach that is commensurate with
the potential risks resulting from new plant construction, the final
rule requires two different levels of FFD requirements for workers in
different job roles. Because of their important oversight
responsibilities, the first category of workers, specified in Sec.
26.4(e), includes any individual whose duties, once construction
activities begin, require him or her to perform the following
activities at the location where the nuclear power plant will be
constructed and operated: serve as security personnel required by the
NRC; perform quality assurance, quality control, or quality
verification activities related to safety- and security-related
construction activities; based on a designation under Sec. 26.406 by a
licensee or other entity, monitor the fitness of the individuals
specified in Sec. 26.4(f); witness or determine inspections, tests,
and analyses certification required under Part 52; supervise or manage
the construction of safety- or security-related SSCs; or direct or
implement the licensee's or other entity's access authorization
program. These individuals must be subject to a full FFD program that
meets the same requirements as FFD programs for operating plants
(including random drug and alcohol testing at the 50 percent annual
rate, behavioral observation training, and a suitable inquiry/
employment history check but excluding the requirements of Subpart I)
when they are performing duties at the location where the nuclear power
plant is being constructed and will operate. However, individuals who
serve as security personnel required by the NRC must meet the
requirements applicable to security personnel in Sec. 26.4(a)(5) at
the time the licensee or other entity
[[Page 16995]]
receives special nuclear material in the form of fuel assemblies.
A new definition of ``supervises or manages'' in Sec. 26.5
explains that these terms mean the exercise of control over work
activity by an individual who is not directly involved in the execution
of the work activity, but who either makes technical decisions for that
activity without subsequent technical review, or is ultimately
responsible for the correct performance of that work activity. The
reference to security personnel is modified by the addition of the
words ``required by the NRC'' to clarify that the FFD requirements are
meant to apply to security personnel who perform duties specified by
NRC regulations and orders, while other security personnel, if any, are
not covered by the requirements.
By contrast to the requirements for those individuals listed under
Sec. 26.4(e), Sec. 26.4(f) provides that the FFD program in Subpart K
applies only to individuals who are constructing or directing the
construction of safety- or security-related SSCs. Section 26.5 explains
that ``construction or construction activities'' means the tasks
involved in building a nuclear power plant that are performed at the
location where the nuclear power plant will be constructed and
operated, and that these tasks include fabricating, erecting,
integrating, and testing safety- and security-related SSCs and the
installation of their foundations, including the placement of concrete.
At a minimum, these individuals must be subject to an FFD program that
meets the requirements of Subpart K, which emphasizes performance
objectives and does not incorporate all of the requirements of Part 26,
unless the licensee or other entity chooses to subject them to an FFD
program that meets the Part 26 requirements for operating plants,
except the fatigue management requirements in Subpart I of the final
rule. The rule adds new definitions of ``safety-related SSCs'' and
``security-related SSCs'' (described further in Section VI.A of this
SOC) that clarify the intended coverage of Sec. 26.4(f).
If a licensee or other entity specified in Sec. 26.3(c) of the
final rule chooses to implement an FFD program for construction under
Subpart K, the entity must submit to the NRC a description of the FFD
program and its implementation as part of the license, permit, or
limited work authorization application. The description must include a
written FFD policy that will be given to all individuals covered by the
program and FFD procedures. The program must include pre-assignment,
for-cause, and post-accident drug and alcohol testing. Subpart K
requires an FFD program for construction to include sanctions for FFD
policy violations, a system of files and procedures to protect personal
information, and procedures for reviewing determinations that an
individual has violated the FFD policy. The entity who elects to
implement a program under Subpart K must conduct periodic audits,
maintain records, provide reports to the NRC, and develop and apply
procedures for suitability and fitness evaluations to determine whether
to assign individuals to constructing safety- and security-related
SSCs. The program description will be evaluated as a part of the
application for the license, permit, or limited work authorization and
the NRC's finding on the application will include a finding on the FFD
program description. Before work begins on the foundations, including
placement of concrete, for the safety- or security-related SSCs under
the license, permit, or limited work authorization, the entity will be
required to implement the FFD program that it has described in its
application.
To detect and deter substance abuse by individuals who are
constructing safety- and security-related SSCs, Subpart K of the final
rule permits a licensee or other entity listed in Sec. 26.3(c) of the
final rule to subject these individuals either to random testing for
drugs and alcohol or a fitness monitoring program. Subpart K also
permits FFD programs for construction to--
(1) Collect specimens other than urine for drug testing and/or rely
on collection sites at local hospitals or clinics that conduct testing
under U.S. DOT procedures, rather than those specified in Subpart E,
``Collecting Specimens for Testing,'' of Part 26;
(2) Rely on healthcare professionals other than a substance abuse
expert to evaluate an individual's fitness;
(3) Designate the persons who will perform fitness monitoring, if
the entity elects this option, and adjust the number of fitness
monitors performing monitoring and the frequency of monitoring to
accommodate the stage of construction and local conditions; and
(4) Establish the random testing rate and limit the selection of
individuals for testing to only those who are present and constructing
safety- or security-related SSCs on a given day, if the entity elects
this option.
In the course of its analysis and development of Subpart K of the
final rule, the NRC published a Federal Register notice (71 FR 13782;
March 17, 2006) that described the NRC's alternative concepts for FFD
programs during construction and announced a meeting to obtain
stakeholder feedback. The concepts described included a requirement for
FFD policies and procedures on a limited set of topics; pre-access drug
and alcohol testing, for-cause drug and alcohol testing, and post-event
testing for accidents; requirements for protection of information;
requirements for collecting specimens and conducting alcohol tests; the
option to test specimens at a licensee testing facility; initial and
confirmatory testing of urine specimens for drugs and validity at an
HHS-certified laboratory; a review of drug test results by an MRO; and
annual reports of FFD program performance. The notice listed fatigue
management requirements, random drug and alcohol testing, the
requirement for an EAP, and the determination of fitness process
described in the proposed Part 26 rule as concepts the NRC was not
currently pursuing for FFD programs for construction. These concepts,
along with draft guidance for construction programs being prepared by
nuclear industry representatives, were discussed at the public meeting
held on March 29, 2006.
On October 24, 2006, the NRC published the entire draft final rule
text of 10 CFR Part 26 on the NRC's rulemaking Web site and, on
November 7, 2006, held a second public meeting with stakeholders to
present the technical basis for Subpart K and to describe the fitness
monitoring option included in Subpart K as an alternative to random
drug and alcohol testing of construction workers. The NRC staff
described four primary reasons for imposing regulatory requirements for
FFD programs during construction: (1) The quality of work could be
adversely affected by construction workers who are impaired by
substance abuse where studies indicate that members of this group have
the highest rates of substance abuse problems among occupational groups
in the U.S. (e.g., SAMHSA's NHSDA covering the years 2000-2001 and
SAMHSA's National Survey on Drug Use and Health covering the years
2002-2004), (2) individuals who have become addicted to illegal drugs
are susceptible to coercion and will interact with others involved in
the drug trade, (3) past experience has demonstrated that errors during
construction can adversely affect subsequent plant operations (NUREG/
CR-6819, Vols. 1-4, ``Common-Cause Failure Event Insights,'' (May 2003)
and NUREG-1837, ``Regulatory Effectiveness Assessment of Generic Issue
43 and Generic Letter 88-14,'' (October, 2005)), and (4) quality
assurance by design uses
[[Page 16996]]
a sampling process. The staff stated that, despite having a high degree
of confidence in the effectiveness of quality assurance/quality control
programs (required under 10 CFR Part 50) and the inspections, tests,
analyses, and acceptance criteria (ITAAC) programs (required under 10
CFR Part 52) to detect construction errors, it is prudent to require an
FFD program during construction to provide reasonable assurance that
impaired construction workers do not introduce faults in safety- or
security-related SSCs that may cause the SSCs to fail when the plant is
operational. In addition, the staff expressed concern that some
construction personnel who have substance abuse problems will have
access to sensitive information that could be useful to an adversary,
as well as physical access to safety- and security-related SSCs that
may provide opportunities for malicious acts.
The staff acknowledged, in part, that the full defense-in-depth
approach of the FFD program for operating plants is not appropriate for
all construction workers because many construction activities do not
have the potential to impact subsequent plant operations, and, before
fuel arrives on site, do not impose immediate radiological risks. The
staff stated that, therefore, the rule's requirements for construction
require a full FFD program for only a limited number of personnel who
have critical oversight responsibilities for verifying that safety- and
security-related SSCs are constructed properly. For workers who will
construct the safety- and security-related SSCs, the FFD program
requirements in Subpart K are less stringent. For example, Subpart K
does not require a suitable inquiry/employment history check for these
workers. In addition, the staff acknowledged the many complex
logistical challenges associated with implementing FFD requirements
during construction. Therefore, the Subpart K requirements provide a
licensee or other entity listed in Sec. 26.3(c) of the final rule
greater flexibility in implementing FFD programs for construction than
the rule permits for FFD programs at operating plants.
The staff also stated that the NRC has decided to defer adopting
requirements for reactor manufacturing facilities in the final rule.
Although proposed Sec. 26.3(e) would have covered these facilities,
and the Part 52 final rule amended Sec. 26.2(c) of the former rule to
include holders of manufacturing licenses, the NRC has concluded that
it needs additional information before proceeding with FFD requirements
for these facilities.
Stakeholder responses to the staff's presentation varied. Industry
stakeholders asserted that Part 26 requirements during nuclear power
plant construction are not warranted until shortly before fuel arrives
on site. Some industry commenters indicated that, because there are no
immediate radiological risks to public health and safety or the common
defense and security during the construction of new plants, the NRC
should not require FFD programs for construction that are more rigorous
than the industrial safety programs implemented during construction of
other large, commercial facilities. Industry stakeholders also asserted
that NRC requirements for FFD programs during construction are
unnecessary because the NRC-mandated quality assurance processes will
detect any errors in construction and are adequate to protect public
health and safety and the common defense and security, and the industry
will voluntarily implement FFD programs during construction for
industrial safety and business reasons. Industry stakeholders also
commented that the fitness monitoring program, which is permitted under
Subpart K in lieu of random drug and alcohol testing of workers who are
constructing safety- and security-related SSCs, is an unfamiliar
concept and asked several implementation questions. The staff indicated
that it will work with stakeholders to develop a guidance document that
would provide examples of acceptable means to implement an FFD program
under Subpart K, including fitness monitoring.
A representative from a public interest group stated that the
Subpart K requirements are necessary for FFD during construction.
However, this representative questioned the staff's concerns about
construction workers having unfettered access to sensitive information
as partial justification for the FFD requirements before fuel receipt.
This individual stated that safety considerations alone, independent of
any potential security concerns, warrant regulations for FFD programs
for construction before fuel receipt.
Based on the staff's assessment of the potential risks to public
health and safety and the common defense and security that the results
of construction activities may pose when a plant begins operations, the
staff concluded that--
(1) Relying on voluntary FFD programs would not ensure that all
workers who construct safety- and security-related SSCs or provide
oversight of those construction activities are subject to a program;
(2) Relying on voluntary FFD programs that include only pre-
employment, for-cause, and post-accident testing would not provide the
on-going detection and deterrence of substance abuse that is achieved
by either random testing or a fitness monitoring program;
(3) The extensive programs required for operating plants are not
warranted for all nuclear power plant construction activities, but
consistent implementation of FFD programs that provide on-going
detection and deterrence of substance abuse is warranted; and
(4) Public confidence in new plant construction will be enhanced by
a program to provide reasonable assurance that individuals who
construct safety- and security-related SSCs are fit for duty.
The NRC believes that the requirements for FFD programs for
construction in Subpart K of the final rule (1) provide reasonable
assurance that individuals who are responsible for constructing and
assuring the quality of safety- and security-related SSCs are fit for
duty, trustworthy, and reliable, commensurate with the potential risk
to public health and safety and the common defense and security, (2)
permit licensees and other entities the flexibility to implement
programs that are appropriate for local circumstances and the
challenges created by a large and transient workforce, and (3) ensure
that the privacy and other rights (including due process) of
individuals who are subject to the requirements will be protected.
Public Comment on Drug and Alcohol Testing Provisions
The NRC received several detailed comments on the drug and alcohol
testing provisions contained in Subparts E, F, and G. Most
significantly, no comments disagreed with NRC's proposed inclusion of
specimen validity testing of all urine specimens collected under Part
26 provisions. Most comments related to improving the clarity and
intent of the proposed rule. Many comments received were of a technical
nature and addressed inconsistencies between the NRC's proposed rule
and requirements in other federal testing programs, mainly the HHS's
Mandatory Guidelines for Federal Workplace Drug Testing and DOT drug
and alcohol testing regulations (49 CFR Part 40). The NRC, in large
part, agrees with many of the comments and has made clarifying
revisions to the final rule.
Stakeholder commenters raised several concerns relating to the drug
and
[[Page 16997]]
alcohol provisions of the proposed rule. First, numerous comments were
received on the validity testing provisions for screening and initial
validity tests conducted at licensee testing facilities. Some
stakeholders disagreed with the NRC's proposal to permit licensee
testing facilities to use point-of-collection type tests to conduct
validity screening tests. The NRC considered the comments, but has
retained in the final rule the proposed provision to allow licensee
testing facilities to use point-of-collection type tests to conduct
validity screening tests. However, in response to the comments
received, the NRC has revised the performance testing provisions in
Sec. 26.137 to ensure that the functional capabilities of the
performance testing of screening tests meet the criteria of the final
rule. In addition, another set of comments pointed out that the
proposed rule did not afford licensee testing facilities the
opportunity to conducting specific gravity testing on specimens, which
is a required component of reporting specimens as dilute, substituted,
or invalid. The NRC continues to believe that any specimen that has a
creatinine concentration below 20 mg/dL must be forwarded for
additional testing at an HHS certified laboratory (including specific
gravity testing). Finally, the NRC received numerous comments on the
use of the term ``non-negative.'' Some commenters believed that the
term created significant confusion with respect to understanding
specimen test results. The NRC agrees with the commenters and has
replaced the term ``non-negative test result'' in the final rule with
the term ``positive'' (for drug test results) and the term
``adulterated, substituted, and invalid'' (for validity test results).
In addition, the NRC has replaced the term ``non-negative test result''
with the new term ``questionable validity'' for licensee testing
facility test results that indicate that a specimen may be adulterated,
substituted, dilute, or invalid.
VI. Section-by-Section Analysis of Substantive Changes
The final rule is organized into twelve subparts that are comprised
of related requirements, as follows:
Subpart A--Administrative Provisions
Subpart B--Program Elements
Subpart C--Granting and Maintaining Authorization
Subpart D--Management Actions and Sanctions to be Imposed
Subpart E--Collecting Specimens for Testing
Subpart F--Licensee Testing Facilities
Subpart G--Laboratories Certified by the Department of Health and
Human Services
Subpart H--Determining Fitness-for-Duty Policy Violations and
Determining Fitness
Subpart I--Managing Fatigue
Subpart J--[Reserved]
Subpart K--FFD Programs for Construction
Subpart L--[Reserved]
Subpart M--[Reserved]
Subpart N--Recordkeeping and Reporting Requirements
Subpart O--Inspections, Violations, and Penalties
A detailed cross-reference table between the former and final Part
26 provisions is included at the end of this document.
The NRC has deleted Appendix A of the former rule and moved the
detailed requirements for conducting drug and alcohol testing that were
contained in Appendix A to 10 CFR Part 26 to Subpart E [Collecting
Specimens for Testing], Subpart F [Licensee Testing Facilities], and
Subpart G [Laboratories Certified by the Department of Health and Human
Services] of the final rule.
Subpart A--Administrative Provisions
Section 26.1 Purpose
Section 26.1 of the final rule amends the language of the
corresponding section of the former rule. The final rule deletes the
term ``certain aspects'' and adds the term ``implementation'' to the
phrase in the former rule which stated, ``for the establishment and
maintenance of * * * fitness-for-duty programs,'' in order to convey
more accurately that the final rule includes requirements for
implementing FFD programs, in addition to requirements for establishing
and maintaining such programs. The NRC has moved the portion of former
Sec. 26.1 that referred to the entities who are subject to the rule to
Sec. 26.3 [Scope] in order to meet Goal 6 of the rulemaking to improve
clarity in the organization and language of the final rule, by
consolidating related requirements into one section.
Section 26.3 Scope
The NRC has reorganized, renumbered, and amended Sec. 26.3
relative to both former Sec. 26.2 [Scope], as modified by the Part 52
final rule, and proposed Sec. 26.3 [Scope] based upon the NRC's
consideration of issues raised by public comments on the proposed rule.
In general, the final rule retains and clarifies most of the provisions
pertaining to the scope of the former and proposed rules. However, one
public comment stated that the proposed rule was confusing with regard
to the entities and individuals who are subject to the different
requirements of this part. Therefore, the final rule amends this
section of the proposed and former rules and adds a new Sec. 26.4 [FFD
program applicability to categories of individuals], as discussed with
respect to that section, to clarify the rule text. Also, the final rule
makes a substantive change to the proposed rule by adding Sec.
26.3(c), which modifies the requirements of proposed Sec. 26.3(e)
pertaining to combined license holders and applicants and construction
permit holders and applicants. As in Sec. 26.3(e) of the proposed
rule, Sec. 26.3(c) of the final rule specifies the requirements to
which these entities are subject. However, the final rule modifies
these requirements and moves them to a new Subpart K [FFD Programs for
Construction]. These changes are discussed in more detail with respect
to Sec. 26.3(c).
Section 26.3(a) of the final rule specifies that licensed nuclear
power reactor operators and combined license holders after the
Commission has made the finding in Sec. 52.103(g) shall comply with
the requirements of this part, with the exception of Subpart K. The
Part 52 final rule modified former Sec. 26.2(a) to expressly require
combined license holders after the Commission has made the finding in
Sec. 52.103(g) to comply with the requirements of Part 26.
The final rule clarifies that the regulations contained in Subpart
K do not apply to the licensees and other entities specified in Sec.
26.3(a) because only entities specified in Sec. 26.3(c) are permitted
to implement an FFD program under the more flexible program
requirements in Subpart K. The final rule also adds a requirement that
licensees who receive their operating license under Sec. 50.57 after
the date of publication of the final rule in the Federal Register and
holders of a combined license under Part 52 after the Commission has
made the finding in Sec. 52.103(g) must implement an FFD program
meeting all of the requirements of Part 26 except Subpart K before
receipt of special nuclear material in the form of fuel assemblies. The
NRC believes that once fuel assemblies have arrived on site, the full
range of potential risks to public health and safety and the common
defense and security that Part 26 is designed to avert are possible.
Therefore, the NRC believes that a more rigorous FFD program must be in
place at this time.
Section 26.3(b) of the final rule combines Sec. 26.3(b) and (c) of
the proposed rule. This section retains the requirement in the first
sentence of former Sec. 26.2(a) that licensees who are authorized to
possess, use, or transport formula quantities of are subject to the
regulations in this part. Section 26.3(b) also retains the requirements
of former
[[Page 16998]]
Sec. 26.2(d) and specifies that corporations and entities other than a
corporation are subject to the regulations of this part because there
may be entities who are organized as firms, partnerships, limited
liability companies, or associations who may also obtain a certificate
or approved compliance plan under Part 76 and elect to engage in
activities involving formula quantities of SSNM.
However, the entities specified in this paragraph are not subject
to the requirements contained in Subpart I [Managing Fatigue] for the
reasons that are discussed with respect to Sec. 26.201
[Applicability]. With respect to the proposed rule, the final rule adds
a specification that the entities listed in Sec. 26.3(b) are not
subject to the requirements contained in Subpart K, because the
requirements of Subpart K apply only to the entities specified in Sec.
26.3(c). The provision also eliminates the cross reference to Sec.
26.25(a)(3) of the proposed rule because the final rule has moved the
proposed provisions in Sec. 26.25 to Sec. 26.4 of the final rule for
increased clarity in the rule's organization.
Section 26.3(c) of the final rule retains but modifies the
provisions of former Sec. 26.2(c) and proposed Sec. 26.3(e). Proposed
Sec. 26.3(e) would have retained and updated the requirements of Sec.
26.2(c) of the former rule before Part 26 was amended by the Part 52
final rule. However, proposed Sec. 26.3(e) did not revise the basic
approach taken in former Sec. 26.2(c), and specified the regulations
in Part 26 that applied to the entities listed in proposed Sec.
26.3(e). Section 26.3(c) of the final rule specifies that the entities
listed are subject to the requirements of Part 26, except Subpart I.
The NRC received a public comment, discussed in detail in Section V
of this document, that argued that proposed Sec. 26.3(e) was unclear
regarding the type of FFD program the NRC expected from the licensees
specified in this paragraph. The NRC acknowledged these concerns, and
for the reasons discussed in Section V of this document, the final rule
amends the requirements of proposed Sec. 26.3(e) and moves them to a
separate Subpart K. The specific requirements applicable to the
entities specified in Sec. 26.3(c) are discussed in this document with
respect to Subpart K.
Like the proposed rule, the final rule specifies the requirements
that are applicable to combined license holders before the Commission
has made the finding under Sec. 52.103(g) and to construction permit
holders. Section 26.3(c)(2) and 26.3(c)(4) specifies that combined
license holders before the Commission has made the finding under Sec.
52.103(g) and construction permit holders, respectively, are subject to
the requirements of Part 26, except for Subpart I.
The final rule, however, to be consistent with the LWA final rule,
amends the proposed rule with respect to combined license applicants
and construction permit applicants. Section 26.3(c)(1) and (c)(3)
addresses combined license applicants and construction permit
applicants, respectively. Although the proposed rule specified combined
license applicants and construction permit applicants who have
``received the authorization to construct under Sec. 50.10(e)(3),''
revisions to Part 50 in the LWA final rule have changed the content and
applicability of Sec. 50.10(e)(3). As a result, the Part 26 final rule
specifies combined license applicants and construction permit
applicants who ``have been issued a limited work authorization under
Sec. 50.10(e), if the limited work authorization authorizes the
applicant to install the foundations, including the placement of
concrete, for safety- and security-related [SSCs] under the limited
work authorization.'' Similarly, in Sec. 26.3(c)(5), the final rule,
with respect to the proposed rule, adds a new specification for early
site permit holders ``who have been issued a limited work authorization
under Sec. 50.10(e), if the limited work authorization authorizes the
early site permit holder to install the foundations, including the
placement of concrete, for safety- and security-related SSCs under the
limited work authorization.'' (The final rule contains definitions of
safety- and security-related SSCs in Sec. 26.5, and those definitions
are discussed with respect to that section.)
The LWA final rule modified the scope of activities that are
considered construction for which a construction permit, combined
license, or LWA is necessary, and specified the scope of construction
activities that may be performed under an LWA. Under an LWA, entities
are allowed to perform some or all of the following activities: driving
of piles, subsurface preparation, placement of backfill, concrete, or
permanent retaining walls within an excavation, and installation of the
foundation, including placement of concrete, any of which are for an
SSC of a production or utilization facility for which either a
construction permit or combined license is otherwise required under 10
CFR 50.10(c).
The NRC has concluded that if the entity is authorized under the
LWA to perform only the driving of piles, subsurface preparation, or
placement of backfill, concrete or permanent retaining walls within an
excavation for safety- and security-related SSCs, it will not be
required to comply with Part 26. Entities who are authorized under the
LWA to perform installation of the foundation, including placement of
concrete, for safety- or security-related SSCs, however, will be
required to comply with Part 26 and establish either an FFD program
under Subpart K of Part 26 or an FFD program that complies with all of
Part 26 except Subparts I and K.
The NRC based its decision to distinguish the installation of the
foundation, including placement of concrete, from the other activities
listed under Sec. 50.10(d)(1) on the following considerations. First,
until the NRC broadened the concept of construction because of its
early interpretation of the National Environmental Policy Act,
construction requiring NRC approval in the form of a construction
permit was defined in Sec. 50.10 as ``pouring the foundation for, or
the installation of, any portion of the permanent facility on the
site.'' Thus, installation of the foundation has in the past been
identified by the agency as a key step in construction.
Second, the NRC concluded that installation of the foundation is
different in kind from the other activities listed under Sec.
50.10(d)(1). A common meaning of ``foundation'' is the underlying base
or support for a building or the substructure of a building. Therefore,
the foundation is an integral component of the fabric of a safety- or
security-related SSC, while piles, backfill, and retaining walls are
not. The foundation must be installed properly on the first attempt, as
any flaws in the foundation or voids or concrete will be difficult to
detect and impossible to correct without complete re-installation of
the foundation. The individuals who install foundations for safety- and
security-related SSCs must therefore be fit-for-duty and trustworthy
and reliable. Thus, the installation of foundations has a closer and
more significant nexus with public health and safety and common defense
and security, and the individuals who construct or direct the
construction of such SSCs should be subject to an FFD program.
Third, the public can be expected to view installation of
foundations as different from, and more important than, other
activities under an LWA because of the integral nature of foundations
with the SSCs and the nexus with public health and safety and common
defense and security. An FFD program that provides reasonable
[[Page 16999]]
assurance that the individuals who perform installation of foundations
of safety- or security-related SSCs are trustworthy and reliable and
fit to perform their duties will enhance public confidence in the NRC's
regulatory processes and the safety and security of newly constructed
nuclear power plants.
Further, Sec. 26.3(c) of the final rule explains that if the
licensees and other entities specified in Sec. 26.3(c)(1) through (5)
receive special nuclear material in the form of fuel assemblies, then
those entities must comply with all of the requirements of Part 26.
This requirement is consistent with the requirement in Sec. 26.3(a)
that licensees who receive their operating license under Sec. 50.57
after the date of publication of the final rule in the Federal Register
and holders of a combined license under Part 52 after the Commission
has made the finding in Sec. 52.103(g) must comply with the
requirements of Part 26, except Subpart K, before the receipt of
special nuclear material in the form of fuel assemblies. Under both
Sec. 26.3(a) and (c), no later than when fuel arrives on site, the
applicable licensees and other entities must implement an FFD program
that complies with the requirements of Part 26 for the reasons
discussed with respect to Sec. 26.3(a).
The NRC has decided to defer adopting requirements for reactor
manufacturing facilities. Although these facilities would have been
covered under proposed Sec. 26.3(e) and were temporarily included in
the former Sec. 26.2(c) as amended by the Part 52 final rule, the
agency has concluded that it needs additional information before going
forward with FFD requirements for such facilities, particularly when
FFD requirements are closely linked to issues of access authorization
and physical security. The NRC is considering, but has not yet
completed, regulatory requirements on those subjects for reactor
manufacturing facilities. Any industry stakeholders with a potential
interest in pursuing a license for a reactor manufacturing facility
should ensure that they engage in early discussions with the NRC so
that suitable requirements can be developed in a timely manner.
Section 26.3(d) of the final rule retains the meaning of a portion
of former Sec. 26.23(a)(1), but amends some of the terminology used in
the former rule. Like the proposed rule, the final rule requires that a
C/V FFD program must meet the standards of Part 26 if licensees and
other entities specified in paragraphs (a) through (c) of Sec. 26.3
rely upon the C/V's FFD program or program elements to meet the
requirements of Part 26. The provision adds C/Vs to the list of
entities who are subject to Part 26 in Sec. 26.3 to more clearly
convey that C/Vs may be directly subject to NRC inspection and
enforcement actions than the former rule language implied. The former
rule text presented the applicability of the rule's requirements to a
C/V's FFD program in terms of the contractual relationship between a
licensee and the C/V. For example, former Sec. 26.23(a)(1) stated,
``The contractor or vendor is responsible to the licensee [emphasis
added] for adhering to the licensee's fitness-for-duty policy, or
maintaining and adhering to an effective fitness-for-duty program;
which meets the standards of this part.'' This paragraph, and others in
the former rule, could be interpreted as implying that a C/V is
accountable to the licensee but not to the NRC, should significant
weaknesses be identified in the C/V's FFD program upon which a licensee
relies. However, this interpretation would be incorrect. Therefore,
Sec. 26.3(d) of the final rule includes C/V FFD programs and program
elements upon which the licensees and other entities specified in
paragraphs (a) through (c) of this section rely within this section to
convey more accurately that C/Vs are directly accountable for meeting
the applicable requirements of Part 26, not only through their
contractual relationships with the licensees and other entities who are
subject to the rule. This clarification also is necessary to maintain
the internal consistency of the final rule because some provisions of
the rule apply only to C/Vs, including, but not limited to Sec.
26.717(g). The final rule makes this change to meet Goal 6 of the
rulemaking to improve the clarity in the organization and language of
the rule.
The phrases ``program elements'' and ``licensees and other entities
specified in paragraphs (a) through (c) of this section'' are used in
Sec. 26.3(d) of the final rule because C/Vs need only meet the
requirements of Part 26 for those FFD program elements upon which
licensees and other entities rely to meet the requirements of the rule.
For example, a C/V may choose to implement all of the program elements
that are required for a full FFD program under the final rule except
drug and alcohol testing. In this case, the final rule does not require
the C/V to address drug and alcohol testing in the C/V's FFD policy,
procedures, and training program; establish contracts with drug-testing
laboratories; collect specimens for drug and alcohol testing; or meet
any other requirements in the final rule that relate to conducting drug
and alcohol testing. However, if a C/V chooses to conduct drug and
alcohol testing under some or all of the conditions specified in Sec.
26.31(c) [Conditions for testing], such as for cause testing, and a
licensee or other entity specified in Sec. 26.3(a) through (c) relies
upon the results of the C/V's tests in determining whether to grant
authorization to an individual (see Subpart C [Granting and Maintaining
Authorization]), then the use of these phrases in the provision would
be correctly interpreted to mean that the C/V's drug and alcohol
testing program element must meet the final rule's requirements related
to drug and alcohol testing when conducting the tests on which the
licensee or other entity relies. In contrast, if a C/V implements an
FFD program element that is addressed in this part, but that program
element is not relied upon by a licensee or other entity specified in
paragraphs (a) through (c) of this section, then the provision does not
require the C/V to meet the applicable Part 26 requirements for that
FFD program element. Section 26.3(d) requires C/Vs to meet the
requirements of Subpart I of the final rule, if any nuclear power
reactor licensees specified in Sec. 26.3(a) through (c) rely upon a C/
V's fatigue management program element to meet the requirements of
Subpart I. The applicability of Subpart I to C/Vs is discussed with
respect to Sec. 26.201.
The NRC has either eliminated or moved to other places of the final
rule other provisions of former Sec. 26.23 [Contractors and vendors].
The NRC has moved the former requirement for licensees to retain
written agreements with C/Vs in the second sentence of Sec. 26.23 to
Subpart N [Recordkeeping and Reporting Requirements] of the final rule.
The NRC has moved the requirement in former Sec. 26.23(a)(1) to
Subpart C of the final rule. That provision requires that individuals
who have violated an FFD program must not be assigned to work within
the scope of this part without the knowledge and consent of the
licensee. The NRC has addressed the audit requirement contained in
former Sec. 26.23(b) in Sec. 26.41(d) [Contracts] of the final rule.
By moving the former requirements to different sections of the final
rule and grouping related requirements together in one section or
subpart that addresses similar topics, the NRC has met Goal 6 of this
rulemaking to improve clarity in the organization and language of the
rule.
The NRC has amended and moved the requirements of proposed Sec.
26.3(e) to
[[Page 17000]]
Sec. 26.3(c) and Subpart K of the final rule. The requirements
contained in proposed Sec. 26.3(e) are discussed in this document with
regard to those sections.
Section 26.3(e) of the final rule, like the proposed rule, retains
the second sentence of former Sec. 26.2(b) and addresses entities who
are not subject to the rule. The NRC has moved the first sentence of
former Sec. 26.2(b), which addressed individuals who are not subject
to the rule, to Sec. 26.4(i) of the final rule for organizational
clarity.
Section 26.4 FFD Program Applicability to Categories of Individuals
In the proposed rule, the NRC moved the provisions in former Sec.
26.2 that specified the individuals whose duties require them to be
subject to the rule and exempt certain other individuals to Sec. 26.25
[Individuals subject to the fitness-for-duty program]. However, the NRC
has deleted Sec. 26.25 from the final rule, and has amended,
reorganized, and moved all of the provisions in proposed Sec. 26.25 to
a new Sec. 26.4 to group related applicability requirements together
in one section.
The provisions moved into new Sec. 26.4 include the second
sentence of former Sec. 26.2(a), the first sentence of former Sec.
26.2(b), and the portion of the second sentence of former Sec. 26.2(d)
that pertained to personnel. The NRC determined that separating into
two different sections the requirements that address the entities who
are subject to the rule and the requirements that address the
individuals who must be subject to the rule makes the two sets of
provisions easier to locate within the final rule without compromising
the intended meaning of these provisions. Also, moving the
applicability requirements for individuals into Subpart A [Scope] from
Subpart B [Program Elements], where they were located in the proposed
rule, is appropriate because some categories of individuals who are
subject to the rule are not subject to Subpart B of the final rule. The
applicability requirements in Sec. 26.4 clearly specify the categories
of individuals who are subject to Part 26. The NRC determined that
grouping all of the applicability requirements into one subpart of the
final rule increases the ease of locating these provisions, consistent
with Goal 6 of this rulemaking to improve clarity in the organization
of the rule.
Section 26.4(a) of the final rule retains portions of proposed
Sec. 26.25(a)(1). Proposed Sec. 26.25(a)(1) amended portions of
former Sec. 26.2(a) and (d) and described the individuals whose duties
require them to be subject to Part 26. The final rule specifies that
the persons who are granted unescorted access to nuclear power reactor
protected areas by the licensees and other entities in Sec. 26.3(a)
and (c), as applicable, and who perform the duties in Sec. 26.4(a)(1)
through (a)(5) shall be subject to an FFD program that meets the
requirements of this part, except Subpart K but including Subpart I.
The NRC has moved the categories of individuals specified in Sec.
26.199(a)(1) through (a)(5) of the proposed rule to Sec. 26.4(a)(1)
through (a)(5) of the final rule in order to group together all related
applicability requirements for individuals in one section. This change
is consistent with Goal 6 of this rulemaking to improve clarity in the
organization and language of the rule. Additional concerns regarding
the reasons why individuals performing these duties shall be subject to
the fatigue management provisions of Subpart I are discussed with
respect to Sec. 26.205(a) [Individuals subject to work hour controls].
The final rule clarifies that these individuals may not be subject to
the more flexible FFD program described in Subpart K because they may
be granted unescorted access by the licensees in Sec. 26.3(a), to whom
all of the requirements of this part, except Subpart K, apply, and
entities in Sec. 26.3(c), as applicable, to whom all of the
requirements of this part apply.
Section 26.4(b) of the final rule retains portions of and amends
proposed Sec. 26.25(a)(1). The final rule adds Sec. 26.4(b) to
clarify that individuals who are granted unescorted access to nuclear
power reactor protected areas by the licensees and other entities in
Sec. 26.3(a) and (c), as applicable and who do not perform the duties
described in Sec. 26.4(a), shall be subject to an FFD program that
meets all of the requirements of Part 26, except Sec. 26.205 [Work
hours] through Sec. 26.209 [Self-declarations] and Subpart K. Section
26.4(b) does not permit these individuals to be subject to an FFD
program that meets the more flexible requirements of Subpart K because
they may be granted unescorted access to protected areas by the
licensees in Sec. 26.3(a), to whom all of the requirements of this
part, except Subpart K, apply, and the entities in Sec. 26.3(c), as
applicable, to whom all of the requirements of this part apply. This
paragraph does not require the individuals in this paragraph to be
subject to an FFD program that meets the requirements of Sec. 26.205
through Sec. 26.209 for the reasons discussed with regard to Sec.
26.205(a).
Section 26.4(c) of the final rule retains and amends proposed Sec.
26.25(a)(2). Proposed Sec. 26.25(a)(2) amended portions of former
Sec. 26.2(a) and (d) and described the individuals whose duties
require them to be subject to Part 26. Section 26.4(c) of the final
rule states that all persons who are required by a licensee or other
entity in Sec. 26.3(a), and, as applicable, (c) to physically report
to the licensee's Technical Support Center or Emergency Operations
Facility shall be subject to an FFD program that meets all of the
requirements of this part, except Sec. 26.205 through Sec. 26.209 and
Subpart K. Section 26.4(c) of the final rule does not permit these
individuals to be subject to an FFD program that meets the more
flexible requirements of Subpart K because they may be granted
unescorted access by the licensees in Sec. 26.3(a), to whom all of the
requirements of this part, except Subpart K, apply, and the entities in
Sec. 26.3(c), as applicable, to whom all of the requirements of this
part apply. This paragraph also does not require the specified
individuals to be subject to an FFD program that meets the requirements
of Sec. 26.205 through Sec. 26.209 for the reasons discussed with
regard to Sec. 26.205(a).
Section 26.4(d) of the final rule retains and amends portions of
proposed Sec. 26.25(a)(3). Proposed Sec. 26.25(a)(3) amended the
portions of former Sec. 26.2(a) and (d) and described the individuals
whose duties require them to be subject to Part 26. Section 26.4(d) of
the final rule specifies that any individual whose duties for the
licensees and other entities in Sec. 26.3(b) require him or her to
have the types of access or perform the activities in paragraphs (d)(1)
through (d)(5) shall be subject to an FFD program that meets all of the
requirements of this part, except Subparts I and K. Section 26.4(d) of
the final rule does not require these individuals to be subject to an
FFD program that meets the requirements of Subparts I or K, which is
consistent with the provisions of the proposed rule.
The NRC has added Sec. 26.4(e) to the final rule to specify that
individuals whose duties when construction activities begin require
them to have the types of access or perform the activities specified in
Sec. 26.4(e)(1) through (e)(6) at the location where the nuclear power
plant will be constructed and operated must be subject to a rigorous
FFD program that complies with the requirements of Part 26, except for
the requirements of Subparts I and K. These individuals have direct
responsibility for assuring the quality and security of construction
activities and, thereby, the safety and security of the completed
nuclear power plant. The NRC considers
[[Page 17001]]
it prudent that these personnel are verified to be trustworthy and
reliable, as demonstrated by the avoidance of substance abuse, and fit
for duty with an FFD program that is equivalent to the program required
for an operating plant, which includes a 50 percent random testing rate
and a suitable inquiry and employment history check. These individuals
include all individuals whose duties at the location where the nuclear
power plant will be constructed and operated require them to: (1) Serve
as security personnel required by the NRC, until the licensee or other
entity receives special nuclear material in the form of fuel
assemblies, at which time individuals who serve as security personnel
required by the NRC must meet the requirements applicable to security
personnel in Sec. 26.4(a)(5); (2) perform quality assurance, quality
control, or quality verification activities related to safety- and
security-related construction activities; (3) based on a designation
under Sec. 26.406 by a licensee or other entity, monitor the fitness
of the individuals specified in Sec. 26.4(f) (and thus has also
received fitness monitoring training); (4) witness or determine
inspections, tests, and analyses certification required by Part 52; (5)
supervise or manage the construction of safety- or security-related
SSCs; or (6) direct, as defined in Sec. 26.5, or implement the access
authorization program. Section 26.4(e)(5) specifies that an individual
who ``supervises or manages the construction of safety- or security-
related SSCs'' must be subject to an FFD program that complies with the
requirements of Part 26, except the requirements of Subparts I and K.
The NRC has added this provision based upon information from
stakeholders at public meetings at which the conceptual framework for
Subpart K was discussed. The NRC has included a definition of
``supervises or manages'' in the final rule, which means ``exercises
control over a work activity by an individual who is not directly
involved in the execution of the work activity.'' The final rule
specifies that this requirement applies only to those individuals who
supervise or manage the construction of safety- or security-related
SSCs ``at the location where the nuclear power plant will be
constructed and operated'' (i.e., only those individuals whose
activities at the site where the nuclear power plant will be
constructed and operated may negatively impact public health and safety
and the common defense and security).
Section 26.4(e)(6)(i) through (e)(6)(vii) specifies that
individuals who direct or implement the licensee's or other entity's
access authorization program during construction must be subject to an
FFD program that complies with the requirements of Part 26, except the
requirements of Subparts I and K. The NRC expects that, in the absence
of an order or regulation requiring a specific access authorization
program during construction, an access authorization program during
construction would require individuals to perform the same duties and
activities as would a licensee's access authorization program under
Sec. 73.55 and Sec. 73.56 when the plant is operating. These duties
and activities include having access to the information used by the
licensee or other entity to make access authorization determinations,
including information stored in electronic format, as specified in
(e)(6)(i); making access authorization determinations, as specified in
(e)(6)(ii); issuing entry-control picture badges in accordance with
access authorization determinations, as specified in (e)(6)(iii);
conducting background investigations or psychological assessments used
by the licensee or other entity to make access authorization
determinations, as specified in (e)(6)(iv); adjudicating reviews or
appeals of access authorization determinations, as specified in
(e)(6)(v); auditing the access authorization program, as specified in
(e)(6)(vi); or performing any of the activities or having any of the
duties listed in Sec. 26.4(e)(6) for any C/V upon whom the licensee's
or other entity's access authorization program will rely, as specified
in (e)(6)(vii). Section 26.4(e)(6)(iv) includes the following exception
for individuals who conduct background investigations or psychological
assessments used by the licensee or other entity to make access
authorization determinations: ``He or she shall be subject to
behavioral observation only when he or she is present at the location
where the nuclear power plant will be constructed and operated, and
licensees and other entities may rely on a local hospital or other
organization that meets the requirements of 49 CFR Part 40, `Procedures
for Department of Transportation Workplace Drug and Alcohol Testing
Programs' (65 FR 41944; August 9, 2001) to collect his or her specimens
for drug and alcohol testing.'' The requirements for persons conducting
background checks and psychological assessments are relaxed for reasons
similar to requirements for MROs and certain FFD program personnel, as
described in detail with respect to Sec. 26.31(b)(1)(v) and (b)(2).
The NRC has added the requirements of Sec. 26.4(e)(6) in accordance
with Goal 1 of this rulemaking, which is to update and enhance the
consistency of 10 CFR Part 26 with advances in other relevant Federal
rules and guidelines.
Section 26.4(e)(1) includes the phrase ``until the licensees or
other entities receive special nuclear material in the form of fuel
assemblies, at which time individuals who serve as security personnel
required by the NRC must meet the requirements applicable to security
personnel in paragraph (a)(5) of this section'' to clarify that, once
fuel is received on site, security personnel must be subject to all the
requirements of this part, except the requirements of Subpart K, and
including the requirements of Subpart I. The individuals listed in
Sec. 26.4(e)(2) through (6), once construction activities begin and
until a licensee or other entity specified in Sec. 26.3(a) or (c)
grants them unescorted access to the nuclear power plant protected
areas, must be subject to the requirements of this part, except the
requirements of Subparts I and K. However, once the individuals listed
in Sec. 26.4(e)(2) through (6) are granted unescorted access to the
nuclear power plant protected areas, they must be subject to the
requirements of Sec. 26.4(b), which require them to be subject to the
requirements of this part, except those in (Sec. Sec. 26.205 through
26.209 and Subpart K.
The NRC has added Sec. 26.4(f) to the final rule to specify the
individuals involved in the construction of a new reactor plant who, at
the licensee's or other entity's discretion, must be subject to either
a more flexible FFD program under Subpart K, or a more rigorous FFD
program that meets the requirements in the other portions of Part 26,
except Subparts I and K. These individuals include any individual who
is constructing or directing the construction of safety- or security-
related SSCs at the location where the nuclear power plant will be
constructed and operated. However, if and when a licensee or entity
specified in Sec. 26.3(a) or (c) grants these individuals unescorted
access to the nuclear power plant protected area, these individuals
must be subject to the requirements of Sec. 26.4(a) or (b), as
applicable. As specified by the definition of (constructing or
construction activities' in Sec. 26.5, these tasks include
fabricating, erecting, integrating, and testing safety- or security-
related SSCs and the installation of their foundations, including the
placement of concrete. The final rule also contains a definition of
``directing'' in Sec. 26.5, which means
[[Page 17002]]
the exercise of control over a work activity by an individual ``who is
directly involved in the execution of the work activity.'' This
definition is distinguished from the term ``supervises or manages,''
used in Sec. 26.4(e)(5), which means the exercise of control over a
work activity by an individual ``who is not directly involved in the
execution of the work activity.'' The NRC determined that it is
necessary to impose FFD requirements on individuals who are
constructing or directing the construction of safety- or security-
related SSCs because (1) the quality of work could be adversely
affected by construction workers who are impaired by substance abuse
where studies indicate that members of this group have the highest
rates of substance abuse problems among occupational groups in the U.S.
(e.g., SAMHSA's NHSDA covering the years 2000-2001 and SAMHSA's
National Survey on Drug Use and Health covering the years 2002-2004),
(2) individuals who have become addicted to illegal drugs are
susceptible to coercion and will interact with others involved in the
drug trade, (3) past experience has demonstrated that errors during
construction can adversely affect subsequent plant operations (NUREG/
CR-6819, Vols. 1-4, ``Common-Cause Failure Event Insights,'' (May 2003)
and NUREG-1837, ``Regulatory Effectiveness Assessment of Generic Issue
43 and Generic Letter 88-14,'' (October 2005)), and (4) quality
assurance by design uses a sampling process. Despite having a high
degree of confidence in the effectiveness of quality assurance and
ITAAC programs to detect construction errors, the NRC believes it is
prudent to require an FFD program during construction to provide
reasonable assurance that impaired construction workers or individuals
directing construction workers do not introduce faults in safety- or
security-related SSCs that may cause the SSCs to fail to perform their
intended functions when the plant is operating. In addition, the NRC is
concerned that some construction personnel who have substance abuse
problems will have access to sensitive information that could be useful
to an adversary, as well as physical access to safety- and security-
related SSCs that may provide opportunities for malicious acts.
Therefore, the NRC is requiring individuals who are directly involved
in constructing safety- and security-related SSCs to be subject to an
FFD program.
Section 26.4(g) of the final rule contains the provisions in
proposed Sec. 26.25(a)(4). Proposed Sec. 26.25(a)(4) clarified the
NRC's original intent that FFD program personnel must be subject to the
FFD program. Although former Section 2.3 in Appendix A to Part 26
required licensees to carefully select and monitor individuals who are
responsible for administering the drug and alcohol testing program
based upon the highest standards of honesty and integrity, some
licensees' testing programs did not include all of the FFD program
personnel who the NRC originally intended to be subject to testing. The
final rule clarifies the NRC's original intent because the actions of
these individuals have an ongoing effect on public health and safety
and the common defense and security as a result of their responsibility
to ensure that FFD programs are effective. In addition, these
individuals' actions affect the confidence that the public, management,
and individuals who are subject to testing have in the integrity of the
program and the accuracy and reliability of test results. Individuals
who are involved in the day-to-day operations of an FFD program are in
a position to permit substance abusers to remain undetected. For
example, specimen collectors could inadvertently commit errors when
testing others as a result of being impaired from drug or alcohol abuse
or intentionally omit testing an individual because of motives
associated with maintaining a collector's substance abuse or empathy
with an abuser. Further, several reported incidents have confirmed the
need to assure that FFD program personnel meet the highest standards of
honesty, integrity, reliability, and trustworthiness. For example, one
licensee added specimen collectors to the testing pool after
investigating an allegation and determining that two collectors were
substance abusers. In another instance, a contracted MRO who was not in
the testing pool was reported to be an alcoholic and an abuser of
prescription drugs. Some MROs who provide their services to other
Federally regulated industries also have been identified as substance
abusers. Therefore, the revision to former Sec. 26.2(a) fulfills the
NRC's original objective and requires licensees and other entities to
extend their programs to include FFD personnel who (1) can link test
results with the individual who was tested before an FFD policy
violation determination is made, including, but not limited to, the
MRO, as specified in Sec. 26.4(g)(1); (2) make determinations of
fitness, as specified in Sec. 26.4(g)(2); (3) make authorization
decisions, as specified in Sec. 26.4(g)(3); (4) are involved in
selecting or notifying individuals for testing, as specified in Sec.
26.4(g)(4); or (5) are involved in the collection or on-site testing of
specimens, as specified in Sec. 26.4(g)(5).
Although job titles and responsibilities may differ among different
Part 26 FFD programs, examples of FFD program personnel who are subject
to Part 26 under the final rule include, but are not limited to, the
following: The FFD program manager under Sec. 26.4(g)(1) through
(g)(5); the MRO and MRO staff under Sec. 26.4(g)(1); the licensee's or
other entity's reviewing officials under Sec. 26.4(g)(3); specimen
collectors under Sec. 26.4(g)(5); SAEs who are under contract to or
employed by the FFD program under Sec. 26.4(g)(2); and licensee
testing facility personnel under Sec. 26.4(g)(5). In some cases,
information technology personnel who design and implement software
programs for selecting individuals for random testing also may be
subject to the rule under Sec. 26.4(g)(4) if such personnel have
knowledge of who was selected for random testing before the individual
is notified or the ability to affect the selection of specific
individuals for random testing.
Section 26.4(g) of the final rule amends the proposed rule to
clarify the requirements that the FFD programs specified in this
paragraph must meet. The section specifies that FFD program personnel
who are involved in the day-to-day operations of the program, as
defined by the procedures of the licensees or other entities, and whose
duties require them to have the types of access and perform the
activities in Sec. 26.4(g)(1) through (g)(5) shall be subject to an
FFD program that meets all of the requirements of Part 26, except
Subparts I and K, and at the licensees's discretion, Subpart C. The
final rule clarifies that the procedures referenced are those of the
licensees and other entities specified in Sec. 26.3(a) through (c)
and, as applicable, (d). Licensees may use different FFD program
personnel for a Subpart K program, in which case, those FFD program
personnel would be subject to a full program under the rule. However,
individuals specified in Sec. 26.4(i)(1) are not subject to an FFD
program under Part 26. The term ``as applicable'' in this provision
specifies that entities listed in Sec. 26.3(d) must subject FFD
program personnel to all of the requirements of this part if they
perform the activities specified in Sec. 26.4(g). The final rule also
clarifies that the FFD programs for FFD program personnel performing
the listed activities in Sec. 26.4(g) must meet all the requirements
of Part 26, except Subparts
[[Page 17003]]
I and K, which is consistent with the provisions of proposed rule. The
final rule clarifies that the licensees and other entities may subject
FFD program personnel to an FFD program that meets the requirements of
Subpart C, for the reasons discussed with respect to Sec. 26.31(b).
These clarifications are consistent with Goal 6 of this rulemaking to
improve clarity in the organization and language of the final rule.
Section 26.4(h) retains and amends the requirements contained in
proposed Sec. 26.25(d). Proposed Sec. 26.25(d) clarified that
individuals who have applied for authorization or perform duties that
require them to be subject to Part 26 also would be subject to some
provisions of Part 26. The former Part 26 required an applicant for
authorization to provide a written statement related to his or her past
activities under this part in former Sec. 26.27(a)(1); provide
permission to the licensee to conduct a suitable inquiry in former
Sec. 26.27(a)(2); and submit to pre-access testing in former Sec.
26.24(a)(1). Although the proposed rule used general terms, such as
``applicable requirements of this part'' and ``applicable protections
of this part,'' the final rule clarifies the requirements to which the
individuals specified in this paragraph are subject. The final rule
requires that individuals who have applied for authorization to have
the types of access or perform the activities described in Sec.
26.4(a) through (d) shall be subject to the requirements in Sec. Sec.
26.31(c)(1), 26.35(b), 26.37, 26.39 and the applicable requirements of
Subparts C, and E [Collecting Specimens for Testing] through H
[Determining Fitness-for-Duty Violations and Determining Fitness].
These clarifications ensure the internal consistency of the final rule
and meet Goal 6 of this rulemaking to improve clarity in the
organization and language of the rule.
Section 26.4(i)(1) through (i)(3) contains the provisions of
proposed Sec. 26.25(b)(1) through (b)(3). The final rule groups
together in one paragraph the former rule's provisions that identify
individuals who would not be subject to the rule. This change has been
made to meet Goal 6 of this rulemaking to improve clarity in the
organization and language of the rule.
The NRC has added Sec. 26.4(i)(1) to the final rule as a result of
extensive discussions with industry stakeholders at the public meetings
mentioned in the Section I.D of this document. Industry stakeholders
expressed strong concern that the related language in the affirmed rule
(which was discussed in the preamble to the proposed rule) that
delineated the FFD program personnel who must be subject to Part 26 was
too broad. Stakeholders agreed that FFD program personnel who work on
site and are involved in the day-to-day operations of the FFD program
should be subject to the rule. However, the stakeholders noted that the
language used in the affirmed rule was so vague that it could be
interpreted as requiring, for example, that offsite human resources
staff at a licensee's or other entity's corporate offices, who may have
access to some FFD information about individuals, must be covered, as
well as any medical or treatment personnel and their managers, at a
hospital or substance abuse treatment facility who provide an
occasional FFD program service. These interpretations of the intent of
the affirmed rule provisions would be incorrect.
The stakeholders also strongly disagreed with the requirement in
the affirmed rule that some FFD program personnel who maintain offices
at locations other than a licensee's or other entity's facilities and
are not involved in day-to-day program operations, such as EAP
counselors and some contract MROs, should be subject to the rule. The
stakeholders indicated that they believe the honesty and integrity of
such off-site personnel is maintained through their professions'
oversight and standards, with the result that requiring these
individuals to be subject to the rule would create a significant and
unnecessary regulatory burden. Stakeholders stated that the regulatory
burden would result from the significant logistical difficulties
involved in ensuring that these individuals are subject to behavioral
observation and drug and alcohol testing, and excessive costs to hire
additional MRO(s) to review any positive, adulterated, substituted, or
dilute drug test results from MRO(s) who serve the FFD program.
Based on the stakeholders' input, lessons learned from FFD program
experience since the rule was first implemented, the experience gained
by other Federal agencies and their regulated industries, and the
continuing need to ensure that FFD program personnel meet the highest
standards of honesty and integrity, the NRC added Sec. 26.4(i)(1) to
the final rule. The provision excludes from the rule individuals who
may be called upon to provide an FFD program service to a licensee or
other entity in special circumstances and who meet all of the following
criteria:
(1) They are not employed by the licensee or other entity;
(2) They do not routinely provide services to the licensee's or
other entity's FFD program; and
(3) They do not normally work at a licensee's or other entity's
facility.
Examples of individuals who are not subject to the rule under this
provision may include, but are not limited to, a nurse at a local
hospital who collects a single specimen for a post-event test from an
individual who has been injured, and a counselor at a residential
substance abuse treatment facility who performs behavioral observation
of a patient while the individual is in residence. Personnel who meet
the three criteria specified in the paragraph are excluded from the FFD
program because the limited nature of their involvement with the FFD
program makes it unlikely that they would be subject to coercion or
influence attempts to subvert the testing process and the NRC is not
aware of any reports indicating that these types of individuals have
been involved in any adverse incidents.
However, Sec. 26.4(g) of the final rule requires MROs and SAEs to
be subject to Part 26 (see the discussion of Sec. 26.187 [Substance
abuse expert] in Section VI of this document for a detailed description
of the SAE's roles and responsibilities under the FFD program), as well
as any EAP counselor who serves as the SAE for a licensee's or other
entity's FFD program. Individuals who serve in these positions play the
key roles of determining whether a positive, adulterated, or
substituted drug test result is an FFD policy violation (i.e., the MRO
under Sec. 26.185) and whether an individual is fit to safely and
competently perform the duties that require the individual to be
subject to this part (i.e., the SAE). Although the NRC recognizes the
significant logistical difficulties and costs that may be associated
with covering these individuals, the NRC concluded that MROs and SAEs
play such critical roles in the effective functioning of an FFD program
that ensuring their continuing honesty and integrity by requiring them
to be subject to the rule is warranted.
Section 26.4(i)(2) and (i)(3) retains the first sentence of former
Sec. 26.2(b) but divides it into two paragraphs. This organizational
change makes it easier to locate these requirements within the rule
text and to support cross-referencing to these paragraphs from other
portions of the rule. The NRC has moved the second sentence of former
Sec. 26.2(b) to Sec. 26.3(e) of the final rule, rather than retain it
in this provision, because it addressed entities who would not be
subject to the rule, rather than individuals. The NRC has made these
[[Page 17004]]
changes to meet Goal 6 of this rulemaking to improve clarity in the
organization and language of the rule.
The final rule adds a new Sec. 26.4(i)(4), which specifies that
FFD program personnel of a program that is regulated by another Federal
agency or State upon which a licensee or other entity relies to meet
the requirements of this part, as permitted in Sec. 26.4(j), Sec.
26.31(b)(2), and Sec. 26.405(e)(3) are not subject to a licensee's or
other entity's program if the FFD program personnel are not employed by
the licensee or other entity and their normal workplace is not at the
licensee's or other entity' facility.
Section 26.4(j) contains the provisions of proposed Sec. 26.25(c).
This provision provides that persons who are covered by a program
regulated by another Federal agency or State need not also be covered
by duplicate elements of a licensee's or other entity's FFD program.
Duplicate testing and training requirements applicable to an
appreciable number of individuals working at nuclear facilities have
become an increasing problem as the facilities have implemented the
DOT's drug and alcohol testing requirements [49 CFR Part 40, 65 FR
41944, August 9, 2001]. This revision reduces the burden on some
individuals who are currently subject to Federal and State programs
with requirements that duplicate those of Part 26. Minor differences in
specific program requirements for conducting drug and alcohol testing
would be unlikely to adversely affect the ability of a licensee's or
other entity's FFD program to meet the performance objectives of this
part. The licensee or other entity continues to be responsible for
implementing any Part 26 program elements that may not be addressed by
the alternate Federal or State program. These program elements may
include, but are not limited to, providing behavioral observation and
initiating for cause testing, if necessary, when an individual who is
covered by an alternate program is on site at a licensee's or other
entity's facility and is performing the duties that require the
individual to be subject to the rule, as well as immediate removal from
duty of persons whose fitness may be questionable.
Section 26.4(j)(1) through (j)(5) of the final rule contains the
provisions in proposed Sec. 26.25(c)(1) through (c)(4) and (c)(6). The
final rule lists the necessary characteristics of an alternative
Federal or State program that, under the final rule, licensees and
other entities may rely upon to satisfy the requirements of this part
for an individual who is subject both to Part 26 and an alternative
program. Paragraphs 26.4(j)(1) and (j)(3) permit licensees and other
entities to rely on the alternative program to meet the final rule's
drug testing requirements if the alternative program tests for the
drugs and drug metabolites that are specified in the final rule at or
below the cutoff levels established in the final rule and an HHS-
certified laboratory conducts the program's specimen validity and drug
testing. Similarly, Sec. 26.4(j)(2) permits licensees and other
entities to rely on the alternative program to meet the final rule's
alcohol testing requirements if the alternative program's alcohol
testing procedures and devices meet the final rule's requirements and
the alternative program uses cutoff levels that are at least as
stringent as those specified in Sec. 26.103(a). Section 26.4(j)(4)
permits the licensee or other entity to rely on an alternative
program's FFD training if that training addresses the knowledge and
abilities listed in Sec. 26.29(a)(1) through (a)(10). If the licensee
or other entity relies on the alternative program, Sec. 26.4(j)(5)
requires the licensee or other entity to ensure that the alternative
program informs the licensee or other entity of any FFD violations.
The final rule deletes the provision that was contained in proposed
Sec. 26.25(c)(5). The proposed provision allowed individuals subject
to Part 26 and to a Federal agency- or State-regulated program to be
covered only by those elements of an FFD program that are not included
in the Federal agency or State program if an impartial and objective
procedure is provided for the review and reversal of any findings of an
FFD policy violation. The NRC has deleted this provision because it
recognizes that it would be impractical to require a licensee to ensure
that a Federal agency or State program would include an impartial and
objective procedure for the review and reversal of any findings of an
FFD policy violation. Such assurance would be beyond the licensee's
ability to obtain or provide because the licensee would not control the
Federal agency or State program. Therefore, this change is consistent
with Goal 5 of this rulemaking to improve Part 26 by eliminating or
modifying unnecessary requirements.
These provisions are consistent with the former and final rules'
approaches to permitting licensees and other entities to rely on C/V
FFD programs and program elements to meet the requirements of this part
if the C/V's program or program element meets the requirements of this
part, as discussed with respect to Sec. 26.21 [Fitness-for-duty
programs]. In general, permitting licensees and other entities to rely
on FFD programs and program elements that are implemented by others,
when those programs or program elements meet the requirements of this
part, fulfills the rule's performance objectives and improves Part 26
by eliminating or modifying unnecessary requirements, which is Goal 5
of this rulemaking. However, an important difference between the final
rule's permission for licensees and other entities to rely on the
programs of other Federal and State agencies, compared to the final
rule's permission for licensees and other entities to rely on C/V
programs, is that the final rule does not require licensees and other
entities to audit the alternate Federal and State programs under Sec.
26.41 [Audits and corrective action]. Auditing Federal and State
programs is unnecessary because these programs are subject to other,
equally effective audit and inspection requirements. Relieving
licensees and other entities who are subject to this part from an audit
requirement also is in keeping with Goal 5 of this rulemaking.
Section 26.5 Definitions
Section 26.5 amends former Sec. 26.3 [Definitions] to (1) clarify
some definitions; (2) make the listed terms and their definitions more
consistent with those used by other Federal agencies (including SAMHSA
and DOT); (3) define new terms used in other sections of the rule; and
(4) move definitions into this section from former Section 1.2 in
Appendix A to 10 CFR Part 26, which contained definitions of important
terms used in Appendix A to Part 26. The rule also eliminates six terms
in former Sec. 26.3 and Section 1.2 in Appendix A to Part 26 because
they are fully defined in the provisions of the final rule or are not
used in the final rule. In addition, the rule eliminates redundant
definitions of some terms, which appear in both former Sec. 26.3 and
Section 1.2 in Appendix A to Part 26. Finally, the NRC has revised some
definitions to make them simpler and easier to understand, consistent
with the NRC's commitment to using plain language. For example, some
definitions in the former rule included requirements that were also
contained in other sections of the rule. In these instances, the final
rule eliminates the embedded requirements from within the definitions,
but retains the definitions in this section. The NRC has moved these
requirements to the related sections of the final rule for
organizational clarity.
The final rule modifies several definitions of the proposed rule
due to public comment or to increase clarity in the language of the
rule, consistent with Goal 6 of the rulemaking. These changes
[[Page 17005]]
are discussed below. Otherwise, the final rule adopts the definitions
of this section as proposed, without change.
The NRC has made the majority of the changes to this section as a
result of adding new requirements for urine drug testing, including
specimen validity testing, to the rule. The rule incorporates advances
in the science and technology of urine drug testing that are based on
the most recent revision to the HHS Guidelines, as published in the
Federal Register on April 13, 2004 (69 FR 19643). These changes require
adding terms to Sec. 26.5, modifying a number of the terms that were
used in the former rule, and revising the definitions of some terms in
the former rule that are also used in the final rule, as described in
the following paragraphs.
The final rule modifies several terms that are used in the former
and proposed rules to describe the results of drug and alcohol testing,
in order to reduce the number of terms, increase consistency with terms
used by other Federal agencies, and address the addition of urine
specimen validity testing requirements. The final rule has deleted the
term ``non-negative'' from the proposed rule. The NRC has added the
term ``non-negative'' to the proposed rule to refer to any adverse test
result from the different types of urine testing that are required
under the final rule. However, the NRC received a public comment that
requested clarification of ``non-negative'' with respect to
``positive'''' in the proposed rule. Therefore, the NRC has deleted
``non-negative'' from the final rule and replaced it with more specific
terminology. The final rule uses the term ``positive'' to refer to
results from drug and alcohol testing indicating the presences of drugs
or drug metabolites in a urine specimen or the presence of alcohol
above the cutoff levels established in this part in breath or oral
fluids specimens. The final rule uses the terms ``adulterated, dilute,
substituted, or invalid,'' as appropriate, to refer to results of
validity tests of urine specimens indicating that the specimen may not
be normal human urine. Consequently, the NRC has replaced the term
``non-negative'' in the following definitions in this section:
``confirmed test result,'' ``cutoff level,'' and ``Medical Review
Officer (MRO).''
The final rule, with respect to both the former and proposed rules,
adds the term ``positive result'' to specify what positive results mean
for drug and alcohol testing. The definition clarifies that, when the
laboratory has conducted the special analysis permitted in Sec.
26.163(a)(2), a result reported by an HHS-certified laboratory that a
specimen contains a drug or drug metabolite below the cutoff
concentration is also a positive result.
The final rule also changes the former term ``confirmed positive
test'' to ``confirmed test result'' to clarify that this term refers to
the results of the MRO's review of both drug and validity tests of
urine specimens, rather than to a type of testing. The final rule also
removes the reference to testing of blood specimens for alcohol that is
contained in the former definition of ``confirmed positive test'' from
the definition of ``confirmed test result'' because blood specimens are
no longer collected at the donor's request for confirmatory alcohol
testing, as discussed with respect to Sec. 26.83(a). With respect to
the proposed rule, the final rule specifies that a confirmed test
result demonstrates that an individual has used drugs ``and/or''
alcohol. The NRC has made these changes to meet Goal 6 of this
rulemaking, as it relates to improving clarity in the language of the
final rule.
The final rule adds several terms to refer to urine specimens that
have characteristics that are inconsistent with those expected of
normal human urine, as identified through validity testing. The terms
include ``adulterated specimen,'' ``dilute specimen,'' ``substituted
specimen,'' and ``invalid result.'' The final rule also adds the term
``oxidizing adulterant'' to refer to one class of substances that may
be used to adulterate urine specimens. These new terms and definitions
have been adapted from the HHS Guidelines.
With respect to the proposed rule, the final rule adds the term
``questionable validity'' to mean the results of validity screening or
initial validity tests at a licensee testing facility indicating that a
urine specimen may be adulterated, substituted, dilute, or invalid. The
NRC has added this term based on the consideration identified by a
commenter that licensee testing facilities may not be able to determine
whether a specimen is substituted, dilute, or meets some of the invalid
criteria because they are not required to test for specific gravity of
a specimen. This term replaces the term ``suspect specimens'' in the
former rule. Therefore, the NRC has made this change to improve clarity
in the language of the rule, consistent with Goal 6 of this rulemaking.
The final rule also adds several terms that are associated with new
requirements for maintaining quality control of urine specimen validity
and drug testing, such as the term ``quality control sample.'' The
final rule also adds definitions of the terms ``calibrator,''
``control,'' and ``standard'' to distinguish among the types of quality
control samples that are associated with urine specimen testing in
Subparts F [Licensee Testing Facilities] and G [Laboratories Certified
by the Department of Health and Human Services] of the final rule.
The final rule changes certain terms that describe drug and alcohol
tests to reflect the addition of urine specimen validity testing
requirements. The changes include replacing the term ``initial or
screening test'' with more specific terms to distinguish between drug
testing and testing for urine specimen validity. The NRC has added the
terms ``validity screening test,'' ``initial drug test,'' and ``initial
validity test'' to refer to the first tests of a urine specimen that
are performed to determine whether a urine specimen is free of drugs
and drug metabolites and has the expected characteristics of normal
urine, or whether further testing of the specimen is required. The
final rule modifies the proposed definition of ``validity screening
test'' to clarify that both non-instrumented tests, in which the
endpoint result is obtained by visual evaluation, and instrumented
(machine read) tests are acceptable methods to determine the need for
initial validity testing of urine specimen. The NRC has made these
changes to improve clarity in the language of the rule, consistent with
Goal 6 of this rulemaking.
The final rule also modifies the definition of ``initial or
screening test'' in the former rule to eliminate the requirement that
the test must be performed using immunoassay techniques because the NRC
addresses that requirement in other sections of the rule. The final
rule replaces the general term ``confirmatory test'' in the former rule
with the more specific terms, ``confirmatory drug or alcohol test'' and
``confirmatory validity test.'' In addition, the definitions of these
terms in the final rule do not include requirements for the methods to
be used in performing confirmatory tests because these requirements are
addressed in other sections of the rule. Therefore, the NRC has removed
the requirement that confirmatory drug testing be performed using gas
chromatography/mass spectrometry (GC/MS) testing from the definition.
The final rule also eliminates the reference to GC/MS testing of blood
samples for confirmatory alcohol testing in the definition of
``confirmatory drug or alcohol test'' because the final rule does not
allow donors the option to provide a blood sample for alcohol
confirmatory testing, as discussed with respect to Sec. 26.83(a).
[[Page 17006]]
The final rule also adds two terms that refer to testing for very
low levels of drugs, drug metabolites, or adulterants in a urine
specimen, ``limit of detection (LOD)'' and ``limit of quantitation
(LOQ).'' The NRC has adapted the definitions of these terms from the
HHS Guidelines.
In addition, the final rule modifies the definitions of two terms
in the former and proposed rules to be consistent with the new drug and
alcohol testing terminology that is used throughout the rule. The final
rule amends the definition of ``cutoff level'' in the former rule to
clarify that the term is also applicable to the interpretation of
results from specimen validity testing. The final rule further modifies
this definition to refer to test results as ``positive,'' ``of
questionable validity,'' and ``adulterated, substituted, dilute, or
invalid'' to account for validity tests results from a licensee testing
facility. The final rule amends the definition of ``Medical Review
Officer (MRO)'' to refer to a ``drug and validity'' test result, rather
than a ``positive'' test result, to clarify that the MRO reviews
validity test results in addition to drug test results.
The rule also adds six terms that are related to the requirements
contained in Subpart C. The term ``potentially disqualifying FFD
information'' refers to the types of information that licensees and
other entities who are subject to the rule consider when deciding
whether to grant or maintain an individual's authorization to have the
types of access or perform the duties that are listed in Sec. 26.4.
The final rule also adds definitions for four terms that are used
within the definition of ``potentially disqualifying FFD information,''
including ``substance abuse,'' ``legal action,'' ``employment action,''
and ``reviewing official.'' The NRC has also added the term ``best
effort'' to refer to the actions that a licensee or other entity who is
subject to the rule must take to obtain the information that is
necessary to complete a suitable inquiry and employment history check,
as discussed with respect to Sec. 26.63(a).
The final rule, with respect to the proposed rule, also adds a
definition of the term ``authorization'' in response to public comment.
The final rule uses the term, ``authorization,'' to refer to an
individual's status as having been determined by a licensee or other
entity to be eligible to perform the duties or have the types of access
listed in Sec. 26.4(a) through (e), and at the licensee's or other
entity's discretion, Sec. 26.4(f) and (g) of the final rule. The
agency selected this term to differentiate ``authorization'' under Part
26 from the terms, ``unescorted access authorization'' and ``unescorted
access,'' that are used by nuclear power plant licensees to refer to
individuals who are subject to both Part 26 and related access
authorization requirements under 10 CFR 73.56 [Personnel access
authorization requirements for nuclear power plants]. The NRC created a
new term because some categories of individuals who are subject to Part
26 are not required to meet the additional requirements of 10 CFR
73.56. For example, the NRC has not promulgated access authorization
requirements in Sec. 73.56 for FFD program personnel. Therefore, the
final rule uses the term ``authorization'' to refer to the
determination that these categories of individuals may perform the
duties or have the types of access specified in Sec. 26.4 to
distinguish the requirements in this part from the additional
requirements that a licensee or other entity must meet in order to
grant individual ``unescorted access authorization'' or ``unescorted
access'' to nuclear power plant protected areas.
The final rule adds a definition of ``maintenance'' to clarify the
scope of duties described as maintenance in Sec. 26.4(a)(4) of the
final rule. The definition also distinguishes duties performed by
individuals covered by Sec. 26.4(a)(4) from duties performed by
individuals that are subject to different work hour limits, such as the
duties described in Sec. 26.4(a)(1) through (3). Specifically, the
definition clarifies that Sec. 26.205(a) requires that individuals
identified in Sec. 26.4(a)(4) (i.e., individuals who are maintaining
or providing onsite direction for the maintenance of systems and
components that ``a risk informed evaluation process has shown to be
significant to public health and safety'') must be subject to the work
hour requirements. These requirements apply to those individuals who
perform the following maintenance activities within the licensee's
owner-controlled area: modification, surveillance, post-maintenance
testing, and corrective and preventive maintenance. This definition is
similar to the language used in GL 83-14, ``Definition of `Key
Maintenance Personnel,' (Clarification of Generic Letter 82-12)'' and
10 CFR 50.65, ``Requirements for Monitoring the Effectiveness of
Maintenance at Nuclear Power Plants.'' The definition of
``maintenance'' in Sec. 26.5 of the final rule excludes the term
``calibration,'' found in GL 83-14, because the NRC considers
``calibration'' to be part of ``preventive maintenance'' and,
therefore, within the definition of ``maintenance.''
The final rule also adds several terms that are necessary to
implement the requirements of Subpart I. These terms include
``fatigue,'' ``acute fatigue,'' and ``cumulative fatigue,'' which refer
to the degradation in an individual's cognitive (mental) and motor
(physical) functioning resulting from inadequate rest within the past
24 hours or over successive days and weeks, respectively. The rule also
uses the term ``alertness'' to refer to an individual's ability to
remain awake and sustain attention, which is adversely affected by
fatigue. The new term ``circadian variation in alertness and
performance'' defines a factor that licensees would consider when
conducting a fatigue assessment under Sec. 26.211 [Fatigue
assessments]. The final rule also adds the term ``increased threat
condition'' to refer to circumstances in which the rule provides
licensees with some flexibility in implementing the work hour controls
of Sec. 26.205. With respect to the proposed rule, the final rule
modifies the term ``increased threat condition'' to clarify that any
increase in the protective measure level is relative to the lowest
protective measure applicable to the site during the previous 60 days.
The final rule, with respect to the proposed rule, adds a
definition of ``shift cycle'' to mean a series of consecutive work
shifts and days off that is planned by the licensee or other entity to
repeat regularly, thereby constituting a continuous shift schedule.
Similarly, the final rule adds ``8-hour shift schedule,'' ``10-hour
shift schedule,'' and ``12-hour shift schedule'' to define these
schedules in terms of allowable hours of a workday averaged over a
shift cycle.
Also, the NRC has added the term ``unit outage'' to the final rule
to clarify that the specific reactor unit has to be disconnected from
the electrical grid to be declared in an outage. This term was added in
response to stakeholder comment raised at a public meeting on whether,
for purposes of implementing the work hour controls, a unit was
considered to be in an outage if reactor power was reduced for repair
or maintenance of a system or component, but the reactor was not
shutdown. Consequently, the NRC defined unit outage as the reactor
being disconnected from the electrical grid. This definition provides a
clearly identifiable plant state for applying the work hour controls in
Sec. 26.205(d)(4) and (d)(5).
The term ``directing'' clarifies new requirements for MRO staff
under Sec. 26.183(d) and the scope of individuals who would be subject
to work hour controls in Sec. 26.205. The NRC has
[[Page 17007]]
revised this definition in response to public comment regarding the
lack of clarity of the term ``directing'' as used in Subpart I in the
proposed rule and the scope of personnel that should be subject to work
hour controls. Specific comments included remarks regarding the scope
of engineering functions that should or should not be subject to work
hour controls. The revised definition in the final rule clarifies the
NRC's expectations that a limited scope of personnel providing
technical input would be subject to the requirements of Sec. 26.205.
The definition explicitly states the criteria that the term
``directing'' refers to an individual who is ``directly involved in the
execution of the work activity'' or ``is ultimately responsible for the
correct performance of that work activity'' as opposed to, for example,
the planning, development or scheduling of the activity, and that the
technical input does not receive ``subsequent technical review.'' The
NRC believes that, in the context of Subpart I, the revised definition
more clearly focuses on activities that have the potential to
substantively and immediately affect safety. These changes are
consistent with the changes that the NRC has made to the final rule in
Subpart I and meet Goal 6 of this rulemaking as it relates to improving
clarity in the language of the rule.
Similarly, with respect to the proposed rule, the NRC has added the
term ``supervises or manages'' to the final rule. The definition of
``supervises or manages'' explicitly states the criteria that the term
refers to an individual who is ``not directly involved in the execution
of the work activity,'' but who either makes technical decisions
without technical review, or is ``ultimately responsible for the
correct performance of that work activity,'' as opposed to, for
example, the planning, development or scheduling of the activity, and
that the technical input does not receive ``subsequent technical
review.'' This definition is intended to clearly focus on activities
that have the potential to substantively and immediately affect safety.
These changes are consistent with the changes that the NRC has made to
the final rule in Subpart I and meet Goal 6 of this rulemaking as it
relates to improving clarity in the language of the rule.
The final rule, with respect to the proposed rule, also adds
several terms that are necessary to interpret and implement the
requirements in Subpart K. The final rule includes definitions of
``constructing or construction activities,'' ``safety-related SSCs,''
and ``security-related SSCs.'' The NRC has added these definitions in
response to public comments that recommended that the NRC reconsider
the proposed requirements for licensees or other entities who will
build new nuclear power plants. The NRC defined these terms to clarify
the point in the construction process at which an FFD program for
construction is required, the physical location where the FFD program
for construction must be implemented, and to specify the individuals
who are subject to an FFD program for construction in terms of the
duties they will perform.
The former rule in Sec. 26.2(c) imposed FFD requirements on
construction permit holders ``with a plant under active construction''
but did not define that term. The proposed rule in Sec. 26.3(e) would
have required an FFD program for construction following NRC
authorization to construct. However, the NRC recognizes that there may
be a period of time that elapses between the authorization to construct
and the commencement of specific construction activities that have the
potential to affect public health and safety and the common defense and
security when the nuclear power plant begins operations. Therefore, the
NRC has added a definition of ``constructing and construction
activities'' to clarify that an FFD program for construction is not
required until a licensee or other entity begins ``fabricating,
erecting, integrating, and testing safety- and security-related SSCs,
and the installation of their foundations, including the placement of
concrete.''
In addition, this definition specifies that the FFD program for
construction applies only to construction activities that are performed
at the location where the new plant will be constructed and operated.
The NRC added this phrase to the definition of construction activities
to clarify that any fabrication, integration, or testing of safety- or
security-related SSCs that is not performed within or near the
licensee's or other entity's owner-controlled area in which the new
plant will be operated would not be subject to Subpart K. For example,
fabricating, integrating, and testing safety- or security-related SSCs
at a vendor's or manufacturer's facility that is located in another
city or state or outside of the U.S. would not be subject to Subpart K,
whereas producing the concrete to be used for the foundation of the
reactor building in a facility located on the site where the nuclear
power plant will be constructed and operated would be subject to
Subpart K (although the construction of the cement mixing facility
would not). The NRC anticipates that the focus of the Subpart K program
on construction activities involving safety- and security-related SSCs
at the location where the new plant will be constructed and operated
will lead licensees and other entities to ensure that the program
covers all those individuals who perform construction activities within
the footprint of the new power reactor (e.g., the exterior boundary of
the reactor building once it is completed) as well as the nearby areas
where safety- and security-related SSCs will be installed and operated
when the plant begins operations.
The former rule and the proposed rule also did not specify the
individuals who would be subject to an FFD program for construction.
The NRC recognizes that there will be other construction work performed
at the location where a new plant will be constructed and operated that
will not have the potential to affect public health and safety and the
common defense and security when the nuclear power plant begins
operations, such as constructing a building that will be used only for
training or administration purposes. The NRC does not intend that
individuals who are performing these other construction activities must
be subject to the FFD program. Therefore, the final rule also includes
definitions of safety- and security-related SSCs to clarify that only
those individuals who are constructing (i.e., fabricating, erecting,
integrating, testing, and installing foundations of) these specific
SSCs must be subject to a Subpart K program. Thus, as one example of a
safety-related SSC, the rule requires individuals who are constructing
the containment structure that surrounds the reactor to be subject to
an FFD program because the containment is relied on to mitigate the
consequences of accidents that could result in potential offsite
exposure. Similarly, individuals who are constructing security-related
SSCs, such as the central and secondary alarm stations, physical
barriers, communications systems, guard towers, surveillance and
detection systems, or installing locks and illumination systems, that
will be necessary to implement the physical security and safeguards
contingency plans that are required under 10 CFR Part 73 also are
subject to an FFD program for construction.
The development of the revised requirements contained in Subpart K
(described in Sections V and VI of this document) compelled the NRC to
define these terms in the final rule. Adding definitions of these terms
satisfies Goal 6 of this rulemaking as it relates to improving clarity
in the language of the rule.
[[Page 17008]]
The final rule also adds many terms related to other revisions to
the former rule. Specifically, the final rule adds ``analytical run''
for use in establishing amended performance testing requirements for
licensee testing facilities in Sec. 26.137 [Quality assurance and
quality control]. For consistency with the use of the term in the
related regulations of other Federal agencies, the term ``donor''
replaces the former terms that are used to refer to an individual from
whom a specimen is collected for drug or alcohol testing. The new term
``nominal'' refers to the leeway in the time periods within which
certain requirements must be met, such as the requirement for annual
FFD refresher training in Sec. 26.29(c)(2). The term ``other entity''
refers to organizations who are subject to Part 26, but who are not
licensed by the NRC, including, but not limited to, the organizations
who hold the NRC certificates or permits listed in Sec. 26.3. The
terms ``formula quantity'' and ``strategic special nuclear material''
(SSNM) have been defined consistently with the definitions of the same
terms in 10 CFR 70.4. The term ``subversion and subvert the testing
process'' clarifies the language of provisions related to urine
specimen validity testing, as discussed with respect to Sec.
26.31(d)(3)(i), and sanctions in Sec. 26.75(b) that are imposed on
individuals who are subject to Part 26.
Section 26.5 of the final rule also retains and amends a number of
other definitions formerly contained in Sec. 26.3 and Section 1.2 in
Appendix A to Part 26, as described in the following paragraphs.
The rule revises the former definition of ``aliquot'' to clarify
that an aliquot is a representative sample of a urine specimen that may
be used for testing. The amended definition is consistent with the same
definition in the HHS Guidelines.
The final rule simplifies the former definition of ``blood alcohol
concentration (BAC)'' by deleting references to the instruments that
licensees and other entities are permitted to use for alcohol testing.
The text of Sec. 26.91 [Acceptable devices for conducting initial and
confirmatory tests for alcohol and methods of use] specifies acceptable
devices for alcohol testing under the final rule.
The final rule revises the definition of ``category IA material''
to conform with the former definition contained in 10 CFR 74.4.
The final rule expands the definition of ``chain of custody'' to
indicate that the terms ``chain of custody'' and ``custody and
control'' are synonymous.
The NRC has modified the definition of ``collection site'' in the
final rule to include a reference to oral fluids as specimens that are
acceptable for initial alcohol testing. The basis for permitting the
use of oral fluids for initial alcohol testing is discussed in Section
VI of this document with respect to Sec. 26.83(a).
The final rule replaces the term ``collection site person'' with
the term ``collector'' to simplify the terminology used to refer to
individuals who collect specimens for testing and for consistency with
the terminology used by other Federal agencies. In addition, the
definition no longer includes the qualifications required for
collectors because they are specified in Sec. 26.85 [Collector
qualifications and responsibilities].
The final rule adds the term ``contractor/vendor (C/V),'' combining
the definitions of ``contractor'' and ``vendor'' in the former rule,
because the final rule does not distinguish between the two types of
entities.
The final rule updates the definition of ``HHS-certified
laboratory'' to reference the most recent version of the HHS Mandatory
Guidelines for Federal Workplace Drug Testing Programs.
In addition, the final rule simplifies the definition of ``licensee
testing facility'' by eliminating the reference to collecting specimens
for alcohol testing in the former definition, because alcohol testing
typically occurs at a collection site rather than at the licensee
testing facility. Also, with respect to the proposed rule, the NRC has
clarified this definition in the final rule to be consistent with the
inclusion of specimen validity testing at licensee testing facilities.
Finally, the final rule eliminates six terms that were defined in
former Sec. 26.3 and Section 1.2 in Appendix A to Part 26.
Specifically, the rule eliminates ``followup testing,'' ``random
test,'' ``suitable inquiry,'' ``reason to believe,'' and ``split
specimen'' because the text of the rule defines them in the section
where each term is used. The rule also eliminates the term ``permanent
record book'' in former Section 1.2 in Appendix A to Part 26 because
laboratories now use other mechanisms to maintain testing records.
Therefore, this term is no longer used in the rule.
Section 26.7 Interpretations
Section 26.7 in the final rule retains former Sec. 26.4
[Interpretations] but moves the qualifying phrase, ``other than a
written interpretation by the General Counsel,'' to the end of the
sentence to improve its clarity. The NRC has made this change in
keeping with the Commission's commitment to using plain language in its
regulations and to meet Goal 6 of this rulemaking to improve clarity in
the organization and language of the final rule.
Section 26.8 Information Collection Requirements: OMB Approval
Section 26.8 in the final rule amends former Sec. 26.8
[Information collection requirements: OMB approval] to reflect the
modified sections of the final rule in which recordkeeping requirements
are incorporated.
Section 26.9 Specific Exemptions
Section 26.9 in the final rule revises former Sec. 26.6
[Exemptions] to include the citation of 10 CFR 50.12 and 70.17. The NRC
has made this change in the final rule to ensure consistency between
Part 26 and these related requirements.
Section 26.11 Communications
New Sec. 26.11 in the final rule improves consistency with similar
sections in other parts of 10 CFR and ensures that communications with
the NRC are addressed and, therefore, processed properly.
Subpart B--Program Elements
Throughout Subpart B, the final rule makes minor clarifications to
the proposed rule because of public comment, to make conforming
changes, and to meet Goal 6 of this rulemaking to improve clarity in
the organization and language of the rule.
The final rule also makes more substantive changes to the proposed
rule in this subpart because of public comment or to improve clarity in
the organization and language of the rule. The substantive changes in
this subpart can be found in Sec. Sec. 26.21; 26.27(b)(3), (c)(1),
(c)(2)(ii), (c)(3), and (c)(3)(ii); 26.29(c)(2); 26.31(d)(1)(ii),
(d)(1)(iii), (d)(2)(i)(A), (d)(2)(v), (d)(3)(i), and (d)(3)(iii);
26.35(b); 26.37(a), (b)(5) and (d); 26.39(c) and (e); and 26.41(a).
These changes are discussed in detail below. However, other than the
changes mentioned above, the final rule adopts the provisions of this
subpart as proposed, without change.
Section 26.21 Fitness-for-Duty Program
The final rule modifies the proposed rule's text in this section to
specify which entities and individuals are subject to the requirements
of this subpart. This section requires that the licensees and other
entities specified in Sec. 26.3(a) through (c) must establish,
implement, and maintain FFD programs that, at a minimum, comprise the
program elements contained in this subpart. This new statement serves
as
[[Page 17009]]
an introduction to the remaining text of the final rule and eliminates
the need for the phrase ``[licensees and other entities] who are
subject to this subpart'' (or a derivation of this phrase) from several
provisions in this subpart. These changes are consistent with Goal 6 of
this rulemaking to improve clarity in the organization and language of
the rule.
The NRC has also added a sentence to this section to specify which
individuals are subject to FFD programs. The sentence in the final rule
includes cross-references to provisions in Sec. 26.4 [FFD program
applicability to categories of individuals], which eliminates the need
for the phrase ``[individuals] who are subject to this part'' (or a
derivation of this phrase) from several provisions in this subpart.
This change is consistent with Goal 6 of this rulemaking to improve
clarity in the organization and language of the rule.
The third sentence of the section of the final rule is based on
former Sec. 26.23(b). This provision retains permission for licensees
and other entities to rely upon the FFD program or program elements of
a C/V to meet the requirements of this part, if the FFD program or
program element of a C/V meets the applicable requirements of this
part. The other requirements contained in former Sec. 26.23
[Contractors and vendors] are discussed with respect to Sec. 26.23
[Performance objectives].
Section 26.23 Performance Objectives
Section 26.23 amends former Sec. 26.10 [General performance
objectives] as described in the following paragraphs.
The final rule divides the performance objectives contained in
Sec. 26.10(a) into two provisions (Sec. 26.23(a) and (b),
respectively) to clarify that the performance objective of assuring
that personnel are trustworthy and reliable is separate and distinct
from the performance objective of assuring that personnel are fit for
duty.
Section 26.23(a) of the final rule requires that FFD programs
provide reasonable assurance that persons who are subject to this part
are trustworthy and reliable as demonstrated by the avoidance of
substance abuse and the adverse behaviors that accompany it. The NRC
has placed an increased emphasis on the trustworthiness and reliability
of individuals who have access to certain types of sensitive
information, certain types of radiological materials, and protected
areas in nuclear power plants since September 11, 2001. These are the
same individuals who are subject to the final rule. Because these
individuals have unimpeded access to sensitive information and safety
equipment and systems, their trustworthiness and reliability are
essential. This level of emphasis is necessary to reduce the risk of an
insider threat, maintain public health and safety, and provide for the
common defense and security in the post-September 11, 2001, threat
environment. Substance abuse by these individuals presents an
unacceptable risk to public health and safety and the common defense
and security in several ways.
First, by increasing an individual's vulnerability to coercion,
substance abuse increases the likelihood that such individuals may pose
an insider threat. Under 10 CFR 73.1 [Purpose and scope], a passive
insider is defined as an individual who obtains or attempts to obtain
safeguards or other relevant information, such as a nuclear power
plant's physical configuration and design, and who does not have a
functional or operational need to know this information. Section 73.1
defines an active insider as a knowledgeable individual who, while
within the protected area of a nuclear power plant in an unescorted
status, takes direct action to facilitate entrance and exit, disable
alarms and communications, and/or participates in a violent attack. An
individual who uses illegal drugs may be coerced into cooperating,
actively or passively, with a terrorist in an attempt to commit
radiological sabotage if, for example, the terrorist were to threaten
the individual with revealing his or her illegal drug use or was
somehow able to withhold drugs from an individual who is addicted.
Second, an individual's judgment and self-control are impaired
while an individual is abusing drugs or alcohol. When an individual is
intoxicated from abusing any of the substances for which testing is
conducted under Part 26, including alcohol, the individual is more
likely to inadvertently reveal sensitive information that terrorists
could use in a radiological sabotage attempt than when he or she is not
intoxicated.
Third, the use of illegal drugs establishes that an individual is
willing to disobey the law, thus indicating that the individual will
disregard other rules and regulations. The use of illegal drugs raises
questions about the individual's trustworthiness and reliability in
terms of scrupulously following the regulations, procedures, and other
requirements, such as safeguards requirements, that ensure the
protection of public health and safety.
Many provisions of the former rule provided means to identify and
reduce the risks posed by any individuals whose substance abuse casts
doubt on their trustworthiness and reliability. In combination with
other measures the NRC has taken since September 11, 2001, a number of
the changes to the former rule provide further assurance that
individuals who are subject to the rule are trustworthy and reliable.
Changes to strengthen the effectiveness of the final rule in assuring
individuals' trustworthiness and reliability include, but are not
limited to, the following:
(1) Adding requirements for specimen validity testing to identify
individuals who are willing to attempt to subvert the testing process,
and may be willing to subvert other rules and regulations that are
important for public health and safety and the common defense and
security;
(2) Increasing the rigor of the evaluations that licensees and
other entities must perform before granting authorization to an
individual who has previously violated Part 26 requirements to ensure
that the individual has ceased abusing drugs or alcohol; and
(3) Imposing more stringent sanctions on individuals who violate
Part 26 requirements, including, but not limited to, permanently
denying authorization to any individual who attempts to subvert the
drug and alcohol testing process.
The NRC believes that implementation of these provisions of the
final rule, in addition to related measures the agency has taken in the
post-September 11, 2001, threat environment, provides an increased
level of requirements appropriate for the new threat environment, as
well as reasonable assurance that individuals who are subject to the
rule are trustworthy and reliable.
Section 26.23(b) of the final rule retains the performance
objective of providing reasonable assurance that personnel are fit for
duty, which appeared in former Sec. 26.10(a). The use of the term
``reasonable'' to describe the level of assurance required by the rule
reflects the NRC's awareness that many different factors may affect an
individual's fitness at any particular moment in time. Some of these
factors may be difficult for the licensee or other entity to detect and
many (such as a transitory illness) may not warrant management action
or the imposition of sanctions because they do not pose a significant
risk to public health and safety.
As mentioned above, the level of requirements associated with
achieving reasonable assurance of trustworthiness and reliability is
greater than that associated with achieving reasonable assurance that
individuals are not
[[Page 17010]]
impaired. Another example of this relates to the sanctions that the
final rule requires licensees and other entities to impose on
individuals who demonstrate questionable trustworthiness and
reliability compared to the management actions licensees are expected
to take with individuals who may be impaired. For example, if an
individual demonstrates dishonesty by attempting to bring a substitute
urine specimen to the collection site with a clear intent to subvert
the testing process or demonstrates a willingness to break the law by
possessing illegal drugs on site, the final rule (under Sec. 26.75(b)
and 26.75(c), respectively) requires the licensee or other entity to
terminate the individual's authorization. Terminating the individual's
authorization is necessary to provide reasonable assurance that the
individual could pose no further risk to public health and safety or
the common defense and security. In contrast, the final rule does not
require a licensee or other entity to terminate an individual's
authorization if he or she is mentally or physically impaired while on
duty from such transitory causes as illness or emotional stress
resulting from a family problem.
For example, an individual who arrives at work with a severe
migraine headache may suffer impairment on the job that would adversely
affect the individual's ability to perform his or her duties safely and
competently while the headache persists. The final (and former) rule
(under Sec. 26.77(b)(3) and former Sec. 26.27(b)(1), respectively)
require the licensee or other entity to take action to prevent the
individual from performing the duties that require the individual to be
subject to this part if the individual's fitness is questionable. These
actions could include, for example, assigning the individual to other
duties until medication brings the headache under control or sending
the individual home until the headache resolves. Such actions `meet the
performance objective of providing reasonable assurance that the
individual is fit when he or she resumes his or her normal duties.
However, it would be unreasonable for a licensee's FFD policy to impose
sanctions on the individual, such as terminating his or her
authorization. Sanctions could have no deterrent effect on the
recurrence of the individual's headache, which is one purpose of
including requirements for minimum sanctions in Part 26. In addition,
there would not be any continuing risk to public health and safety from
permitting the individual to resume his or her duties after the
headache is resolved.
Another difference between the performance objectives of providing
``reasonable'' assurance of trustworthiness and reliability and
``reasonable'' assurance that the individuals who are subject to the
final rule are fit for duty lies in the severity of the enforcement
actions that the NRC would be likely to take against an FFD program
that failed to meet these performance objectives. The NRC's enforcement
actions would be severe in the case of an FFD program that, for
example, granted authorization to an individual who had previously had
his or her authorization permanently denied under Sec. 26.75(b) but
would take less severe enforcement action in the case of an FFD program
that failed to remove an individual who was experiencing impairment
related to family stress from his or her duties under Sec.
26.77(b)(3).
Section 26.23(c) of the final rule retains the performance
objective in former Sec. 26.10(b) to ``provide reasonable measures for
the early detection of persons who are not fit to perform activities
within the scope of this part.'' However, the final rule replaces the
phrase ``perform activities within the scope of this part'' with the
phrase ``perform the duties that require them to be subject to the FFD
program.'' The final rule requires that certain individuals must be
subject to an FFD program based on their duties. These duties include
performing activities, such as measuring, guarding, or transporting
Category IA material. They also include having access to certain
locations, material, and sensitive information, such as nuclear power
plant protected areas, Category IA material, procedures and records for
safeguarding SSNM, and the drug test results of an individual before
the MRO reviews those results. Therefore, the phrase ``perform the
duties that require them to be subject to the FFD program'' is more
accurate. Replacing the former phrase with the more accurate phrase is
consistent with Goal 6 of the rulemaking to improve clarity in the
organization and language of the rule.
Section 26.23(d) of the final rule amends former Sec. 26.10(c) to
require that FFD programs must provide reasonable assurance that the
workplaces subject to this part are free from the presence and effects
of illegal drugs and alcohol. The final rule revises the former
performance objective to ``have a goal of achieving a drug-free
workplace and a workplace free of the effects of such substances'' for
several reasons. First, the terms ``drug-free'' and ``free from the
effects of such substances'' do not accurately capture the NRC's intent
with respect to this performance objective. These terms could be
misunderstood as requiring FFD programs to have the goal of preventing
any drugs and their effects from being present in the workplace, which
could include medications that individuals who are subject to the rule
may take to treat health problems. Therefore, the final rule replaces
``drug-free'' and ``free of the effects of such substances'' with the
more specific phrase ``free from the presence and effects of illegal
drugs and alcohol'' to refer to the specific substances that are
proscribed. This revision clarifies that the NRC does not intend for
FFD programs to prohibit individuals from taking the medications they
need to maintain their health or bringing those medications to the
workplace. The NRC has made this change to meet Goal 6 of this
rulemaking to improve clarity in the organization and language of the
rule.
The final rule also replaces the phrase ``have a goal of'' in the
former rule with the phrase ``provide reasonable assurance'' which more
accurately captures the intent of this performance objective. The NRC
has eliminated the phrase ``have a goal of'' because Sec. 26.23(d) is
a performance objective and, therefore, the phrase is unnecessary. The
NRC has made this change to meet Goal 6 of this rulemaking to improve
clarity in the organization and language of the rule without changing
the intended meaning of the performance objective.
Section 26.23(e) of the final rule adds a provision to require
licensees and other entities to provide reasonable assurance that the
effects of fatigue and degraded alertness on individuals' abilities to
safely and competently perform their duties are managed commensurate
with maintaining public health and safety. This new performance
objective, consistent with Goal 2 of this rulemaking to strengthen the
effectiveness of FFD programs at nuclear power plants in ensuring
against worker fatigue adversely affecting public health and safety and
the common defense and security by establishing clear and enforceable
requirements for the management of worker fatigue, specifies the
objective of the requirements concerning worker fatigue that the NRC
has added to the final rule. Worker fatigue cannot be measured or
controlled with precision. Also, licensees and other entities do not
have direct control over all matters that may influence worker fatigue.
Therefore, Sec. 26.23(e) establishes a ``reasonable assurance''
criterion for the performance objective. Worker fatigue
[[Page 17011]]
can result from many causes (e.g., work hours, sleep disorders, demands
outside the workplace). In addition, individuals differ in their
responses to conditions that cause fatigue. As a consequence, work-hour
limits alone do not address all causes of fatigue, nor do they prevent
fatigue related to work hours for all workers. Contemporary methods for
addressing worker fatigue (e.g., Rogers, 1996, 1997; Hartley, 1998;
Carroll, 1999) are commonly referred to as ``fatigue management''
programs and use diverse methods (e.g., training, behavioral
observation, fatigue countermeasures) in addition to work-hour controls
to prevent, detect, and mitigate fatigue. Accordingly, Sec. 26.23(e)
establishes a performance objective of reasonable assurance that the
effects of fatigue and degraded alertness on individuals' abilities to
safely and competently perform their duties are ``managed''
commensurate with maintaining public health and safety. The performance
objective permits licensees and other entities to apply risk-informed
fatigue management controls for individuals consistent with the
significance of their work activities to the protection of public
health and safety.
Section 26.25 [Reserved]
The final rule has amended and moved the requirements from proposed
Sec. 26.25 [Individuals subject to the fitness-for-duty program] to
Sec. 26.4 of the final rule. This change is discussed in detail in
this document with regard to Sec. 26.4.
Section 26.27 Written Policy And Procedures
Section 26.27 of the final rule reorganizes and amends former Sec.
26.20 [Written policy and procedures. The final rule divides into
separate paragraphs the requirements related to the FFD policy and FFD
program procedures that are intermixed within the former section. This
organizational change makes the requirements related to the FFD policy
and procedures easier to locate within this section, consistent with
Goal 6 of this rulemaking to improve clarity in the organization and
language of the rule.
Section 26.27(a) of the final rule amends the first paragraph of
former Sec. 26.20. The former provision required licensees to
establish and implement written policies and procedures designed to
meet the performance objectives and specific requirements of this part
and to retain superseded copies of the policies and procedures. The
final rule replaces the term ``licensee'' in the former rule with the
phrase ``licensees and other entities'' because entities other than
licensees are subject to this requirement, as discussed with respect to
Sec. 26.3 [Scope]. The final rule adds the term ``maintain'' to the
former requirement to ``establish and implement'' written policies and
procedures to reflect the fact that licensees and other entities who
are subject to Part 26 must occasionally revise FFD program policies
and procedures to keep them current when FFD program personnel or other
aspects of the FFD program change. The final rule replaces ``specific''
with the term ``applicable'' in the final sentence because all the
requirements in Part 26 do not apply to all the licensees and other
entities who are subject to the rule, as discussed with respect to
Sec. 26.3. The final rule also eliminates ``designed to'' from this
sentence because it is unnecessary. The NRC has moved the records
retention requirements contained in the second sentence of the former
provision to Sec. 26.713(d) in Subpart N [Recordkeeping and Reporting
Requirements] of the final rule. Subpart N groups together the
recordkeeping and reporting requirements that are interspersed
throughout the former rule. The NRC has made these changes to the
organization and language of former Sec. 26.20 to meet Goal 6 of this
rulemaking to improve clarity in the organization and language of the
rule.
Section 26.27(b) of the final rule amends former Sec. 26.20(a).
The former provision established requirements for the written FFD
policy, and the final rule expands the list of topics that the FFD
policy must address as a result of discussions with stakeholders during
the public meetings mentioned in Section I.D. Stakeholders noted that
the list of topics in the former rule is incomplete because it does not
include many topics about which individuals who are subject to the
policy should be aware in order to be able to comply with the policy.
Therefore, the final rule adds topics to the policy content
requirements in former Sec. 26.20(a) to ensure that FFD policies will
be complete. The NRC has made this change to meet Goal 7 of this
rulemaking to protect the rights (including due process) of individuals
who are subject to Part 26.
Section 26.27(b) of the final rule also adds requirements for the
written FFD policy to be clear, concise, and readily available to all
individuals who are subject to the policy because neither the former
nor final rules require licensees and other entities to provide site-
specific FFD training to individuals. However, FFD policies may vary
between licensees and other entities with respect to, for example, the
sanctions that are applied for confirmed positive, adulterated, or
substituted test results, the cutoff levels used in drug or alcohol
testing, or the time periods within which an individual who has been
selected for random testing must report to the collection site.
Under this final rule, the written FFD policy continues to be the
primary means by which a licensee or other entity communicates local
variations in FFD policy. In the past, however, a few individuals
challenged determinations that they had violated a licensee's FFD
policy on the basis that they were not aware of the specific provisions
of the policy to which they were subject. Therefore, the final rule
adds requirements that the FFD policy must be clear, concise, and
readily available in order to promote individuals' awareness of the
site-specific FFD policy to which they are subject. The NRC has made
this change to meet Goal 7 of this rulemaking to protect the rights
(including due process) of individuals who are subject to Part 26.
The final rule also adds examples of acceptable methods to make the
written policy ``readily available'' to individuals who are subject to
the FFD policy, including, but not limited to, posting the policy in
various work areas throughout the licensee's or other entity's
facilities, providing individuals with brochures, or allowing
individuals to print the policy from a computer. The NRC has added
these examples to meet Goal 6 of this rulemaking to improve clarity in
the organization and language of the rule.
Section 26.27(b)(1) amends the second sentence of former Sec.
26.20(a). Former Sec. 26.20(a) required that ``the policy must address
the use of illegal drugs and abuse of legal drugs (e.g., alcohol,
prescription and over-the-counter drugs).'' Section 26.27(b)(1) of the
final rule expands this sentence to require the FFD policy to describe
the consequences of onsite or offsite use, sale, or possession of
illegal drugs in Sec. 26.27(b)(i); the abuse of legal drugs and
alcohol in Sec. 26.27(b)(ii); and the misuse of prescription and over-
the-counter drugs in Sec. 26.27(b)(iii). The final rule replaces the
phrase ``must address'' in the former sentence with the phrase ``must
describe the consequences of.'' The updated phrase clarifies the
information that the policy must convey to ensure that individuals who
are subject to the policy are aware of the consequences of these
actions, as specified in the licensee's or other entity's FFD policy.
The NRC has made these changes to meet Goal 6 of this
[[Page 17012]]
rulemaking to improve clarity in the organization and language of the
rule.
The final rule adds Sec. 26.27(b)(2) that requires the FFD policy
to state the time period specified by the licensee or other entity
within which individuals must report to the collection site after being
notified that they have been selected for random testing. The provision
does not establish a time limit because there are a variety of
circumstances among the different licensees and other entities who are
subject to this rule that make it impractical to establish a universal
time limit. However, adding the requirement for the licensee's or other
entity's FFD policy to establish and convey a time limit is necessary
because some programs have not done so. As a result, circumstances have
arisen in which individuals who were selected for random testing
intentionally delayed reporting to the collection site in order to take
steps to subvert the testing process, such as obtaining an adulterant
to bring to the collection site or drinking large amounts of liquid to
be able to provide a dilute specimen. Furthermore, the longer that an
individual who has abused illegal drugs or alcohol is able to delay
providing specimens for testing, the more likely it is that the
concentrations of an illegal drug or alcohol in the individual's urine,
breath, or oral fluids will decrease because of metabolism. As a
result, the concentrations may fall below the cutoff levels for those
substances by the time the specimens are collected and the individual's
substance abuse would not be detected. Therefore, the requirement to
establish a time limit within which individuals must report for random
testing after notification meets Goal 3 of this rulemaking to improve
the effectiveness and efficiency of FFD programs. The final rule also
requires the FFD policy to convey this time limit to ensure that
individuals are aware of it, given that a failure to appear for testing
within the prescribed time limit may lead to the imposition of
sanctions under the FFD policy. The NRC has made this change to meet
Goal 7 of this rulemaking to protect the rights (including due process)
of individuals who are subject to Part 26.
Section 26.27(b)(3) adds a requirement that the FFD policy inform
individuals of the consequences of refusing to be tested and attempting
to subvert the testing process. With respect to the proposed rule, the
final rule clarifies that the written policy statement must also
describe the actions that constitute a refusal to provide a specimen
for testing. This change, in response to a public comment, clarifies
the intent of the provision, consistent with Goal 6 of the rulemaking
to improve clarity in the language and organization of the rule. This
provision ensures that persons who are subject to the rule are aware of
Sec. 26.75(b), which requires licensees and other entities to impose
the sanction of permanent denial of authorization for these actions.
Section 26.27(b)(3) protects the due process rights of individuals who
are subject to drug and alcohol testing under this part by ensuring
that they are informed, in advance, of the licensee's or other entity's
policies to which they are subject. Therefore, adding this requirement
to the final rule meets Goal 7 of this rulemaking to protect the rights
(including due process) of individuals who are subject to Part 26.
Section 26.27(b)(4)(i) amends former Sec. 26.20(a)(1). Former
Sec. 26.20(a)(1) required the FFD policy to prohibit the consumption
of alcohol within an abstinence period of at least 5 hours preceding
``any scheduled working tour.'' The final rule replaces the phrase
``any scheduled working tour'' with the phrase ``the individual's
arrival at the licensee's or other entity's facility'' as a result of
stakeholder comments on the language in the former rule at the public
meetings mentioned in Section I.D. The stakeholders commented that the
former phrase lacked clarity and could be misinterpreted as meaning,
``any working tour scheduled by the licensee or other entity.'' If the
phrase was so interpreted, individuals who are subject to the rule may
believe that, if they work on a weekend or work overtime that is not
part of their normally scheduled working tour, the rule would permit
them to consume alcohol within the 5-hour period before they arrive at
work, which would be incorrect. Therefore, the revised language of the
final rule clarifies that the pre-work abstinence period applies to the
5 hours before an individual arrives at the licensee's or other
entity's facility for any purpose, except if an individual is called in
to perform an unscheduled working tour, as discussed with respect to
Sec. 26.27(c)(3). The NRC has made this final change to meet Goal 6 of
this rulemaking to improve clarity in the organization and language of
the rule.
Section 26.27(b)(4)(ii) retains former Sec. 26.20(a)(2) without
change.
The NRC has added Sec. 26.27(b)(5) to the final rule to require
that the FFD policy inform individuals that abstinence from alcohol
during the 5 hours preceding any scheduled tour of duty may not be
sufficient to ensure that an individual is fit for duty upon reporting
to work. Some individuals who have complied with the 5-hour abstinence
requirement could have BACs above the cutoff levels specified in Sec.
26.103 [Determining a confirmed positive test result for alcohol]
preceding a scheduled tour of duty, depending on the amount of alcohol
and food that the individual consumed before the abstinence period
began, body weight, and other factors. By ensuring that individuals who
are subject to this part are aware that the required 5-hour abstinence
period may be insufficient to ensure they have a BAC below the cutoff
levels in this part when arriving at the licensee's or other entity's
facility, this provision to meet Goal 7 of this rulemaking to protect
the rights (including due process) of individuals who are subject to
alcohol testing under Part 26.
Section 26.27(b)(6) amends the last sentence of former Sec.
26.20(a). That sentence required the FFD policy to address other
factors that could affect individuals' abilities to perform their
duties safely and competently, such as mental stress, fatigue, and
illness. The final rule adds a requirement for the FFD policy also to
address the use of prescription and over-the-counter medications that
could cause impairment at work. For example, some licensees or other
entities may require individuals to self-report to the FFD program
their use of any prescription medications that are labeled with a
warning indicating that use of the medication may cause impairment. The
licensee's or other entity's FFD policy may require that an individual
who is taking a medication that can cause impairment must be
temporarily reassigned to duties that the individual can perform
without posing a risk to the individual or public health and safety
while he or she is taking the medication. Therefore, the final rule
requires licensees and other entities to include such information in
the FFD policy to ensure that individuals are aware of the actions they
may be required to take when using these substances, consistent with
Goal 7 of this rulemaking with respect to protecting the rights
(including due process) of individuals who are subject to the policy.
The addition of this requirement also increases the internal
consistency of the rule because other portions of the final rule
establish requirements related to using prescription and over-the-
counter medications. For example, Sec. 26.29(a)(6) requires FFD
training to address use of prescription and over-the-counter
medication. Also, Sec. 26.185(j)(2) requires the MRO to determine
whether a positive confirmatory drug test result that results from
using a prescription or over-the-counter medication represents
[[Page 17013]]
substance abuse. Therefore, the requirement for the FFD policy to
address the use of prescription and over-the-counter medications that
could cause impairment at work also meets Goal 6 of this rulemaking to
improve clarity in the organization and language of the rule.
Section 26.27(b)(7) amends former Sec. 26.20(b). Former Sec.
26.20(b) required the FFD policy to describe programs that are
available to individuals desiring assistance in dealing with drug,
alcohol, or other problems that may adversely affect their performance
of their duties. Section 26.27(b)(7) of the final rule adds fatigue as
one of the problems for which individuals may be seeking assistance
because sleep disorders (e.g., sleep apnea, insomnia, restless leg
syndrome) can substantially affect individuals' abilities to obtain
sufficient quality sleep. Poor quality sleep causes fatigue that may
degrade an individual's ability to safely and competently perform his
or her duties. Sleep disorders affect a sizeable portion of the U.S.
work force. According to polls conducted by NSF, about two-thirds of
U.S. adults report experiencing one or more symptoms associated with
insomnia, sleep apnea, or restless leg syndrome at least a few nights a
week (National Sleep Foundation, 2003) and nearly one out of five (19
percent) report making occasional or frequent errors because of
sleepiness (National Sleep Foundation, 2000). Section 26.27(b)(7)
ensures that individuals are aware of the services that are available
for diagnosing and treating sleep disorders that can adversely affect
their job performance. The NRC has made this change to meet Goal 2 of
this rulemaking to strengthen the effectiveness of FFD programs at
nuclear power plants by reducing the potential for worker fatigue to
adversely affect public health and safety and the common defense and
security, through establishing clear and more readily enforceable
requirements concerning the management of worker fatigue. In addition,
the final rule replaces the phrase ``adversely affect the performance
of activities within the scope of this part'' in the former provision
with the phrase ``could adversely affect an individual's ability to
safely and competently perform the duties that require an individual to
be subject to this part'' for the reasons discussed with respect to
Sec. 26.23(c).
Section 26.27(b)(8) retains the requirement in former Sec.
26.20(d) that the FFD policy must specify the consequences of violating
the policy. The NRC has moved the former requirements that were related
to the procedures that the licensee or other entity would implement if
an individual violates the FFD policy to Sec. 26.27(c) of the final
rule, which addresses FFD program procedures, for organizational
clarity.
Section 26.27(b)(9) adds a requirement that licensees' and other
entities' FFD policies must describe the individual's responsibility to
report legal actions, as defined in Sec. 26.5 [Definitions]. The new
requirement to report legal actions is discussed with respect to Sec.
26.61 [Self-disclosure and employment history]. The final rule requires
the FFD policy to address the reporting of legal actions to ensure that
individuals are aware of this and are not at risk of sanctions for
failing to report any legal actions. Thus, the NRC has made this change
to meet Goal 7 of this rulemaking to protect the rights (including due
process) of individuals who are subject to the policy.
Section 26.27(b)(10) adds a requirement for the FFD policy to
describe the responsibilities of managers, supervisors, and escorts to
report FFD concerns. The former rule implied that managers and
supervisors have the responsibility to report FFD concerns in Sec.
26.22(a)(5), which required managers and supervisors to be trained in
procedures ``for initiating appropriate corrective action.'' Similarly,
the last phrase of former Sec. 26.22(b) required that escorts be
trained in procedures ``for reporting problems to supervisory or
security personnel'' and, therefore, also implied that escorts have a
reporting responsibility. However, the former rule did not explicitly
state that the FFD policy must convey this requirement. Therefore, the
final rule adds Sec. 26.27(b)(10) to enhance the internal consistency
of the rule. The NRC has made this change to meet Goal 6 of this
rulemaking to improve clarity in the organization and language of the
rule.
Section 26.27(b)(11) adds a requirement for the FFD policy to state
that individuals who are subject to the rule must report FFD concerns,
consistent with Sec. 26.33 [Behavioral observation]. Section 26.33
requires individuals who are subject to the rule to perform behavioral
observation and to report an FFD concern if they detect behaviors that
may indicate possible use, sale, or possession of illegal drugs; use or
possession of alcohol on site or while on duty; or impairment from
fatigue or any cause that, if left unattended, may constitute a risk to
the health and safety of the public. Section 26.29 [Training] requires
individuals to be trained in behavioral observation. The agency has
added these requirements to enhance the effectiveness of Part 26 by
ensuring the early detection of individuals who are not fit to perform
the duties that require them to be subject to this part. This is one of
the performance objectives that FFD programs must meet, as discussed
with respect to Sec. 26.23(c). This provision also improves
consistency between FFD requirements and access authorization
requirements established in 10 CFR 73.56 [Personnel access
authorization requirements for nuclear power plants] as supplemented by
orders to nuclear power plant licensees dated January 7, 2003, as
discussed in Section IV.B of this document. The specific requirement in
Sec. 26.27(b)(11) for licensees' and other entities' FFD policies to
state that individuals must report FFD concerns is necessary to ensure
that individuals are aware of their responsibility to report concerns
(and that sanctions may be imposed if they do not) to meet Goal 7 of
this rulemaking to protect the rights (including due process) of
individuals who are subject to the policy.
Section 26.27(c) of the final rule combines the requirements
related to procedures contained in former Sec. 26.20(c) through (e),
and adds other requirements, as described in the following paragraphs.
Section 26.27(c)(1) retains the requirements in former Sec.
26.20(c). The NRC has replaced the phrase in the proposed rule
``privacy and due process rights of an individual who provides a
specimen'' with the phrase ``privacy and other rights (including due
process) of an individual who provides a specimen'' in the final rule.
The NRC has made this change in response to a public comment that
stated the proposed phrase may be interpreted to limit individuals'
protected rights to due process. This phrase clarifies the requirement
for ``protecting the employee'' contained in former Sec. 26.20(c). For
example, individuals' privacy rights under the final rule include, but
are not limited to, requirements for the protection of personal
information that is collected about the individual and individual
privacy during specimen collections. Other examples of individuals'
rights under the final rule include, but are not limited to, the right
to an objective and impartial review of a determination that the
individual has violated the FFD policy, the right to advance knowledge
of rule provisions and FFD policy requirements that affect the
individual, and the right to request testing of a split specimen or
retesting an aliquot of a single specimen, if the individual questions
a confirmed positive, adulterated, or substituted test result.
[[Page 17014]]
The NRC has made this change to meet Goal 6 of this rulemaking to
improve clarity in the organization and language of the rule.
Section 26.27(c)(2)(i) and (c)(2)(ii) divides former Sec. 26.20(d)
into separate paragraphs that address different topics. Section
26.27(c)(2)(i) retains the former requirement that licensees and other
entities must have procedures that specify the immediate and followup
actions that must be taken if an individual is determined to have been
involved in the use, sale, or possession of illegal drugs. Like the
former provision, Sec. 26.27(c)(2)(ii) requires licensees' and other
entities' procedures to specify the immediate and followup actions to
be taken if an individual is determined to have consumed alcohol to
excess before the mandatory prework abstinence period, or while on
duty, as determined by a test that measures BAC. With respect to the
proposed rule, the final rule also adds the phrase ``or consumed any
alcohol during the mandatory prework abstinence period'' to clarify the
prohibition against any alcohol consumption, not only excess
consumption, during the pre-work abstinence period. The NRC has made
these changes to meet Goal 6 of this rulemaking to improve clarity in
the organization and language of the rule.
Section 26.27(c)(2)(iii) and (c)(2)(iv) adds requirements that
licensees and other entities must prepare written procedures for
implementing the FFD program that describe immediate and followup
actions for attempted subversion of the testing process. Section
26.27(c)(2)(iii) requires procedures to specify immediate and followup
actions if an individual has attempted to subvert the testing process
by adulterating, substituting, or diluting specimens (in vivo or in
vitro), or by any other means. Section 26.27(c)(2)(iv) requires
procedures to address the actions to be taken if an individual has
refused to provide a specimen for testing. The final rule adds these
provisions for consistency with Sec. 26.75(b). Section 26.75(b)
requires licensees and other entities to terminate an individual's
authorization and, thereafter, permanently deny authorization to any
individual who has committed or attempted any act to subvert the
testing process, including refusing to provide a specimen and providing
or attempting to provide a substituted or adulterated specimen for any
test required under Sec. 26.31(c). Adding the requirements for
procedures to address these circumstances meets Goal 6 of this
rulemaking to improve clarity in the organization and language of the
rule.
Section 26.27(c)(2)(v) adds a requirement that the written
procedures must describe immediate and followup actions for individuals
who have had drug- or alcohol-related legal actions taken against them,
as defined in Sec. 26.5. This provision supports related provisions in
Sec. 26.69(d). Section 26.69(d), in general, requires licensees and
other entities to take certain steps if an individual has had drug- or
alcohol-related legal actions taken against them while they are
maintaining authorization to perform the duties that require them to be
subject to this part. Adding the requirement for procedures to address
these circumstances ensures the internal consistency of the final rule
and meets Goal 6 of this rulemaking to improve clarity in the
organization and language of the rule.
The NRC has reorganized Sec. 26.27(c)(3) of the final rule, with
respect to the proposed rule, to clarify which provisions apply to
``emergencies'' and which apply to ``unscheduled working tours.'' The
NRC received a public comment that suggested the term ``emergency'' may
be too limiting. However, the NRC believes the term ``emergency''
accurately reflects NRC's intent and has retained this term in the
final rule. Section 26.27(c)(3) amends former Sec. 26.20(e). The
provision requires licensees and other entities to have procedures to
describe the process that the licensee or other entity will use to
ensure that individuals who are called in to perform an unscheduled
working tour are fit for duty.
The final rule retains and modifies the other requirements of
former Sec. 26.20(e), as described in the following paragraphs.
Section 26.27(c)(3)(i) retains former Sec. 26.20(e)(1). The
provision requires the individual who is called in to state whether the
individual considers himself or herself fit for duty and whether he or
she has consumed alcohol within the pre-duty abstinence period stated
in the FFD policy. The final rule adds the requirement to state whether
he or she considers himself or herself to be fit for duty, in addition
to stating whether he or she has consumed alcohol because the NRC
recognizes that conditions other than the consumption of alcohol may
cause an individual to be unable to safely and competently perform
duties, including, but not limited to, fatigue (as discussed with
respect to Subpart I [Managing Fatigue]). The NRC received a comment
suggesting that individuals who are called in should only be required
to report if they are not fit for duty or have consumed alcohol during
the pre-duty abstinence period. The NRC believes that this alternative
would be less protective of public health and safety, as an affirmative
obligation to provide a statement may dissuade individuals who would be
tempted to remain silent. Requiring individuals to report other
conditions that may cause them to be impaired when called in under
Sec. 26.27(c)(3)(i), strengthens the effectiveness of FFD programs by
providing the licensee or other entity with more complete information
about the individual's condition to determine whether there is a need
to establish controls and conditions under which the individual may
safely perform work, as required under Sec. 26.27(c)(3)(iii).
Therefore, the NRC has adopted the proposed provision as final. The NRC
has made these changes to meet Goal 3 of this rulemaking to improve the
effectiveness and efficiency of FFD programs.
Section 26.27(c)(3)(ii) specifies the procedures to follow if the
individual has consumed alcohol in the pre-duty abstinence period and
is called in for an unscheduled working tour, including an unscheduled
working tour to respond to an emergency. Section 26.27(c)(3)(ii)(A)
retains former Sec. 26.20(e)(2). The provision requires that an
individual who reports that he or she has used alcohol and is called in
must be subject to a determination of fitness by breath analysis. The
NRC has added a new Sec. 26.27(c)(3)(ii)(B) to the final rule to
permit the licensee or other entity to assign the individual to duties
that require him or her to be subject to this part, if the results of
the determination of fitness indicate that the individual is fit to
safely and competently perform his or her duties. The NRC has also
added a new Sec. 26.27(c)(3)(ii)(C) to the final rule to prohibit the
licensee or other entity from assigning the individual to duties that
require him or her to be subject to this part, if the individual is not
required to respond to an emergency and the results of the
determination of fitness indicate that the individual may be impaired.
The NRC has also added Sec. 26.27(c)(3)(ii)(D) that retains a portion
of former Sec. 26.20(e)(3). The provision requires the procedures to
state that consumption of alcohol during the 5-hour abstinence period
required in paragraph (b)(4)(i) of this section may not by itself
preclude a licensee or other entity from using individuals who are
needed to respond to an emergency. This provision also retains and
modifies a portion of former Sec. 26.20(c)(3). It states that if the
determination of fitness indicates that an individual who has been
called in for an unscheduled working tour to
[[Page 17015]]
respond to an emergency may be impaired, the procedure must require the
establishment of controls and conditions under which the individual who
has been called in can perform work if necessary.
The NRC has added Sec. 26.27(c)(3)(ii)(E) to the final rule to
clarify that licensees and other entities may not impose sanctions if
an individual is called in for an unscheduled working tour for having
consumed alcohol during the preduty abstinence period specified in the
FFD policy. This change ensures that, if an individual who is called in
unexpectedly has a confirmed positive test result for alcohol, he or
she would not be subject to the sanctions that are otherwise required
under this part for a confirmed positive alcohol test result. The NRC
believes that sanctions for the consumption of alcohol in these
circumstances would be inappropriate because the individual would have
been unaware that he or she would be called in to work. The revision is
also consistent with the original intent of the rule. Therefore, the
NRC has made these changes to meet Goal 6 of this rulemaking to improve
clarity in the organization and language of the rule.
Section 26.27(c)(4) adds a requirement that FFD procedures must
describe the process to be followed when another individual's behavior
raises an FFD concern and the process for reporting the concern. As
discussed with respect to Sec. 26.27(b)(11), this provision is
consistent with Sec. 26.33, which establishes a requirement that all
individuals must perform behavioral observation and report any FFD
concerns. This provision is also consistent with Sec. 26.29, which
requires individuals to be trained to perform behavioral observation.
The NRC has added this requirement to meet Goal 3 of this rulemaking to
improve the effectiveness and efficiency of FFD programs and Goal 4 to
improve consistency between FFD requirements and access authorization
requirements established in 10 CFR 73.56, as supplemented by orders to
nuclear power plant licensees dated January 7, 2003.
Section 26.27(d) of the final rule retains the requirements of
former Sec. 26.20(f) without changes.
Section 26.29 Training
Section 26.29 of the final rule combines and amends former Sec.
26.21 [Policy communications and awareness training] and Sec. 26.22
[Training of supervisors and escorts]. This section clarifies that all
individuals subject to this subpart must receive the same scope of
training, to include, for example, behavioral observation, whereas
former Sec. 26.22 required that only supervisors and escorts must
receive behavioral observation training. Increasing the number of
individuals who are trained in behavioral observation enhances the
effectiveness of FFD programs by increasing the likelihood of detecting
potential impairment, consistent with Goal 3 of this rulemaking.
Section 26.29(a) of the final rule combines the training topics
listed in former Sec. Sec. 26.21(a)(1) through (a)(5), 26.22(a)(1)
through (a)(5), and 26.22(b). The agency has rewritten the required
training topics in terms of knowledge and abilities (KAs) to be
consistent with terminology used by licensees and other entities in
other required training programs. This change meets Goal 6 of this
rulemaking to improve clarity in the organization and language of the
rule.
Section 26.29(a)(1) combines former Sec. 26.21(a)(1) with the
latter portion of former Sec. 26.21(a)(5). Consistent with the former
training requirements, the provision requires licensees and other
entities to ensure that individuals who are subject to this subpart
have knowledge of the FFD policy and procedures that apply to them, the
methods used to implement the policy and procedures, and the
consequences of violating the policy and procedures.
Section 26.29(a)(2) retains the requirement in former Sec.
26.22(a)(1) that licensees and other entities must ensure that
individuals understand their roles and responsibilities under the FFD
program, such as avoiding substance abuse and reporting for testing
within the time limit specified in FFD program procedures.
Section 26.29(a)(3) amends the terminology used in former Sec.
26.22(a)(2). Former Sec. 26.22(a)(2) required FFD training to address
the roles and responsibilities of others, such as the personnel,
medical, and EAP staffs. The final rule replaces the references to the
``personnel'' function and ``medical'' staff in former Sec.
26.22(a)(2) with ``human resources'' and ``FFD'' staff, respectively.
The final rule also moves the reference to the MRO into this section
from former Sec. 26.21(a)(3). These updates to the terminology in this
section are consistent with other terms used throughout the final rule
to meet Goal 6 of this rulemaking to improve clarity in the
organization and language of the rule.
Section 26.29(a)(4) and (a)(5) amends former Sec. 26.21(a)(4) and
(a)(2), respectively, by changing some of the language used in the
former provisions. Former Sec. 26.21(a)(4) required FFD training to
inform individuals who are subject to the rule of any EAPs that are
available to them. The final rule eliminates the reference to EAPs
``provided by the licensee'' in the former provision and amends it as
``EAP services available to the individual'' because other entities are
also subject to this requirement under the final rule. Section
26.29(a)(5) amends former Sec. 26.21(a)(2) by replacing the phrase
``abuse of drugs and misuse of alcohol'' with ``abuse of illegal and
legal drugs and alcohol'' for greater accuracy in describing the
required knowledge. The NRC has made these changes to meet Goal 6 of
this rulemaking to improve clarity in the language of the rule.
Section 26.29(a)(6) retains the portion of former Sec. 26.21(a)(3)
that required licensees to ensure that individuals understand the
effects of prescription and over-the-counter drugs and dietary factors
on job performance. The final rule adds a requirement for FFD training
to address the effects of alcohol, illness, mental stress, and fatigue
on job performance, in order to ensure that individuals understand the
bases for the licensee's or other entity's FFD policy regarding these
conditions. The NRC has moved the requirement in the last sentence of
former Sec. 26.20(a) to Sec. 26.27(b)(6) of the final rule because
that section addresses FFD policy requirements. The NRC has made these
changes to meet Goal 6 of this rulemaking to improve clarity in the
organization and language of the rule.
Section 26.29(a)(7) retains the portion of former Sec. 26.21(a)(3)
that required licensees and other entities to ensure that individuals
who are subject to the rule understand the effects of prescription and
over-the-counter drugs and dietary factors on drug and alcohol test
results. Examples of medications, supplements, and dietary factors that
can affect drug and alcohol test results may include, but are not
limited to, ingesting foods containing poppy seeds, drinking coca tea,
using some liquid or inhalant cold and cough preparations containing
alcohol or codeine, and taking supplements containing hemp oil.
Section 26.29(a)(8) and (a)(9) of the final rule retains the
requirements in former Sec. 26.22(a)(3) and (a)(4), respectively,
without changes.
Section 26.29(a)(10) amends former Sec. 26.22(a)(5). The provision
retains the former requirement for FFD training to address the
licensee's or other entity's process for initiating appropriate
corrective action if an individual has an FFD concern about another
person, including referral to the EAP. The final rule adds a
requirement for FFD training
[[Page 17016]]
to ensure that individuals understand their responsibility to report
FFD concerns to the person(s) who are designated to receive such
reports in FFD program procedures. This change is consistent with Sec.
26.33, which requires individuals to perform behavioral observation and
report any FFD concerns, as discussed with respect to Sec.
26.27(b)(11). The change is also consistent with Sec. 26.27(c)(4),
which requires procedures for implementing the requirement. The NRC has
added this group of interrelated requirements to meet Goal 3 of this
rulemaking to improve the effectiveness and efficiency of FFD programs
and Goal 4 to improve consistency between FFD requirements and access
authorization requirements established in 10 CFR 73.56, as supplemented
by orders to nuclear power plant licensees dated January 7, 2003.
Section 26.29(b) of the final rule adds a requirement that
individuals must demonstrate attainment of the KAs specified in Sec.
26.29(a) by passing a comprehensive examination. The NRC has added this
requirement because in several instances since Part 26 was first
promulgated, individuals were able to overturn determinations that they
had violated a licensee's FFD policy on the basis that they had not
understood the information they received during FFD training and could
not be expected to comply with the requirements of the policy.
Therefore, the final rule requires individuals to demonstrate their
attainment of the KAs listed in Sec. 26.29(a) to ensure that the FFD
training has been effective. The final rule requires remedial training
for those who fail to achieve a passing score of 80 percent on the
examination. Section 26.29(b) also requires the examination to include
at least one question for each KA. These requirements are modeled on
other required training programs that have been successful in ensuring
that examinations are valid and individuals have achieved an adequate
understanding of the subject matter. Establishing a method to ensure
that individuals understand the requirements with which they must
comply meets Goal 3 of this rulemaking to improve the effectiveness of
FFD programs.
The provision also permits the use of various media for
administering the comprehensive examination, in order to achieve the
efficiencies associated with computer-based training and testing, for
example, and other new training delivery technologies that may become
available. Permitting the use of various media to administer the
examination meets the portion of Goal 3 of this rulemaking to improve
the efficiency of FFD programs. The permission also meets Goal 5 to
improve Part 26 by eliminating or modifying unnecessary requirements
through providing flexibility in the methods that licensees and other
entities may use to administer the required examination.
Section 26.29(c) of the final rule combines and amends the portions
of former Sec. Sec. 26.21(b) and 26.22(c) that required FFD training
for individuals who are subject to this section before they are
permitted to perform duties that require them to be subject to this
part.
Section 26.29(c)(1) requires that all personnel who are subject to
this section must complete FFD training before the licensee or other
entity grants initial authorization to the individual, as defined in
Sec. 26.55 [Initial authorization]. The final rule also requires that
an individual's training must be current before the licensee or other
entity grants an authorization update or reinstatement to the
individual, as defined in Sec. 26.57 [Authorization update] and Sec.
26.59 [Authorization reinstatement], respectively. The provision also
eliminates the requirement in former Sec. 26.22(c) to upgrade training
for newly assigned supervisors within 3 months of a supervisory
assignment because all personnel will receive the same scope of
training and be required to complete the training before a licensee or
other entity grants authorization to any individual. These changes are
consistent with the requirements related to granting and maintaining
authorization that are established in Subpart C [Granting and
Maintaining Authorization] of the final rule, as discussed in this
document with respect to that subpart. The changes also meet Goal 3 of
this rulemaking to improve the effectiveness and efficiency of FFD
programs.
Section 26.29(c)(2) retains and combines the requirements for
annual refresher training in former Sec. Sec. 26.21(b) and 26.22(c).
Former Sec. 26.21(b) addressed individuals who are subject to this
part and former Sec. 26.22(c) addressed supervisors and escorts. The
final rule combines the former requirements because all personnel
receive the same scope of training under the final rule. The final rule
specifies that individuals must complete the refresher training every
12 months, or more frequently when the need is indicated. With respect
to the proposed rule, the final rule gives some examples of situations
that indicate a need to conduct the refresher training more frequently
than every 12 months, but this list is not inclusive of all situations
that may indicate this need. Adding these examples clarifies the NRC's
intent and meets Goal 6 of the rulemaking to clarify the language of
the rule. The final provision permits individuals who pass a
comprehensive annual examination that demonstrates their continued
understanding of the FFD program requirements to be excused from the
refresher training that the provision otherwise requires. The
examination is necessary to meet the examination requirements specified
in Sec. 26.29(b) [Comprehensive examination]. Individuals who do not
pass must undergo remedial training. Permitting individuals to pass a
comprehensive examination rather than take refresher training each year
ensures that they are retaining their FFD KAs while reducing some costs
associated with meeting the annual refresher training requirement.
Therefore, this change meets Goal 5 of this rulemaking to improve Part
26 by eliminating or modifying unnecessary requirements.
Section 26.29(c)(3) permits licensees and other entities to use
various media, in addition to traditional classroom instruction, for
presenting initial and refresher training for the same reasons
discussed with respect to the portion of Sec. 26.29(b) that permits
licensees and other entities to use various media to administer the
comprehensive examination. The requirements for a licensee or other
entity to monitor the completion of training and provide access to an
instructor or subject matter expert ensures that individuals who are
trained using different media achieve the same understanding as persons
who are trained in a classroom setting with an instructor present. This
flexibility may reduce the costs associated with presenting initial and
refresher training only in a classroom setting. Therefore, this change
meets Goal 5 of this rulemaking to improve Part 26 by eliminating or
modifying unnecessary requirements.
To meet the annual refresher training requirement for individuals,
Sec. 26.29(d) of the final rule permits licensees and other entities
to accept the training of individuals who have been subject to another
training program that meets the requirements of this section. Licensees
and other entities are also permitted to accept a passing result from a
comprehensive examination that was administered by another training
program that meets the requirements of this section in lieu of
refresher training, if the examination meets the requirements of Sec.
26.29(b). This requirement meets Goal 3 of this rulemaking to improve
the effectiveness and efficiency of FFD programs.
[[Page 17017]]
Section 26.31 Drug and Alcohol Testing
Section 26.31 of the final rule renames former Sec. 26.24
[Chemical and alcohol testing]. The final rule, in general, replaces
the former term ``chemical testing'' with ``drug testing'' because the
testing for chemicals that is required in the rule is performed only in
the context of urine drug testing. Therefore, the term ``drug testing''
more accurately conveys the nature of the testing that is performed.
The NRC has made these changes to meet Goal 6 of this rulemaking to
improve clarity in the organization and language of the rule.
Section 26.31(a) [General] of the final rule retains but updates
the language in former Sec. 26.24(a) to be consistent with the new
terminology used throughout the rule as discussed in Sec. 26.5. The
NRC has made this change to meet Goal 6 of this rulemaking to improve
clarity in the language of the rule.
Section 26.31(b) [Assuring the honesty and integrity of FFD program
personnel] of the final rule amends former Section 2.3 in Appendix A to
Part 26. Other than making minor clarifications to the rule text as
explained below, the NRC has adopted the requirements of paragraph (b)
of this section as proposed, without change.
Section 26.31(b)(1) amends the first paragraph of former Section
2.3 in Appendix A to Part 26. This paragraph required licensees to
carefully select and monitor persons responsible for administering the
testing program to ensure that they meet the highest standards of
honesty and integrity. The final rule replaces the former list of
individuals who are subject to this requirement with a cross-reference
to Sec. 26.4(g) of the final rule, which specifies in detail the FFD
program personnel who must be subject to the FFD program. This cross-
reference avoids repeating the list of personnel in this provision.
The provision also adds a reference to factors, other than a
personal relationship with an individual who is subject to testing,
that have the potential to cause an individual to be subject to
influence attempts or may adversely affect the honesty and integrity of
FFD program personnel. In addition to a personal relationship with an
individual who is subject to testing, factors that could cause an
individual to be compromised may include, but are not limited to, a
substance abuse problem or financial problems. Therefore, the final
rule adds a reference to these additional factors to more accurately
characterize the scope of potential concerns that licensees and other
entities must consider when selecting and monitoring the honesty and
integrity of FFD program personnel. The NRC has made these changes to
meet Goal 6 of this rulemaking to improve clarity in the language of
the rule.
Section 26.31(b)(1)(i) amends former Section 2.3(2) in Appendix A
to Part 26 in response to implementation questions regarding the former
requirements. The provision clarifies that the background
investigations, credit and criminal history checks, and psychological
evaluations that are required for persons who are granted unescorted
access to protected areas in nuclear power plants are acceptable when
determining the honesty and integrity of FFD program personnel. The
final rule retains the term ``appropriate'' in the former rule for two
reasons. First, it indicates that FFD program personnel who are
employed by entities who are subject to the rule but are not nuclear
power plants, may meet the requirements through investigations, checks,
and evaluations that provide the information needed to determine the
honesty and integrity of FFD program personnel, but the investigations,
checks, and evaluations may differ from those required under nuclear
power plant access authorization programs. In addition, the final rule
retains the term ``appropriate'' because it has particular relevance to
the requirement for licensees and other entities to conduct criminal
history checks for FFD program personnel. In some cases, licensees and
other entities cannot legally obtain the same type of criminal history
information about FFD program personnel as they are able to obtain for
other individuals who are subject to Part 26. Therefore, the term
``appropriate'' is used to indicate that local criminal history checks
for FFD program personnel who do not have unescorted access to nuclear
power plant protected areas are acceptable. The NRC has made these
changes to meet the portion of Goal 6 of this rulemaking that pertains
to improving clarity in the language of the rule.
The NRC has relaxed the requirement in former Section 2.3(2) in
Appendix A to Part 26 for appropriate background checks and
psychological evaluations to be conducted at least once every 3 years
to require that credit and criminal history checks and updated
psychological assessments be conducted nominally every 5 years. The
final rule relaxes the former requirement for several reasons. First,
the NRC is not aware of any instances in which licensees and other
entities have identified new information about FFD program personnel
from updating the background checks and psychological assessments that
had not already been identified through other avenues, including self-
reports by FFD program personnel, drug and alcohol testing, and
behavioral observation. However, the NRC continues to believe that the
required updates provide an independent method to verify the ongoing
honesty and integrity of FFD program personnel that is necessary
because of the critical importance of FFD program personnel in assuring
program effectiveness. Therefore, the final rule retains the former
requirement for updated background checks and psychological
assessments, but reduces the required frequency of these updates from
every 3 years to every 5 years under the final rule. The NRC has made
this change to meet Goal 5 of this rulemaking to improve Part 26 by
eliminating or modifying unnecessary requirements. In addition, the
frequency for these updates increases the consistency of Part 26 with
access authorization requirements established in 10 CFR 73.56, as
supplemented by orders to nuclear power plant licensees dated January
7, 2003, which is Goal 4 of this rulemaking.
Section 26.31(b)(1)(ii) amends and clarifies former Section 2.3(1)
in Appendix A to Part 26 in response to the many implementation
questions that have arisen after the regulation was published. The
former rule prohibited individuals who have a personal relationship
with the individual being tested (i.e., a donor), such as the donor's
``supervisors, coworkers, and relatives,'' from performing any
``collection, assessment, or evaluation procedures'' involving the
individual being tested. The NRC included the restriction on
``supervisors, coworkers, and relatives'' in the former rule to provide
examples of the ``personal relationships'' referenced in the
introductory paragraph of former Section 2.3 in Appendix A to Part 26.
Some licensees have misinterpreted the restriction on coworkers in the
former rule as meaning that no one who is an employee of the same
corporation may be involved in collection, assessment, or evaluation
procedures. However, in a large corporation, many individuals employed
by the same corporation will not have personal relationships with FFD
program personnel, specifically, or with other individuals who are
subject to testing, in general. Therefore, in Sec. 26.31(b)(1)(ii),
the phrase ``in the same work group'' clarifies that the example
regarding coworkers pertains to individuals who report to the same
manager. For example, FFD program
[[Page 17018]]
personnel report to the FFD program manager and would be considered
``coworkers in the same work group'' to whom the restriction applies.
In addition, the section adds a reference to determinations of fitness
(discussed with respect to Sec. 26.189 [Determination of fitness]) to
provide a clarifying example of the assessment and evaluation
procedures that FFD program personnel are prohibited from performing if
the FFD program staff member has a personal relationship with the
subject individual. The NRC has made these changes to meet Goal 6 of
this rulemaking to improve clarity in the organization and language of
the rule.
Section 26.31(b)(1)(iii) relaxes the prohibition on individuals who
have ``personal relationships'' with the donor from performing specimen
collection procedures in former Section 2.3(1) in Appendix A to Part
26. The NRC acknowledges that the former restriction imposed an
unnecessary burden when the objective of ensuring the integrity of
specimen collections in these circumstances could be achieved by other
means. Therefore, in Sec. 26.31(b)(1)(iii), individuals who have a
personal relationship with a donor are permitted to collect specimens,
if another individual who does not have a personal relationship with
the donor and is not a supervisor, a coworker in the same work group,
or a relative of the donor monitors the collection and preparation of
the specimens for shipping. The section also provides examples of the
types of individuals who may monitor the integrity of specimen
collection procedures in these circumstances, including but not limited
to, security force or quality assurance personnel. By permitting
monitored collections in these circumstances while continuing to assure
the integrity of specimen collections from FFD program personnel, this
provision meets Goal 5 of this rulemaking to improve Part 26 by
eliminating or modifying unnecessary requirements. The final rule
retains the prohibition for individuals who have personal relationships
with the donor from performing assessment and evaluation procedures
because monitoring of these activities by qualified personnel is not
feasible.
If a directly observed collection is required, Sec.
26.31(b)(1)(iv) of the final rule adds a prohibition for an individual
who has a personal relationship with the donor from acting as a urine
collector or observer. This prohibition is necessary to minimize
embarrassment to the donor (and the collector) during a directly
observed collection. The NRC has added this provision to meet Goal 7 of
this rulemaking, relating to protecting the privacy rights of
individuals who are subject to Part 26.
Section 26.31(b)(1)(v) amends former Section 2.3(3) in Appendix A
to Part 26 to require that MROs who are on site at a licensee's or
other entity's facility must be subject to behavioral observation. For
the purposes of Sec. 26.31(b)(1)(v), a ``facility'' includes, but is
not limited to, a licensee's or other entity's corporate offices and
any medical facilities that the licensee or other entity operates. The
NRC has added this requirement because MROs are ``persons responsible
for administering the testing program,'' but some FFD programs have not
included MROs in the behavioral observation element of their programs.
However, the final rule limits the behavioral observation of MROs to
those times when they are on site at a licensee's or other entity's
facility in order to permit licensees and other entities to continue
relying on the services of MROs who normally work independently, often
alone, in offices at a geographical distance from the licensee's or
other entity's facilities so that behavioral observation is
impractical. Limiting the requirement for behavioral observation of
MROs to those instances in which the MRO is working on site at a
licensee's or other entity's facility is adequate to ensure the
continuing honesty and integrity of these MROs because MROs who work
off site would not interact on a daily basis with other individuals who
are subject to the FFD program. Therefore, off site MROs would be less
likely to be subject to potential influence attempts than MROs who
normally work on site because they are generally inaccessible. The
final rule continues to require all MROs to be subject to the other FFD
program elements that are required in this subpart. These elements
include drug and alcohol testing and regular psychological assessments
and background investigations, which permit licensees and other
entities to monitor the honesty and integrity of off site MROs. The NRC
has added this relaxation to meet Goal 5 of this rulemaking to improve
Part 26 by eliminating or modifying unnecessary requirements.
A new Sec. 26.31(b)(2) provides another relaxation from the former
rule related to collecting specimens from FFD program personnel. The
provision permits FFD program personnel to submit specimens for testing
at collection sites that meet the requirements of 49 CFR Part 40,
``Procedures for Department of Transportation Workplace Drug and
Alcohol Testing Programs'' (65 FR 41944; August 9, 2001). As discussed
with respect to Sec. 26.31(b)(1), some FFD program personnel, such as
contract MROs and EAP staff members, normally work at locations that
are so distant from a licensee's collection site(s) as to make it
impractical for them to be randomly tested at a licensee's or other
entity's collection site. Permitting these FFD program personnel to be
tested at local collection sites that follow similar procedures is
adequate to meet the goal of ensuring their continuing honesty and
integrity. Therefore, the NRC has added this provision to meet Goal 5
of this rulemaking to improve Part 26 by eliminating or modifying
unnecessary requirements.
Section 26.31(c) [Conditions for testing] replaces former Sec.
26.24(a)(1) through (a)(4). The provision lists the situations in which
testing is required in separate paragraphs, such as ``pre-access,''
``for cause,'' and ``post-event'' testing to clarify that each
situation for which testing is required stands on its own. The former
provision in Sec. 26.24(a)(3), in particular, has led to confusion and
misinterpretation of the requirements, to be corrected as noted below.
Subparts E [Collecting Specimens for Testing], F [Licensee Testing
Facilities], and G [Laboratories Certified by the Department of Health
and Human Services] address the specific requirements for conducting
the testing. The final rule reorganizes and amends former Sec.
26.24(a)(1) through (a)(4) to meet Goal 6 of this rulemaking to improve
clarity in the organization and language of the rule.
Section 26.31(c)(1) [Pre-access] amends former Sec. 26.24(a)(1).
Former Sec. 26.24(a)(1) required pre-access testing within 60 days
before the initial granting of unescorted access to protected areas or
assignment to duties within the scope of this part. Section 26.31(c) of
the final rule introduces the concepts of ``initial authorization,''
``authorization update,'' and ``authorization reinstatement,'' which
refer to categories of requirements that licensees and other entities
must meet in order to assign an individual to duties that require the
individual to be subject to Part 26. Section 26.65 [Pre-access drug and
alcohol testing] in Subpart C of the final rule specifies detailed
requirements for conducting pre-access testing.
Section 26.31(c)(2) [For cause] and (c)(3) [Post event] clarifies
and amends former Sec. 26.24(a)(3), as follows:
Section 26.31(c)(2) continues to require for-cause testing in
response to any observed behavior or physical
[[Page 17019]]
condition indicating possible substance abuse. The final rule also
retains the former requirement for testing if the licensee or other
entity receives credible information that an individual is engaging in
substance abuse. Section 26.3 defines the term ``substance abuse.''
Section 26.31(c)(3) [Post event] amends the portion of former Sec.
26.24(a)(3) that required drug and alcohol testing when an event
involving a failure in individual performance leads to significant
consequences. The final rule amends the former provision because it has
been subject to misinterpretation and numerous questions from
licensees.
The phrase ``if there is reasonable suspicion that the worker's
behavior contributed to the event'' in former Sec. 26.24(a)(3) has
been subject to misinterpretation. The location of this phrase at the
end of the list of conditions under which post-event testing must be
performed has led some licensees to conclude that this phrase applies
only to events involving actual or potential substantial degradations
of the level of safety of the plant. Other licensees have
misinterpreted the term ``reasonable suspicion'' as meaning
``reasonable suspicion of substance abuse'' or some other ``illegal''
or ``disreputable'' activity. Neither of these interpretations is
consistent with the intent of this provision. Therefore, to clarify the
intent of the provision, the final rule eliminates the phrase ``if
there is reasonable suspicion that the worker's behavior contributed to
the event'' from the end of the list of significant events that require
post-event testing and, instead, requires post-event testing as soon as
practical after significant events (as listed in Sec. 26.31(c)(3)(i)
through (c)(3)(iii)) involving a human error that may have caused or
contributed to the event. The final rule uses the term ``human error''
rather than the former term ``worker's behavior'' to emphasize that
post-event testing is required for acts that unintentionally deviated
from what was planned or expected in a given task environment (see
NUREG/CR-6751, ``The Human Performance Evaluation Process: A Resource
for Reviewing the Identification and Resolution of Human Performance
Problems'') as well as failures to act (i.e., errors of omission).
Therefore, testing is required regardless of whether there was
``reasonable suspicion'' that the individual was abusing drugs or
alcohol for the consequences listed in the section.
In addition, the NRC has added the second sentence of Sec.
26.31(c)(3) to clearly delineate the scope of individuals who must be
subject to post-event testing. Some licensees have misinterpreted the
former provision as requiring the testing of all individuals who are
involved in a significant event, including individuals whose behavior
played no causal or contributing role in the event. For example, these
licensees' FFD programs would require testing an individual who was
exposed to radiation in excess of regulatory limits, even if other
individuals' actions (or failures to act) were responsible for the
event and the individual who suffered the exposure was a bystander.
Therefore, the second sentence of the provision clarifies the original
intent of this section by stating that only the individual(s) who
committed the error(s) is subject to post-event testing.
Section 26.31(c)(3)(i) provides a threshold for the types of
workplace personal injuries and illnesses for which post-event testing
is required in response to implementation questions related to former
Sec. 26.24(a)(3). Some licensees have misinterpreted the former
provision as requiring post-event testing for any personal injury, no
matter how minor. This section clarifies the type of personal injuries
and illnesses for which post-event testing would be required by
establishing a threshold that is based on the general criteria
contained in 29 CFR 1904.7, ``General Recording Criteria,'' of the
regulations of the Occupational Safety and Health Administration (OSHA)
for recording occupational injuries and illnesses. As defined in the
OSHA standard and the final rule, these include any injuries and
illnesses which result in death, days away from work, restricted work,
transfer to another job, medical treatment beyond first aid, loss of
consciousness, or other significant injury or illness as diagnosed by a
physician or other licensed health care professional. In the case of a
significant injury or illness diagnosed by a physician or health care
professional, a serious injury or illness does not need to result in
death, days away from work, restricted work, transfer to another job,
medical treatment beyond first aid, or loss of consciousness. The final
rule adds this clarification to reduce the number of unnecessary post-
event tests performed for minor injuries and illnesses and meet Goal 3
of this rulemaking to improve the effectiveness and efficiency of FFD
programs.
Section 26.31(c)(3)(i) also includes the qualifying phrase,
``within 4 hours after the event,'' with reference to the recordable
personal injuries and illnesses that would trigger post-event testing.
The NRC acknowledges that in some cases it is difficult to detect
illnesses and injuries that meet the threshold for post-event testing
at the time they occur. For example, if an individual has been injured
on site but does not report the injury to the licensee or other entity
and waits for several days to seek treatment from his or her private
physician, the licensee or other entity may not learn of the injury.
The extent of an injury may be unclear at the time it occurs and may
appear to fall below the threshold for post-event testing until several
days have passed. In these examples, if the licensee or other entity
learns after several days that the injury would have met the threshold
for post-event testing, it would be too late for post-event testing to
be of any value in determining whether the individual's use of drugs or
alcohol may have contributed to the event. If alcohol or drug use had
contributed to the event, testing several days later would be unlikely
to detect it because of the effects of metabolism. Further, it would be
difficult to prove that any positive test results reflected the
individual's condition at the time the event occurred rather than
subsequent drug or alcohol use. Therefore, the final rule limits post-
event testing to situations in which the licensee or other entity can
determine that an injury or illness meets the threshold within four
hours after the event has occurred, and can conduct the testing within
a time frame that will provide useful information about the
individual's condition at the time of the event. However, the section
should not be misinterpreted as requiring post-event testing to be
completed within four hours after the event. Section 26.31(c)(3)
defines the time period after the event within which testing must be
completed as ``as soon as practical.'' The NRC has made this change to
meet Goal 3 of this rulemaking to improve the effectiveness and
efficiency of FFD programs.
Section 26.31(c)(3)(ii) retains the relevant language in the
corresponding portion of former Sec. 26.24(a)(3) without change.
Section 26.31(c)(3)(iii) retains the relevant language in the
corresponding portion of former Sec. 26.24(a)(3). However, as
discussed with respect to Sec. 26.31(c), the final rule eliminates the
former qualifying phrase ``if there is reasonable suspicion that the
worker's behavior contributed to the event.'' The NRC has eliminated
this phrase because it is preferable to determine the need for post-
event testing using an objective standard based on the severity of the
underlying event. The experience of the DOT with post-accident testing,
for example, is that it is more effective to separate completely ``for
cause''
[[Page 17020]]
concepts (such as ``reasonable suspicion'' of substance abuse) from
post-event testing. Under the final rule's approach, if one of the
events occurs that is defined in the regulations as requiring post-
event testing, then that testing should be carried out irrespective of
the presence or absence of any ``reasonable suspicion'' of substance
abuse.
Section 26.31(c)(4) [Followup] retains the intent of former Sec.
26.24(a)(4) but amends its language. The final rule eliminates the
former phrase ``to verify an individual's continued abstention from the
use of substances covered under this part'' because it could be
misinterpreted as limiting the substances for which followup testing is
permitted to only those listed in Sec. 26.31(d)(1) [Substances
tested]. The final rule revises this phrase as ``to verify continued
abstinence from substance abuse'' to clarify that FFD programs are
permitted to conduct followup testing for any substances an individual
may have abused, subject to certain additional requirements discussed
with respect to Sec. 26.31(d)(1)(i). Section 26.69 [Authorization with
potentially disqualifying fitness-for-duty information] establishes
detailed requirements for conducting followup testing, where they apply
to licensees' and other entities' processes for granting and
maintaining authorization. The final rule makes these changes to meet
Goal 6 of this rulemaking to improve clarity in the organization and
language of the rule.
Section 26.31(c)(5) [Random] simplifies former Sec. 26.24(a)(2) to
define random testing as one of the conditions under which testing is
required. The NRC has moved the detailed requirements for implementing
random testing that were contained in former Sec. 26.24(a)(2) to Sec.
26.31(d) [General requirements for drug and alcohol testing] of the
final rule. The NRC has made these changes to meet Goal 6 of this
rulemaking to improve clarity in the organization and language of the
rule.
The NRC has added Sec. 26.31(d) to the final rule to better
organize requirements related to the general administration of drug and
alcohol testing. The final rule presents more detailed requirements for
conducting drug and alcohol testing in Subparts E, F, and G. The NRC
has made these changes to meet Goal 6 of this rulemaking to improve
clarity in the organization and language of the rule.
Section 26.31(d)(1) [Substances tested] retains the list of drugs
for which testing must be conducted in former Section 2.1(a) in
Appendix A to Part 26, but clarifies that for some drugs the testing is
conducted to detect drug metabolites. The NRC has moved the provisions
detailing the circumstances in which testing for these substances must
be performed (i.e., pre-access, post-event, random) to Sec. 26.31(c)
for organizational clarity. In addition, the section adds adulterants
to the list of substances for which testing must be conducted,
consistent with the addition of specimen validity testing requirements
to the final rule, as discussed with respect to Sec. 26.31(d)(3)(i).
Section 26.31(d)(1)(i) retains the permission in the second sentence of
former Sec. 26.24(c) for licensees and other entities to consult with
local law enforcement agencies or other sources of information to
identify drugs that may be abused by individuals in the geographical
locale of the FFD program.
Section 26.31(d)(1)(i)(A) retains the permission in former Sec.
26.24(c) for licensees and other entities to add to the panel of drugs
for which testing is required in Sec. 26.31(d)(1). Additional drugs
may include, but are not limited to, ``designer drugs,'' such as
ecstasy or ketamine, and illegal drugs that are popular in some
geographical areas, such as lysergic acid diethylamide-25 (LSD). The
provision also requires that any additional drugs must be listed on
Schedules I-V of section 202 of the Controlled Substances Act [21
U.S.C. 812], which is consistent with the definition of ``illegal
drugs'' in former Sec. 26.3.
Section 26.31(d)(1)(i)(B) retains the last sentence in former Sec.
26.24(c). The provision requires licensees and other entities to
establish appropriate cutoff levels for any additional substances for
which testing will be conducted.
Section 26.31(d)(1)(i)(C) retains the requirement in former Section
2.1(c) in Appendix A to Part 26. The provision specifies that licensees
and other entities must establish rigorous testing procedures for any
additional drugs.
Section 26.31(d)(1)(i)(D) further clarifies the requirement in
Sec. 26.31(d)(1)(i)(C) for ``rigorous testing procedures.'' The
provision replaces the portion of former Section 1.1(2) in Appendix A
to Part 26 that required licensees to obtain written approval from the
NRC to test for additional drugs. The purpose of the former requirement
was to provide an opportunity for the NRC to verify that the assays and
cutoff levels licensees use in testing for additional drugs are
scientifically sound and legally defensible. However, the former
requirement also imposed a reporting burden. The final provision
eliminates this reporting requirement and replaces it with requirements
for an independent forensic toxicologist who has no relationships that
could be construed as potential conflicts of interest to conduct the
review that the NRC currently performs. The final rule requires the
independent forensic toxicologist to certify, in advance and in
writing, that the assay to be used in testing for any additional drugs
or drug metabolites, and the cutoff levels to be applied, are
scientifically sound and legally defensible. This section also
specifies the required qualifications for the forensic toxicologist.
Certification of the assay and cutoff levels are not required in
two circumstances: (1) If the HHS Guidelines are revised to permit use
of the assay and the cutoff levels in Federal workplace drug testing
programs and the licensee or other entity uses the cutoff levels
established in the HHS Guidelines for drug or drug metabolites; and (2)
if the licensee and other entity received written approval of the NRC
to test for the additional drug or drug metabolites before the
implementation date of the final rule, which is 365 days after the date
the final rule is published in the Federal Register. Certification by a
toxicologist is unnecessary in these two circumstances because it would
be redundant. By eliminating or modifying unnecessary requirements,
while continuing to ensure that any drug testing conducted under Part
26 is scientifically sound and legally defensible, this provision meets
Goal 5 of this rulemaking.
Section 26.31(d)(1)(ii) amends former Section 2.1(b) in Appendix A
to Part 26. The provision permits licensees and other entities, when
conducting for-cause, post-event, and followup testing, to test for any
drugs listed on Schedules I-V of the Controlled Substances Act that the
licensee or other entity suspects the individual may have abused, as
follows:
The section adds a reference to post-event testing for consistency
with the intent of former Section 2.1(b) in Appendix A to Part 26,
which permitted testing for any illegal drugs during a for-cause test.
The former rule included post-event testing within the definition of
for-cause testing. The final rule uses a distinct term ``post-event''
testing to refer to the testing that is required following certain
events as discussed with respect to Sec. 26.31(d)(3). Therefore, it is
necessary to add a reference to post-event testing to this section to
retain the full intent of the former provision.
The section also adds a reference to followup testing, which
permits the
[[Page 17021]]
licensee or other entity to test for an additional drug if an
individual who is subject to followup testing is suspected of having
abused it. For example, if an SAE, in the course of performing a
determination of fitness under Sec. 26.189 found that an individual
was abusing barbiturates, this provision would permit followup testing
to verify that the individual is abstaining from such abuse. The NRC
has made this change to strengthen the followup testing element of FFD
programs by ensuring that followup testing would detect continued drug
abuse. Therefore, this provision is consistent with Goal 3 of this
rulemaking to improve the effectiveness and efficiency of FFD programs.
The section retains the limitation in former Section 2.1(b) in
Appendix A to Part 26 that permitted testing only for illegal drugs
that the individual is suspected of having abused and extends that
limitation to followup testing. The final rule extends this limitation
to followup testing to protect donors' rights to privacy, which is the
same reason that the limitation was established in the former rule with
respect to for-cause testing. Licensees and other entities are
prohibited from conducting a wide spectrum of tests for any drugs
without suspicion that the individual had abused them because such
tests could reveal personal medical information about the individual
that is irrelevant to the performance objectives of this part, as
discussed with respect to Sec. 26.23. Thus, extending the former
limitation on for-cause testing to followup testing meets Goal 7 of
this rulemaking to protect the privacy rights and other rights
(including due process) of individuals who are subject to Part 26.
The final rule replaces the term ``illegal drugs'' in former
Section 2.1(b) in Appendix A to Part 26 with a specific reference to
the drugs that are listed on Schedules I-V of the Controlled Substances
Act. These schedules list drugs with abuse potential and include many
drugs with legitimate medical uses that are not ``illegal'' when used
with a valid prescription for medical purposes. Therefore, replacing
the term ``illegal drugs'' with the reference to Schedules I-V of the
Controlled Substances Act (CSA) more accurately characterizes the
specific drugs for which testing is permitted. The NRC has made this
change to meet Goal 6 of this rulemaking to improve clarity in the
language of the rule.
Section 26.31(d)(1)(ii) also applies the new requirements in Sec.
26.31(d)(1)(i)(D) related to testing for drugs that are not included in
the FFD program's panel of drugs to for-cause, post-event, and followup
testing. The section requires that a forensic toxicologist certify the
assays and cutoff levels to be used in testing for the additional
drugs. The provision provides consistency with Sec. 26.31(d)(1)(i)(D)
and ensures that the testing is scientifically sound and legally
defensible. The NRC has made this change to protect donors' rights as
it relates to minimizing the possibility of false positive test
results. The provision also strengthens the effectiveness of FFD
programs by ensuring that tests for additional drugs that are conducted
for cause, post-event, or as part of a followup program will accurately
detect drugs that an individual may have abused. Therefore, the NRC has
made this change to meet Goal 7 of this rulemaking to protect the
rights (including due process) of individuals who are subject to Part
26 and Goal 3 to improve the effectiveness and efficiency of FFD
programs.
The NRC has added the last sentence of Sec. 26.31(d)(1)(ii) to
prohibit inappropriate practices that some FFD programs have
implemented. The NRC is aware that some FFD programs have directed
their HHS-certified laboratories to test specimens that are collected
for for-cause, post-event, or followup testing at the assay's LOD
without first subjecting the specimens to initial testing. In addition,
if a drug or drug metabolite is detected at the LOD, the MROs in these
programs have confirmed the test result as an FFD policy violation even
if the quantitative test result falls below the FFD program's
established confirmatory cutoff level. Although these practices may
increase the likelihood of detecting drug abuse, they are inconsistent
with one of the bases for establishing cutoff levels for drug testing.
This basis is to minimize the likelihood of false positives that could
result in the imposition of sanctions on an individual who has not
abused drugs. It also subjects individuals who are undergoing for-
cause, post-event, or followup testing to unequal treatment when
compared to individuals who are subject to random and pre-access
testing, in which the established cutoff levels must be applied.
Therefore, the final rule specifically prohibits these practices, but
adds, with respect to the proposed rule, an exception for a situation
in which the specimen is dilute and the licensee or other entity has
requested the HHS-certified laboratory to evaluate the specimen under
Sec. Sec. 26.163(a)(2) and 26.185(g)(3). The NRC has made these
changes to meet Goal 7 of this rulemaking as it relates to protecting
the rights of individuals (including due process) who are subject to
Part 26, by requiring that individuals who are subject to for-cause,
post-event, and followup testing must be subject to the same testing
procedures and cutoff levels as others who are tested under this part.
With respect to the proposed rule, the NRC has added Sec.
26.31(d)(1)(iii) to the final rule to require the licensee or other
entity to document the additional drug(s) for which testing will be
performed in written policies and procedures. A public comment
suggested that licensees and other entities should not screen for drugs
in addition to those listed in paragraph (d)(1) of this section without
identifying them in advance. The NRC agrees that informing individuals
of the substances for which testing will routinely occur and the cutoff
levels to be applied may deter abuse of those substances. Information
about the drugs for which testing will occur, and their potential
effects on job performance, is also an important part of the FFD
training that individuals must receive under Sec. 26.29, to assist
individuals in meeting their responsibilities under the rule. This
added provision is also consistent with Sec. 26.31(d)(3)(iii)(A) that
requires licensees and other entities to document more stringent cutoff
levels for drug testing than those specified in Sec. 26.163 in written
policies and procedures. However, the NRC does not agree that a
licensee should be prohibited from testing for drugs in addition to
those listed in the rule without identifying them in advance. Although
deterring substance abuse is an important goal of the rule, detecting
substance abuse is equally important. Therefore, both the former and
final rules permit licensees to add drugs to the panel of substances
for which they routinely test, as well as to conduct tests to detect
any drugs listed on Schedules I-IV of the CSA in followup, post-event,
and for-cause testing that the individual is suspected of abusing. The
NRC has added this requirement to meet Goal 3 of this rulemaking to
improve the effectiveness and efficiency of FFD programs and Goal 6 to
improve clarity in the organization and language of the rule.
Section 26.31(d)(2) [Random testing] reorganizes and amends the
requirements for conducting random testing. These requirements appeared
in former Sec. 26.24(a)(2), as described in the following paragraphs.
Section 26.31(d)(2)(i) adds a requirement for licensees and other
entities to administer random testing in a manner that provides
reasonable assurance that individuals are unable to
[[Page 17022]]
predict the time periods during which specimens will be collected. The
NRC has added this provision because the NRC is aware of instances when
individuals who believed they would have a positive test result if
tested have been able to determine the days on which collections were
being conducted. This determination then gave them the opportunity to
leave work under the guise of illness in order to avoid the possibility
of being tested. The ability to detect that specimens are being or will
be collected for random testing also provides an opportunity for
individuals to be prepared to subvert the testing by procuring an
adulterant or urine substitute and keeping it available on their
persons during the periods that specimens are collected. However, the
NRC also recognizes that it is impossible to ensure that individuals
are unable to detect the periods when specimens are being collected. At
a minimum, coworkers will be suspicious that collections are occurring
if they observe an individual leaving the work site and returning
within a short time, even if the supervisor and individual do not
discuss the reason for the individual's short absence. Therefore, the
section requires licensees and other entities to conduct random testing
in a manner that would provide ``reasonable assurance'' that
individuals are unable to predict when specimens will be collected,
rather than requiring them to ``ensure'' that the period of time during
which specimens will be collected cannot be detected. However,
licensees and other entities are required to minimize the likelihood
that individuals who are subject to testing know that they are more
likely to be called for testing at certain times than others.
Within this context, Sec. 26.31(d)(2)(i)(A) adds a requirement
that licensees and other entities take reasonable steps to either
conceal from the workforce that collections will be performed during a
scheduled collection period, or create the appearance that specimens
are being collected during a portion of each day on at least 4 days in
each calendar week at each site. With respect to the proposed rule, the
final rule clarifies that in the latter instance, the portions of each
day and the days of the week must vary in a manner that cannot be
predicted by donors. The NRC, after publishing the proposed rule,
recognized the need for additional clarity in this provision to
illustrate the NRC's intent. Therefore, the NRC has made this change to
meet Goal 6 of this rulemaking to improve clarity in the language of
the rule.
Section 23.31(d)(2)(i)(A) requires licensees and other entities to
take reasonable steps to minimize the cues that persons may use to
detect that specimens will be collected at a certain time. These cues
may include, but are not limited to, the presence of a mobile
collection facility on site and the presence of collectors at the site
only on days that collections occur, or having the lights on in a
designated collection site and occupying it only when the collection
site is in use. A reasonable step to minimize cues associated with
activities inside a collection site could be covering any outside
windows so that a passerby cannot detect whether the collection site is
occupied. Other steps to meet the requirement could include, but would
not be limited to, stationing a mobile collection facility on site for
some part of the day on 4 days each week or assigning individuals to
staff the designated collection site during periods that specimens are
not being collected during some portion of each day on at least 4 days
in each calendar week. Maintaining the appearance that the collection
site is active on more than half of the days in each week makes it more
difficult for individuals to plan to subvert the testing process by
leaving work when they believe specimens are being collected. By
reducing the opportunities for individuals to subvert the testing
process by having advanced warning that specimens are being collected,
the requirements in Sec. 26.31(d)(2)(i) and paragraph (A) of this
section meet Goal 3 of this rulemaking to improve the effectiveness of
FFD programs.
Section 26.31(d)(2)(i)(B) amends the third sentence of former Sec.
26.24(a)(2). This sentence required that specimens must be collected
``at various times during the day.'' The final rule expands the former
requirement to require licensees and other entities to collect
specimens on an unpredictable schedule, including weekends, backshifts,
and holidays, and at various times during a shift. The purpose of the
former and final provisions is to ensure that individuals cannot
predict the times they will be tested, as well as prevent them from
perceiving that there are ``safe'' periods during which they will not
be tested, which may lead them to believe they could engage in
substance abuse without fear of detection. Varying the time periods
during which specimens are collected on an unpredictable schedule also
increases the rule's effectiveness in deterring substance abuse, which
meets Goal 3 of this rulemaking to improve the effectiveness of FFD
programs.
Section 26.31(d)(2)(ii) retains the third sentence of former Sec.
26.24(a)(2). Section 26.31(d)(2)(ii) states that random testing must be
administered on a nominal weekly frequency. The former requirement to
collect specimens for random testing at ``various times during the
day'' is retained in Sec. 26.31(d)(2)(i)(B).
Section 26.31(d)(2)(iii) requires individuals who are selected for
random testing to report to the collection site as soon as reasonably
practicable after they have been notified that they have been selected
for testing within the time period established in the FFD policy. The
necessity for the FFD policy to establish a time limit within which
individuals must report for testing is discussed with respect to Sec.
26.27(b)(2). Section 26.31(d)(2)(iii) further clarifies this
requirement by emphasizing the individual's responsibility to report as
soon as reasonably practicable after notification. For example, in
order to cover all of the possible situations when it may not be
possible for an individual to immediately report for testing after
notification (which could include the time required to travel to a
collection site or to change clothes and be monitored for contamination
after working under a radiation work permit), the FFD policy may permit
individuals up to two hours to report for testing after notification.
However, if no legitimate work, travel, or other demands would prevent
an individual from immediately reporting for testing, the provision
requires the individual to report as soon as he or she is notified.
This provision strengthens FFD programs by further reducing
opportunities for individuals to subvert the testing process and,
therefore, meets Goal 3 of this rulemaking to improve the effectiveness
of FFD programs.
Section (d)(2)(iv) retains the portion of the first sentence of
former Sec. 26.24(a)(2) that required licensees to ensure that
individuals subject to testing have an equal probability of being
selected and tested. The final rule splits proposed Sec.
26.31(d)(2)(iv) into two paragraphs after the first sentence of the
proposed paragraph, and renumbers the subsequent paragraphs to
accommodate this change. This reorganization is an effort to clarify
the requirements of this section, consistent with Goal 6 of this
rulemaking to improve clarity in organization and language of the rule.
As a result of this renumbering, Sec. 26.31(d)(2)(v) of the final
rule amends the first sentence of former Sec. 26.24(a)(2) to clarify
that individuals who are off site when selected for testing and not
reasonably available for testing when selected, must be tested at the
earliest
[[Page 17023]]
reasonable and practical opportunity. However, the final rule, with
respect to the proposed rule, adds a clarification that individuals who
are on site and not reasonably available for testing also must be
tested at the earliest reasonable and practical opportunity. The NRC
has made this change in response to a public comment, which suggested
that the second sentence of proposed Sec. 26.31(d)(2)(iv) could be
interpreted as requiring individuals who are on site but not reasonably
available for testing to be tested immediately. The commenter gave the
example of an individual who is suited up for work in a radiologically
controlled area from which he or she could not exit to be tested in a
reasonable period of time. The NRC notes that in these cases,
individuals who are on site but not reasonably be available for testing
are required to report to the collection site as soon as reasonably
practical after notification (emphasis on ``notification''), under
Sec. 26.31(d)(2)(iii). In the given example, the supervisor would only
notify the individual about testing after he or she is out of
containment and has changed back to street clothes. If this were to
occur at the end of the shift when collectors have left the site, this
individual would not be notified that he or she must report for testing
until the next time both the donor and the collectors are available to
collect specimens for testing. Because there would be no known reason
that this individual will test positive at the time of collection, any
possible delays in testing should not compromise the performance
objectives of the FFD program. However, the FFD program is responsible
for preventing potential abuses brought on by such delays, which could
include a supervisor protecting known substance abusers through
improper notifications or delaying testing until completion of a
critical job. Therefore, based on this analysis, the NRC has clarified
this provision to reflect the public comment and clarify the NRC's
intent, consistent with Goal 6 of this rulemaking to improve clarity in
the language of the rule.
The requirements of Sec. 26.31(d)(2)(v) prohibit licensees and
other entities from returning the names of the individuals who are
offsite when selected for testing or who are on site and not reasonably
available for testing when selected to the random testing pool without
conducting a test, as has been the practice of some licensees.
Returning these individuals' names to the random testing pool without
conducting a test ensures that they are immediately eligible for
another unannounced test, as required in Sec. 26.31(d)(2)(vi), but
does not ensure that all individuals who are subject to this part have
an equal probability of being tested. Therefore, the requirement that
individuals who are off site when selected for testing or who are on
site and not reasonably available for testing when selected must be
tested at the earliest reasonable and practical opportunity meets Goal
3 of this rulemaking to improve the effectiveness of FFD programs.
The section includes the phrase ``at the earliest reasonable and
practical opportunity when both the donor and collectors are available
to collect specimens for testing'' to clarify that licensees and other
entities are not required to call an individual back to the site if he
or she is off site when selected for testing. In addition, the
provision does not require licensees and other entities to make special
arrangements to ensure that a collector is available to collect the
specimens as soon as the individual returns to the site. The NRC is
aware that some licensees have called in individuals and collectors in
the past under these circumstances. However, these practices may permit
individuals to predict that they will be subject to testing when they
return to the site. This prediction would provide them with an
opportunity to take actions to subvert the testing process, as
discussed with respect to Sec. 26.31(d)(2)(i). Therefore, the
provision requires licensees and other entities to collect specimens
from an individual who is off site when selected for testing or on site
and not reasonably available for testing, in a manner that also ensures
that the individual does not have advance notification that he or she
has been selected for testing. The NRC has made this change to meet
Goal 3 of this rulemaking to improve the effectiveness and efficiency
of FFD programs.
Section 26.31(d)(2)(vi) of the final rule, renumbered from
(d)(2)(v) in the proposed rule, retains the second sentence of former
Sec. 26.24(a)(2). This provision requires that an individual who has
completed a test is immediately eligible for another random test.
Section 26.31(d)(2)(vii) of the final rule, renumbered from
(d)(2)(vi) in the proposed rule, amends the last sentence of former
Sec. 26.24(a)(2). The NRC has made this change in response to licensee
implementation questions with respect to the meaning of the term
``workforce'' in the former rule. These questions related to whether
``workforce'' means all individuals who are employed by the licensee,
including individuals who are not subject to Part 26, all individuals
at a site, or all individuals who are subject to the licensee's FFD
program. This provision clarifies that the number of random tests that
must be performed in a year must equal 50 percent of the population of
individuals who are subject to random testing under the FFD program. If
a common FFD program covers several sites, the ``population'' would
include all individuals who are subject to the common FFD program. The
population also includes individuals who have applied for authorization
and who are subject to random testing under Sec. 26.67 [Random drug
and alcohol testing of individuals who have applied for authorization].
The NRC has made this change to meet Goal 6 of this rulemaking to
improve clarity in the organization and language of the rule.
The NRC has added Sec. 26.31(d)(3) [Drug testing] to the final
rule to group requirements in one section that are related to the
general administration of drug testing. The NRC has made this change
because requirements that address this topic were dispersed throughout
the former rule. Grouping them together in a section makes them easier
to locate within the final rule. This reorganization meets Goal 6 of
this rulemaking to improve clarity in the organization and language of
the rule.
Section 26.31(d)(3)(i) combines and modifies some of the
requirements in former Section 1.1(3) in Appendix A to Part 26, former
Sec. 26.24(f), the first sentence of former Section 2.8(e)(1) in
Appendix A, and former Section 2.8(a) and (b) in Appendix A to Part 26.
These former provisions required licensees and other entities to use
only HHS-certified laboratories to perform drug testing, except if
initial tests were performed at a licensee testing facility. However,
the final rule has clarified the first sentence of this section, with
respect to the proposed rule, to include validity tests, validity
screening tests, and initial validity tests. The NRC has retained other
detailed requirements in these sections, but they are presented in the
appropriate sections in Subparts E, F, and G of the final rule. The
agency has made these changes to meet Goal 6 of this rulemaking to
improve the organizational clarity of the rule.
In addition, Sec. 26.31(d)(3)(i) requires that specimens sent to
the HHS-certified laboratory by the licensee or other entity must be
subject to initial validity and drug testing by the laboratory.
However, the final rule clarifies the language of the proposed rule to
require that any specimens that yield ``positive initial drug test
results or are determined by initial validity testing to be of
[[Page 17024]]
questionable validity'' must be subject to confirmatory testing by the
laboratory. The final rule deletes the term ``non-negative'' from the
proposed rule and adds the term ``questionable validity'' for the
reasons discussed with respect to Sec. 26.5. The NRC has made these
changes to meet Goal 6 of this rulemaking to improve the organizational
clarity of the rule.
Specimen validity testing refers to testing conducted by a
laboratory to identify attempts to tamper with a specimen. Attempts to
tamper with a specimen may include:
(1) Adulteration, which means putting a substance into a specimen
that is designed to mask or destroy the drug or drug metabolite that
the specimen may contain or to adversely affect the assay reagent;
(2) Dilution, which means adding a liquid that, in contrast to an
adulterant, would not be detected by validity testing, to the urine
specimen to decrease the concentration of a drug or metabolite below
the cutoff concentration; and
(3) Substitution, which means replacing a valid urine specimen with
a drug-free specimen.
When HHS published its Notice of Final Revisions to the HHS
Guidelines (66 FR 43876; August 21, 2001) to establish requirements for
specimen validity testing performed by HHS-certified laboratories, HHS
reported that the number of adulterated and substituted urine specimens
has been increasing among the specimens tested under the Federal agency
workplace drug testing program and the DOT regulations (49 CFR Part
40). Program experience gained after Part 26 was first promulgated has
also indicated an increasing number of adulterated and substituted
urine specimens submitted to HHS-certified laboratories from Part 26
testing programs.
Although former Part 26 contained a number of requirements related
to specimen validity (e.g., the fifth sentence of former Sections
2.1(e), 2.4(f)(2), 2.4(g)(14) through (g)(16), and 2.7(d) in Appendix A
to Part 26), the methods available to tamper with specimens have become
more sophisticated after the rule was first published and more
sophisticated methods of detecting tampering are necessary. Therefore,
the final rule incorporates new requirements for HHS-certified
laboratories to conduct specimen validity tests that are consistent
with similar provisions contained in the most recent revision to the
HHS Guidelines (69FR 19643; April 13, 2004). The NRC has added these
new requirements for specimen validity testing to strengthen FFD
programs by improving current laboratory procedures to detect specimens
that are diluted, adulterated, or substituted. This change is
consistent with Goal 1 of this rulemaking to update and enhance the
consistency of Part 26 with advances in other relevant Federal rules
and guidelines. Detecting specimen tampering is necessary to identify
individuals who may attempt to hide drug abuse. Attempts to tamper with
a specimen provide clear evidence that the individual is not
trustworthy and reliable. Also, these individuals' drug use may pose a
risk to public health and safety and the common defense and security,
as discussed with respect to Sec. 26.23.
Section 26.31(d)(3)(ii) amends the first sentence of former Sec.
26.24(d)(1). This sentence permits licensees and other entities to
conduct initial testing of urine specimens at a licensee testing
facility, provided that the licensee testing facility staff possesses
the necessary training and skills for the tasks assigned, the staff's
qualifications are documented, and adequate quality controls for the
testing are implemented. The final rule adds permission for licensees
and other entities to perform initial validity testing at a licensee
testing facility for the reasons discussed with respect to Sec.
26.31(d)(3)(i). Subpart F establishes detailed requirements related to
specimen validity testing at licensee testing facilities.
Section 26.31(d)(3)(iii) is based upon the portions of former
Section 2.7(e)(1) and (f)(2) in Appendix A to Part 26. These former
sections established the cutoff levels for initial and confirmatory
drug testing, respectively, which licensees must apply under the former
rule. However, the final rule requires FFD programs to apply the
updated cutoff levels specified in Sec. 26.163(a)(1) for initial drug
testing and Sec. 26.163(b)(1) for confirmatory drug testing. The final
rule clarifies the language of the proposed rule by adding that either
the licensee testing facility or HHS-certified lab conducts the initial
drug testing and the HHS-certified laboratory conducts the confirmatory
testing. Consistent with the first sentence of former Sec. 26.24(b),
the second sentence of this provision permits FFD programs to implement
more stringent cutoff levels than specified in the rule, but
establishes additional requirements related to lower cutoff levels, as
is discussed with respect to paragraphs (d)(3)(iii)(A) through (C). The
NRC has relocated the permission in the first sentence of former Sec.
26.24(b) to implement a broader panel of drugs to Sec. 26.31(d)(1), as
discussed with respect to that section. The NRC has made these changes
to meet Goal 6 of this rulemaking to improve clarity in the
organization and language of the rule.
Section 26.31(d)(3)(iii)(A) retains the third and fourth sentences
of former Sec. 26.24(b) regarding management actions and sanctions for
confirmed positive drug test results based on any lower cutoff levels
established by the FFD program. The final rule adds a requirement that
the FFD program's written policy and procedures must document the FFD
program's lower cutoff levels in the written policy and procedures to
ensure that individuals who are subject to testing are aware of the
cutoff levels that would be applied to their drug test results in order
to protect their rights. The NRC has made this change to meet Goal 7 of
this rulemaking to protect the privacy and other rights (including due
process) of individuals who are subject to Part 26.
Section 26.31(d)(3)(iii)(B) requires the uniform application of the
FFD program's cutoff levels for drugs and drug metabolites, including
any more stringent cutoff levels in all tests conducted under this part
and equally to all individuals who are subject to testing, except as
permitted under Sec. Sec. 26.31(d)(1)(ii), 26.163(a)(2) for dilute
specimens, and Sec. 26.165(c)(2) for retesting specimens. As discussed
with respect to Sec. 26.31(d)(1)(ii), some FFD programs have adopted
the practice of testing specimens at the assay's LOD for for-cause,
post-event, and followup tests, which results in some individuals
receiving unequal treatment under the rule. Therefore, the NRC has
added the section to meet Goal 7 of this rulemaking to protect the
privacy and other rights (including due process) of individuals who are
subject to Part 26.
The NRC has added Sec. 26.31(d)(3)(iii)(C) to the final rule to
specify requirements for establishing more stringent cutoff levels.
Before implementing the more stringent cutoff levels, licensees and
other entities are required to obtain certification from a forensic
toxicologist that the more stringent cutoff levels are technically
sound and legally defensible, with two exceptions. Certification by a
forensic toxicologist is not required if: (1) If the HHS Guidelines are
revised to lower the cutoff levels for the drug or drug metabolites in
Federal workplace drug testing programs and the licensee or other
entity implements the cutoff levels published in the HHS guidelines; or
(2) if the licensee or other entity received written approval of the
NRC to test for lower cutoff levels before the implementation date of
this rule, which is 365 days after the date the final rule
[[Page 17025]]
is published in the Federal Register. Certification by a toxicologist
is unnecessary in these two circumstances because it would be
redundant. The NRC has made this change to meet Goal 5 of this
rulemaking to improve Part 26 by eliminating or modifying unnecessary
requirements, while continuing to protect donors' right to accurate and
reliable drug testing.
Section 26.31(d)(4) [Alcohol testing] updates former Sec. 26.24(g)
that contained general requirements for conducting alcohol testing. The
update reflects other changes that have been made in the final rule.
The NRC has amended the former cross-reference to Section 2.7(o)(3) in
Appendix A to Part 26 to refer to Sec. 26.91(a) in Subpart E, which
contains detailed requirements for conducting alcohol testing. The NRC
has added the reference to oral fluids as acceptable specimens for
initial alcohol testing to this section. The basis for adding oral
fluids as acceptable specimens for initial alcohol testing is discussed
with respect to Sec. 26.83 [Specimens to be collected]. The NRC has
changed the BAC at which a confirmatory test is required to 0.02
percent (from 0.04 percent) in the provision for consistency with the
revised alcohol cutoff levels in Sec. 26.99 [Determining the need for
a confirmatory test for alcohol] and Sec. 26.103 [Determining a
confirmed positive test result for alcohol]. The basis for the revised
alcohol cutoff levels is discussed with respect to those sections of
the final rule. The agency has deleted reference to blood testing for
alcohol because the final rule no longer permits donors to request
blood testing for alcohol, as discussed with respect to Sec. 26.83(a)
of the final rule.
The NRC has added Sec. 26.31(d)(5) [Medical conditions] to the
final rule to address circumstances when it may be impossible or
inadvisable to test an individual using the procedures specified in
this part. Circumstances have arisen under Part 26, as well as the
programs of other Federal agencies, when an individual's medical
condition has made it inadvisable to implement testing procedures under
the relevant requirements. Therefore, Sec. 26.31(d)(5)(i) permits
alternative specimen collection and evaluation procedures for rare
instances when it would be difficult or hazardous to the donor to
collect breath, oral fluids, or urine specimens, including, but not
limited to, required post-event testing when an individual has been
seriously injured. Only the MRO is permitted to authorize an
alternative evaluation procedure that may include, but is not limited
to blood testing for alcohol. Section 26.31(d)(5)(ii) clarifies that
necessary medical treatment may not be delayed in order to conduct drug
and alcohol testing. These sections are consistent with the
requirements of other Federal agencies and meet Goal 1 of this
rulemaking to update and enhance the consistency of Part 26 with
advances in other relevant Federal rules and guidelines.
Section 26.31(d)(6) [Limitations of testing] retains and amends
former Section 2.1(d) in Appendix A to Part 26. This former section
stated that specimens collected under Part 26 may only be designated or
approved for testing as described in this part and may not be used for
any other analysis or test without the permission of the tested
individual. The final rule adds examples of the types of analyses and
tests that are prohibited without the donor's written permission.
Although the NRC is not aware of any instances when such unauthorized
testing has occurred in FFD programs under this part, the technology
for performing these analyses and tests has become increasingly
available since the regulation was first promulgated. The NRC has added
these examples to meet Goal 7 of this rulemaking to protect the privacy
and other rights (including due process) of individuals who are subject
to Part 26.
Section 26.33 Behavioral Observation
The NRC has added Sec. 26.33 to the final rule to emphasize that
behavioral observation is a required element of FFD programs. The first
sentence of Sec. 26.33 requires behavioral observation of individuals
subject to this subpart. The second sentence retains former Sec.
26.22(a)(3), (a)(4), and (b), which stated that the individuals who
perform behavioral observation must be trained. The third sentence of
the section requires that individuals must report FFD concerns arising
from behavioral observation to the appropriate personnel designated in
the FFD program procedures. The NRC has added these requirements to the
final rule to strengthen the behavioral observation element of FFD
programs by increasing the likelihood that the licensees and other
entities detect and appropriately address impairment and other adverse
behaviors. These changes are consistent with Goal 3 of the rulemaking
to improve the effectiveness and efficiency of FFD programs.
Section 26.35 Employee Assistance Programs
Section 26.35 amends former Sec. 26.25 [Employee assistance
programs].
Section 26.35(a) retains the former provision without change and
specifies that licensees and other entities shall maintain EAPs that
offer confidential assessment, short-term counseling, referral
services, and treatment monitoring to individuals who have problems
that could adversely affect the individuals' abilities to safely and
competently perform their duties. The provision also requires that the
EAP be designed to achieve early intervention and provide for
confidential assistance.
The NRC has added Sec. 26.35(b) to the final rule to clarify that
licensees and other entities are not required to provide EAP services
to C/V employees, including those who are working at a licensee's or
other entity's facility. With respect to the proposed rule, the final
rule clarifies that licensees and other entities are not required to
provide EAP services to C/V employees whose work location is a
licensee's or other entity's facility. This provision is consistent
with the interpretation of the former rule in item 13.1.4 of NUREG-
1354. The final rule continues to require that C/V employees who are
subject to Part 26 must have access to an EAP, and that licensees and
other entities who rely upon the FFD program of a C/V continue to be
required to ensure that the EAP of a C/V meets the requirements of this
part.
The provision also states that licensees and other entities need
not provide EAP services to individuals who have applied for but have
not yet been granted authorization under Subpart C. Licensees and other
entities are not required to provide an EAP to applicants for
authorization because these individuals would not yet be performing
duties that could affect public health and safety or the common defense
and security. The NRC has added this clarification because applicants
are subject to other requirements under the final rule as discussed
with respect to Sec. 26.4(h).
Section 26.35(c) amends the last sentence of former Sec. 26.25.
The provision emphasizes that the identity and privacy of an individual
who seeks EAP services must be protected and clarifies the conditions
under which EAP personnel may or must violate an individual's
confidentiality. The final rule permits EAP personnel to communicate
information about an individual by name to the licensee or other entity
under only two conditions: (1) If the individual waives the right to
privacy, or (2) EAP personnel determine that the individual's condition
or actions pose or have posed an immediate threat to himself or herself
or others. By clarifying the NRC's intent
[[Page 17026]]
with respect to EAP confidentiality, the provision meets Goal 6 of this
rulemaking to improve clarity in the language of the rule because the
former provision has been misinterpreted.
The last sentence of former Sec. 26.25 required confidentiality
for individuals who seek EAP services, except if EAP professionals
determine that the individual's condition ``constitutes a hazard to
himself or herself or others.'' Some licensees have over-interpreted
this phrase and routinely require EAP staff to report individuals who
self-refer for any reason, which is not the intent of this provision.
The NRC is also aware that some individuals who are subject to the rule
have misinterpreted this phrase as meaning that no self-referral to the
EAP would remain confidential and that EAP staff always report self-
referrals to licensee management. This perception appears to be widely
shared, including by individuals who are subject to FFD programs that
have not misinterpreted the former rule and who correctly permit EAP
staff to make the determination of whether to report an individual's
condition to licensee management.
A key purpose of requiring EAPs under Part 26 is to encourage
individuals and their family members to self-refer for any type of
problem that could potentially impair job performance, so that early
intervention may be offered to prevent the problem from adversely
affecting the individuals' job performance. Upon assessment, it is not
uncommon for EAP staff to find that a developing substance abuse
problem is contributing to a financial or family problem for which an
individual has sought assistance. As a result, the EAP provides an
important means to detect and achieve early resolution of developing
substance abuse and other problems, which if left untreated could have
the potential to adversely affect an individual's ability to safely and
competently perform his or her duties. The knowledge or perception
among individuals who are subject to the rule that self-referrals to
the EAP will be reported to management and will routinely result in the
loss of authorization represents a significant barrier to the
effectiveness of the EAP element of FFD programs. Therefore, the
section amends the last sentence of former Sec. 26.25 to clarify that
an individual's use of the licensee's or other entity's EAP must remain
confidential, except in very limited circumstances.
The NRC has added Sec. 26.35(c)(1) to the final rule to prohibit
licensees and other entities from requiring the EAP to routinely report
the names of individuals who self-refer to the EAP and the nature of
assistance the individuals sought. The provision is necessary to
eliminate some licensees' practices of requiring these reports, protect
individuals' privacy, and strengthen the EAP element of FFD programs by
eliminating a former barrier to self-referrals in some FFD programs.
The term ``routinely'' is used to indicate that the final rule permits
EAP personnel to report individuals' names and the nature of their
problems if the individuals have waived the right to privacy in writing
or EAP personnel determine that an individual's condition or actions
pose or have posed an immediate risk to public health and safety or the
common defense and security. The provision does not prohibit EAPs from
reporting program utilization statistics or aggregated data that
characterize the types of problems for which the program has provided
services because this type of information does not compromise
individuals' privacy.
The NRC has added Sec. 26.35(c)(2) to the final rule to provide
further clarity in the language of the rule with respect to the
conditions under which EAP personnel are excepted from the
confidentiality requirement in Sec. 26.35(c) and required to report a
concern about an individual to the licensee or other entity. The NRC is
confident that EAP personnel have the qualifications and training
necessary to continue to make the professional judgments required under
the regulations in these circumstances. However, the final rule
includes more detail with respect to the conditions and actions that an
EAP professional is required to report to ensure that licensees, other
entities, and individuals who are subject to the rule better understand
the intent of the former and final provisions. The final rule requires
EAP personnel to report a concern about a specific individual to
licensee or other entity management only when they have substantive
reasons to believe that an individual's condition or actions pose or
have posed an immediate hazard to themselves or others. The phrase
``substantive reasons to believe'' is used to clarify that casual and/
or contextually appropriate comments made by an individual during a
counseling session are not a sufficient basis for reporting to the
licensee or other entity. For example, an individual's statement that
he or she is concerned about becoming an alcoholic would not constitute
a substantive reason to believe that the individual's condition poses
an immediate hazard. In contrast, this stated concern, in addition to
evidence that the individual's personal relationships, financial
condition, and/or health are suffering from his or her alcohol
consumption, and any indications that the individual has been impaired
while in a work status, would constitute substantive reasons to believe
that the individual's condition poses an immediate hazard and must be
reported.
The NRC has added Sec. 26.35(c)(2)(i) through (iii) to the final
rule to provide several examples of conditions and actions that require
EAP personnel to provide a report about an individual who has self-
referred to licensee or other entity management. Section 26.35(c)(2)(i)
requires reporting if the EAP staff has substantive reasons to believe
that an individual may harm himself or herself or others, including,
but not limited to, plans threatening suicide, radiological sabotage,
or physical violence against others. Section 26.35(c)(2)(ii) requires
reporting if the EAP staff has substantive reasons to believe that an
individual has been impaired from drugs or alcohol while in a work
status and is likely to be impaired in the future, as discussed with
respect to Sec. 26.35(c)(2). Section 26.35(c)(2)(iii) requires
reporting if the EAP staff has substantive reasons to believe that an
individual has committed any of the acts that would require a report to
the NRC under Sec. 26.719(b)(1) through (b)(3), including but not
limited to, the use, sale, distribution, possession, or presence of
illegal drugs, or the consumption or presence of alcohol within a
protected area or while performing duties that require the individual
to be subject to this part. The examples included in these sections are
illustrative, and do not represent an exhaustive list of the conditions
and actions that EAP staff may encounter that would be reported to
licensee or other entity management under the final rule.
For additional clarity, the NRC has added Sec. 26.35(c)(3) to the
final rule to cross-reference the provisions in the final rule that
specify the actions that licensees and other entities would take after
receiving a report from EAP personnel that an individual's condition or
actions pose or have posed an immediate hazard to himself or herself or
others. As discussed with respect to (Sec. Sec. 26.69(d) and 26.77(b)
of the final rule, those provisions require the licensee or other
entity to take immediate action to prevent the individual from
performing any duties that require the individual to be subject to this
part, ensure that a determination of fitness is performed by a
professional who has specific qualifications and
[[Page 17027]]
training to address the nature of the individual's problem, and either
terminate the individual's authorization or ensure that the condition
is resolved before permitting him or her to return to performing duties
under this part.
These changes to former Sec. 26.25 are consistent with Goal 7 of
this rulemaking to protect the privacy and other rights (including due
process) of individuals who are subject to Part 26, as well as Goal 3
to improve the effectiveness and efficiency of FFD programs.
Section 26.37 Protection of Information
Section 26.37 amends former Sec. 26.29 that contained requirements
for protecting the personal information that must be collected under
Part 26. In general, this section of the final rule groups requirements
related to the protection of personal information that were dispersed
throughout the former rule to aid in locating these requirements in the
final rule. The NRC has moved the records retention requirement in
former Sec. 26.29(a) to Subpart N of the final rule. The NRC has made
these changes to meet Goal 6 of this rulemaking to improve clarity in
the organization of the rule.
Section 26.37(a) combines and retains the first sentence of former
Sec. 26.29(a) and the second sentence of former Section 3.1 in
Appendix A to Part 26. The final rule modifies the language of the
proposed rule to require licensees and other entities to establish,
use, and maintain a system of files and procedures that protects the
individuals' privacy. The NRC, after publishing the proposed rule,
recognized the need for more clarity in the language of this provision
to illustrate the NRC's intent. Therefore, this change meets Goal 6 of
the rulemaking to improve clarity in the language of the rule.
Section 26.37(b) amends former Sec. 26.29(b) and divides it into
several sections for clarity. The first sentence of the section amends
the first sentence of former Sec. 26.29(b) that prohibited licensees
and other entities from disclosing personal information collected under
this part to any individuals other than those listed in the sentence.
The final rule continues to permit disclosure of the personal
information to the listed individuals and adds permission for the
licensee or entity to disclose the personal information to others if
the licensee or other entity has obtained a signed release for such a
disclosure from the individual. The NRC has added the permission to
release the personal information to individuals who are not listed in
the section with the written consent of the subject individual because
some licensees have misinterpreted the former requirement as
prohibiting them from releasing the personal information under any
circumstances, except to the parties listed in this section. In some
instances, such failures to release information have inappropriately
inhibited an individual's ability to obtain information that was
necessary for a review or appeal of the licensee's determination that
the individual had violated the FFD policy. Therefore, the NRC has
added the explicit permission for licensees and other entities to
release personal information when an individual consents to the
release, in writing, to meet Goal 7 of this rulemaking to protect the
privacy rights and other rights (including due process) of individuals
who are subject to Part 26.
Section 26.37(b)(1) through (b)(8) lists the individuals to whom
licensees and other entities are permitted to release personal
information about an individual. Section 26.37(b)(3), (b)(4), and
(b)(8) retains unchanged the permission for the release of information
to NRC representatives, appropriate law enforcement officials under
court order, and other persons as required by court order. Section
26.37(b)(1), (b)(2), (b)(5), (b)(6), and (b)(7) amends the related
requirements contained in former Sec. 26.29(b) to meet Goal 6 of this
rulemaking to improve clarity in the organization and language of the
rule. The specific changes to former Sec. 26.29(b) include the
following:
Section 26.37(b)(1) retains the permission for the release of
information to the subject individual and his or her designated
representative. The provision adds requirements for the individual to
designate his or her representative in writing and specify the FFD
matters to be disclosed. The NRC has made these changes in response to
implementation questions from licensees. Licensees have sought guidance
from the NRC related to the way an individual must ``designate'' a
representative.
Section 26.37(b)(2) retains the permission for the release of
information to the licensee's or other entity's MROs. The final rule
also permits the release of information to MRO staff members for
consistency with Sec. 26.183(d), which permits MRO staff to serve some
MRO functions under the direction of the MRO. MRO staff require access
to the personal information in order to perform their duties. The role
of MRO staff in FFD programs is discussed with respect to Sec.
26.183(d) of the final rule.
Section 26.37(b)(5) amends the former reference to licensee
representatives who have a need to have access to the information in
performing assigned duties. The former rule referred only to
individuals who are performing audits of FFD programs. As a result,
some licensees have misinterpreted the former rule as limiting the
release of personal information only to such individuals. This was not
the intent of the provision. Rather, the NRC intended that licensees
and other entities were permitted to release information to their
representatives who must have access to the personal information in
order to perform assigned duties.
With respect to the proposed rule, the final rule modifies proposed
Sec. 26.37(b)(5) to clarify the NRC's intent that the only licensee or
other entity representatives who may have access to the personal
information collected under this part are persons who have a need for
that information to implement the requirements of the rule. The NRC
made this change to provide greater assurance that personal
information, such as medical records that an individual has submitted
to the MRO to document prescription medication for a ``shy bladder''
situation, is not released to persons who do not have assigned duties
under the FFD program that specifically require access to that
information. Reviewing officials, MROs, SAEs, and other FFD program
personnel, as well as auditors, require access to some personal
information about individuals in order to perform their assigned duties
to implement the FFD program. Human resources personnel may need to
know that an individual has violated the FFD policy, if the licensee or
other entity terminates an individual's employment in response to an
FFD policy violation, but do not need access to the personal
information collected about the individual under the FFD program to
carry out the process of terminating the individual's employment. The
NRC has determined that this additional clarification is necessary to
provide further protection of the privacy of persons who are subject to
the rule.
Section 26.37(b)(6) and (b)(7) amends the portion of former Sec.
26.29(b) that referred to ``persons deciding matters on review or
appeal.'' The NRC has amended the provision in response to
implementation questions from licensees, including whether the rule
covers persons deciding matters in judicial proceedings or only the
internal appeals process specified in former Sec. 26.28 [Appeals], as
well as whether
[[Page 17028]]
information could be released in a judicial proceeding that the subject
individual did not initiate. The final rule clarifies that the
permission includes individuals who are presiding in a judicial or
administrative proceeding, but only if the subject individual in Sec.
26.37(b)(6) initiates the proceeding. Section 26.37(b)(7) covers
``persons deciding matters under review in Sec. 26.39'' [Review
process for fitness-for-duty policy violations], as discussed with
respect to that section. The NRC has made these changes to meet Goal 6
of this rulemaking relating to improving clarity in the organization
and language of the rule.
The NRC has added Sec. 26.37(c) to the final rule to require the
disclosure of relevant information to licensees and other entities,
including C/Vs, and their authorized representatives who have a
legitimate need for the information and a signed release from an
individual who is seeking authorization under this part. This provision
clarifies former Sec. 26.29(b) because some licensees have
misinterpreted the former provision as prohibiting the release of
information to C/Vs who have licensee-approved FFD programs and conduct
suitable inquiries on behalf of licensees and other entities. The NRC
has made this change to meet Goal 6 of this rulemaking to improve
clarity in the organization and language of the rule.
Section 26.37(d) through (f) retains several requirements related
to the protection of information in the former rule but moves them into
this section for organizational clarity. Section 26.37(d) combines
requirements in former Sec. 26.29(b) and Section 3.2 in Appendix A to
Part 26 as they relate to an individual's access to records that are
necessary for a review of an FFD policy violation. However, the final
rule modifies the language of the proposed rule by specifying that it
is the FFD program that is required to promptly provide all requested
records. The NRC has made this change to meet Goal 6 of the rulemaking
to improve clarity in the language of the rule. The final rule also
adds ``collection site'' and ``SAE'' to the list of entities who must
provide records to an individual or his or her designated
representative. The final rule also expands the proposed language to
specify the types of records that must be provided. The examples given
for the types of records that must be provided to the individual are
illustrative, but are not comprehensive of all the types of records
that must be provided upon request. The agency has made these changes
in response to public comment, to clarify the rule language, to ensure
that individuals and representatives can verify the accuracy of FFD
records, and to meet Goal 7 of this rulemaking to protect the privacy
and other rights (including due process) of individuals subject to Part
26. Section 26.37(e) and (f) retains former Section 3.1 in Appendix A
to Part 26 and the last sentence of former Sec. 26.29(b),
respectively.
Section 26.39 Review Process for Fitness-for-Duty Policy Violations
Section 26.39 amends former Sec. 26.28 and separates it into
several sections. The change from the former section heading eliminates
the implication that the internal management review is a legal
proceeding. The agency has added several requirements to clarify and
strengthen individuals' rights during the review, consistent with Goal
7 of this rulemaking, as described in the following paragraphs.
Former Sec. 26.28 required that individuals who are subject to the
rule have an opportunity for a management review of a determination
that the individual has violated the licensee's or other entity's FFD
policy. Section 26.39(a) retains the requirement that the review must
be impartial and adds a requirement that the review must be objective.
The NRC has added the requirement for an objective review because some
licensees have permitted the same individuals who were involved in the
initial determination that an individual violated the FFD policy to
provide the review that was required under former Sec. 26.28. The
impartiality of individuals who are reviewing their own decisions is
questionable and calls into question the effectiveness of the review
process. Therefore, the requirement for the review to be both impartial
and objective emphasizes the NRC's intent that the review process be
effective.
In keeping with revisions to several other sections that are
intended to counter subversion of the testing process, Sec. 26.39(a)
extends this opportunity to request a review to all FFD violations,
including, but not limited to, violations based upon confirmed
positive, adulterated, or substituted, or invalid test results. The
section also clarifies that applicants for authorization must be given
the opportunity for a review. Experience with implementing this section
of Part 26 has indicated that some licensees did not provide a review
process to individuals who tested positive on pre-access tests.
However, the factors that could produce false positive test results
among licensee and C/V employees (e.g., administrative or testing
errors) are equally likely to occur during pre-access testing of
applicants for authorization. If applicants are not provided with a
review process, it is possible that some of them would be effectively
barred from the industry based on test results erroneously determined
to be a violation of the licensee's or other entity's FFD policy.
Providing applicants with the opportunity to request a review also
enhances program credibility.
Section 26.39(b) specifies that FFD procedures must describe the
contents and purpose of the notice that licensees and other entities
would be required to provide to an individual who has violated an FFD
policy. The provision also requires that the procedures must state that
the individual may submit additional relevant information as part of
the review process. This clarification is necessary because experience
with implementing former Sec. 26.28 has indicated that individuals do
not understand the purpose of the review process and their associated
rights in some cases.
Section 26.39(c) specifies that the procedure must ensure that the
individual who conducts the review is not associated with the
administration of the FFD program. The final rule modifies the proposed
rule by requiring that only one representative of the licensee's or
other entity's management shall conduct the review. The final rule
allows only one individual to conduct the review in response to a
public comment that stated that the review process required by this
section should be consistent with that required by 10 CFR 73.56(e)
(personnel access authorization) because this would simplify licensee
procedures and would improve the consistency between FFD requirements
and access authorization requirements. In specifying that the reviewer
may not be anyone associated with the administration of the FFD
program, including anyone who made the initial determination that the
individual violated the FFD policy, the final rule strengthens the
impartiality and objectivity of the review process in order to further
enhance individuals' rights. The NRC has made these changes to meet
Goal 3 of the rulemaking to increase the effectiveness and efficiency
of FFD programs, and Goal 7 to protect the privacy and other rights
(including due process) of individuals who are subject to Part 26.
Section 26.39(d) adds a requirement that any records associated
with the FFD policy violation must be deleted or corrected, as
appropriate, if the policy violation decision is overturned. This
requirement is necessary because the final rule permits licensees and
other entities to share and rely on information
[[Page 17029]]
gathered by other Part 26 programs to a greater extent than is
currently possible. Therefore, incorrect records related to an FFD
policy violation could significantly inhibit an individual from further
employment under a Part 26 program if this information is transmitted
to other licensees and entities who are considering whether to grant
authorization to an individual. The requirement to delete or correct
any records associated with an FFD policy violation that has been
overturned will protect individuals from such potential adverse
consequences.
Section 26.39(e) of the final rule amends the last sentence of
former Sec. 26.28. This sentence stated that licensees and other
entities are not required to provide a review procedure to C/V
employees and applicants when the C/V is administering its own drug and
alcohol testing. The final rule amends the former paragraph in response
to implementation questions from licensees who have asked whether the
former provision excuses them from providing a review process for C/V
employees at any time, including situations when the FFD policy
violation was determined as a result of testing conducted by the
licensee. The final rule revises this sentence to clarify that the
licensee or other entity need not provide a review process if the C/V's
drug and alcohol testing program identified the FFD violation to be
reviewed. If the licensee's drug and alcohol testing determined the FFD
violation, the licensee is required to provide the impartial and
objective review. The final rule modifies the proposed rule to state
that the licensee need not provide a review procedure to a C/V
subcontractor when the FFD policy violation was determined under a C/
V's program. These changes are consistent with Goal 6 of this
rulemaking to improve clarity in the organization and language of the
rule.
Section 26.41 Audits and Corrective Action
Section 26.41 of the final rule renames and amends former Sec.
26.80 [Audits]. The NRC has added the phrase ``and corrective action''
to the section heading to emphasize the NRC's intent that licensees and
other entities must ensure that corrective actions are taken in
response to any adverse findings resulting from an audit. In addition,
the final rule reorganizes the audit requirements in former Sec.
26.80, and moves several audit and inspection requirements into this
section that were addressed in Appendix A to Part 26. The NRC has made
these changes to meet Goal 6 of this rulemaking to improve clarity in
the organization and language of the rule.
Section 26.41(a) [General] of the final rule amends the last
sentence in former Sec. 26.80(a). This sentence stated that licensees
retain responsibility for the effectiveness of C/V programs and the
implementation of appropriate corrective action. The final rule revises
this requirement to include HHS-certified laboratories, as well as any
C/V FFD program elements and FFD programs that the licensee or other
entity relies upon, consistent with the intent of the former
requirement. The final rule has added a phrase to the proposed rule
that requires licensees to be responsible for the continuing
effectiveness of any FFD program services a subcontractor provides to
the C/V. The NRC has made these changes to meet Goal 6 of this
rulemaking to improve clarity in the language of the rule.
Section 26.41(b) [FFD program] of the final rule amends the
required audit frequency in former Sec. 26.80(a). (Other provisions of
Sec. 26.41 address the other requirements contained in former Sec.
26.80(a), as discussed with respect to the sections of the final rule
that address those topics.) The final rule decreases the former 12-
month FFD program audit frequency to a nominal 24-month frequency,
which grants a petition for rulemaking (PRM-26-1) submitted by Virginia
Power on December 30, 1993. Experience with implementing Part 26 has
shown that annual audits of the entire FFD program are unnecessary to
ensure continued program effectiveness and, therefore, place an
unnecessary burden on those entities who are subject to the rule. The
NRC decreased the audit frequency to 24 months to relieve this burden
and to be consistent with the NRC's schedule for inspecting FFD
programs. The change is consistent with Goal 5 of this rulemaking to
improve Part 26 by eliminating or modifying unnecessary requirements.
Although the final rule decreases the required audit frequency,
licensees and other entities are required to monitor program
performance indicators and operating experience, consistent with a
performance-based approach, and audit FFD program elements more
frequently than every 24 months as needed. In determining the need for
more frequent audits, the final rule requires licensees and other
entities to consider FFD performance, including but not limited to, the
frequency, nature, and severity of discovered problems, testing errors,
personnel or procedural changes, and previous audit findings. The
provision is intended to promote performance-based rather than
compliance-based audit activities and clarify that programs must be
audited following a significant change in personnel, procedures, or
equipment as soon as reasonably practicable. The NRC recognizes that
FFD programs evolve and new issues and problems continue to arise.
Turnover of FFD program personnel and contracted services personnel,
such as specimen collectors, exacerbates this concern. Licensee audits
have identified problems that were associated in some way with
personnel changes, such as new personnel not understanding their duties
or procedures, the implications of actions that they took or did not
take, or changes in processes. The purpose of these focused audits is
to ensure that changes in personnel, procedures, or equipment do not
adversely affect the operation of the particular program element or
function in question. Accordingly, the audit requirement ensures that
any programmatic problems that may result from significant changes in
personnel, procedures, or equipment are detected and corrected on a
timely basis. By requiring more frequent audits of FFD program
performance that may require closer monitoring than a nominal 24-month
frequency would provide, these changes meet Goal 3 of this rulemaking
to improve the effectiveness and efficiency of FFD programs.
Section 26.41(c) [C/Vs and HHS-certified laboratories] of the final
rule amends the audit and inspection requirements that are contained in
the second sentence of former Sec. 26.80(a) and the third sentence of
Section 2.7(m) in Appendix A to Part 26, as follows:
Section 26.41(c)(1) further amends the requirement in former Sec.
26.80(a) for annual audits of C/V FFD programs and program elements and
HHS-certified laboratories. The former annual audit frequency is
retained only for those portions of C/V FFD programs whose personnel
work off site and are not under the daily supervision of FFD program
personnel. The activities of C/V personnel who work on site and are
under the daily supervision of FFD program personnel are audited under
Sec. 26.41(b). Retention of the annual audit requirement for C/Vs
whose personnel work off site meets Goal 3 of this rulemaking to
improve the effectiveness and efficiency of FD programs. The provision
is necessary to ensure that the services provided continue to be
effective because other means of monitoring their effectiveness, such
as daily oversight, are unavailable. The section also retains the
annual audit requirement for HHS-certified laboratories. The NRC has
retained this audit frequency because of the key role
[[Page 17030]]
the laboratories play in the overall effectiveness of Part 26 programs.
Retention of these annual audit requirements in the section denies the
petition for rulemaking (PRM-26-1) submitted by Virginia Power on
December 30, 1993.
Section 26.41(c)(2) relaxes some requirements related to annual
audits and inspections of the HHS-certified laboratories that licensees
and other entities rely upon for drug testing services. The final rule
permits licensees and other entities who are subject to the rule to
rely upon the inspections of HHS laboratories that are performed for
HHS-certification reviews and no longer requires licensees and other
entities to audit the effectiveness of services that HHS inspectors
review. The former rule contained a number of requirements that are
inconsistent with the requirements for drug testing under other
Federally mandated programs. For example, the former rule permitted
donors to request confirmatory alcohol testing of a blood specimen at
an HHS-certified laboratory, which other Federal agencies do not
permit. Also, some of the cutoff levels established in the former rule
are higher, in the case of testing for marijuana metabolite, or lower,
in the case of testing for opiates, than those of other Federal
agencies. These programmatic discrepancies have made licensee audits of
HHS-certified laboratories necessary to ensure the effectiveness of the
unique drug and alcohol testing services required for Part 26 programs
because HHS inspections do not address these services. The final rule
eliminates the majority of these discrepancies. Therefore, the annual
audits of HHS-certified laboratories by licensees that have been
necessary under the former rule would be redundant under the final
rule, except in certain conditions described below. The NRC has made
these changes to meet Goal 5 of this rulemaking to improve Part 26 by
eliminating or modifying unnecessary requirements.
Section 26.41(c)(2) continues to require licensees and other
entities to conduct annual audits of any services provided to the
licensee or other entity that the annual HHS-certification review did
not address. The NRC has retained this annual audit requirement because
Sec. 26.31(d) retains the permission in the former rule for licensees
and other entities to establish lower cutoff levels and test for drugs
in addition to those for which testing is required under this part. If
a licensee or other entity chooses to implement more stringent cutoff
levels or a broader panel of drugs than required under the final rule,
the licensee or other entity is required to ensure that annual audits
of the HHS-certified services related to those cutoff levels and drug
tests are performed.
The NRC has added the last sentence of Sec. 26.41(c)(2) to clarify
the scope of the former audit requirements. The final rule does not
require licensees and other entities to audit organizations that do not
routinely provide FFD services to the licensee or other entity, such as
local hospitals or a substance abuse treatment facility. It is
unnecessary to audit these organizations because the FFD program would
use their services infrequently, there would be a reasonable
expectation of quality, and weaknesses in these services could be
identified through other means. For example, Sec. 26.187 [Substance
abuse expert] requires the SAE to monitor the substance abuse treatment
of individuals who require it and the SAE would have the qualifications
and information necessary to assess the quality of the treatment
services an individual receives. The SAE has the authority to seek
other services on behalf of the FFD program if he or she identifies
weaknesses in a treatment program. Therefore, the NRC has made these
changes to meet Goal 5 of this rulemaking to improve Part 26 by
eliminating or modifying unnecessary requirements.
Section 26.41(d) [Contracts] of the final rule incorporates and
amends the requirements of former Section 2.7(m) in Appendix A to Part
26 and others that addressed contractual relationships to permit
licensees and other entities access to the HHS-certified laboratories
for the purposes of conducting the audits and inspections required
under the rule. The portions of former Section 2.7(m) in Appendix A to
Part 26 that related to NRC inspections of HHS-certified laboratories
have been moved to Sec. 26.821 [Inspections] in Subpart O
[Inspections, violations, and penalties] of the final rule, consistent
with Goal 6 of this rulemaking to improve clarity in the organization
and language of the rule.
Section 26.41(d)(1) amends the second sentence of former Section
2.7(m) in Appendix A to Part 26. The former section required licensee
contracts with HHS-certified laboratories for drug testing and alcohol
confirmatory testing, as well as contracts for collection site
services, to permit the licensee to conduct unannounced inspections.
The final rule retains the former requirement with respect to HHS-
certified laboratories and expands it to require that contracts with
any C/V (which would include collection services providers) must permit
the licensee or other entity to conduct audits at any time, including
unannounced times, and to review all information and documentation that
is reasonably relevant to the audits. The provision extends the former
requirement to any C/V with whom the licensee or other entity contracts
for FFD program services to enhance the effectiveness of the licensees'
and other entities' audits should unannounced audits appear to be
necessary. For example, a licensee or other entity may receive
allegations that an offsite C/V is falsifying records or that a
contract MRO or SAE is using drugs. The licensee or other entity may
determine that an unannounced audit would provide the most effective
means to investigate these allegations. This provision ensures that the
licensee's or other entity's contract with the C/V permits the
unannounced audit as well as access to any information necessary to
conduct the audit. Therefore, the NRC has made this change to meet Goal
3 of this rulemaking to improve the effectiveness and efficiency of FFD
programs.
The NRC had added Sec. 26.41(d)(2) to ensure that licensees' and
other entities' contracts with C/Vs and HHS-certified laboratories
permit the licensee or other entity to obtain copies of and take away
any documents that auditors may need to assure that the C/V, its
subcontractors, or the HHS-certified laboratory are performing their
functions properly and that staff and procedures meet applicable
requirements. This provision responds to several incidents when parties
under contract to licensees did not permit Part 26 auditors to remove
documents from a premises of a C/V that were necessary to document
audit findings, develop corrective actions, and ensure the
effectiveness of the corrective actions. Therefore, the new requirement
meets Goal 3 of this rulemaking to improve the effectiveness and
efficiency of FFD programs. The provision permits HHS-certified
laboratories to reasonably limit the use and dissemination of the
documentation that auditors copy and take off site. This change meets
Goal 7 of this rulemaking to protect the privacy of individuals who are
subject to Part 26 and protects the trade secrets of HHS-certified
laboratories who are subject to auditing under the final rule.
Section 26.41(d)(3) amends the third sentence of former Section
2.7(m) in Appendix A to Part 26. This sentence required licensees and
other entities to carry out inspections and evaluations of the
procedural aspects of an HHS-certified laboratory drug testing
operations before awarding a contract to the laboratory. The final rule
adds a cross-reference to Sec. 26.41(g). Section
[[Page 17031]]
26.41(g) permits licensees and other entities to forego the otherwise
required pre-award evaluation under certain specific circumstances, as
discussed with respect to that section.
Section 26.41(e) [Conduct of audits] of the final rule retains the
requirements in former Sec. 26.80(b).
Section 26.41(f) [Audit results] of the final rule retains the
portion of former Sec. 26.80(c) that required licensees and other
entities to document audit findings and recommendations, report them to
senior management, and document corrective actions taken in response to
any identified adverse conditions. The final rule adds two
requirements. The second sentence of Sec. 26.41(f) specifies the
required content of audit reports, including identification of any
conditions that are adverse to the proper performance of the FFD
program, the cause of the condition(s), and recommended corrective
actions. The third sentence of the section requires licensees and other
entities to review the audit findings and take corrective actions,
including reauditing of indicated deficient areas, to preclude, within
reason, repetition of the condition. The final rule adds these two
sentences for consistency with Criterion XVI in Appendix B to 10 CFR
Part 50 [Domestic licensing of production and utilization facilities]
to indicate that the corrective action programs of licensees and other
entities must include FFD audit reports. Some licensees have handled
FFD audit reports outside of their normal corrective action programs
that address other conditions adverse to quality. As a result, some
corrective actions for FFD program weaknesses have not been timely or
effective. Therefore, the final rule adds these requirements to meet
Goal 3 of this rulemaking to improve the effectiveness and efficiency
of FFD programs.
The NRC has deleted the last sentence of former Sec. 26.80(c) that
referred to the requirements for auditing HHS-certified laboratories in
Appendix A to Part 26 because it is redundant with Sec. 26.41(c). The
NRC has made this change to meet Goal 6 of this rulemaking to improve
clarity in the organization of the rule.
Section 26.41(g) [Sharing of audits] of the final rule responds to
licensees' implementation questions related to the third and fourth
sentences in former Sec. 26.80(a) that permitted licensees and other
entities to accept audits of C/Vs that other FFD programs conduct. The
section clarifies the former permission to accept and rely on others'
audits in response to implementation questions that the NRC has
received from licensees with respect to the sharing of audits, as
documented in Section 17 of NUREG-1354, and items 11.4 and 11.5 of
NUREG-1385, ``Fitness for Duty in the Nuclear Power Industry: Responses
to Implementation Questions.''
Section 26.41(g) amends the former provision to incorporate
specific permission for licensees and other entities to jointly conduct
audits as well as rely on one another's audits. The NRC has also added
a reference to HHS-certified laboratories to indicate the applicability
of these permissions to licensees' and other entities' audits of HHS-
certified laboratories. These changes are consistent with the guidance
issued by the NRC in the documents referenced above and current
licensee practices. Therefore, the NRC has made these changes to meet
Goal 6 of this rulemaking to improve clarity in the organization and
language of the rule.
The NRC has added Sec. 26.41(g)(1) and (g)(2) to the final rule to
require licensees and other entities to identify any areas that were
not covered by a shared or accepted audit and ensure that any unique
services used by the licensee or other entity that were not covered by
the shared audit are audited. For example, an FFD program may use lower
cutoff levels for drug testing than the FFD program(s) that conducted a
shared audit with the result that the shared audit did not address the
HHS-certified laboratories' procedures for testing at the first FFD
program's lower cutoff levels. In this case, the first FFD program is
not permitted to rely on the shared audit with respect to the lower
cutoff levels and is required to ensure that the HHS-certified
laboratories' procedures for testing at the lower cutoff levels are
audited separately (or in conjunction with other FFD programs that use
the same cutoff levels). These provisions are consistent with the
guidance issued by the NRC in the documents referenced above and
current licensee practices. Therefore, the NRC has made these changes
to meet Goal 6 of this rulemaking to improve clarity in the
organization and language of the rule.
Section 26.41(g)(3) retains the portion of the third sentence of
former Sec. 26.80(a) that stated that licensees and other entities
need not re-audit the same C/V for the same period of time. This
provision extends this permission to audits of HHS-certified
laboratories, which is consistent with the guidance issued by the NRC
in the documents referenced above and current licensee practices.
Therefore, the NRC has made this change to meet Goal 6 of this
rulemaking to improve clarity in the organization and language of the
rule.
Section 26.41(g)(4) retains the fourth sentence of former Sec.
26.80(a). This provision requires licensees and other entities to
retain copies of the shared audit reports.
The NRC has added Sec. 26.41(g)(5) to the final rule. The
provision permits licensees and other entities to immediately obtain
drug testing services from another HHS-certified laboratory, subject to
certain conditions, if the laboratory used by the licensee or other
entity loses its certification. Within 3 months of obtaining services
from the replacement laboratory, the section requires the licensee or
other entity to ensure that an audit is conducted of any aspects of the
laboratory's services that the licensee or other entity use that have
not been audited within the past 12 months by another licensee or
entity who is subject to this subpart. This provision enhances the
effectiveness of FFD programs by ensuring that drug testing will not be
interrupted or delayed if an HHS-certified laboratory loses its
certification as some licensees have experienced. The reliability of
drug testing services provided by the replacement laboratory is ensured
by the auditing and inspection activities of other licensees and
entities who have been using the services of the replacement
laboratory, as well as the audit conducted by the licensee or other
entity of any services that have not been audited by other licensees or
entities who are subject to this part. The NRC has made this change to
meet Goal 3 of this rulemaking to improve the effectiveness and
efficiency of FFD programs.
Subpart C--Granting and Maintaining Authorization
Throughout Subpart C, the final rule makes minor clarifications to
the proposed rule based on public comment, to accommodate conforming
changes, and to meet Goal 6 of this rulemaking to improve clarity in
the organization and language of the rule.
One clarification that the final rule makes in numerous sections in
this subpart is to state that licensees or other entities subject to
this subpart shall ``ensure'' that a requirement under this subpart has
been met. This language differs from that of the proposed rule, which
stated that the licensee or other entity shall explicitly perform the
activity (i.e., obtain, review, conduct, complete) to meet the
requirement. For example, in Sec. 26.55(a)(1), the proposed rule
stated that the licensee or other entity shall ``obtain and review a
self-disclosure.'' The final rule states that the licensee or other
entity shall ``ensure that a self-disclosure has been obtained
[[Page 17032]]
and reviewed.'' This modified language clarifies the NRC's intent that
licensees or other entities may rely on other entities to assist in
performing the activities necessary to meet the requirements of this
subpart. For example, many licensees rely on contractors to conduct the
suitable inquiry required under Sec. 26.63. However, the final rule
retains the language of the proposed rule in Sec. 26.69(b) for the
reasons discussed with respect to that paragraph. In another change
from the proposed rule text, the NRC has eliminated the term ``non-
negative'' and replaced it with the phrase ``positive, adulterated, or
substituted'' for the reasons discussed with respect to Sec. 26.5
[Definitions].
The final rule also makes more substantive changes to the proposed
rule in this subpart because of public comment or to improve clarity in
the organization and language of the rule. The substantive changes in
this subpart can be found in Sec. Sec. 26.51; 26.53(d) through (i);
26.57(b); 26.61(c) and (d); 26.63(c), (c)(3), (d) and (f); 26.65(c),
(c)(2), (d)(1)(i), (d)(2)(ii), (e) and (f); and 26.69(c), (c)(1) and
(e)(1). These changes are discussed in detail below. However, other
than the changes mentioned above, the final rule adopts the provisions
of this subpart as proposed, without change.
Section 26.51 Applicability
The final rule amends Sec. 26.51 of the proposed rule to describe
the applicability of the subpart. The NRC has changed the heading of
this section from ``Purpose'' to ``Applicability'' because the NRC has
revised the content of the section to specify the licensees, entities,
and categories of individuals to whom the requirements Subpart C apply
by using cross-references to the relevant paragraphs in Sec. Sec.
26.3 [Scope] and 26.4 [FFD program applicability to categories of
individuals]. The NRC made this change in response to public comments
requesting this clarification in the rule text and to meet Goal 6 of
this rulemaking.
Section 26.53 General Provisions
The NRC has added Sec. 26.53 to the final rule to provide an
overview of the requirements and process for determining when
individuals may be granted and maintain authorization. With respect to
the proposed rule, paragraph (e) has been added to this section to
specify the requirements for relying on the FFD program of a C/V when
granting or maintaining authorization. Paragraph (f) specifies that
licensees and other entities may not rely on FFD programs under Subpart
K [FFD programs for Construction] of this rule to meet the requirements
of this subpart. The reasons for adding these paragraphs are discussed
with respect to the specific paragraphs.
Section 26.53(a) of the final rule introduces four new terms to
Part 26: ``Initial authorization,'' ``authorization update,''
``authorization reinstatement,'' and ``authorization with potentially
disqualifying FFD information.'' The final rule uses these terms to
describe categories of requirements for granting authorization. These
categories are based on whether an applicant has previously held
authorization under Part 26 and the length of time that has elapsed
after the individual's last period of authorization ended, and are
described in Sec. 26.55 [Initial authorization], Sec. 26.57
[Authorization update], Sec. 26.59 [Authorization reinstatement], and
Sec. 26.69 [Authorization with potentially disqualifying fitness-for-
duty information]. Section 26.53(a) directs licensees or other entities
to use the criteria for granting authorization to individuals found in
Sec. Sec. 26.55, 26.57, 26.59, or 26.69, depending on which of these
sections applies to the individual seeking authorization. The former
rule in Sec. 26.27 [Management actions and sanctions to be imposed]
discussed actions that the licensee must take before initially granting
access or assigning specified duties to an individual, but did not use
the concepts of ``initial authorization,'' ``authorization update,''
``authorization reinstatement,'' or ``authorization with potentially
disqualifying FFD information.'' The final rule uses these concepts to
focus the requirements for authorization more precisely on whether the
individual has an established record (i.e. authorization history) in
the industry. The NRC also uses these concepts to specify the amount of
original information-gathering activities licensees or other entities
are required to perform, according to whether previous FFD programs
have collected information about the individual. In addition, the NRC
uses similar concepts in access authorization requirements found in 10
CFR 73.56 [Personnel access authorization requirements for nuclear
power plants] and access authorization orders issued by the agency to
nuclear power plant licensees. The NRC has incorporated these concepts
into Part 26 to increase the consistency between the related
regulations in accordance with Goal 4 of this rulemaking.
Section 26.53(b) of the final rule defines the meaning of the term
``interruption'' which is used in Sec. 26.57 and Sec. 26.59 to refer
to the interval of time between periods during which an individual
holds authorization under Part 26. Licensees and other entities shall
calculate an interruption in authorization as the total number of days
falling between the day the individual's last period of authorization
ended and the day the licensee or other entity grants authorization to
the individual. Section 26.53(b) also specifies that if potentially
disqualifying FFD information is disclosed or discovered about an
individual, licensees and other entities must implement the applicable
requirements in Sec. 26.69 in order to grant or maintain an
individual's authorization, rather than relying on the requirements in
Sec. Sec. 26.55, 26.57, or 26.59.
Section 26.53(c) of the final rule references the FFD training
requirements in Sec. 26.29 [Training] and the fatigue training
requirements in Sec. 26.203(c) [Training and examinations] to clarify
that all individuals who are subject to Subpart C must meet the
applicable requirements for initial or refresher FFD training, as
appropriate, before the licensee or other entity may grant
authorization to the individuals. This provision references the
training requirements for organizational clarity because they apply to
the authorization process. As discussed in the preamble to the proposed
rule, stakeholders requested that the regulation present requirements
in the order in which they would apply to licensees' and other
entities' FFD processes. The NRC has added this paragraph to meet Goal
6 of this rulemaking to improve clarity in the organization and
language of the rule.
Section 26.53(d) of the final rule permits licensees and other
entities to rely on other licensees' or entities' FFD programs and
program elements to meet the requirements of this subpart for granting
and maintaining authorization. Section 26.53(d) expands upon a section
of the former rule that similarly permitted licensees and other
entities to accept and rely on other FFD programs and program elements.
Specifically, former Sec. 26.24(a)(1) permitted licensees to accept
results from drug and alcohol tests that were administered under
another Part 26 program within the past 60 days. Consistent with the
principle of permitting licensees to accept and rely on other Part 26
programs in their authorization decisions, guidance contained in NUREG-
1385, ``Fitness for Duty in the Nuclear Power Industry: Responses to
Implementation Questions,'' also indicates that licensees may
``accept'' an authorization granted by a previous licensee for
individuals
[[Page 17033]]
who transfer between licensees with only a short break in
authorization.
The final rule substantially increases the specificity of the
requirements that licensees or other entities must meet for granting
authorization and establishes detailed minimum standards that all
programs must meet. The agency designed these detailed minimum
standards to address recent changes in industry practices that have
resulted in a more transient workforce. Because the FFD programs of
licensees and other entities will be substantially more consistent than
in the past under these detailed standards, permitting licensees and
other entities to rely on other FFD programs to meet the rule's
requirements is reasonable and appropriate. Section 26.53(d) eliminates
unnecessary redundancies in the steps required to grant authorization
to an individual who is transferring from one FFD program to another,
consistent with Goal 5 of this rulemaking to improve Part 26 by
eliminating or modifying unnecessary requirements. With respect to the
proposed rule, the final rule specifies that the receiving FFD program
shall ensure that the program elements to which the individual is
subject under the transferring FFD program remain current. The NRC has
made this change to the proposed rule in recognition of the need for
additional consistency between the final rule and the access
authorization requirements. Therefore, this change helps meet Goal 4 of
this rulemaking to improve consistency between FFD requirements and
access authorization requirements established in 10 CFR 73.56, as
supplemented by orders to nuclear power plant licensees dated January
7, 2003.
In response to public comment, the final rule adds paragraph (e) to
Sec. 26.53 to clarify the relationship between licensees' and other
entities' FFD programs and those of C/Vs. Section 26.53(e) retains the
permission in former Sec. 26.23 [Contractors and vendors] for
licensees to rely upon C/Vs' FFD programs that have been formally
reviewed and approved by the licensee. The paragraph also permits the
licensees and other entities in Sec. 26.3(a) through (c) to rely on a
C/V's FFD program elements that meet the requirements of Part 26. For
example, some C/Vs ensure that their employees receive initial and
refresher FFD training so that, when the employee is assigned to work
on a contract that requires him or her to have unescorted access to a
nuclear power plant protected area, it is unnecessary for the licensee
to provide FFD training to the C/V's employee in order to grant
unescorted access to this individual. The final rule adds this
permission to rely on a C/V's FFD program elements to codify a long-
standing industry practice that has been endorsed by the NRC and to
provide clarity in the language of the rule.
Section 26.53(e)(1) permits a C/V to grant, maintain, deny, or
unfavorably terminate an individual's authorization under the C/V's FFD
program. As defined in Sec. 26.5, granting authorization in this case
means that a C/V has determined that the individual has met the
requirements in this subpart and is eligible to have the types of
access and perform the duties specified in Sec. 26.4. Maintaining
authorization under a C/V's FFD program means that the individual
continues to meet the requirements of this subpart and be eligible to
perform the duties specified in Sec. 26.4. However, the second
sentence of Sec. 26.53(e)(1) retains the intent of the provisions in
former Sec. 26.23 that placed responsibility on licensees for ensuring
that individuals who are ``performing activities within the scope of
this part'' meet the requirements in Part 26. However, the final rule
updates the terminology used to convey this intent and adds cross-
references to other sections of the rule for clarity and consistency
with other rule changes.
Section 26.53(e)(2) further clarifies the relationship between
authorization under a C/V's FFD program and authorization under the FFD
programs of licensees and other entities in Sec. 26.3(a) through (c).
This provision addresses circumstances when a C/V's FFD program
determines that an individual does not meet the requirements of this
subpart to be granted or maintain authorization and denies or
unfavorably terminates the individual's authorization under the C/V's
program. The rule requires that if the C/V's FFD program denies or
unfavorably terminates the authorization of an individual who is
performing the duties for a licensee that are listed in the specified
sections of Sec. 26.4, the C/V must inform the affected licensee or
other entity of the denial or unfavorable termination. In this case,
the licensee or other entity shall, on the day the licensee receives
the information from the C/V, deny or unfavorably terminate the
individual's authorization or implement the applicable process in Sec.
26.69 to maintain the individual's authorization. For example, if a C/
V's employee is convicted of selling illegal drugs and reports the
conviction to the C/V, the C/V would unfavorably terminate this
individual's authorization under the C/V's FFD program. If the
individual was also assigned to a contract that required him or her to
have unescorted access to the protected area of a nuclear power plant
at the time he or she was convicted, this provision requires the C/V to
inform the FFD program of the licensee or other entity of the
conviction. The licensee would then either terminate the individual's
unescorted access on the day that the licensee or other entity receives
the information from the C/V or, in unlikely circumstances, may
implement the process established in Sec. 26.69(d) for determining
whether an individual may maintain authorization after potentially
disqualifying FFD information is disclosed or discovered. This
provision codifies a long-standing industry practice that has been
endorsed by the NRC and adds clarity in the rule language. The NRC has
also added this requirement in recognition of the need for additional
consistency between the final rule and the access authorization
requirements. Therefore, this change helps meet Goal 4 of this
rulemaking to improve consistency between FFD requirements and access
authorization requirements established in 10 CFR 73.56, as supplemented
by orders to nuclear power plant licensees dated January 7, 2003.
The final rule has added Sec. 26.53(e)(3) to the final rule to
explicitly permit the licensees and other entities in Sec. 26.3(a)
through (c) to rely on a C/V's FFD program and program elements, or a
combination of program elements from the licensee's or other entity's
FFD program and the C/V's FFD program, to satisfy the requirements of
Subpart C for maintaining an individual's authorization. This paragraph
repeats the language in Sec. 26.53(d), which permits licensees and
other entities to rely on one another's FFD programs and program
elements, but applies it to C/V FFD programs and program elements for
additional clarity in the language of the rule. The final rule also
clarifies that the receiving licensee's or other entity's FFD program
shall ensure that the program elements to which the individual is
subject under the C/V's FFD program remain current. The NRC has made
this change to the proposed rule in recognition of the need for
additional consistency between the final rule and the access
authorization requirements. Therefore, this change helps meet Goal 4 of
this rulemaking to improve consistency between FFD requirements and
access authorization requirements established in 10 CFR 73.56, as
supplemented by orders to nuclear power plant licensees dated January
7, 2003.
The NRC has also added Sec. 26.53(f) to the final rule to prohibit
licensees and
[[Page 17034]]
other entities from relying on an FFD program that has been implemented
under Subpart K of this part when granting authorization to an
individual. This prohibition is necessary because Subpart K permits the
licensees and other entities specified in Sec. 26.3(c) greater
flexibility in establishing and implementing an FFD program than is
permitted in Subpart C. For example, Subpart K does not require the
licensees and other entities in Sec. 26.3(c) to conduct a suitable
inquiry of individuals who are permitted to perform the duties
described in Sec. 26.4(f). Therefore, in order to grant authorization
to such an individual to have the types of access or perform the duties
in Sec. 26.4(a) or (b), for example, a licensee in Sec. 26.3(a) would
be required to ensure that a suitable inquiry has been completed under
Sec. 26.63. However, this new provision would permit a licensee or
other entity to rely on the program elements of a Subpart K FFD program
if the program elements meet the applicable requirements of Subpart C.
For example, if a Subpart K program included suitable inquiry
requirements and implemented them under Sec. 26.63, a licensee or
other entity could rely on those suitable inquiry results when granting
authorization under Subpart C. This section satisfies Goal 3 of this
rulemaking by improving the effectiveness and efficiency of FFD
programs.
The NRC has added 26.53(g) to the final rule to require licensees
and other entities to identify any FFD violation to any licensee who
has relied or intends to rely on the FFD program element that is
determined to be in violation of this part. The NRC has made this
change to the proposed rule in recognition of the need for additional
consistency between the final rule and the access authorization
requirements. Therefore, this change helps meet Goal 4 of this
rulemaking to improve consistency between FFD requirements and access
authorization requirements established in 10 CFR 73.56, as supplemented
by orders to nuclear power plant licensees dated January 7, 2003.
In the final rule, the NRC has added a new provision in Sec.
26.53(h) to prohibit licensees and other entities from initiating any
actions under Subpart C, such as beginning to gather information about
the individual's authorization history from other licensees or
entities, without the knowledge and consent of the individual who is
applying for authorization. The new provision in the final rule also
informs individuals that they may withdraw consent at any time, and
specifies the actions that licensees and other entities must take if an
individual withdraws his or her consent. The NRC has added this
provision to provide additional protection of individuals' privacy by
ensuring that licensees and other entities do not gather personal
information about an individual without his or her permission. The
requirements to inform the individual that he or she may withdraw
consent and for licensees and other entities to inform the individual
of what information will be documented and shared with other licensees
or entities following a withdrawal of consent are necessary to protect
individuals' other rights under the rule, including due process.
Therefore, this provision meets Goal 7 of this rulemaking to protect
the privacy and other rights (including due process) of individuals
subject to Part 26. This provision meets Goal 4 of this rulemaking to
improve consistency between FFD requirements and access authorization
requirements established in 10 CFR 73.56, as supplemented by orders to
nuclear power plant licensees dated January 7, 2003.
The NRC has added Sec. 26.53(i) to the final rule to require
licensees and other entities specified in Sec. 26.3(a) and, as
applicable, (c) and (d), to inform individuals applying for
authorizations of the actions related to providing and sharing personal
information that are sufficient cause for denial or unfavorable
termination of authorization. The actions that are sufficient cause for
denial or unfavorable termination of authorization include refusal to
provide written consent, as specified in Sec. 26.53(i)(1), and refusal
to provide or the falsification of any personal information required
under this subpart, including the failure to report any previous denial
or unfavorable termination of authorization, as specified in Sec.
26.53(i)(2). These provisions were moved from Sec. 26.63(d) and Sec.
26.61(d) of the proposed rule, respectively. The NRC has added Sec.
26.53(i)(3) and (i)(4) to specify that a refusal to provide written
consent for the sharing of personal information with other licensees or
other entities, as required in Sec. 26.53(h), and a failure to report
any legal actions, respectively, are also sufficient cause for denial
or unfavorable termination of authorization. Also, the NRC has made
these changes to the proposed rule in recognition of the need for
additional consistency between the final rule and the access
authorization requirements. Therefore, this change helps meet Goal 4 of
this rulemaking to improve consistency between FFD requirements and
access authorization requirements established in 10 CFR 73.56, as
supplemented by orders to nuclear power plant licensees dated January
7, 2003.
Section 26.55 Initial Authorization
The NRC has added Sec. 26.55 to the final rule, which defines the
category of ``initial authorization'' requirements as applying both to
individuals who have not previously held authorization under Part 26
and those whose authorization has been interrupted for a period of 3
years or more and ended favorably.
Two considerations support the mandate for individuals whose last
period of authorization ended 3 or more years previously to satisfy the
same requirements as individuals who have never previously held
authorization. In general, the longer the period of time since the
individual's last period of authorization ended, the greater the
possibility that the individual has developed an active substance abuse
problem or undergone significant changes in lifestyle or character that
would diminish his or her trustworthiness, reliability, and ability to
perform work safely and competently. Therefore, it is reasonable to
require a full and extensive screening identical to that given an
individual who has not held authorization, and has not been subject to
drug and alcohol testing and behavioral observation, for 3 years or
more. For similar reasons, access authorization requirements also
require that individuals who have not held authorization for 3 years or
more must be subject to the same screening as individuals who have not
previously held authorization. Therefore, mandating that individuals
whose last period of authorization ended 3 or more years previously
must satisfy the same requirements as individuals who have never held
authorization increases the consistency of Part 26 with the related
access authorization requirements, consistent with Goal 4 of this
rulemaking.
Section 26.55(a)(1) requires the licensee or other entity, before
granting initial authorization to an individual, to ensure that a self-
disclosure has been obtained and reviewed in accordance with the
applicable requirements of Sec. 26.61 [Self-disclosure and employment
history]. As discussed with respect to Sec. 26.61, the self-disclosure
and employment history requirements mandate that the individual report
violations, if any, involving drugs or alcohol and the individual's
current and past employment history. The requirement is similar to that
in Sec. 26.27(a)(1) of the former rule that a
[[Page 17035]]
written statement must be obtained from the individual addressing the
topics that are specified in former Sec. 26.27(a)(1). The discussion
of Sec. 26.61 in this document compares the topics required to be
addressed in the written statement under the former rule with the
topics that are addressed in the self-disclosure under this final rule.
As discussed with respect to Sec. 26.61(b)(3), an applicant for
initial authorization must address in the self-disclosure the shorter
period of either the past 5 years or the interval of time that has
elapsed since the individual's eighteenth birthday.
Section 26.55(a)(2) requires the licensee or other entity to ensure
that a suitable inquiry has been completed under the applicable
requirements of Sec. 26.63 [Suitable inquiry] before granting initial
authorization to an individual. The requirement is similar to that in
Sec. 26.27(a)(2) of the former rule that a suitable inquiry must be
completed addressing the topics that are specified in Sec.
26.27(a)(2). The discussion of Sec. 26.63 in this document compares
the topics that the suitable inquiry must address under the former rule
with the topics that it addresses under the final rule. Section
26.63(f)(1) specifies that the suitable inquiry for an initial
authorization must address the shorter period of either the past 3
years or the interval of time that has elapsed since the individual's
eighteenth birthday.
Section 26.55(a)(3) requires the licensee or other entity to ensure
that the individual has been subject to pre-access drug and alcohol
testing under the applicable requirements of Sec. 26.65 [Pre-access
drug and alcohol testing] before granting initial authorization to an
individual. Former Sec. 26.24(a)(1) required testing within the 60
days before initially granting unescorted access to protected areas or
assignment to activities within the scope of Part 26. The discussion of
Sec. 26.65 in this document compares the pre-access drug and alcohol
testing requirements for initial authorization in this rule to the
requirements in the former rule. Section 26.65 requires the licensee or
other entity to ensure that the individual had negative drug and
alcohol test results from testing that had been completed within the
past 30 days before granting authorization to the individual.
Section 26.55(a)(4) requires the licensee or other entity also to
ensure that the individual has been subject to random drug and alcohol
testing under the applicable requirements of Sec. 26.67 [Random drug
and alcohol testing of individuals who have applied for authorization].
Former Sec. 26.64(a)(2) required unannounced drug and alcohol tests
imposed in a statistically random and unpredictable manner. The
discussion of Sec. 26.67 in this document compares the random drug and
alcohol testing requirements for initial authorization in this rule to
the requirements in the former rule.
Section 26.55(b) of the final rule mandates that the licensee or
other entity must meet the requirements in Sec. 26.69 to grant
authorization to the individual, if potentially disqualifying FFD
information is disclosed or discovered about the individual who is
applying for authorization that another licensee or other entity has
not previously evaluated.
Section 26.57 Authorization Update
The NRC has added Sec. 26.57 to the final rule, which defines the
category of ``authorization update'' requirements for granting
authorization to individuals whose authorization has been interrupted
for more than 365 days but less than 3 years and whose last period of
authorization was terminated favorably.
As noted in the discussion of Subpart C in Section IV.C, the
requirements for granting an authorization update are less stringent
than the requirements for granting initial authorization. The
requirements are less stringent because (1) the individual who is
applying for an authorization update will have a more recent history of
successful performance within the industry, and (2) the licensee or
other entity will have access to information about the individual from
the licensee or other entity who last granted authorization to him or
her because of the increased information-sharing requirements of the
final rule. However, the requirements in the final rule for an
authorization update focus on gathering and evaluating information from
the interruption period because the licensee or other entity will not
have information about the individual's activities during the period of
the interruption. For example, in the case of an individual whose last
period of authorization ended 2 years ago, the licensee or other entity
will focus on gathering information about the individual's activities
within the 2-year interruption period. If an individual's last period
of authorization ended 13 months ago, the licensee or other entity will
focus on gathering information about the individual's activities within
those 13 months.
Section 26.57(a) of the final rule, like Sec. 26.55(a), requires
the licensee or other entity before granting authorization to ensure
that:
(1) A self-disclosure has been obtained and reviewed under the
applicable requirements of Sec. 26.61;
(2) A suitable inquiry has been completed under the applicable
requirements of Sec. 26.63;
(3) The individual has been subject to pre-access drug and alcohol
testing under the applicable requirements of Sec. 26.65; and
(4) The individual has been subject to random drug and alcohol
testing under the applicable requirements of Sec. 26.67.
However, Sec. 26.61(b)(3)(iii) and (c)(3) limits the period of
time to be addressed in the self-disclosure and employment history to
the interruption period. If an individual's last period of
authorization ended 2 years ago, the self-disclosure and employment
history would cover only the past 2 years. Similarly, Sec. 26.63(f)(2)
provides that the suitable inquiry for an authorization update must
cover the interruption period. The final rule requires the self-
disclosure, employment history, and suitable inquiry to address only
the interruption period because the licensee or other entity may obtain
information from earlier periods in the individual's history from the
licensee or other entity who had last granted authorization to the
individual.
The NRC has added Sec. 26.57(b) to specify that if potentially
disqualifying FFD information is disclosed or discovered about the
individual who is applying for authorization, the licensee or other
entity may not grant authorization to the individual, except under
Sec. 26.69.
Section 26.59 Authorization Reinstatement
The NRC has added Sec. 26.59 to the final rule, which establishes
two categories of authorization reinstatement requirements for
individuals whose authorization has been interrupted for a short period
and whose last period of authorization was terminated favorably.
One category of authorization reinstatement requirements applies to
individuals whose authorization has been interrupted for more than 30
days but no more than 365 days in Sec. 26.59(a), and the other to
individuals whose authorization has been interrupted for 30 or fewer
days in Sec. 26.59(c). The steps for reinstating an individual's
authorization after an interruption of 365 or fewer days are less
stringent than those required for initial authorization or an
authorization update because these individuals will have a recent,
positive record within the industry and pose little risk to public
health and
[[Page 17036]]
safety or the common defense and security.
The requirements that are related to an individual whose
authorization has been interrupted for more than 30 days but no more
than 365 days are more extensive than the requirements for granting
authorization to an individual whose authorization has been interrupted
for 30 or fewer days. The requirements for the 31-365-day category are
consistent with those contained in the access authorization orders
issued by the NRC to nuclear power plant licensees dated January 7,
2003. However, the requirements for individuals whose authorization has
been interrupted for 30 or fewer days are more stringent than those
contained in those orders. Under the access authorization orders,
licensees are required to obtain and review a self-disclosure and
employment history from the applicant before reinstating the
individual's authorization. Under this amendment, licensees and other
entities are also required to subject the individual to the possibility
of selection for pre-access testing under Sec. 26.65(e) [Authorization
reinstatement after an interruption of 30 or fewer days]. The NRC has
determined that this additional requirement is necessary to meet the
final rule's performance objective of providing reasonable assurance
that individuals are trustworthy and reliable by extending the
deterrent effect of pre-access testing to individuals who have had an
interruption in authorization of 30 or fewer days in length.
For individuals whose authorization has been interrupted for 31-365
days, Sec. 26.59(a)(1) requires the licensee or other entity to ensure
that a self-disclosure and employment history has been obtained and
reviewed in order to reinstate authorization. Consistent with the
requirements for authorization updates in Sec. 26.57, the final rule
in Sec. 26.61(b)(3)(iii) and (c)(3) limits the period of time to be
addressed in the self-disclosure and employment history to the period
of the interruption in authorization. A self-disclosure and employment
history for earlier periods of time is unnecessary because the granting
licensee or other entity will have access to information about the
individual from the licensee or other entity who recently terminated
the individual's authorization.
Section 26.59(a)(2) permits the licensee or other entity to
reinstate an individual's authorization without first ensuring that a
suitable inquiry has been completed, in contrast to the requirements
for an initial authorization and an authorization update. The final
rule permits this because these individuals will have a recent,
positive record within the industry and pose little risk to public
health and safety or the common defense and security. As is required
for an authorization update, this provision limits the period of time
to be addressed by the suitable inquiry to the interruption period in
Sec. 26.63(f)(3). However, this provision requires licensees and other
entities to ensure that the suitable inquiry is completed within 5
business days after reinstating the individual's authorization. If the
suitable inquiry is not completed within the 5-day period, the licensee
or other entity can maintain the individual's authorization for up to
10 business days following the day authorization was reinstated, but
only if the licensee or other entity is unaware of any potentially
disqualifying information about the individual. If the suitable inquiry
is not completed within 10 business days, the rule requires the
licensee or other entity to administratively withdraw the individual's
authorization until the suitable inquiry is completed.
Section 26.59(a)(3) requires the licensee or other entity to ensure
that the individual whose authorization has been interrupted for 31-365
days has been subject to pre-access drug and alcohol testing, and Sec.
26.59(a)(4) requires the licensee or other entity to ensure that the
individual whose authorization has been interrupted for 31-365 days is
subject to random testing. Section 26.65(d) [Authorization
reinstatement after an interruption of more than 30 days] establishes
pre-access drug and alcohol testing requirements for authorization
reinstatements. Section 26.67 specifies the requirements for the random
testing of individuals who are applying for an authorization
reinstatement.
The NRC has added Sec. 26.59(b) to the final rule to ensure that
any administrative withdrawal of authorization required under Sec.
26.59(a)(2) is not reported or recorded as an unfavorable termination
of authorization until the suitable inquiry is completed and it
indicates that authorization should not be granted. This provision
ensures that a temporary administrative withdrawal of authorization
caused by a licensee's or other entity's delay in completing the
suitable inquiry is not treated as an unfavorable termination caused by
an FFD violation. The final rule specifies that the individual may not
be required to disclose the administrative action in response to
requests for self-disclosure of potentially disqualifying FFD
information. With respect to the proposed rule, the final rule
clarifies that the individual is required to disclose the
administrative action if the individual's authorization was
subsequently denied or terminated unfavorably. The NRC has made this
change to the proposed rule in recognition of the need for additional
consistency between the final rule and the access authorization
requirements. Therefore, this change helps meet Goal 4 of this
rulemaking to improve consistency between FFD requirements and access
authorization requirements established in 10 CFR 73.56, as supplemented
by orders to nuclear power plant licensees dated January 7, 2003.
Section 26.59(b) is necessary to meet Goal 7 of this rulemaking to
protect the privacy and other rights (including due process) of
individuals who are subject to Part 26 by ensuring that they are not
subject to any adverse consequences for the licensee's or other
entity's delay in completing the suitable inquiry.
Section 26.59(c) of the final rule establishes authorization
requirements for individuals whose authorization has been interrupted
for 30 or fewer days. Section 26.59(c)(1) requires the licensee or
other entity to ensure that a self-disclosure has been obtained and
reviewed with certain exceptions that are specified in Sec. 26.61. The
licensee or other entity is permitted to forego conducting a suitable
inquiry for individuals whose authorization has been interrupted for
such a short period. Section 26.59(c)(2) permits licensees and other
entities also to forego pre-access drug and alcohol testing of
individuals whose authorization has been interrupted for 5 or fewer
days. However, pre-access testing may be required under Sec. 26.65(e)
for individuals whose authorization has been interrupted for 6 to 30
days. Sections 26.61 and 26.65 specify the exceptions to the self-
disclosure and pre-access testing requirements in this provision,
respectively.
Section 26.61 Self-Disclosure and Employment History
The NRC has added Sec. 26.61 to the final rule to replace former
Sec. 26.27(a)(1) for the reasons discussed in Section IV.C. The final
rule replaces the term ``written statement'' in the former rule with
the phrase ``self-disclosure and employment history'' to more
accurately characterize the requirement. The NRC has made this change
to meet Goal 6 of this rulemaking to improve clarity in the language of
the rule.
The NRC has added Sec. 26.61(a) to the final rule to require
licensees and other entities to ensure that a written self-disclosure
and employment history has
[[Page 17037]]
been obtained from every applicant before granting authorization to the
individual, except in two circumstances, as follows.
Section 26.61(a)(1) permits the licensee or other entity to forego
obtaining a self-disclosure and employment history if all three of the
following conditions are met:
(1) The individual previously held authorization under Part 26;
(2) The individual's last period of authorization was terminated
favorably; and
(3) The individual has been subject to a behavioral observation and
arrest-reporting program that meets the requirements of this part
throughout the time the individual's authorization was interrupted.
The information to be obtained from the self-disclosure and
employment history is unnecessary in these circumstances because it
will already be available to the granting licensee or other entity from
the FFD program that had been implementing the behavioral observation
and arrest-reporting program during the interruption in the
individual's authorization. A requirement for licensees and other
entities to conduct another suitable inquiry is redundant and imposes
an unnecessary burden.
Section 26.61(a)(2) permits licensees and other entities to forego
obtaining an employment history from applicants for an authorization
reinstatement whose authorization has been interrupted for 30 or fewer
days. The employment history information is unnecessary in this case
because the final rule does not require licensees or other entities to
conduct a suitable inquiry for individuals who have had such a short
break in authorization.
The NRC has added Sec. 26.61(b) to the final rule to specify the
required content of the written self-disclosure. Affirmative responses
to any of the questions in Sec. 26.61(b)(1) are considered potentially
disqualifying FFD information, as defined in Sec. 26.5. The final rule
expands the scope of the questions to be asked from those required in
former Sec. 26.27(a)(1) in order to provide greater assurance that
individuals will disclose information indicating an active substance
abuse problem or an increased risk of recidivism into an active
substance abuse problem after treatment. Former Sec. 26.27(a)(2)
required information about whether the applicant ``tested positive for
drugs or use of alcohol that resulted in on-duty impairment.'' Section
26.61(b)(1) requires information about whether the applicant used,
sold, or possessed illegal drugs, subverted or attempted to subvert a
drug or alcohol testing program, or refused to take a drug or alcohol
test. Both former Sec. 26.27(a)(2) and Sec. 26.61(b)(1) require
information on whether the applicant has been subject to a plan for
substance abuse treatment (except for a self-referral). Both require
information about previous denials or terminations of authorization.
The NRC has added Sec. 26.61(b)(2) to the final rule to require
the applicant to disclose the circumstances surrounding any potentially
disqualifying FFD information and the resolution of the matter. For
example, Sec. 26.61(b)(1) requires an applicant to report an arrest on
drug-related charges, while Sec. 26.61(b)(2) requires the applicant to
report the outcome of the arrest (e.g., charges, a conviction, a
finding of not guilty, the dropping of the charges).
Section 26.61(b)(3) defines the time period that the self-
disclosure must address. The final rule establishes a time limit on the
number of years in the past for which an individual is required to
report and account for potentially disqualifying FFD information. One
purpose of the self-disclosure is to identify indicators of an active
substance abuse problem or an increased risk of recidivism into an
active substance abuse problem after treatment. The relevant research
literature indicates that post-treatment recidivism (i.e., relapse)
rates decrease after 3 years of no further substance abuse, and a
larger decrease occurs in the recidivism rate after 5 years. If the
applicant discloses no indicators of a substance abuse problem within
the past 5 years (or since the applicant's eighteenth birthday, in the
case of an applicant who is less than 23 years of age), an applicant
for initial authorization (see Sec. 26.55) is not required to disclose
earlier events related to substance abuse. For applicants who held
authorization within the past 3 years, the self-disclosure addresses
only the time interval after the individual's last period of
authorization ended. However, the licensee or other entity shall obtain
further information about the applicant over the past 5 years by
reviewing the information made available by licensees or other entities
who granted authorization to the applicant in the past. This includes
information developed as part of previous suitable inquiries (see Sec.
26.63) as well as information from the period(s) during which the
individual was subject to other FFD programs.
Section 26.61(c) in the final rule modifies this provision as
proposed. The proposed rule specified that applicants must provide
information about current and past employers, which the licensee or
other entity then uses for the suitable inquiry if a suitable inquiry
is required under Sec. 26.63. However, the final rule requires the
individual to provide a list of employers to include the employer by
whom he or she claims to have been employed on the day before he or she
completes the employment history. The agency has also made this change
in Sec. 26.63(c). The NRC has made this change in response to a public
comment, which stated that a licensee or other entity has the ability
to ensure that a suitable inquiry has been conducted only of those
employers that are listed in the self-disclosure or employment history.
The NRC believes that this revision provides more specificity in cases
when an individual's current employer changes after he or she submits
the self-disclosure. This change is consistent with Goal 6 of the
rulemaking to improve clarity in the organization and language of the
rule.
The NRC has moved the provision in proposed Sec. 26.61(d) to Sec.
26.53(i)(2) of the final rule to meet Goal 6 of this rulemaking to
improve clarity in the organization of the rule.
Section 26.63 Suitable Inquiry
The NRC has added Sec. 26.63 to the final rule. This section
amends former Sec. 26.27(a)(2) and the requirements related to
conducting a suitable inquiry that are contained within the definition
of the term ``suitable inquiry'' in former Sec. 26.3. The former rule
defined a suitable inquiry as a ``best-effort verification of
employment history for the past 5 years, but in no case less than 3
years, obtained through contacts with previous employers to determine
if a person was, in the past, tested positive for illegal drugs,
subject to a plan for treating substance abuse, removed from, or made
ineligible for activities within the scope of 10 CFR Part 26, or denied
unescorted access at any other nuclear power plant or other employment
in accordance with a fitness-for-duty policy.'' In general, the NRC
intends that the changes to the former requirements better focus the
suitable inquiry on indicators of an active substance problem and/or an
increased risk of recidivism into an active substance abuse problem
following treatment, as discussed in Section IV.C; increase the
consistency in implementing suitable inquiries among FFD programs by
providing more detailed requirements, also as discussed in Section
IV.C; and improve Part 26 by eliminating or modifying unnecessary
[[Page 17038]]
requirements, which is Goal 5 of this rulemaking.
For all authorization categories, the suitable inquiry required by
the final rule is more thorough than previous industry practices to
increase the likelihood that any potentially disqualifying FFD
information is identified and provide reasonable assurance that
individuals are trustworthy and reliable, as demonstrated by avoiding
substance abuse. For individuals who have established a recent,
favorable work history under Part 26, as demonstrated by having held
authorization that was terminated favorably within the past 3 years,
the NRC has reduced the period of time addressed in the suitable
inquiry from the past 5 years in every case, to the past 3 years or
fewer, depending on how recently the applicant held authorization. If
potentially disqualifying FFD information within the past 5 years is
identified regarding an applicant and a previous licensee or other
entity has not addressed and favorably resolved it, the suitable
inquiry requirements are more extensive, as described in Sec. 26.69.
The NRC has added Sec. 26.63(a) to the final rule to require
licensees and other entities to ensure that a suitable inquiry has been
conducted to verify the information provided by the applicant in the
self-disclosure and employment history obtained under Sec. 26.61 and
to determine if additional potentially disqualifying FFD information is
available regarding the applicant. The provision also establishes the
circumstances in which a licensee or other entity is permitted to
forego the suitable inquiry in order to grant authorization to
individuals. A licensee or other entity is permitted to forego the
suitable inquiry if the individual previously held authorization under
Part 26, his or her last period of authorization was terminated
favorably, and the individual was subject to a behavioral observation
and arrest-reporting program that meets the requirements of this part
throughout the period during which the individual's authorization was
interrupted. The information to be obtained from a suitable inquiry is
unnecessary in these circumstances because it will already be available
to the granting licensee or other entity from the Part 26 program that
implemented the behavioral observation and arrest-reporting program
during the interruption in authorization.
The final rule adds Sec. 26.63(b) to the final rule to permit
licensees and other entities to rely on suitable inquiry information
that was gathered by previous licensees and other entities who are
subject to this subpart. This provision reduces the number of redundant
suitable inquiries that licensees and other entities must conduct when
the suitable inquiries would address the same employers and same time
periods. The provision also permits licensees and other entities to
accept the results of determinations of fitness that were performed
under a previous Part 26 program, rather than requiring each new
licensee and other entity to reevaluate the same information that was
reviewed and resolved under the same requirements in another Part 26
program. The NRC has made this change to meet Goal 5 of this rulemaking
to improve Part 26 by eliminating or modifying unnecessary
requirements.
With respect to the proposed rule, the final rule adds a cross-
reference to Sec. 26.189 [Determination of fitness] in Sec. 26.63(b)
to specify that licensees and other entities may only rely on
determinations of fitness that were conducted under Sec. 26.189. This
change is necessary because the licensees and other entities specified
in Sec. 26.3(c) have greater latitude in conducting fitness
evaluations under Subpart K than is permitted under Sec. 26.189.
However, as discussed with respect to Sec. 26.53(f), a licensee or
other entity who is subject to this subpart is permitted to rely on a
determination of fitness conducted under a Subpart K program if the
determination of fitness met the requirements in Sec. 26.189.
The NRC has added Sec. 26.63(c) to the final rule, which specifies
requirements for conducting suitable inquiries. Licensees and other
entities shall ensure that a ``best effort'' is demonstrated to
complete the suitable inquiry. The ``best effort'' criterion recognizes
licensees' and other entities' status as commercial entities with no
legal authority to require the release of the information from other
private employers and educational institutions. Because of privacy and
potential litigation concerns, some private employers and educational
institutions may be unable or unwilling to release qualitative
information about a former employee or student. For example, a former
employer may verify the dates that the company employed an individual,
but may be unwilling to reveal that the individual had been in
treatment for drug or alcohol abuse while employed with the company.
Therefore, the ``best effort'' criterion requires licensees and other
entities to ensure that suitable inquiry information is sought from the
primary source (e.g., a company, private employer, or educational
institution that the applicant has listed on his or her employment
history), but recognizes that it may not be forthcoming. The ``best
effort'' criterion in the paragraph is consistent with the ``best-
efforts basis'' in former Sec. 26.27(a)(2). However, the final rule
provides more detailed requirements in response to questions that the
NRC has received from licensees about implementing a suitable inquiry
on a ``best effort'' basis after Part 26 was first promulgated. Also,
the final rule modifies the proposed rule to more clearly specify which
employers must be questioned as discussed with respect to Sec.
26.61(c).
The NRC has added Sec. 26.63(c)(1) to the final rule, which
specifies the type of information that the licensee or other entity
must seek from employers regarding the applicant for authorization.
This provision requires the licensee or other entity to ascertain the
reason that the individual's employment was terminated, his or her
eligibility for rehire, and other information that could reflect on the
individual's fitness to be granted authorization. The requirement to
obtain this information is consistent with long-standing industry
practices related to granting access authorization and related
requirements in the access authorization requirements established in 10
CFR 73.56, as supplemented by orders to nuclear power plant licensees
dated January 7, 2003.
Section 26.63(c)(2) specifies the type of information that
licensees and other entities must seek when an applicant's claimed
periods of employment include military service. The NRC has added this
requirement for consistency with related requirements in the access
authorization requirements established in 10 CFR 73.56, as supplemented
by orders to nuclear power plant licensees dated January 7, 2003.
The NRC has added Sec. 26.63(c)(3) to the final rule to address
circumstances in which a primary source of information refuses to
provide the necessary suitable inquiry information or indicates an
inability or unwillingness to provide it within 3 days of the request.
Licensees and other entities are required to document that the request
for information was directed to the primary source and the nature of
the response (i.e., a refusal, inability, or unwillingness). If a
licensee or other entity encounters the circumstances addressed in
Sec. 26.63(c)(3), the provision requires the licensee or other entity
to seek suitable inquiry information from an alternate source to the
extent of the alternate source's ability to provide the information. An
alternate source may include, but is not limited to, a co-
[[Page 17039]]
worker or supervisor at the same company who had personal knowledge of
the applicant, if such an individual could be located. However, the
final rule prohibits the licensee or other entity from using the
alternate source of suitable inquiry information to meet any other
access authorization requirements for a character reference. The
provision permits licensees and other entities to grant authorization,
if warranted, when a response has been obtained from an alternate
source without waiting more than 3 days after the request for
information was directed to a primary source. With respect to the
proposed rule, the final rule clarifies that the licensee shall
evaluate and document the response if it is received. The NRC has made
this change to the proposed rule in recognition of the need for
additional consistency between the final rule and the access
authorization requirements. Therefore, this change helps meet Goal 4 of
this rulemaking to improve consistency between FFD requirements and
access authorization requirements established in 10 CFR 73.56, as
supplemented by orders to nuclear power plant licensees dated January
7, 2003. These alternative methods of meeting the suitable inquiry
requirement are necessary because some employers are unwilling or
unable to provide suitable inquiry information.
The NRC has added Sec. 26.63(d) to the final rule, which requires
licensees and other entities to share suitable inquiry information that
they have collected when contacted by another licensee or entity who
has a release signed by the applicant for authorization that permits
the sharing of that information. This provision restates the permission
to release suitable inquiry information in former Sec. 26.29(b) as a
requirement that licensees and other entities must share the
information necessary to conduct the suitable inquiry. With respect to
the proposed rule, the final rule clarifies this provision as a result
of a public comment that disagreed with the use of the word
``presentation'' in the proposed provision. The NRC concurred with the
comment and believes that current practices in the industry allow for
verification of a signed release without the licensee presenting the
actual document. Therefore, the NRC has made this change to meet Goal 6
of the rulemaking to improve clarity in the organization and language
of the rule. Also, the final rule expands the list of the types of
information that licensees and other entities must make available and
on which the denial or unfavorable determination of authorization was
based. The NRC has made this change because after publishing the
proposed rule, it recognized the need for additional clarity to reflect
the NRC's intent beyond what the proposed rule contained.
Section 26.63(d) clarifies that the information must also be
released to C/Vs who have licensee-approved FFD programs when the C/V
has obtained the required signed release from the applicant. This
clarification is necessary because some licensees have misinterpreted
former Sec. 26.29(b) as prohibiting the release of suitable inquiry
information to C/Vs who have licensee-approved FFD programs. The
provision also imposes the requirement on licensees and other entities
who may be implementing an FFD program under Subpart K of this part.
The NRC has made this change for consistency with the new requirements
in Subpart K of this rule and to meet Goal 3 of the rulemaking to
improve the effectiveness and efficiency of FFD programs.
The NRC has moved the portion of proposed Sec. 26.63(d) that
specified that a failure of an individual to authorize the release of
information for the suitable inquiry is sufficient cause for a denial
of authorization to Sec. 26.53(i)(1) of the final rule. The NRC has
made this change to meet Goal 6 of the rulemaking to improve clarity in
the organization and language of the rule.
The NRC has added Sec. 26.63(e) to the final rule to permit
licensees and other entities to use electronic means to obtain the
suitable inquiry information. This permission is consistent with access
authorization requirements established in 10 CFR 73.56, as supplemented
by orders to nuclear power plant licensees dated January 7, 2003. The
paragraph also adds cross-references to the applicable records
retention requirements in Sec. 26.711 [General provisions] and Sec.
26.713 [Recordkeeping requirements for licensees and other entities] in
Subpart N [Recordkeeping and Reporting Requirements] to the final rule
to ensure that licensees and other entities are aware of the
applicability of these requirements to the suitable inquiry information
obtained electronically. These changes are consistent with Goal 6 of
this rulemaking to improve clarity in the organization and language of
the rule.
The NRC has added Sec. 26.63(f) to the final rule, which specifies
the period(s) of time that the suitable inquiry must address for
applicants for initial authorization, authorization update, and
authorization reinstatement. The final rule specifies that the suitable
inquiry requirements in this provision apply only to those individuals
about whom no potentially disqualifying FFD information is known at the
time the suitable inquiry is initiated. The NRC added this provision to
meet Goal 6 of the rulemaking to improve clarity in the organization
and language of the rule.
Section 26.63(f) specifies the following additional requirements
for conducting the suitable inquiry for these authorization categories.
Section 26.63(f)(1) [Initial authorization] requires licensees and
other entities to conduct a suitable inquiry to address the 3-year
period preceding the date the individual applies for authorization. The
NRC has reduced the period of time that the suitable inquiry must
address for applicants for initial authorization who do not disclose
any potentially disqualifying FFD information. The NRC has reduced the
period of time to be addressed in the suitable inquiry from 5 years in
the former regulation to 3 years to better focus the suitable inquiry
on identifying indicators of an active substance abuse problem or an
increased risk of recidivism following treatment. If an applicant for
initial authorization discloses no potentially disqualifying FFD
information from the past 5 years and none is identified through the
suitable inquiry or other means, it is unlikely that the applicant has
an active substance abuse problem. Therefore, seeking a full 5 years of
information about the individual would be unlikely to provide useful
data and imposes an unnecessary burden. Industry experience has shown
that employers are often reluctant to disclose adverse information to
other private employers about former employees. Also, the longer it has
been since an individual was employed, the less likely it is that a
former employer will disclose useful information. Therefore, rather
than retaining the requirement for a 5-year suitable inquiry in all
cases, the final rule increases the thoroughness of the suitable
inquiry over the past 3 years.
Section 26.63(f)(1) requires the licensee or other entity to ensure
that the suitable inquiry has been conducted with every employer by
whom the applicant claims to have been employed within the past year.
This requirement leads to a more rigorous suitable inquiry than was
common industry practice before the issuance of the January 7, 2003,
access authorization orders, which imposed additional compensatory
measures related to access authorization. The purpose of contacting
every employer is to ensure that the licensee or other entity sought
information related to any active substance abuse problem. For the
earlier years of the suitable inquiry period, the
[[Page 17040]]
provision requires the licensee or other entity to ensure that the
suitable inquiry has been conducted with every employer by whom the
applicant claims to have been employed the longest within each calendar
month. Contacting these employers increases the likelihood that the
employers would have knowledge of the applicant and may provide more
useful information than contacting employers who employed the applicant
only briefly.
The NRC has added Sec. 26.63(f)(2) [Authorization update] to the
final rule, which specifies the period of time that the suitable
inquiry must address for applicants for an authorization update (i.e.,
those who held authorization within the past 3 years and whose last
period of authorization was terminated favorably, but who have not held
authorization within the past year). The paragraph requires the
licensee or other entity to ensure that the suitable inquiry has been
conducted in the same manner as described in Sec. 26.63(f)(1).
However, for an authorization update, the suitable inquiry addresses
only the period during which the individual's authorization was
interrupted, rather than the full 3 years that is required for initial
authorization. A 3-year period for the suitable inquiry is unnecessary
for these individuals because the licensee or other entity will have
access to the information about the individual that was gathered by the
licensee or other entity under whose program the individual had been
granted and successfully maintained authorization within the past 3
years.
Section 26.63(f)(3) [Authorization reinstatement after an
interruption of more than 30 days] specifies the period of time that
the suitable inquiry must address for applicants who held authorization
within the past year and whose last period of authorization was
terminated favorably, but who have not held authorization within the
past 30 days. The final rule requires licensees and other entities to
ensure that the suitable inquiry has been conducted with the employer
by whom the applicant claims to have been employed the longest in each
calendar month of the interruption. This provision does not require
licensees and other entities to ensure that every employer by whom the
individual claimed to have been employed during the interruption is
contacted for the reasons discussed with respect to Sec. 26.59(a)(2).
Because these individuals have had only a short break in authorization,
a sampling of employers from the interruption period is sufficient to
determine if any indications exist that the individual has developed a
previously undetected substance abuse or other problem that would
adversely affect his or her fitness to have authorization reinstated.
The time periods and approach to conducting the suitable inquiry
established in Sec. 26.63(f)(1) through (f)(3) are consistent with
those established in the access authorization orders issued to nuclear
power plant licensees dated January 7, 2003.
Section 26.65 Pre-Access Drug and Alcohol Testing
Section 26.65 of the final rule amends former Sec. 26.24(a)(1).
The former provision required drug and alcohol ``testing within 60 days
prior to the initial granting of unescorted access to protected areas
or assignment to activities within the scope of this part.'' The final
rule amends the former pre-access drug and alcohol testing requirement
for individuals who are seeking authorization under Part 26 to
strengthen the effectiveness of FFD programs.
The NRC has added Sec. 26.65(a) [Purpose] to the final rule to
describe the purpose of the section and identify the individuals to
whom the requirements in the section apply. The pre-access testing
requirements in this section cover applicants for authorization who
have never held authorization under Part 26 or have held authorization
under Part 26 and whose most recent period of authorization was
terminated favorably, and about whom no potentially disqualifying FFD
information has been discovered or disclosed that was not reviewed and
favorably resolved by another licensee or entity who is subject to
Subpart C. Requirements for granting authorization to individuals whose
previous periods of authorization were terminated unfavorably or
denied, or about whom new potentially disqualifying FFD information has
been discovered or disclosed, are contained in Sec. 26.69.
The NRC has added Sec. 26.65(b) [Accepting tests conducted within
the past 30 days] to the final rule to permit licensees and other
entities to forego pre-access testing of an individual who has negative
results from drug and alcohol tests that were performed under the
requirements of Part 26 within the 30-day period before the licensee or
other entity grants authorization to the individual, including tests
that were conducted before the individual applied for authorization
from the licensee or other entity. For example, if an individual was
subject to random testing under another Part 26 program and was
selected for testing under the other program before applying for
authorization from the granting licensee or other entity, the final
rule permits the granting licensee or other entity to accept negative
test results from the random test in lieu of performing a pre-access
test, if the random test was conducted within 30 days before the day
authorization is granted to the individual. A requirement for the
licensee or other entity to conduct pre-access testing in these
circumstances is redundant and unnecessary.
The NRC has added Sec. 26.65(c) [Initial authorization and
authorization update] to the final rule, which establishes pre-access
testing requirements for individuals who are applying for initial
authorization and an authorization update. The final rule, with respect
to the proposed rule, has added a specification that before granting
initial authorization, any pre-access drug and alcohol tests must be
conducted within the 30-day period preceding the day the licensee or
other entity grants authorization to the individual. Under former Sec.
26.24(a)(1), licensees and other entities were permitted to complete
pre-access testing within the 60-day period before authorization is
granted. The inclusion in the final rule of a shorter time period
within which pre-access testing must be conducted, if required,
increases the likelihood of detecting an active substance abuse problem
among applicants for unescorted access to nuclear power plants and
others who are subject to Part 26 by increasing the number of pre-
access tests that are performed. In addition, the decreased time period
for pre-access testing increases the likelihood that recent drug use,
particularly marijuana, is detected before the concentration of
metabolites in an individual's body could decrease below the cutoff
levels prescribed in the final rule. Also, the final rule's provision
for a decreased time period within which pre-access testing must be
performed provides greater assurance that individuals subject to this
part are trustworthy and reliable, as demonstrated by the avoidance of
substance abuse, as discussed with respect to Sec. 26.23(a).
The final rule requires negative results from pre-access testing
before the licensee or other entity grants authorization to the
individual, except in the two circumstances described in Sec.
26.65(c)(1) and (c)(2). Pre-access testing in these two circumstances
is unnecessary because there is sufficient opportunity to detect
substance abuse without the testing. In Sec. 26.65(c)(1), licensees
and other entities are permitted to forego pre-access testing if the
applicant had been subject to drug and alcohol testing (including
random testing), behavioral observation, and
[[Page 17041]]
arrest-reporting requirements under a Part 26 FFD program throughout
the period the individual's authorization was interrupted.
In proposed Sec. 26.65(c)(2), licensees and other entities were
permitted to forego pre-access testing of an applicant who had negative
results from Part 26 drug and alcohol tests that were performed within
the past 30 days and who was subject to behavioral observation and
arrest-reporting requirements during the time interval between the day
the specimens were collected and the day the licensee or other entity
grants authorization to the individual. However, the NRC received a
public comment regarding this provision, which stated that licensees
should be able to rely on drug and alcohol tests that were conducted
before the individual applied for authorization if the individual has
been subject to a behavioral observation and arrest-reporting program,
and random drug and alcohol testing, during the time period following
the drug and alcohol tests. The NRC agrees that pre-access testing
within 30 days before authorization is granted is unnecessary in these
circumstances and has removed reference to Sec. 26.65(b) in this
provision. This amendment clarifies that licensees may rely on drug and
alcohol tests that were conducted at any time before the individual
applied for authorization, provided that the individual has been
subject to a random drug and alcohol testing program, a behavioral
observation program, and an arrest-reporting program that meet the
applicable requirements of this part. The NRC has made this change
under Goal 5 of the rulemaking to improve the rule by eliminating or
modifying unnecessary requirements.
The NRC has added Sec. 26.65(d) [Authorization reinstatement after
an interruption of more than 30 days] and (e) [Authorization
reinstatement after an interruption of 30 or fewer days] to the final
rule, which establish requirements for the pre-access testing of
individuals who are applying for an authorization reinstatement. The
requirements for pre-access testing of these individuals are less
stringent than the requirements for initial authorization and an
authorization update. The provision relaxes the pre-access testing
requirements in former Sec. 26.24(a)(1), which mandated that all
applicants for authorization must be subject to pre-access testing
within 60 days before granting authorization. Less stringent pre-access
testing requirements are appropriate because these individuals have met
the rigorous criteria for initial authorization, established a recent
record of successfully maintaining authorization under Part 26, and had
only a short break in authorization.
Section 26.65(d) of the final rule specifies pre-access testing
requirements for individuals whose authorization has been interrupted
for more than 30 days but no more than 1 year. Section 26.65(d)(1)(i)
requires the licensee or other entity to administer an alcohol test and
collect a urine specimen for drug testing. The final rule, with respect
to the proposed rule, clarifies that before granting initial
authorization, any required pre-access drug and alcohol tests must be
conducted within the 30-day period preceding the day the licensee or
other entity grants authorization to the individual. The licensee or
other entity is permitted to reinstate the individual's authorization
if the alcohol test results are negative before the drug test results
are available. Section 26.65(d)(1)(ii) permits the licensee or other
entity to maintain the individual's authorization for 5 business days
after reinstatement without receiving the drug test results. However,
if the licensee or other entity does not receive negative drug test
results within 5 business days of reinstating the individual's
authorization, the final rule requires the licensee or other entity to
administratively withdraw the individual's authorization until negative
drug test results are received. These requirements ensure that
individuals whose authorization has been interrupted for more than 30
days are subject to pre-access drug and alcohol testing to deter
substance abuse and to detect any current substance abuse problem.
However, the provisions do not unduly delay authorization reinstatement
because these individuals' recent successful histories of maintaining
authorization under Part 26 indicate that they are at low risk of
engaging in substance abuse.
Section 26.65(d)(2) permits licensees and other entities to forego
pre-access testing of these applicants for reinstatement in the
circumstances discussed with respect to Sec. 26.65(c)(1) and (c)(2).
The discussion with regard to Sec. 26.65(c)(2) also specifies the
reasons for the changes from the proposed rule in Sec.
26.65(d)(2)(ii).
The NRC has added Sec. 26.65(e)(1) to the final rule to permit
licensees and other entities to forego pre-access testing of applicants
whose authorization has been interrupted for 5 or fewer days. This
provision is consistent with current licensee practices and
recommendations regarding short breaks in authorization in NUREG-1385
and other access authorization requirements. The final rule also has
moved the provisions from paragraph (e)(3) of the proposed rule into
this paragraph of the final rule to improve clarity in the organization
of the final rule, consistent with Goal 3 of the rulemaking. This
provision permits licensees and other entities also to forego
subjecting an individual to the possibility of selection for pre-access
testing if the applicant has been subject to the drug and alcohol
testing (including random testing), behavioral observation, and arrest-
reporting elements of a Part 26 FFD program throughout the interruption
in the individual's authorization. The NRC believes that being subject
to these program elements during the interruption period is sufficient
to deter substance abuse and provide assurance that substance abuse
would be detected. Section 26.65 enhances the deterrent effect of pre-
access testing for individuals who have had a very short break in
authorization without imposing the burden of requiring that every
individual must be tested.
Section 26.65(e)(2) of the final rule requires licensees and other
entities to subject applicants whose authorization has been interrupted
for 6 to 30 days to the possibility of selection for pre-access testing
in order to deter any potential for substance abuse. However, this
provision specifies that the licensee or other entity may forego
subjecting an individual to the possibility of being selected for pre-
access testing if the applicant has been subject to the drug and
alcohol testing (including random testing), behavioral observation, and
arrest-reporting elements of a Part 26 FFD program throughout the
interruption in the individual's authorization.
Section 26.65(e)(2)(i) requires the licensee or other entity to
subject the applicant to a one-time chance of being selected for
testing at a probability of approximately 4 percent. This probability
approximates the likelihood that individuals who are subject to random
testing at the 50-percent annual testing rate in Sec. 26.31(d)(2)(vii)
are selected for testing at some point within a 30-day period. Section
26.65(e)(2)(ii) clarifies that if an applicant is not selected for pre-
access testing under the preceding section, the licensee or other
entity is not required to perform a pre-access test. Section
26.65(e)(2)(iii)(A) and (B) specifies requirements for conducting the
pre-access testing if an individual is selected for testing under Sec.
26.65(e)(2)(i). The licensee or other entity shall complete an alcohol
test and collect a specimen for drug testing before reinstating the
individual's authorization. In order to maintain the individual's
reinstated authorization,
[[Page 17042]]
the final rule requires that the licensee or other entity must receive
negative drug test results within 5 business days after reinstatement
or administratively withdraw the individual's authorization until
negative drug test results are received.
The NRC has deleted from the final rule Sec. 26.65(f) [Time period
for testing] of the proposed rule. The proposed provision mandated that
specimens that are collected for any pre-access testing required in
this section must be collected within the 30-day period preceding the
day the licensee grants authorization to an individual. The NRC
received a public comment that stated that licensees currently conduct
pre-access drug and alcohol testing within the 30-day period preceding
the date the licensee grants authorization and that proposed Sec.
26.65(f) only requires licensees to collect a sample in this timeframe.
The NRC agrees with the comments and, therefore, has deleted this
provision from the final rule to increase efficiency, consistent with
Goal 5 of the rulemaking to eliminate unnecessary requirements.
However, the NRC has added requirements to Sec. 26.65(c) and (d)(1)(i)
to specify that any pre-access testing required in this section must be
conducted within the 30-day period preceding the day upon which the
licensee grants authorization to an individual, consistent with the
proposed rule's intent. Under former Sec. 26.24(a)(1), licensees and
other entities were permitted to complete pre-access testing within the
60-day period before authorization is granted. The reason why the final
rule shortens this time period to 30 days is discussed with respect to
Sec. 26.65(c).
The NRC has added Sec. 26.65(f) [Administrative withdrawal of
authorization] (changed from Sec. 26.65(g) in the proposed rule
because of renumbering) to the final rule to ensure that the licensee
or other entity does not record or report as an unfavorable termination
any administrative withdrawal of authorization that may be required
under paragraphs (d)(1)(ii) or (e)(2)(iii)(B) of this section. The time
a licensee or other entity receives drug test results is not under the
applicant's control and does not reflect on the applicant's fitness,
trustworthiness, or reliability, if the licensee or other entity is
unable to obtain drug test results within the 5 days permitted and must
administratively withdraw the individual's authorization. Therefore,
subjecting the individual to the severe consequences associated with a
record of an unfavorable termination is inappropriate, except if the
individual's authorization was subsequently denied or terminated
unfavorably by a licensee or entity. However, if the drug test results
are positive, adulterated, or substituted and the licensee or other
entity terminates the individual's authorization for cause, the
termination is then recorded as unfavorable. However, with respect to
the proposed rule, the final rule adds a clarification that the
individual is required to disclose administrative action if the
individual's authorization was subsequently denied or terminated
unfavorably. The NRC has made this change to the proposed rule in
recognition of the need for additional consistency between the final
rule and the access authorization requirements. Therefore, this change
helps meet Goal 4 of this rulemaking to improve consistency between FFD
requirements and access authorization requirements established in 10
CFR 73.56, as supplemented by orders to nuclear power plant licensees
dated January 7, 2003.
The NRC has added Sec. 26.65(g) [Sanctions] (changed from Sec.
26.65(h) in the proposed rule because of renumbering) to the final
rule, which specifies the minimum sanctions to be imposed on an
individual whose pre-access test results the MRO confirms as an FFD
policy violation. Section 26.65(g)(1) and (g)(2) contains cross-
references to the relevant sanctions specified in Subpart D [Management
Actions and Sanctions To Be Imposed] to clarify that those sanctions
apply to applicants for authorization. For example, if the MRO
determines that an individual has submitted an adulterated urine
specimen for a pre-access drug test, the licensee or other entity is
required to impose the sanction for an attempt to subvert the testing
process (i.e., permanent denial of authorization) in Sec. 26.75(b).
The NRC has added Sec. 26.65(g)(3) to the final rule to permit
licensees and other entities to grant authorization to an individual
whose confirmed positive, adulterated, or substituted test result is a
first drug- or alcohol-related violation under a Part 26 program,
consistent with former Sec. 26.27(b)(2). However, the final rule
permits authorization to be granted only under the stringent
requirements contained in Sec. 26.69.
Section 26.67 Random Drug and Alcohol Testing of Individuals Who Have
Applied for Authorization
The NRC has added Sec. 26.67 to the final rule, which extends
former random testing requirements to individuals who have applied for
authorization under Part 26 but who have not yet been granted
authorization. The NRC has added the requirements in this section to
the access authorization requirements that were established by orders
to nuclear power plant licensees dated January 7, 2003, to enhance the
effectiveness of FFD programs by increasing the likelihood that
substance abuse will be detected before authorization is granted and to
deter the potential for substance abuse among applicants. Therefore,
the NRC has made these changes to meet Goal 3 of this rulemaking to
improve the effectiveness and efficiency of FFD programs.
The NRC has added Sec. 26.67(a) to the final rule, which requires
licensees and other entities to conduct random testing of applicants
under the requirements of Sec. 26.31(d)(2). The licensee or other
entity must add applicants for authorization to the FFD program's
normal population of individuals who are subject to random testing,
select individuals for testing at the 50-percent annual rate, and
otherwise subject applicants to the same random testing requirements as
individuals who currently hold authorization under Part 26. An
applicant is subject to random testing beginning when the licensee or
other entity collects the specimens for any required pre-access test
and continues thereafter, if the licensee or other entity grants
authorization to the individual.
Licensees and other entities are permitted to forego random testing
of applicants in the two circumstances described in Sec. 26.67(a)(1)
and (a)(2). Section 26.67(a)(1) permits a licensee or other entity to
discontinue random testing of any applicant to whom the licensee or
other entity does not grant authorization for any reason, including a
termination or denial of authorization or a withdrawal of the
application for authorization by the individual or the individual's
employer, in the case of a C/V. Section 26.67(a)(2) addresses the
circumstance described in Sec. 26.65(b), in which the licensee or
other entity is permitted to meet pre-access testing requirements by
relying on negative test results from specimens collected under another
Part 26 program within 30 days before granting authorization to the
individual. Under Sec. 26.67(a)(2), the licensee or other entity shall
begin subjecting the applicant to random testing when the licensee or
other entity takes the first formal action to process the individual's
application for authorization.
The formal actions may include, but are not limited to, the time
when the licensee or other entity receives the individual's signed
consent form and begins creating a record of the
[[Page 17043]]
individual's application that would be accessible to other licensees
and entities; conducts a psychological evaluation; begins a suitable
inquiry; or takes other actions that are required under NRC regulations
to grant authorization. The first formal action that the licensee or
other entity takes to process an individual's application for
authorization will vary, depending on the licensee's FFD and access
authorization program procedures, whether the applicant's FFD training
is up-to-date, and other factors. These considerations make it
impractical to establish a single point in the authorization process
established in the rule when random testing must begin. Therefore, the
provision requires the licensee or other entity to begin subjecting the
individual to random testing when the licensee or other entity takes
the first formal action, but does not define a specific formal action
that would initiate random testing of applicants in all cases.
The NRC has added Sec. 26.67(b) to the final rule, which permits
licensees and other entities to grant authorization to an individual
before random testing is completed if the individual has met all of the
requirements for authorization but has been selected for one or more
random tests while in applicant status. The final rule does not require
the testing to be completed before the licensee or other entity grants
authorization to the individual because the primary purpose of randomly
testing applicants is to deter substance abuse rather than to provide
information for the authorization decision. Pre-access testing provides
the necessary information for authorization decision making.
Section 26.67(c) of the final rule cross-references the minimum
sanctions to be imposed on an individual whose drug or alcohol results
from random testing are confirmed as positive, adulterated, or
substituted. The final rule also makes a minor language clarification
to the proposed rule by modifying the term ``non-negative'' of this
section. Section 26.67(c)(1) and (c)(2) refers to the relevant
sanctions specified in Subpart D. Section 26.67(c)(3) continues to
permit licensees and other entities to grant authorization to an
individual whose confirmed positive, adulterated, or substituted test
result is a first drug- or alcohol-related violation under a Part 26
program, consistent with former Sec. 26.27(b)(2). However, the final
rule permits authorization to be granted only under the stringent
requirements contained in Sec. 26.69.
Section 26.69 Authorization With Potentially Disqualifying Fitness-for-
Duty Information
The NRC adds Sec. 26.69 to the final rule to replace and clarify
the requirements contained in former Sec. 26.27(b)(4). Former Sec.
26.27(b)(4) established requirements for granting authorization to an
individual who has violated an FFD policy and had his or her
authorization terminated unfavorably or denied for a period of 3 or
more years under the former rule. Consistent with Goal 6 of this
rulemaking to improve clarity in the organization and language of the
rule, this section of the final rule addresses problems that have
arisen in implementing the former rule and clarifies the NRC's intent
with respect to several situations that the former rule did not
address.
The NRC has added Sec. 26.69(a) [Purpose] to the final rule to
describe the purpose of the section and the applicants who are subject
to these requirements. The provision requires licensees and other
entities to meet the applicable requirements in this section before
granting authorization to an individual or permitting an individual to
maintain his or her authorization when potentially disqualifying FFD
information is obtained about the individual through any means and a
previous licensee or other entity has not assessed and favorably
resolved the information. Section 26.63(b) permits licensees and other
entities to rely on the results of determinations of fitness that
previous licensees or other entities conducted, rather than requiring
each new licensee or other entity to reevaluate the same information
that was reviewed and resolved under another Part 26 program. However,
if the potentially disqualifying FFD information was not previously
reviewed and favorably resolved by another FFD program under this
subpart, licensees and other entities must implement the requirements
contained in this section.
Section 26.69(a) also revises the language contained in former
Sec. 26.27(b)(2) to recognize that licensees and other entities may
decide not to grant authorization to the subject individual and so, in
that case, are not required to implement these requirements. At the
public meetings discussed in Section I.D, stakeholders noted that some
individuals have misinterpreted the former rule as requiring licensees
to provide individuals who have violated an FFD policy with the
opportunity to seek treatment for a substance abuse problem and to have
authorization reinstated. However, although the NRC continues to affirm
that individuals who pursue treatment and maintain sobriety may be
considered for authorization, both the former and final rules assign
the responsibility for making authorization decisions to the licensee
or other entity. Therefore, the paragraph clarifies that granting or
maintaining the authorization of an individual about whom potentially
disqualifying FFD information has been disclosed or discovered is ``at
the licensee's or other entity's discretion.''
The NRC has added Sec. 26.69(b) [Authorization after a first
confirmed positive drug or alcohol test result or a 5-year denial of
authorization] to the final rule to define requirements for granting
authorization at the licensee's or other entity's discretion to an
individual who had confirmed positive drug or alcohol test results and
whose authorization was previously terminated unfavorably or denied for
5 years. The requirements in this section apply to:
(1) An applicant who had a first confirmed positive test result on
a pre-access test and was consequently denied authorization by a
licensee;
(2) An individual who is returning to duty following the 14-day
assessment period required in Sec. 26.75(e)(1) (The NRC has moved the
provisions in former Sec. 26.26(b)(2) to Sec. 26.75(e)(1));
(3) An individual whose authorization was terminated unfavorably
under another Part 26 program and who had an interruption in
authorization that was longer than 14 days; and
(4) An individual whose authorization was denied for 5 years under
the requirements of Sec. 26.75(c), (d), (e)(2), or (f).
This provision replaces and strengthens the requirements contained
in former Sec. 26.27(b)(2) and expands them to address confirmed
positive alcohol test results, which were excluded from this process in
former Sec. 26.27(b)(5). The paragraph includes confirmed positive
alcohol test results for the reasons discussed with respect to Sec.
26.75(e).
The NRC has retained the language of the proposed rule to state
that the licensee or other entity shall perform the activities listed
in paragraphs (b)(1) through (b)(6) of this section. In the situations
presented in this section, the NRC believes that the licensees or other
entities will likely conduct these tasks themselves because another
licensee has not reviewed and resolved the individual's situation.
Therefore, the licensees will have to collect more original data about
the individual, rather than relying on that collected by another
licensee. However, by retaining
[[Page 17044]]
the language of the proposed rule in this section, the NRC does not
intend to require that the licensees or other entities must conduct
these tasks themselves in these situations. The NRC maintains that the
licensee may rely on information collected by others to meet the
requirements of Sec. 26.69 if that is the most reasonable way to
proceed. For example, if the licensee or other entity uses a background
screening company, they would most likely continue to have the company
perform the employment history required in this section.
Section 26.69(b)(1) requires the licensee or other entity to obtain
and review a self-disclosure and employment history from the applicant
to verify that it does not contain any previously undisclosed
potentially disqualifying FFD information. The final rule has added
``employment history,'' with respect to the proposed rule, to state the
intent that both a self-disclosure and employment history shall be
reviewed. When an individual's last period of authorization was
terminated unfavorably or denied, licensees and other entities are not
permitted to forego obtaining a self-disclosure and employment history
under any circumstances because it is important to review the
individual's activities during the interruption period. The period of
time the self-disclosure must address is the shorter of either the past
5 years or the intervening period after the individual last held
authorization.
Section 26.69(b)(2) increases the scope of the suitable inquiry by
requiring the licensee or other entity to conduct the suitable inquiry
with every employer by whom the applicant claims to have been employed
during the period of time addressed in the individual's employment
history. The final rule replaces ``self-disclosure'' in the proposed
rule with ``employment history'' to clarify that the time period
covered is that which the employment history addresses. This extensive
suitable inquiry is necessary to determine if any indications exist
that the individual has continued to engage in substance abuse. The
final rule also requires licensees and other entities to obtain and
review any records that other licensees or entities may have developed
related to any potentially disqualifying FFD information about the
individual from the past 5 years. These records may include, but are
not limited to, the results of past suitable inquiries or other
investigations, records of arrests or convictions, drug and alcohol
test results, treatment records, and the results of determinations of
fitness. The SAE uses this information to assess the individual's
fitness and the licensee's or other entity's reviewing official uses it
to determine whether authorization is warranted.
Section 26.69(b)(3) applies only to individuals whose authorization
was denied for 5 years under the former rule or under Sec. 26.75(c),
(d), (e)(2), or (f) of the final rule. The paragraph requires the
licensee or other entity to verify, before granting authorization, that
the individual had not abused alcohol or drugs during the 5-year
interruption, at a minimum. The requirement is consistent with the
portion of former Sec. 26.27(b)(4) that required licensees to obtain
``satisfactory medical assurance that the person has abstained from
drugs for at least 3 years.'' However, the final rule extends the
requirement to 5 years to ensure that such an individual is at the
lowest risk of recidivism into an active substance abuse problem before
the licensee or other entity grants authorization to the individual.
Section 26.69(b)(4) amends the requirement in former Sec.
26.27(b)(2). The former provision mandated that an individual who has a
first confirmed positive test result must be referred to the EAP for
assessment and counseling before the licensee or other entity may grant
authorization to the individual. The final rule makes several changes
to the former provision. First, the final rule replaces the term
``management and medical assurance of fitness'' which was used in
former Sec. 26.27(b)(2) and (b)(4), with the term ``determination of
fitness'' to improve the accuracy of the language in the final rule.
The final rule does not use ``management'' because the licensee's or
other entity's reviewing official [see the discussion of Sec.
26.69(c)(3) and the definition of ``reviewing official'' in Sec. 26.5]
is the individual who licensees and other entities currently designate
to make authorization decisions and the reviewing official may not be a
manager. In addition, the final rule permits professionals other than a
licensed physician to conduct a determination of fitness, for the
reasons discussed with respect to Sec. 26.189. The NRC has made these
change to meet Goal 6 of this rulemaking to improve clarity in the
organization and language of the rule.
Consistent with the intent of the former requirement, the provision
requires the licensee or other entity to ensure that an SAE has
conducted a determination of fitness, as defined in Sec. 26.189, as
part of the authorization decision. Section 26.187 [Substance abuse
expert] requires that an SAE must perform determinations of fitness
that are conducted for authorization decisions. Section 26.187 also
defines the role, responsibilities, and required qualifications of an
SAE. Therefore, Sec. 26.69(b)(4) requires that the individual must be
referred to an SAE for a determination of fitness. However, the final
rule does not require the SAE to be an EAP employee. Permitting
licensees and other entities to rely on a professional who meets the
required qualifications for an SAE rather than only on EAP personnel,
more appropriately focuses this requirement on ensuring that the
professional who performs the assessment and treatment planning is
qualified, rather than on the professional's organizational
affiliation. The NRC received a comment requesting that the rule rely
on a Substance Abuse Professional (SAP) to meet the requirement of this
section. The NRC acknowledges that the SAP training and credentialing
process emphasizes knowledge about the SAP role in programs under 10
CFR Part 40, ``Domestic Licensing of Source Material.'' However,
although an SAP under Part 40 meets many of the criteria established in
the rule, thorough knowledge of Part 26 requirements is also necessary.
Therefore, the NRC has not modified the proposed provision in the final
rule.
Section 26.69(b)(4)(i) through (b)(4)(iii) replaces and strengthens
the requirement in former Sec. 26.27(b)(2). The former provision
stated that ``any rehabilitation program deemed appropriate must be
initiated during such suspension period.'' The final rule requires that
the individual must be in compliance with or have successfully
completed treatment and follow-up testing plans, rather than simply
started treatment, in order for the licensee or other entity to grant
authorization to the individual and maintain the individual's
authorization after it has been granted.
The NRC has added Sec. 26.69(b)(5) to the final rule to impose
more stringent pre-access testing requirements on an individual who is
being considered for authorization following an unfavorable termination
or denial of authorization than those required for individuals whose
last period of authorization was terminated favorably. The provision
requires negative results from an alcohol test performed within 10
business days before authorization is granted. Similarly, the provision
requires negative results from a urine specimen that was collected
under direct observation for drug testing within 10 business days
before authorization is granted. The provision prohibits the licensee
or other entity from granting authorization to the individual before
the drug test results are reported to the
[[Page 17045]]
licensee's or other entity's MRO. The MRO may then determine whether
the drug test results indicate that the individual has not engaged in
any further drug abuse [see the discussion of Sec. 26.69(f)].
Completing drug and alcohol testing within 10 business days before
granting authorization rather than the 30 days that is permitted in
Sec. 26.65 for the other authorization categories provides evidence
that the individual has abstained from abusing proscribed substances
during the interruption period and that the individual is able to
safely and competently perform duties under this part when
authorization is reinstated, if the individual's authorization has been
interrupted for the 14-day assessment period required under former
Sec. 26.27(b)(2) and retained in Sec. 26.75(e)(1). Requiring direct
observation of the urine specimen collection is necessary to provide
added assurance that the specimen is valid and yields accurate drug
test results.
Section 26.69(b)(6) applies only to individuals whose authorization
has been unfavorably terminated or denied for at least 14 days for a
first confirmed positive drug or alcohol test result. The provision
replaces the third sentence of former Sec. 26.27(b)(4). This sentence
established requirements and a schedule for followup drug and alcohol
testing for an individual whose authorization was denied for 3 years
under the former rule. The final rule applies the requirement for
followup testing to individuals who have had a first confirmed positive
test result for drugs or alcohol. This requirement provides greater
deterrence of further drug and alcohol use than former Sec.
26.27(b)(4), which required this followup testing only for the more
serious FFD violations that result in a denial of authorization for 3
years or longer. The more stringent requirement provides higher
assurance that individuals who are subject to this part are
trustworthy, reliable, and fit for duty.
Section 26.69(b)(6) amends the former fixed schedule for followup
testing by requiring licensees and other entities to subject the
individual to the possibility of being selected for followup testing,
during any period in which he or she holds authorization under Part 26,
for a period of 3 calendar years after the individual's authorization
is restored following termination or denial for the first confirmed
positive drug or alcohol test result. The rule requires licensees and
other entities to ensure that the individual is subject to unannounced
testing at least 15 times within the 3-year period and to verify that
the individual's test results are negative. Either random or followup
tests, which are both unannounced, may be used to meet this final
requirement. The final rule requires licensees and other entities to
distribute the unannounced tests over the 3-year period, with at least
one unannounced test conducted each quarter.
The NRC has added Sec. 26.69(b)(6)(i) through (b)(6)(iii) to the
final rule to address circumstances when an individual is not
continuously subject to a Part 26 program during the 3 years following
the restoration of authorization. Section 26.69(b)(6)(i) requires that
an individual who intermittently holds authorization over the 3-year
period must be subject to unannounced testing at least once in each
quarter during which the individual is authorized. Section
26.69(b)(6)(ii) permits the licensee or other entity to extend the
followup testing period to 5 years, if the requirement for 15 tests
over the 3-year period has not been met because the individual has not
been authorized a sufficient number of times or for sufficient periods
of time during the first 3 years to meet the final 15-test requirement.
Section 26.69(b)(6)(iii) permits the licensee or other entity to have
an SAE conduct a determination of fitness to determine whether further
followup testing is required, if an individual is unable to meet the
15-test requirement after 5 years because of brief and infrequent
periods of authorization. The revision of these requirements increase
the flexibility with which licensees and other entities may implement
followup testing, but retains the former effectiveness of followup
testing in detecting and deterring substance abuse.
The NRC has added Sec. 26.69(b)(7) to the final rule, which
requires the licensee or other entity to verify that the results of all
drug and alcohol tests that are administered to the individual under a
Part 26 program following the restoration of the individual's
authorization indicate no further drug or alcohol abuse. The provision
does not specify that the drug test results must be negative because
the metabolites of some drugs, such as marijuana, may be present in an
individual's urine for several weeks after the individual has stopped
using the drug. If an individual is tested again soon after the
original test that resulted in an FFD violation was conducted, the
specimen may yield positive results which would not, in fact, reflect
new drug use. Therefore, if subsequent drug test results show the
presence of the same drug or drug metabolites in the individual's urine
as detected in the original confirmed positive test result, the MRO,
under Sec. 26.185(o), is required to determine whether the results
indicate new drug use or are consistent with results that are expected
from the drug use that resulted in the previous confirmed positive test
result. The rule adds this requirement in response to inconsistencies
in the way some MROs have implemented former requirements related to
return-to-duty drug testing. Some MROs have been inappropriately
reluctant to declare a second drug test result as negative if any
concentration of the drug or drug metabolites that resulted in a first
confirmed positive drug test result are detected in the specimen. The
change permits an individual who has not engaged in further drug use
after a first confirmed positive drug test result to regain
authorization at the licensee's discretion rather than be incorrectly
denied authorization for 5 years on the basis of a subsequent FFD
policy violation, under Sec. 26.75(e)(2).
The NRC has added Sec. 26.69(c) [Granting authorization with other
potentially disqualifying FFD information] to the final rule to
establish requirements for granting authorization to an individual
about whom potentially disqualifying FFD information is discovered or
disclosed that was not a confirmed positive, adulterated, substituted,
or invalid drug or alcohol test result or 5-year denial of
authorization. For example, this type of potentially disqualifying FFD
information may include, but is not limited to:
(1) A report of an arrest for an alcohol-related traffic violation;
(2) Information from the suitable inquiry that a previous private-
sector employer terminated an individual's employment because of drug-
or alcohol-related job performance problems; or
(3) Information obtained from the suitable inquiry or other sources
of information indicating that the individual is known to abuse illegal
drugs or alcohol or is experiencing significant mental or emotional
stress.
This provision is necessary because the former rule did not address
the authorization process in these circumstances and the NRC is aware
that licensees and other entities have handled these circumstances
inconsistently. Therefore, the final rule adds these requirements to
establish the NRC's intent with respect to these circumstances and
increase consistency between Part 26 programs.
The NRC has added a second sentence to Sec. 26.69(c) in the final
rule to clarify that if potentially disqualifying FFD information is
obtained about an
[[Page 17046]]
individual by any means, the licensee shall perform the activities in
paragraphs (c)(1) through (c)(5) of this section before granting
authorization to the individual. The NRC has made this change to meet
Goal 6 of the rulemaking to improve clarity in the organization and
language of the rule.
The NRC has added Sec. 26.69(c)(1) to the final rule, which
requires the licensee or other entity to obtain and review the
individual's self-disclosure and employment history. The final rule has
added the term ``employment history'' to clarify that the licensee must
obtain and review that in addition to the self-disclosure. The final
rule also modifies the language of the proposed rule by eliminating
reference to Sec. 26.31(b)(3) and instead adding paragraphs (c)(1)(i)
through (c)(1)(iii) to Sec. 26.69 to specify exactly the time period
that the self-disclosure and employment history must address. The NRC
has made this change in response to a public comment suggesting that
this provision needed clarification and to meet Goal 6 of the
rulemaking to improve clarity in the organization and language of the
rule.
Section 26.69(c)(2) requires the licensee or other entity to
conduct a suitable inquiry with every employer for the period that the
employment history addresses. In this section, the final rule deletes
``self-disclosure'' and replaces it with the phrase ``employment
history required under paragraph 26.63(a) through (e)'' to clarify the
time period addressed. If the potentially disqualifying FFD information
was identified during the course of conducting a suitable inquiry under
Sec. 26.63(f) so that the suitable inquiry was partially completed,
Sec. 26.69(c)(2) requires the licensee or other entity to conduct a
more complete suitable inquiry by contacting every employer that the
individual listed during the interruption period. The provision also
requires that if the individual held authorization within the past 5
years, the licensee or entity shall obtain and review any records that
other licensees or entities who are subject to this part may have
developed with regard to potentially disqualifying FFD information
about the individual from the past 5 years. The final rule, with
respect to the proposed rule, has added the phrase ``if the individual
held authorization within the past 5 years'' to meet Goal 6 of the
rulemaking to improve clarity in the language of the rule. This more
complete suitable inquiry is necessary to ensure that the licensee or
other entity has more information about the individual than is required
for individuals whose last period of authorization was terminated
favorably in order to make an appropriate authorization decision.
The NRC has added Sec. 26.69(c)(3) to the final rule, which uses
the term ``reviewing official'' to refer to the employee whom the
licensee or other entity designates to make authorization decisions as
discussed with respect to Sec. 26.5. This provision permits the
reviewing official to grant or deny authorization based upon his or her
review of the circumstances associated with the potentially
disqualifying FFD information. Because of the variety of circumstances
that may arise, the provision also grants discretion to the reviewing
official in deciding whether a determination of fitness is required
rather than requiring a determination of fitness in every case.
However, if the reviewing official requests a determination of fitness
and the professional who performs it recommends any form of treatment
or drug and alcohol testing, including the collection of urine
specimens under direct observation, Sec. 26.69(c)(4) requires the
licensee or other entity to implement the treatment and testing
recommendations.
The NRC has added Sec. 26.69(c)(5) to the final rule to require
pre-access and random testing of the applicant for authorization. This
provision requires the licensee or other entity to verify that the
results of pre-access drug and alcohol tests are negative before
granting authorization to the individual, to provide evidence that the
individual is avoiding substance abuse.
The NRC has added Sec. 26.69(d) [Maintaining authorization with
other potentially disqualifying FFD information] to the final rule,
which establishes requirements for maintaining an individual's
authorization when new potentially disqualifying FFD information is
disclosed or discovered that was not a confirmed positive drug or
alcohol test result, or 5-year denial of authorization, if the
reviewing official determines that maintaining authorization is
warranted. A self-disclosure, suitable inquiry, and pre-access testing
are not required because the individual would not be applying for
authorization. However, the provision requires the reviewing official
to consider the circumstances related to the information and, at his or
her discretion, ensure that a professional with the appropriate
qualifications makes a determination of fitness. The provision mandates
that the licensee or other entity must implement any treatment or
testing requirements resulting from the determination of fitness. The
NRC has added the provision because the former rule did not address
maintaining an individual's authorization in these circumstances. Also,
the NRC is aware that licensees and other entities have handled these
circumstances inconsistently. Therefore, the final rule adds these
requirements to establish the NRC's intent with respect to these
circumstances and to increase consistency between Part 26 programs.
The NRC has added Sec. 26.69(e) [Accepting followup testing and
treatment from another Part 26 program] to the final rule to establish
continuity of care requirements for individuals who were subject to a
followup testing and/or a substance abuse treatment plan under one Part
26 program and transfer to another FFD program, or leave and then
return to the same FFD program.
Section 26.69(e)(1) requires the receiving licensee or other entity
to continue the testing and treatment plan to which the individual was
subject under the previous FFD program. However, with respect to the
proposed rule, the final rule clarifies that the licensee or other
entity who imposed the treatment and/or followup testing plan shall
ensure that information documenting the treatment and/or followup
testing plan is identified to any subsequent licensee or other entity
who seeks to grant authorization to the individual. The NRC has made
this change to clarify the intent of the provision and in recognition
of the need for additional consistency between the final rule and the
access authorization requirements. Therefore, this change helps meet
Goal 4 of this rulemaking to improve consistency between FFD
requirements and access authorization requirements established in 10
CFR 73.56, as supplemented by orders to nuclear power plant licensees
dated January 7, 2003.
Section 26.69(e)(1) of the final rule also adds a specification
that if it is impractical for the individual to comply with the
treatment plan that was developed under another FFD program, the
granting FFD program shall ensure that an SAE develops a comparable
treatment plan. The NRC has made this change because it received a
public comment stating that the proposed provision that required the
licensee to assume responsibility for overseeing the continuation of
treatment and follow-up testing for an employee who had a positive test
result under another FFD program could be burdensome, especially if the
individual is applying for authorization at a new site that makes it
impossible to use the same treatment providers.
Section 26.69(e)(2) permits the receiving licensee or other entity
to
[[Page 17047]]
accept and rely on any followup testing that was completed while the
individual was subject to the previous Part 26 program to determine how
long followup testing must continue. For example, if an individual met
all of the requirements for authorization by a new licensee but had
completed only 2 of the 3 years of followup testing required under a
previous Part 26 program, the granting licensee would then administer
the final year of the followup testing. However, the licensee is not
required to conduct another 3 full years of followup testing after the
individual was authorized. If the transferring individual successfully
completed any followup testing and treatment program required under the
first FFD program, a previous determination of fitness indicated that
the individual is fit for duty, and the individual's authorization by
the first licensee or other entity was terminated favorably, this
provision permits the receiving licensee or other entity to accept the
previous determination of fitness and does not require the granting
licensee to develop and implement an additional testing and treatment
plan.
The NRC has added Sec. 26.69(f) [Sanctions] to the final rule to
clarify the minimum sanctions to be imposed on an individual who has
confirmed positive, adulterated, or substituted drug and alcohol test
results on any tests that may be required under this section. Section
26.69(f)(1) and (f)(2) cross-references the relevant sanctions
specified in Subpart D to establish that those sanctions apply to
individuals about whom potentially disqualifying FFD information has
been discovered or disclosed.
Section 26.71 Maintaining Authorization
The NRC has added Sec. 26.71 to the final rule to state the
requirements for maintaining authorization under this part and has
adopted the provisions in this section as proposed without change.
Section 26.71(a) of the final rule provides that individuals may
maintain authorization under the conditions listed in Sec. 26.71(a)(1)
through (a)(4), as follows:
Section 26.71(a)(1) establishes that an individual must comply with
the licensee's or other entity's FFD policies to which the individual
is subject. This requirement relates, although it does not refer to
Sec. 26.27 [Written policy and procedures] that requires the licensee
or other entity to prepare a clear and concise statement of its FFD
policy and make that policy readily available to all individuals who
are subject to the policy. The final rule requires that all individuals
who are subject to the FFD policy must have information on the
expectations of them and the consequences that may result from a lack
of adherence to the policy. Section 26.71 also requires that in order
to maintain authorization, an individual must report any legal actions
as defined in Sec. 26.5. Finally, although not explicitly specified in
Sec. 26.71(a)(1), Sec. 26.33 [Behavioral observation] requires
individuals to report any FFD concern to the personnel designated in
the FFD policy.
Section 26.71(a)(2) establishes that an individual may maintain
authorization if the individual remains subject to a drug and alcohol
testing program that complies with the requirements of Part 26,
including random testing. Licensees and other entities who are subject
to Part 26 are responsible for implementing drug and alcohol testing
programs that comply with the requirements in Sec. 26.31 [Drug and
alcohol testing]. The failure of a licensee or other entity to maintain
a program would terminate the authorizations of individuals who have
been granted authorization by the licensee or other entity (see the
discussion of Sec. 26.71(b)). Section 26.31 also places certain
responsibilities on individuals who are subject to the testing program.
In particular, under Sec. 26.31(d)(2)(iii), individuals who are
selected for random testing are required to report to the collection
site as soon as reasonably practicable after notification within the
time period specified in FFD program procedures, as well as to
cooperate in the testing process. In appropriate circumstances, an
individual's failure to report or cooperate could be the basis for
terminating the individual's authorization.
Section 26.71(a)(3) establishes that an individual may maintain
authorization if the individual remains subject to a behavioral
observation program that complies with the requirements of Part 26.
Behavioral observation, as required by Sec. 26.33, is performed by
individuals, including coworkers, who have been trained to detect
behaviors that may indicate possible use, sale, or possession of
illegal drugs; use or possession of alcohol on site or while on duty;
or impairment from fatigue or any cause that, if left unattended, might
constitute a threat to the health and safety of the public or the
common defense and security.
Section 26.71(a)(4) establishes that a condition for maintaining
authorization is the individual's successful completion required of FFD
training, according to the schedule in Sec. 26.29(c). As specified in
Sec. 26.29(c)(1), the final rule requires the individual to complete
training before the licensee or other entity grants initial
authorization. Thereafter, as specified in Sec. 26.29(c)(2), the rule
requires individuals to complete refresher training or pass a
comprehensive examination on a nominal 12-month frequency. Section
26.29(d) provides that licensees and other entities may accept the
training of individuals who have been subject to another Part 26
program and have either had initial or refresher training or
successfully passed a comprehensive examination within the past 12
months that meets the requirements of Sec. 26.29.
Section 26.71(b) of the final rule requires a licensee or other
entity to terminate an individual's authorization if the individual is
not subject to an FFD program that meets the requirements of Part 26
for more than 30 (consecutive) days. The requirements of the paragraph
permits an individual to be away from all elements of a Part 26 program
for this period of time in order to accommodate vacations and
significant illnesses when the individual is not reasonably available
for behavioral observation or to collect specimens for random drug and
alcohol testing. The NRC has added this paragraph to the final rule in
response to stakeholder requests, and it is consistent with related
requirements in the access authorization orders issued to nuclear power
plant licensees on January 7, 2003.
Subpart D--Management Actions and Sanctions To Be Imposed
Throughout this subpart, the final rule makes minor clarifications
to the proposed rule due to public comment, to accommodate conforming
changes, and to meet Goal 6 of this rulemaking to improve clarity in
the organization and language of the rule. The final rule makes other
substantive changes in Sec. Sec. 26.73; 26.75(e)(1) and (h); and
26.77(b)(2) that are discussed with regard to those sections.
Otherwise, the final rule has adopted the provisions in this section as
proposed without change.
Section 26.73 Applicability
The NRC has added Sec. 26.73 to the final rule to describe the
applicability of the subpart. The new Sec. 26.73 specifies, by using
applicable cross-references to Sec. Sec. 26.3 [Scope] and 26.4 [FFD
program applicability to categories of individuals], the licensees and
other entities, as well as individuals, to whom the requirements of
this subpart apply.
Section 26.75 Sanctions
The first sentence of Sec. 26.75(a) of the final rule introduces
the purpose of the section, which is to define the minimum
[[Page 17048]]
sanctions that licensees and other entities must impose when an
individual has violated the drug and alcohol provisions of an FFD
policy. The second sentence of the paragraph restates the second
sentence of former Sec. 26.27(b). This sentence permits licensees and
other entities to impose more stringent sanctions than those specified
in the final rule. The final rule adds a cross-reference to paragraph
(h) of this section, which establishes limits on the sanctions that
licensees and other entities may impose for positive, adulterated,
substituted, or invalid drug test results. Adding a cross-reference to
paragraph (h) of this section clarifies that the blanket permission to
impose more stringent sanctions granted in this paragraph has one
exception, as discussed with respect to paragraph (h) of this section.
The NRC has made these changes to meet Goal 6 of this rulemaking to
improve clarity in the organization and language of the rule.
The NRC has added Sec. 26.75(b) to the final rule to require
licensees and other entities to permanently deny authorization to
individuals who refuse to be tested or who in any way subvert or
attempt to subvert the testing process. This sanction is necessary
because acts to subvert the testing process reflect a sufficiently
egregious lack of trustworthiness and reliability to warrant permanent
denial of authorization. An individual's willingness to subvert or
attempt to subvert the testing process provides strong evidence that
the individual will also be willing to disregard other rules and
regulations, such as safeguards requirements, which ensure the
protection of public health and safety and the common defense and
security. In addition, if an individual succeeds in subverting the
testing process in order to hide substance abuse, the individual may
pose an undetected and unacceptable risk to public health and safety or
the common defense and security by performing the duties that require
him or her to be subject to this part while impaired. Therefore, by
deterring acts to defeat the testing process as well as preventing any
individuals who engage in them from posing any further risk to public
health and safety and the common defense and security, this change
meets Goal 3 of this rulemaking to improve the effectiveness of FFD
programs.
The final rule specifies three examples of actions that are
considered subversion or an attempt to subvert the testing process.
These include refusing to provide a specimen and providing or
attempting to provide a substituted or adulterated specimen. However,
these examples are not intended to be exhaustive. For example, if a
licensee or other entity determines that several individuals colluded
to notify potential donors that they would be selected for random
testing on a particular day, so that the potential donors could plan to
avoid work on that day or take other actions to ensure that their
illegal drug use would not be detected, the NRC expects the licensee or
other entity to permanently deny authorization to all of the
individuals who were involved in the collusion.
The final rule does not include submitting a dilute specimen as an
example of a subversion attempt without additional evidence that the
donor had diluted the specimen in order to mask the presence of drugs
or drug metabolites in the specimen, for the reasons discussed with
respect to Sec. 26.185(g). Submitting a dilute specimen, in itself,
does not necessarily indicate an attempt to subvert the testing process
because there are many legitimate causes for a dilute specimen,
including drinking liquids in order to provide a specimen of sufficient
quantity, as permitted in Section 2.4(g)(11) in Appendix A of the
former rule and in Sec. 26.109(b)(1) of the final rule. Therefore, the
final rule does not require licensees and other entities to apply the
sanction of permanent denial of authorization for submitting a dilute
specimen, unless there is other evidence that the donor had diluted the
specimen in an attempt to subvert the testing process.
The NRC used the phrase ``for any test required under this part''
in Sec. 26.75(b) in the proposed rule to indicate that applicants for
authorization who subvert or attempt to subvert a pre-access or random
test are also subject to permanent denial of authorization. However,
the NRC has changed this phrase in the final rule to ``for any test
required under 26.31(c).'' This change clarifies the intent of the
provision and is consistent with Goal 6 of this rulemaking to improve
clarity in the organization and language of the rule. Although these
individuals would not yet be performing any duties that could affect
public health and safety or the common defense and security, an attempt
to subvert the testing process while in an applicant status provides
strong evidence that the individual cannot be trusted to perform those
duties. Therefore, it is necessary to ensure that any applicant who
subverts or attempts to subvert the testing process is denied
authorization.
Section 26.75(c) of the final rule amends former Sec. 26.27(b)(3).
Former Sec. 26.27(b)(3) established sanctions for the sale, use, or
possession of illegal drugs within a protected area of any nuclear
power plant, within a facility that is licensed to possess or use
formula quantities of SSNM, or within a transporter's facility or
vehicle. The final rule retains the former sanction of a 5-year denial
of authorization in these instances and adds two other instances in
which a 5-year denial of authorization is required.
First, the final rule requires licensees and other entities to
impose a 5-year denial of authorization on any individual who is
determined to have consumed alcohol within a protected area of any
nuclear power plant, within a facility that is licensed to possess or
use formula quantities of SSNM, or within a transporter's facility or
vehicle. This change from the former rule is necessary because
consuming alcohol causes impairment, which poses the same risks to
public health and safety as impairment from illegal drugs. Extending
the scope of the former sanction to alcohol consumption is also
consistent with the revised FFD program performance objective in Sec.
26.23(d), which is to provide reasonable assurance that the workplaces
subject to this part are free from the presence and effects of alcohol
as well as illegal drugs. Therefore, by reducing the risk to public
health and safety and the common defense and security that the onsite
use of alcohol poses, this change meets Goal 3 of this rulemaking to
improve the effectiveness of FFD programs.
Second, the final rule adds the phrase ``or while performing the
duties that require the individual to be subject to this part'' to
address circumstances in which an individual may be performing the
duties that require him or her to be subject to this part but is not
doing so within the protected area of a nuclear power plant, within a
facility that is licensed to possess or use formula quantities of SSNM,
or within a transporter's facility or vehicle. As one example, many
nuclear power plant licensees' designated collection sites are located
outside of the plant's protected area. The intent of the former rule
was to prohibit the presence, sale, and use of alcohol or illegal drugs
by FFD program personnel at a collection site that is located outside
of the protected area, but the former rule did not specifically address
such circumstances. The majority of licensees have appropriately
interpreted the intent of the former rule, but the final rule adds this
phrase to meet Goal 6 of this rulemaking to improve clarity in the
organization and language of the rule.
[[Page 17049]]
In addition, the final rule deletes the list of activities in the
paragraph of the former rule that an individual is prohibited from
performing. The final rule replaces this list with the summary term
``authorization'' for consistency with the use of this term throughout
the final rule. As discussed with respect to Sec. 26.4, the NRC
presents the list of duties that require individuals to maintain
authorization and to be subject to this part once in that section,
rather than repeatedly throughout the rule, for consistency with Goal 6
of this rulemaking to improve clarity in the organization and language
of the rule.
Section 26.75(d) of the final rule amends a portion of former Sec.
26.27(c) that required licensees or other entities to record as a
removal ``for cause'' an individual's resignation that occurs before
the licensee removes the individual for violating the FFD policy. This
portion of the former provision has raised implementation questions
from licensees regarding the appropriate action to take in these
circumstances. Licensees have questioned whether the former requirement
was intended to deny authorization to an individual for some period of
time, as required under former Sec. 26.27(b)(2) through (b)(4),
permanently deny authorization to the individual, or merely to record
the resignation. Therefore, the final rule clarifies the intent of the
former provision as follows:
The final rule establishes the sanction of a 5-year denial of
authorization for an individual who resigns before a licensee or other
entity terminates the individual's authorization or denies
authorization to an applicant for a first violation of the FFD policy
involving a confirmed positive drug or alcohol test result. The
paragraph establishes a 5-year denial of authorization because the
confirmed positive drug or alcohol test result in combination with such
a resignation, is a strong indication that the individual has an active
substance abuse problem. However, because the individual resigned or
withdrew his or her application for authorization, the individual would
not be available for the SAE to evaluate the seriousness of his or her
substance abuse problem and devise an appropriate treatment plan, as
required under Sec. 26.189 [Determination of fitness]. Therefore,
prohibiting the individual from being granted authorization for a 5-
year period gives the individual an opportunity to seek treatment and
establish a 5-year history of sobriety, which is required to regain
authorization under Sec. 26.69 [Authorization with potentially
disqualifying fitness-for-duty information]. This prohibition also
ensures that such an individual is not granted authorization without
having demonstrated that he or she has overcome the substance abuse
problem. Therefore, the NRC has made this change to meet Goal 3 of this
rulemaking to improve the effectiveness and efficiency of FFD programs.
In addition, for any type of FFD policy violation, this provision
requires the licensee or other entity to record the fact that the
individual had resigned or withdrawn his or her application for
authorization, the nature of the FFD policy violation, and the sanction
that would have been imposed if the individual had not resigned or
withdrawn. Recording this information is necessary to ensure that any
licensees or other entities who may consider granting authorization to
the individual in the future are aware of the individual's behavior and
the nature of the FFD policy violation. Subsequent licensees and other
entities will then be able to ensure that the minimum requirements of
this section are met. For example, if the FFD policy violation was a
third confirmed positive drug or alcohol test result, Sec. 26.75(g)
prohibits a subsequent licensee or other entity from granting
authorization to the individual under any circumstances. The NRC has
made this change to meet Goal 3 of this rulemaking to improve the
effectiveness and efficiency of FFD programs.
The NRC has moved the portion of former Sec. 26.27(c) that
referred to a refusal to provide a specimen for testing to Sec.
26.75(b) of the final rule to meet Goal 6 of this rulemaking, regarding
organizational clarity.
Section 26.75(e) of the final rule amends former Sec. 26.27(b)(2)
and expands its scope to include alcohol. The NRC no longer excludes
the abuse of alcohol from the sanctions specified in this section for
several reasons. First, although the possession and use of alcohol are
legal for adults and do not adversely reflect on an individual's
trustworthiness and reliability, a perceived need to conceal an
untreated active alcohol abuse problem could cause an individual to be
vulnerable to influence to act in ways that are adverse to the common
defense and security. Second, alcohol-related impairment in the nuclear
workplace poses an undue potential risk to public health and safety
that is comparable to the risk imposed by impairment from the use of
drugs. Third, some licensees have not imposed appropriately stringent
sanctions on individuals who have abused alcohol in a manner that could
cause the individual to be impaired while performing the duties that
require individuals to be subject to this part. Therefore, in order to
deter individuals from abusing alcohol and ensure that individuals who
may be impaired from alcohol are not permitted to perform the duties
that require individuals to be subject to this part, this final rule
imposes the same sanctions for abusing alcohol as those required for
abusing drugs. The NRC has made this change to meet Goal 3 of this
rulemaking to improve the effectiveness of FFD programs.
Section 26.75(e)(1) retains but amends the intent of the second
sentence of former Sec. 26.27(b)(2). The former Sec. 26.27(b)(2)
stated that licensees and other entities must remove an individual from
performing activities under this part for at least 14 days following a
first confirmed positive test result. However, the final rule requires
licensees and other entities to immediately unfavorably terminate the
individual's authorization for at least 14 days from the date of the
unfavorable termination, rather than ``remove'' the individual. With
respect to the proposed rule, the final rule adds a clarification that
the 14-day termination begins on the date of the unfavorable
termination. The NRC has made this change because after publishing the
proposed rule, it recognized the need for additional clarity in this
provision to illustrate the NRC's intent. At the public meetings
discussed in Section I.D, the stakeholders indicated that the term
``remove'' is confusing because it could be interpreted as requiring
licensees and other entities to terminate the individual's employment,
which is not the intent of this paragraph. The stakeholders suggested
using the phrase ``terminate the individual's authorization'' to more
accurately characterize the required action. This change is consistent
with Goal 6 of this rulemaking to improve clarity in the organization
and language of the rule.
The stakeholders also requested that the agency eliminate from
Sec. 26.75(e)(1) the requirements in the former paragraph related to
referring the individual to the EAP for assessment and counseling. The
stakeholders noted that many licensees terminate an individual's
employment at the same time that they terminate the individual's
authorization after a first confirmed positive test result. They
suggested that if the licensee or other entity terminates the
individual's employment and does not intend to provide the individual
with an opportunity to regain authorization, it is inappropriate to
require the licensee or other entity to provide assessment and
counseling services to the individual. However, some licensees have
interpreted the
[[Page 17050]]
former provision as requiring them to provide EAP services to
individuals whom they no longer employ. The NRC concurs that the intent
of the former rule is for licensees and other entities to provide
assessment and counseling services only in those instances when the
licensee or other entity desires to reinstate the individual's
authorization. Therefore, the NRC has made this change, consistent with
Goal 6 of this rulemaking to improve clarity in the organization and
language of the rule.
The final rule also moves the requirements in former Sec.
26.27(b)(2) that were related to permitting the individual to regain
authorization to Subpart C [Granting and Maintaining Authorization] of
the final rule instead of retaining them in Sec. 26.75(e)(1) because
Sec. 26.75(e)(1) addresses sanctions for FFD policy violations, rather
than FFD requirements for granting authorization. Subpart C addresses
the requirements for granting authorization to an individual after his
or her authorization has been terminated unfavorably for a first
confirmed positive drug or alcohol test result in Sec. 26.69(b). The
NRC has made this change to meet Goal 6 of this rulemaking to improve
organizational clarity in the rule.
Section 26.75(e)(2) increases the length of the period for which
licensees and other entities must deny an individual's authorization
for a second confirmed positive drug or alcohol test result from 3
years in former Sec. 26.27(b)(vii) to 5 years in the final rule. This
change provides greater assurance that individuals who have had a
second confirmed positive drug or alcohol test result are able to
abstain from substance abuse for at least 5 years before a licensee or
other entity may again consider granting authorization to them. The 5-
year period is based on the research literature indicating that
individuals who abstain from substance abuse for 5 years after
treatment are less likely to relapse than individuals who have been
able to abstain for 3 years. In addition, the more stringent sanction
for a second confirmed positive drug or alcohol test result provides
greater deterrence to recidivism than the former 3-year period. The NRC
has made this change to meet Goal 3 of this rulemaking to improve the
effectiveness and efficiency of FFD programs.
Section 26.75(f) of the final rule amends former Sec. 26.27(b)(5).
Former Sec. 26.27(b)(5) stated that the sanctions for confirmed
positive drug test results in former Sec. 26.27 [Written policy and
procedures] did not apply to the misuse of alcohol, valid
prescriptions, and over-the-counter drugs, but required licensee FFD
policies to establish sanctions that are sufficient to deter the misuse
of those substances. The final rule requires the same minimum sanctions
for alcohol abuse as those required for drug abuse. Impairment caused
by alcohol abuse creates a risk to public health and safety that is
fundamentally similar to the risk posed by the use of illegal drugs.
However, some licensees have imposed lesser sanctions for alcohol
violations, an approach that is inconsistent with the NRC's intent.
Therefore, the final rule rectifies this situation by explicitly
requiring the same minimum sanctions for the abuse of alcohol as
currently required for the use of illegal drugs. The NRC has made this
change to meet Goal 3 of this rulemaking to improve the effectiveness
and efficiency of FFD programs and Goal 6 to improve clarity in the
organization and language of the rule.
In addition, Sec. 26.75(f) of the final rule requires licensees
and other entities to impose the same sanctions as mandated for the
abuse of illegal drugs if the MRO determines that the misuse of
prescription drugs or over-the-counter medications resulting in a
positive drug or alcohol test result represents substance abuse. The
MRO makes this determination under Sec. 26.185(j). Misuse of
prescription and over-the-counter medications may include, for example,
the use of a spouse's or other family member's prescription medications
that may cause impairment, such as some pain relievers, or the
excessive use of some over-the-counter cold and cough preparations
containing alcohol or other active ingredients that may cause
impairment. However, an individual who has a substance abuse problem
may use the same substances. For example, an individual who has become
addicted to opiates may use a spouse's or other family member's codeine
tablets or other opiates that were prescribed for pain relief to assist
the addicted individual in avoiding withdrawal symptoms. Under this
provision, if the MRO determines that an individual's use of a
prescription or over-the-counter medication represents substance abuse,
the licensee or other entity is required to impose the minimum
sanctions specified in this section for a confirmed positive drug or
alcohol test result, as appropriate. If the MRO determines that the
misuse of a prescription or over-the-counter medication does not
represent substance abuse, the final rule requires the licensee or
other entity to impose the sanctions for substance misuse that the
licensee or other entity specifies in the FFD policy.
The final rule also retains but revises the requirement in the last
sentence of former Sec. 26.27(b)(5). Section 26.75(f) retains the
former requirement that sanctions for the misuse of prescription and
over-the-counter drugs must be sufficient to ``deter abuse of legally
obtainable substances'' because such misuse may lead to impairment on
the job. However, the final rule eliminates the phrase ``as a
substitute for abuse of prescribed drugs'' in the last sentence of
former Sec. 26.27(b)(5) because it unnecessarily limited the
circumstances in which sanctions for the misuse of prescription and
over-the-counter drugs must be imposed. The NRC has made these changes
to meet Goal 3 of the rulemaking to improve the effectiveness and
efficiency of FFD programs, and Goal 6 to improve clarity in the
organization and language of the rule.
Section 26.75(g) of the final rule amends former Sec. 26.27(b)(4).
The NRC has moved the portions of the former paragraph that established
requirements for granting authorization to an individual who has
violated the licensee's or other entity's FFD policy to Sec. 26.69 in
Subpart C of the final rule for organizational clarity because Sec.
26.75(g) only addresses sanctions for FFD policy violations. This
provision retains the portion of the former paragraph that required
licensees and other entities to permanently deny authorization to an
individual who has repeatedly violated a licensee's or other entity's
FFD policy. The final rule requires the permanent denial of an
individual's authorization if he or she has another confirmed positive
drug or alcohol test result after he or she has had authorization
denied for 5 years under other paragraphs in this section. Requiring
this more stringent sanction meets Goal 3 of this rulemaking to improve
the effectiveness and efficiency of FFD programs because this provides
reasonable assurance that individuals are trustworthy and reliable, as
demonstrated by avoiding substance abuse, and increases the assurance
that only individuals who are fit for duty are permitted to perform the
duties listed in Sec. 26.4.
Section 26.75(h) and (i) of the final rule amends former Sec.
26.24(d)(2). The former provision permitted licensees to temporarily
suspend an individual's authorization or take other administrative
action if an individual has a positive drug test result for marijuana
or cocaine metabolites that is identified through initial testing at
the licensee testing facility. For organizational clarity, consistent
with Goal 6 of this rulemaking, the final rule divides the former
paragraph into two paragraphs to separate the requirements related to
the conditions under which licensees and other entities may and
[[Page 17051]]
may not take action on the basis of initial test results.
Section 26.75(h) prohibits licensees and other entities from taking
administrative actions or imposing sanctions on an individual based on
a positive test result from any initial drug test result reported by an
HHS-certified laboratory. This section also permits licensees and other
entities to take administrative actions on the basis of positive
initial drug test results for marijuana and cocaine from a licensee
testing facility. However, in order for the licensee or other entity to
take action, the final rule requires that the urine specimen that
yields a positive, adulterated, or substituted drug test result(s) must
also appear to be a valid specimen, based on the results of validity
screening or initial validity test results at the licensee testing
facility. In addition, this section prohibits licensees and other
entities from imposing sanctions or taking other actions in response to
adulterated, substituted, or invalid screening or initial validity test
results from a specimen in which no drug metabolites were detected. The
NRC has added this prohibition because the procedures, instruments, and
devices used in conducting validity screening and initial validity
tests have not yet been proven to be sufficiently accurate and reliable
to support management actions or sanctions without confirmatory
testing. Permitting licensees and other entities to take actions on the
basis of validity screening or initial validity test results risks
imposing substantial burdens on individuals from false positive,
adulterated, substituted, or invalid test results. Therefore, the NRC
has added this prohibition to meet Goal 7 of this rulemaking to protect
the privacy and other rights (including due process) of individuals who
are subject to Part 26.
With respect to the proposed rule, the final rule adds a provision
that the licensee or other entity may not subject an individual to
administrative action based upon validity testing results indicating
that a specimen is of questionable validity. This change is based on
analysis of public comment, which is discussed with respect to the term
``questionable validity'' in Sec. 26.5 [Definitions].
Section 26.75(i)(1) through (i)(4) retains the requirements in
former Sec. 26.24(d)(2)(i) through (iv) that established the
conditions under which licensees and other entities may take
administrative actions on the basis of a positive initial drug test
result for marijuana or cocaine metabolites from a licensee testing
facility. The final rule adds a requirement for specimen validity
testing (see the discussion of Sec. 26.31(d)(3)(i) with respect to the
addition of validity testing requirements in this rule and the
requirement that the specimen for which action will be taken must
appear to be valid, based on validity screening or initial validity
test results from the licensee testing facility). The final rule also
revises the terminology used in the former provision to be consistent
with the terminology used throughout the final rule (see the discussion
of Sec. 26.5 with respect to the new terminology adopted in the final
rule) and updates the cross-references to other sections of the rule to
be consistent with the organization of the final rule. The NRC has made
these changes to meet Goal 6 of this rulemaking to improve clarity in
the organization and language of the rule.
Section 26.77 Management Actions Regarding Possible Impairment
The NRC has added Sec. 26.77 [Management actions regarding
possible impairment], which amends the requirements of former Sec.
26.27(b)(1). The former section required licensees and other entities
to remove impaired workers, or those whose fitness may be questionable,
from performing activities within the scope of this part. The former
provision also permitted licensees and other entities to return the
individuals to duty only after the individuals were determined to be
fit to safely and competently perform their duties. The final rule
retains the intent of the former provision, but the terminology used in
the section is consistent with the terminology used throughout the
final rule. The NRC has updated cross-references to other sections of
the rule, consistent with Goal 6 of this rulemaking to improve clarity
in the organization and language of the rule. In addition, the agency
has added several new requirements.
The NRC has added Sec. 26.77(a) to the final rule to introduce and
describe the purpose of the section, which is to prescribe the
management actions that licensees and other entities must take when an
individual shows indications that he or she is not fit to safely and
competently perform their duties. The NRC has added this paragraph to
meet Goal 6 of this rulemaking to improve clarity in the organization
and language of the rule.
Section 26.77(b) of the final rule retains the portion of former
Sec. 26.27(b)(1) that required the licensee or other entity to take
immediate action to prevent an individual from performing the duties
that require him or her to be subject to this part if an individual
appears to be impaired, or his or her fitness is questionable. This
section of the final rule adds cross-references to Sec. Sec.
26.27(c)(3), 26.207, and 26.209 (updated from the proposed rule)
because those provisions provide exceptions to the requirement for
immediate action. Section 26.27(c)(3) permits licensees and other
entities to use individuals who have consumed alcohol if they are
needed to respond to an emergency and the licensee or other entity
establishes controls and conditions under which the individual may
perform work safely. Sections 26.207 and 26.209 contain the provisions
for waivers and exceptions and self-declarations, which exempt
individuals from the work hour controls of Subpart I [Managing Fatigue]
under certain circumstances. The NRC has added the cross-references to
meet Goal 6 of this rulemaking to improve clarity in the organization
and language of the rule.
The final rule also revises some terminology used in the former
provision in response to stakeholder requests during the public
meetings discussed in Section I.D. The stakeholders indicated that,
because the former rule requires them to ``remove'' individuals whose
fitness may be questionable, some FFD programs have interpreted the
former paragraph as requiring them to terminate the individual's
authorization. This was not the intent of the former provision. In this
instance, the intent of the rule was for licensees and other entities
to prevent the individual from performing the duties that would require
the individual to be subject to this part in order to ensure that any
potential impairment could not result in errors or lapses in judgment
that may pose a risk to public health and safety or the common defense
and security until the cause of the problem could be identified and
resolved. Therefore, the final rule replaces the phrase, ``removed from
activities within the scope of this part,'' with the phrase, ``prevent
the individual from performing the duties,'' and makes other minor
changes to the wording of the former requirement to clarify the intent
of the provision. The NRC has made these changes to meet Goal 6 of this
rulemaking to improve clarity in the language of the rule.
Section 26.77(b)(1) retains the intent of former Sec. 26.24(a)(3).
This provision requires licensees and other entities to conduct drug
and alcohol testing for cause. The final rule requires for-cause
testing based upon a ``reasonable suspicion'' that the individual may
be impaired from possible substance abuse. Reasonable suspicion of
substance abuse could be based upon an observed
[[Page 17052]]
behavior, such as unusual lack of coordination or slurred speech, or a
physical condition, such as the smell of alcohol. If the only basis for
a reasonable suspicion is the smell of alcohol, then alcohol testing is
required. However, the final rule does not require the licensee or
other entity to perform a drug test unless other physical or behavioral
indicators of possible impairment are present.
The stakeholder comments received during the public meetings
discussed in Section I.D reported that many of the for cause tests they
perform are initiated as a result of a security officer or other person
reporting that an individual smells of alcohol without behavioral
indications of impairment. They also noted that the very large majority
of the for-cause drug tests that they conduct in these circumstances
yields negative results, including those instances in which the alcohol
test results are positive. The stakeholders suggested that the former
requirement to conduct drug tests in these circumstances imposes a
significant burden because the drugs tests impose costs, not only for
collecting and testing the urine specimens, but also because they
cannot permit the individual to resume performing his or her duties
until the drug test results are available, which may take several days.
The stakeholders argued that the burden is unnecessary because the drug
tests yield positive results so infrequently and, therefore, do not
serve their intended purpose of detecting drug abuse. Based on these
stakeholders' arguments and the FFD program performance data that
support them, the NRC concurs that drug testing is unnecessary when the
smell of alcohol is the only indication that for cause testing is
required, and has eliminated it from the final rule. The final rule
continues to require drug testing if there are behavioral or physical
indications of impairment in addition to the smell of alcohol.
The NRC has added Sec. 26.77(b)(2) to apply only to nuclear power
plant licensees and C/Vs who are subject to Subpart I. With respect to
the proposed rule, the final rule modifies the language of this
provision to improve its clarity and to more clearly specify the NRC's
intent. This section permits these entities to forego drug and alcohol
testing and the determination of fitness process required by Sec.
26.189 if a fatigue assessment conducted under Sec. 26.211 confirms
that the individual's observed behavior or physical condition is solely
a result of fatigue. This section applies only to licensees and C/Vs
who are subject to Subpart I because licensees not subject to Subpart I
would not have the requisite training to evaluate whether the observed
behavior is caused by fatigue. The NRC has made this change to meet
Goal 2 of this rulemaking to ensure against worker fatigue at nuclear
power plants and Goal 3 to improve the effectiveness and efficiency of
FFD programs.
The NRC has added Sec. 26.77(b)(3) to specify the actions that
licensees and other entities must take when there are indications that
an individual may be impaired, other than behavior or a physical
condition that creates a reasonable suspicion of substance abuse (or
fatigue, in the case of licensees who are subject to Subpart I).
Consistent with former Sec. 26.27(b)(1), the final rule permits the
licensee or other entity to return the individual to duty only after
identifying and resolving the cause of the impairing condition and
making a determination of fitness indicating that the individual is fit
to safely and competently perform his or her duties (see the discussion
of Sec. 26.189 for more details regarding the determination of fitness
process). This section does not require licensees and other entities to
unfavorably terminate an individual's authorization for illness,
fatigue, temporary mental and emotional stress, or other conditions
that may affect an individual's fitness, but prohibits the licensee or
other entity from assigning the impaired individual to perform the
duties that require him or her to be subject to this subpart until a
determination is made that the individual is fit to return to duty. The
NRC has made this change to meet Goal 2 of this rulemaking to ensure
against worker fatigue at nuclear power plants and Goal 3 to improve
the effectiveness and efficiency of FFD programs.
Section 26.77(c) of the final rule updates former Sec. 26.27(d) to
be consistent with current NRC notification procedures.
Subpart E--Collecting Specimens for Testing
Throughout Subpart E, the final rule makes minor clarifications to
the proposed rule because of public comment, to accommodate conforming
changes, and to meet Goal 6 of this rulemaking to improve clarity in
the organization and language of the rule. The final rule also makes
more substantive changes to the proposed rule in this subpart because
of public comment or to improve clarity in the organization and
language of the rule. The substantive changes in this subpart can be
found in Sec. Sec. 26.81; 26.85(c)(1), (c)(2), and (e); 26.87(e);
26.89(a)(2) and (c); 26.91(e)(4); 26.109(b)(1); and 26.111(a), (c) and
(d). These changes are discussed in detail below. However, other than
the changes mentioned above, the final rule adopts the provisions of
this subpart as proposed without change.
Section 26.81 Purpose and Applicability
This added section describes the purpose of Subpart E, which is to
establish requirements for collecting specimens for drug and alcohol
testing. The new section assists in locating provisions within the rule
and is consistent with Goal 6 of the rulemaking to improve clarity in
the organization and language of the rule.
The NRC revised the title of this section from ``Purpose'' in the
proposed rule to ``Purpose and applicability'' in the final rule to
reflect other modifications to this paragraph that the agency has made
in response to public comments that the applicability of the proposed
rule's requirements was unclear. This paragraph specifies that the
requirements of Subpart E apply to the licensees and other entities in
Sec. 26.3(a) through (d) to the extent that a C/V conducts drug and
alcohol testing on which a licensee or other entity in Sec. 26.3(a)
through (d) relies. The provision further specifies the applicability
of Subpart E's requirements by also listing the categories of
individuals who are subject to the subpart. These include the
categories of individuals listed in Sec. 26.4(a) through (e). In
addition, licensees and other entities may choose to conduct specimen
collections and alcohol testing under the requirements of this subpart
for the categories of individuals specified in Sec. 26.4(f) and (g).
However, Sec. Sec. 26.4(j), 26.31(b)(2), and Subpart K [FFD Programs
for Construction] permit licensees and other entities to rely on
specimen collections and alcohol testing that are conducted under the
requirements of 49 CFR Part 40, ``Procedures for Transportation
Workplace Drug Testing Programs'' (65 FR 41944; August 9, 2001), for
the reasons discussed with respect to those sections. In these
instances, Sec. 26.81 permits the specimen collections and alcohol
testing to be performed under DOT's procedures, rather than those
contained in Subpart E, for individuals who are subject to another
Federal or State FFD program in Sec. 26.4(j), FFD program personnel in
Sec. 26.31(b)(2), and the categories of individuals identified in
Sec. 26.4(f). These changes meet Goal 6 of the rulemaking to improve
clarity in the organization and language of the rule.
[[Page 17053]]
Section 26.83 Specimens To Be Collected
The NRC has added Sec. 26.83, which specifies the types of
specimens that licensees and other entities must collect for initial
and confirmatory drug and alcohol testing.
Section 26.83(a) requires licensees and other entities to collect
either breath or oral fluids (i.e., saliva) for initial alcohol tests.
The final rule continues to require collecting only breath specimens
for confirmatory alcohol testing. The final rule permits the use of
oral fluids (i.e., saliva) for initial alcohol tests because devices
for testing oral fluids for alcohol have matured sufficiently to
provide valid and reliable initial test results. Circumstances may
arise, such as collecting a specimen of oral fluids from a donor who
has impaired lung functioning, in which the use of these devices is
more efficient than collecting breath specimens for both donors and the
FFD program. Therefore, the permission to collect oral fluids for
initial alcohol testing meets Goal 3 of this rulemaking to improve the
efficiency of FFD programs. Additionally, other Federally mandated
alcohol testing programs permit the use of these devices for initial
alcohol testing. Therefore, adding permission to collect oral fluids
for initial alcohol testing to the final rule is consistent with Goal 1
of the rulemaking to update and enhance the consistency of Part 26 with
advances in other relevant Federal rules and guidelines.
The final rule eliminates the use of blood as a specimen for
alcohol testing at the donor's discretion, which was permitted in
former Sec. 26.24(g) and Section 2.2(d)(4) in Appendix A to Part 26.
The final rule eliminates the former provisions related to blood
alcohol testing for several reasons. Since the former rule was first
promulgated, licensees have repeatedly raised questions related to the
proper interpretation of a confirmatory alcohol test result using an
evidential breath testing device (EBT) and an alcohol test result
derived from a blood specimen when the results from the two types of
testing differ. Specifically, if a confirmatory alcohol test result
using an EBT is positive, but the result from testing a blood specimen
is negative, licensees have asked which test result they should rely on
in determining whether the donor has violated the FFD policy. Although
the NRC's original intent was that the result from the blood test was
to be definitive, delays in obtaining a blood specimen sometimes
resulted in blood test results that fell below the alcohol cutoff level
of 0.04 percent BAC due to alcohol metabolism during the period of the
delay. Some licensees have been reluctant to apply sanctions for a
positive alcohol test result in these instances even though alcohol
metabolism over time explains the lower test result from the blood
sample. Further, experience has shown that few donors request testing
of a blood sample. Data gathered from a sampling of representative FFD
programs show that individuals requested an average of fewer than one
blood test per program within the period reviewed (January-May 2002).
Additionally, the use of EBTs for confirmatory alcohol tests has
consistently withstood legal challenge. The added protection of donors'
rights that the NRC envisioned when promulgating the provisions for
voluntary testing of blood specimens has not been realized in practice.
The former requirement has also been costly for licensees. Licensees
must ensure that an individual who is trained to draw blood is
available to do so should a donor request blood testing. Based on
information provided by stakeholders at the public meetings discussed
in the preamble to the proposed rule, the NRC determined that the costs
associated with retaining this provision are not justified because of
the very few instances in which donors have requested blood alcohol
testing. Therefore, the agency has deleted from the final rule
references to collecting and testing blood specimens for alcohol.
Section 26.83(b) retains, but makes explicit, the implied
requirement in the first sentence of former Sec. 26.24(b) (and other
provisions that are interspersed throughout the former rule) for
licensees and other entities to collect only urine specimens for drug
testing. When the former rule was promulgated, it was unnecessary to
establish an explicit requirement to collect and test only urine
specimens for drugs in Part 26 programs because methods for testing
other specimens were not available and the HHS Guidelines only
addressed testing urine specimens. Since that time, methods for testing
alternate specimens, such as oral fluids, sweat, and hair, have become
commercially available and HHS has published proposed revisions to its
guidelines (69 FR 19673; April 13, 2004) that would permit the use of
alternate specimens for drug testing in Federal workplace drug testing
programs. The NRC is considering permitting the use of alternate
specimens for drug testing when HHS has published final revisions to
its guidelines related to these types of specimens. The revised HHS
Guidelines will establish acceptable collection procedures and testing
methods. However, HHS has not yet published final guidelines for
collecting and testing these alternate specimens. Therefore, it is
necessary to add Sec. 26.83(b) to the final rule to clarify that the
NRC intends to continue prohibiting the collection and drug testing of
specimens other than urine in this rulemaking except as permitted under
Sec. 26.31(d)(5) [Medical conditions]. The reasons are as discussed
with respect to that section.
Section 26.85 Collector Qualifications and Responsibilities
This added section replaces the collector qualifications and
training requirements specified in the definition of ``collection site
person'' in the former rule and in former Sections 1.2, 2.2(d), and
2.4(b) in Appendix A to Part 26. This section retains the intent of the
former provisions, but the final rule groups the requirements together
to improve organizational clarity. In addition, the final rule amends
the former collector qualifications and training requirements to
increase the consistency of Part 26 with the requirements of other
Federal agencies and incorporates the lessons learned from those
programs as discussed with respect to Goal 1 of this rulemaking.
Section 26.85(a) [Urine collector qualifications] provides more
detailed requirements for urine collector qualifications and training
than are contained in the former definition of ``collection site
person'' and former Section 2.2(d) in Appendix A to Part 26. The final
rule requires urine collectors to be knowledgeable of the requirements
of this part, the FFD policy and procedures of the licensees or other
entities for whom they perform collections, and to keep current on any
changes to urine collection procedures. These changes increase the
consistency of urine collector qualification requirements with those of
other Federal workplace drug testing programs as well as consistency in
urine collection procedures among FFD programs that are subject to this
subpart.
Section 26.85(a) retains the requirements in former Section 2.2(d)
that urine collectors must receive training to perform their duties and
demonstrate proficiency in applying the requirements of this section
before serving as a collector. Section 26.85(a)(1) through (a)(4) lists
the topics that the final rule requires collector training to address.
Section 26.85(a)(1) requires collectors to be trained in the steps that
are necessary to complete a collection correctly and the proper
[[Page 17054]]
completion and transmission of the custody-and-control form to the
licensee testing facility or HHS-certified laboratory, as appropriate.
Section 26.85(a)(2) requires training in methods to address ``problem''
collections. These may include, but are not limited to, collections
involving ``shy bladder'' (see the discussion of proposed Sec. 26.119
[Determining ``shy'' bladder] for an explanation of this term and the
procedures involved) and attempts by a donor to tamper with a specimen.
Section 26.85(a)(3) requires the training to instruct collectors on
correcting collection problems. These may include, but are not limited
to, a donor refusing to cooperate with the collection process or an
incident in which a urine specimen is spilled. Section 26.85(a)(4)
requires training so that a collector is knowledgeable in maintaining
the integrity of the specimen collection and transfer process, and
ensuring that donors' privacy and modesty are maintained. The NRC added
these requirements to meet Goal 1 of this rulemaking to update and
enhance the consistency of Part 26 with advances in other relevant
Federal rules and guidelines.
Section 26.85(a)(4) retains the portion of former Section 2.2(d)(1)
in Appendix A to Part 26 that required collector training to emphasize
the collector's responsibility for maintaining the integrity of the
specimen collection and transfer process, carefully ensuring the
modesty and privacy of the donor, and avoiding any conduct or remarks
that might be construed as accusatorial or otherwise offensive or
inappropriate.
The NRC added Sec. 26.85(b) [Alcohol collector qualifications] to
specify requirements related to alcohol collector qualifications and
training. Portions of this section are the same as the requirements for
urine collectors in Sec. 26.85(a), including the first three sentences
of Sec. 26.85(b), and (b)(4) and (b)(5). The agency added these
requirements here for the same reasons discussed with respect to the
first three sentences of Sec. 26.85(a), and (a)(3) and (a)(4),
respectively. The final rule repeats the requirements that are
applicable to both urine and alcohol collectors in each of these
paragraphs because some FFD programs may not train collectors to
perform both types of collections. Repeating the requirements makes it
easier to locate the requirements that apply to urine or alcohol
collectors and meets Goal 6 of the rulemaking to improve clarity in the
organization of the rule.
Section 26.85(b)(1) and (b)(3) requires alcohol collectors to
receive training that addresses the alcohol testing requirements of
this part and methods to address ``problem'' collections. These
include, but are not limited to, collections involving ``shy lung''
problems or attempts by a donor to tamper with a specimen. In contrast
to Sec. 26.85(a)(2), which addresses ``shy bladder'' problems in urine
collections, the final rule does not incorporate the related DOT
procedures for evaluating ``shy lung'' problems in alcohol collections.
During the public meetings discussed in the preamble to the proposed
rule, stakeholders requested that the proposed rule incorporate DOT's
``shy bladder'' procedures, but did not believe that adding DOT's ``shy
lung'' procedures to the final rule is necessary. The stakeholders
reported that donors have not experienced problems related to ``shy
lung,'' based on their experience implementing the breath testing
requirements of Part 26 since the rule was first promulgated.
Therefore, Sec. 26.85(b)(3) requires alcohol collectors to be able to
implement the ``shy lung'' procedures established by any FFD program
for whom the collectors are providing collection services, but does not
establish requirements for responding to ``shy lung'' problems in the
rule.
The final rule adds Sec. 26.85(b)(2) to require alcohol collectors
to be trained in the operation of the particular alcohol testing
device(s) (i.e., the ASDs and EBTs) to be used in conducting alcohol
tests, consistent with the most recent version of the manufacturers'
instructions. The final rule adds this requirement because the NRC is
aware that some FFD programs did not implement device manufacturers'
recommended changes to instructions for using the testing devices.
Although the NRC staff is not aware of any testing errors or instances
in which donors have challenged the results of alcohol tests that were
not performed in accordance with the most recent version of the device
manufacturer's instructions, the final rule adds this requirement to
ensure that alcohol test results continue to be accurate and cannot be
challenged on this basis. The changes are also consistent with the
alcohol collector training requirements of other Federal agencies.
Section 26.85(c) [Alternative collectors] amends the last sentence
of former Section 2.2(d)(2) in Appendix A to Part 26. The former
provision permitted medical personnel to perform specimen collections
without receiving the required training for non-medical collectors. The
final rule permits medical personnel to conduct specimen collections
for the purposes of this subpart only under the conditions specified in
Sec. 26.85(c)(1) through (c)(5). These conditions may include, but are
not limited to, the collection of specimens for post-event testing by a
nurse or medical technician at a hospital. The final rule limits the
circumstances in which an untrained medical professional, technologist,
or technician may perform collections for a licensee or other entity
because the experience of other Federal agencies has shown that medical
personnel who are untrained in specific collection procedures have
committed errors in collections that resulted in unnecessary legal
challenges to test results. At the same time, the NRC is also aware
that licensees and other entities may occasionally have to rely on
these individuals to collect specimens for drug and alcohol testing, as
discussed with respect to Sec. 26.4(i)(1). Therefore, the final rule
permits untrained medical personnel to collect specimens to facilitate
the collection of specimens for testing in rare circumstances in which
a qualified collector could not reasonably be expected to be available,
but otherwise requires medical personnel who do not meet the criteria
specified in Sec. 26.85(c)(1) through (c)(5) to receive the same
training as non-medical collectors. The NRC made this change to meet
Goal 3 of the rulemaking to improve the effectiveness and efficiency of
FFD programs, by reducing the likelihood of errors and legal challenges
to test results. In addition, the final rule also makes minor changes
to the organization of this paragraph in response to a public comment
indicating a lack of clarity in the same provision in the proposed
rule.
The NRC has eliminated former Section 2.2(d)(4) in Appendix A to
Part 26, which required that donors must be informed of the option to
request blood testing. The agency eliminated the former requirement
because the final rule no longer permits donors to request blood
testing for alcohol, as discussed with respect to Sec. 26.83(a).
Section 26.85(d) amends former Section 2.7(o)(5) [Personnel
available to testify at proceedings] in Appendix A to Part 26. This
section required the licensee testing facility and HHS-certified
laboratory to make available qualified individuals to testify in
administrative or disciplinary proceedings related to drug and alcohol
test results. The final rule adds an explicit requirement for
collection site personnel to be available to testify at proceedings
because the former provision implied, but did not explicitly state this
requirement. When the rule was first published, licensee testing
facilities and collection sites were
[[Page 17055]]
typically co-located at a site. However, this is no longer the case. In
some current FFD programs, alcohol testing and urine specimen
collections occur at the collection site, but initial testing of urine
specimens is performed at a licensee testing facility that may not be
co-located with the collection site. Therefore, the NRC has added this
paragraph to retain the former rule's original intent that licensees
and other entities must make available collection site personnel to
testify, as needed, in administrative and/or legal proceedings related
to an alcohol or drug test result. For organizational clarity, the
final rule moves the requirements in the former paragraph that
addressed the availability of personnel to testify in proceedings
related to drug test results from the licensee testing facility to
Sec. 26.139(c) of Subpart F [Licensee Testing Facilities] and those
related to HHS-certified laboratories to Sec. 26.153(f)(2) of Subpart
G [Laboratories Certified by the Department of Health and Human
Services].
The NRC added Sec. 26.85(e) to the final rule in response to a
public comment noting that the proposed rule did not include a
requirement for licensees and other entities to ensure that personnel
files are maintained for collectors. The new paragraph establishes
requirements for personnel files for collectors to document their
training and other qualifications for the positions they hold. This
documentation may be necessary in administrative and/or legal
proceedings related to an alcohol or drug test result.
Section 26.87 Collection Sites
The NRC has reorganized requirements related to specimen collection
sites in the former rule and grouped them together in this section.
Requirements related to collection sites were distributed among several
different sections in Appendix A to Part 26 of the former rule. The
agency made this change to improve organizational clarity in the rule.
Section 26.87(a) amends former Section 2.4(a) in Appendix A to Part
26. This former section required FFD programs to designate collection
sites and ensure that they are fully equipped to collect specimens for
testing. The final rule deletes references to blood specimens because
the final rule no longer provides donors with the option to request
blood testing for alcohol for the reasons discussed with respect to
Sec. 26.83(a). The final rule adds a requirement for collection sites
to be capable of alcohol testing that the former section implied but
did not explicitly state. The agency made this change to meet Goal 6 of
this rulemaking to improve clarity in the language of the rule. This
section retains the permission in the former rule for licensees and
other entities to use properly equipped mobile collection facilities.
Section 26.87(b) revises the first sentence of former Section
2.4(f) in Appendix A to Part 26 to require visual privacy for donors
while the donor and collector are viewing the results of an alcohol
test and retains the former requirement for individual privacy during
urine specimen collections, except if the urine specimen collection
must be conducted under direct observation. The new requirement for
visual privacy while viewing alcohol test results increases the
consistency of Part 26 with the alcohol testing procedures of other
Federal agencies and assures greater privacy for donors who are subject
to FFD programs that did not provide visual privacy under the former
rule. The NRC made this change to meet Goal 7 of this rulemaking to
protect the privacy of individuals who are subject to Part 26. For
organizational clarity, the final rule moves the former requirements in
Section 2.4(f) in Appendix A to Part 26 that are related to collecting
a specimen under direct observation to Sec. 26.115 [Collecting a urine
specimen under direct observation].
Section 26.87(c) retains only the portion of former Section 2.7(m)
in Appendix A to Part 26 that required licensees' and other entities'
contracts for collection site services to permit unfettered NRC,
licensee, and other entity access to collection sites for unannounced
inspections. The final rule moves the portions of the former section
that apply to HHS-certified laboratories to Sec. 26.153(f) of Subpart
G for organizational clarity. In addition, Sec. 26.87(c) adds a
requirement that licensees' and other entities' contracts for
collection site services must permit unfettered NRC, licensee, and
other entity access to all information and documentation that is
reasonably relevant to inspections and audits. The final rule adds this
requirement for access to documentation for consistency with the HHS
Guidelines, which also require collection sites to provide information
and documentation as part of inspections and audits. Therefore, this
change meets Goal 1 of this rulemaking to update and enhance the
consistency of Part 26 with advances in other relevant Federal rules
and guidelines. The agency also added the term ``audit'' to this
section because, although the NRC conducts inspections, licensees and
other entities are required to conduct audits under Sec. 26.41 [Audits
and corrective action]. Adding this term to this paragraph increases
the clarity of its language, consistent with Goal 6 of the rulemaking.
Section 26.87(d) revises former Section 2.4(c) in Appendix A to
Part 26 to clarify requirements for assuring collection site security
and the integrity of specimen collection procedures. For organizational
clarity, the final rule groups requirements related to assuring the
security of a licensee's or other entity's designated collection site
in this paragraph. For the same reason, the final rule moves to Sec.
26.87(f) the requirements contained in former Section 2.4(c) in
Appendix A to Part 26 that address assuring collection security when a
designated collection site is inaccessible and there is an immediate
requirement to collect a urine specimen. Section 26.87(d) includes
other clarifying changes to former Section 2.4(c) in Appendix A to Part
26, in response to stakeholder requests at the public meetings
discussed in Section IV.D.
Section 26.87(d)(1) retains the first sentence of former Section
2.4(e) in Appendix A to Part 26 and permits only authorized personnel
to have access to any part of a collection site in which specimens are
collected and stored. For organizational clarity, the final rule moves
this requirement to this section because it addresses the topic of
collection site security.
Section 26.87(d)(2) amends the second sentence of former Section
2.4(c) in Appendix A to Part 26. The former provision required
collection sites to be secure, and the final rule adds examples of
acceptable methods to assure collection site security. The NRC added
these examples in response to stakeholder requests during the public
meetings discussed in the preamble to the proposed rule. The
stakeholders noted that the requirement that collection sites ``must be
secure'' has raised many implementation questions. Therefore, the final
rule adds examples of acceptable means to ensure collection site
security, including, but not limited to, physical measures to control
access, such as locked doors, alarms, or visual monitoring of the
collection site when it is not occupied. The agency made this change to
meet Goal 6 of this rulemaking to improve clarity in the language of
the rule.
Section 26.87(d)(3) amends the third sentence in former Section
2.4(c) in Appendix A to Part 26. The former provision required that the
portion of any facility that is not dedicated solely to drug and
alcohol testing must be secured during testing. The final rule
[[Page 17056]]
retains that requirement and combines it with the third sentence of
former Section 2.4(c)(1) in Appendix A to Part 26. The provision
requires the protection of the facility against unauthorized access
during the collection. The final rule replaces the phrase, ``in the
case of a public restroom,'' in the last sentence of former Section
2.4(c)(1) in Appendix A to Part 26, with the phrase, ``if a collection
site cannot be dedicated solely to collecting specimens,'' to clarify
that a specimen may be collected at locations other than public
restrooms. The NRC makes these changes to meet Goal 6 of this
rulemaking to improve clarity in the organization and language of the
rule.
The agency has added Sec. 26.87(e) to specify the steps that
licensees and other entities must take to deter dilution and
adulteration of specimens during urine collections. This section
retains and amends portions of former Section 2.4(g) in Appendix A to
Part 26.
Section 26.87(e)(1) relaxes the former requirement in Section
2.4(g)(1) of Appendix A to Part 26 to use a bluing agent in any source
of standing water, such as a toilet bowl or tank. The final rule
permits licensees and other entities to use colors other than blue.
However, the final rule prohibits use of a yellow coloring agent
because it precludes the collector's ability to determine whether a
donor had diluted the specimen with water from a source of standing
water in the stall or room in which the donor provides a specimen. The
relaxation does not affect the accuracy of drug tests but gives FFD
programs increased flexibility in the choice of coloring agents. The
agency made this change in response to stakeholder requests during the
public meetings discussed in the preamble to the proposed rule and to
meet Goal 5 of this rulemaking to improve Part 26 by eliminating or
modifying unnecessary requirements.
Section 26.87(e)(2) retains the second sentence of former Section
2.4(g)(1) in Appendix A to Part 26, which requires sources of standing
water to be secured, but shortens it without changing the intended
meaning of the requirement. The agency made this change to improve
clarity in the language of the rule.
The final rule adds Sec. 26.87(e)(3) to require that chemicals or
products that could be used to adulterate a urine specimen must be
secured or removed from the collection site. The paragraph also
requires the collector to inspect the enclosure to ensure that no
potential adulterants are available before the donor enters the stall
or enclosure. The agency intends these requirements to prevent possible
donor attempts to subvert the testing process by adulterating a urine
specimen with materials that are available at the collection site. This
provision meets Goal 3 of this rulemaking to improve the effectiveness
of FFD programs. The provision is also consistent with the related
requirements of other Federal agencies.
Section 26.87(f) reorganizes former Section 2.4(c)(1), portions of
Section 2.4(c)(2), and Section 2.4(g)(10) in Appendix A to Part 26 to
prescribe acceptable procedures for collecting specimens at locations
other than a designated collection site in unusual circumstances, such
as a specimen collection for post-event testing at a hospital. The
final rule groups these requirements together in a single paragraph and
separates them from those related to collecting specimens at a
designated collection site in Sec. 26.87(d) and (e) to make it easier
to locate these requirements within the rule. The NRC made this change
to improve organizational clarity in the rule.
Section 26.87(f)(1) amends former Section 2.4(c)(1) in Appendix A
to Part 26, which established requirements for securing a location that
is not a designated collection site but will be used for a specimen
collection(s). The final rule requires either an individual to guard
access to a public rest room while the collection is occurring or the
posting of a sign to ensure that no unauthorized personnel enter the
area during the collection. The former rule required only the posting
of a sign. However, stationing an individual to guard access is at
least as effective. The final rule permits an individual to guard
access to the collection area in response to stakeholder requests for
this flexibility during the public meetings discussed in the preamble
to the proposed rule. This change meets Goal 5 of this rulemaking to
improve Part 26 by eliminating or modifying unnecessary requirements.
Section 26.87(f)(2) retains the third sentence of former Section
2.4(g)(10) in Appendix A to Part 26 that requires using a water-
coloring agent, if possible, to deter a possible dilution or
adulteration attempt when a collection must occur at a location other
than the licensee's or other entity's designated collection site.
Section 26.87(f)(3) retains the requirement in the second sentence
of former Section 2.4(g)(10) that the collector must be the same gender
as the donor in the exceptional event of a specimen collection
occurring at a location other than the FFD program's designated
collection site. However, if a collector of the same gender is
unavailable, the rule permits another person of the same gender who is
instructed in the requirements of Subpart E [Collecting Specimens for
Testing] to assist in the collection. The provision requires either the
collector or the observer to remain outside the area in which the donor
will provide the urine specimen to protect the donor's privacy and the
integrity of the collection process. The rule requires documentation of
the observer's identity on the custody-and-control form so that the
observer may be located should any subsequent questions arise with
respect to the collection in a review under Sec. 26.39 [Review process
for fitness-for-duty policy violations] or legal proceedings. The
flexibility to rely on a person of the same gender as an observer, if a
collector of the same gender is unavailable, is consistent with the
procedures of other Federal agencies and reduces potential
embarrassment to the donor. Therefore, this change meets Goal 1 of this
rulemaking to update and enhance the consistency of Part 26 with
advances in other relevant Federal rules and guidelines, and Goal 7 to
protect the privacy of individuals who are subject to Part 26.
Section 26.87(f)(4) requires the collector, once he or she is in
possession of the donor's specimen, to inspect the area in which the
specimen donation occurred for any evidence of a subversion attempt by
the donor. This paragraph amends the fifth and sixth sentences of
former Section 2.4(g)(10) in Appendix A to Part 26 that described the
required sequence of actions during a specimen collection and specified
that a donor is permitted to flush the toilet after a specimen
donation. The final rule eliminates the option for the donor to flush
the toilet and directs the collector to instruct the donor not to flush
the toilet. The change reduces the possibility that a donor could
dispose of evidence of a subversion attempt by flushing it down the
toilet. Section 26.87(f)(4) directs the collector to inspect the toilet
bowl and area once he or she receives the specimen from the donor. The
final rule adds these provisions to reduce the opportunities for a
donor to subvert the testing process at a location that is not a
designated collection site to meet Goal 3 of this rulemaking to improve
the effectiveness of FFD programs. The requirements also meet Goal 1 to
update and enhance the consistency of Part 26 with advances in other
relevant Federal rules and guidelines.
Section 26.87(f)(5) amends the portions of former Section 2.4(c)(2)
in Appendix A to Part 26 that defined requirements for maintaining
control of
[[Page 17057]]
specimens that are not collected at a designated collection site. The
final rule permits an ``authorized individual,'' including, for
example, a security officer or hospital medical technician, to maintain
physical custody and control of specimens, rather than only the
collector, as the former rule required. The licensee or other entity
must designate the ``authorized individual'' and ensure that he or she
is instructed in his or her responsibilities for maintaining custody
and control of the specimen. The authorized individual's custody of the
specimen must be documented on the custody-and-control form to ensure
that the individual may be located should any subsequent questions
arise with respect to the collection in a review under Sec. 26.39 or
legal proceedings. This change continues to ensure specimen integrity
and security, but responds to industry experience, as described by
stakeholders at the public meetings discussed in the preamble to the
proposed rule. The stakeholders reported that it is sometimes difficult
in unusual circumstances, such as the hospital setting, for the
collector to maintain physical custody of the specimen until it is
prepared for transfer, storage, or shipping. Therefore, the NRC made
this change to meet Goal 5 of this rulemaking, to improve Part 26 by
eliminating or modifying unnecessary requirements, while also
continuing to meet Goal 7 to protect the privacy and other rights
(including due process) of individuals who are subject to Part 26.
Section 26.89 Preparing To Collect Specimens for Testing
This added section describes the preliminary steps that the
collector and donor must take before specimens will be collected for
drug and alcohol testing. This section reorganizes and amends portions
of the former Appendix A to Part 26, and adds several new requirements.
The final rule presents these requirements in a new section to
facilitate locating them within the final rule to meet Goal 6 of this
rulemaking to improve clarity in the organization of the rule.
Section 26.89(a) provides more detailed requirements than those
contained in former Section 2.4(g)(3) in Appendix A to Part 26 for
actions to be taken if an individual does not appear for testing. The
former rule required the collector to contact an ``appropriate
authority'' to determine the actions to take if a donor does not appear
for testing. At the public meetings discussed in the preamble to the
proposed rule, some stakeholders indicated that the lack of specificity
in the former rule with respect to the actions that the ``appropriate
authority'' must take in these circumstances has led some FFD programs
to interpret this provision as requiring the imposition of the
sanctions for a ``refusal to test'' on an individual who fails to
appear, including situations in which there is clear evidence that the
individual had not been informed that he or she was required to appear
for testing or was otherwise not at fault for the failure. This was not
the NRC's intent. Therefore, under this new provision, when informed
that an individual who was selected for testing has not appeared at the
required time, FFD program management must ensure that the
circumstances are investigated and determine whether the individual's
absence or tardiness represents an attempt to avoid testing and,
therefore, subvert the testing process. The final rule requires the
licensee or other entity to impose the sanctions specified in Sec.
26.75(b) for a refusal to test only if the investigation identifies
evidence that the individual's failure to appear for testing was a
subversion attempt. If the investigation does not identify evidence of
a subversion attempt, the final rule prohibits the licensee or other
entity from imposing sanctions and requires testing the individual at
the earliest reasonable and practical opportunity after the individual
is located. The NRC has added these more detailed requirements to
strengthen the rule's effectiveness in preventing subversion by
ensuring that a failure to appear for testing is investigated to
increase the likelihood of detecting a willful attempt to avoid
testing. In addition, the requirements prevent an individual from being
subject to a permanent denial of authorization, as required under Sec.
26.75(b), if the individual's failure to appear is determined to be
outside of the individual's control or otherwise not a result of a
willful attempt to avoid testing. The agency has made these changes to
meet Goal 3 of this rulemaking to improve the effectiveness of FFD
programs, and Goal 7 to protect the privacy and other rights (including
due process) of individuals who are subject to Part 26.
Section 26.89(b) reorganizes and expands former Section 2.4(g)(2)
in Appendix A to Part 26, which required the collector to ensure that
an individual who arrives at the collection site for testing is
positively identified. The final rule adds more detailed requirements
for the reasons discussed with respect to each requirement.
Section 26.89(b)(1) retains the requirement in former Section
2.4(g)(2) in Appendix A to Part 26 for the collector to positively
identify the donor before beginning a collection. This section
specifies the types of photo identification that the licensee or other
entity may accept to establish a donor's identity.
Section 26.89(b)(2) amends the portion of former Section 2.4(g)(2)
in Appendix A to Part 26 that directed the collector to stop the
collection if the individual cannot be positively identified. The
amended provision directs the collector to proceed with the collection
and inform FFD program management that the donor did not present
acceptable photo identification. This paragraph requires FFD management
to take the necessary steps to determine whether the lack of
identification is an attempt to subvert the testing process. However,
the provision retains the former requirement for the collector to delay
the collection until the individual can be identified if it is a pre-
access test. The NRC has made these changes for several reasons.
First, lessons learned from implementing the former rule have
indicated that the large majority of failures to present acceptable
identification result from miscommunication or other errors that are
easily resolved. However, stopping or delaying the specimen collection
may alter test results (e.g., if an individual has consumed alcohol,
the individual's alcohol test result would show a lower BAC after a
delay or may not be detected if testing is not conducted). Therefore,
collecting the specimens first and then resolving the individual's
identity ensures that test results are available and accurate from
donors who are currently authorized and whose identity the licensee or
other entity has previously confirmed. Therefore, this change meets
Goal 3 of this rulemaking to improve the effectiveness and efficiency
of FFD programs.
Second, the former requirement to stop the collection without
investigating the reasons that the individual is unable to present
acceptable identification does not ensure that an attempt by an
individual to subvert the testing process is detected. For example, an
individual who has engaged in substance abuse could delay specimen
collection by claiming to have ``forgotten'' his or her photo
identification in his or her car or locker. Permitting the individual
to leave the collection site to obtain his or her identification
provides an opportunity for the individual to obtain an adulterant or
substitute urine that he or she could then use to subvert the testing
process. Steps that FFD program management could take to investigate
[[Page 17058]]
the reasons that the individual did not present acceptable
identification in this instance could include assigning a security
officer to accompany the individual to his or her car or locker to
verify the individual's claim, as well as to ensure that the individual
does not have the opportunity to bring an adulterant or substitute
urine back to the collection site. Therefore, the new requirement
strengthens the effectiveness of FFD programs in detecting attempts to
subvert the testing process.
The final rule modifies the proposed rule to permit an individual's
supervisor, except for pre-access tests, to positively identify an
individual who appears for testing without acceptable photo
identification. The NRC made this change in response to a public
comment, which noted that under many FFD programs, supervisors are
trusted to notify donors that they have been selected for random
testing, and, therefore, it is reasonable to trust supervisors also to
verify a donor's identity. The change increases the consistency of Part
26 with access authorization requirements established in 10 CFR 73.56,
as supplemented by orders to nuclear power plant licensees dated
January 7, 2003 (Goal 4 of this rulemaking).
Section 26.89(b)(3) retains the former requirement to delay the
specimen collection until the individual presents acceptable
identification if it is a pre-access test, at the request of
stakeholders during the public meetings discussed in the preamble to
the proposed rule. The stakeholders noted that the former requirement
to delay pre-access testing until the individual presents acceptable
photo identification does not present a risk to public health and
safety or the common defense and security from a possible subversion
attempt because the individual does not yet have access to sensitive
information, radiological materials, or safety systems and equipment.
Furthermore, stakeholders noted that retaining the former provision
saves licensees and other entities from the expense associated with
collecting and testing a specimen from the wrong individual. Therefore,
the NRC believes it is reasonable to retain the former requirement as
it relates to pre-access tests.
Section 26.89(b)(4) updates former Section 2.4(g)(4) and
2.4(g)(23)(ii) in Appendix A to Part 26, in which, before any specimens
are collected, donors were required to list the prescription and over-
the-counter medications they had used within the 30 days before
testing. To be consistent with the privacy requirements of the
Americans with Disabilities Act [Pub. L. 101-336, July 26, 1990], the
final rule eliminates the requirement to list medications prior to
specimen collection and testing. The final rule requires donors to
provide medication information to the MRO only in the event of
positive, adulterated, substituted, or invalid confirmatory validity
and/or drug test result to enhance their rights to privacy under the
rule. This revised requirement is also consistent with the procedures
of other Federal agencies and meets Goal 1 of this rulemaking to update
and enhance the consistency of Part 26 with advances in other relevant
Federal rules and guidelines.
Section 26.89(b)(4) also adds a requirement for the collector to
explain the testing procedure to the donor. Former Section 2.2(d)(3) in
Appendix A to Part 26 required providing individuals who are subject to
testing with standard written instructions setting forth their
responsibilities. However, the NRC is aware that individuals typically
receive these instructions as part of the training that is required
under former Sec. 26.21 [Policy communications and awareness training]
rather than at the collection site before starting the specimen
collection process. This was not the intent of Section 2.2(d)(3) in
Appendix A to Part 26. Rather than retaining and clarifying the former
provision for standard written instructions that some individuals may
have difficulty comprehending, the final rule adopts the related
practices of other Federal agencies, which require the collector to
explain the testing procedure to the donor. This change ensures that
individuals are informed of the testing process in which they must
participate and their responsibilities. It also meets Goal 7 of this
rulemaking to protect the privacy and other rights (including due
process) of individuals who are subject to Part 26, and Goal 1, by
enhancing the consistency of Part 26 with the requirements of other
Federal agencies.
The NRC added Sec. 26.89(c) to ensure that the donor is aware of
his or her responsibilities to cooperate with the specimen collection
process. This paragraph responds to reports from stakeholders at the
public meetings discussed in the preamble to the proposed rule that
some donors have attempted to obstruct or delay the collection process
on the basis that the former rule implied, but did not explicitly
state, the donor's responsibility to cooperate with the collection
process. Therefore, the new provision eliminates that basis for
obstructing or delaying collections, which improves the effectiveness
and efficiency of FFD programs, consistent with Goal 3 of this
rulemaking.
This section also requires the collector to inform the donor that a
failure to cooperate in the specimen collection process is considered a
refusal to test and may result in a permanent denial of authorization
under Sec. 26.75(b). In response to public comment, the final rule
adds examples to those in the proposed rule describing behavior that
may be determined to be a refusal to test. In addition to leaving the
collection site before the collection is complete, the final rule adds
behaving in a confrontational manner that disrupts the testing process;
admitting to the collector that the donor has substituted, diluted, or
adulterated the specimen; or the collector finds that the donor has a
device, such as a prosthetic appliance, the purpose of which is to
interfere with providing an actual urine specimen. Other examples could
include a donor refusing to permit the collector to examine the
contents of the donor's pockets or the donor refusing to wash his or
her hands when directed by the collector. The final rule does not
provide an exhaustive list of behaviors that comprise a refusal to test
because they are too numerous to list. However, the NRC has added these
examples for increased clarity in the rule. Informing donors of the
potential consequences of failing to cooperate in the collection
process, in advance, is consistent with Goal 7 of this rulemaking to
protect the privacy and other rights (including due process) of
individuals who are subject to Part 26. The requirements of this
section also meet Goal 1 to improve the consistency of NRC requirements
with those of other Federal agencies.
Section 26.89(d) retains the last two sentences of former Section
2.4(e) in Appendix A to Part 26. These provisions require the collector
to conduct only one urine specimen collection at a time and define the
point at which the collection process ends, which is when the donor has
left the collection site. The NRC has retained these provisions in this
paragraph because they relate to the topic of this section, which is
preparing for specimen collections, to ensure that collectors are aware
of this requirement before they begin collecting any specimens. The
change improves the organizational clarity of the rule.
Section 26.91 Acceptable Devices for Conducting Initial and
Confirmatory Tests for Alcohol and Methods of Use
This added section amends requirements in the former rule that
addressed alcohol testing devices and
[[Page 17059]]
methods of use. The requirements in the former rule that are related to
this topic appeared in former Sec. 26.24(g) and Sections 2.4(g)(18)
and 2.7(o)(3)(ii) in Appendix A to Part 26. This section combines these
requirements, amends the former requirements, and adds others. The
final rule groups these requirements in one section to meet Goal 6 of
this rulemaking to improve clarity in the organization of the rule.
The agency added Sec. 26.91(a) [Acceptable alcohol screening
devices] to permit the use of alcohol screening devices (ASDs) for
initial testing and establish requirements for the ASDs that may be
used. Acceptable ASDs include alcohol saliva analysis devices and
breath testing devices that are listed on the most recent version of
NHTSA's Conforming Products List (CPL) for ASDs (66 FR 22639; May 4,
2001, and subsequent amendments). Former Section 2.7(o)(3)(ii) in
Appendix A to Part 26 limited FFD programs to using only evidential-
grade breath testing devices. However, permitting FFD programs to use
ASDs listed on NHTSA's CPL for initial alcohol testing is consistent
with other Federal agencies' procedures for workplace alcohol testing.
Therefore, the change meets Goal 1 of this rulemaking to update and
enhance the consistency of Part 26 with advances in other relevant
Federal rules and guidelines.
Further, permitting the use of some ASDs for initial alcohol
testing provides increased flexibility in conducting initial alcohol
tests. Licensees and other entities may find that, over time, it is
less expensive to use a particular ASD than to continue using EBTs for
all initial alcohol tests. The option to use alcohol saliva analysis
devices also may reduce the burden of alcohol testing for some donors,
such as individuals who have impaired lung functioning. The final
rule's permission to use ASDs that are listed on NHTSA's CPL for ASDs
for initial alcohol testing meets Goal 5 of this rulemaking to improve
Part 26 by eliminating or modifying unnecessary requirements by
increasing FFD programs' flexibility in administering initial alcohol
tests.
Section 26.91(b) [Acceptable evidential breath testing devices]
amends former Section 2.7(o)(3)(ii) in Appendix A to Part 26 and
establishes new requirements for the EBTs that licensees and other
entities must use for confirmatory alcohol breath testing. The new
section requires licensees and other entities to use EBTs that are
listed on the most recent version of NHTSA's CPL for evidential breath
testing devices without an asterisk (67 FR 62091; October 3, 2002, and
subsequent amendments) when conducting confirmatory alcohol tests, and
permits licensees and other entities to use these EBTs for conducting
initial alcohol tests. The EBTs that are listed without an asterisk
incorporate many improvements in EBT technology and have been shown to
accurately detect BACs at the 0.02 percent level. Therefore, they are
the appropriate instruments to use for confirmatory testing at the
revised alcohol cutoff levels specified in Sec. 26.103 [Determining a
confirmed positive test result for alcohol].
Further, because these EBTs have been shown to provide valid,
reliable, and legally defensible results in other Federal programs that
also require workplace alcohol testing, the new requirement to use
these EBTs permits two additional changes to the alcohol testing
procedures contained in former Section 2.4(g)(18) in Appendix A to Part
26: (1) Collecting only one breath specimen for the initial alcohol
test and one for the confirmatory test in Sec. Sec. 26.95(c) and
26.101(c), rather than the two specimens that were required for each
test under the former rule; and (2) conducting both the initial and
confirmatory tests (if a confirmatory test is required) using the same
EBT in Sec. 26.101(d). As discussed further with respect to Sec. Sec.
26.95(c) and 26.101(c) and (d), these changes to the former alcohol
testing requirements improve the efficiency of alcohol testing while
continuing to provide valid, reliable, and legally defensible results
that are necessary to protect donor's rights under workplace alcohol
testing programs. The use of these improved EBTs is similarly required
for confirmatory alcohol testing and permitted for initial testing
under 49 CFR Part 40. Therefore, this change meets Goal 1 of this
rulemaking to update and enhance the consistency of Part 26 with
advances in other relevant Federal rules and guidelines; Goal 3 to
improve the efficiency of FFD programs; and Goal 5 to improve Part 26
by eliminating or modifying unnecessary requirements.
The NRC added Sec. 26.91(c) [EBT capabilities] to specify the
required capabilities of the EBTs that licensees and other entities may
use for initial alcohol testing and must use for confirmatory alcohol
tests. The EBT capabilities listed in Sec. 26.91(c)(1) through (c)(3)
are necessary to ensure that a confirmatory alcohol test result can be
uniquely associated with the instrument used, the time of testing, and
the donor. These capabilities are necessary to establish an
unimpeachable chain of custody for confirmatory alcohol test results as
well as permit the accurate identification of any test results that may
have been affected by instrument malfunctions that are discovered later
through additional quality assurance checks. The EBT capabilities
listed in Sec. 26.91(c)(4) and (c)(5) ensure that test results will be
accurate by requiring collectors to verify before each test that the
instrument is functioning properly and there will be no carryover
effects from previous testing. With respect to the proposed rule, the
final rule revises the language of proposed Sec. 26.91(c)(6) to
clarify that EBTs must have the capability to support a calibration
check using an external standard in response to public comments that
the intended meaning of the proposed provision was unclear. Commenters
were unfamiliar with the meaning of the term, ``external calibration
check,'' and stated that the proposed provision implied that the EBT
itself must be capable of performing an external calibration check to
be acceptable for testing under this part. This was not the NRC's
intent. As discussed with respect to Sec. 26.91(e)(1), EBT
manufacturers must submit a quality assurance plan to NHTSA that, among
other attributes, specifies the minimum frequency with which the EBT
must be subject to an external calibration check. An external
calibration check simulates delivering a breath sample with a known
alcohol concentration to the EBT to verify that the EBT is reading
within acceptable limits. The external standards used for the
calibration checks are typically either wet bath (i.e., a solution of
ethanol in water) or dry gas (i.e., a mixture of pressurized gas,
usually ethanol in nitrogen) and are delivered to the EBT through a
regulator or other device that simulates a human breath exhalation.
Calibrating devices may be included in an EBT ``kit'' or sold
separately. Section 26.91(c)(6) of the final rule clarifies that EBTs
used for confirmatory alcohol testing must be capable of being
calibrated using external standards, rather than implying that the EBTs
must be self-calibrating with external standards. The capabilities
specified in Sec. 26.91(c)(4) through (c)(6) improve the effectiveness
and efficiency of confirmatory alcohol testing by limiting the need to
cancel test results due to instrument errors, as required under Sec.
26.91(e)(3). Using EBTs that have the required capabilities for
confirmatory alcohol tests protects donors' rights to accurate test
results, provides greater assurance that test results will withstand
any legal challenges, and improves FFD
[[Page 17060]]
programs' abilities to identify tests that instrument errors may have
affected. Therefore, these requirements meet Goal 3 of this rulemaking
to improve the effectiveness and efficiency of FFD programs.
The NRC added Sec. 26.91(d) [Quality assurance and quality control
of ASDs] to establish quality assurance and quality control
requirements for ASDs. These requirements are necessary to ensure that
initial tests that are conducted using an ASD do not yield false
negative test results. If an ASD provides a false negative test result,
the test would not detect a donor who has an alcohol concentration that
exceeds the cutoff levels established in this part, and the donor may
be permitted to perform duties while impaired, potentially creating an
unacceptable risk to public health and safety or the common defense and
security. The final rule continues to require confirmatory testing if
initial alcohol test results are positive, so false positive test
results from an ASD lead to confirmatory testing, which provides
accurate test results. False positive test results from initial testing
reduce the efficiency of FFD programs and inconvenience donors by
causing them to be subject to unnecessary confirmatory testing, but do
not pose any risks to public health and safety or the common defense
and security. However, confirmatory testing is not required if the
result of an initial alcohol test result is negative. Therefore, the
quality assurance and quality control requirements contained in this
paragraph are necessary to maintain the effectiveness of FFD programs,
which is Goal 3 of this rulemaking.
The agency added Sec. 26.91(d)(1) to require FFD programs to
implement the most recent version of the quality assurance plan that a
manufacturer has submitted to NHTSA for any ASD that the licensee or
other entity uses for initial alcohol testing. To obtain NHTSA approval
for an ASD, the manufacturer of the device must submit a quality
assurance plan that (1) specifies the methods that must be used for
quality control checks, (2) the temperatures at which the ASD must be
stored and used, (3) the shelf life of the device, (4) environmental
conditions (e.g., temperature, altitude, humidity) that may affect the
ASD's performance, (5) instructions for its use and care, (6) the time
period after specimen collection within which the device must be read,
where applicable, and (7) the manner in which the reading is made. This
paragraph requires licensees and other entities who intend to use an
ASD to obtain and implement the most recent version of the
manufacturer's quality assurance plan to ensure that the ASD will not
provide false negative test results from improper storage or use. As
discussed with respect to Sec. 26.91(d), the new provision is
necessary to maintain the effectiveness of FFD programs that rely on
ASDs for initial alcohol testing.
The NRC added Sec. 26.91(d)(2) to prohibit licensees and other
entities from using an ASD that fails the quality control checks that
are specified in the most recent version of the manufacturer's quality
assurance plan or that has passed its expiration date. This prohibition
is necessary to ensure that test results from using the ASD are
accurate both to protect public health and safety and donors' rights to
accurate test results under the rule.
The NRC added Sec. 26.91(d)(3) to require licensees and other
entities to follow the device use and care requirements that are
specified in Sec. 26.91(e) for any ASD that tests breath specimens.
The agency added this requirement because some ASDs test specimens of
oral fluids while others test breath specimens, and some ASDs that test
breath specimens also appear on NHTSA's CPL for evidential breath
testing devices (67 FR 62091: October 3, 2002, and subsequent
amendments). Those ASDs that do test breath specimens and are used for
confirmatory testing have more detailed quality assurance and quality
control provisions because their results must be legally defensible.
Section 26.91(e) [Quality assurance and quality control of EBTs]
establishes new quality assurance and quality control requirements for
EBTs. The new requirements are consistent with those of other Federal
agencies that require workplace alcohol testing and, therefore, update
and enhance the consistency of Part 26 with advances in other relevant
Federal rules and guidelines.
Section 26.91(e)(1) adds a requirement that licensees and other
entities must implement the most recent version of the manufacturer's
instructions for the use and care of the EBT consistent with the
quality assurance plan submitted to NHTSA for the EBT, including the
required frequency for conducting calibration checks using external
standards (``external calibration checks''). An EBT manufacturer is
required to submit to NHTSA a quality assurance plan that addresses
methods used to perform external calibration checks on the EBT, the
tolerances within which the EBT is regarded as being in proper
calibration, and the intervals at which these checks must be performed.
The final rule requires licensees and other entities to perform
calibration checks using external standards at the manufacturer's
recommended intervals, at a minimum. These calibration intervals take
into account factors such as frequency of use, environmental conditions
(e.g., temperature, humidity, altitude), and type of operation (e.g.,
stationary or mobile). Therefore, this provision is intended to ensure
that the EBT will not provide false test results from improper storage
or use.
Section 26.91(e)(2) adds a requirement for licensees and other
entities to use only calibration devices appearing on NHTSA's CPL for
``Calibrating Units for Breath Alcohol Tests'' when conducting external
calibration checks. This requirement is necessary to ensure that the
calibrating units used by licensees and other entities meet minimum
standards and provide accurate results.
The final rule adds Sec. 26.91(e)(3) to address circumstances in
which an EBT fails an external calibration check. This section requires
the licensee or other entity to take the EBT out of service and
prohibits its use until it has been repaired and passes an external
calibration check. An EBT that has failed an external calibration check
must be taken out of service to avoid inaccurate reporting of breath
alcohol test results that could result either in the imposition of
sanctions on a donor who has not abused alcohol or the failure to
identify a donor who has.
The NRC moved and amended the requirement in proposed Sec.
26.91(e)(3) to cancel any positive confirmatory alcohol test results
that were obtained from an EBT that fails an external calibration check
and also to cancel the results of any tests that were conducted with
that EBT subsequent to its last successful external calibration check.
The final rule retains this requirement in Sec. 26.91(e)(4)(i), but
presents it as one of two options licensees and other entities must
implement if an EBT fails an external calibration check. The final rule
adds a second option for handling circumstances in which an EBT fails
an external calibration check in Sec. 26.91(e)(4)(ii). This new
section permits licensees and other entities to conduct an external
calibration check of the EBT after each positive confirmatory alcohol
test result. If the EBT fails the check, the provision requires the
collector to cancel the donor's test result and perform another initial
and confirmatory alcohol test, if necessary, using a different EBT. The
requirements to cancel tests from an EBT that has failed an external
calibration check are necessary to protect donors' right to accurate
testing under the rule because
[[Page 17061]]
positive test results from an EBT that has failed an external
calibration check are questionable and donors should not be subject to
sanctions on the basis of these test results.
The NRC added Sec. 26.91(e)(4)(ii) in response to a public comment
on proposed Sec. 26.91(e)(3). The commenter stated that canceling
donors' positive confirmatory test results from an EBT that fails an
external calibration check may not adequately protect donors' rights
under the rule, if a licensee or other entity performs external
calibration checks at the manufacturers' recommended intervals. The
commenter noted that most EBT manufacturers' recommended intervals for
conducting external calibration checks are 1 month, which could result
in several canceled tests, if an EBT has yielded false positive test
results that are only discovered when the EBT fails the monthly check.
However, if the licensee or other entity has already imposed sanctions
on a donor for a positive confirmatory alcohol test result from the
EBT, the donor will experience the adverse consequences of those
sanctions, which may include job loss, before the licensee or other
entity identifies the instrument malfunction and cancels the donor's
confirmed positive test result.
The NRC considered several options to address this concern,
including requiring more frequent external calibration checks, but
could not identify a technical basis for establishing schedules that
would be more appropriate for every EBT on the NHTSA list than those
recommended by the EBT manufacturers. Further, the agency recognizes
that canceling tests imposes a burden on licensees and other entities
as well as on donors and expects that licensees and other entities will
likely choose to conduct external calibration checks more often than
recommended by the EBT manufacturers to avoid canceling multiple tests.
Therefore, the final rule retains the proposed requirement as an option
in Sec. 26.91(e)(4)(i), but adds a second option for handling
circumstances in which an EBT fails an external calibration check in
Sec. 26.91(e)(4)(ii). Under the latter provision, it is unnecessary
for a licensee or other entity to cancel any previous donors' confirmed
positive alcohol test results from using the EBT because the licensee
or other entity will perform the external calibration check after every
positive confirmatory test result and no other donors will have been
affected by false positive test results from an EBT that fails the
check. Under this option, a donor will not be subject to adverse
consequences for a false positive test result because the malfunction
will be detected before the licensee or other entity imposes any
sanctions. The NRC has added this provision to meet Goal 7 of the
rulemaking to protect donors' privacy and other rights (including due
process) under the rule.
The final rule renumbers as Sec. 26.91(e)(5) the provision
contained in Sec. 26.91(e)(4) of the proposed rule. This section
requires an EBT manufacturer or a maintenance representative or other
individual who is certified by the manufacturer, a State health agency,
or other appropriate State agency to inspect, maintain, and calibrate
the EBT. This new provision ensures that qualified personnel perform
inspection, maintenance, and calibration of EBTs (1) to ensure that the
EBTs used in Part 26 programs continue to provide accurate test
results, and (2) because the experience of other Federal agencies that
require workplace alcohol testing has demonstrated that such stringent
EBT inspection, maintenance, and calibration requirements are necessary
to withstand legal challenges to alcohol test results. The final rule
adds ``or other individual who is certified'' to the proposed provision
because some licensees and other entities may choose to obtain the
required certification for their FFD program personnel or other
employees, and the NRC does not intend to prohibit this practice.
Section 26.93 Preparing for Alcohol Testing
This added section expands on former Section 2.4(g)(18) in Appendix
A to Part 26, which specified procedures for alcohol testing. The final
rule provides more detailed procedures than the former paragraph to
increase the consistency of these procedures with those of other
Federal workplace alcohol testing programs as well as consistency among
the alcohol testing procedures of Part 26 programs. The agency added
more detailed requirements for the reasons discussed in Section IV.B.
Section 26.93(a) contains more detailed procedures for implementing
the requirement in the first sentence of former Section 2.4(g)(18) in
Appendix A. That provision instructed collectors to delay alcohol
breath testing for 15 minutes if the donor has engaged in any of the
activities listed (e.g., smoking, regurgitation of stomach contents
from vomiting). Section 26.93(a)(1) through (a)(6) requires the
collector to provide the donor with more detailed information about
mouth alcohol and the testing process than was required under the
former rule and document that the information is provided. Providing
more detailed requirements for the 15-minute waiting period improves
the effectiveness and efficiency of the alcohol testing process by
reducing false positive test results that are due to residual mouth
alcohol or other substances that could potentially trigger a false
positive result. Section 26.93(a)(1) retains the former requirement for
the collector to ask the donor about behaviors such as eating and
drinking that may have occurred within the 15 minutes before an alcohol
test and adds a requirement for the collector to advise the donor to
avoid these activities during the collection process. Section
26.93(a)(2) permits alcohol testing to proceed if the donor states that
none of the activities listed in Sec. 26.93(a)(1) has occurred, while
Sec. 26.93(a)(3) retains the former requirement for a 15-minute
waiting period before a donor may be tested if he or she had engaged in
the activities listed in Sec. 26.93(a)(1). Section 26.93(a)(4) adds a
requirement for the collector to explain that it is to the donor's
benefit to avoid the activities listed in Sec. 26.93(a)(1) during the
collection process. Section 26.93(a)(5) adds a requirement for the
collector to explain to the donor that initial and confirmatory alcohol
tests will be conducted at the end of the waiting period regardless of
whether the donor has engaged in any of the activities listed in Sec.
26.93(a)(1). Section 26.93(a)(6) adds a requirement for the collector
to document that he or she has communicated the instructions to the
donor. The additional requirements for the collector to communicate
with the donor about the potential effects on test results of the
activities listed in Sec. 26.93(a)(1) ensure that donors clearly
understand the reasons for avoiding those activities and the potential
consequences of engaging in them to protect their rights to accurate
test results under the rule. The requirement for the collector to
document that the instructions were communicated to the donor ensures
that the collector does not inadvertently omit the instructions and,
therefore, improves the legal defensibility of the collection
procedure, should a donor challenge it.
The final rule adds Sec. 26.93(b) to require collectors to
minimize delays in administering for-cause drug and alcohol tests and
complete alcohol testing before collecting a specimen for drug testing.
These requirements decrease the likelihood that a donor's test results
will fall below the program's cutoff levels as a result of metabolic
[[Page 17062]]
processes over time, which could prevent the detection of proscribed
alcohol consumption and drug use. Delays between the time at which a
donor reports for testing and the time at which testing occurs continue
to be permitted for tests conducted under conditions other than for
cause, because, in contrast to for-cause testing, there is no reason to
believe that an individual may have used drugs or alcohol in violation
of the FFD policy. Therefore, there is no basis for a concern that
metabolic processes may cause inaccurate test results. The new
provision is consistent with the related regulations of other Federal
agencies.
Section 26.95 Conducting an Initial Test for Alcohol Using a Breath
Specimen
Section 26.95 replaces portions of former Section 2.4(g)(18) in
Appendix A to Part 26 that specified procedures for conducting an
initial test for alcohol. Collectors follow the procedures in this
section when using ASDs that test breath specimens and EBTs. The new
section increases the consistency of Part 26 with the procedures of
other Federal agencies for workplace alcohol testing. Consistent with
other agencies' procedures, the final rule eliminates the requirement
in former Section 2.4(g)(18) in Appendix A to Part 26 for collecting a
second breath specimen for the initial alcohol test. The experience of
other Federal agencies indicates that the former Part 26 requirement
for two breath specimens is unnecessary to obtain a valid, reliable,
and legally defensible test result if the procedures specified in the
new section are followed. Therefore, the final rule amends the former
procedures to reduce the burden on FFD programs and donors that is
associated with collecting two breath specimens for the initial alcohol
test, while continuing to ensure that breath alcohol testing provides
accurate results.
The agency added Sec. 26.95(a) to require the collector to start
breath testing as soon as reasonably practical after the donor
indicates that he or she has not engaged in any activities that may
result in the presence of mouth alcohol or after the 15-minute waiting
period, if required. The final rule adds the phrase, ``as soon as
reasonably practical,'' to this paragraph in response to stakeholder
comments at the public meetings discussed in the preamble to the
proposed rule. The intent of the provision is for the collector to
conduct the initial alcohol test as soon as the individual has received
the instructions specified in Sec. 26.93 [Preparing for alcohol
testing] to ensure the accuracy of the test result. Delays in
conducting the test increase the possibility that the donor may
inadvertently engage in a behavior that could result in the presence of
mouth alcohol as well as permit the donor's metabolism to lower the
alcohol concentration in the specimen if the donor has consumed
alcohol. However, the stakeholders noted that when preparing for
outages, in which it is sometimes necessary to test large numbers of
individuals, collectors often provide the instructions in Sec. 26.93
to groups of donors at the same time and it is not feasible to test
each one immediately after providing the instructions. Therefore, the
final rule adds the phrase, ``as soon as reasonably practical,'' to
permit reasonable delays in testing associated with outage planning.
Section 26.95(b)(1) permits the donor to select a mouthpiece to be
used for his or her test, at the collector's discretion. The rule does
not require the collector to permit the donor to select the mouthpiece.
However, this practice may increase the donor's confidence in the
integrity of the testing process by assuring the donor that the
selection of the mouthpiece is random if he or she is concerned that a
collector may attempt to subvert the testing process by selecting a
mouthpiece that had been contaminated with alcohol or other means of
tampering with the testing device. The NRC is not aware of any
instances in Part 26 programs in which a donor has accused a collector
of altering an alcohol testing device. However, the experience of other
Federal agencies who similarly require workplace alcohol testing
indicates that taking steps to reduce potential donor concerns about
the integrity of the testing process increases donors' willingness to
participate in the testing procedures and reduces the potential for
legal challenges.
In Sec. 26.95(b)(2), the NRC has added a requirement for the
collector to open the mouthpiece packaging and insert it into the
device in view of the donor for the same reason described with respect
to Sec. 26.95(b)(1).
Section 26.95(b)(3) requires the donor to blow into the mouthpiece
for at least 6 seconds in order to obtain an adequate breath sample.
The NRC deleted the requirement to obtain the specimen from the end of
the breath exhalation in former Section 2.4(g)(18) in Appendix A to
Part 26 because it is unnecessary, based on improvements to breath-
testing technology.
Section 26.95(b)(4) requires the collector to show the test result
to the donor. This requirement is consistent with current industry
practices and is intended to increase donor confidence in the integrity
of the testing process by ensuring that both the donor and the
collector have access to the same information about the donor's test
result. The requirement is consistent with Goal 7 of this rulemaking to
protect the privacy and other rights (including due process) of
individuals who are subject to Part 26, by ensuring that donors are
aware of the information used by the collector to determine whether an
alcohol test result is positive or negative.
Section 26.95(b)(5) requires the collector to ensure that the test
result record can be associated with the donor and is maintained
securely, consistent with the many provisions throughout the former and
final rules that the chain of custody must be maintained for specimens
and the associated documentation of test results. Sections 26.129
[Assuring specimen security, chain of custody, and preservation] and
26.159 [Assuring specimen security, chain of custody, and preservation]
establish similar requirements for urine specimens at licensee testing
facilities and HHS-certified laboratories, respectively.
The NRC has added Sec. 26.95(c) to require the collection of only
one breath specimen for the initial test unless problems in the
collection require repetition of the collection. Problems in the
collection may include, but are not limited to, device malfunctions or
a donor's inability to provide an adequate breath specimen on the first
try. If a repeat collection is required, the collector must rely on the
result from the first successful collection in determining the need for
confirmatory alcohol testing. If the procedures specified in this
paragraph are followed, relying on one breath specimen for the initial
test, rather than the two required in the former rule, increases the
consistency of Part 26 collection procedures with those of other
Federal agencies, in accordance with Goal 1 of this rulemaking. The new
requirement also reduces the time required for breath specimen
collections without compromising the accuracy, validity, or reliability
of the test results. Therefore, the provision also meets Goal 3 to
improve the efficiency of FFD programs.
Section 26.97 Conducting an Initial Test for Alcohol Using a Specimen
of Oral Fluids
The NRC added this section to establish requirements for conducting
initial alcohol tests using an ASD for testing oral fluids specimens.
The final rule permits licensees and other entities to rely on ASDs
that test oral fluids for
[[Page 17063]]
the reasons discussed with respect to Sec. 26.83(a). The procedures
for conducting alcohol testing of oral fluids with an ASD incorporate
the related requirements from 49 CFR Part 40 and have been added to the
final rule to ensure that initial alcohol tests of oral fluids provide
accurate and legally defensible test results.
The agency has added Sec. 26.97(a) to specify the procedures that
the collector must follow in using an ASD for testing oral fluids.
Section 26.97(a)(1) requires the collector to check the expiration
date on the device and show it to the donor. Because some devices
degrade during storage, this step is necessary to assure both the donor
and the collector that the device can be expected to function properly.
Section 26.97(a)(2) requires the collector to open an individually
wrapped or sealed package containing the device in the presence of the
donor for the reasons discussed with respect to Sec. 26.95(b)(1).
Section 26.97(a)(3) requires the collector to offer the donor a
choice of using the device or having the collector use it. If the donor
chooses to use the device, the collector must provide instructions for
its proper use. The final rule requires the collector to offer the
donor the choice of using the device to increase the donor's confidence
in the integrity of the testing process, as discussed with respect to
Sec. 26.95(b)(1).
Section 26.97(a)(4) requires the collector to gather oral fluids in
the proper manner if the donor chooses not to use the device, or in
cases in which a second test is necessary because the device failed to
activate. In addition, the collector is required to wear single-use
examination or similar gloves while doing so and change them following
each test. Section 26.97(a)(5) requires the collector to follow the
manufacturer's instructions to ensure that the device has activated.
The NRC has added the requirements in these sections to ensure that the
collection is properly conducted. The requirement to use single-use
examination gloves ensures that the collector and donor are protected
from possible infection from exposure to body fluids.
The NRC added Sec. 26.97(b) to specify the procedures that the
collector must follow if the first attempt to conduct the test using
the ASD fails for any reason, including, but not limited to, the ASD
failing to activate or because the device is dropped on the floor.
Section 26.97(b)(1) requires the collector to discard the device
and conduct another test using a new device that has been under the
collector's control if the first attempt fails. The final rule requires
the second device to have been under the collector's control to ensure
that the donor or another individual has no opportunity to substitute
the new device with another that has been altered to provide a false
negative test result. This provision is necessary to protect the
integrity of the collection process.
Section 26.97(b)(2) requires the collector to record the reason for
the new test. This requirement ensures that the information is
available, should any questions arise with respect to the collection
procedure in a review conducted under Sec. 26.39 or legal proceedings.
Section 26.97(b)(3) requires the collector to offer the donor the
choice of using the device or having the collector use it, unless the
collector concludes that the donor was responsible for the new test
needing to be conducted. The final rule requires the collector to offer
the donor the choice of using the device for the reasons discussed with
respect to Sec. 26.95(b)(1). The requirement for the collector to use
the device if he or she concludes that the donor was responsible for
the second test needing to be conducted enhances the efficiency of the
collection procedure by ensuring that the second collection is
conducted properly.
Section 26.97(b)(4) requires the collector to repeat the collection
procedures outlined in Sec. 26.97(a) for the second collection.
If the second collection attempt fails, Sec. 26.97(c) directs the
collector to use an EBT to perform the initial alcohol test instead.
The final rule requires the collector to use an EBT to perform the
initial test after two failed attempts at testing oral fluids specimens
to ensure that a valid test result is obtained to enhance the
efficiency of the collection procedure by changing the method used to
conduct the test.
If the specimen collection using the ASD for testing oral fluids is
successful, Sec. 26.97(d) instructs the collector to follow the device
manufacturer's instructions for reading the result and show the result
to the donor. The final rule prohibits the collector from reading the
result sooner than instructed by the device manufacturer because some
devices require several minutes after specimen collection to provide an
accurate result, but no more than 15 minutes in all cases. The
requirement for the collector to show the test result to the donor is
intended to increase donor confidence in the integrity of the testing
process by ensuring that both the donor and the collector have access
to the same information about the donor's test result. This paragraph
also requires the collector to record the test result and document that
an ASD was used to ensure that the information is available, should any
questions arise with respect to the collection procedure in a review
conducted under Sec. 26.39 or legal proceedings.
To protect collectors and donors from any possible biohazards, the
final rule adds Sec. 26.97(e) to prohibit the reuse of any devices,
swabs, gloves, and other materials used in collecting oral fluids.
Section 26.99 Determining the Need for a Confirmatory Test for Alcohol
Section 26.99 amends the requirements in former Sec. 26.24(g) and
the portion of Section 2.7(e)(1) in Appendix A to Part 26 that
addressed cutoff levels for alcohol testing. The final rule amends the
former requirements for consistency with a new approach to determining
positive alcohol test results in Sec. 26.103. The NRC adopted the new
approach because some licensees have not taken appropriate action when
a donor has obtained alcohol test results just below the 0.04 percent
BAC cutoff level after the donor has been at work for several hours. A
BAC below 0.04 percent after the donor has been at work for several
hours allows very little doubt that the donor has had an unacceptably
high BAC, and has probably been impaired, at some time during the work
period. Therefore, the final rule establishes new cutoff levels for
alcohol testing in Sec. Sec. 26.99 and 26.103 that take into account
the average rate at which individuals metabolize alcohol over time. In
Sec. 26.99(a), the agency decreased the cutoff level for the initial
alcohol test result from 0.04 to 0.02 percent BAC and requires a
confirmatory alcohol test if a donor's initial test result is 0.02
percent BAC or higher. In addition, Sec. 26.99(b) requires the
collector to record the time at which the initial alcohol test result
is obtained, so that the length of time during which the donor has been
in a work status can be calculated to determine whether a confirmatory
test result is positive, in accordance with Sec. 26.103. These changes
to the initial alcohol test cutoff level and testing procedure are
necessary to support the provisions of Sec. 26.103, which require the
collector to declare an alcohol test as positive if the donor's
confirmatory test result is 0.03 percent or higher after the donor has
been on duty for 1 hour, or 0.02 percent or higher after the donor has
been on duty for 2 hours. The revised lower cutoff level for the
initial test of 0.02 percent BAC permits licensees and other entities
to identify donors who
[[Page 17064]]
have had a BAC of 0.04 percent or higher while in a work status, and to
initiate confirmatory testing for those individuals.
Section 26.101 Conducting a Confirmatory Test for Alcohol
The NRC added this section to provide detailed procedures for
conducting confirmatory breath alcohol tests. These procedures
incorporate the related requirements from 49 CFR Part 40, which the NRC
has added to the final rule to ensure that confirmatory breath alcohol
tests provide accurate and legally defensible test results when using
the EBTs that are required in Sec. 26.91(b) [Acceptable evidential
breath testing devices] and relying on one breath specimen for
confirmatory testing, as is required in Sec. 26.91(c).
Section 26.101(a) requires licensees and other entities to conduct
the confirmatory test as soon as possible following the initial alcohol
test, and in all cases, no later than 30 minutes after the initial
test. The final rule adds this requirement to reduce the possibility
that alcohol metabolism will cause a confirmatory test to provide a
result falling below the applicable cutoff level. Former Section
2.4(g)(18) in Appendix A to Part 26 did not require conducting a
confirmatory test as soon as possible after obtaining a positive
initial alcohol test result, although licensees follow this practice.
However, the agency had added a 30-minute limit because some FFD
program personnel may be tested under DOT procedures, as permitted in
Sec. 26.31(b)(2), and an EBT that is suitable for confirmatory testing
may not be immediately available at the collection site, such that
transport to another collection site is required. The 30-minute interim
period is unnecessary at licensees' and other entities' collection
sites because licensees' and other entities' collection sites must have
the capability to conduct confirmatory tests with an EBT, as required
under Sec. 26.87(a). Therefore, except in these unusual circumstances,
licensees and other entities are expected to continue their current
practice of conducting the confirmatory test immediately after a
donor's initial test result is determined to be positive.
The NRC added Sec. 26.101(b) to specify procedures for conducting
a confirmatory alcohol test.
Sections 26.101(b)(1) and (b)(2) require the collector to conduct
an air blank before beginning the confirmatory test and verify that the
air blank reading is 0.00. These steps are necessary to ensure that the
EBT is functioning properly before the test begins.
Section 26.101(b)(3) requires the collector to take the EBT out of
service if a second air blank test reading is above 0.00. This step is
necessary because a reading above 0.00 on an air blank test indicates
that the EBT is not functioning properly and may provide inaccurate
test results.
The NRC has added Sec. 26.101(b)(4) through (b)(7) to specify
requirements for handling the EBT's mouthpiece; reading the test number
displayed on the EBT; blowing into the EBT; and showing, recording, and
documenting the result displayed on the EBT, respectively. The need for
these steps is the same as for those discussed with respect to the
related steps in Sec. 26.95 [Conducting an initial test for alcohol
using a breath specimen]. However, the final rule does not permit the
donor to insert the mouthpiece into the EBT for the confirmatory test
because it is necessary to ensure that the confirmatory test is
conducted strictly in accordance with the proper procedures to produce
a result that meets evidential standards. Meeting evidential standards
is necessary if any questions arise with respect to the collection
procedure in a review conducted under Sec. 26.39 or legal proceedings.
Section 26.101(c) requires that only one breath specimen must be
collected for the confirmatory alcohol test, unless problems in the
collection require that the collection be repeated. If a repeat
collection is required, the collector must rely on the result from the
first successful collection in determining the confirmatory test
result. As discussed under Sec. 26.95(c), if the specified procedures
are followed, relying on one breath specimen for the initial test
rather than the two required in the former rule increases the
consistency of Part 26 collection procedures with those of other
Federal agencies. This also reduces the time required for breath
specimen collections without compromising the accuracy, validity, or
reliability of the test results. This section also prohibits licensees
and other entities from combining or averaging results from more than
one test in order to arrive at the confirmatory test result. These
calculations, required by former Section 2.4(g)(18) in Appendix A to
Part 26, are no longer necessary because of the mandatory use of the
EBTs specified in Sec. 26.91(b). The change meets Goal 3 of this
rulemaking to improve the efficiency of FFD programs.
Section 26.101(d) amends the portion of former Section 2.4(g)(18)
in Appendix A of Part 26 that required using a different EBT to conduct
the confirmatory alcohol test than used for initial alcohol testing.
The final rule permits the use of the same EBT for both initial and
confirmatory alcohol testing, instead of requiring the use of two
different EBTs. The licensee or other entity must obtain one breath
specimen for initial alcohol testing and one for confirmatory testing,
if necessary, but is permitted to conduct both tests using the same
EBT. The NRC has made this change because improvements in EBT
technology assure that valid and reliable test results may be obtained
from a single EBT if the specimen collection and quality assurance
procedures in this part are followed. Reducing the number of breath
specimens required for alcohol testing not only reduces the costs
associated with alcohol testing, but also reduces the burden on donors
that the collection process imposes. Use of the same EBT for initial
and confirmatory testing is consistent with the procedures of other
Federal agencies for workplace alcohol testing.
Section 26.103 Determining a Confirmed Positive Test Result for Alcohol
Section 26.103 amends the cutoff level for determining whether a
confirmatory alcohol test result is positive, as specified in former
Sec. 26.24(g) and Section 2.7(f)(2) in Appendix A to Part 26. This
section establishes new cutoff levels that take into account the length
of time the donor has been in a work status for the reasons discussed
with respect to Sec. 26.99 [Determining the need for a confirmatory
test for alcohol]. Section 26.103(a)(1) retains the 0.04 percent BAC in
former Sec. 26.24(g) and Section 2.7(f)(2) in Appendix A to Part 26 as
the cutoff level for a confirmed positive alcohol test result at any
time regardless of the length of time the donor has been in a work
status. Sections 26.103(a)(2) and (a)(3) establish new cutoff levels
for positive alcohol test results that are above the 0.02 percent BAC
cutoff level on the initial test and do not meet or exceed the 0.04
percent BAC cutoff level on confirmatory testing but indicate that the
donor had a BAC of 0.04 percent or greater while in a work status or
consumed alcohol while on duty. The cutoff levels and time periods in
Sec. 26.103(a)(2) and (a)(3) are based on the average rate at which
normal metabolic processes reduce an individual's BAC over time, which
is about 0.01 percent BAC per hour. Therefore, a donor whose BAC is
measured as 0.03 percent after the donor has been in a work status for
1 hour would have had a BAC of approximately 0.04 percent when he or
she reported for work an hour ago.
[[Page 17065]]
Through the same metabolic processes, a donor whose BAC is measured as
0.02 percent after he or she has been in a work status for 2 hours
would also have had a BAC of approximately 0.04 percent when he or she
reported for work 2 hours ago. These changes improve the effectiveness
of FFD programs by ensuring that confirmatory alcohol testing
identifies donors who have been impaired from alcohol use while on duty
and, therefore, may have posed a risk to public health and safety.
The NRC added Sec. 26.103(b) to strengthen FFD programs by
requiring licensees and other entities to address circumstances in
which a donor's confirmatory alcohol test result is greater than 0.01
percent BAC when the individual has been in a work status for 3 hours
or more, but his or her BAC falls below the cutoff levels in Sec.
26.103(a). The final rule requires the collector to declare the test as
negative because NHTSA has not thoroughly evaluated some of the EBTs
that licensees and other entities are permitted to use for confirmatory
alcohol testing under the final rule for accurately estimating BAC
levels below 0.02 percent. However, if an individual has an alcohol
test result above 0.01 percent BAC and has been in a work status for 3
hours or more, the test result provides a reason to believe that the
individual has been impaired while on duty. Therefore, the provision
requires the licensee or other entity, after testing, to ensure that
the donor's alcohol use is evaluated, a determination of fitness is
performed, and the determination of fitness indicates that the donor is
fit to safely and competently perform his or her duties before the
individual is permitted to perform the duties that require him or her
to be subject to this part. This change strengthens the effectiveness
of FFD programs by ensuring that the alcohol use of individuals who may
have been impaired when reporting for duty is assessed to determine
whether such individuals' alcohol use is problematic and may pose a
future risk to public health and safety and the common defense and
security.
The NRC has deleted former Section 2.4(g)(19) in Appendix A to Part
26, which established requirements for collecting a blood specimen for
alcohol testing, in its entirety because the final rule no longer
permits blood testing for alcohol, at the donor's discretion, for the
reasons discussed with respect to Sec. 26.83(a).
Section 26.105 Preparing for Urine Collection
This section is added to describe the preliminary steps for
collecting a urine specimen for drug testing. For organizational
clarity, this section reorganizes the requirements in former Section
2.4(g)(5) through (g)(7) in Appendix A to Part 26 by separating alcohol
and urine specimen collection procedures into separate sections of the
final rule. The section also establishes several new requirements that
the agency has added to meet Goal 1 of this rulemaking to update and
enhance the consistency of Part 26 with advances in other relevant
Federal rules and guidelines.
Section 26.105(a) revises former Section 2.4(g)(5) in Appendix A to
Part 26. The final rule retains the former requirement for the donor to
remove any unnecessary outer garments and belongings that might conceal
items or substances that could be used to tamper with a urine, breath,
or blood specimen. However, the final rule eliminates the references to
blood and breath specimens in the former paragraph because the final
rule no longer permits donors to request blood testing for alcohol.
This paragraph also eliminates reference to breath specimens because
the final rule presents requirements related to preparing for alcohol
testing in a separate section (Sec. 26.93) for organizational clarity.
The NRC added Sec. 26.105(b) to require the donor to empty his or
her pockets and display the items contained in them. The new
requirement for the collector to examine the articles in the donor's
pockets increases the likelihood of detecting items (e.g., a vial of
powdered urine, bleach, a portable heating unit, a false penis or any
other tube or device that may be used to replicate the function of
urinary excretion) that could be used to adulterate or substitute the
specimen in a subversion attempt. The rule requires the collector to
use his or her judgment in determining whether an item found in the
donor's pockets indicates a clear intent to attempt to subvert the
testing process. For example, whereas a container of urine found in a
donor's pocket would be clear evidence of an intent to subvert the
testing process, a container of eye drops, which could be used to
adulterate the specimen, would, in most cases, be unlikely to indicate
an intent to subvert the testing process. Should the collector identify
an item that indicates a possible intent to subvert the testing
process, this section requires him or her to contact the FFD program
manager or MRO in order to obtain direction regarding the need for a
directly observed collection. If the collector identifies an item that
could be used to tamper with the specimen, but does not indicate an
intent to subvert testing, then the collector must secure the item and
continue with the collection. The agency added these requirements to
meet Goal 1 of this rulemaking to update and enhance the consistency of
Part 26 with advances in other relevant Federal rules and guidelines,
as well as Goal 3 to improve the effectiveness of FFD programs, by
improving the ability of the collector to identify attempts to subvert
the drug testing process. Adding the requirement for the donor to
permit the collector to make this examination ensures that donors
understand that they must cooperate with the examination.
Section 26.105(c) retains former Section 2.4(g)(6) in Appendix A to
Part 26, which required the individual to be instructed to wash his or
her hands prior to urination. The final rule makes two minor editorial
changes to the former provision for clarity in the language of the
final rule. The final rule clarifies that the collector is to instruct
the donor to wash and dry his or her hands and replaces the term
``individual'' with the term ``donor.''
Section 26.105(d) retains former Section 2.4(g)(7) in Appendix A to
Part 26 and requires the donor to remain in the presence of the
collection site person and not to have access to any source of water or
other materials that could be used to tamper with the specimen. The
final rule makes two minor editorial changes to the former provision
for clarity in the language of the rule. The final rule replaces the
term ``collection site person'' with the simpler term ``collector'' and
the term ``individual'' with the term ``donor.''
The NRC added Sec. 26.105(e) to permit the donor, at the
collector's discretion, to select the specimen collection container
that he or she will use. Permitting the donor to select the collection
kit is not required. However, this practice may increase the donor's
confidence in the integrity of the testing process by assuring the
donor that the selection of the collection kit is random if he or she
is concerned that a collector may attempt to subvert the testing
process by selecting a kit that had been contaminated with a substance
that would produce a positive, adulterated, substituted, or invalid
test result in order to entrap the donor. The importance of providing
assurance to the donor regarding the integrity of the collection
process is discussed with respect to Sec. 26.95(b)(1). This paragraph
also prohibits the donor from taking collection kit materials (such as
the specimen label) other than the collection container, into the
private area used for urination. This prohibition ensures that a donor
could not tamper
[[Page 17066]]
with the other collection kit materials and thereby disrupt the chain
of custody for the urine specimen.
This section is consistent with the related requirements of other
Federal agencies and so meets Goal 1 of this rulemaking to update and
enhance the consistency of Part 26 with advances in other relevant
Federal rules and guidelines, as well as Goal 3 to improve the
effectiveness of FFD programs, by improving the ability of the
collector to identify attempts to subvert the drug testing process. The
final rule adds the new provision requiring the donor to permit the
collector to make this examination in response to stakeholder requests
at the public meetings discussed in the preamble to the proposed rule
to ensure that donors understand that they must cooperate with the
examination.
Section 26.107 Collecting a Urine Specimen
Section 26.107 amends former Section 2.4(g)(8), (g)(9), and (g)(12)
in Appendix A to Part 26 to update the rule's urine specimen collection
procedures and incorporate advances in other relevant Federal rules and
guidelines, consistent with Goal 1 of this rulemaking.
The NRC added Sec. 26.107(a)(1) to specify the instructions that
the collector is required to provide to the donor. This paragraph
requires the collector to instruct the donor to go into the room or
stall used for urination, provide a specimen of the quantity that the
licensee or other entity has predetermined, refrain from flushing the
toilet, and return with the specimen as soon as the donor has completed
the void. The final rule requires the collector to provide these
instructions to the donor so that the donor understands his or her
responsibilities with respect to the urine collection procedure. In
addition, the instructions are necessary to implement other provisions
of the final rule. For example, the quantity of urine that the
collector instructs the donor to provide is based on the requirements
of the licensee's or other entity's drug testing program, as discussed
with respect to Sec. 26.109 [Urine specimen quantity]. The collector
instructs the donor not to flush the toilet so that the collector may
inspect the private area in which the donor voided after receiving the
specimen, as discussed with respect to Sec. 26.109(c). The collector
must instruct the donor to return with the specimen as soon as the
donor has completed the void in order to minimize the possibility that
the urine specimen cools and its temperature falls below the acceptable
specimen temperature range specified in Sec. 26.111(b).
Section 26.107(a)(1) further amends former Section 2.4(g)(8) in
Appendix A to Part 26. The former provision stated that the individual
may provide his or her urine specimen in the privacy of a stall or
otherwise partitioned area that protects individual privacy. For
clarity, this paragraph replaces ``may'' in the former rule with
``shall'' to indicate that the area in which the donor will urinate
must provide for individual privacy. The final rule also adds an
exception to the former requirement for privacy in the case of a
directly observed collection. The agency made this change for greater
accuracy in the rule language because the requirement for individual
privacy does not apply in the case of a directly observed collection,
as discussed with respect to Sec. 26.115.
The NRC added Sec. 26.107(a)(2) to further emphasize the
requirement in former Section 2.4(g)(8) in Appendix A to Part 26 that
donors must be afforded individual privacy when providing a urine
specimen. The new paragraph requires that, unless the specimen is to be
collected under direct observation, no one other than the donor may go
into the private area in which the donor will urinate. Although the NRC
is not aware of any instances in Part 26 programs in which the former
requirement for individual privacy has been compromised, the experience
of other Federal agencies has indicated that such emphasis is
necessary.
Section 26.107(a)(3) permits the collector to set a reasonable time
limit for the donor to void. Rather than establishing a specific time
limit, the final rule permits the collector to rely on his or her
professional judgment in order to ensure that individuals who may
experience difficulty in voiding have sufficient time to provide a
specimen while also permitting collectors to prevent donors from
disrupting the testing process by taking an unduly long time to provide
a specimen. In Sec. 26.85(a), the rule specifies new training and
qualification requirements to ensure that collectors are able to
exercise professional judgment appropriately. At the public meetings
discussed in the preamble to the proposed rule, stakeholders reported
incidents in which donors appeared to be attempting to disrupt the
testing process by spending an unduly long time providing a specimen
and challenged the collector's authority to set a time limit. The new
paragraph clarifies that collectors have the authority to set a
reasonable time limit for voiding. In addition, this paragraph
increases the consistency of Part 26 with the procedures implemented by
other Federal agencies in accordance with Goal 1 of this rulemaking.
Section 26.107(b) amends former Section 2.4(g)(9) in Appendix A to
Part 26. The former provision required the collector to note any
unusual behavior or appearance in the permanent record book and on the
custody-and-control form. This section clarifies the intent of the
former requirement, which raised implementation questions from
licensees, by specifying that the collector must pay careful attention
to the donor during the collection process so that the collector can
note any conduct that may indicate an attempt to substitute or tamper
with the specimen. This section also provides examples of the types of
behavior that may indicate a subversion attempt and requires the
collector to contact FFD program management if he or she observes such
behavior. This section requires FFD program management to determine
whether a directly observed collection is necessary under Sec. 26.115.
The NRC added Sec. 26.107(c) to specify the actions to be taken by
the collector and donor to complete the specimen collection procedure.
The first sentence of Sec. 26.107(c) retains the instruction in former
Section 2.4(g)(12) in Appendix A to Part 26 that prohibits the donor
from washing his or her hands until the specimen has been delivered to
the collector. This paragraph also adds a requirement for the collector
to inspect the private area for any evidence of a subversion attempt
prior to flushing the toilet. This additional requirement is consistent
with existing industry practices and the procedures of other Federal
agencies. It is intended to increase the likelihood of detecting
subversion attempts if the donor leaves any physical evidence in the
toilet bowl or private area where the donor voided, which could
include, but is not limited to, an empty vial that contains an
adulterant, powdered urine spilled on the floor, or the remains of an
adulterant in the toilet bowel.
Section 26.109 Urine Specimen Quantity
Section 26.109 amends former Section 2.4(g)(11) in Appendix A to
Part 26. The former provision established 60 milliliters (mL) as the
minimum quantity of urine that an FFD program must collect from donors
and the procedures to be followed if a donor is unable to provide the
specified quantity. The final rule reduces to 30 mL the basic quantity
of urine to be collected.
Section 26.109(a) introduces a new term ``the predetermined
quantity.'' The licensee or other entity establishes a
[[Page 17067]]
predetermined quantity of urine that each donor is requested to
provide, depending on the characteristics of the licensee's or other
entity's testing program. The final rule requires the predetermined
quantity to include at least 30 mL of urine, but licensees and other
entities may request a larger quantity of urine if--
The specimen will be initially tested at a licensee testing
facility;
Testing will be conducted for additional drugs beyond those
required in Sec. 26.31(d)(1);
Split specimen procedures will be followed; or
The licensee's or other entity's program includes some combination
of these characteristics.
The NRC has reduced the 60-mL quantity that was required in former
Section 2.4(g)(11) in Appendix A to Part 26 to 30 mL to decrease the
burden on donors, while ensuring that a sufficient quantity of urine is
available to complete initial validity and drug tests, confirmatory
validity and drug tests (if required), and any retests that may be
requested by the donor and authorized by the MRO under Sec. 26.165(b).
NRC staff discussions with representatives of HHS-certified
laboratories indicated that advances in testing technologies allow for
these minimum testing and retesting procedures to be completed on a 30-
mL specimen. Therefore, a 60-mL specimen is no longer necessary to
achieve the NRC's minimum objectives of conducting validity and drug
tests on each specimen for the five classes of drugs specified in Sec.
26.31(d)(1), as well as retesting of the specimen, if required.
Section 26.109(a) also specifies the additional quantity of urine,
above the basic 30 mL, to be collected when the testing program follows
split specimen procedures. The rule requires licensees and other
entities to collect an additional 15 mL for transfer into Bottle B of a
split specimen for storage and possible testing. (As discussed with
respect to Sec. 26.113(b), the final rule replaces the terms,
``primary specimen'' and ``split specimen,'' in the former rule with
the terms, ``Bottle A'' and ``Bottle B,'' for clarity in the language
of the rule and consistency with the terminology used by other Federal
agencies.) This additional 15 mL is sufficient to permit the HHS-
certified laboratory to conduct validity and drug tests of the specimen
in Bottle B, at the donor's request, and is consistent with the
quantity required in the related provisions of other Federal agencies.
Therefore, if a licensee's or other entity's testing program follows
split specimen procedures, but does not include initial tests at the
licensee testing facility or testing for additional drugs beyond those
specified in Sec. 26.31(d)(1), then the predetermined quantity for
this testing program is 45 mL (30 mL for basic testing + 15 mL for the
split specimen). The predetermined quantity must be larger than 45 mL
if the testing program also includes initial tests at a licensee
testing facility and testing for additional drugs.
Section 26.109(a) also permits licensees and other entities to
include in the predetermined quantity the additional amount of urine
that is necessary to support testing for additional drugs beyond those
specified in Sec. 26.31(d)(1). Licensees and other entities must
consult with the HHS-certified laboratories they use to identify the
quantity of urine required to test for the additional drugs. For
example, if the licensee's or other entity's testing program does not
include initial tests at a licensee testing facility and does not
follow split specimen procedures, then the predetermined quantity for
that testing program consists of the 30-mL basic quantity plus the
additional amount of urine needed to test for additional drugs. As
another example, if a licensee's or other entity's testing program
includes initial tests at a licensee testing facility, follows split
specimen procedures, and tests for additional drugs, then the
predetermined quantity consists of the 30-mL basic quantity plus 15 mL
for the split specimen plus the additional amount required by the
licensee testing facility and HHS-certified laboratory to test for the
additional drugs.
Section 26.109(a) also permits licensees and other entities to
include in the predetermined quantity the additional amount of urine
that is necessary to perform initial validity and drug tests at the
licensee testing facility, if initial tests are performed there. For
example, one licensee testing program currently requires an additional
10 mL of urine for initial testing at the licensee testing facility,
but does not test for other drugs or follow split specimen procedures.
In this program, the predetermined quantity that collectors must
request the donor to provide is 40 mL. As another example, if a
licensee's or other entity's testing program includes initial tests at
the licensee testing facility, does not test for additional drugs, and
follows: split specimen procedures, the predetermined quantity may be
55 mL (30 mL for basic testing + 15 mL for the split specimen + 10 mL
for initial testing at the licensee testing facility). If this program
also tests for additional drugs, the predetermined quantity may be
larger than 55 mL.
The final rule adds Sec. 26.109(b) to establish the actions that
the collector must take if a donor provides a specimen that is less
than the 30-mL basic quantity. NRC staff discussions with
representatives of HHS-certified laboratories indicated that 30 mL is
sufficient to meet the NRC's primary objectives of detecting drug use
and subversion attempts through initial validity and drug testing, and
for confirmatory validity and drug tests, if required, at an HHS-
certified laboratory for the panel of drugs for which testing is
required in Sec. 26.31(d)(1). The 30-mL quantity also ensures that
sufficient urine is available for retesting the specimen for validity
and for drugs and drug metabolites, should the donor request such
retesting, as permitted in Sec. 26.165(b). Therefore, the 30-mL basic
quantity is necessary to achieve the NRC's drug-testing objectives,
although it is insufficient to permit testing for additional drugs,
initial testing at licensee testing facilities, or splitting the
specimen, which this part does not require.
Section 26.109(b)(1) amends the portions of former Section
2.4(g)(11) in Appendix A to Part 26 that prescribed collector actions
if a donor provides an insufficient specimen. The final rule requires
the collector to ``encourage'' the donor to drink a reasonable amount
of liquid in order to provide a specimen of at least 30 mL, rather than
``allow'' the donor to drink additional liquid as required under the
former rule. The NRC made this change to enhance the efficiency of FFD
programs, consistent with Goal 3 of this rulemaking, by potentially
reducing the time required to obtain a specimen of the required
quantity from the donor and, thereby, to complete the collection,
should the donor choose to comply. However, this paragraph establishes
a limit on the amount of liquid that the individual is permitted to
consume to avoid the potential for ``water intoxication,'' which is a
physical response to consuming too many liquids that may cause harm to
the donor. Although the limit of 24 ounces of water over a 3-hour
period in the proposed rule is the same limit imposed in the HHS
Guidelines, the NRC raised the limit in the final rule to 40 ounces
over a 3-hour period for consistency with the DOT limit, in response to
public comment. This limit continues to be conservative to ensure that
individuals who may have a medical condition that makes them more
subject to water intoxication, such as some forms of renal disease, or
who are taking some medications, would not be placed at risk. The final
rule retains
[[Page 17068]]
the former requirement in Section 2.4(g)(11) in Appendix A to Part 26
to collect successive specimens in separate containers.
The NRC added Sec. 26.109(b)(2) to require the collector to end
the specimen collection process as soon as the donor provides a
specimen of at least 30 mL in a subsequent attempt. This requirement
reduces the burden on donors who may have some difficulty providing a
urine specimen while meeting the NRC's objectives of obtaining a
specimen of sufficient size to support initial and confirmatory
validity and drug testing, as well as retesting of the specimen.
Section 26.109(b)(2) also specifies that the licensee or other
entity may not impose any sanctions if a donor provides a subsequent
specimen that is less than the licensee's or other entity's
predetermined quantity, as long as the specimen quantity is at least 30
mL. Imposing sanctions for failing to provide sufficient urine to
support initial testing at the licensee's testing facility, split
specimen procedures, or testing for additional drugs is inappropriate,
because a specimen of at least 30 mL is sufficient to meet the NRC's
objectives and, therefore, could not be considered a refusal to test.
Section 26.109(b)(2) also requires the collector to forward a
subsequent specimen that is greater than 30 mL, but less than the
licensee's or other entity's predetermined quantity, to the HHS-
certified laboratory for testing, rather than permit the specimen to be
tested at the licensee testing facility. This provision is necessary to
ensure that a sufficient quantity of urine is available for validity
and drug testing and retesting at the HHS-certified laboratory, if
required, consistent with the NRC's objectives. However, if the
subsequent specimen is equal to or greater than the licensee's or other
entity's predetermined quantity, the licensee or other entity is
permitted to follow the FFD program's normal testing procedures.
Following normal testing procedures in this instance is permissible
because there is sufficient urine to implement the FFD program's
testing procedures (e.g., split specimen procedures, testing for
additional drugs, initial testing at a licensee testing facility),
while continuing to ensure that sufficient urine is available for
testing and retesting at the HHS-certified laboratory, if required.
The agency added Sec. 26.109(b)(3) to require the implementation
of ``shy bladder'' procedures if a donor is unable to provide a 30-mL
specimen within 3 hours of the initial attempt to provide a specimen,
for the reasons discussed with respect to Sec. 26.119. Requirements
for implementing ``shy bladder'' procedures are contained in that
section.
The NRC added Sec. 26.109(b)(4) to establish additional
requirements for specimen collections when a donor provides a specimen
of less than 30 mL.
This section eliminates the requirement in former Section
2.4(g)(11) in Appendix A to Part 26 to combine successive specimens
from a donor in order to obtain a specimen of 60 mL. The final rule
prohibits the practice of combining specimens to ensure that successive
specimens neither contaminate nor dilute a specimen that will be
tested. In addition, the prohibition increases the consistency of Part
26 with the related requirements of other Federal agencies (Goal 1 of
this rulemaking).
Section 26.109(b)(4) also requires the collector to discard any
specimens of less than 30 mL unless there is reason to believe that a
specimen may have been altered. Examples of reasons to believe that a
donor may have attempted to alter the specimen may include, but are not
limited to: (1) Observation of powder (that could be an adulterant or
powdered urine) spilled in the private area in which the donor urinated
or on the donor's clothing; (2) unexpected sounds from the private area
while the donor should be voiding, such as the sound of something being
unwrapped or dropping to the floor; (3) observation that the donor's
pocket appears to contain an item that was not visible before the donor
entered the private area (that the donor may have previously had taped
to his body); and (4) an unusual color or lack of clarity in the urine
specimen. The final rule requires the collector to discard specimens of
less than 30 mL when there is no reason to believe that the specimens
have been subject to tampering because they are not used for testing
and there is no reason to retain them.
If the collector suspects that a specimen has been altered and the
suspect specimen is equal to or greater than 15 mL, the rule requires
the collector to forward the suspect specimen to the HHS-certified
laboratory for testing, consistent with former Section 2.4(g)(16) in
Appendix A to Part 26. NRC staff discussions with representatives of
HHS-certified laboratories indicate that 15 mL is the minimum quantity
necessary for HHS-certified laboratories to perform the initial and
confirmatory (if necessary) validity and drug testing required in this
part, although it is insufficient to support retesting of the specimen
at the donor's request. When the collector has observed donor conduct
or specimen characteristics that indicate there is a reason to believe
that the donor may have altered the specimen, the NRC's interest in
assuring that the testing process is not subverted takes precedence
over the donor's ability to request retesting of the specimen. Any
results of validity testing that confirm that the specimen was
adulterated or substituted, in combination with the collector's
observations, provide clear evidence that a donor has tampered with the
specimen and thereby attempted to subvert the testing process.
This section also amends former Section 2.4(g)(17) in Appendix A to
Part 26. The former provision required a directly observed collection
whenever there is a reason to believe that a donor has or may attempt
to alter a specimen. The amended provision requires the collector to
contact FFD program management to determine whether a directly observed
collection is required, but does not require a directly observed
collection in every circumstance. At the public meetings discussed in
the preamble to the proposed rule, the stakeholders requested
flexibility in the decision to collect another specimen under direct
observation. They noted that numerous instances have occurred in which
a collector identified incontrovertible evidence that the donor
intended to or had tampered with a specimen and that, in such cases,
drug testing would not provide additional information that justifies
the costs associated with conducting a directly observed collection and
testing the additional specimen. The NRC believes that the presence of
drugs and drug metabolites in a specimen that is collected under direct
observation establishes a clear motive for an alleged attempt to tamper
with a specimen and adds further evidence supporting the imposition of
sanctions on the donor for attempting to subvert the testing process.
However, the NRC believes that such additional evidence is unnecessary
when there is incontrovertible evidence that the donor intends to or
has attempted to tamper with a specimen. Therefore, the final rule
permits FFD program management to determine whether an additional
specimen collection under direct observation must be conducted. The
agency has made this change to meet Goal 3 of this rulemaking to
improve the efficiency of FFD programs, by reducing the number of
directly observed collections required under the rule.
[[Page 17069]]
Section 26.111 Checking the Acceptability of the Urine Specimen
Section 26.111 amends former requirements for assessing specimen
validity at the collection site, which appeared in Section 2.4(g)(13)
through (g)(17) in Appendix A to Part 26. In general, the NRC has made
changes in this section to meet Goal 1 of this rulemaking to update and
enhance the consistency of Part 26 with advances in other relevant
Federal rules and guidelines. In addition, the NRC changed the heading
of this section from ``Checking the validity of the urine specimen'' in
the proposed rule to ``Checking the acceptability of the urine
specimen,'' in response to a public comment which noted that
``acceptability'' more accurately characterizes the purpose of the
requirements in this section.
Section 26.111(a) amends former Section 2.4(g)(13) in Appendix A to
Part 26. The former provision required the collector to measure the
temperature of the specimen immediately after the urine specimen is
collected. The new provision requires the collector to measure the
temperature of any specimen that is 15 mL or more. The final rule does
not mandate measuring the temperature of smaller specimens because the
collector is required to discard them, as discussed with respect to
Sec. 26.109(b)(4). This paragraph also replaces former Section
2.4(g)(14) in Appendix A to Part 26, which established the acceptable
specimen temperature range and required conducting a second specimen
collection under direct observation if a specimen's temperature falls
outside the acceptable range. The final rule increases the range of
acceptable specimen temperatures from 90.5[deg]F-99.8[deg]F in the
former provision to 90[deg]F-100[deg]F for consistency with the
temperature range specified in the HHS Guidelines. The wider acceptable
temperature range provides increased protection against false low or
false high temperature readings and, therefore, protects donors from
the imposition of sanctions based on inaccurate specimen temperature
readings. The portion of former Section 2.4(g)(14) that specified
collector actions if there is a reason to believe that the individual
may have tampered with the specimen has been moved to Sec. 26.111(d)
for organizational clarity.
In response to a public comment, the final rule eliminates the
requirement in Sec. 26.111(a), which appeared in both the former and
proposed rules, for the collector to offer the donor an opportunity to
provide a measurement of body temperature. In addition, the final rule
deletes Sec. 26.111(b) in the proposed rule entirely and has
renumbered the paragraphs in this section accordingly. The NRC has made
these changes in response to public comments, which reported that DOT's
experience indicates that there are often discrepancies when comparing
the temperature provided by a specimen container temperature strip and
that provided by a device that measures body temperature. Further, with
the increase in the range of acceptable specimen temperatures, as
discussed with respect to Sec. 26.111(a), a measurement of body
temperature is less useful to counter a reason to believe that the
donor has altered the specimen (e.g., humans who have a body
temperature at or below 90[deg]F would be suffering from severe
hypothermia). Therefore, eliminating the opportunity for a donor to
provide a measure of body temperature in this paragraph meets Goal 5 of
this rulemaking to improve Part 26 by eliminating or modifying
unnecessary requirements.
Section 26.111(b) amends former Section 2.4(g)(15) in Appendix A to
Part 26. The former provision required the collector to inspect the
specimen's color, determine whether there were any signs of
contaminants, and record any unusual findings in the permanent record
book. The final rule amends this provision by deleting reference to the
permanent record book and requiring the collector to use the custody-
and-control form to record this information. The NRC has made this
change because the final rule no longer requires collection sites to
maintain a permanent record book, consistent with the elimination of
the requirement to maintain a permanent record book in the HHS
Guidelines. The final rule also makes minor editorial revisions to the
former provision by incorporating the related language from the HHS
Guidelines. The agency made these changes to meet Goal 1 of this
rulemaking to update and enhance the consistency of Part 26 with the
regulations of other Federal agencies.
Section 26.111(c) replaces and amends the first sentence of former
Section 2.4(g)(14) in Appendix A to Part 26. The former provision
required a second specimen to be collected under direct observation if
the temperature of the first specimen submitted by a donor fell outside
of the acceptable specimen temperature range. The final rule eliminates
the requirement for a second specimen collection under direct
observation if the specimen temperature falls outside of the required
range, although licensees and other entities could, at their
discretion, continue this practice. Instead, the new provision requires
the collector to contact the FFD program manager, if the collector has
a reason to believe the donor has attempted to subvert the testing
process based on observed donor behavior, the specimen temperature,
unusual specimen characteristics, or other observations. The FFD
program manager, at his or her discretion, may consult with the MRO to
determine whether the collector's observations provide sufficient
evidence that a subversion attempt has occurred to warrant the
imposition of sanctions. If the MRO and/or FFD program manager
determine that a subversion attempt has occurred on the basis of the
collector's observations, the final rule permits the licensee or other
entity to impose the sanctions for a subversion attempt in Sec.
26.75(b) without conducting a directly observed collection. However, at
the FFD program manager's or the MRO's discretion, a second specimen
may be collected under direct observation. The rule permits a second
specimen to be collected under direct observation to provide further
information to assist the MRO in determining whether or not a
subversion attempt has occurred. For example, positive drug test
results from a second specimen that is collected under direct
observation provide additional evidence that the donor attempted to
tamper with his or her first specimen to hide drug use. The NRC has
made this change in response to stakeholder requests, for the reasons
discussed with respect to proposed Sec. 26.109(b)(4).
The NRC also added permission in Sec. 26.111(c) for a donor to
volunteer to submit another specimen under direct observation to
counter any reason to believe that he or she may have altered the first
specimen. The agency added this permission in response to a public
comment suggesting this change and because it is consistent with Goal 7
of the rulemaking to protect donor's rights (including due process)
under the rule.
Section 26.111(d) replaces and revises former Section 2.4(g)(16) in
Appendix A to Part 26. The former provision required forwarding all
urine specimens that are suspected of being adulterated or diluted to
the HHS-certified laboratory for testing. The final rule adds a third
reason, suspicion that a specimen has been substituted, for forwarding
a specimen to the HHS-certified laboratory. As discussed with respect
to Sec. 26.31(d)(3)(i), substitution entails replacing a valid urine
specimen with a drug-free specimen. The NRC has made this change for
consistency with the addition of substitution to the final
[[Page 17070]]
rule as another method of attempting to subvert the testing process for
which licensees and other entities are required to impose sanctions, as
discussed with respect to Sec. 26.75(b). This paragraph also adds a
provision that specifically prohibits testing any suspect specimen at a
licensee testing facility to (1) limit the potential for specimen
degradation during the time period required to conduct testing at the
licensee testing facility; (2) decrease the time required to obtain
confirmatory validity test results if the specimen, in fact, has been
altered; and (3) ensure that a sufficient quantity of urine is
available for conducting validity tests at more than one HHS-certified
laboratory if, for example, the specimen contains a new adulterant or
an adulterant that the licensee's or other entity's primary laboratory
is not capable of identifying (see Sec. 26.161(g)). Only suspect
specimens of 15 mL or more must be sent for testing, rather than all
specimens. The final rule establishes this lower limit on specimen
quantity to ensure that there is sufficient urine available for the
HHS-certified laboratory to conduct all of the validity and drug tests
on the specimen that are required under this part. In response to a
comment, this paragraph of the final rule also adds a requirement to
send specimens of 15 mL or more, collected under direct observation in
accordance with Sec. 26.111(c), to an HHS-certified laboratory for
initial and confirmatory testing.
Section 26.111(e) requires collectors and the HHS-certified
laboratory to preserve as much of a suspect specimen as possible. The
NRC has added this requirement to provide increased assurance that a
sufficient quantity of urine is available to support further testing,
in the event that further testing of the specimen is necessary, and to
enhance the consistency of Part 26 with the related provisions of other
Federal agencies.
The agency also added Sec. 26.111(f) to inform donors and
collectors of the characteristics of a specimen that is acceptable for
testing at an HHS-certified laboratory. This paragraph incorporates the
related provision from the HHS Guidelines.
Section 26.113 Splitting the Urine Specimen
Section 26.113 updates former Sections 2.4(g)(20) and 2.7(j) in
Appendix A to Part 26. This section amends collection site procedures
for split specimens in the former rule and groups them together in one
section within the final rule for organizational clarity.
Section 26.113(a) of the final rule revises the same provision in
the proposed rule, in that the NRC has deleted the phrase ``who are
subject to this part'' to provide additional clarity to the language of
the rule, in response to public comment. The NRC deleted this phrase
because not all of the licensees and entities who are subject to Part
26 are required to meet the requirements of this section.
For organizational clarity, the NRC has added Sec. 26.113(b) to
group together in one paragraph the steps that the collector and donor
must follow for the split specimen collection procedure. These steps
were embedded in former Section 2.4(g)(20) and portions of Section
2.7(j) in Appendix A to Part 26. The final rule also replaces the
terminology used in the former rule that referred to the split specimen
as an ``aliquot,'' and uses the terms, ``Bottle A'' and ``Bottle B,''
to refer to the primary and split specimen, respectively. The agency
made these changes for increased clarity in the language of the rule
and consistency with the terminology used in other relevant Federal
rules and guidelines.
In response to a public comment, the NRC revised proposed Sec.
26.113(b)(1) to delete the option of using a specimen bottle to collect
a urine specimen to eliminate the possibility of problems arising from
collecting urine in two different types of containers. The final rule
retains the requirement for the collector to instruct the donor to void
into a specimen container to clarify that the donor is not required to
divide a specimen into Bottle A and Bottle B while urinating. This
paragraph incorporates the related provision in the HHS Guidelines.
Section 26.113(b)(2) amends the portions of former Section 2.7(j)
in Appendix A to Part 26 that specified the amount of urine to be
poured into the split specimen bottles. The rule replaces the implied
requirements in the second and third sentences of Section 2.4(j), which
referred to the split specimens as ``halves'' of the specimen that was
collected, with updated requirements that are consistent with those
established in Sec. 26.109 and the related provisions in the HHS
Guidelines. This paragraph requires the collector to ensure that Bottle
A contains 30 mL and that Bottle B contains a minimum of 15 mL of
urine. As discussed with respect to Sec. 26.109, advances in urine
testing technologies since the agency first promulgated Part 26 permit
a reduction in the quantity of urine that must be collected from donors
in order to conduct the testing this part requires. Therefore, 30 mL of
urine is now a sufficient quantity for conducting all of the testing
that may be required under this part and 15 mL is sufficient for
conducting testing of the specimen in Bottle B.
In response to public comment, the NRC has revised this paragraph
in the final rule to more clearly specify that the specimen in Bottle A
must be used for drug and validity testing even if there is less than
15 mL of urine available for Bottle B. The agency added this
clarification to the final rule because, in the experience of other
Federal agencies, some collection sites have discarded any specimen of
less than 45 mL and conducted another collection to obtain a sufficient
amount of urine to fill both Bottles A and B. Following this practice
would reduce the efficiency of FFD programs and unnecessarily increase
the burden on donors who are subject to testing. The final rule
incorporates this clarification from the HHS Guidelines to ensure that
Part 26 programs do not adopt this inefficient and burdensome practice.
Section 26.113(b)(3) retains the portion of former Section
2.4(g)(20) in Appendix A to Part 26 that requires the donor to observe
the process of splitting the specimens and maintain visual contact with
the specimen bottles until they are sealed and prepared for storage or
shipping.
The NRC added Sec. 26.113(c) to establish priorities for using the
specimen that has been collected. The paragraph permits the licensee
testing facility to test aliquots of the specimen at a licensee testing
facility or to test for additional drugs beyond those required under
Sec. 26.31(d)(1), but only if the donor has provided a specimen of at
least the predetermined quantity, as discussed with respect to Sec.
26.109. As discussed with respect to Sec. 26.113(b)(2), the final rule
requires the collector first to ensure that 30 mL of urine is available
for Bottle A and 15 mL for Bottle B. If the donor has provided more
than 45 mL of urine and the additional amount is sufficient to support
testing at the licensee testing facility, testing for additional drugs,
or both, the final rule permits the remaining amount of urine to be
subject to such testing. However, if the donor has provided only 45 mL
of urine, the final rule requires that the 15 mL of urine that remains
after 30 mL has been retained for Bottle A must be used for Bottle B
rather than to conduct testing at the licensee testing facility or
testing for additional drugs. The final rule establishes this priority
because the FFD program has established the expectation among donors in
this instance that the FFD program will follow split specimen
procedures and
[[Page 17071]]
that Bottle B will be available for retesting at the donor's request.
Reserving the 15 mL of urine for Bottle B is also consistent with the
principle that is established in the last sentences of Sec. Sec.
26.135(b) and 26.165(a)(4) that control over testing of the specimen
contained in Bottle B resides with the donor.
Section 26.115 Collecting a Urine Specimen Under Direct Observation
Section 26.115 groups together in one section the former rule's
requirements that apply to collecting a urine specimen under direct
observation. The NRC has made this organizational change because
requirements that address this topic were dispersed throughout the
former rule. This section also incorporates more detailed procedures
for collecting specimens under direct observation that are based on
related requirements from other relevant Federal rules and guidelines.
More detailed procedures are necessary because devices and techniques
to subvert the testing process have been developed since Part 26 was
first published that are difficult to detect in many collection
circumstances, including under direct observation, such as a false
penis or other realistic urine delivery device containing a substitute
urine specimen and heating element that may be used to replicate
urination. Therefore, the agency has made these changes to increase the
likelihood of detecting attempts to subvert the testing process and
increase the effectiveness of directly observed collections in assuring
that a valid specimen is obtained from the donor.
Section 26.115(a) amends and combines former Section 2.4(f),
2.4(g)(17), and (g)(25) in Appendix A to Part 26. The former provisions
established requirements for collecting a urine specimen under direct
observation. This paragraph of the final rule assigns responsibility
for approving a directly observed collection to the MRO or FFD program
manager, rather than a ``higher level supervisor'' of the collector, as
stated in former Section 2.4(b)(25) in Appendix A to Part 26. This
change ensures that an individual who is thoroughly knowledgeable of
the requirements of this part, and the emphasis that the NRC places on
maintaining the individual privacy of donors, makes the decision to
conduct a directly observed collection. The change is also consistent
with revised requirements in the HHS Guidelines related to who may
authorize a directly observed collection.
The final rule also lists the circumstances that constitute a
reason to believe that a donor may dilute, substitute, adulterate, or
otherwise alter a specimen, and that warrant the invasion of individual
privacy associated with a directly observed collection.
Section 26.115(a)(1) amends former Section 2.4(f)(2) in Appendix A
to Part 26, which stated that a directly observed collection may be
performed if the last urine specimen provided by the donor yielded
specific gravity and creatinine concentration results that were
inconsistent with normal human urine. The new paragraph amends the
former provision in several ways.
First, the final rule eliminates the limitation in the former
paragraph that a specimen may be collected under direct observation if
``the last urine specimen'' provided by the individual yielded specific
gravity and creatinine concentration results that are inconsistent with
normal human urine. The final rule permits a directly observed
collection if the donor had presented a specimen with characteristics
that are inconsistent with normal human urine ``at this or a previous
collection.'' The change is consistent with Sec. 26.75(b), which
requires that an individual who has subverted or attempted to subvert
any test conducted under Part 26 must be subject to a permanent denial
of authorization. Because Sec. 26.75(b) requires permanent denial of
authorization to a donor who has engaged in a subversion attempt,
individuals whose last specimen had characteristics that are
inconsistent with normal human urine are not subject to further testing
under the rule. However, instances may arise in which a licensee or
other entity is aware that an individual engaged in a subversion
attempt under a drug testing program that the NRC does not regulate. If
the licensee or other entity is considering granting authorization
under Part 26 to the individual, then a directly observed collection is
warranted to ensure that the donor does not have an opportunity to
tamper with the specimen and, therefore, that drug test results will be
accurate. The amended language of the new provision permits collecting
a specimen under direct observation in these circumstances.
Second, the final rule updates the former provision by replacing
the specific gravity and creatinine concentration values in the former
paragraph with references to a urine specimen that ``the HHS-certified
laboratory reported as being substituted, adulterated, or invalid to
the MRO and the MRO reported to the licensee or other entity that there
is no adequate medical explanation for the result.'' The NRC made this
change for consistency with the addition of more detailed requirements
for validity testing throughout the final rule, as discussed with
respect to Sec. 26.31(d)(3)(i). Section 26.161 [Cutoff levels for
validity testing] specifies the cutoff concentrations and specimen
characteristics that require the HHS-laboratory to report a specimen as
substituted, adulterated, or invalid. Section 26.185 [Determining a
fitness-for-duty policy violation] specifies the requirements for the
MRO's review of these test results.
Section 26.115(a)(2) combines and updates former Sections 2.4(f)(1)
and 2.4(g)(14) in Appendix A to Part 26. The former provisions stated
that the presentation of a specimen that falls outside of the required
temperature range is sufficient grounds to conduct a directly observed
collection. The new paragraph retains the requirement in former Section
2.4(f)(1) in Appendix A to Part 26, which specified that a directly
observed collection may be conducted at any time the specimen's
temperature falls outside of the required temperature range. However,
the final rule deletes the provisions of the proposed rule that
addressed measuring the donor's body temperature for the reasons
discussed with respect to Sec. 26.111(a).
Section 26.115(a)(3) updates former Section 2.4(f)(3) in Appendix A
to Part 26. The former provision permitted a directly observed
collection if a collector observed donor conduct that clearly and
unequivocally demonstrates an attempt by the donor to substitute the
specimen. The final rule adds references to attempts to dilute and
adulterate a specimen, in addition to substitution, as behaviors that
demonstrate a subversion attempt, consistent with the NRC's heightened
concern in the final rule for ensuring specimen validity, as discussed
with respect to Sec. 26.31(d)(3)(i). As discussed with respect to
Sec. 26.107(b), donor conduct that clearly and unequivocally
demonstrates an attempt to alter a specimen may include, but is not
limited to, possession of a urine specimen before the collection has
occurred; possession of a vial, or vials, filled with chemicals that
are subsequently determined to be urine or an adulterant; possession of
a heating element; or evidence that the coloring agent used by the
licensee or other entity in a source of standing water at the
collection site (see Sec. 26.87(e)(1)) discolors the specimen.
Section 26.115(a)(4) updates former Section 2.4(f)(4) in Appendix A
to Part 26. The former provision permitted
[[Page 17072]]
directly observed collections if a donor had previously been determined
to have engaged in substance abuse and the specimen was being collected
as part of a rehabilitation program and/or pre-access testing following
a confirmed positive test result. This paragraph updates the former
requirement by adding a cross-reference to Sec. 26.69 [Authorization
with potentially disqualifying fitness-for-duty information], which
establishes requirements for granting or maintaining the authorization
of an individual about whom potentially disqualifying FFD information
has been discovered or disclosed. Several provisions in Sec. 26.69
permit or require directly observed collections, including Sec.
26.69(b)(5), which requires specimens to be collected under direct
observation for pre-access drug testing of individuals who have been
subject to sanctions under the rule. For organizational clarity, this
paragraph replaces the former requirement with a cross-reference to
Sec. 26.69, rather than repeat the applicable requirements in this
section.
Section 26.115(b) amends the requirement in former Section
2.4(g)(25) in Appendix A to Part 26 that the collector must obtain
permission from a ``higher level supervisor'' before conducting a
directly observed collection, as discussed with respect to Sec.
26.115(a). The NRC has added the second sentence of this paragraph to
require that, once the decision has been made to conduct a directly
observed collection based on a reason to believe that the donor may
alter a specimen, the collection must occur as soon as reasonably
practical. Although the NRC is not aware of any occasions in Part 26
programs in which a directly observed collection has been unreasonably
delayed, the new requirement ensures that test results from the
directly observed collection provide information about the presence or
absence of drugs and drug metabolites in the donor's urine. If a
collection is delayed for a day or more, metabolism may cause the
concentration of drugs and drug metabolites in the donor's urine, if
any are present, to fall below the cutoff levels established in this
part or by the FFD program and, therefore, not be detected by testing.
Positive, adulterated, substituted, or invalid test results from a
specimen collected under direct observation provide evidence to support
a conclusion that the individual had attempted to subvert the testing
process in order to mask drug abuse, whereas negative test results may
counter the reason to believe that the individual had attempted to
subvert the testing process. Therefore, conducting the directly
observed collection as soon as reasonably practical ensures that test
results from the specimen provide relevant and useful information. The
requirement is also consistent with those of other relevant Federal
rules and guidelines.
The agency added Sec. 26.115(c) to require the collector to inform
the donor of the reason(s) for the directly observed collection so that
the donor is aware of the nature of the concern that has initiated a
directly observed collection. The final rule includes this requirement
for two reasons: (1) knowing the reason for a directly observed
collection may increase a donor's willingness to cooperate in the
procedure in order to counter the reason to believe that the donor has
or may attempt to alter the specimen, and (2) informing the donor of
the reason for a directly observed collection meets Goal 7 of this
rulemaking to protect the privacy and other rights (including due
process) of individuals who are subject to Part 26 by ensuring that the
donor is aware of the concern that has initiated the collection. This
paragraph also meets Goal 1 of this rulemaking by improving consistency
with the requirements of other relevant Federal rules and guidelines.
The NRC added Sec. 26.115(d) to establish recordkeeping
requirements related to the directly observed collection. This
provision requires the collector to record on the specimen's custody-
and-control form that the specimen was collected under direct
observation and the reason(s) for the directly observed collection.
This requirement ensures that the HHS-certified laboratory and the MRO
have this information available when the specimen is tested and the MRO
conducts his or her review of the test results, as is required under
Sec. 26.185. This information is important in an MRO's decision to
request the laboratory to test a specimen that appeared to have been
diluted, as permitted under Sec. 26.185(g)(2), in order to compare the
results from testing the dilute specimen with those obtained from
testing the specimen that was collected under direct observation.
Positive, adulterated, substituted, or invalid test results from the
dilute specimen and the presence of the same drugs or drug metabolites
in the specimen collected under direct observation provide evidence
that the donor diluted the first specimen in an attempt to mask drug
use. This section is also consistent with the requirements of other
relevant Federal rules and guidelines.
Section 26.115(e) retains and combines the former requirements in
Sections 1.2, 2.4(b), 2.4(g)(14), (g)(17), and (g)(25) in Appendix A to
Part 26. These provisions required that the individual who observes the
specimen collection must be of the same gender as the donor. Consistent
with the former requirements, the final rule permits another individual
of the same gender to serve as the observer if a qualified urine
collector of the same gender is not available as long as the observer
receives the instructions specified in Sec. 26.115(f). The final rule
combines the former requirements in this paragraph for organizational
clarity.
The NRC added Sec. 26.115(f) to specify the procedures that must
be followed in conducting a directly observed collection by either a
qualified collector or an individual of the same gender who may serve
as the observer. These more detailed procedures are necessary because
devices and techniques to subvert the testing process have been
developed since Part 26 was first published that can be used under
direct observation without detection. Therefore, the agency made these
changes to increase the likelihood of detecting attempts to subvert the
testing process and, thereby, increase the effectiveness of directly
observed collections in assuring that a valid specimen is obtained from
the donor.
The NRC added Sec. 26.115(f)(1) to specify that the observer must
instruct the donor to adjust his or her clothing to ensure that the
area of the donor's body between the waist and knees is exposed. This
requirement ensures that the observer is able to detect the use of an
anatomically correct urine delivery device.
The agency added Sec. 26.115(f)(2) to specify the action to be
observed during the collection. This paragraph is consistent with the
requirements of other Federal agencies and is intended to ensure that
the urine specimen is obtained from the donor's body.
The rule adds Sec. 26.115(f)(3) to prohibit an observer who is not
the collector from touching the specimen container. The new provision
is consistent with the related requirements of other Federal agencies
and is intended to protect the observer from any potential claims by a
donor that the observer had altered the specimen.
The new Sec. 26.115(f)(4) requires the collector to record the
observer's name on the custody-and-control form if the observer is not
the collector. This mandate is consistent with the related requirements
of other Federal agencies
[[Page 17073]]
and is intended to ensure that the observer's identity is documented
should future questions arise regarding the collection.
The NRC added Sec. 26.115(g) to clarify that a donor's refusal to
participate in the directly observed collection constitutes a refusal
to test and, therefore, is considered to be an act to subvert the
testing process under Sec. 26.75(b). Former Section 2.4(j) in Appendix
A to Part 26 required the collector to inform the MRO, and the MRO to
inform licensee management, if a donor failed to cooperate with the
specimen collection process, including, but not limited, to a refusal
to provide a complete specimen, complete paperwork, or initial the
specimen bottles. The former requirement did not specifically mention
that a refusal to participate in a directly observed collection is also
an instance of a failure to cooperate. In addition, the former rule did
not require the licensee or other entity to impose sanctions on a donor
for refusing to be tested. Therefore, the final rule adds a provision
that both clarifies the NRC's original intent by stating that a refusal
to participate in a directly observed collection constitutes a refusal
to test and updates the former requirement by adding a cross-reference
to the sanction of permanent denial of authorization that is required
under Sec. 26.75(b).
The agency added Sec. 26.115(h) to specify the actions that a
collector must take if a directly observed collection was required but
not performed. The collector must report the omission to the FFD
program manager or designee, who ensures that a directly observed
collection is immediately performed. Although the concentrations of any
drugs, drug metabolites, or blood alcohol in the donor's specimens may
fall below the cutoff levels that are specified in this part or in the
licensee's or other entity's FFD policy if several days have elapsed
since the directly observed collection should have occurred, testing a
specimen collected several days later increases the likelihood of
detecting any subsequent drug or alcohol use. In addition, the
metabolites from using some drugs, such as marijuana, linger in an
individual's body. Therefore, conducting a directly observed collection
may result in detecting these metabolites. However, because elapsed
time reduces the concentrations of drugs, drug metabolites, or alcohol
in the donor's specimens, the final rule requires a directly observed
collection to be performed immediately. This section uses the term
``immediately'' to indicate that the licensee or other entity may be
required to call in the donor and a collector to perform the directly
observed collection, if the donor and collectors are not on site when
the oversight is identified. This requirement increases consistency
with the related requirements of other Federal agencies and is intended
to provide instructions for correcting an oversight that the former
rule did not address.
Section 26.117 Preparing Urine Specimens for Storage and Shipping
A new Sec. 26.117 reorganizes and presents together in one section
former requirements for safeguarding specimens and preparing them for
transfer from the collection site to the licensee's testing facility or
the HHS-certified laboratory for testing. The NRC made this
organizational change because requirements that address these topics
were dispersed throughout the former rule and grouping them together in
a single section in the final rule makes them easier to locate.
Section 26.117(a) amends former Section 2.4(g)(20) in Appendix A to
Part 26, which required the donor and collector to maintain visual
contact with specimens until they were sealed and labeled. The final
rule eliminates reference to blood specimens because donors are no
longer permitted to request blood testing for alcohol under the final
rule, as discussed with respect to Sec. 26.83(a). The new paragraph
also amends the requirements in the second sentence of the former
provision. For organizational clarity, the final rule moves to Sec.
26.113 [Splitting the urine specimen] procedural requirements for
observing the splitting of a specimen and sealing the split specimen
bottles. However, this provision broadens the former requirement, which
addressed only split specimens, to require the donor to observe the
transfer of any specimen or aliquot that the collector transfers to a
second container and the sealing of the container(s). This requirement
is necessary because some FFD programs who operate licensee testing
facilities may transfer an aliquot of the urine specimen to a second
container for initial testing at the licensee testing facility, while
preserving the primary specimen in the first or another container. The
final rule requires the donor to observe these actions to ensure that
the specimen or aliquot(s) that are transferred belong to the donor and
that the identity and integrity of the specimen are maintained.
Section 26.117(b) retains former Section 2.4(g)(21) in Appendix A
to Part 26. This provision requires the donor and collector to remain
present while the procedures for sealing and preparing the specimen
(and aliquots, if applicable) for transfer are performed.
Section 26.117(c) retains the meaning of former Section 2.4(g)(22)
in Appendix A to Part 26. This provision establishes requirements for
labeling and sealing the specimen(s), but the final rule splits the
former requirement into several sentences for increased clarity in the
language of the provision.
For organizational clarity, Sec. 26.117(d) retains and combines
former Section 2.4(g)(23) and 2.4(g)(23)(i) in Appendix A to Part 26.
These provisions required the donor to certify that the specimen was
collected from him or her. However, the final rule deletes former
Section 2.4(g)(23)(ii), which required the donor to have an opportunity
to list on the custody-and-control form any medications he or she had
taken within the past 30 days for the reasons discussed with respect to
Sec. 26.89(b)(3).
The final rule deletes former Section 2.4(g)(24) in Appendix A to
Part 26, which required the collector to enter into the permanent
record book all information identifying the specimen. The agency
eliminated this requirement because the final rule no longer requires
collection sites to maintain a permanent record book, consistent with
the elimination of the requirement to maintain a permanent record book
in the HHS Guidelines. Collection sites are permitted to use other
means of tracking specimen identity, including, but not limited to, bar
coding.
Section 26.117(e) amends former Section 2.4(g)(26) in Appendix A to
Part 26. The former provision required the collector to complete the
chain-of-custody forms for both the aliquot and the split sample and
certify proper completion of the collection. The final rule eliminates
reference to the aliquot and split sample in the former section to
clarify the intent of this requirement, which is that the collector
must complete the appropriate chain-of-custody forms for all of the
sealed specimen and aliquot containers, not simply those resulting from
a split specimen procedure. For example, if an FFD program follows
split specimen procedures and conducts initial testing at a licensee
testing facility, the donor's urine specimen may be divided into Bottle
A, Bottle B, and another container that would be used for tests at the
licensee testing facility. This section retains the former requirement
for the collector to certify proper completion of the collection.
Section 26.117(f) amends former Section 2.4(g)(27) in Appendix A to
Part 26. The former provision stated that the specimens and chain-of-
custody forms
[[Page 17074]]
``are now ready for transfer'' and must be appropriately safeguarded if
they are not immediately prepared for shipment. The final rule replaces
the first sentence of the former provision, which stated that the
specimens and forms are ready for transfer, with a requirement for the
collector to package the specimens and forms for transfer to the HHS-
certified laboratory or licensee testing facility. This change improves
the clarity in the rule's language because it is necessary for the
collector to package the specimens and chain-of-custody forms for
transfer before they are ready to be transferred. This section retains
the second sentence of the former provision.
Section 26.117(g) retains former Section 2.4(g)(28) in Appendix A
to Part 26. This provision requires the collector to maintain control
of the specimens and custody documents and ensure they are secure, if
he or she must leave the workstation or collection site for any reason.
The final rule makes minor editorial changes to some of the terminology
used in the former section for consistency with the terminology used
throughout the final rule, as discussed with respect to Sec. 26.5
[Definitions], but retains the intended meaning of the former
requirements.
Section 26.117(h) retains the requirements in former Section
2.4(c)(2) in Appendix A to Part 26 related to maintaining specimen
security until the specimens are sent from the collection site to the
licensee testing facility or the HHS-certified laboratory for testing.
For organizational clarity, the NRC moved the former paragraph to this
section of the final rule because requirements for maintaining specimen
security apply at this point in the specimen collection process.
Likewise, the agency has moved the portion of the former section that
applies to situations in which it is impractical to maintain continuous
physical security of a collection site to Sec. 26.87(f)(5) because
Sec. 26.87(f) addresses those circumstances.
Section 26.117(i) updates the specimen packaging requirements in
former Section 2.7(i) in Appendix A to Part 26 by replacing the former
section with the related provision from the HHS Guidelines. For
organizational clarity, the rule moves Sec. 26.117(j) to the first
sentence of the former section, which directs collection site personnel
to arrange to transfer the specimens to the licensee testing facility
or HHS-certified laboratory. Section 26.117(j) addresses transfer and
storage requirements, while Sec. 26.117(i) addresses packaging
requirements. This section also eliminates the initial phrases in the
second sentence of the former provision, which listed the conditions
under which specimens were transferred offsite (e.g., shipping
specimens that test as ``presumptive positive'' on initial testing at
the licensee testing facility, special processing of suspect
specimens), because they are redundant with other portions of the final
rule. For organizational clarity, the rule moves new requirements
related to transferring specimens from a licensee testing facility to
an HHS-certified laboratory for further testing to Sec. 26.129(g) in
Subpart F. The final rule also eliminates the third sentence of the
former section, which required the collector to sign and date the tape
used to seal the container. The NRC eliminated this requirement because
licensees and other entities now transfer specimens using courier
services who offer other means of tracking the sender and the date that
a container of specimens is shipped. Program experience has shown these
other means to be equally effective. This new section retains the
intended meaning of the former requirements for the collector to place
the specimens in a second container that minimizes the possibility of
damage during shipment and seal them so that tampering will be
detected. At the request of stakeholders during the public meetings
discussed in the preamble to the proposed rule, the final rule adds
shipping bags to the former set of examples of acceptable shipping
containers that protect the specimens from damage. Also at the request
of stakeholders, the final rule deletes the last sentence of the former
section, which required the collector to ensure that chain-of-custody
documents were attached to the container used to ship the specimens to
the licensee testing facility or laboratory. The stakeholders requested
this change because their practice is to seal a specimen's custody-and-
control documentation inside the shipping container to ensure that it
cannot be altered. The NRC endorses this practice as providing greater
protection for donors and, therefore, adopts this change.
Section 26.117(j) amends and combines the first sentence of former
Section 2.4(i) in Appendix A to Part 26 with the requirements
applicable to the short-term storage of specimens at collection sites
in former Section 2.7(c) in Appendix A to Part 26. The NRC moved to
this section the first sentence of former Section 2.4(i) in Appendix A
to Part 26 for the reasons discussed with respect to Sec. 26.117(i).
Under this section, as a result of advances in testing technologies,
the rule no longer requires short-term refrigerated storage of
specimens within 6 hours of collection. However, the final rule
continues to require licensees and other entities to protect specimens
from any conditions that could cause specimen degradation. Collection
site personnel are required to refrigerate specimens that are not
transferred or shipped to the licensee testing facility or the HHS-
certified laboratory within 24 hours of collection. The final rule also
requires that any specimens that may have been substituted or
adulterated must be refrigerated as soon as they are collected because
some adulterants may interfere with drug testing results unless the
specimen is refrigerated. The final rule establishes a time limit of 2
business days for receipt of specimens at the licensee testing facility
or HHS-certified laboratory after shipment from the collection site to
further protect against potential specimen degradation.
Section 26.117(k) amends the portions of former Section 2.4(h) in
Appendix A to Part 26 that required a specimen's custody-and-control
form to identify every individual in the chain of custody. The final
rule does not require couriers to meet the requirements in former
Section 2.4(h), which stated that each time a specimen is handled or
transferred, the date and purpose of the transfer must be documented on
the chain-of-custody form and every individual in the chain of custody
must be identified. Couriers are not required to meet these
requirements because custody-and-control forms for individual specimens
are packaged inside the shipping container, where they are inaccessible
to couriers, so that it is impractical to expect them to sign the forms
when handling the specimen shipping containers. This new paragraph
codifies licensees' and other entities' practice of relying on courier
services' normal package tracking systems to maintain accountability
for specimen shipping containers, which is consistent with the HHS
Guidelines and standard forensic practices. The final rule also
eliminates the former requirement, contained in the last sentence of
Section 2.4(h) in Appendix A to Part 26, to minimize the number of
persons handling specimens because this requirement cannot be enforced.
Section 26.119 Determining ``Shy'' Bladder
The agency has adapted a new Sec. 26.119 from the DOT Procedures
at 49 CFR 40.193 [What happens when an employee does not provide a
sufficient amount of urine for a drug test?] to specify procedures for
determining whether a donor who does not provide a urine specimen of 30
mL within the 3 hours that is permitted for a specimen
[[Page 17075]]
collection is refusing to test or has a medical reason for being unable
to provide the required 30 mL specimen. This new section responds to
stakeholder requests during public meetings discussed in the preamble
to the proposed rule. The stakeholders reported that some donors have
had difficulty providing the minimum 60 mL of urine required in former
Section 2.4(g)(11) for medical reasons, but the former rule did not
establish procedures for handling such circumstances. As a result, some
FFD programs have adopted the DOT ``shy bladder'' procedures, but
stakeholders preferred that the final rule incorporate the requirements
to (1) clarify that the NRC accepts the procedures, (2) inform donors
of the procedures that they are required to follow if they have medical
reasons for being unable to provide a sufficient quantity of urine for
testing, (3) enhance consistency among Part 26 programs, and (4)
enhance the consistency of Part 26 procedures with the procedures that
collectors must follow when conducting tests under DOT requirements.
The NRC expects that fewer donors will be subject to ``shy bladder''
problems under the final rule because Sec. 26.109 reduces the minimum
quantity of urine required from 60 mL in the former rule to 30 mL.
However, because some donors' medical problems may also interfere with
their ability to provide 30 mL of urine, the final rule incorporates
the DOT procedures. These procedures are intended to protect the due
process rights of individuals who are subject to Part 26. That is, this
section establishes procedures for ensuring that there is a legitimate
medical reason that a donor was or is unable to provide a urine
specimen of the required quantity so that the licensee or other entity
has a medical basis for not imposing sanctions on the individual. In
addition, the MRO is authorized to devise alternative methods of drug
testing, if it appears that the donor's medical problem prevents him or
her from being able to provide sufficient urine for drug testing in
future tests.
The agency has added Sec. 26.119(a) to require that a licensed
physician, who has appropriate expertise in the medical issues raised
by the donor's failure to provide a sufficient specimen, must evaluate
a donor who was unable to provide a urine specimen of at least 30 mL.
The rule permits the MRO to perform the evaluation if the MRO possesses
the appropriate expertise. If not, the rule requires the MRO to review
the qualifications of the physician and agree to the selection of that
physician. These requirements for the physician who performs the
evaluation to be qualified in the relevant medical issues ensure that
the results of the evaluation are valid.
This section also requires that the evaluation must be completed
within 5 calendar days of the unsuccessful collection. The agency has
established the time limit of 5 calendar days as a trade off between
the need to provide the donor with sufficient time to locate a
qualified physician, obtain an appointment, and for the physician to
complete the evaluation (i.e, the donor's right to due process), and
the public's interest in a rapid determination of whether the donor had
attempted to subvert the testing process by refusing to provide a
sufficient specimen. DOT's experience indicates that 5 days is
sufficient to complete the evaluation.
The final rule adds Sec. 26.119(b) to specify the information that
the MRO must provide to the physician who is selected to perform the
evaluation if the MRO does not perform it. Sections 26.119(b)(1) and
(b)(2) require the MRO to inform the physician that the donor was
required to take a drug test under Part 26 but was unable to provide a
sufficient quantity of urine for testing and explain the potential
consequences to the donor for a refusal to test. These requirements
ensure that the evaluating physician understands the context in which
he or she is being asked to perform the evaluation. Section
26.119(b)(3) also requires the MRO to inform the physician that he or
she must agree to follow the procedures specified in Sec. 26.119(c)
through (f) if he or she performs the evaluation. This requirement
ensures that the physician understands and consents to follow the
procedures specified in this section.
The NRC added Sec. 26.119(c) to describe the conclusions that the
physician must provide to the MRO following the evaluation. Under Sec.
26.119(c)(1), the physician may determine that a medical condition has,
or with a high degree of probability could have, precluded the donor
from providing the required quantity of urine. Or, under Sec.
26.119(c)(2), the physician may determine that there is an inadequate
basis for determining that a medical condition has, or with a high
degree of probability could have, precluded the donor from providing a
sufficient quantity of urine. The final rule limits the physician's
conclusions to one of these two alternatives to ensure that the results
of the evaluation are relevant to and useful for determining whether
sanctions must be imposed on the donor for a refusal to test.
The agency added Sec. 26.119(d) to define the physical and
psychological conditions that constitute a medical condition that could
have precluded the donor from providing a 30-mL specimen as well as to
provide examples of conditions that do not constitute a legitimate
medical condition. Legitimate medical conditions include an
ascertainable physiological condition (e.g., a urinary system
dysfunction) or a medically documented pre-existing psychological
disorder that precluded the donor from providing a 30-mL specimen.
Unsupported assertions of ``situational anxiety'' or dehydration are
examples of conditions that could not be considered legitimate medical
conditions. The final rule adds this section to provide necessary
guidance to the evaluating physician.
The final rule adds Sec. 26.119(e) to require the evaluating
physician to provide a written statement of his or her findings and
conclusion from the evaluation. By implication, if the MRO performs the
evaluation, the MRO provides this written statement. The written
statement is necessary to communicate the results of the evaluation and
create a record of it, should any question arise later with respect to
the determination.
This section also requires that the physician must provide only the
information that is necessary to support the physician's conclusion.
The NRC has added this requirement to protect the donor's privacy by
ensuring that the physician documents only the medical information that
is necessary to support the determination.
The NRC added Sec. 26.119(f) to require the physician to inform
the MRO, in the written statement, whether any medical condition that
may be identified also precludes the donor from providing specimens of
30 mL or more in future collections. This information is necessary for
the MRO to determine whether to implement alternative methods of drug
testing for the donor, as required under Sec. 26.119(g)(3).
The agency added Sec. 26.119(g) to prescribe the actions that the
MRO must take based on the results of the evaluation, as follows:
Section 26.119(g)(1) requires the MRO to determine that the donor
did not violate the FFD policy, if the physician concluded that a
medical condition could account for the insufficient specimen and the
MRO concurred with that conclusion. In this instance, the licensee or
other entity does not impose sanctions on the donor because the donor
had not violated the FFD policy by refusing to test.
[[Page 17076]]
Section 26.119(g)(2) requires the MRO to determine that the donor
had refused to be tested by failing to provide a sufficient specimen,
if the physician concluded that a medical condition could not account
for the insufficient specimen. In this instance, the licensee or other
entity imposes the sanction of a permanent denial of authorization for
an attempt to subvert the testing process, as required under Sec.
26.75(b).
Section 26.119(g)(3) requires the MRO to devise an alternative
method of collecting specimens for drug testing, if the donor's medical
condition, over the long-term, consistently prevents the donor from
providing urine specimens of 30 mL or more. For example, the provision
permits the MRO to direct the collection and testing of alternate
specimens, including, but not limited to, hair, or other bodily fluids,
if, in the MRO's professional judgment, the collection and analysis of
these alternate specimens is scientifically defensible and forensically
sound. The section grants flexibility to the MRO in exercising his or
her professional judgment in determining an alternative method of
conducting drug testing, rather than establishing detailed requirements
that may not appropriately address the range of possible medical
conditions that could arise.
Subpart F--Licensee Testing Facilities
In this subpart, the final rule replaces two terms used in the
proposed rule in response to public comments. These language changes
affect numerous sections within Subpart F. First, one public comment
addressed a proposed provision in Sec. 26.137(b) [Performance testing
and quality control requirements for validity screening tests] that
permitted licensee testing facilities to use validity screening tests
approved by the U.S. Food and Drug Administration (FDA). The NRC has
eliminated both the requirement and the use of the term ``device'' with
respect to validity screening testing because the FDA is not
responsible for approving validity screening devices. The final rule
has replaced the term ``device'' in ``validity screening device'' with
the term ``test'' throughout Subpart F. Second, several public comments
addressed the use of the term ``non-negative'' to refer to drug and
validity test results and requested that the NRC eliminate the term
from the final rule and instead use a more familiar term such as
``positive'' test result. Throughout Subpart F, the NRC has replaced
the term ``non-negative'' with a new term to address validity screening
and initial validity testing results from a licensee testing facility
that indicate that a specimen may be adulterated, substituted, dilute,
or invalid. The new term used for these validity testing results is
``questionable validity.'' The NRC has added a definition for
``questionable validity'' to Sec. 26.5 [Definitions]. Adding the term
``questionable validity'' addresses the commenters' concern and
improves the clarity of the final rule to meet Goal 6 of this
rulemaking. The NRC retained the use of ``positive'' to refer to
results from initial testing for drugs that indicate the presence of a
prohibited drug in the specimen.
Section 26.121 Purpose
The NRC added Sec. 26.121 to provide an overview of the contents
of the proposed subpart, consistent with Goal 6 of this rulemaking to
improve clarity in the organization and language of the final rule.
Section 26.123 Testing Facility Capabilities
Section 26.123 amends the second sentence of former Section
2.7(l)(2) in Appendix A to Part 26 as it related to the capabilities of
licensee testing facilities. The final rule retains the former
requirement for licensee testing facilities to be capable of performing
initial tests for each drug and drug metabolite for which testing is
conducted by the FFD program and adds a requirement for licensee
testing facilities to have the capability to perform either validity
screening tests, initial validity tests, or both. The agency moved the
first sentence of former Section 2.7(l)(2), which established
requirements for the capabilities of HHS-certified laboratories, to
Subpart G [Laboratories Certified by the Department of Health and Human
Services]. The NRC deleted the last sentence of the former paragraph,
which permitted the testing of breath specimens for alcohol at the
collection site, because the final rule addresses alcohol testing in
Subpart E [Collecting Specimens for Testing]. The NRC made these
changes to the former provision to meet Goal 6 of this rulemaking to
improve organizational clarity in the final rule.
Section 26.125 Licensee Testing Facility Personnel
Section 26.125 amends former Section 2.6 in Appendix A to Part 26
[Licensee testing facility personnel], as follows:
Section 26.125(a) retains former Section 2.6(a) in Appendix A to
Part 26. This provision requires each licensee testing facility to have
one or more individuals who are responsible for the day-to-day
operations of the facility and establishes requirements for those
individuals' qualifications. The final rule makes minor changes in the
former provision to improve consistency with amended language in the
related portion of the HHS Guidelines.
Section 26.125(b) amends former Section 2.6(b) in Appendix A to
Part 26. This provision required laboratory technicians and
nontechnical staff to have the necessary training and skills for the
tasks assigned to them. The final rule retains the former provision and
adds another. The final rule requires laboratory technicians who
perform urine specimen testing to demonstrate proficiency in operating
the instruments and tests used at the licensee testing facility. The
NRC added this proficiency requirement to ensure that technicians are
capable of correctly using the instruments and tests that the licensee
testing facility has selected for validity and drug testing. This
change is necessary for several reasons. First, the final rule adds new
requirements for licensee testing facilities to conduct validity
testing, and the instruments and tests that the technicians will use
are likely to differ from those previously used at licensee testing
facilities. Therefore, additional training and proficiency testing is
required to ensure that validity testing is conducted properly. Second,
the final rule permits licensees and other entities to rely on drug
test results from testing that was performed by another Part 26 program
to a greater extent than the former rule. Therefore, it is necessary to
ensure that all drug testing performed under Part 26, including tests
performed at licensee testing facilities, meets minimum standards. The
requirement for technicians to demonstrate proficiency, then,
contributes to meeting this goal. Third, the experience of other
Federal agencies has shown that requirements for technicians to
demonstrate proficiency assist in any litigation that may occur with
respect to urine test results.
With respect to the proposed rule and in response to a public
comment that proficiency documentation requirements were missing from
the proposed rule in several locations, the final rule adds a
requirement for licensee testing facilities to document the proficiency
of its technicians. Although proposed Sec. 26.125(c) required licensee
testing facility personnel files to include documentation of training
and experience and the results of tests that establish employee
competency for the position he or she holds, the final rule adds a
requirement for documentation of proficiency in Sec. 26.125(b) to
further clarify that this documentation is required and
[[Page 17077]]
specifically applies to laboratory technicians who perform urine drug
testing. The NRC made this change to meet Goal 6 of this rulemaking to
improve clarity in the organization and language of the rule.
Section 26.125(c) amends former Section 2.6(c) in Appendix A to
Part 26. The provision establishes recordkeeping requirements for the
personnel files of licensee testing facility staff. The final rule,
with respect to the proposed rule, further clarifies the intent of the
licensee testing facility personnel competency requirements by
specifying that personnel must be proficient in conducting testing
using the most recent instructions from instrument and test
manufacturers. In addition, in response to comments received on the
elimination of the former provision in Section 2.5(f) in Appendix A to
Part 26 that required licensees and other entities to maintain color
blindness testing records in files for licensee testing facility
personnel, the final rule reinstates the requirement. The final rule
retains the color blindness testing recordkeeping requirement because
some validity screening and initial validity tests require laboratory
testing facility personnel to visually evaluate the color of the assay
to determine the test result. Retaining records of color blindness
testing is necessary to demonstrate licensee testing facility personnel
competency.
Section 26.127 Procedures
Section 26.127 combines, reorganizes, and amends requirements for
procedures that were interspersed throughout Appendix A to Part 26,
including requirements in former Sections 2.2 [General administration
of testing] and 2.7 [Laboratory and testing facility analysis
procedures]. These changes improve clarity in the organization of the
final rule by grouping procedural requirements for licensee testing
facilities in one section, consistent with Goal 6 of this rulemaking.
Section 26.127(a) makes minor editorial changes to the first
sentence of former Section 2.2 in Appendix A to Part 26. The former
provision required licensee testing facilities and HHS-certified
laboratories to have detailed procedures for conducting testing. The
final rule deletes the reference to blood samples in the former
provision because donors no longer have the option to request blood
testing for alcohol, as discussed with respect to Sec. 26.83(a). For
organizational clarity, the final rule moves the reference to HHS-
certified laboratories to Sec. 26.157(a) in Subpart G. The final rule
also deletes the former reference to procedures for specimen
collections in this paragraph because procedural requirements for
specimen collections are addressed in Subpart E.
Section 26.127(b) amends and combines portions of the requirements
in the first sentence of former Section 2.4(d) and 2.7(a)(2) in
Appendix A to Part 26 related to the content and implementation of
specimen chain-of-custody procedures. The final rule retains the
portions of the former provisions that required licensee testing
facilities to develop, implement, and maintain written chain-of-custody
procedures to maintain control and accountability of specimens from
receipt through completion of testing and reporting of results, during
storage and shipping to the HHS-certified laboratory, and continuing
until final disposition of the specimens. For organizational clarity,
the NRC moved the former requirements related to HHS-certified
laboratories to Sec. 26.157(b) in Subpart G. The final rule also
removes references to custody-and-control procedures for blood
specimens because donors no longer have the option to request blood
testing for alcohol, as discussed with respect to Sec. 26.83(a).
Section 26.127(c) retains the portions of former Section 2.7(o)(1)
in Appendix A to Part 26 that addressed the required content of
procedures for licensee testing facilities and amends the former
requirements. The final rule retains the portions of the former
provision that required licensee testing facilities to develop and
maintain procedures to specify all of the elements of the testing
process, including, but not limited to, the principles of each test and
the preparation of reagents, standards, and controls. The final rule
presents the required topics of the procedures in a list format in
Sec. 26.127(c)(1)-(c)(12) to clarify that each topic stands on its own
and to meet Goal 6 of this rulemaking to improve clarity in the
organization of the rule.
Section 26.127(c) also amends former Section 2.7(o)(1) in Appendix
A to Part 26 in several ways. First, the final rule eliminates the
former requirement for the procedures to be maintained in a laboratory
manual as unnecessarily restrictive. The final rule permits licensee
testing facilities to use other means to maintain their procedures.
Second, the agency has added a requirement for the development,
implementation, and maintenance of written standard operating
procedures for all laboratory instruments and validity screening tests,
consistent with the addition of requirements to conduct validity
testing throughout the final rule. Third, the final rule moves two
portions of the former provision to other subparts of the rule that
address related topics to improve clarity in the organization and
language of the final rule, as follows: The agency relocated the last
two sentences of former Section 2.7(o)(1) in Appendix A to Part 26,
which addressed requirements for retaining copies of superceded
procedures, to Sec. 26.715(a) of Subpart N [Recordkeeping and
Reporting Requirements], and the final rule moves procedural
requirements for HHS-certified laboratories to Sec. 26.157(b) in
Subpart G.
Section 26.127(d) amends former Section 2.7(o)(3)(iii) in Appendix
A to Part 26. This provision required procedures for the setup and
normal operation of testing instruments, a schedule for checking
critical operating characteristics for all instruments, tolerance
limits for acceptable function checks, and instructions for major
troubleshooting and repair. The final rule extends the former
requirements to non-instrumented tests (such as some validity screening
tests, if the licensee testing facility uses these tests), consistent
with the addition of requirements to conduct validity testing
throughout the final rule. The final rule also makes three
organizational changes to the former provision. The final rule presents
the required topics of the procedures in a list format in Sec.
26.127(d)(1)-(d)(3) to clarify that each topic stands on its own. The
NRC relocated the former requirement to maintain records of
preventative maintenance to Sec. 26.715(b)(10) in Subpart N. And, the
NRC has moved the former requirements that applied to HHS-certified
laboratories to Sec. 26.157(d) in Subpart G. These changes improve
clarity in the organization of the rule, consistent with Goal 6 of this
rulemaking.
Section 26.127(e) reorganizes and amends former Section 2.7(o)(4)
in Appendix A to Part 26. The former provision required corrective
actions to be documented if systems are out of acceptable limits or
errors are detected. The final rule extends the former requirement to
validity screening tests if the licensee testing facility uses these
tests, consistent with the addition of requirements to conduct validity
testing throughout the final rule. The final rule, with respect to the
proposed rule, also adds the term ``instrumented'' to clarify that a
licensee testing facility must develop and implement procedures for
remedial actions on testing facility equipment, instruments, and tests.
The NRC has moved the requirements in the former paragraph that applied
to HHS-
[[Page 17078]]
certified laboratories to Sec. 26.157(e) in Subpart G for
organizational clarity.
Section 26.129 Assuring Specimen Security, Chain of Custody, and
Preservation
Section 26.129 has been added to group together in one section the
requirements of the final rule that apply to licensee testing
facilities with respect to the safeguarding of specimen identity,
integrity, and security. The NRC made this organizational change
because requirements that addressed these topics were dispersed
throughout the former rule. Grouping them together in a single section
makes them easier to locate within the final rule and meets Goal 6 of
this rulemaking to improve clarity in the language and organization of
the rule.
Section 26.129(a) retains the first four sentences of former
Section 2.7(a)(1) in Appendix A to Part 26. The provision requires
licensee testing facilities to be secure and accessible only to
authorized personnel. The final rule moves the requirements in the
former provision that applied to HHS-certified laboratories to Sec.
26.159(a). The final rule moves the last sentence of the former
paragraph, which established recordkeeping requirements, to Sec.
26.715(b)(13) in Subpart N. The NRC made these changes for
organizational clarity.
Section 26.129(b) amends former Section 2.7(b)(1) in Appendix A to
Part 26. This provision established requirements for receiving
specimens at the licensee testing facility and assuring their integrity
and identity. For organizational clarity, the final rule moves the
former requirements related to HHS-certified laboratories to Sec.
26.159(b) in Subpart G. The final rule, with respect to the proposed
rule, adds Sec. 26.129(b)(1) and (b)(2) to improve the clarity of the
organization of the rule. The NRC has also added several requirements
to the former provision, as follows:
In Sec. 26.129(b), the final rule retains the requirement for
licensee testing facility personnel to inspect specimens received for
testing to determine whether there is any evidence of tampering with
the specimens and to ensure that the custody-and-control documents are
correct. With respect to the proposed rule, the final rule adds a
requirement for licensee testing facility personnel to attempt to
resolve any discrepancies in the information on specimen bottles or on
the accompanying custody-and-control forms to ensure the identity and
integrity of specimens and prevent specimens from being unnecessarily
rejected for testing by the HHS-certified laboratory (if the specimen
must be subject to additional testing) when flaws can be corrected. For
example, if the collector's signature is missing on the custody-and-
control form, licensee testing facility personnel will work with
collection site personnel to attempt to identify the collector and
obtain a memorandum for the record from the collector if possible. This
requirement reduces the potential burden on donors who may otherwise be
required to submit additional specimens to replace those for which the
chain of custody could not be confirmed. The final rule, with respect
to the proposed rule, adds a provision that specifies the procedures to
be followed by licensee testing facility personnel to correct custody-
and-control form errors that are identified after the specimen
collection process has been completed and the donor has departed from
the collection site. This addition is based on a comment received on
the proposed rule requesting the addition of these procedures. The
requirements also improve the efficiency of FFD programs by avoiding
the need to conduct additional specimen collections when discrepancies
can be corrected. The additional provision meets Goal 7 of this
rulemaking to protect the privacy and other rights (including due
process) of individuals who are subject to Part 26, as well as Goal 1
of this rulemaking, to update and enhance the consistency of Part 26
with advances in other relevant Federal rules and guidelines.
Section 26.129(b)(1) adds requirements for licensee testing
facility personnel to report to management any indications of specimen
tampering within 8 hours of the discovery. This provision also requires
licensee or other entity management personnel to initiate an
investigation to determine whether tampering has occurred. Section
26.129(b)(i) requires management to take corrective actions if
tampering is confirmed. The final rule adds these requirements because
some licensees did not investigate or take corrective actions in
response to indications of tampering with specimens under the former
rule. The appropriate corrective actions that management personnel
would take depend on the nature of the tampering identified as a result
of the investigation. For example, if the investigation indicated that
the tampering was an attempt to subvert the testing process and the
persons involved were identified, management personnel would impose the
sanctions in Sec. 26.75(b) for a subversion attempt. This provision
also requires management personnel to correct any systematic weaknesses
in specimen custody-and-control procedures that may be identified in
the investigation, such as inadequate safeguarding of specimen shipping
containers.
Section 26.129(b)(1)(ii) adds a prohibition on testing of any
specimen if the licensee or other entity has reason to believe that the
specimen was subject to tampering or altered in a manner as to affect
specimen identity and integrity. In this circumstance, the MRO will
cancel testing of the specimen or any test results for the specimen,
and require the licensee or other entity to retest the donor who
submitted the original specimen. The final rule, with respect to the
proposed rule, adds an exception for split specimen collections in
response to a public comment that requested additional clarification of
the proposed rule's requirements for cancelling tests. For a split
specimen collection, if the tamper-evident seal remains intact on
either Bottle A or Bottle B of the specimen and the bottle contains at
least 15 mL of urine, the final rule requires the licensee testing
facility to forward the intact specimen to the HHS-certified laboratory
and prohibits any testing at the licensee testing facility. This new
provision serves to eliminate unnecessary additional specimen
collections, thereby meeting Goal 3 of this rulemaking to improve the
effectiveness and efficiency of FFD programs.
The NRC added Sec. 26.129(b)(2) in the final rule, with respect to
the proposed rule, to include specific instances that would require the
cancellation of the testing of a donor's urine specimen. This change
has been made in response to a public comment that requested the NRC to
add information in the final rule to describe the actions that must be
taken if the integrity of a specimen is in question. Adding this
information to the final rule meets Goal 7 of this rulemaking to
protect the privacy and other rights (including due process) of
individuals who are subject to Part 26, as well as Goal 1 to improve
the consistency of NRC requirements with those of other Federal
agencies. The provisions are modeled on similar requirements in the
DOT's drug testing program.
Although the NRC is not aware of any instances when these
circumstances have arisen in Part 26 programs, the experience of other
Federal agencies indicates that specimen tampering is possible.
Therefore, the requirements in Sec. 26.129(b) are necessary to ensure
that donors are not subject to sanctions for positive, adulterated,
substituted, or invalid test results from a specimen that
[[Page 17079]]
may not have been theirs. These changes meet Goal 7 of this rulemaking
to protect the privacy and other rights (including due process) of
individuals who are subject to Part 26 and ensure that the individuals
are afforded accurate and consistent testing. These requirements are
also consistent with the requirements of other Federal agencies.
Section 26.129(c) amends former Section 2.7(b)(2) in Appendix A to
Part 26. This provision established requirements for chain-of-custody
procedures for specimens and aliquots at licensee testing facilities.
The final rule moves the requirements in the former paragraph that were
related to HHS-certified laboratories to Subpart G to improve
organizational clarity.
The section incorporates two additional changes to the former
provision at the request of stakeholders at the public meetings
discussed in Section I.D. The stakeholders requested that the NRC
permit licensee testing facilities to use methods other than a custody-
and-control form to maintain the chain of custody for aliquots of a
specimen that are tested at the licensee testing facility. The NRC
incorporated this change because methods other than a custody-and-
control form, such as the use of bar coding, have been shown to be
equally effective at tracking the chain of custody for an aliquot at
licensee testing facilities. Adding this flexibility is consistent with
Goal 5 of this rulemaking to improve Part 26 by eliminating or
modifying unnecessary requirements.
The stakeholders also requested that the section specify the
conditions under which specimens and aliquots may be discarded because
the former rule did not address discarding of negative specimens.
Therefore, the final rule permits licensee testing facilities to
discard specimens and aliquots as soon as practical after validity
screening or initial validity tests have demonstrated that the specimen
is valid and initial test results for drugs and drug metabolites are
negative. The clarification codifies licensee practices. This
permission has no impact on donors' rights under the final rule because
donors are not at risk of management actions or sanctions as a result
of negative test results and, therefore, do not need the licensee
testing facility to retain the specimen for additional testing for
review or litigation purposes. The change has been made to meet Goal 6
of this rulemaking to improve clarity in the language of the final
rule.
Section 26.129(d) updates former Section 2.7(a)(2) in Appendix A to
Part 26. This provision required licensee testing facility personnel to
maintain and document the chain of custody for specimens and aliquots.
The final rule incorporates the simpler language of the related
provision from the HHS Guidelines while retaining the intent of the
former provision. The final rule relocates the requirements in the
former section that were related to HHS-certified laboratories to Sec.
26.159(d) and (e) in Subpart G to improve organizational clarity.
Section 26.129(e) amends the first sentence of former Section
2.7(d) in Appendix A to Part 26 [Specimen processing]. That sentence
required specimens that test as ``presumptive positive'' at the
licensee testing facility to be shipped to the HHS-certified laboratory
for further testing. The final rule replaces the term ``presumptive
positive'' with terms to describe the specific test results, as
appropriate (i.e., ``positive,'' ``questionable validity'') in order to
address validity testing results, consistent with the addition of
requirements to conduct validity testing throughout the final rule, as
discussed with respect to Sec. 26.31(d)(3)(i). For organizational
clarity, the agency has moved the requirements in former Section 2.7(d)
in Appendix A to Part 26 that related to quality control procedures for
testing at licensee testing facilities and HHS-certified laboratories
to Sec. 26.137 [Quality assurance and quality control] and Sec.
26.167 [Quality assurance and quality control] of the final rule,
respectively.
Section 26.129(f) clarifies and revises former Section 2.7(c) in
Appendix A to Part 26 [Short term refrigerated storage], as it related
to refrigerating urine specimens to protect them from degradation. For
organizational clarity, the final rule moves the former requirements
that applied to HHS-certified laboratories to Sec. 26.159(h) in
Subpart G. The final rule restates portions of the former provision and
adds a performance standard regarding ``appropriate and prudent
actions'' to minimize specimen degradation. For the reasons discussed
with respect to Sec. 26.117(j), the final rule no longer requires all
specimens to be refrigerated within 6 hours after collection, but adds
a requirement that any specimen that has not been tested within 24
hours of receipt at the licensee testing facility must be refrigerated.
The final rule continues to require the licensee or other entity to
refrigerate any specimen (and the associated Bottle B for that specimen
if the FFD program follows split specimen procedures) that yields a
positive test result from initial drug testing at the licensee testing
facility. The final rule also adds a requirement for refrigerating any
specimen (and the associated Bottle B specimen if a split specimen
collection is performed) that yields a questionable validity test
result from validity screening or initial validity testing.
Refrigerating these specimens is necessary because some adulterants
have been shown to interfere with drug test results more rapidly if the
specimen remains at room temperature.
The final rule also updates the terminology used in the former
paragraph to be consistent with the new terminology adopted throughout
the final rule for referring to split specimens. Therefore, in the
final rule, the licensee testing facility continues to be responsible
for protecting from degradation the primary specimen (Bottle A) and the
specimen in Bottle B of a split specimen if the FFD program follows
split specimen procedures. The rule also requires the licensee testing
facility to refrigerate any specimen that yields a positive test result
or a questionable validity test result. This includes the specimen in
Bottle B associated with any aliquot that yields a positive or
questionable validity test result at the licensee testing facility. The
NRC made these changes in the terminology of the paragraph to improve
clarity in the language of the final rule.
The final rule separates former Section 2.4(i) in Appendix A to
Part 26 [Transportation to laboratory or testing facility] into two
paragraphs, Sec. 26.129(g) and (h), for organizational clarity and
amends the former provision for the reasons previously discussed with
respect to Sec. 26.117(i) and (k). Section 26.129(g) and (h), which
repeats the requirements for packaging and shipping specimens contained
in Sec. 26.117(i) and (k) of Subpart E, applies these requirements to
packaging and shipping specimens from licensee testing facilities to
HHS-certified laboratories. The basis for these requirements is
discussed with respect to Sec. 26.117(i) and (k).
Section 26.131 Cutoff Levels for Validity Screening and Initial
Validity Tests
The NRC has added Sec. 26.131 to establish cutoff levels for
validity screening and initial validity tests that are conducted at
licensee testing facilities. The procedures, substances, and cutoff
levels for initial validity testing in this section incorporate related
requirements from the HHS Guidelines (69 FR 19643; April 13, 2004). The
validity screening test requirements have been adapted, in large part,
from the HHS proposed
[[Page 17080]]
revision to the Guidelines that was also published in the Federal
Register on April 13, 2004 (69 FR 19673).
In contrast to the requirements for initial validity testing in the
HHS Guidelines, the final rule does not permit licensee testing
facilities to evaluate the specific gravity of any specimens. To
determine if a specimen is dilute or substituted, specific gravity
testing is required. If the creatinine concentration of a specimen is
less than 20 mg/dL, the final rule requires the licensee testing
facility to forward the specimen to the HHS-certified laboratory to
complete the testing, where the specimen's specific gravity will be
measured. The final rule differs from the HHS Guidelines in this
provision because the costs of the instruments (i.e., refractometers)
that are required in the Guidelines for measuring specific gravity are
high. Some licensee testing facilities are currently measuring the
specific gravity of specimens. However, the cutoff levels established
in the Guidelines require more sensitive measurement and licensee
testing facilities would be required to purchase new equipment in order
to test at the new HHS specific gravity cutoff levels. Therefore, the
final rule requires licensee testing facilities to transfer all
specimens with creatinine concentrations less than 20 mg/dL to an HHS-
certified laboratory to complete the initial testing process and does
not include cutoff levels for specific gravity or quality control
requirements for measuring specific gravity.
Section 26.131(a) has been added to require licensee testing
facilities to perform either validity screening tests, initial validity
tests, or both. Consistent with related requirements for further
testing of a specimen at an HHS-certified laboratory when initial drug
testing at the licensee testing facility yields a positive test result,
the final rule also requires licensee testing facilities to forward
specimens that yield a questionable validity screening or initial
validity test result to an HHS-certified laboratory for further
testing. Further testing at an HHS-certified laboratory is necessary
because licensee testing facilities do not have the sophisticated
testing instruments required for conducting confirmatory testing that
are required under the HHS Guidelines. In addition, further testing at
an HHS-certified laboratory provides an independent check on test
results from licensee testing facilities that is necessary to ensure
that donors are afforded accurate and consistent testing under this
part, consistent with Goal 7 of this rulemaking.
As discussed in Section IV.C, the primary distinction between
validity screening tests and initial validity tests is that validity
screening tests may be performed using non-instrumented devices, such
as dipsticks, whereas initial validity tests generally rely on more
complex instrumented testing technologies. The final rule permits
licensee testing facilities to perform validity screening tests before
performing initial validity tests but does not require them to do so
because validity screening tests are unnecessary if the licensee
testing facility performs initial validity testing. Licensees and other
entities may choose to conduct validity screening tests, followed by
initial validity testing of any specimens that are identified to be of
questionable validity as a result of validity screening, potentially to
reduce the number of donor specimens that must be forwarded to the HHS-
certified laboratory. In addition, the rule permits licensee testing
facilities to choose whether to conduct validity screening tests or
initial validity testing for each type of validity testing that is
required under the rule. For example, a licensee or other entity may
choose to use dipsticks (a validity screening test) to evaluate a
specimen's creatinine concentration and only a pH meter (a method for
conducting initial validity testing) without first performing a
validity screening test for pH to evaluate the specimen's pH. The NRC
is permitting flexibility in the means licensee testing facilities use
to conduct specimen validity testing to meet Goal 3 of this rulemaking
to enhance the efficiency and effectiveness of FFD programs.
Section 26.131(b) requires licensee testing facilities to test each
urine specimen for creatinine concentration, pH, and the presence of
one or more oxidizing adulterants, such as nitrite or bleach. Abnormal
creatinine concentrations, abnormal pH values, or the possible presence
of an oxidizing adulterant indicate that a donor may have altered the
specimen (e.g., adulterated the specimen or substituted another
substance in place of the donor's urine) in an attempt to subvert the
testing process. The final rule permits licensees and other entities to
choose the oxidizing adulterant(s) for which testing will be conducted.
The requirements in this paragraph are consistent with the related
requirements in the HHS Guidelines.
Because validity testing is complex and the methods for testing are
relatively new, the second sentence of Sec. 26.131(b) prohibits an FFD
program from establishing more stringent cutoff levels for validity
screening and initial validity testing than the cutoff levels
established in this provision. This prohibition is necessary to
decrease the risk of obtaining false adulterated, substituted, or
invalid test results and ensures that donors are not subject to
sanctions on the basis of inaccurate test results.
Section 26.131(b)(1)-(b)(8) specifies the criteria for determining
whether the licensee testing facility must forward a specimen to an
HHS-certified laboratory for further validity testing. These criteria
are incorporated from the HHS Guidelines. With respect to the proposed
rule, the agency modified the requirements in the final rule in
response to public comments received on the proposed specimen pH and
nitrite levels. Specifically, the commenters identified that the
proposed rule did not include pH and nitrite levels that would permit
the licensee testing facility to detect a specimen that meets the
criteria for an invalid test result in the HHS Guidelines. Therefore,
Sec. 26.131(b)(2) in the final rule establishes a pH level of less
than 4.5, rather than a pH level of less than 3.0 in the proposed rule,
as one criterion for determining that a specimen requires additional
validity testing. The NRC also revised the nitrite concentration from
equal to or greater than 500 micrograms (mcg) per mL in proposed Sec.
26.131(b)(3) to equal to or greater than 200 mcg/mL in the final rule.
These changes to the pH and nitrite criteria in the final rule are
consistent with the current HHS Guidelines and meet Goal 1 of this
rulemaking to update and enhance the consistency of Part 26 with
advances in other relevant Federal rules and guidelines. By ensuring
detection of specimens that may be invalid, these changes also meet
Goal 3 of this rulemaking to improve the effectiveness and efficiency
of FFD programs.
Section 26.133 Cutoff Levels for Drugs and Drug Metabolites
Section 26.133 replaces former Section 2.7(e)(1) in Appendix A to
Part 26. That section established cutoff levels for initial testing for
drugs and drug metabolites. Section 26.133 replaces and amends some
cutoff levels for initial tests for drugs and drug metabolites in
former Section 2.7(e)(1) in Appendix A to Part 26 to be consistent with
the HHS cutoff levels for the same substances.
The NRC has decreased the initial test cutoff level for marijuana
metabolites from 100 nanograms (ng) per milliliter (mL) to 50 ng/mL.
Current immunoassay techniques can now reliably detect the presence of
marijuana metabolites at
[[Page 17081]]
this cutoff level. As discussed in Section IV.B, this change
strengthens the effectiveness of FFD programs by increasing the
likelihood of detecting marijuana use.
The final rule increases the initial test cutoff level for opiate
metabolites from 300 ng/mL in the former rule to 2,000 ng/mL. The
change in the cutoff level for opiate metabolites substantially reduces
the number of positive opiate test results that are reported to MROs by
HHS-certified laboratories that MROs ultimately verify as negative.
The final rule retains the permission in the former rule for
licensees and other entities to establish more stringent cutoff levels
for initial drug tests, subject to the requirements specified in Sec.
26.31(d)(3)(iii), for the reasons discussed with respect to that
paragraph.
The final rule eliminates the former requirement for licensees and
other entities to report drug test results for both the cutoff levels
in the former rule and any more stringent cutoff levels they applied.
The NRC in the former rule required FFD programs to report test results
for the cutoff levels specified in this part, when the licensee was
applying more stringent cutoff levels, because it provided means for
the NRC to monitor licensees' implementation of the permission to use
more stringent cutoff levels. The final rule eliminates this
requirement because Sec. 26.31(d)(3)(iii)(C) requires a qualified
forensic toxicologist to certify the scientific and technical validity
of the licensee's or other entity's testing process at any lower cutoff
levels. Therefore, the reporting requirement is no longer needed to
ensure licensee testing facility performance in this area. Eliminating
this requirement meets Goal 5 of this rulemaking to improve Part 26 by
eliminating or modifying unnecessary requirements.
Section 26.135 Split Specimens
The NRC has added Sec. 26.135 to reorganize and amend the
requirements contained in former Section 2.7(j) in Appendix A to Part
26 that related to licensee testing facility handling of split
specimens. The requirements in this section apply only to FFD programs
that follow split specimen collection procedures. The NRC has divided
the former provision into separate paragraphs in this section to
indicate that each requirement stands on its own. This change has been
made to meet Goal 6 of this rulemaking to improve clarity in the
organization and language of the final rule.
Section 26.135(a) amends the second, third, and fourth sentences of
former Section 2.7(j) in Appendix A to Part 26. The final rule revises
the terminology used in these sentences (e.g., ``Bottle A'' rather than
``primary specimen,'' ``Bottle B'' rather than ``split specimen,''
``positive or of questionable validity'' rather than ``presumptive
positive'') to be consistent with terminology used in other parts of
the regulation without amending the meaning of the sentences. The final
rule deletes the requirement in the third sentence of former Section
2.7(j) to seal the split specimen prior to placing it in secure storage
because Bottles A and B have already been sealed at the collection
site, as required under Sec. 26.113(b)(3). The final rule adds a
requirement to forward the Bottle A specimen to an HHS-certified
laboratory if the licensee testing facility obtains a questionable
validity test result. This requirement is consistent with the addition
of requirements to conduct validity testing throughout the final rule,
as discussed with respect to Sec. 26.31(d)(3)(i). With respect to the
proposed rule, the final rule adds a requirement that Bottle B
specimens must remain in secure storage under the requirements in Sec.
26.159(i) if the licensee testing facility retains Bottle B specimens
rather than sending the specimens to the HHS-certified laboratory with
Bottle A specimens.
Section 26.135(b) amends the requirements in former Section 2.7(j)
in Appendix A to Part 26 related to donor requests for testing of the
specimen in Bottle B. The final rule adds adulterated or substituted
validity test results as a basis for a donor request for testing the
specimen in Bottle B consistent with the addition of requirements to
conduct validity testing throughout the final rule, as discussed with
respect to Sec. 26.31(d)(3)(i). The final rule, with respect to the
proposed rule, imposes a requirement on the MRO to ensure that Bottle B
is forwarded to a second HHS-certified laboratory that did not test the
specimen in Bottle A, at the request of the donor, and to follow the
procedures specified in Sec. 26.165(b). In addition, the NRC
eliminated the procedures for donor requests for testing the specimen
in Bottle B that were included in this provision in the proposed rule
because they were incomplete and partially redundant with the related
provision in Sec. 26.165(b). The NRC made these changes to meet Goal 6
of this rulemaking to improve clarity in the organization and language
of the rule.
The final rule eliminates the requirement in the fourth sentence of
former Section 2.7(j) in Appendix A to Part 26 that required the
licensee testing facility or HHS-certified laboratory to forward the
split specimen to another HHS-certified laboratory for testing on the
same day of the donor request. The final rule, with respect to the
proposed rule, references the provisions in Sec. 26.165(b) pertaining
to the time period (1 business day) within which licensee testing
facilities must forward a specimen to a second HHS-certified laboratory
following the donor request. This change responds to stakeholder
feedback provided during the public meetings discussed in Section IV.D.
The stakeholders reported that implementing the former same-day
requirement was often difficult for a number of reasons, including, for
example, communication delays among donors, MROs, and FFD program
personnel, particularly on weekends and holidays, and the time required
to identify a second laboratory with the appropriate capability to test
the split specimen, depending on the nature of the non-negative test
result. The final rule alleviates some of these logistical difficulties
(e.g., logistical problems associated with weekends and holidays) while
continuing to provide the donor with timely test results. Therefore,
the NRC made this change to meet Goal 5 of this rulemaking to improve
Part 26 by eliminating or modifying unnecessary requirements.
Section 26.135(c) amends former Section 2.7(c) in Appendix A to
Part 26 that applied to storing specimens at licensee testing
facilities. The NRC has amended some of the terminology used in the
former provision for consistency with the terminology changes made
throughout the rule. For example, the provision replaces the term
``split specimen'' with the term ``Bottle B.'' In addition, the final
rule imposes the requirements for long-term frozen storage of split
specimens in former Section 2.7(h) in Appendix A to Part 26 on
licensees and other entities who choose to retain Bottle B of a split
specimen at the licensee testing facility rather than forwarding it
with Bottle A to the HHS-certified laboratory when additional testing
at the HHS-certified laboratory is required. The final rule requires
licensees and other entities to ensure that Bottle B of any specimen
that the MRO has confirmed to be positive, adulterated, substituted, or
invalid is retained in long-term frozen storage for at least 1 year.
The final rule, with respect to the proposed rule, includes a
requirement that licensee testing facilities who retain Bottle B
specimens must ensure that proper specimen storage conditions (i.e.,
frozen storage) are maintained during extended power outages. This
change is based on comments received on the proposed
[[Page 17082]]
rule noting the oversight. The final rule is consistent with former
Section 2.7(c) in Appendix A to Part 26, which required licensee
testing facilities to have emergency power equipment available in case
of a prolonged power failure. The final rule extends the former
requirement to apply to Bottle B of any specimen that has yielded
adulterated, substituted, or invalid validity test results, consistent
with the addition of requirements to conduct validity testing
throughout the final rule, as discussed with respect to Sec.
26.31(d)(3)(i). The final rule moves the portions of former Section
2.7(h) in Appendix A to Part 26 that applied to HHS-certified
laboratories to Sec. 26.159(i) in subpart G to improve the
organizational clarity of the final rule.
Section 26.137 Quality Assurance and Quality Control
The NRC has added Sec. 26.137 to amend former Section 2.8 in
Appendix A to Part 26 [Quality assurance and quality control] . This
section adds quality control requirements for performing validity
screening tests, initial validity tests, and initial tests for drugs
and drug metabolites at the licensee testing facility, for the reasons
discussed with respect to each paragraph. The final rule incorporates
the related requirements from the HHS Guidelines to meet, in part, Goal
1 of this rulemaking to update and enhance the consistency of Part 26
with advances in other relevant Federal rules and guidelines. The NRC
has relocated the portions of former Section 2.8 in Appendix A to Part
26 that established requirements for HHS-certified laboratories to
Sec. 26.167 in Subpart G of the final rule for organizational clarity.
The agency has made many changes in this section with respect to the
proposed rule in response to detailed technical comments the NRC
received on the proposed rule. The performance testing and quality
control requirements in the final rule are consistent, in large part,
with those required for initial testing at the HHS-certified
laboratories.
Section Sec. 26.137(a) [Quality assurance program] amends former
Section 2.8(a) in Appendix A to Part 26, which required licensee
testing facilities and HHS-certified laboratories to have a quality
assurance program for all aspects of the testing process. The NRC moved
the former requirements related to HHS-certified laboratories to Sec.
26.167(a) in Subpart G to improve organizational clarity. The final
rule extends the former requirements for licensee testing facilities to
have a quality assurance program and procedures for drug testing to
validity testing at the licensee testing facility, consistent with the
addition of requirements to conduct validity testing throughout the
proposed rule, as discussed with respect to proposed Sec.
26.31(d)(3)(i).
Section 26.137(b) [Performance testing and quality control
requirements for validity screening tests] establishes new requirements
for performance testing and quality control of validity screening
testing at the licensee testing facility. This section permits licensee
testing facilities to use validity screening tests to determine whether
a specimen is valid or must be subject to further validity testing.
However, any specific validity screening test that a licensee testing
facility chooses to use (e.g., a validity screening test for creatinine
concentration, a validity screening test for pH, a validity screening
test for oxidizing adulterants) must meet the stringent performance
testing requirements in this section. The requirements in this section
are based on requirements that were proposed by HHS in a Notice of
Proposed Revisions to the Mandatory Guidelines dated April 13, 2004 (69
FR 19673). However, in response to detailed public comments on the
proposed rule and further technical analyses, the NRC has revised
several of the proposed HHS requirements that were incorporated in this
section in the proposed rule, as discussed with respect to each
provision the NRC has changed.
Section 26.137(b)(1) permits licensee testing facilities to use
validity screening tests to determine whether a specimen is valid or
must be subject to further validity testing. However, under Sec.
26.137(b)(1)(i) and (ii), the NRC requires licensee testing facilities
to use only validity screening tests that either have been placed on
the SAMHSA list of point-of-collection testing devices that are
certified for use in the Federal Workplace Drug Testing Program as
published in the Federal Register, or that meet the performance testing
criteria set forth in Sec. 26.137(b)(1)(ii) for the reasons discussed
with respect to that provision. With respect to the proposed rule,
Sec. 26.137(b)(1) in the final rule includes a new provision to
address an unintentional omission in the proposed rule. Specifically,
the NRC has added a requirement that licensee testing facilities must
use an HHS-certified laboratory that has the capabilities to confirm
the presence of any adulterant for which the licensee testing facility
conducts validity screening tests. The inclusion of this provision is
necessary because, as proposed, a licensee testing facility could have
used a validity screening test that identified an adulterant that the
HHS-certified laboratory could not identify because the laboratory did
not also test for the adulterant in their validity testing panel. If
this was the case, a specimen with a questionable validity result from
a licensee testing facility would be tested by the HHS-certified
laboratory and the specimen would receive a negative or invalid
validity test result, creating conflicting results. The final rule
resolves this inconsistency.
In addition, the final rule eliminates the term, ``non-instrumented
devices,'' that was used in proposed Sec. 26.137(b)(1). By eliminating
the specific reference to non-instrumented tests and by revising the
definition of ``validity screening test'' in Sec. 26.5, the NRC is
permitting licensee testing facilities to use instrumented tests, in
addition to non-instrumented tests, to perform validity screening
testing. The NRC made this change in response to a public comment. The
commenter suggested that the proposed requirement that limited licensee
testing facilities to using only non-instrumented devices to perform
validity screening tests was unduly restrictive. Specifically, the
commenter stated that instrumented tests could successfully meet the
performance testing requirements (e.g., pH testing) for some validity
screening tests described in proposed Sec. 26.137(b)(1). The inclusion
of instrumented tests for validity screening testing meets Goal 3 of
this rulemaking to improve the effectiveness and efficiency of FFD
programs.
In Sec. 26.137(b)(1)(i) of the final rule, the NRC permits
licensee testing facilities to use validity screening tests that are
identified, by lot number, on the SAMHSA list of point-of-collection
tests approved for use in the Federal Workplace Drug Testing Program,
as published in the Federal Register. The NRC is aware that SAMHSA has
yet to publish a list of approved point-of-collection tests but added
this permission so that licensee testing facilities may rely on that
list when it is available. With respect to the proposed rule, the final
rule has removed the requirement that validity screening tests must be
cleared by the FDA in response to a public comment. The NRC eliminated
the proposed requirement because, as the commenter pointed out, the FDA
is not responsible for clearing specimen validity point-of-collection
tests. The final rule also clarifies the proposed provision by adding
the requirement that licensee testing facilities may only use validity
screening tests from ``lots'' (i.e., batches or groups of tests that
are manufactured
[[Page 17083]]
from the same original materials) that are identified on the SAMHSA
list when it is available. The NRC added this clarification because
SAMHSA approval will apply to all validity screening tests from the
same lot but may not apply to other lots of the test that do not meet
SAMHSA's criteria for approval.
Because SAMHSA has yet to publish a list of approved validity
screening tests, the NRC has added Sec. 26.137(b)(1)(ii) to permit
licensee testing facilities to use validity screening tests that meet
the stringent performance testing requirements established in this
section. Adding these requirements to the final rule permits licensee
testing facilities to conduct the required performance testing and
begin using any validity screening tests that meet the criteria before
SAMHSA's list is published. The NRC is aware that the performance
testing requirements in Sec. 26.137(b)(1)(ii) are stringent and that
few, if any, validity screening devices are yet available that meet
them. However, because individuals may be subject to a temporary
administrative withdrawal of authorization on the basis of a positive
initial drug test result for marijuana or cocaine from a specimen that
yields negative test results from validity screening (see proposed
Sec. 26.75(i)), it is critical that any validity screening tests used
in Part 26 programs provide accurate results. The proposed performance
testing requirements are necessary to protect donors from inaccurate
results and ensure that specimens of questionable validity are
detected.
The final rule eliminates the proposed provision in Sec.
26.137(b)(1)(ii)(A) that required a licensee testing facility or HHS-
certified laboratory to conduct performance testing of 100 validity
screening devices from all currently available manufactured lots of the
device to ensure that the devices met the performance testing criteria
in proposed Sec. 26.137(b)(1)(ii)(C) before the licensee testing
facility began using the validity screening test. The NRC eliminated
proposed Sec. 26.137(b)(1)(ii)(A) to address public comments received
suggesting that licensee testing facilities and HHS-certified
laboratories may not have the experience or expertise to conduct
performance testing of validity screening devices. The commenters
suggested that the NRC should instead consider requiring the
manufacturer of the validity screening tests to perform and document
validation studies of the validity screening tests as well as conduct
tests of performance testing samples that licensee testing facilities
submit to the manufacturer. The NRC agrees with the commenters and has
revised the proposed rule to require manufacturers to perform and
document validation studies in Sec. 26.137(b)(1)(ii)(D) of the final
rule. The final rule also requires licensees and others entities that
intend to use validity screening tests to submit performance testing
samples to the validity screening test manufacturer in Sec.
26.137(b)(1)(ii)(E) of the final rule. This change ensures that the
evaluation of a validity screening test is conducted by an
individual(s) endorsed by the manufacturer. If an individual with
limited training were used to conduct the tests, the manufacturer may
have a reason to question the test results obtained by the licensee
testing facility or the HHS-certified laboratory. The NRC believes that
the validity screening test manufacturer is best qualified to
demonstrate the effectiveness of each test because the manufacturer is
the entity with the greatest knowledge of correct testing procedures.
Another public comment received on proposed Sec.
26.137(b)(1)(ii)(A) stated that the requirement to test 100 validity
screening devices was overly burdensome. The NRC agrees with the
commenter, has revised the requirement, and relocated the amended
provision to Sec. 26.137(b)(1)(ii)(E). The new Sec.
26.137(b)(1)(ii)(E) requires a licensee or other entity to submit three
consecutive sets (at least 6 samples in each set) of performance
testing samples to the validity screening test manufacturer for
performance testing before the licensee testing facility begins using a
validity screening to test donor specimens. Therefore, the final rule
requires the licensee or other entity to submit a minium of 18 samples
for each validity screening test to be used by a licensee or other
entity. If a licensee or other entity chooses to use validity screening
tests to conduct all of the validity testing required by this subpart
(e.g., creatinine, pH, and oxidizing adulterants), the total minimum
number of performance test samples that a licensee testing facility
must submit to meet the minimum performance testing requirements in the
final rule is 72 samples (18 samples for a creatinine test divided into
three sets, 18 samples for pH testing at levels equal to or less than
4.5 divided into three sets, 18 samples for pH testing at levels equal
to or greater than 9 divided into three sets, and 18 samples for an
oxidant test divided into three sets). If a licensee or other entity
chooses to use a validity screening test for only one of the types of
validity testing required in this subpart, the total number of
performance test samples that the licensee testing facility must submit
is less. For example, if a licensee or other entity chooses to use a
validity screening test only for determining creatinine concentration,
the total number of performance samples that the licensee testing
facility must submit for testing is 18 samples divided into three sets.
The NRC believes that the revised performance testing sample
requirements reduce the burden on licensees and other entities imposed
by these performance testing requirements while ensuring that the
validity screening tests provide accurate and consistent test results.
The agency has also relocated and revised the requirements in
proposed Sec. 26.137(b)(1)(ii)(B) and (b)(1)(ii)(C). These proposed
provisions established requirements for the formulation of performance
testing samples and criteria for licensees and other entities to apply
when evaluating performance testing results, respectively. The final
rule combines these requirements in Sec. 26.137(b)(1)(ii)(E) and
presents them in the rule in the sequence in which licensees and other
entities would implement them for organizational clarity. The NRC has
also made other changes to the provisions in proposed Sec.
26.137(b)(1)(ii) to address a public comment that stated that the
performance testing standards in the proposed rule were unduly
prescriptive and should instead be performance based. The NRC agrees
with the commenter and has further revised the performance testing
provisions in proposed Sec. 26.137(b) as is subsequently discussed
with respect to each provision in the final rule.
Section 26.137(b)(1)(ii)(A) of the final rule specifies that a
validity screening test that a licensee testing facility intends to use
to conduct creatinine testing must be able to detect whether a
specimen's creatinine concentration is less than 20 mg/dL. This
provision replaces the portions of proposed Sec. 26.137(b)(1)(ii)(B)
and (b)(4) that established the required creatinine measurement
capabilities of validity screening devices. The NRC revised the
provision in response to a public comment received on proposed Sec.
26.137(b)(4) that stated that tests currently available that could be
used for validity screening testing for creatinine cannot distinguish
creatinine concentrations in the proposed ranges of 5-20 and 1-5 mg/dL.
The commenter noted that current validity screening tests, at best, can
detect creatinine concentration at a cutoff of 20 mg/dL. Because the
rule does not require licensee testing facilities to determine
[[Page 17084]]
whether a specimen meets the criteria for substitution or dilution,
which depend on the results of specific gravity testing in addition to
lower creatinine concentrations, the NRC agrees with the commenter that
the proposed creatinine testing to lower concentrations is unnecessary.
A validity screening test that can detect creatinine concentration at a
cutoff of 20 mg/dL is adequate for a licensee testing facility to
determine that a specimen is of questionable validity and requires
further testing at an HHS-certified laboratory. This revision avoids
imposing an unnecessary burden on licensee testing facilities while
ensuring that the validity screening test will support the creatinine
concentration cutoff at 20 mg/dL established in Sec. 26.131(b)(1).
Section 26.137(b)(1)(ii)(B) of the final rule specifies that a
validity screening test that a licensee testing facility intends to use
to conduct pH testing must be able to identify specimens with pH of
less than 4.5 and pH equal to or greater than 9. This provision
replaces the portions of proposed Sec. 26.137(b)(1)(ii)(B) and (b)(4)
that established the required pH measurement capabilities of validity
screening devices. Proposed Sec. 26.137(b)(1)(ii)(B) and (b)(4) would
have required pH validity screening tests to be capable of detecting pH
in the ranges of 1-3 and 10-12. However, the NRC received two comments
noting that the proposed pH ranges would not permit the licensee
testing facility to detect a specimen that meets the criteria for an
invalid test result in the HHS Guidelines (i.e., pH less than 4.5 or
equal or greater than 9). Therefore, this change addresses the issue
raised by the commenter and ensures that the validity screening test
will support the pH cutoffs established in Sec. 26.131(b)(2) as
revised in the final rule.
Section 26.137(b)(1)(ii)(C) of the final rule specifies the
required performance capabilities for a validity screening test that a
licensee testing facility intends to use to conduct testing for
oxidizing adulterants. This provision replaces the portions of proposed
Sec. 26.137(b)(1)(ii)(B) and (b)(4) that established the required
oxidizing adulterant measurement capabilities of validity screening
devices. Proposed Sec. 26.137(b)(1)(ii)(B) and (b)(4) would have
required oxidizing adulterant validity screening tests to be capable of
detecting nitrite in the ranges of 250 mcg/mL to 400 mcg/mL and from
650 mcg/mL to 800 mcg/mL. However, one commenter on the proposed rule
noted that the proposed nitrite concentrations for performance testing
samples ranging from 250 mcg/mL to 400 mcg/mL and from 650 mcg/mL to
800 mcg/mL would not identify specimens that meet the invalid specimen
testing criteria in the HHS Guidelines (i.e., nitrite concentration
equal to or greater than 200 mcg/mL). The NRC agrees with the commenter
and has revised the oxidant measurement requirements for validity
screening tests to detect nitrite concentration at a cutoff of 200 mcg/
mL in Sec. 26.137(b)(1)(ii)(C) of the final rule. For completeness,
the final rule also includes performance testing criteria for
additional oxidant tests (i.e., chromium, halogen) that a licensee
testing facility could perform to meet the requirements for testing for
oxidizing adulterants in Sec. 26.131(b). Therefore, these changes
improve the clarity of the performance testing requirements in this
section and the consistency of the final rule with the HHS Guidelines.
At the suggestion of a commenter, the NRC has added Sec.
26.137(b)(1)(ii)(D) to the final rule. This provision requires the
manufacturer of a validity screening test to conduct and document
validation studies demonstrating the performance characteristics of the
validity screening test around the cutoff levels established in this
subpart. The commenter suggested that the majority of the burden of
demonstrating the performance capabilities of validity screening tests
should rest with the manufacturer rather than with licensees and other
entities or HHS-certified laboratories, as required by several
provisions of the proposed rule. The NRC agrees with the commenter and
believes that the manufacturer of each validity screening test is the
most appropriate entity to demonstrate the performance characteristics
of the validity screening tests before a licensee or other entity
begins using a test in an FFD program. The NRC believes it is necessary
to establish requirements similar to those that exist for other types
of testing performed by licensee testing facilities and HHS-certified
laboratories. Both the former and final rules require licensee testing
facilities and HHS-certified laboratories to validate their analytical
methods before conducting drug testing of donor specimens. The
requirement for manufacturers to validate their validity screening
tests before providing them to licensee testing facilities is
essentially parallel to these requirements for licensee testing
facilities and HHS-certified laboratories. The NRC believes the
validation requirement is necessary to ensure that the manufacturer has
verified the performance characteristics of the validity screening test
before shipment to suppliers and use by licensee testing facilities.
As discussed with respect to proposed Sec. 26.137(b)(1)(ii)(A),
the NRC has revised the performance testing requirements in proposed
Sec. 26.137(b)(1)(ii)(A)-(b)(1)(ii)(C). In addition to the changes to
performance testing requirements previously discussed, the final rule
revises the portion of proposed Sec. 26.137(b)(1)(ii)(C) that
established the percentage of total performance test samples that
validity screening tests must correctly identify when licensees and
other entities submit performance testing samples to the manufacturer.
In Sec. 26.137(b)(1)(ii)(E), the NRC has increased this required
percentage from 80 percent in the proposed rule to 90 percent in the
final rule. The more rigorous criterion for validity screening tests
increases consistency among the rule's criteria for licensee testing
facility drug testing performance and criteria in the HHS Guidelines
for HHS-certified laboratory drug and validity testing performance. The
NRC has made this revision in the final rule to ensure that validity
screening tests perform accurately and reliably and that each FFD
program effectively evaluates the validity of urine specimens.
Section 26.137(b)(1)(iii) revises proposed Sec. 26.137(b)(1)(iii)
to further reduce the performance testing burden on licensees and other
entities who use validity screening tests. The proposed rule would have
required licensees and other entities to ensure the continued
effectiveness of any validity screening tests it is using, after they
have been placed in service, by conducting or requesting the HHS-
certified laboratory to conduct performance testing of 50 devices on a
nominal annual frequency. Consistent with other changes to the
performance testing requirements in Sec. 26.137(b), the final rule
requires the validity screening tests' manufacturers to conduct this
followup performance testing rather than licensee testing facilities or
HHS-certified laboratories as proposed. In addition, the final rule
eliminates the specific requirement for testing of 50 devices annually
and replaces it with a performance-based standard in response to a
public comment suggesting that the specificity in the proposed
provision was unnecessarily burdensome. The final rule does not specify
the number of performance testing samples to be tested by the
manufacturer using validity screening tests from the lot in use by the
licensee testing facility. The final rule instead requires the
manufacturer to test performance testing samples that are formulated
around the cutoff levels for
[[Page 17085]]
validity testing in this subpart. The NRC believes this standard is
adequate to determine whether validity screening tests in each lot are
continuing to provide accurate and consistent test results and avoids
imposing unnecessarily restrictive requirements.
The NRC has eliminated proposed Sec. 26.137(b)(1)(iv) from the
final rule. That provision required licensees and other entities to
ensure that the manufacturer of a validity screening test that is used
by the licensee testing facility informs the licensee or other entity
of any changes to the device that may require additional performance
and to conduct additional performance testing if recommended by the MRO
or HHS-certified laboratory. This provision is no longer necessary
because the revised performance testing requirements in the final rule
are focused on each lot of validity screening tests the licensee
testing facility intends to use. Because manufacturers cannot make
changes to a validity screening test after a lot of the tests has been
produced, information about changes to the tests in that lot and
additional performance testing are not required.
Section 26.137(b)(2) establishes quality control requirements that
licensee testing facility personnel must implement at the beginning of
any 8-hour period when validity screening tests will be performed and
while conducting validity screening testing. With respect to the
proposed rule, the NRC has revised the quality control requirements
that were in Sec. 26.137(b)(2) in the proposed rule and relocated them
to Sec. 26.137(b)(2)(i). The agency made this change because the final
rule adds a new Sec. 26.137(b)(2)(ii) and it is necessary to group the
related requirements together for organizational clarity in the final
rule.
In response to a public comment, the agency has revised Sec.
26.137(b)(2) in the final rule to require that the licensee testing
facility personnel who will be or are performing validity screening
testing must implement the quality control requirements in this
section. The commenter reasoned that because some validity screening
tests have visually read endpoints, the test result must be interpreted
by the tester. Therefore, it is necessary to verify that each tester is
able to interpret the quality control samples correctly before
conducting tests on donor specimens and during the testing process. The
NRC agrees with this comment and made the appropriate change in the
final rule.
Section 26.137(b)(2)(i) revises portions of proposed Sec.
26.137(b)(2) and requires that the quality control samples to be tested
before beginning to test donor specimens in any 8-hour period must
consist of one sample that is certified as negative and one that is
formulated to appropriately challenge each type of validity screening
test to be conducted (e.g., certified to contain an oxidizing
adulterant, to have creatinine below 20 ng/mL). For example, the final
rule requires that if a licensee testing facility is using a validity
screening test to determine the nitrite concentration of a specimen,
licensee testing facility personnel must use a certified quality
control sample containing nitrite. This requirement is necessary to
verify that the validity screening tests to be used are functioning
properly and that licensee testing facility personnel are able to
conduct the tests appropriately, as discussed with respect to Sec.
26.137(b)(2). The final rule replaces the term ``non-negative'' in the
proposed rule, which was used to describe the quality control samples
that licensees and other entities must use, with a requirement that the
quality control samples must be formulated to challenge each validity
screening test around the cutoffs for initial validity testing
specified in this subpart. The NRC made this change to improve the
clarity in the language of the rule, as discussed with respect to Sec.
26.5.
The final rule, with respect to the proposed rule, adds a provision
to require validity screening tests to be challenged by licensee
testing facility personnel after screening every 10 donor specimens in
Sec. 26.137(b)(2)(ii). Specifically, this provision requires the
licensee testing facility to test at least 1 quality control sample
after testing every 10 donor specimens during an 8-hour testing period
and requires the quality control sample to be formulated to challenge
the validity screening test(s) in use around the cutoffs specified in
Subpart F. The NRC has added this provision to enhance the consistency
of quality control procedures for conducting validity screening testing
with quality control procedures for conducting initial validity and
drug testing at licensee testing facilities. As discussed with respect
to Sec. 26.137(d) and (e), the NRC requires licensee testing
facilities to test calibrators, controls, and blind quality control
samples during each analytical run of initial validity and drug testing
conducted at the licensee testing facility (See Sec. 26.5 for a
discussion of the term, ``analytical run'') to monitor the accuracy of
testing. However, because it may not be possible to conduct validity
screening tests in batches (i.e., the tester may have to insert a
dipstick into an aliquot of each donor's specimen manually), it is
impractical to impose similar requirements for calibrators, controls
and blind quality control testing each time a single validity screening
test is performed. Therefore, the NRC added this provision to ensure,
without imposing unrealistic requirements, that validity screening
tests continue to perform reliably during any 8-hour period in which
the validity screening tests are used and to increase consistency among
quality control requirements for validity screening and initial
validity and drug testing in this section.
The NRC has moved the requirements in proposed Sec. 26.137(b)(2)
that addressed the steps that licensee testing facilities must take if
a validity screening tests fails to perform correctly when testing
quality control samples. For organizational clarity, the NRC relocated
the proposed provisions to Sec. 26.137(f) in the final rule because
Sec. 26.137(f) establishes requirements related to the topic of the
proposed provisions, errors in testing.
Section 26.137(b)(3) requires licensee testing facility personnel
to submit 1 out of every 10 donor specimens that yield negative results
using validity screening tests to an HHS-certified laboratory. This
requirement is necessary to detect false negative test results from
validity screening tests. A false negative test result in this instance
is a result from a validity screening test indicating that the specimen
is valid when, in fact, validity testing at the HHS-certified
laboratory identifies the specimen as adulterated, substituted, or
invalid. Assessing the validity screening test's rate of false negative
test results is necessary because false negative results from a
validity screening test could mean that some attempts to subvert the
testing process may not be detected. For example, if an individual had
adulterated his or her specimen and it was not detected because of a
faulty device, the licensee or other entity would have no reason to
terminate the individual's authorization. As a result, an individual
who has demonstrated that he or she is not trustworthy and reliable
would be permitted to perform duties under this part and may pose a
risk to public health and safety and the common defense and security.
With respect to the proposed rule, the NRC has moved the
requirements in proposed Sec. 26.137(b)(3) that addressed the steps
that licensee testing facilities must take if the HHS-certified
laboratory's results indicate that the validity screening test provided
a false negative result. For organizational clarity, the NRC relocated
the proposed provisions to Sec. 26.137(f) in the final rule
[[Page 17086]]
because Sec. 26.137(f) establishes requirements related to the topic
of the proposed provisions, errors in testing.
The NRC notifications required in Sec. 26.137(b)(2)and (b)(3) are
necessary because false negative results from a validity screening test
indicate the laboratory testing process may not be successfully
detecting donor attempts to subvert the testing process through
specimen adulteration or substitution. For example, if an individual
had adulterated his or her specimen and it was not detected because of
a faulty test, the licensee or other entity would have no reason to
terminate the individual's authorization. As a result, an individual
who has demonstrated that he or she is not trustworthy and reliable
would be permitted to perform duties under this part and may pose a
risk to public health and safety and the common defense and security.
The NRC will use the information to ensure that HHS is notified of the
test failure as well as inform other licensees and entities who may
also be using the test of the false negative results to prevent
additional testing errors. Therefore, the notifications are necessary
to protect donors from inaccurate test results, to ensure that
specimens of questionable validity are detected, and to ensure that any
problems with a test are detected and corrected as soon as possible.
In response to public comments, the NRC has eliminated proposed
Sec. 26.137(b)(4) that required validity screening tests to be capable
of measuring a specimen's creatinine concentration to 1 decimal place.
Specificity below 20 mg/dL is unnecessary because NRC is not requiring
licensee testing facilities to conduct the tests for specific gravity
that are necessary for reporting substituted, dilute, or invalid
validity test results, as discussed with respect to Sec.
26.137(b)(1)(ii)(A). This change reflects the current capabilities of
validity screening tests and supports the intent of the NRC that
licensee testing facilities need only be able to identify whether a
specimen has a creatinine concentration of less than 20 mg/dL and
therefore requires additional testing at an HHS-certified laboratory.
The NRC has added a new Sec. 26.137(b)(4) in the final rule to
establish requirements for storing validity screening tests and
requires licensee testing facilities to maintain the tests consistent
with the manufacturer's storage specifications. Storing the tests as
required by the manufacturer's instructions is necessary to ensure that
the tests continue to function optimally. This requirement is
consistent with the quality control requirements for ASDs in Sec.
26.91(d) and meets Goal 3 of this rulemaking to improve the
effectiveness and efficiency of FFD programs.
The NRC has deleted proposed Sec. 26.137(b)(5) and (b)(6) from the
final rule and replaced these provisions with the performance testing
requirements in Sec. 26.137(b)(1)(ii) for the reasons discussed with
respect to that section.
The NRC added Sec. 26.137(c) [Validity screening test results] to
specify the actions that the licensee testing facility must take if a
donor's specimen yields questionable results from validity screening
testing. If a specimen has a questionable validity screening test
result, the final rule requires instrumented initial validity testing
either at the licensee testing facility or the HHS-certified
laboratory. This provision is consistent with the rule's requirements
for transferring to the HHS-certified laboratory specimens with initial
positive drug test results from testing at a licensee testing facility.
Further testing of a specimen of questionable validity is necessary to
protect donors from inaccurate test results, as well as provide
assurance that specimens of questionable validity are detected using
the more sophisticated technologies required for instrumented initial
validity testing in the HHS Guidelines and the final rule. The final
rule, with respect to the proposed rule, eliminates the term ``non-
negative'' from the heading of the provision for the reasons discussed
with respect to Sec. 26.5 related to the elimination of this term
throughout the final rule.
The agency added Sec. 26.137(d) [Quality control requirements for
performing initial validity tests] to specify the required methods for
performing initial validity tests at a licensee testing facility that
are necessary to ensure that initial validity testing at the licensee
testing facility provides accurate results. The requirements in this
paragraph incorporate the related requirements in the HHS Guidelines as
revised on April 13, 2004 (69 FR 19644). The paragraph has been added
to meet Goal 1 of this rulemaking to update and enhance the consistency
of Part 26 with advances in other relevant Federal rules and
guidelines.
Section 26.137(d)(1) requires licensee testing facilities to
measure creatinine concentration to 1 decimal place and establishes
requirements for the controls to be used in initial tests for
creatinine concentration.
Section 26.137(d)(2) establishes quality control requirements for
performing initial pH tests. Sections 26.137(d)(2)(i)-(d)(2)(v) specify
the required calibrators and controls for initial pH testing, based on
the type of testing instrument used and whether a pH validity screening
test has been performed.
Section 26.137(d)(3) establishes quality control requirements for
performing initial tests for oxidizing adulterants, including nitrite,
and Sec. 26.137(d)(4) establishes quality control requirements for
performing initial tests for ``other'' adulterants at the licensee
testing facility.
Section 26.137(d)(5) requires that one of the quality control
samples included in each analytical run must appear to be a donor
specimen to laboratory analysts. The final rule retains the related
requirement in the last paragraph of Section 2.8(c)(3) in Appendix A to
Part 26 and amends the provision to be consistent with the same
requirement in the HHS Guidelines. With respect to the proposed rule,
the NRC relocated this requirement from proposed Sec. 26.137(e)(7) to
Sec. 26.137(d)(5) in the final rule to clarify that the requirement to
test one blind quality control sample in each analytical run applies to
initial validity test runs as well as to initial drug testing if the
licensee testing facility does not conduct initial validity and drug
testing concurrently. However, if a licensee testing facility conducts
initial validity and drug testing of specimens concurrently, the NRC
intends that the licensee testing facility would include only one blind
performance test sample in the analytical run to meet this requirement
as well as the same requirement in Sec. 26.137(e)(6)(v) for drug
testing runs. The NRC made these changes to meet Goal 6 of this
rulemaking to improve clarity in the organization of the rule.
The NRC also added Sec. 26.137(d)(6) in the final rule to require
licensee testing facilities to send 1 out of 10 specimens that test
negative on initial validity tests to an HHS-certified laboratory for
initial and, if necessary, confirmatory validity testing. The NRC added
this requirement in response to public comments noting inconsistencies
in the proposed rule's quality control requirements for validity
screening, initial validity testing, and initial drug testing, and for
the reasons discussed with respect to the addition of a similar
requirement applicable to validity screening testing in Sec.
26.137(b)(3). Adding this provision ensures that licensee testing
facilities can assess their rates of false negative initial validity
test results and therefore meets Goal 3 of this rulemaking to improve
the effectiveness of FFD programs.
Section 26.137(e) [Quality control requirements for initial drug
tests]
[[Page 17087]]
amends and combines portions of former Section 2.7(d), 2.7(e)(1), and
2.8(b) in Appendix A to Part 26. The former provisions established
quality control requirements for performing initial tests for drugs and
drug metabolites at licensee testing facilities. The final rule groups
together in one paragraph the requirements that were dispersed
throughout the former rule to meet Goal 6 of this rulemaking to improve
clarity in the organization of the final rule.
Section 26.137(e)(1) amends the first sentence of former Section
2.7(e)(1) in Appendix A to Part 26 but retains the intent of the former
provision as it applies to licensee testing facilities. This provision
retains the former requirement that licensee testing facilities may use
only immunoassay tests that meet the requirements of the Food and Drug
Administration for commercial distribution. The NRC has moved the
requirements in the former provision related to initial drug testing at
HHS-certified laboratories to Sec. 26.167(d)(1) of Subpart G of the
final rule to improve organizational clarity in the rule.
In addition, Sec. 26.137(e)(1) prohibits licensee testing
facilities from relying on drug test results from any tests they may
use to perform validity screening tests. The NRC added this prohibition
because several non-instrumented devices are available that combine
tests for the presence of drugs and drug metabolites in a urine
specimen with tests for other attributes of a urine specimen, such as
creatinine concentration. The final rule permits licensee testing
facilities to use such combination tests as validity screening tests if
the tests meet the requirements of Sec. 26.137(b)(1). However, the
drug testing capabilities of these tests are not yet sufficiently
accurate and sensitive to be used in Part 26 programs, in which
licensees and other entities are permitted to administratively withdraw
an individual's authorization on the basis of positive initial drug
test results for marijuana and cocaine metabolites. The NRC may
consider accepting the use of initial drug test results from non-
instrumented tests in a future rulemaking, when HHS publishes a final
revision to the Mandatory Guidelines that establishes requirements for
their use in Federal workplace drug testing programs. At this time,
however, the final rule retains the former prohibition on using such
tests for drug testing at licensee testing facilities.
The NRC added Sec. 26.137(e)(2) to require licensee testing
facilities to either discard specimens that yield negative results from
initial tests at the licensee testing facility or pool them and use
these specimens as quality control specimens, if the specimens are
certified as negative and valid by an HHS-certified laboratory. This
provision incorporates the related provision from the HHS Guidelines to
meet Goal 1 of this rulemaking to update and enhance the consistency of
Part 26 with advances in other relevant Federal rules and guidelines.
With respect to the proposed rule, the final rule adds a sentence
prohibiting licensee testing facilities from retaining any information
linking donors to specimens pooled for use in the internal quality
control program. The agency added this prohibition in response to a
public comment requesting this addition. This change meets Goal 7 of
this rulemaking to protect the privacy and other rights (including due
process) of individuals who are subject to Part 26.
Section 26.137(e)(3) permits licensee testing facilities to conduct
multiple tests of a single specimen for the same drug or drug class.
The NRC has revised Sec. 26.137(e)(3) in the final rule, with respect
to the proposed rule, to include a more precise description of when
multiple initial drug tests on a specimen (also know as rescreening)
are permitted. The NRC added this information in the final rule in
response to a comment received on the proposed provision requesting the
addition. The requirements in the provision are consistent with a
similar provision in the HHS Guidelines and, therefore, meet Goal 1 of
this rulemaking to update and enhance the consistency of Part 26 with
advances in other relevant Federal rules and guidelines.
Section 26.137(e)(4) amends the first sentence of former Section
2.8(b) in Appendix A to Part 26. The former sentence stated that
licensee testing facilities are not required to assess their false
positive rates in drug testing. The final rule retains the intent of
the former requirement, but the NRC has updated the terminology in the
provision to use the new terms that are used throughout the final rule,
e.g., ``initial'' rather than ``screening,'' as discussed with respect
to Sec. 26.5.
Section 26.137(e)(5) amends the second sentence of former Section
2.8(b) in Appendix A to Part 26. This provision required licensee
testing facilities to submit specimens that yield negative results from
initial testing to the HHS-certified laboratory as a quality control
check on the licensee testing facility's drug testing process. The
paragraph retains the intent of the former provision but makes several
changes to the specific requirements.
The paragraph uses the term ``analytical run'' rather than the
former term ``test run'' to reflect changes in testing technologies
that some licensee testing facilities have adopted since the former
rule was published. Requirements for blind performance and other
quality control testing in the former rule were based on the assumption
that specimens would be tested in batches. However, many licensee
testing facilities now conduct continuous testing, and no longer test
specimens in batches. Therefore, the final rule uses the term,
``analytical run,'' to refer to both batch and continuous processing,
as defined in Sec. 26.5. This change has been made to meet Goal 6 of
this rulemaking to improve clarity in the language of the final rule.
The former rule did not establish a number or percentage of
negative specimens that licensee testing facilities were required to
submit to the HHS-certified laboratory for performance testing, which
raised implementation questions from licensees who have wanted to know
how many specimens must be submitted. Therefore, to clarify the former
requirement to ``submit a sampling of specimens,'' the final rule
requires licensee testing facilities to forward at least one specimen
that yields negative drug test results from each analytical run to the
HHS-certified laboratory for performance testing. The final rule also
establishes five percent of the specimens tested in each analytical run
as the percentage of negative specimens that the licensee testing
facility must submit to the HHS-certified laboratory for testing,
except if five percent of an analytical run is a number less than one
specimen. In the latter case, the licensee testing facility submits at
least one negative specimen from the analytical run. This requirement
ensures the ongoing evaluation of the accuracy of the licensee testing
facility's initial drug testing without imposing a large performance
testing burden.
The NRC has moved the last sentence of the former paragraph, which
addressed performance testing of breath analysis equipment for alcohol
testing, to Sec. 26.91(e) in Subpart E because that subpart of the
final rule addresses quality control requirements for alcohol testing.
The NRC made this change to meet Goal 6 of this rulemaking to improve
clarity in the organization of the final rule.
Section 26.137(e)(6) amends the requirements of former Section
2.8(c) in Appendix A to Part 26 and applies them to licensee testing
facilities. The NRC is applying requirements for quality
[[Page 17088]]
controls to initial drug testing at licensee testing facilities to
provide greater assurance that initial drug tests performed by these
facilities provide accurate results. The increased performance testing
requirements in the final rule are necessary because the final rule
permits licensees and other entities to rely on test results from other
Part 26 programs to a greater extent that the former rule. Therefore,
it is necessary to ensure that any tests performed at licensee testing
facilities meet minimum standards. This change meets Goal 3 of this
rulemaking to improve the effectiveness of FFD programs.
The final rule, with respect to the proposed rule, moves the
provision in proposed Sec. 26.137(e)(7) to Sec. 26.137(e)(6) in the
final rule to improve organizational clarity. The NRC made this change
to address a public comment received on the proposed rule that noted
that because the second sentence in proposed Sec. 26.137(e)(7)
discussed a quality control sample requirement, the provision would be
more appropriately located in Sec. 26.137(e)(6) which describes the
quality control sample requirements for each analytical run.
Section 26.137(e)(6) establishes requirements for the number of
quality control samples to be included in each analytical run at the
licensee testing facility. The final rule requires that a minimum of 10
percent of the specimens in each analytical run must be quality control
samples. For example, if an analytical run consists of 50 donor
specimens, an additional 5 quality control samples would be included in
the analytical run for a total of 55 specimens tested in the run. The
licensee testing facility will not send the quality control samples to
the HHS-certified laboratory for confirmatory testing, but use them for
internal quality control purposes only. The requirements in this
paragraph incorporate the related requirements in the HHS Guidelines
and meet Goal 1 of this rulemaking, which is to update and enhance the
consistency of Part 26 with advances in other relevant Federal rules
and guidelines.
The final rule also requires licensee testing facilities to ensure
that quality control samples that are positive for each drug and
metabolite for which the FFD program conducts testing are included in
at least one analytical run in each quarter of the calendar year. The
NRC added this provision at the request of comments received addressing
inconsistences within the proposed rule. The proposed rule required
quality control samples for each type of validity test, but failed to
specify the required distribution of quality control samples among the
drugs and metabolites for which the FFD program tests. This provision
clarifies the former rule and increases the internal consistency of
this subpart. Additionally, this provision provides for enhanced
monitoring of the effectiveness of the licensee testing facilities'
drug testing procedures to meet Goal 3 of this rulemaking to improve
the effectiveness of FFD programs.
The NRC has added Sec. 26.137(e)(6)(i)-(e)(6)(iii) to describe the
required characteristics of the quality control samples that the
licensee testing facility must include in each analytical run of
specimen testing. These provisions require each analytical run to
include at least one negative quality control sample as well as quality
control samples targeted at 25 percent above the cutoff and at 25
percent below the cutoff level for each drug and drug metabolite for
which testing is conducted. The final rule, with respect to the
proposed rule, revises the requirement that a quality control sample
must be targeted at 75 percent of the cutoff level and instead, the
final rule requires the calibrator to be targeted at 25 percent below
the cutoff level. This change was made to improve the clarity of the
language of the final rule without changing the intent of the
provision. These requirements are consistent with the current HHS
Guidelines for processing quality control samples during initial drug
testing.
With respect to the proposed rule, the final rule has added Sec.
26.137(e)(6)(iv) and Sec. 26.137(e)(6)(v) to further enhance quality
control requirements for initial drug testing at licensee testing
facilities. In response to a public comment, the NRC added Sec.
26.137(e)(6)(iv) to require that each analytical run has a sufficient
number of calibrators to ensure linearity of the assay. This additional
provision is consistent with the related requirement in the HHS
Guidelines. Section 26.137(e)(6)(v) requires that one sample must
appear to be a donor sample to the laboratory analysts. This
requirement was previously embedded in Sec. 26.137(e)(7) of the
proposed rule, and the NRC moved the requirement to Sec.
26.137(e)(6)(v) of the final rule in response to a comment received
that noted this move would enhance organizational clarity in the rule.
The NRC agrees with the commenter.
Section 26.137(e)(7) extends to licensee testing facilities the
requirement in the third sentence of the last paragraph of former
Section 2.8(c) in Appendix A to Part 26. That provision required HHS-
certified laboratories to implement procedures to ensure that carryover
does not contaminate the testing of a donor's specimen and to document
the procedures. The final rule extends this requirement to licensee
testing facilities because it is a standard forensic practice that is
necessary to ensure the integrity of the testing process.
The NRC has added Sec. 26.137(f) [Errors in testing] to require
licensees and other entities who maintain testing facilities to
investigate any errors or unsatisfactory performance of the testing
process, identify the cause(s) of the adverse conditions, and correct
them. The final rule requires the licensee or other entity to document
the investigation and any corrective actions taken. The provision
requires licensees and other entities to investigate any testing errors
or unsatisfactory performance identified throughout the testing process
or during the review process that are required under Sec. 26.91
[Review process for fitness-for-duty policy violations]. The NRC
intended, in the original rule, that testing or process errors
discovered in any part of the program, including through the review
process, be investigated as an unsatisfactory performance of a test.
This provision clarifies that intent. Thorough investigation and
reporting of such test results will continue to assist the NRC, the
licensees, HHS, and the HHS-certified laboratories in preventing future
occurrences.
The NRC has reorganized the requirements in proposed Sec.
26.137(f) into a list format in Sec. 26.137(f)(1)-(f)(5) in the final
rule to improve the organizational clarity of the rule and added new
requirements to this section for the reasons discussed with respect to
each provision.
Section 26.137(f)(1) requires, whenever possible, that the
investigation of testing or processing errors must determine relevant
facts and identify the root cause(s) of the error. Section 26.137(f)(2)
requires the licensee testing facility to take action to correct the
cause of any error or unsatisfactory performance within the licensee
testing facility's control.
The NRC has added Sec. 26.137(f)(3) to the final rule, with
respect to the proposed rule, to address instances when testing of a
quality control sample at a licensee testing facility yields a false
negative test result. This provision requires the licensee testing
facility to forward all donor specimens from the analytical run in
which the error is detected to the HHS-certified laboratory for
additional testing. This requirement is necessary to ensure that
licensees and other entities do not permit individuals who may have
altered a specimen or
[[Page 17089]]
used prohibited drugs to be granted or maintain authorization to have
the types of access or perform the duties that require them to be
subject to the rule. Additional testing at the HHS-certified laboratory
of the donor specimens included in the analytical run during which the
error is identified ensures that public health and safety and the
common defense and security are not placed at risk because initial
validity or drug test results from the licensee testing facility failed
to identify an individual who has attempted to subvert the testing
process or engaged in substance abuse. In addition, testing of these
specimens at the HHS-certified laboratory may also provide the licensee
testing facility with additional information regarding the cause(s) and
extent of condition that resulted in the error. The NRC added this
requirement to the final rule to enhance consistency of the rule's
requirements for addressing errors in testing at licensee testing
facilities with those required for addressing errors in testing at HHS-
certified laboratories and in response to public comments received on
the proposed rule noting the inconsistencies. This requirement is
consistent with standard forensic practices and meets Goal 1 of this
rulemaking to update and enhance the consistency of Part 26 with
advances in other relevant Federal rules and guidelines.
Section Sec. 26.137(f)(3) also requires the licensee testing
facility to implement corrective actions before resuming testing of
donor specimens. For example, if testing of a certified-positive
quality control sample at the licensee testing facility yields false
negative test results for opiates, this provision requires the licensee
testing facility to stop testing donor specimens for opiates until the
cause(s) of the false negative test are identified and corrected.
Similarly, if a quality control sample that has been certified to
contain an adulterant at a concentration above the cutoff levels
established in Subpart F for validity screening or initial validity
testing yields a false negative test result, this provision requires
the licensee testing facility to stop testing for that adulterant until
the cause(s) of the false negative test result are identified and
corrected. This requirement is necessary to prevent additional errors
in testing that could permit individuals who may have altered a
specimen or used prohibited drugs to be granted or maintain
authorization to have the types of access or perform the duties that
require them to be subject to the rule. The NRC added this requirement
to the final rule to enhance consistency of the rule's requirements for
addressing errors in testing at licensee testing facilities with those
required for addressing errors in testing at HHS-certified laboratories
and in response to public comments received on the proposed rule
mentioning the inconsistencies. This requirement is consistent with
standard forensic practices and meets Goal 1 of this rulemaking to
update and enhance the consistency of Part 26 with advances in other
relevant Federal rules and guidelines.
The NRC has added Sec. 26.137(f)(4) to address instances where
testing conducted at an HHS-certified laboratory identifies a specimen
that yielded a false negative test result from the licensee testing
facility. To evaluate whether tests at a licensee testing facility may
be providing false negative test results, Sec. 26.137(b)(3), (d)(6),
and (e)(5) require the licensee testing facility to submit some donor
specimens that yield negative test results to an HHS-certified
laboratory for additional testing. If, after confirmatory testing by
the HHS-certified laboratory, a donor specimen yields positive,
substituted, adulterated, or invalid results, Sec. 26.137(f)(4)
mandates that the licensee testing facility must take corrective
action(s) before resuming testing for the drug(s), drug metabolite(s),
adulterant(s), or other specimen characteristics (i.e., creatinine, pH)
associated with the donor specimen(s) that yielded the false negative
result(s). Additionally, Sec. 26.137(f)(4) permits the licensee or
other entity to re-collect and test specimens from any donor whose test
results from initial testing at the licensee testing facility may have
been inaccurate. The NRC added this provision to the final rule for the
same reasons discussed with respect to Sec. 26.137(f)(3).
Section 26.137(f)(5) requires the licensee or other entity to
document the investigation and any corrective actions taken for
consistency with Criterion XVI in Appendix B to 10 CFR Part 50.
Section 26.137(g) [Accuracy] retains former Section 2.7(o)(3)(i) in
Appendix A to Part 26 as it applied to licensee testing facilities.
This provision requires checking the instruments used in testing for
accuracy. The final rule moves the former requirement as it relates to
HHS-certified laboratories to Sec. 26.167(h) in Subpart G for
organizational clarity.
Section 26.137(h) [Calibrators and controls] updates former Section
2.7(o)(2) in Appendix A to Part 26, which established requirements for
the standards and quality control samples used for performance testing.
At the time the original paragraph was written, most laboratories
prepared their own standards and controls. In the ensuing years, the
number and variety of sources for materials used in performance testing
have increased. This provision updates the former requirements to refer
to several of the alternatives, including, but not limited to, pure
drug reference materials, stock standard solutions from other
laboratories, and standard solutions obtained from commercial
manufacturers. The requirements in this paragraph incorporate the
related requirements in the HHS Guidelines and meet Goal 1 of this
rulemaking to update and enhance the consistency of Part 26 with
advances in other relevant Federal rules and guidelines.
Section 26.139 Reporting Initial Validity and Drug Test Results
The NRC has added Sec. 26.139 to combine requirements related to
the reporting and management of test results from the licensee testing
facility that were interspersed throughout former Appendix A to Part
26. The agency made this change to meet Goal 6 of this rulemaking to
improve clarity in the organization of the final rule, by grouping
related requirements together in a single section.
Section 26.139(a) amends former Section 2.7(g)(2) in Appendix A to
Part 26. That provision established requirements for the manner in
which HHS-certified laboratories and licensee testing facilities must
report test results to licensee management. The final rule amends the
former provision by moving the former requirements that were related to
reporting test results from HHS-certified laboratories to Sec.
26.169(b) of Subpart G for organizational clarity. The final rule also
deletes the former reference to ``special processing'' and replaces it
with reference to validity test results, consistent with the addition
of requirements to conduct validity testing throughout the final rule,
as discussed with respect to Sec. 26.31(d)(3)(i). The NRC made these
changes to improve clarity in the language and organization of the rule
consistent with Goal 6 of this rulemaking.
With respect to the proposed rule, the final rule eliminates use of
the term ``non-negative'' in Sec. 26.139(a) for the reasons discussed
with respect to Sec. 26.5 for eliminating this term throughout the
proposed rule. Eliminating the term ``non-negative'' and replacing it
with terms to describe specific results of drug and validity testing
(e.g., ``positive,'' ``adulterated''), necessitates splitting the last
sentence of proposed Sec. 26.139(a) into two sentences for clarity.
Therefore, the final rule prohibits licensee testing facilities from
reporting to licensee or
[[Page 17090]]
other entity management any positive drug test results from initial
drug testing at the licensee testing facility, except as permitted
under Sec. 26.75(h). The final rule also prohibits licensee testing
facilities from reporting to licensee or other entity management any
validity screening and initial validity test results that indicate a
specimen is of questionable validity and any positive initial drug test
results from specimens that are of questionable validity. The NRC made
these changes to improve clarity in the language of the rule,
consistent with Goal 6 of this rulemaking.
Section 26.139(b) amends the last sentence of former Sec.
26.24(d)(1), which specified the individuals to whom results of initial
tests from the licensee testing facility may be released. The NRC added
the MRO's staff to the list of individuals who are permitted to have
access to the results of initial tests performed at the licensee
testing facility consistent with the addition of this job role to the
final rule. Individuals who are serving as MRO staff members require
access to initial test results from a licensee's testing facility in
the course of performing their administrative duties for the MRO.
Additionally, with respect to the proposed rule, the final rule permits
an SAE to access initial test results when appropriate consistent with
the addition of this job role to the final rule. Omitting the SAE from
this provision was an unintended oversight in the proposed rule which
the NRC has corrected in the final rule.
Section 26.139(c) amends former Section 2.7(o)(5) in Appendix A to
Part 26. The NRC has moved the requirements in the former paragraph
that addressed the availability of personnel to testify in proceedings
related to drug test results from an HHS-certified laboratory to Sec.
26.153(f)(2) of Subpart G for organizational clarity. The final rule
moves the former requirement for licensee testing facility personnel to
be available to testify at any proceedings with respect to breath
analysis test results to Sec. 26.85(d) [Personnel available to testify
at proceedings] because the collection site and not the licensee
testing facility is typically responsible for quality control of
alcohol testing equipment. The agency made these changes for
organizational clarity in the rule, consistent with Goal 6 of this
rulemaking.
Section 26.139(d) amends the portions of former Section 2.7(g)(6)
in Appendix A to Part 26 that applied to the summary report that
licensee testing facilities must provide to FFD program management. The
NRC has replaced the former requirement for the licensee testing
facility to prepare a monthly report of test results with a requirement
for the licensee testing facility to summarize the data annually in the
FFD program performance report required under Sec. 26.717(b) of the
final rule. Experience implementing the former requirement for a
monthly statistical summary has indicated that the monthly summary has
not been as useful to licensees for ongoing monitoring of testing
program effectiveness as other mechanisms that licensees have
developed. Therefore, the final rule replaces the monthly reporting
requirement in former Section 2.7(g)(6) in Appendix A to Part 26 with a
requirement in Sec. 26.139(f) of the final rule for FFD program
management to monitor the ongoing effectiveness of the licensee testing
facility testing program. This change meets Goal 5 of this rulemaking
to improve Part 26 by eliminating or modifying unnecessary
requirements. The NRC has moved the requirements in the former
paragraph that addressed summary reports from HHS-certified
laboratories to Sec. 26.169(k) of Subpart G for organizational
clarity. With respect to the proposed rule, the agency changed the
cross-reference to FFD program performance reporting requirements in
Sec. 26.217(b) in the proposed rule to Sec. 26.717(b) in the final
rule to reflect the changes the NRC has made in the organization of the
final rule.
Section 26.139(e) amends former Section 2.7(g)(7) in Appendix A to
Part 26. That provision required licensee testing facilities and HHS-
certified laboratories to report test results for both the cutoff
levels specified in Part 26 and any more stringent cutoff levels used
by the FFD program. The NRC has relocated the former requirement
related to HHS-certified laboratories to Sec. 26.169(c) of Subpart G
for organizational clarity. The final rule requires licensees and other
entities who operate testing facilities, and have adopted more
stringent cutoff levels for initial tests for drugs and drug
metabolites than those specified in Sec. 26.133 [Cutoff levels for
drugs and drug metabolites], to conduct tests and report test results
based only on their more stringent cutoff levels. The basis for the
former requirement to conduct tests and report test results for the
cutoff levels specified in this part, when the licensee is using more
stringent cutoff levels, was a method by which the NRC monitored
licensee implementation of the permission to use more stringent cutoff
levels. The final rule eliminates this requirement, because Sec.
26.31(d)(3)(iii)(C) requires a qualified forensic toxicologist to
certify the scientific and technical suitability of the licensee's or
other entity's testing process at any lower cutoff levels. Therefore,
the testing and reporting requirements in the former rule are no longer
needed to monitor licensee testing facility performance in this area.
The final rule continues to require licensee testing facilities to
report test results (and the cutoff levels used) from testing for
additional drugs and drug metabolites, beyond those specified in Sec.
26.31(b)(1).
Section 26.139(f) has been added to require FFD program management
to monitor the ongoing effectiveness of the licensee testing facility
testing program. The final rule provides examples of the types of
information and possible program performance indicators that licensees
and other entities may use for program monitoring. The final rule also
requires FFD program management to make adjustments to the testing
program in response to information gained from the ongoing monitoring.
These requirements replace the monthly summary report required under
former Section 2.7(g)(7) in Appendix A to Part 26 to strengthen FFD
programs by ensuring that licensees monitor licensee testing facility
performance on an ongoing basis and correct any weaknesses as they are
identified. The paragraph is also consistent with the NRC's
performance-based approach to regulation. This change meets Goal 3 of
this rulemaking to improve the effectiveness of FFD programs, as
discussed in Section IV.B.
Subpart G--Laboratories Certified by the Department of Health and Human
Services
Section 26.151 Purpose
The NRC has added Sec. 26.151 to introduce the purpose of the
subpart, which is to establish requirements for the HHS-certified
laboratories that licensees and other entities must use for testing
urine specimens for validity and the presence of drugs and drug
metabolites. Adding this paragraph meets Goal 6 of this rulemaking to
improve clarity in the organization and language of the rule. The
majority of the requirements in this subpart are based on the former
requirements in Appendix A to Part 26, as they relate to HHS-certified
laboratories. However, the rule substantially updates the former
requirements to be consistent with the HHS Guidelines.
[[Page 17091]]
Section 26.153 Using Certified Laboratories for Testing Urine Specimens
The NRC added Sec. 26.153 to group into one section requirements
related to the use of HHS-certified laboratories by licensees and other
entities who are subject to the rule.
Section 26.153(a) combines and updates former requirements for
licensees and other entities to use HHS-certified laboratories for
initial and confirmatory drug testing of urine specimens. The paragraph
relocates and combines former Sec. 26.24(f) and former Sections 1.1(3)
and 4.1(a) in Appendix A to Part 26. These provisions required
licensees and other entities to use HHS-certified laboratories for drug
testing. The NRC made this change to eliminate redundancies in the
former rule and improve organizational clarity. The paragraph updates
the former citations for the HHS Guidelines because the guidelines have
been amended several times since the former rule was published. In
addition, the provision provides current contact information for
obtaining information about the certification status of HHS-certified
laboratories because the contact information has changed since the
former rule was published. The paragraph also adds a requirement for
licensees and other entities to use HHS-certified laboratories for
initial and confirmatory validity testing, consistent with the addition
of urine specimen validity testing requirements to the rule, as
discussed with respect to Sec. 26.31(d)(3)(i). The rule also updates
the cross-reference to former Sec. 26.24(d), which permitted licensee
testing facilities to conduct initial drug tests, to reference the
related provision in the final rule, Sec. 26.31(d)(3)(ii).
Section 26.153(b) amends the first sentence of former Section
2.7(l)(2) in Appendix A to Part 26. The former provision required HHS-
certified laboratories to have the capability, at the same laboratory
premises, of performing initial and confirmatory tests for any drug and
drug metabolite for which service is offered and confirmatory testing
of blood for alcohol concentrations. The former requirement for HHS-
certified laboratories to be capable of conducting confirmatory alcohol
testing of blood has been deleted for the reasons discussed with
respect to Sec. 26.83(a). The paragraph adds a requirement for HHS-
certified laboratories to have the capability to perform both initial
validity and confirmatory validity tests at the same premises for
consistency with the addition of requirements to perform validity
testing to the rule, as discussed with respect to Sec. 26.31(d)(3)(i).
The second sentence of former Section 2.7(l)(2) in Appendix A to Part
26, which established requirements for the capabilities of licensee
testing facilities, has been moved to Sec. 26.123 of Subpart F
[Licensee Testing Facilities] for organizational clarity. The agency
deleted the last sentence of the former paragraph, which permitted the
testing of breath specimens for alcohol at the collection site, because
the rule addresses alcohol testing in Subpart E [Collecting Specimens
for Testing]. These organizational changes to the former paragraph have
been made to meet Goal 6 of this rulemaking to improve clarity in the
organization and language of the rule.
Section 26.153(c) amends the first sentence of former Section
2.7(k) in Appendix A to Part 26. The former provision prohibited HHS-
certified laboratories from subcontracting unless authorized by the
licensee. The rule extends this restriction to subcontracting for
specimen validity testing for consistency with the addition of
requirements to perform validity testing to the rule, as discussed with
respect to Sec. 26.31(d)(3)(i). The second sentence of former Section
2.7(k) has been deleted from the paragraph for several reasons: First,
the requirement to have the capability to test for marijuana, cocaine,
opiates, phencyclidine, and amphetamines has been deleted because it is
redundant with Sec. 26.31(d)(1). The requirement to be capable of
testing whole blood has been deleted because the rule no longer permits
donors to request confirmatory alcohol testing of blood for the reasons
discussed with respect to Sec. 26.83(a). Finally, the requirement for
laboratories to be capable of using gas chromatography/mass
spectrometry (GC/MS) has been eliminated because HHS-certified
laboratories would be permitted to use other methods of confirmatory
testing, consistent with related revisions to the HHS Guidelines.
Section 26.153(d) amends former Section 4.1(b) in Appendix A to
Part 26, which required licensees and C/Vs to use only HHS-certified
laboratories who agree to follow the same rigorous testing, quality
control, and chain-of-custody procedures when testing for more
stringent cutoff levels, additional drugs to those for which testing
required under Part 26, and blood. The final rule eliminates reference
to testing for blood in this provision because the rule no longer
permits donors to request confirmatory alcohol testing of blood for the
reasons discussed with respect to Sec. 26.83(a).
Section 26.153(e) amends the third sentence of former Section
2.7(m) in Appendix A to Part 26. That sentence required licensees to
conduct an inspection and evaluation of a laboratory's drug testing
operations before using the laboratory's services. Some licensees have
incorrectly interpreted the former regulation as requiring licensee
employees to perform the pre-award inspection and evaluation. In many
cases, however, appropriately qualified licensee employees may not be
available to perform the inspection and evaluation, and the use of
contracted experts may be necessary to achieve the NRC's intent. The
paragraph revises the former requirement to indicate that licensees and
other entities are responsible ``to ensure'' that the inspection and
evaluation is performed, in order to clearly indicate that the use of
expert contractors is acceptable. In addition, the rule clarifies that
the pre-award inspection and evaluation must be performed by qualified
individuals.
Section 26.153(e) also permits a licensee or other entity to begin
using the services of another HHS-certified laboratory immediately,
without a pre-award evaluation and inspection, in the event that the
licensee's or other entity's primary laboratory loses its
certification. To be considered acceptable, the rule requires that the
replacement laboratory must be in use by another Part 26 program. The
rule adds this provision to ensure that testing can continue, in the
event that the HHS-certified laboratory on whom a licensee or other
entity relies loses its certification, as some licensees have
experienced. Related requirements for auditing the replacement
laboratory are specified in Sec. 26.41(g)(5).
The agency added Sec. 26.153(f) to require that licensees' and
other entities' contracts with HHS-certified laboratories must require
the laboratories to implement the applicable requirements of this part.
Because the NRC does not regulate HHS-certified laboratories, this
revision would ensure that the agency has a legal basis for requiring
HHS-certified laboratories to comply with this part when conducting
testing for licensees and other entities.
Section 26.153(f)(1) retains the requirement in former Section
2.7(l)(1) in Appendix A to Part 26. The former requirement stated that
HHS-certified laboratories must comply with applicable State licensor
requirements. The final rule replaces the term ``HHS-certified
laboratories'' with the term ``laboratory facilities'' to clarify that
State requirements apply to laboratory facilities rather than to the
HHS-
[[Page 17092]]
certified laboratory as a corporate entity. The clarification is
necessary because some HHS-certified laboratories are operated by large
national corporations with facilities in several different States, and
only the facilities in a specific State are required to meet the
requirements of that State. The NRC made this change for clarity in the
language of the rule as well as consistency with the HHS Guidelines.
Section 26.153(f)(2) amends former Section 2.7(o)(5) in Appendix A
to Part 26. The former regulation required HHS-certified laboratories
to make available qualified personnel to testify in proceedings based
on urinalysis results reported by the laboratory. The NRC moved the
reference to licensee testing facilities to Sec. 26.139(c) in Subpart
F for organizational clarity. The requirement for qualified personnel
to be available to testify in proceedings related to breath analysis
results has been moved to Sec. 26.85(d) in Subpart E for
organizational clarity and because responsibility for testifying with
respect to breath analysis results resides with the licensee's or other
entity's collection site personnel.
Section 26.153(f)(3) updates former Section 3.1 in Appendix A to
Part 26, which required HHS-certified laboratories to protect donors'
records. The former requirement for licensee testing facilities to
protect donors' records has been subsumed within the second sentence of
Sec. 26.37(a) for organizational clarity. The cross-reference to
former Sec. 26.29 has been updated to reference Sec. 26.39 in the
final rule.
Section 26.153(f)(4) updates former Section 3.2 in Appendix A to
Part 26. Specifically, the rule adds a reference to Sec. 503 of Pub. L.
100-71 to document the basis for this requirement. The paragraph adds a
requirement for a donor to have access to records relating to his or
her validity test results for consistency with the addition of validity
testing requirements to the rule, as discussed with respect to Sec.
26.31(d)(3)(i). The paragraph deletes the former reference to records
related to alcohol test results because the final rule will no longer
require HHS-certified laboratories to be capable of testing blood
specimens for alcohol, as discussed with respect to Sec. 26.83(a).
With respect to the proposed rule, the NRC has added a phrase to the
provision to clarify that a donor's designated representative is also
permitted to have access to records relating to the donor's validity
test results. The NRC made this change in response to a public comment
requesting the clarification.
The NRC added Sec. 26.153(f)(5) to clarify that HHS-certified
laboratories must avoid relationships with a licensee's or other
entity's MRO(s) that may be construed as a potential conflict of
interest. The final rule, with respect to the proposed rule, adds a
reference to provisions added in the final rule at Sec. 26.183(b) to
specify specific conflict of interest relationships. The NRC added the
provisions in Sec. 26.183(b) in response to a comment on the proposed
rule requesting the NRC to consider using the examples of MRO conflict
of interest relationships specified in DOT's drug and alcohol testing
regulations. The paragraph responds to the experiences of other Federal
agencies regarding apparent conflicts of interest involving
laboratories and MROs. Although the NRC is not aware of any situations
of this type in Part 26 programs, the integrity of the MRO function is
sufficiently important that incorporating this requirement is warranted
to prevent potential conflict of interest concerns. The paragraph is
consistent with the related provision in the HHS Guidelines.
Section 26.153(f)(6) amends the requirements in the first two
sentences of former Section 2.7(m) in Appendix A to Part 26, which
required HHS-certified laboratories to permit the NRC, licensees, and
other entities to conduct inspections at any time, including
unannounced inspections. The rule deletes, for organizational clarity,
the existing references to collection site services and licensee
testing facilities, which are covered under Subpart F. The paragraph
also deletes reference to confirmatory testing of blood specimens for
alcohol because HHS-certified laboratories are no longer testing blood
specimens for alcohol, as discussed with respect to Sec. 26.83(a).
A new Sec. 26.153(g) requires licensees and other entities to
provide a memorandum for the record to the HHS-certified laboratories
that they use to document why the licensee or other entity is using a
non-Federal custody-and-control form. Under the HHS Guidelines,
laboratories may reject any specimen that is submitted for testing with
a non-Federal custody-and-control form unless the licensee or other
entity provides a memorandum for the record. The paragraph is necessary
to prevent licensee and other entity specimens from being rejected.
Section 26.155 Laboratory Personnel
Section 26.155 updates former Section 2.5 in Appendix A to Part 26
to be consistent with revisions to the HHS Guidelines.
Section 26.155(a) [Day-to-day management of the HHS-certified
laboratory] amends former Section 2.5(a)(1) in Appendix A to Part 26,
which required the HHS-certified laboratory to have a qualified
individual to assume responsibility for day-to-day management of the
HHS-certified laboratory. Specifically, the paragraph replaces the term
``qualified individual'' with the term ``responsible person'' for
consistency with terminology that other Federal agencies use to refer
to this job role. The final rule retains the majority of Section
2.5(a)(2) in Appendix A to Part 26 and establishes qualification
requirements for the responsible person. The provisions in Sec.
26.155(a)(1)(i)-(a)(1)(iv) retain former Section 2.5(a)(2)(i)-
(a)(2)(iv) in Appendix A to Part 26, with minor grammatical changes
that are consistent with similar changes to the related provisions in
the HHS Guidelines.
Section 26.155(a)(2) and (a)(3) establishes minimum day-to-day
management responsibilities of the responsible person and retains
former Section 2.5(a)(4) and (a)(5) in Appendix A to Part 26.
Section 26.155(a)(4) retains former Section 2.5(a)(5) in Appendix A
to Part 26, which relates to the responsible person's responsibility to
maintain the HHS-certified laboratory procedures in a manual. With
respect to the proposed rule, the final rule includes a provision that
HHS-certified laboratories' procedures be maintained in a manual of
standard operating procedures. The proposed rule eliminated the former
requirement in Section 2.5(a)(5) to provide flexibility to HHS-
certified laboratories in how laboratory operating procedures were
maintained. However, based on a comment received on the proposed rule,
the NRC has reinstituted the former requirement that laboratory
procedures be maintained in a manual to improve consistency with the
HHS Guidelines, meeting Goal 1 of this rulemaking. The paragraph
retains the former requirements in the second and third sentences of
Section 2.5(a)(5) in Appendix A to Part 26, and requires the
responsible person to review, sign, and date the procedures when they
are first placed in use, changed, or a new individual assumes
responsibility for management of the laboratory. The responsible person
must also maintain copies of the procedures. The final rule updates the
former cross-reference to Section 2.7(o) in Appendix A to Part 26 to
reference Sec. 26.157, consistent with the organizational changes made
to the rule.
Section 26.155(a)(5) and (a)(6) retains former Section 2.5(a)(6)
and (a)(7) in
[[Page 17093]]
Appendix A to Part 26. These provisions define the responsible person's
responsibilities with respect to maintaining a quality assurance
program and taking remedial actions to maintain satisfactory laboratory
operations.
Section 26.155(b) [Certifying scientist] amends former Section
2.5(b) in Appendix A to Part 26 to be consistent with changes made to
the related requirement in the HHS Guidelines. Consistent with the HHS
Guidelines, the rule provides more detailed requirements with respect
to the individual who certifies test results at the HHS-certified
laboratory before they are transmitted to the licensee or other
entity's MRO.
In Sec. 26.155(b)(1), a new job title, ``certifying scientist,''
replaces the term ``qualified individual(s)'' in the first sentence of
former Section 2.5(b) in Appendix A to Part 26 for consistency with a
related change in the HHS Guidelines. The final rule, with respect to
the proposed rule, replaces the phrase ``attest the validity of'' with
``certify'' test results, as this is a more accurate description of the
responsibilities of a certifying scientist. The NRC made this change in
response to a comment received on the proposed rule. Section
26.155(b)(2) specifies the required qualifications of individuals who
serve as certifying scientists. Section 26.155(b)(3) permits
laboratories to use more than one certifying scientist with differing
responsibilities.
Section 26.155(c) [Day-to-day operations and supervision of
analysts] retains former Section 2.5(c) in Appendix A to Part 26. The
rule makes minor language changes to the former paragraph to increase
the consistency of the language in this provision with that of the
related provision in the HHS Guidelines.
Section 26.155(d) [Other personnel] and (e) [Training] retains
former Section 2.5(d) and (e) in Appendix A to Part 26, respectively.
Section 26.155(f) [Files] updates former Section 2.5(f) in Appendix
A to Part 26. The revisions are consistent with related requirements in
the HHS Guidelines.
Section 26.157 Procedures
Section 26.157 reorganizes and amends requirements for HHS-
certified laboratories' procedures. The requirements for procedures
were interspersed throughout former Appendix A to Part 26, including
requirements contained in former Sections 2.2 and 2.7 in Appendix A to
Part 26. The NRC has combined procedural requirements for the
laboratories into a single section to improve organizational clarity in
the rule.
In Sec. 26.157(a), the agency has made minor editorial changes to
the first sentence of former Section 2.2 in Appendix A to Part 26, but
retains the former requirement for HHS-certified laboratories to have
detailed procedures for conducting testing. The rule deletes the former
reference to blood samples because donors no longer have the option to
request blood testing for alcohol, as discussed with respect to Sec.
26.83(a). Reference to licensee testing facilities has been moved to
Sec. 26.127(a) in Subpart F for organizational clarity. The rule also
deletes reference to procedures for specimen collections, because the
NRC relocated procedural requirements for specimen collections to
Subpart E in the final rule.
Section 26.157(b) combines and amends portions of the requirements
in the first sentence of former Sections 2.4(d) and 2.7(a)(2) in
Appendix A to Part 26 related to the content and implementation of
specimen chain-of-custody procedures. The regulation retains the
portions of the former paragraphs that required HHS-certified
laboratories to develop, implement, and maintain written chain-of-
custody procedures to maintain control and accountability of specimens
from receipt through completion of testing and reporting of results,
during storage and shipping to another HHS-certified laboratory, and
continuing until final disposition of the specimens. The former
requirements related to licensee testing facilities have been moved to
Sec. 26.127(b) in Subpart F for organizational clarity. The rule also
removes references to custody-and-control procedures for blood
specimens because donors no longer have the option to request blood
testing for alcohol, as discussed with respect to Sec. 26.83(a).
The NRC has amended the portions of former Section 2.7(o)(1) in
Appendix A to Part 26 that address the required content of procedures
for HHS-certified laboratories. Section 26.157(c) retains the portions
of the former provision that required laboratories to develop and
maintain written procedures to specify all of the elements of the
testing process, including, but not limited to, the principles of each
test and the preparation of reagents, standards, and controls. The
paragraph presents the required topics of the procedures in a list
format in Sec. 26.157(c)(1) through (c)(12) to clarify that each topic
stands on its own. For organizational clarity, two portions of the
former provision have been moved to other subparts of the rule that
address related topics. The NRC relocated requirements for licensee
testing facility procedures to Sec. 26.127(c) in Subpart F. In
addition, the rule moves the last two sentences of former Section
2.7(o)(1), which specify records retention requirements, to Sec.
26.715(b)(4) of Subpart N [Recordkeeping and Reporting Requirements].
Section 26.157(d) amends former Section 2.7(o)(3)(iii) in Appendix
A to Part 26. The final (and former) provision requires procedures for
the setup and normal operation of testing instruments; a schedule for
checking critical operating characteristics for all instruments;
tolerance limits for acceptable function checks; and instructions for
major troubleshooting and repair. The rule makes three changes to the
former provision for organizational clarity. The paragraph presents the
required topics of the procedures in a list format in Sec.
26.157(d)(1)-(d)(3) to clarify that each topic stands on its own. The
former requirement to maintain records of preventative maintenance has
been relocated to Sec. 26.715(b)(10) in Subpart N. And, the rule moves
the former requirements that apply to licensee testing facilities to
Sec. 26.127(d) in Subpart F.
Section 26.157(e) amends former Section 2.7(o)(4) in Appendix A to
Part 26, but continues to require documented corrective actions if
systems are out of acceptable limits or errors are detected. The
requirements in the former paragraph that apply to licensee testing
facilities have been moved to Sec. 26.127(e) in Subpart F for
organizational clarity.
Section 26.159 Assuring Specimen Security, Chain of Custody, and
Preservation
The NRC added Sec. 26.159 to present in one section the
requirements of the rule that apply to HHS-certified laboratories with
respect to the safeguarding of specimen identity, integrity, and
security. This organizational change consolidates requirements that
were dispersed throughout the former rule.
Section 26.159(a) amends former Section 2.7(a)(1) in Appendix A to
Part 26. This provision retains the first three sentences of former
Section 2.7(a)(1) in Appendix A to Part 26, which required HHS-
certified laboratories to be secure and accessible only to authorized
personnel. For organizational clarity, the NRC moved the requirements
that apply to licensee testing facilities to Sec. 26.129(a) in Subpart
F. The last sentence of the former paragraph, which establishes
recordkeeping requirements, has been moved to Sec. 26.715(b)(13) in
Subpart N. In addition, the NRC has
[[Page 17094]]
revised the last sentence of the former paragraph to increase clarity
in the requirement and expands the list of persons who are authorized
to have access to the laboratory to include representatives of the
Secretary of HHS and emergency responders. This change increases the
consistency of Part 26 with the related provision in the HHS
Guidelines.
Section 26.159(b) amends former Section 2.7(b)(1) in Appendix A to
Part 26. That provision established requirements for receiving
specimens at the HHS-certified laboratory and assuring their integrity
and identity. The final rule makes several organizational changes to
the former rule by dividing the provision into paragraphs Sec.
26.159(b)(1) and (b)(2) for increased organizational clarity.
Section 26.159(b)(1) retains the former requirement for the HHS-
certified laboratory to report evidence of tampering to licensees' or
other entities' management within 24 hours of discovery, as well as the
requirement for the laboratory to document any evidence of tampering on
the specimen's custody-and-control form. The rule moves the former
requirements related to licensee testing facilities to Sec. 26.129(b)
in Subpart F for organizational clarity. With respect to the proposed
rule, the final rule adds several requirements to the provision.
The NRC has renumbered as Sec. 26.159(b)(1)(i), but retained
without change, the portion of proposed Sec. 26.159(b)(1) that
required licensee or other entity management personnel to ensure that
an investigation is initiated if any indications of specimen tampering
are identified, and take corrective actions if tampering is confirmed.
The appropriate corrective actions will depend on the nature of the
tampering identified as a result of the investigation. For example, if
the investigation indicates that the tampering was an attempt to
subvert the testing process and the persons involved are identified,
the rule requires licensee and other entity management personnel to
impose the sanctions in Sec. 26.75(b) for a subversion attempt.
Section 26.159(b)(1)(ii) requires the licensee and other entity to
collect another specimen as soon as possible, if the licensee or other
entity has reason to question the integrity and identity of a specimen.
With respect to the proposed rule, the final rule eliminates the need
to collect another specimen if a split specimen collection was
performed, either the Bottle A or Bottle B seal remains intact, and the
intact specimen contains at least 15 mL of urine. If this circumstance
arises and the licensee testing facility has retained the specimen in
Bottle B and it is intact, the rule requires the licensee testing
facility to forward the intact specimen for testing to the HHS-
certified laboratory. The NRC added this provision to the final rule in
response to public comments on the related provision in the proposed
rule. The commenters requested the NRC to include this provision from
DOT's procedures. The NRC agreed with the commenters' suggestion
because eliminating the recollection when an intact specimen is
available reduces the burden on donors that a recollection would
impose.
The final rule, with respect to the proposed rule, establishes a
new section, Sec. 26.159(b)(2) to specify the exclusive grounds
requiring an MRO to cancel a test. The NRC added this section in
response to public comments received on the proposed rule that
requested this clarification. Section 26.159(b)(2)(i) requires the MRO
to cancel a test if the custody and control form does not contain
information to identify the specimen collector and the collection site
cannot provide conclusive evidence of the collector's identity. Section
26.159(b)(2)(ii) requires the MRO to cancel a test if the
identification numbers on the specimen bottle seal(s) do not match the
identification numbers on the custody-and-control form. Section
26.159(b)(2)(iii) requires the MRO to cancel a test if a specimen
bottle seal is broken or shows evidence of tampering and an intact
specimen, as specified in paragraph (b)(1)(ii) of this section, does
not exist. Section 26.159(b)(2)(iv) requires the MRO to cancel a test
if the specimen appears to have leaked out of its sealed bottle and
there is less than 15 mL remaining, and an intact specimen, as
specified in paragraph (b)(1)(ii) of this section, does not exist.
Section 26.159(b)(2)(v) requires the MRO to cancel a test if the
provisions of Sec. 26.165(f)(2) apply. The NRC incorporated these
requirements from the related DOT procedures.
Section 26.159(c) updates and combines former Section 2.7(b)(2) in
Appendix A to Part 26 with portions of former Sections 2.7(n) and 3.1
in Appendix A to Part 26. These regulations in the former rule
established requirements for chain-of-custody procedures for specimens
and aliquots at licensee testing facilities and HHS-certified
laboratories. For organizational clarity, the NRC has relocated the
requirements in the former paragraphs that are related to licensee
testing facilities to Sec. 26.129(c) in Subpart F. The final rule
retains the requirements in former Sections 2.7(n) and 3.1 in Appendix
A to Part 26, which require the laboratory to maintain the original
specimen and custody-and-control form in secure storage at the HHS-
certified laboratory. The NRC made these changes to reduce redundancies
and improve the organizational clarity of the rule.
Section 26.159(d) and (e) updates the portions of former Section
2.7(a)(2) in Appendix A to Part 26 that established requirements for
HHS-certified laboratory personnel to maintain and document the chain
of custody for specimens and aliquots, by replacing the former
paragraph with two related provisions from the HHS Guidelines.
Paragraph (d) in this section requires the laboratory's internal
custody-and-control form to allow for identification of the donor,
documentation of the testing process and transfers of custody of the
specimen. The agency added the phrase, ``within the laboratory,'' to
paragraph (e) of this section to clarify that the requirement to
document each instance of handling and transfer of specimens applies to
internal laboratory activities and does not apply to transfers
involving couriers. For organizational clarity, the rule relocates the
requirements in the former paragraph that are related to licensee
testing facilities to Sec. 26.129(d) and (e) in Subpart F.
Section 26.159(f) and (g) separates former Section 2.4(i) in
Appendix A to Part 26 into two paragraphs, for the reasons discussed
with respect to the similar provisions of Sec. 26.117(i) and (k) and
Sec. 26.129(g) and (h). The paragraphs repeat the requirements for
packaging and shipping positive, adulterated, substituted, or invalid
specimens that have been presented in Sec. 26.117(i) and (k) of
Subpart E and Sec. 26.129(g) and (h) in Subpart F, but apply them to
packaging and shipping specimens from one HHS-certified laboratory to
another. The bases for these requirements are discussed with respect to
Sec. 26.117(i) and (k). With respect to the proposed rule, the final
rule clarifies Sec. 26.159(f) to ensure that a copy of the custody-
and-control form, rather than the original custody-and-control form, is
included with an aliquot of a single specimen or Bottle B of a split
specimen that is transferred to a second HHS-certified laboratory for
testing. The NRC made this change in response to a public comment on
this provision that noted the proposed provision was inconsistent with
the related requirement in the HHS Guidelines.
Section 26.159(h) replaces former Section 2.7(c) in Appendix A to
Part 26. The former provision established requirements for
refrigerating urine
[[Page 17095]]
specimens at the HHS-certified laboratory and licensee testing facility
to protect them from degradation. The rule replaces the former
paragraph with the simplified language of the related provision in the
HHS Guidelines. The NRC moved the requirements related to short-term
refrigerated storage at licensee testing facilities to Sec. 26.129(f)
in Subpart F for organizational clarity. The final rule, with respect
to the proposed rule, adds the Fahrenheit temperature level that is
equivalent to the Celsius temperature level included in the proposed
rule to improve the clarity of the final rule.
In Sec. 26.159(i), the NRC amends former Section 2.7(h) in
Appendix A to Part 26. The former requirement established requirements
for long-term frozen storage of positive urine specimens at HHS-
certified laboratories and licensee testing facilities. For
organizational clarity, the NRC moved the requirements related to long-
term storage of specimens by licensee testing facilities to Sec.
26.135(c) in Subpart F. The rule adds requirements for storing
specimens that yield adulterated, substituted, or invalid test results
from specimen validity testing, consistent with the addition of
requirements to conduct validity testing throughout the rule, as
discussed with respect to Sec. 26.31(d)(3)(i). The NRC has eliminated
the reference to ``administrative or disciplinary proceedings'' in the
first sentence of the former paragraph because there are other
circumstances in which it may be necessary to have a specimen available
for retesting, including, but not limited to, retesting an aliquot of
an invalid specimen at a second HHS-certified laboratory under Sec.
26.161(g). The rule also updates the terminology used in the former
paragraph by adding a reference to ``Bottle B'' of a split specimen. As
discussed with respect to Sec. 26.5 [Definitions], these changes in
terminology are intended to improve clarity in the language of the
rule.
The NRC added Sec. 26.159(j) to incorporate related changes to the
HHS Guidelines. The final rule permits the HHS-certified laboratory to
discard negative specimens. This paragraph also permits laboratories to
pool specimens that are certified to be negative for drugs and drug
metabolites and valid, as well as use them as quality control samples,
as permitted under the HHS Guidelines. With respect to the proposed
rule, the final rule prohibits the laboratory from retaining any
information linking donors to specimens that are pooled for use in the
laboratory's internal quality control program. The NRC added this
prohibition in response to a public comment received on the proposed
rule. This addition meets Goal 7 of this rulemaking to protect the
privacy and other rights (including due process) of individuals who are
subject to Part 26.
Section 26.161 Cutoff Levels for Validity Testing
A new Sec. 26.161 establishes maximum cutoff levels and methods
for conducting specimen validity testing at HHS-certified laboratories,
consistent with the addition of requirements to conduct validity
testing throughout the rule, as discussed with respect to Sec.
26.31(d)(3)(i). The rule incorporates these requirements from the HHS
Guidelines as revised on April 13, 2004, (69 FR 19644) to meet, in
part, Goal 1 of this rulemaking to update and enhance the consistency
of Part 26 with advances in other relevant Federal rules and
guidelines. This section prohibits licensee and other entities from
using more stringent validity test cutoff levels to ensure consistency
among licensees and other entities and reduce the likelihood of false
adulterated, substituted, or invalid test results, and ensure that
donors are not subject to sanctions on the basis of inaccurate test
results. The prohibition supports Goal 7 of this rulemaking to protect
the privacy and other rights (including due process) of individuals who
are subject to Part 26.
The NRC added Sec. 26.161(a) to specify that HHS-certified
laboratories must conduct initial and, if necessary, confirmatory
validity testing using two different aliquots of a urine specimen. This
provision incorporates the related provision from the HHS Guidelines.
With respect to the proposed rule, the final rule revises the provision
to clarify that confirmatory testing of a second aliquot is required if
initial validity test results indicate that the specimen may be
adulterated, substitute, dilute, or invalid. The final rule also adds a
requirement that licensees and other entities must ensure that the HHS-
certified laboratory is capable of conducting, and conducts,
confirmatory testing for at least one oxidizing adulterant and any
other adulterants for which the licensee's or other entity's FFD
program conducts testing. The agency made these changes in response to
public comments and to improve clarity in the language of the rule.
The agency added Sec. 26.161(b) to establish requirements and
cutoff levels for initial validity tests to be performed at HHS-
certified laboratories. With respect to the proposed rule, the final
rule renumbers these paragraphs to improve the organization and clarity
of the rule. Section 26.161(b)(1) through (b)(5) establishes
requirements for initial validity tests that HHS-certified laboratories
must conduct on a primary specimen. The primary specimen is either a
single specimen submitted by an FFD program that does not follow split
specimen procedures, or the specimen contained in Bottle A of a split
specimen. For initial validity tests of each specimen, HHS-certified
laboratories will determine the creatinine concentration of each
specimen under Sec. 26.161(b)(1). If the creatinine concentration is
less than 20 mg/dL, the laboratory will determine the specimen's
specific gravity under Sec. 26.161(b)(2). Section 26.161(b)(3)
requires the laboratory to determine each specimen's pH. Section
26.161(b)(4) requires the laboratory to test the specimen for the
presence of oxidizing adulterants, and Sec. 26.161(b)(5) requires
additional validity testing, depending on the characteristics of the
specimen.
With respect to the proposed rule, the final rule deletes proposed
Sec. 26.161(b)(2). The proposed paragraph specified the results from
initial validity testing that would indicate the need for the HHS-
certified laboratory to conduct confirmatory validity testing. The NRC
deleted this paragraph in the final rule because the criteria it
contained repeated the criteria embedded in Sec. 26.161(c)-(f). In
addition, the HHS Guidelines do not include these criteria separately.
Therefore, this revision increases the consistency of Part 26 with the
related provisions in the HHS Guidelines.
The final rule adds Sec. 26.161(c) to establish criteria for HHS-
certified laboratories to apply in determining whether to report to a
licensee's or other entity's MRO that a specimen is adulterated.
Section 26.161(c)(1) through (c)(8) specifies results from initial and
confirmatory validity testing that indicate that a specimen is
adulterated. The paragraphs also specify the appropriate testing
devices and instruments to be used for initial and confirmatory
validity tests. In general, the paragraphs require the HHS-certified
laboratory to report to the MRO that a urine specimen is adulterated if
it meets any one of the following criteria: (1) It is confirmed to
contain a substance that should not be present at all in normal human
urine; (2) it is confirmed to contain a substance which, although it
could be present in normal human urine, is found to be at a
concentration that appears to be inconsistent with human physiology; or
(3) it presents an acid/base balance (pH) that appears to be
inconsistent with human life. The paragraphs address several substances
[[Page 17096]]
that some donors have used to try to defeat drug tests through ``in
vitro'' contamination (i.e., adding the substance to a urine specimen).
These adulterants include substances that create a urine pH
inconsistent with human life, oxidizing adulterants, chromium (VI),
halogens, glutaraldehyde, pyridine, and surfactants. These substances,
when either placed into an already voided urine specimen or used in
place of a urine specimen, generally either attempt to defeat the
chemistry of the test or destroy a drug that is present. The NRC
recognizes that this list will be updated and/or modified as new
substances and formulas are introduced, and methods to detect them have
been developed and implemented by HHS-certified laboratories. Section
26.161(c)(8) recognizes that new adulterants will be found and,
therefore, requires HHS-certified laboratories to use appropriate
testing methods when conducting initial and confirmatory testing for
new adulterants for which cutoff levels and criteria have not yet been
established.
Section 26.161(d) and (e) establishes cutoff levels and criteria
for a determination by the laboratory that a specimen has been
substituted or is dilute, respectively. In Sec. 26.161(d), the HHS-
certified laboratory will report to the MRO that a specimen is
substituted if it contains less than 2 mg/dL of creatinine and the
specific gravity is less than or equal to 1.0010 or equal to or greater
than 1.0200. These low creatinine concentrations combined with the
highly skewed specific gravity values indicate that the specimen is not
human urine. In Sec. 26.161(e), the HHS-certified laboratory is
required to report to the MRO that a specimen is dilute if the
creatinine concentration is equal to or greater than 2 mg/dL but less
than 20 mg/dL and the specimen specific gravity is greater than 1.0010
but less than 1.0030.
The NRC added Sec. 26.161(f)(1) through (f)(12) to establish the
criteria that HHS-certified laboratories apply when determining that a
specimen is invalid. In 1998, HHS established criteria for what were
termed ``unsuitable'' specimens (Program Document 35, September 28,
1998). An unsuitable specimen was defined as one that contained an
interfering substance but the laboratory could not determine the nature
of the substance with scientific certainty. In these circumstances, the
laboratory could not achieve a ``valid'' test result. The HHS
recognized that in some cases, an interfering substance could be a
legitimately ingested medication (some non-steroidal anti-inflammatory
drugs have been known to interfere with the chemistry of some of the
initial tests). However, it was also recognized that many of these
problem specimens actually contained an adulterant that the laboratory
could not specifically identify with ``scientific certainty'' which is
the requirement for reporting a specimen as adulterated. Therefore, the
HHS adopted the term ``invalid specimen'' to mean that the laboratory
has determined that valid test results cannot be obtained from a
specimen or an unknown substance interfered with the confirmatory test.
The rule adopts the term ``invalid specimen'' with the same meaning.
The rule adds Sec. 26.161(g) to address circumstances in which an
HHS-certified laboratory suspects that a specimen is adulterated but
cannot identify the adulterant. The paragraph permits the laboratory to
transfer the specimen to a second HHS-certified laboratory for
additional testing, if the first HHS-certified laboratory cannot
identify a possible adulterant in the specimen using their standard
testing technologies and the licensee's or other entity's MRO concurs
with the additional testing. Personnel at the first HHS-certified
laboratory will consult with the licensee's or other entity's MRO to
determine whether to transfer the specimen to a second laboratory for
additional testing.
The agency added Sec. 26.161(h) to prohibit licensees and other
entities from requiring an HHS-certified laboratory to apply validity
testing cutoff levels and criteria that are more stringent than those
specified in this proposed section. Because validity testing is complex
and the methods for testing are relatively new, the rule does not
permit an FFD program to establish more stringent cutoff levels for
validity testing. The prohibition is necessary to decrease the risk of
obtaining false adulterated, substituted, or invalid test results and
ensure that donors are not subject to sanctions on the basis of
inaccurate test results.
Section 26.163 Cutoff Levels for Drugs and Drug Metabolites
Section 26.163 groups together in one section, for organizational
clarity, the requirements for conducting initial and confirmatory tests
for drugs and drug metabolites at HHS-certified laboratories. The
section also updates requirements related to cutoff levels for drugs
and drug metabolites in the former rule to meet Goal 1 of this
rulemaking to update and enhance the consistency of Part 26 with
advances in other relevant Federal rules and guidelines.
Section 26.163(a) [Initial drug testing] amends former Section
2.7(e) in Appendix A to Part 26. When determining whether to report to
the MRO that a specimen is positive for drug(s) or drug metabolite(s),
Sec. 26.163(a)(1) requires HHS-certified laboratories to apply the
same cutoff levels that licensee testing facilities are required to use
in Sec. 26.133, except if the FFD program specifies more stringent
cutoff levels or the specimen is dilute, as discussed further in Sec.
26.163(a)(2). The paragraph reiterates the former permission for
licensees and other entities to establish lower cutoff levels. In
addition, Sec. 26.163(a)(1) decreases the initial test cutoff level
for marijuana metabolites from 100 nanograms (ng) per milliliter (mL)
to 50 ng/mL and increases the initial test cutoff level for opiate
metabolites from 300 ng/mL to 2,000 ng/mL for the reasons discussed
with respect to Sec. 26.133. The changes are consistent with the HHS
cutoff levels for the same substances.
A new Sec. 26.163(a)(2) establishes requirements and criteria for
the initial drug testing of any specimen that confirmatory validity
testing indicates is dilute. Although there are many legitimate reasons
that a donor may provide a urine specimen that is dilute, dilution is
also a method used to subvert the testing process. Dilution of a
specimen decreases the concentration of any drugs or drug metabolites
in the specimen. Dilution may decrease the concentration sufficiently
that applying the cutoff levels specified in this part, or a licensee's
or other entity's more stringent cutoff levels, would provide false
negative drug test results. Therefore, the rule adds special testing
procedures and criteria for determining which dilute specimens must be
subject to confirmatory drug testing. With respect to the proposed
rule, the NRC has eliminated the optional provision for FFD programs to
test specimens with initial validity test results that indicate a
specimen is dilute using FDA approved kits for the lowest concentration
levels marketed for the technologies being used to conduct initial
testing of specimens for drug or drug metabolites. This change is based
on a comment received on the proposed provision. Instead, the NRC is
adopting the procedure proposed by the commenter. That is, for dilute
specimens, the final rule permits an FFD program to request the HHS-
certified laboratory to conduct confirmatory testing of dilute
specimens at the confirmatory assay's LOD for a drug or drug class, if
the response to the initial drug test for any drug class for
[[Page 17097]]
which testing is performed is within 50 percent of the cutoff
calibrator level. The NRC agrees that the commenter's approach is
consistent with the intent of the proposed provision, while reducing
the burden on HHS-certified laboratories imposed by the proposed
requirements. This special processing of dilute specimens increases the
likelihood that any drugs and drug metabolites in the specimen will be
detected. Therefore, this requirement meets Goal 3 of this rulemaking
to improve the effectiveness of FFD programs, by increasing the
likelihood that testing of dilute specimens will reveal drug use if the
donor had engaged in substance abuse.
As discussed with respect to Sec. 26.133, the final rule
eliminates the requirement in the last sentence of former Section
2.7(e)(1) of Appendix A to Part 26 for HHS-certified laboratories to
report drug test results for both the cutoff levels in the rule and any
more stringent cutoff levels that the licensee or other entity may
establish. The basis for the former requirement to report test results
for the cutoff levels specified in this part, when the licensee is
using more stringent cutoff levels, was a means by which the NRC
monitored implementation of the permission to use more stringent cutoff
levels. The rule eliminates this requirement, because Sec.
26.31(d)(3)(iii)(C) requires a qualified forensic toxicologist to
certify the scientific and technical validity of any testing at lower
cutoff levels. Therefore, the former reporting requirement is no longer
needed to ensure laboratory performance in this area. Eliminating this
requirement meets Goal 5 of this rulemaking to improve Part 26 by
eliminating or modifying unnecessary requirements.
The rule also eliminates former Section 2.7(e)(2) in Appendix A to
Part 26. The former provision stated that the list of substances and
cutoff levels contained in Appendix A to Part 26 were subject to change
by the NRC. At the time the former rule was published, the NRC expected
to be able to amend the list of substances and cutoff levels in the
former rule without additional rulemaking. However, the NRC has
determined that rulemaking is required to make such changes. Therefore,
the rule deletes this paragraph because it is unnecessary.
The final rule replaces former Section 2.7(f) in Appendix A to Part
26 with Sec. 26.163(b) [Confirmatory drug testing]. The former
provision established cutoff levels and requirements related to
confirmatory testing for drugs and drug metabolites at the HHS-
certified laboratory. The rule also makes a number of changes to the
former paragraph.
The agency has moved former Section 2.7(f)(1) in Appendix A to Part
26 to Sec. 26.169(b)(1) of the final rule. Former Section 2.7(f)(1)
required the HHS-certified laboratory to report to the MRO that test
results are negative for any specimens that yield negative test results
when they are subjected to confirmatory testing. The NRC moved this
requirement to Sec. 26.169(b)(1) for organizational clarity because
Sec. 26.169 addresses the topic of reporting test results by the HHS-
certified laboratory to the MRO.
The NRC has also eliminated the requirement in former Section
2.7(f)(1) in Appendix A to Part 26 that the laboratory must conduct
confirmatory testing using both the maximum cutoff values established
in Part 26 as well as any more stringent cutoff levels adopted by the
licensee's or other entity's FFD program. The former requirement to
conduct testing for the cutoff levels specified in this part, when the
licensee is using more stringent cutoff levels, was a means by which
the NRC monitored implementation of the permission to use more
stringent cutoff levels. The rule eliminates this requirement, because
Sec. 26.31(d)(3)(iii)(C) requires a qualified forensic toxicologist to
certify the scientific and technical validity of any testing at lower
cutoff levels. Therefore, the requirement to test at both cutoff levels
is no longer needed to assure laboratory performance in this area.
For organizational clarity, the NRC has moved the first sentence of
former Section 2.7(f)(2) in Appendix A to Part 26 that required the
laboratory to use GC/MS techniques for confirmatory testing to Sec.
26.167(e)(1) in the final rule. Section 26.167(e)(1) addresses quality
control requirements for conducting confirmatory drug tests.
The rule eliminates former Section 2.7(f)(3) in Appendix A to Part
26. The former provision required HHS-certified laboratories to use GC
analysis of blood specimens in testing for alcohol. The final rule also
eliminates the confirmatory alcohol cutoff level in former Section
2.7(f)(1) in Appendix A to Part 26. The NRC eliminated these provisions
because the rule no longer permits donors to request confirmatory
testing of a blood specimen for alcohol, as discussed with respect to
Sec. 26.83(a).
In addition, the rule eliminates former Section 2.7(f)(4) in
Appendix A to Part 26 for the same reasons discussed with respect to
former Section 2.7(e)(2) in Appendix A to Part 26.
Section 26.163(b)(1) amends several of the cutoff levels in former
Section 2.7(f)(1) in Appendix A to Part 26 that the HHS-certified
laboratory uses to determine that a confirmatory drug test result is
positive. The rule increases the confirmatory test cutoff levels for
morphine and codeine to 2,000 ng/mL. This change in the cutoff level
for opiate metabolites substantially reduces the number of positive
opiate test results that are reported to MROs by HHS-certified
laboratories that MROs ultimately verify as negative and is consistent
with the opiate cutoff levels contained in the HHS Guidelines.
Section 26.163(b)(1) also amends two of the testing procedures in
former Section 2.7(f) in Appendix A to Part 26. The rule amends former
Section 2.7(f)(5) in Appendix A to Part 26, which required the
laboratory to test for 6-acetylmorphine (6-AM) if a specimen tests
positive for opiates on the initial drug test. The rule requires the
HHS-certified laboratory to test for 6-AM, if test results for morphine
are at or above the 2,000 ng/mL opiate cutoff levels, and establishes a
cutoff level of 10 ng/mL for determining that a specimen is positive
for 6-AM. In addition, Sec. 26.163(b)(1) adds a requirement that a
specimen must also contain amphetamine at a concentration equal to or
greater than 200 ng/mL in order for the HHS-certified laboratory to
report to the MRO that the specimen has yielded a positive test result
for methamphetamine. These changes are consistent with the related
provisions in the HHS Guidelines.
Section 26.163(b)(1) updates the terminology used in former Section
2.7(f)(1) in Appendix A to Part 26. As discussed with respect to Sec.
26.5, the final rule replaces the term ``presumptive positive'' with
the phrase ``positive on an initial drug test'' to increase clarity in
the language of the rule.
A new Sec. 26.163(b)(2) amends the second sentence of former
Section 2.7(f)(2) in Appendix A to Part 26. The former sentence
required the HHS-certified laboratory to document drug and drug
metabolite concentrations that exceed the linear region of the standard
curve in the laboratory record. The rule replaces the former sentence
with a paragraph that incorporates the related provision from the HHS
Guidelines. The HHS Guidelines permit the laboratory to dilute an
aliquot of the specimen to obtain an accurate quantitative result when
the concentration is above the upper limit of the linear range. This
change has been made to meet Goal 1 of this rulemaking to update and
enhance the consistency of Part 26 with advances in other relevant
Federal rules and guidelines.
[[Page 17098]]
Section 26.165 Testing Split Specimens and Retesting Single Specimens
Section 26.165 reorganizes and amends the requirements formerly
found in Sec. 26.24(f), and Section 2.7(i) and (j) in Appendix A to
Part 26 that related to testing split specimens and retesting specimens
at HHS-certified laboratories. For organizational clarity, the final
rule groups the requirements together in a single section to make them
easier to locate in the rule. The section also adds several new
requirements.
Section 26.165(a) [Testing split specimens] combines and amends
former Sec. 26.24(f) and Section 2.7(j) in Appendix A to Part 26.
Those provisions established requirements for HHS-certified
laboratories when testing split specimens. The final rule uses the
terms ``Bottle A'' and ``Bottle B'' to refer to the primary and split
specimens, respectively, for consistency with the updated terminology
used throughout the rule. The rule also requires specimen validity
testing, consistent with the addition of requirements to conduct
validity testing throughout the rule, as discussed with respect to
Sec. 26.31(d)(3)(i).
Section 26.165(a)(1) retains the portions of former Section 2.7(j)
in Appendix A to Part 26 that required the HHS-certified laboratory to
analyze the primary specimen of a split specimen. The former
requirements related to licensee testing facilities in this section
have been moved to Sec. 26.135 in Subpart F for organizational
clarity. This paragraph retains the former requirement that the primary
specimen (Bottle A) must be subject to initial testing by the HHS-
certified laboratory, and confirmatory testing, if the results of
initial testing indicate that the specimen is positive. The final rule
adds a requirement for HHS-certified laboratories also to conduct
initial and, if necessary, confirmatory validity testing of the
specimen in Bottle A of a split specimen.
Section 26.165(a)(2) retains the portion of the second sentence of
former Sec. 26.24(f) that required the HHS-certified laboratory to
perform initial and confirmatory tests, if required, on the primary
specimen in Bottle A, even if a licensee testing facility conducted
initial testing on an aliquot of the specimen. The NRC moved the former
requirement to this section for organizational clarity. With respect to
the proposed rule, the final rule replaces the term ``non-negative'' in
the proposed rule with the more specific terms ``positive'' and ``of
questionable validity'' to refer to the results of testing at the
licensee testing facility. The agency made this change to improve the
clarity of the rule's language.
Section 26.165(a)(3) retains the authorization in the second
sentence of former Section 2.7(j) in Appendix A to Part 26 for licensee
testing facilities to retain custody of the split specimen in Bottle B
or forward it with Bottle A to the HHS-certified laboratory for storage
until testing of Bottle A is completed. The final rule also retains the
former authorization for the specimens in Bottle A and Bottle B to be
discarded if test results from the HHS-certified laboratory are
negative. With respect to the proposed rule, the final rule makes minor
editorial changes to this provision to increase the clarity of the
language. In addition, the final rule adds cross-references to Sec.
26.135(a) and (c). These provisions contain requirements for storing
Bottle B of a split specimen at a licensee testing facility, if the
licensee testing facility chooses to retain Bottle B rather than
forwarding it with Bottle A to the HHS-certified laboratory. The NRC
made these changes to improve clarity in the language of the rule and
in response to a public comment requesting the clarifications.
The NRC added Sec. 26.165(b) [Donor request to MRO for a retest of
a single specimen or testing Bottle B of a split specimen] to permit
donors to request retesting of an aliquot from a single specimen, if
the FFD program does not follow split specimen procedures, and testing
of Bottle B if the program follows split specimen procedures. This
paragraph assures that donors who are subject to a program that does
not follow split specimen procedures have the right to request
additional testing. With respect to the proposed rule, the final rule
combines and reorganizes the provisions in proposed Sec. 26.165(b)
pertaining to a donor's request for retesting a single specimen with
those in proposed Sec. 26.165(c) pertaining to a donor's request for
testing of Bottle B of a split specimen. The agency made these changes
in response to a public comment. The commenter noted that the separate
paragraphs in the proposed rule contained redundant requirements and
that separating the requirements into two paragraphs was inconsistent
with the related provisions in the HHS Guidelines. Therefore, the NRC
also changed the title of this section from ``Donor request to MRO for
a retest of a single specimen'' in the proposed rule to ``Donor request
to MRO for a retest of a single specimen or testing of Bottle B of a
split specimen'' in the final rule.
Section 26.165(b)(1) assures that donors may request through the
MRO additional testing of an aliquot from a single specimen or testing
of Bottle B by a second HHS-certified laboratory. This permission is
consistent with related provisions in the HHS Guidelines and amends the
requirements in former Section 2.7(j) in Appendix A to Part 26 that
pertained to donor requests to test the specimen in Bottle B. The final
rule permits donors to request retesting of an aliquot of a single
specimen by a second HHS-certified laboratory to protect donors' rights
to retesting under FFD programs that do not follow split specimen
procedures. The rule adds confirmed adulterated and substituted
validity test results as bases for a donor request for testing the
specimen in Bottle B or retesting an aliquot of a single specimen,
consistent with the addition of requirements to conduct validity
testing throughout the rule, as discussed with respect to Sec.
26.31(d)(3)(i). However, in order to have sufficient urine to support
retesting, the paragraph applies only if the donor had originally
submitted a specimen of 30 mL or more in a single specimen, or a
specimen in Bottle A. Specimens that the HHS-certified laboratory
determines to be invalid are not eligible for retesting because of the
risk of damage to laboratory equipment that some invalid specimens may
pose and because retesting the specimen would not provide useful
information. The procedures for requesting and conducting the retest of
a single specimen are consistent with those for requesting and
conducting tests on the specimen in Bottle B of a split specimen in the
final rule.
Section 26.165(b)(2) adds a requirement for the MRO to inform the
donor that he or she may, within 3 business days of notification by the
MRO of a confirmed positive, adulterated, or substituted test result,
request a retest of an aliquot of a single specimen or, as appropriate,
Bottle B of a split specimen. The NRC also added a requirement that the
donor must request retesting an aliquot of a single specimen or testing
the Bottle B specimen within 3 business days after notification by the
MRO that a single specimen or the specimen in Bottle A of a split
specimen has yielded positive, adulterated, or substituted test
results. Since 1994, the HHS Guidelines have allowed up to 72 hours for
a donor to make this request, so this change increases the consistency
of Part 26 with the HHS Guidelines. This provision combines proposed
Sec. 26.165(a)(4) and (b)(1) into one paragraph for the reasons
discussed with respect to Sec. 26.165(b).
The final rule, with respect to the proposed rule, includes a new
[[Page 17099]]
requirement that the MRO must provide the donor with specific contact
information and have the ability to verify the time the donor's call
was received by the MRO's office if telephone notifications for
retesting are the preferred method of the MRO's office. The NRC added
this provision in response to a public comment received on the proposed
rule that requested the addition to further protect donors' rights
under the rule. The requirement is consistent with related requirements
in the DOT's drug and alcohol testing procedures and, therefore, meets
Goal 1 of the this rulemaking to enhance the consistency of Part 26
with the related regulations of other Federal agencies.
In Sec. 26.165(b)(2) of the final rule, the NRC has modified the
requirement in proposed Sec. 26.165(a)(4) that a donor must inform the
MRO in writing of his or her request to conduct testing of an aliquot
of the single specimen or the specimen contained in Bottle B at a
second HHS-certified laboratory. This change is based on public
comments received on the proposed rule which stated that requiring a
donor to make a written request for additional specimen testing would
be unduly restrictive given that other Federal agencies permit the
donor to make these requests verbally. The NRC agrees that a donor
should be provided with as much flexibility as possible, while ensuring
the request is made in a secure and accurate manner. Therefore, the
final rule permits the donor to make his or her request for additional
testing verbally to the MRO or in writing. This change meets Goal 1 of
this rulemaking to update and enhance the consistency of Part 26 with
advances in other relevant Federal drug and alcohol testing programs.
Section 26.165(b)(3) combines into one paragraph the requirements
that were contained in the last sentences of proposed Sec.
26.165(a)(4) and (b)(1) for the reasons discussed with respect to Sec.
26.165(b). The final rule requires permission from the donor for
testing Bottle B of a split specimen or retesting an aliquot of a
single specimen and prohibits the MRO, NRC, or any other entity from
requiring additional tests of a donor's specimen without his or her
permission. These limitations are consistent with the principle
established in Sec. 26.31(d)(6) that affirms the donor's right to
retain control over his or her specimen. Therefore, adding this
provision meets Goal 7 of this rulemaking to protect the privacy and
other rights (including due process) of individuals who are subject to
Part 26.
In Sec. 26.165(b)(4) of the final rule, with respect to the
proposed rule, the NRC has added a new provision that permits a donor
to present to the MRO evidence supporting the inability of the donor to
make a timely request for retesting of a single specimen or the testing
of the Bottle B specimen after the 3-business-day period permitted has
elapsed. For example, a donor may have been severely ill when informed
of a confirmed positive, adulterated, or substituted test result and
was unable to contact the MRO to make the request because of
hospitalization. On the basis of the information the donor presents,
the MRO will make the sole determination whether the circumstances
described unavoidably prevented the donor from making a timely request.
If the MRO makes this determination, he or she will direct a retest of
an aliquot of a single specimen or testing of Bottle B of a split
specimen by a second HHS-certified laboratory, as if a timely request
was made. The NRC added this provision in response to public comments
on the proposed rule, and has incorporated the related requirement in
the DOTs' procedures. The added provision protects donors' rights to
fair and consistent testing procedures under the rule, consistent with
Goal 7 of this rulemaking, and meets Goal 1 to update and enhance the
consistency of Part 26 with advances in other relevant Federal rules
and guidelines.
Section 26.165(b)(5) requires the MRO, in response to a donor's
timely request for a retest of an aliquot of a single specimen or
testing of Bottle B of a split specimen, to ensure that either the HHS-
certified laboratory forwards an aliquot of a single specimen, or the
HHS-certified laboratory or licensee testing facility forwards Bottle B
of a split specimen, as appropriate, to a second HHS-certified
laboratory that did not test the specimen in Bottle A. This paragraph
amends the requirement in the fourth sentence of former Section 2.7(j)
in Appendix A to Part 26, which required that the split specimen must
be forwarded to another HHS-certified laboratory for testing on the
same day of the donor request. The final rule requires the licensee
testing facility or HHS-certified laboratory, as applicable, to forward
Bottle B of a split specimen or the aliquot of a single specimen to a
second laboratory as soon as reasonably practical and not more than 1
business day following the day of the donor's request. The NRC amended
the former provision to respond to stakeholder comments during the
public meetings discussed in Section I.D. The stakeholders indicated
that implementing the ``same-day'' requirement for forwarding Bottle B
in former Section 2.7(j) of Appendix A to Part 26 has often been
difficult for a number of reasons. These reasons included communication
delays among donors, MROs, the HHS-certified laboratory, and FFD
program personnel, particularly on weekends, holidays, and the time
required to identify a second HHS-certified laboratory with the
appropriate capability to test the specimen, depending on the nature of
the positive test result. The change alleviates some types of
logistical problems associated with weekends and holidays while
continuing to provide the donor with timely test results. This change
meets Goal 5 of this rulemaking to improve Part 26 by eliminating or
modifying unnecessary requirements. The final rule renumbers proposed
Sec. 26.165(a)(5) as Sec. 26.165(b)(5) for the reasons discussed with
respect to Sec. 26.165(b).
Section 26.165(b)(6) retains the last sentence of former Section
2.7(j) in Appendix A to Part 26. This provision requires the second
HHS-certified laboratory to provide quantitative test results from
Bottle B to the MRO, who provides them to the donor. The rule adopts
the simpler language from the related provision in the HHS Guidelines,
consistent with Goal 6 of this rulemaking to improve clarity in the
language of the rule. This provision also extends the former
requirement to apply to communicating results from retesting an aliquot
of a single specimen, consistent with the explicit permission the NRC
has added for a donor to request retesting of a single specimen if the
FFD program does not follow split specimen procedures. With respect to
the proposed rule, Sec. 26.165(b)(6) combines the redundant
requirements in proposed Sec. 26.165(a)(6) and (c)(4) for the reasons
discussed with respect to Sec. 26.165(b).
Section 26.165(c) [Retesting a specimen for drugs] amends former
Section 2.7(i) in Appendix A to Part 26, which specified that retesting
of a specimen is not subject to cutoff requirements. This paragraph
updates and expands the former requirements for retesting a single
specimen or Bottle B of a split specimen for drugs and drug metabolites
to be consistent with the related provisions in the HHS Guidelines, as
follows:
The NRC added Sec. 26.165(c)(1) to require the second HHS-
certified laboratory to use the laboratory's confirmatory test for the
drug or drug metabolite for which the specimen tested positive at the
first laboratory. The second HHS-certified laboratory will not conduct
initial tests, or tests for
[[Page 17100]]
other drugs or drug metabolites, consistent with the related
requirements in the HHS Guidelines. With respect to the proposed rule,
for completeness, the final rule adds a reference to conducting
confirmatory tests on specimens that the first laboratory confirmed to
be positive and dilute as a result of the special analysis permitted in
Sec. 26.169(a)(2). In addition, in response to a public comment, the
final rule eliminates the reference to the second laboratory's
``standard'' confirmatory drug test in the proposed provision because
HHS-certified laboratories do not have ``standard'' confirmatory drug
tests. The NRC made this change to enhance clarity in the language of
the rule.
Section 26.165(c)(2) amends former Section 2.7(i) in Appendix A to
Part 26, which specified that retesting of a specimen is not subject to
cutoff requirements. The paragraph retains the requirement for the
second HHS-certified laboratory to provide data sufficient to confirm
the presence of the drug(s) or drug metabolite(s) and adds permission
to test the specimen at the assay's LOD. This addition ensures that the
second laboratory's testing is as sensitive to the presence of the
drug(s) or drug metabolite(s) as is scientifically and legally
defensible.
The NRC has added Sec. 26.165(c)(3) to require the second
laboratory, if retesting fails to confirm the presence of the drug(s)
or drug metabolite(s) identified by the first HHS-certified laboratory,
to attempt to determine the reason why it could not reconfirm the drug
test results from the first laboratory. The provision requires the
second laboratory to conduct specimen validity testing if the second
laboratory fails to reconfirm the first laboratory's findings,
consistent with the related requirements in the HHS Guidelines.
Section 26.165(c)(4) retains the requirement in the last sentence
of former Section 2.7(j) in Appendix A to Part 26 that requires the
second laboratory to report the test results of testing a split
specimen to the MRO. The rule extends this requirement to reporting
results from retesting an aliquot of a single specimen, consistent with
the explicit permission the rule adds in Sec. 26.165(b) for a donor to
request retesting of a single specimen if the FFD program does not
follow split specimen procedures. The requirement is consistent with
the related requirements in the HHS Guidelines.
The NRC added Sec. 26.165(d) [Retesting a specimen for
adulterants] to incorporate related requirements in the HHS Guidelines
for performing retests for adulterants at a second HHS-certified
laboratory. The final rule limits retesting for adulterants to
conducting confirmatory testing only for the adulterant(s) identified
by the first laboratory. This limitation is consistent with limitations
on retesting specimens for drugs and drug metabolites in the related
requirements of the HHS Guidelines. With respect to the proposed rule,
the final rule, when discussing confirmatory validity testing in Sec.
26.165(d), replaces the phrase ``appropriate confirmatory test'' with
``required confirmatory test'' in response to a comment received on the
proposed rule. The commenter noted that the confirmatory testing
requirements in Sec. 26.161(d) are ``required'' rather than
``appropriate,'' and the NRC concurs. The agency made this change to
enhance the consistency of the final rule with the HHS Guidelines and
improve clarity in the language of the rule.
The NRC added Sec. 26.165(e) [Retesting a specimen for
substitution] to incorporate related requirements in the HHS Guidelines
for performing retests on substituted specimens at a second HHS-
certified laboratory. The rule limits retesting for specimen
substitution to conducting confirmatory testing only for creatinine and
specific gravity. This limitation is consistent with limitations on
retesting specimens for drugs and drug metabolites and the related
requirements in the HHS Guidelines. With respect to the proposed rule,
the final rule eliminates the second sentence of the proposed provision
in response to a public comment that noted it was inconsistent with the
related provision in the HHS Guidelines.
Section 26.165(f) [Management actions and sanctions] has been added
to specify the management actions that licensees and other entities
must take when a donor requests a retest of a single specimen or
testing of Bottle B of a split specimen. The NRC added this paragraph
to establish the requirements for management actions and sanctions when
an individual has had a confirmed positive, adulterated, or substituted
test result and requests a retest of a single specimen or Bottle B of a
split specimen. This section responds to stakeholder comments at the
public meetings discussed in Section I.D. The stakeholders noted that
the former rule did not address required management actions when an
individual has had a confirmed positive test result and requests a
retest of a single specimen or Bottle B of a split specimen. Therefore,
the NRC added this section to establish such requirements.
The agency added Sec. 26.165(f)(1) to address circumstances in
which the MRO has confirmed a positive, adulterated, or substituted
test result from the first HHS-certified laboratory that tested the
specimen as a violation of the licensee's or other entity's FFD policy
and the donor requests a retest of a single specimen or testing of the
specimen in Bottle B. This provision requires the licensee or other
entity to take the same actions in response to the confirmed positive,
adulterated, or substituted test result(s) from the first HHS-certified
laboratory, as explained in Sec. 26.75(i), in response to a positive
drug test result for marijuana or cocaine from initial testing at a
licensee testing facility. That is, Sec. 26.165(f)(1) requires the
licensee or other entity to administratively withdraw the donor's
authorization until the test results from the second HHS-certified
laboratory have been reported to and reviewed by the MRO. If the test
results from the second laboratory reconfirm any positive, adulterated,
or substituted test results from the first HHS-certified laboratory,
the rule requires the licensee or other entity to impose the
appropriate sanctions that are specified in subpart D for any positive,
adulterated, or substituted results that were confirmed by the second
laboratory. If the test results from the second laboratory do not
reconfirm the positive, adulterated, or substituted test results from
the first laboratory, the rule (1) prohibits the licensee or other
entity from imposing any sanctions on the individual; (2) requires the
licensee or other entity to eliminate any records of the first
confirmed positive, adulterated, or substituted results; and (3)
requires the licensee or other entity to inform the donor, in writing,
that the records have been expunged and that he or she need not
disclose the temporary administrative action to any other licensee or
entity. These requirements protect public health and safety and the
common defense and security by ensuring that an individual whose
fitness for duty is questionable does not perform any duties or have
the types of access that require the individual to be subject to this
part, while serving to protect the privacy rights of individuals who
are subject to Part 26 and ensure that the individuals are afforded
accurate and consistent testing.
The NRC added Sec. 26.165(f)(2) to address the unlikely
circumstances in which a donor requests retesting of a single specimen
or testing Bottle B of a split specimen, but the testing cannot be
performed because the single specimen or Bottle B is no longer
available due to causes that are outside of the donor's control. These
causes could include, but are not limited to, an insufficient
[[Page 17101]]
quantity of urine in the single specimen to permit retesting, either
Bottle B or the aliquot of a single specimen is lost in transit to the
second HHS-certified laboratory, or Bottle B has been misplaced. This
provision requires the MRO to cancel the original test result,
prohibits the licensee or other entity from imposing any sanctions on
the donor, and requires the licensee or other entity to ensure that any
records are expunged that could link the donor to the original
positive, adulterated, or substituted test result and the
administrative action required under Sec. 26.165(f)(1). The final
rule, with respect to the proposed rule, adds the requirement that the
MRO must direct the licensee or other entity to collect a second
specimen under direct observation as soon as reasonably practical. The
paragraph requires a second collection as soon as reasonably practical
because other provisions of the regulation (see Subpart C) require
negative test results in order for the licensee or other entity to
grant or maintain the donor's authorization. The NRC made this change
in response to public comments received on the proposed rule and to
increase the consistency of Part 26 with the related requirements in
the HHS Guidelines.
The last sentence of Sec. 26.165(f)(2) requires the licensee or
other entity to impose the appropriate sanctions, as specified in
Subpart D, if the results of testing the specimen from a second
collection are positive, adulterated, or substituted and confirmed by
the MRO to be an FFD policy violation. However, the rule prohibits the
licensee or other entity from considering the results of testing the
original specimen when imposing sanctions because the donor was
(inadvertently) denied his or her right to due process in this case.
The new requirements in Sec. 26.165(f) are generally consistent
with the related requirements in the HHS Guidelines. The differences
from the HHS Guidelines' requirements in the rule are variations in the
terminology used to adapt the language for the NRC's purposes and the
addition of cross-references to other portions of the rule.
Section 26.167 Quality Assurance and Quality Control
Section 26.167 updates former Section 2.8 in Appendix A to Part 26
[Quality assurance and quality control], which established quality
assurance and quality control requirements for drug testing at HHS-
certified laboratories. This section provides more detailed
requirements for the quality assurance and quality control programs of
HHS-certified laboratories to improve consistency with related
provisions in the HHS Guidelines, and adds new requirements for
validity testing, consistent with the addition of requirements to
conduct validity testing throughout the rule, as discussed with respect
to Sec. 26.31(d)(3)(i).
Section 26.167(a) [Quality assurance program] amends and combines
former Section 2.8(a) and the last two sentences of Section 2.8(d) in
Appendix A to Part 26, which required HHS-certified laboratories and
licensee testing facilities to have quality assurance programs. For
increased clarity in the language of the rule, the rule replaces the
term ``specimen acquisition'' with the term ``specimen accessioning''
in the first sentence of former Section 2.8(a), which is the more
accurate term. The rule also adds a requirement for the quality
assurance program to encompass the certification of calibrators and
controls to ensure that calibrators and controls are accurate. This
requirement is consistent with the related provision in the HHS
Guidelines.
In addition, the rule moves to Sec. 26.167(a) and amends the
requirements in the last two sentences of former Section 2.8(d) in
Appendix A to Part 26, which required that the linearity and precision
of testing methods used must be periodically documented as well as the
procedures to ensure that carryover does not contaminate a donor's
specimen. The rule updates these requirements for consistency with the
HHS Guidelines and requires that (1) the performance characteristics
(e.g., accuracy, precision, LOD, limit of quantitation (LOQ),
specificity) for each test must be validated and documented; (2)
validation of procedures must document that carryover does not affect
the donor's specimen results, and (3) the laboratory must periodically
re-verify the analytical procedures. The NRC relocated the updated
requirements to Sec. 26.167(a) for organizational clarity because they
are aspects of the laboratory's quality assurance program.
The NRC has moved the requirements in former Section 2.8(a) in
Appendix A to Part 26 that applied to licensee testing facilities to
Sec. 26.137(a) [Quality assurance program] in Subpart F. Section
26.167(a) retains the second sentence of former Section 2.8(a). The NRC
also relocated the quality control requirements for initial tests at
licensee testing facilities in former Section 2.8(b) in Appendix A to
Part 26 to Sec. 26.137 in Subpart F. The NRC made these changes for
organizational clarity in the rule.
Section 26.167(b) [Calibrators and controls required] retains the
portions of former Section 2.8(c) and (d) in Appendix A to Part 26 that
required HHS-certified laboratories to use appropriate calibrators and
controls for initial and confirmatory drug testing. The rule adds a
requirement to include appropriate calibrators and controls for initial
and confirmatory validity testing, consistent with the addition of
requirements to conduct validity testing throughout the rule, as
discussed with respect to Sec. 26.31(d)(3)(i). The NRC has added more
detailed requirements for calibrators and controls to this section than
were contained in the former section for consistency with the HHS
Guidelines. The final rule presents these requirements in separate
paragraphs that address each type of test to be performed by the HHS-
certified laboratory for organizational clarity.
The NRC added Sec. 26.167(c) [Quality control requirements for
performing initial and confirmatory validity tests] to establish
quality control requirements for performing initial and confirmatory
validity tests at an HHS-certified laboratory. The quality control
requirements for validity tests in this paragraph incorporate the
related provisions of the HHS Guidelines.
The final rule adds Sec. 26.167(c)(1) [Requirements for performing
creatinine tests] to require HHS-certified laboratories to measure
creatinine concentration to 1 decimal place on initial and confirmatory
creatinine tests and to establish requirements for the quality control
samples to be used in initial and confirmatory tests for creatinine
concentration.
Section 26.167(c)(2) [Requirements for performing specific gravity
tests] establishes the required characteristics of the refractometers
that HHS-certified laboratories must use to measure specific gravity
and the characteristics of the quality control samples to be used for
initial and confirmatory tests for a specimen's specific gravity.
Section 26.167(c)(3) [Requirements for performing pH tests]
establishes quality control requirements for performing initial and
confirmatory pH tests. Section 26.167(c)(3)(ii) through (c)(3)(vi)
specifies the required calibrators and controls for pH testing, based
on the type of testing instrument used and whether the laboratory has
performed a pH validity screening test. In response to a public comment
on the proposed rule, the NRC relocated the requirements for
calibrators and controls for an initial colorimetric pH test from Sec.
26.167(c)(3)(ii) in the proposed rule to Sec. 26.167(c)(3)(vi) in the
final rule. The agency made this change to increase consistency between
the organization of Part 26 and the
[[Page 17102]]
organization of the related requirements in the HHS Guidelines.
The NRC has added three additional paragraphs related to quality
control of initial and confirmatory validity testing: Sec.
26.167(c)(4) [Requirements for performing oxidizing adulterant tests],
Sec. 26.167(c)(5) [Requirements for performing nitrite tests], and
Sec. 26.167(c)(6) [Requirements for performing ``other'' adulterant
tests]. These paragraphs establish quality control requirements for
performing initial and confirmatory tests for oxidizing adulterants,
among which nitrites are one example, and for ``other'' adulterants.
The added paragraphs are consistent with the related requirements in
the HHS Guidelines. With respect to the proposed rule, the agency made
minor editorial changes to these provisions in response to public
comments to improve the clarity of the requirements. For example, the
NRC implemented one commenter's suggestion to add cross-references in
Sec. 26.167(c)(4)(i) and (c)(4)(ii) to the specific provisions in
Sec. 26.161 that establish the cutoff criteria for oxidizing
adulterants to clarify the adulterant concentrations that calibrators
must contain.
Section 26.167(d) [Quality control requirements for initial drug
tests] amends and combines portions of former Sections 2.7(d) and
(e)(1), and 2.8(c) in Appendix A to Part 26. The former sections
established quality control requirements for performing initial tests
for drugs and drug metabolites at HHS-certified laboratories. For
organizational clarity, the final rule groups together these related
requirements that were dispersed throughout the former rule. In
addition, the NRC has amended a number of the former requirements, as
follows:
Section 26.167(d)(1) updates the first sentence of former Section
2.7(e)(1) in Appendix A to Part 26 but retains the intent of the former
provision as it applies to HHS-certified laboratories. This section
requires laboratories to use only immunoassay tests that meet the
requirements of the Food and Drug Administration for commercial
distribution. The requirements in the former paragraph related to
initial drug testing at licensee testing facilities have been moved to
Sec. 26.137(e)(1) of Subpart F to improve organizational clarity in
the rule.
Section 26.167(d)(2) permits HHS-certified laboratories to conduct
multiple tests of a single specimen for the same drug or drug class.
The final rule, with respect to the proposed rule, includes an example
to clarify this section in response to a public comment. The
requirements and example in this paragraph are consistent with a
similar provision in the HHS Guidelines.
Section 26.167(d)(3)(i)-(d)(3)(v) updates former Section 2.8(c) in
Appendix A to Part 26. The former section required HHS-certified
laboratories to include quality control samples in each analytical run
of specimens for initial drug testing. Section 26.167(d)(3)(i)-
(d)(3)(v) specifies the number and characteristics of the quality
control samples to be included in each analytical run of specimens.
With respect to the proposed rule, the final rule contains minor
language clarifications. These requirements are identical to those
contained in Sec. 26.137(e)(6) and (e)(7) for initial drug tests at
licensee testing facilities and have been added for consistency with
the related provisions in the HHS Guidelines.
In addition, in response to a public comment on the organization of
this section, the final rule, with respect to the proposed rule, moves
proposed Sec. 26.167(d)(3)(v) to Sec. 26.167(d)(4) to improve
organizational clarity. Section 26.167(d)(4) requires that 10 percent
of the specimens in each analytical run must be quality control
samples.
Proposed Sec. 26.167(e) [Quality control requirements for
performing confirmatory drug tests] updates and combines portions of
former Sections 2.7(f)(2) and 2.8(d) in Appendix A to Part 26. The
former sections addressed quality control requirements for performing
confirmatory drug tests. In general, the changes the NRC has made to
the former requirements are made for organizational clarity in the
final rule and to incorporate the related provisions in the HHS
Guidelines.
Section 26.167(e)(1) amends former Section 2.7(f)(2) in Appendix A
to Part 26. The former provision required that confirmatory drug tests
must be performed using GC/MS testing. The final rule permits HHS-
certified laboratories to use other techniques for confirmatory drug
testing that the HHS Guidelines approve for use in Federal workplace
drug testing programs.
The NRC added Sec. 26.167(e)(2) to update Section 2.8(d) in
Appendix A to Part 26 by establishing a requirement for the percentage
of quality control samples that HHS-certified laboratories must include
in each analytical run for confirmatory testing. The former rule did
not specify a percentage. The NRC added this requirement for
consistency with the HHS Guidelines. With respect to the proposed rule,
the final rule separates the first and second sentences of the proposed
provision into separate paragraphs and renumbers the second sentence of
proposed Sec. 26.167(e)(2) as Sec. 26.167(e)(3) for organizational
clarity, in response to a public comment.
Section 26.167(e)(3)(i) through (e)(3)(iv) amends the requirements
for quality control samples in former Section 2.8(d) in Appendix A to
Part 26. The final rule, with respect to the proposed rule, makes minor
language clarifications in this paragraph. Section 26.167(e)(3)(i) and
(e)(3)(ii) retains the former requirements for laboratories to include
blank samples and samples that contain known standards in each
analytical run. The requirements adopt the simpler language from the
related provisions in the HHS Guidelines to improve clarity in the
language of the rule. For consistency with the related requirements in
the HHS Guidelines, the paragraph provides more detailed requirements
for ``positive controls with the drug or metabolite at or near the
threshold'' than in former Section 2.8(d)(1) in Appendix A to Part 26.
The rule requires, in Sec. 26.167(e)(3)(iii), at least one control
fortified with a drug or drug metabolite targeted at 25 percent above
the cutoff and, in Sec. 26.167(e)(3)(iv), at least one calibrator or
control that is targeted at or below 40 percent of the cutoff.
The NRC moved the requirements in proposed Sec. 26.167(f) [Blind
performance testing] to a new section in the final rule, Sec. 26.168
[Blind performance testing]. The agency made this change because
licensees and other entities, rather than HHS-certified laboratories,
are primarily responsible for implementing these requirements.
Therefore, presenting requirements for licensees' and other entities'
blind performance testing of HHS-certified laboratories in a separate
section makes them easier to locate in the final rule and meets Goal 6
to improve clarity in the organization of the rule.
With respect to the proposed rule, the final rule renumbers
proposed Sec. 26.167(g) [Errors in testing] as Sec. 26.167(f). This
section amends former Section 2.8(e)(4) through (e)(6) in Appendix A to
Part 26, and imposes requirements on licensees, other entities, and
HHS-certified laboratories related to unsatisfactory performance,
including false positive and false negative test results from the HHS-
certified laboratory. This paragraph requires the licensee or other
entity to ensure that the HHS-certified laboratory investigates any
conditions that may adversely reflect on the testing process. Notably,
the rule no longer requires the licensee to perform the investigation,
but rather to ``ensure'' that the
[[Page 17103]]
laboratory completes an investigation. The NRC made this change because
licensees and other entities do not typically retain personnel with the
expertise required to investigate the complex technologies and
processes involved in testing at HHS-certified laboratories. The agency
has moved the requirements for reporting and documentation of the
investigation, which formerly appeared in Section 2.8(e)(4) in Appendix
A to Part 26, to Sec. Sec. 26.715(b)(8) and 26.719(c) in Subpart N of
the final rule for organizational clarity.
Section 26.167(f)(1) explicitly states the requirements that were
implied in former Section 2.8(e)(4) in Appendix A to Part 26 that the
investigation must identify the root cause(s) of any unsatisfactory
performance and the HHS-certified laboratory must take corrective
actions. The rule expands these requirements to include the licensee or
other entity, as well as the HHS-certified laboratory, depending on the
causes identified and the extent to which the causes are within each
entity's control. The NRC revised the former requirement to recognize
that some testing errors are not attributable to the HHS-certified
laboratory.
Section 26.167(f)(2) amends former Section 2.8(e)(5) in Appendix A
to Part 26. This provision required the licensee to notify the NRC if a
false positive error occurred on a blind performance test sample and
the error was determined to be administrative. The final rule requires
the licensee or other entity, and the HHS-certified laboratory, to take
corrective actions for any false positive errors in blind performance
testing, in response to the findings of the investigation that would be
required in this section. The rule continues to authorize licensees and
other entities to require the laboratory to review and re-analyze
previously tested specimens, if the investigation indicates that the
error could have been systematic. The rule also deletes reference to
administrative errors, which appeared in former Section 2.8(e)(5), so
that any type of errors falls under the requirements of the paragraph.
The NRC moved the reporting requirement in former Section 2.8(e)(5) to
Sec. 26.719(c)(2) in Subpart N for organizational clarity.
Section 26.167(f)(3) amends former Section 2.8(e)(6) in Appendix A
to Part 26. This section addressed false positive errors resulting from
technical or methodological errors by the laboratory. The rule
incorporates reference to validity testing, consistent with the
addition of requirements to conduct validity testing throughout the
rule, as previously discussed with respect to Sec. 26.31(d)(3)(i). The
rule deletes the last sentence of the former paragraph because it
addressed the responsibilities of the HHS and is not relevant to the
NRC or the licensees and other entities who are subject to Part 26. The
paragraph retains the other provisions of former Section 2.8(e)(6), but
adopts the simpler language of the related provision in the HHS
Guidelines for increased clarity in the language of the rule. With
respect to the proposed rule, the final rule replaces the term
``certifying scientist'' in the third sentence of the proposed
provision with the accurate term ``responsible person'' in response to
a public comment which noted the use of the incorrect term in the
proposed rule.
Section 26.167(g) [Accuracy] retains former Section 2.7(o)(3)(i) in
Appendix A to Part 26 with minor editorial revisions. The agency
relocated the former paragraph to Sec. 26.167(g) because it relates to
quality control of the HHS-certified laboratory's drug testing
processes. The NRC made this change to meet Goal 6 of this rulemaking
to improve clarity in the organization and language of the rule.
Section 26.167(h) [Calibrators and controls] updates former Section
2.7(o)(2) in Appendix A to Part 26. At the time the original paragraph
was written, most laboratories prepared their own standards and
controls. In the ensuing years, the number and variety of sources for
materials used in performance testing has increased. The final rule
updates former requirements to refer to several of the alternatives,
including, but not limited to pure drug reference materials, stock
standard solutions from other laboratories, and standard solutions
obtained from commercial manufacturers. The requirements in this
paragraph incorporate the related requirements in the HHS Guidelines
and meet Goal 1 of this rulemaking to update and enhance the
consistency of Part 26 with advances in other relevant Federal rules
and guidelines. The labeling requirements in the second sentence of
former Section 2.7(o)(2) have been retained without change.
Section 26.168 Blind Performance Testing
Section 26.168 updates and expands former Section 2.8(e) in
Appendix A to Part 26 [Licensee blind performance test procedures]. The
former paragraph established requirements for licensees and other
entities to conduct blind performance testing of HHS-certified
laboratories. With respect to the proposed rule, the final rule has
moved the requirements in proposed Sec. 26.167(f) to this new section
because presenting them in a separate section makes them easier to
locate in the final rule. The final rule also provides more detailed
requirements for the formulation of blind performance test samples that
licensees and other entities use to obtain HHS-certified laboratory
performance data and revises the number, composition, and percentages
of blind samples that licensees and other entities must submit to the
HHS-certified laboratories. The NRC made these changes in response to
detailed public comments that addressed these issues.
The NRC added Sec. 26.168(a) to require licensees and other
entities to submit blind performance test samples to the HHS-certified
laboratories with whom they contract for drug testing services. To
improve clarity in the language of the rule, the NRC added this
provision to make explicit the same requirement that was implied in
former Section 2.8(e) of Appendix A to Part 26.
Section 26.168(a)(1) amends the portion of former Section 2.8(e)(2)
in Appendix A to Part 26 that established the percentages and numbers
of blind performance test samples that licensees and other entities
must submit to the HHS-certified laboratory during the first 90 days of
any initial contract with the HHS-certified laboratory. The final rule
decreases the percentage of blind performance test samples that
licensees and other entities must submit to the HHS-certified
laboratory during the initial 90-day period of any contract (not
including rewritten or renewed contracts). Specifically, the rule
reduces the percentage from 50 percent to 20 percent of the total
number of specimens submitted in the 90-day period, up to a maximum of
100 blind samples, rather than a maximum of 500 samples as specified in
the former rule. This decrease in the blind performance testing rate
increases the consistency of Part 26 with related provisions in the HHS
Guidelines. In addition, since the NRC published the former rule, the
number and size of Federal agencies who conduct drug testing has
substantially increased. These agencies are also required to submit
blind performance test samples under the HHS Guidelines. As a result,
especially with respect to the issue of correctly identifying negative
specimens, the burden on Part 26 programs to conduct performance tests
of the HHS-certified laboratories can be reduced without affecting the
likelihood that errors in testing will be detected.
The regulation also adds a requirement for licensees and other
entities to submit a minimum of 30 blind performance test samples in
the
[[Page 17104]]
initial 90-day period. The agency has established this minimum to
address Part 26 programs who submit only a small number of specimens to
HHS-certified laboratories for testing each quarter. For example, for a
very small program, 20 percent of the number of specimens submitted in
the initial 90-day period could be less than one blind performance test
sample. Establishing a minimum number of samples will provide assurance
that the HHS-certified laboratories used by these Part 26 programs are
providing accurate test results.
Section 26.168(a)(2) amends the portion of former Section 2.8(e)(2)
in Appendix A to Part 26 that addressed ongoing blind performance
testing after the first 90 days of an initial contract with an HHS-
certified laboratory. The rule decreases the rate at which licensees
and other entities must submit blind performance test samples to an
HHS-certified laboratory in each quarter after the initial 90-day
period from 10 percent in the former rule to one percent, or a total of
10 samples, whichever is greater. The rule also decreases the maximum
number of samples to be submitted per quarter from 250 to 100 samples.
The rationale for these changes is the same as discussed with respect
to Sec. 26.168(a)(1).
The NRC added Sec. 26.168(a)(3) to require licensees and other
entities to submit blind performance test samples to the HHS-certified
laboratory at a frequency that is similar to the frequency for other
specimens. This change enhances the consistency of Part 26 with the HHS
Guidelines.
Section 26.168(b) amends and expands former Section 2.8(e)(3) in
Appendix A to Part 26, which required that 80 percent of the blind
samples submitted by the licensee or other entity each quarter to the
HHS-certified laboratory must be ``blank'' (i.e., certified to contain
no drugs or drug metabolites). With respect to the proposed rule, the
NRC has substantially changed the requirements in proposed Sec.
26.167(f)(3) in response to extensive comments on the proposed blind
performance test sample provisions. In the final rule, Sec. 26.168(b)
now requires that approximately 60 percent of all blind performance
test samples that licensees and other entities send to the HHS-
certified laboratory must be positive for one or more of the drugs for
which the licensee or other entity tests, and that all drugs for which
the licensee or other entity tests must be submitted to the HHS
certified laboratory at least once a quarter except as indicated in
Sec. 26.168(b)(1) and (2). The requirement that approximately 60
percent of all blind samples submitted to HHS-certified laboratories
must be positive for one or more drugs per sample will ensure that all
licensees, including those who will only send the minimum number of
blind samples required under this rule, will submit several samples for
each drug being tested. This change will permit licensees and other
entities to better monitor and make more informed decisions regarding
their HHS-laboratories' performance. Under the previous ``80 percent
negative'' rule, licensees who submitted only the 40 minimum blind
samples required would nominally receive two results per year on three
drugs (which were chosen by the licensee or other entity). This
requirement provided licensees with scant information to determine
independently, as required by rule, whether the HHS-certified
laboratory was meeting the licensee or other entity contract provisions
with the HHS-certified laboratory. Under the revised section, assuming
a reasonable distribution, even those licensees and other entities who
submit only the minimum 40 required blind samples a year will receive
results from marijuana blind performance test samples at least 8 times
a year, from cocaine text samples at least 7 times a year, from
amphetamines and opiate test samples at least 3 times a year, and from
PCP test samples at least 2 times a year. The NRC's increased emphasis
on testing for marijuana and cocaine and the reduction in testing for
PCP in Sec. 26.168(b)(1) and (2) reflect the fact that among all FFD
programs, marijuana and cocaine have resulted in the largest number of
confirmed positive drug tests and PCP the least number of confirmed
positive drug tests, as reported in the NRC's ``Summary of FFD
Performance Reports'', from 1990 through 2005. Therefore, the NRC has
made these changes to meet Goal 3 of this rulemaking to enhance the
effectiveness and efficiency of the rule.
Section 26.168(c) limits the submission of positive blind
performance test samples to the HHS-certified laboratory to samples
containing only those drugs for which the licensee or other entity
tests and requires that the blind samples sent to HHS-certified
laboratories must be formulated according to the requirements
established in Sec. 26.168(g)(2). This provision updates former
Section 2.8(e)(3) in Appendix A to Part 26, which also limited
performance testing to only those drugs included in the licensee's
panel. With respect to the proposed rule, the final rule replaces the
proposed requirement for positive samples to be spiked to between 60
and 80 percent of the initial cutoff levels used by the licensee or
other entity with a cross-reference to the more detailed requirements
for positive blind performance test samples in Sec. 26.168(g)(2), as
discussed with respect to that section.
The NRC has added Sec. 26.168(d) to require licensees and other
entities to submit approximately 10 percent of all blind performance
test samples as false negative challenge samples to the HHS-certified
laboratory according to the requirements established in Sec.
26.168(g)(3). The NRC has added this provision in response to public
comments on proposed Sec. 26.167(f) that blind samples containing
drugs or drug metabolites at a concentration 20 percent above the
cutoff levels would frequently yield false negative test results and,
therefore, unfairly challenge HHS-certified laboratories. False
negatives occur when drug levels that are positive but close to the
initial drug test cutoff level may actually be reported as negative.
Assuming that an initial negative drug test has an error rate of one
percent (one percent false negatives) and all HHS-certified
laboratories perform equally, then over time, for every 100 people who
have recently used drugs and been tested by licensees and other
entities, one person will not be identified as having a positive test
result for one or more drugs on the basis of the initial test alone.
Recent research [Cone et al., 2003] strongly suggests that the issue of
false negatives may be significantly greater than previously
understood. The NRC recognizes that false negatives will occur within
its drug testing guidelines, but intends to minimize them as much as is
reasonably possible within scientific constraints and practical
limitations of resources. Therefore, the NRC has established the
requirements for the characteristics of false negative challenge
samples under the final rule to present a fair test to HHS-certified
laboratories because they are targeted at specimens clearly above the
range of laboratory controls yet below the standard cutoff levels.
Section 26.168(e) requires licensees and other entities to submit
approximately 20 percent of all blind samples as adulterated, diluted,
or substituted and formulated according to the requirements established
in Sec. 26.168(g)(4)-(g)(6). The NRC added this provision for
consistency with the addition of requirements to conduct validity
testing throughout the proposed rule, as discussed with respect to
proposed Sec. 26.31(d)(3)(i). This
[[Page 17105]]
performance testing is necessary to challenge the accuracy of the HHS-
certified laboratories' specimen validity testing. With respect to the
proposed rule at proposed Sec. 26.167(f)(3), the final rule increases
the proportion of blind samples that licensees and other entities must
submit to challenge the laboratories' specimen validity testing. The
NRC made this change in response to public comments on the proposed
rule and the NRC's concern that validity test results are accurate. The
requirements elaborated in this section protect public health and
safety and the common defense and security by increasing the
effectiveness of FFD programs (Goal 3 of this rulemaking) in ensuring
that an individual whose fitness for duty is questionable does not
perform duties or have the types of access that require the individual
to be subject to this part.
The final rule substantially decreases the percentage of negative
blind performance test samples that licensees were required to submit
to HHS-certified laboratories in former Section 2.8(e)(3) of Appendix
A, as retained in proposed Sec. 26.168(f). The former and proposed
provision required 80 percent of blind samples to be negative. The
final rule revises this percentage to 10 percent. The NRC made this
change in response to public comments on the proposed rule and because
the NRC believes that carryover effects (i.e., a positive sample
contaminates a negative sample because of improper laboratory equipment
cleaning), while a concern during the early years of drug testing, are
not an issue in current HHS-certified laboratories based on current
specimen testing practices. The agency also believes that it is more
appropriate to challenge the drug and validity testing capabilities of
HHS-certified laboratories and therefore, is increasing the percentage
of positive, adulterated, substituted, dilute, and invalid specimens
submitted as blind performance test samples in each quarter of testing.
With regard to the issue of correctly identifying negative specimens
(i.e., ensuring that laboratories do not report false positive test
results), the NRC is confidant that the 10 percent negative sample
requirement in the final rule will provide adequate oversight regarding
false positive test results due to carryover and other related issues.
Another reason that the NRC is decreasing the required percentage of
negative samples in the final rule is that the number and size of
Federal agencies who conduct drug testing has substantially increased
since Part 26 was first promulgated. Also, these agencies are required
to submit negative blind performance test samples at a rate of 80
percent under the HHS Guidelines. Therefore, the previous need for Part
26 programs to so extensively challenge the HHS-certified laboratories'
false positive rates is reduced.
The NRC has added formulation standards for the blind performance
test samples that licensees and other entities must use in Sec.
26.168(g). The final rule revises proposed Sec. 26.167(f)(5)(i) in
response to detailed public comments on the scientific and technical
suitability of the proposed standards in achieving the NRC's objective
of ensuring that the performance testing required under this rule
ensures that test results from HHS-certified laboratories are accurate.
The agency added Sec. 26.168(g)(1) to require that negative blind
performance test samples may not contain a measurable amount of a
target drug or analyte, and must be confirmed by immunoassay and
confirmatory testing. Section 26.168(g)(2) requires that positive blind
performance test samples must contain drug or analyte concentrations
between 150 and 200 percent of the initial cutoff levels and be
certified by immunoassay and confirmatory testing to contain one or
more drug(s) or drug metabolites. Section 26.168(g)(3) requires that
false negative challenge samples must contain target drug or analyte
concentrations between 130 and 155 percent of the initial cutoff
values. Section 26.168(g)(4) requires that an adulterated blind
performance test sample must have a pH of less than or equal to 2, or
greater than or equal to 12, or nitrite or other oxidant concentration
equal to or greater than 500 mcg/mL) using either a nitrite
colorimetric test or a general oxidant colorimetric test. Section
26.168(g)(5) requires that a dilute blind performance test sample must
contain a creatinine concentration that is equal to or greater than 5
mg/dL but less than 20 mg/dL, and the specific gravity must be greater
than 1.0010 but less than 1.0030. Section 26.168(g)(6) requires that a
substituted blind performance test sample must contain less than 2 mg/
dL of creatinine and the specific gravity must be less than or equal to
1.0010, or equal to or greater than 1.0200.
The NRC has made these changes in Sec. 26.168(b)-(g) to increase
the ability of licensees and other entities to independently monitor
the ability of their HHS-certified laboratories to consistently
identify positive, adulterated, dilute, and substituted specimens and
hold false negatives to a minimum. The NRC recognizes that these issues
are routinely scrutinized and evaluated by the HHS Laboratory
Certification Program (LCP), but is mindful that the LCP challenges are
not blind to the HHS-certified laboratories. Because of its over-
arching interest in making the Part 26 drug testing program as rigorous
as possible, as evidenced by the detail of Subparts F and G, the NRC
believes that a more aggressive licensee and other entity blind
challenge to the HHS-certified laboratories in these area adds an
important independent dimension to ensuring licensee and other entity
confidence in the overall drug testing program.
Section 26.168(h) has been added to establish additional detailed
requirements for the blind performance test samples that licensees and
other entities must submit to the HHS-certified laboratories and to
ensure the consistency and effectiveness of the blind performance
testing process. Section 26.168(h)(1) requires the supplier of the
blind samples to certify that all blind specimen batches are confirmed
by an HHS-certified laboratory prior to being put into service and to
remove blind specimen batches from service after they have been open
for 6 months. Section 26.168(h)(2) requires the supplier to provide an
expiration date for each sample. Section 26.168(h)(3) requires the
supplier to monitor each open batch on a bi-monthly (i.e., every two
months) basis to ensure that the remaining batch does not fall below
the criteria in this section. These requirements are based on related
provisions in the HHS Guidelines and DOT's procedures for drug and
alcohol testing. The NRC added these requirements in response to a
public comment on the proposed rule requesting the NRC to clarify the
requirements in proposed Sec. 26.167(f)(5).
The NRC added Sec. 26.168(i) to provide specific requirements for
ensuring that blind performance test samples are indistinguishable to
laboratory personnel from a donor's specimen in response to a public
comment on proposed Sec. 26.167(f)(5). These requirements are based on
the related DOT procedures.
Section 26.168(i)(1) requires the licensee or other entity to ship
blind performance test samples to the HHS-certified laboratory in the
same way donors' specimens are sent to the laboratory. This provision
provides greater assurance than the former rule that personnel at the
HHS-certified laboratories will not be aware that the specimen they are
handling is a blind performance test sample. The NRC
[[Page 17106]]
added this provision to increase the effectiveness of blind performance
testing under the rule.
Section 26.168(i)(2) specifies the information that must be entered
on the custody-and-control form accompanying the blind performance test
sample. This information is necessary to ensure that the MRO is aware
that the specimen is a blind performance test sample.
Section 26.168(i)(3) requires licensees and other entities to
submit split samples where applicable. This provision is necessary to
ensure that the FFD program submits blind performance test samples that
appear to be normal specimens that the laboratory may receive from a
donor.
Section 26.169 Reporting Results
This section contains requirements for HHS-certified laboratories'
reporting of test results to the licensee's or other entity's MRO. The
final rule in Sec. 26.169 updates former Section 2.7(g) in Appendix A
to Part 26. The rule updates the former requirements for consistency
with the HHS Guidelines. In addition, the rule adds requirements for
reporting the results of validity testing, consistent with the addition
of requirements to conduct validity testing throughout the rule, as
discussed with respect to Sec. 26.31(d)(3)(i). With respect to the
proposed rule, the NRC has made several organizational changes to
improve clarity by presenting the provisions in the order that is more
consistent with the order in which HHS-certified laboratories,
licensees, and other entities will implement them, consistent with Goal
6 of this rulemaking.
Section 26.169(a) amends former Section 2.7(g)(1) in Appendix A to
Part 26, which established a time-limit on the HHS-certified
laboratory's reporting of test results to the MRO and requirements for
the processing and content of the report. The NRC has retained the
requirement for the laboratory to report results to the MRO within 5
business days of receiving the specimen at the laboratory. Under the
final rule, the HHS-certified laboratory's ``certifying scientist,''
rather than the laboratory's ``responsible individual,'' certifies the
test results. This change has been made for consistency with the
updated term used to refer to this individual, as discussed with
respect to Sec. 26.155(b). The rule adds a reference to validity test
results, consistent with the addition of requirements to conduct
validity testing throughout the proposed rule, as discussed with
respect to Sec. 26.31(d)(3)(i). The final rule deletes the former
prohibition on reporting test results for any specimen in a group of
specimens sent to the laboratory by the licensee or other entity until
the laboratory completes testing of all of the specimens in the group.
The prohibition in the former rule was based on a concern for
maintaining control of specimen identity. However, new technologies for
identifying specimens and aliquots (such as bar codes on specimen
labels matched to bar codes on aliquots and the associated custody-and-
control forms) have reduced the likelihood that specimen identity may
be lost, and, therefore, have substantially reduced the need for the
requirement in the former rule.
Section 26.169(b) amends portions of former Section 2.7(f)(2) in
Appendix A to Part 26 by eliminating the requirement for the HHS-
certified laboratory to conduct tests for drugs and drug metabolites
using both the cutoff levels specified in this part and any more
stringent cutoff levels specified by the FFD program. If the FFD
program specifies cutoff levels that are more stringent than those
specified in this part, the final rule requires the laboratory only to
conduct testing using those more stringent cutoff levels, and only to
report results from those tests to the MRO. The NRC made this change
for the reasons discussed with respect to Sec. 26.31(d)(1)(i)(D). This
provision was Sec. 26.169(c) in the proposed rule.
Section 26.169(c) (Sec. 26.169(b) in the proposed rule)
establishes requirements for the laboratory's reporting of validity
test results. This provision amends former Section 2.7(g)(2) in
Appendix A to Part 26, which established requirements for the manner in
which HHS-certified laboratories and licensee testing facilities must
report test results to licensee management. The NRC has moved the
requirements in the former paragraph that are related to reporting test
results from the licensee testing facility to Sec. 26.139(a) of
Subpart F for organizational clarity. The final rule deletes the former
reference to ``special processing'' and replaces it with reference to
validity test results, consistent with the addition of requirements to
conduct validity testing throughout the final rule, as discussed with
respect to Sec. 26.31(d)(3)(i). In addition, the final rule makes
minor changes in terminology, such as referring to a ``drug or drug
metabolite,'' rather than a ``substance,'' for clarity in the rule
language.
The NRC has renumbered proposed Sec. 26.169(e) as Sec.
26.169(c)(1) in the final rule. The NRC added this provision to require
the HHS-certified laboratory to report all test results for a single
specimen, if the laboratory obtains more than one positive,
adulterated, substituted, or invalid test result from testing of the
specimen. The regulation requires the laboratory to report any positive
test results, as well as any adulterated, substituted, or invalid
validity test results from the same specimen. This change is necessary
because sanctions for the different test results differ under Sec.
26.75. Reporting multiple test results for a single specimen is
consistent with related requirements in the HHS Guidelines.
Section 26.169(c)(2) updates former Section 2.7(g)(3) in Appendix A
to Part 26, which permitted the MRO routinely to obtain quantitative
test results from the HHS-certified laboratory. This paragraph
incorporates the first two sentences of proposed Sec. 26.169(d).
Specifically, the final rule revises the first sentence of former
Section 2.7(g)(3) by stating that the HHS-certified laboratory shall
provide quantitative test results for a positive confirmatory drug test
result to the MRO on request. The paragraph clarifies the former
requirement by stating that the MRO's request may be either a general
request covering all such results or a specific case-by-case request.
The changes to this paragraph are consistent with the related
provisions in the HHS Guidelines. The final rule also moves the
requirement that was contained in proposed Sec. 26.169(g) to this
paragraph for organizational clarity. Therefore, this provision of the
final rule requires the HHS-certified laboratory to routinely report to
the MRO, whether requested or not, quantitative values for confirmatory
opiate test results for morphine or codeine that are equal to or
greater than 15,000 ng/mL. The rule adds this requirement for
consistency with the related provision in the HHS Guidelines and
because the MRO is not required to perform an assessment for clinical
signs of opiate abuse in this instance, as discussed with respect to
Sec. 26.185(j)(1). The reference to test results from blood specimens
in former Section 2.7(g)(3) in Appendix A to Part 26 has been deleted
for the reasons discussed with respect to Sec. 26.83(a).
In response to public comments on the proposed rule, the NRC has
added Sec. 26.169(c)(3) to require the HHS-certified laboratory to
report to the MRO numerical values supporting an adulterated or
substituted test result. The final rule also adds instructions for the
laboratory's report to the MRO if a specimen's numerical values for
creatinine are below the LOD. The NRC added this provision for
consistency with the HHS Guidelines.
Section 26.169(c)(4) requires the HHS-certified laboratory to
contact the MRO after the HHS-certified laboratory has
[[Page 17107]]
determined that a specimen has an invalid result, but before reporting
out the test result, to determine whether testing by a second HHS-
certified laboratory would be useful. The rule permits the laboratory's
contact with the MRO to occur using electronic means, such as
telephone, fax, and e-mail. If no further testing is necessary, the
final rule requires the laboratory to report the invalid result to the
MRO. These reporting requirements have been added for consistency with
the related provisions in the HHS Guidelines. This provision retains
the portions of proposed Sec. 26.169(d) that pertained to reporting
invalid test results but the final rule presents them in a separate
paragraph to improve organizational clarity.
Section 26.169(c)(5) establishes requirements for the HHS-certified
laboratory in reporting drug, metabolite, or adulterant concentrations
that exceed normal testing ranges. This provision updates the last
sentence of former Section 2.7(f)(2) in Appendix A to Part 26 for
consistency with the HHS Guidelines. This provision appeared in the
proposed rule as the third sentence of proposed Sec. 26.169(d).
Section 26.169(d) retains the portion of former Section 2.7(g)(3)
in Appendix to Part 26 that prohibited the MRO from disclosing
quantitative results to a licensee or other entity and extends it to
MRO staff for clarity in the language of the rule. This provision
requires the MRO to only report whether the specimen was positive (and
for which analyte), adulterated, substituted, dilute, invalid, or
negative, except as permitted under Sec. 26.37(b). This provision
appeared as the fourth and fifth sentences of proposed Sec. 26.169(f).
Section 26.169(e), which was Sec. 26.169(h) in the proposed rule,
amends former Section 2.7(g)(4) in Appendix A to Part 26, which
established requirements for the electronic transmission of test
results from the HHS-certified laboratory to the MRO. Specifically, the
rule clarifies that the licensee or other entity is responsible for
assuring the security of data transmissions from the laboratory to the
MRO, rather than only the HHS-certified laboratory, as specified in the
former requirement. This change responds to stakeholder comments at the
public meetings discussed in Section V. The stakeholders accurately
noted that licensees and other entities are responsible to the NRC for
ensuring the security of their HHS-certified laboratories' data storage
and transmission systems through their contracts with and audits of the
laboratories. This revision accurately characterizes these
relationships without changing the intent of the former provision.
Section 26.169(f) updates former Section 2.7(g)(5) in Appendix A to
Part 26, which established requirements for transmitting chain-of-
custody documentation with test results to the MRO. The rule permits
HHS-certified laboratories to use various means to transmit test
results to the MRO, including transmittal of a computer-generated
electronic report for negative test results. However, for positive,
adulterated, substituted, or invalid test results, the rule requires
the laboratory to transmit a legible image or copy of the completed
custody-and-control form to the MRO. The change has been made for
consistency with the related provision in the HHS Guidelines. This
provision contains the requirements in Sec. 26.169(i) of the proposed
rule.
Section 26.169(g) further amends former Section 2.7(g)(5) in
Appendix A to Part 26. The paragraph continues to require that the HHS-
certified laboratory must retain the original custody-and-control form
for any positive, adulterated, substituted, or invalid specimens.
However, the paragraph assigns responsibility for certifying the test
results to the laboratory's certifying scientist, rather than to ``the
individual responsible for day-to-day management of the laboratory or
the individual responsible for attesting to the validity of the test
reports.'' The change has been made for consistency with the updated
terminology used to refer to this individual in the HHS Guidelines, as
discussed with respect to Sec. 26.155(b). This provision was Sec.
26.169(j) in the proposed rule.
Section 26.169(h) combines and amends former Section 2.7(g)(6) and
(g)(7) in Appendix A to Part 26, which required the laboratory to
submit a monthly statistical summary of drug test results to the
licensee or other entity. The rule reduces the required frequency of
the statistical summary report from monthly to annually in order to
reduce the burden on licensees, other entities, and their laboratories.
The requirement for annual reporting makes the reporting time
consistent with the NRC's need for the information as it relates to the
NRC's inspection schedule and the annual FFD program performance report
that is required under Sec. 26.717, for the reasons discussed with
respect to that section. The rule also deletes the existing reference
to blood specimens because the option for donors to request blood
testing for alcohol has been eliminated from the rule, as discussed
with respect to Sec. 26.83(a). The rule also deletes the requirement
to report drug test results at the cutoff levels specified in this
part, if the FFD program uses more stringent cutoff levels, for the
reasons discussed with respect to Sec. 26.169(b). The rule adds a
requirement to report initial and confirmatory test results for
additional drugs (if the FFD program tests for additional drugs), as
well as a requirement to report the number of specimens with confirmed
positive 6-AM test results. (The rule includes testing for 6-AM,
because the presence of 6-AM in a specimen uniquely identifies heroin
use.) In addition, the rule adds requirements to report the results of
validity testing. The NRC has made these changes to conform to other
changes in the rule, as discussed with respect to Sec. Sec.
26.717(b)(2), 26.185(j)(1), and 26.31(d)(3)(i). With respect to the
proposed rule, the NRC has added requirements for the laboratory to
report whether a specimen that has been reported as positive and dilute
was subject to the special analyses permitted under Sec. 26.163(a)(2)
and the number of specimens reported as rejected for testing. The NRC
added these reporting requirements in response to public comment noting
that the NRC will require this information to maintain adequate
oversight of FFD programs and for consistency with related provisions
in the HHS Guidelines. This requirement appeared as proposed Sec.
26.169(k) in the proposed rule.
Subpart H--Determining Fitness-for-Duty Policy Violations and
Determining Fitness
Throughout this subpart, the final rule makes minor clarifications
to the proposed rule because of public comment, to accommodate
conforming changes, and to meet Goal 6 of this rulemaking to improve
clarity in the organization and language of the rule. For example, the
final rule eliminates the term ``non-negative,'' which was used in
proposed Subpart H in many places and replaces it with the terms
``positive, adulterated, substituted, dilute, or invalid,'' as
appropriate, for the reasons discussed with respect to Sec. 26.5
[Definitions]. Also, in Sec. 26.185, the final rule adds the term
``confirmatory'' when referring to test results that have been reported
to the MRO by the HHS-certified laboratory and deletes the ambiguous
term ``referral'' when referring to a physician. The final rule also
uses ``business days'' instead of only ``days'' to be consistent with
other provisions in the rule.
The final rule also makes more substantive changes to the proposed
rule in this subpart because of public comment or to improve clarity in
the organization and language of the rule.
[[Page 17108]]
The substantive changes in this subpart can be found in Sec. Sec.
26.183(b), (d), (d)(1), and (d)(2)(iv); 26.185(g), (g)(2), (g)(5),
(h)(1), and (i)(1); 26.187(a) and (f); and 26.189(a) and (c). These
changes are discussed in detail below. However, other than the changes
mentioned above, the final rule adopts the provisions of this subpart
as proposed, without change.
Section 26.181 Purpose
Section 26.181 of the final rule describes the purpose of Subpart
H, which is to establish requirements for MRO reviews of positive,
adulterated, substituted, dilute or invalid confirmatory drug test
results and for making determinations of fitness. This section provides
an overview of the contents of the subpart, consistent with Goal 6 of
this rulemaking to improve clarity in the organization and language of
the rule.
Section 26.183 Medical Review Officer
The NRC has added Sec. 26.183 to the final rule to present
requirements related to the qualifications, relationships, staff, and
responsibilities of the MRO. Grouping these requirements together in a
single section meets Goal 6 of this rulemaking to improve clarity in
the organization and language of the rule.
Section 26.183(a) [Qualifications] of the final rule combines and
amends the requirements in former Sec. 26.3 [Definitions] and Section
1.2 of Appendix A to Part 26, as well as portions of former Section
2.9(b) in Appendix A to Part 26. The provision reorganizes the former
requirements to eliminate redundancies and group in one paragraph the
related provisions in the former rule. These changes meet Goal 6 of
this rulemaking to improve clarity in the organization and language of
the rule.
The provision amends portions of the former requirements related to
MRO qualifications. It continues to provide that the MRO must be a
licensed physician, but clarifies that the MRO may hold either a Doctor
of Medicine or Doctor of Osteopathy degree for consistency with the
related regulations of other Federal agencies. The provision adds a
requirement that the MRO must be knowledgeable of Part 26 and the FFD
policies and procedures of the licensees and other entities for whom
the MRO provides services. The requirements of this part and the
policies and procedures of various Part 26 FFD programs may differ from
those of other workplace drug and alcohol testing programs for which an
MRO provides services. This provision ensures that an MRO is able to
perform his or her function appropriately under this part. In addition,
the provision adds a requirement that within 2 years following the date
on which this rule is published in the Federal Register, the MRO must
pass an MRO certification examination. The requirement increases
consistency in the performance of the MRO function among FFD programs
because licensees and other entities are permitted to accept test
results and the results of determinations of fitness conducted by other
licensees and entities who are subject to the FFD rule. The 2-year
implementation date provides MROs who are not currently certified with
an opportunity to pass the required examination. With the exception of
the first sentence of this provision that specifically relates to the
MRO function under Part 26, these MRO qualification requirements are
consistent with those of other Federal agencies.
Section 26.183(b) [Relationships] of the final rule establishes
requirements related to the relationships that are permitted or
prohibited between the MRO, the licensee or other entity, and HHS-
certified laboratories. The first sentence of this provision retains
the portion of the first sentence of former Section 2.9(b) in Appendix
A to Part 26 that permitted the MRO to be an employee of a licensee or
other entity, or a contractor. The NRC has added requirements to
prohibit the MRO from being an employee or agent of, or have any
financial interest in, a laboratory or a contracted operator of a
licensee testing facility for whom the MRO reviews drug testing results
for the licensee or other entity. The NRC has added this prohibition
based upon the experiences of other Federal agencies and to be
consistent with the related provision in the HHS Guidelines, consistent
with Goal 1 of the rulemaking to update and enhance the consistency of
Part 26 with advances in other relevant Federal rules and guidelines.
With respect to the proposed rule, the final rule adds the last
sentence of Sec. 26.183(b) and paragraphs (b)(1) through (b)(6) to
provide some examples of relationships between laboratories and MROs
that create conflicts of interest. The NRC has included these examples
in response to a public comment requesting more clarification regarding
such conflict-of-interest relationships. The basis for these examples
is 49 CFR Part 40, ``Procedures for Department of Transportation
Workplace Drug and Alcohol Testing Programs'' (65 FR 41944; August 9,
2001). Adding these examples meets Goal 1 of this rulemaking to update
and enhance the consistency of Part 26 with advances in other Federal
rules and guidelines and Goal 6 of the rulemaking to improve clarity in
the rule language.
Section 26.183(c) [Responsibilities] of the final rule reorganizes
and updates the requirements in former Sec. 26.3, as well as former
Sections 1.2, 2.4(j), 2.7(d), and 2.9(a) and (b) in Appendix A to Part
26 to specify the responsibilities of the MRO in Part 26 programs. This
provision reorganizes the former provisions and combines them. In
addition, the NRC has revised the terminology to be consistent with
that used throughout the FFD rule. These changes meet Goal 6 of this
rulemaking to improve clarity in the organization and language of the
rule.
Section 26.183(c) retains the requirement in former Section 2.9(a)
in Appendix A to Part 26 for the MRO to review positive confirmatory
drug test results from the HHS-certified laboratory. The provision also
adds a requirement for the MRO to review adulterated, substituted, or
invalid results from confirmatory validity testing, consistent with the
addition of requirements to conduct validity testing throughout the
rule, as discussed with respect to Sec. 26.31(d)(3)(i). If a
licensee's or other entity's FFD program elects to conduct the special
analyses of dilute specimens permitted in Sec. 26.163(a)(2), the MRO
also is required to review those results. This provision also requires
the MRO to identify evidence of subversion of the testing process,
identify issues or problems associated with the collection and testing
of specimens, and work with FFD program management to ensure the
overall effectiveness of the FFD program. The final rule adds these
responsibilities to clarify that the MRO carries programmatic
responsibilities within a licensee's or other entity's FFD program, in
addition to responsibility for reviewing drug and specimen validity
test results. These additional responsibilities strengthen the
effectiveness of FFD programs by ensuring that the MRO's expertise is
brought to bear in the management of FFD programs. This provision also
increases the consistency of the MROs' responsibilities under Part 26
with the responsibilities of MROs in the drug and alcohol testing
programs of other Federal agencies. Therefore, the changes meet Goal 1
of this rulemaking to update and enhance the consistency of Part 26
with advances in other relevant Federal rules and guidelines and Goal 3
to improve the effectiveness and efficiency of FFD programs.
[[Page 17109]]
Section 26.183(c)(1) retains and updates the former definitions of
the term ``Medical Review Officer'' contained in former Sec. 26.3 and
Sections 1.2 and 2.9(b) in Appendix A to Part 26. This provision
continues to require the MRO to examine alternate medical explanations
for any positive drug test results. It also adds a requirement to
examine alternate medical explanations for adulterated, substituted,
invalid, or, at the licensee's or other entity's discretion, dilute
test results report by the HHS-certified laboratory. The provision also
retains the former provision that the MRO may interview the donor and
review the donor's medical history and any other relevant biomedical
factors, and review all medical records that the donor may make
available to the MRO. In addition to the responsible use of legally
prescribed medication, this provision requires the MRO to consider a
documented condition or disease state and the demonstrated physiology
of the donor in determining whether a positive, adulterated,
substituted, or invalid test result is an FFD policy violation. The
provision requires the MRO to consider the latter factors because they
may cause some adulterated, substituted, invalid, or dilute validity
test results. These changes are necessary for consistency with the
addition of requirements to conduct validity testing throughout the
rule, as discussed with respect to Sec. 26.31(d)(3)(i). The changes
also increase the consistency of Part 26 with advances in other
relevant Federal rules and guidelines, which is Goal 1 of this
rulemaking.
Section 26.183(c)(2) retains the meaning of the last sentence of
former Section 2.9(b) in Appendix A to Part 26, but adds minor
editorial revisions for consistency with the terminology used
throughout the rule. For example, the rule replaces the term ``split
samples'' in the former rule with the term ``split specimens.'' The NRC
has made these changes to meet Goal 6 of this rulemaking to improve
clarity in the organization and language of the rule.
The NRC has added Sec. 26.183(d) [MRO staff] to the final rule to
establish requirements related to individuals who provide routine
administrative support functions to MROs, whether the individuals are
employees of the licensee or other entity, employees of the MRO, or
employees of an organization with whom the licensee or other entity
contracts for MRO services. This provision adds requirements related to
MRO staff because these individuals have access to drug test results
that are forwarded to an MRO from the HHS-certified laboratory, perform
some administrative functions for MROs that permit them to view donors'
private medical information, and often have contact with donors. The
NRC is not aware of any instances when individuals who serve as MRO
staff have compromised the confidentiality of donors' test results,
medical information, or otherwise acted improperly in Part 26 programs.
However, this provision adopts requirements related to the MRO staff
function from the regulations of other Federal agencies who similarly
permit MRO staff to provide administrative support to MROs to ensure
that donors' medical information is handled with the highest concern
for individual privacy. The requirement also ensures that information
related to positive, adulterated, substituted, invalid, or dilute test
results is not released to licensee or other entity management
personnel unless the MRO has determined that a donor has violated the
FFD policy. These changes meet Goal 1 of this rulemaking to update and
enhance the consistency of Part 26 with advances in other relevant
Federal rules and guidelines and Goal 7 to protect the privacy and due
process rights of individuals who are subject to Part 26.
With respect to the proposed rule, the final rule adds another
sentence to Sec. 26.183(d) to clarify that employees of a licensee or
other entity who serve MRO staff functions may also perform other
duties for the licensee or other entity and need not be under the
direction of the MRO while performing those other duties. The final
rule also clarifies Sec. 26.183(d)(1) to reflect this intent and
specify that individuals who serve MRO staff functions need only to be
under the direction of the MRO while performing those functions. The
NRC has added these changes to specify NRC's intent in response to a
public comment that requested clarification on this issue.
The NRC has added Sec. 26.183(d)(1) [Direction of MRO staff
activities] to require an MRO to be directly responsible for the
administrative, technical, and professional activities of individuals
who perform MRO staff duties. As discussed with respect to Sec. 26.5,
directing means the exercise of control over a work activity by an
individual who is directly involved in the execution of the activity
and either makes technical decisions for that activity without
subsequent technical review, or is ultimately responsible for the
correct performance of that work activity. The NRC does not intend to
mandate that MROs must share the same physical space with all their
staff members at all times. Direction of staff activities need not
occur face-to-face on an all-day, every-day basis. Also, the definition
of directing, specifically the phrase ``directly involved in the
execution of the work activity,'' does not require the MRO to be on
site when giving direction to individuals who are performing MRO staff
functions. For example, the MRO must be directly involved in the work
of onsite licensee MRO staff, even if that direct involvement occurs by
telephone. Direction may also take place through using a variety of
electronic communications.
However, this provision requires that the MRO's direction of staff
must be meaningful. Meaningful direction involves personal oversight of
staff members' work; providing input to their performance evaluation;
line authority over the staff for decisions, direction, and control;
and regular contact and oversight concerning drug testing program
matters. This provision also requires that the MRO's direction and
control of the staff members cannot be superseded by or delegated to
anyone else with respect to the review of negative tests and other
functions that staff members perform for the MRO. In addition, the
provision requires that MROs must personally review a confirmed
positive drug test result that is received from the HHS-certified
laboratory, as well an adulterated, substituted, invalid, or dilute
result. This requirement is consistent with the addition of
requirements to conduct validity testing throughout the rule, as
discussed with respect to Sec. 26.31(d)(3)(i).
Section 26.183(d)(1)(i) requires that MRO staff duties must be
independent from any other activity or interest of the licensee or
other entity. The rule has added this requirement because, in contrast
to other Federal agencies' regulations, Part 26 permits employees of
licensees and other entities to perform MRO staff activities for MROs
who work off site and are not physically present to supervise the
staff. These circumstances may provide greater opportunities for
inadvertent compromise of the independence of the MRO function than
situations when the MRO and his or her staff are physically co-located,
such as the inadvertent release of positive, adulterated, substituted,
or invalid test results before the MRO has discussed the results with
the donor. Therefore, the NRC believes that the requirement is
necessary to protect the integrity of the MRO function and donors'
privacy, consistent with Goal 7 of this rulemaking to protect the
privacy and other rights (including
[[Page 17110]]
due process) of individuals who are subject to Part 26.
The NRC has added Sec. 26.183(d)(ii) to the final rule to further
specify the MRO's responsibilities for directing MRO staff. These
responsibilities include, but are not limited to, ensuring that the
procedures that must be followed by MRO staff meet the regulations of
this part and HHS and professional standards of practice. The MRO must
also ensure that personal information about the donor is maintained
confidentially with the highest regard for individual privacy. These
requirements meet Goal 7 of this rulemaking to protect the privacy and
other rights (including due process) of individuals who are subject to
Part 26.
The NRC has also added Sec. 26.183(d)(1)(iii) to prohibit the MRO
from delegating his or her responsibilities for directing MRO staff
activities to any individual or entity, other than another MRO.
Although the NRC is unaware of any instances when the MRO function has
been compromised by MRO staff in Part 26 programs, the experience of
other Federal agencies has indicated that clear limits on who may
direct MRO staff activities are advisable to maintain the independence
and integrity of the MRO function. Therefore, Sec. 26.183(d)(1)(iii)
establishes these clear limits and is consistent with Goal 3 of this
rulemaking to improve the effectiveness of the FFD program.
The NRC has added Sec. 26.183(d)(2) [MRO staff responsibilities]
to specify the duties that MRO staff may and may not perform. The
provisions are also based on the experience of other Federal agencies,
which has indicated that clear limits on MRO staff duties are necessary
to protect donor confidentiality and the integrity of the MRO process.
Therefore, this addition is consistent with Goal 1 of this rulemaking
to update and enhance the consistency of Part 26 with advances in other
relevant Federal rules and guidelines. Section 26.183(d)(2)(i) permits
MRO staff to receive results from the HHS-certified laboratory and to
review and report negative test results to the licensee's or other
entity's designated reviewing official under the MRO's direction.
Section 26.183(d)(2)(ii) permits MRO staff to review the custody-and-
control forms for specimens that the laboratory reports as positive,
adulterated, substituted, invalid, or dilute, and to correct errors.
However, the MRO is required to review and approve the corrections.
Section 26.183(d)(2)(iii) prohibits staff from conducting interviews
with donors to discuss positive, adulterated, substituted, invalid, or
dilute test results. The provision also prohibits MRO staff from
requesting or reviewing medical information from donors related to any
positive, adulterated, substituted, dilute, or invalid test results.
Section 26.183(d)(2)(iv) prohibits MRO staff from reporting or
discussing positive, adulterated, substituted, invalid, or dilute test
results received from the HHS-certified laboratory with any individuals
other than the MRO and other MRO staff. The provisions are necessary to
protect donor confidentiality and the integrity of the MRO review
process, consistent with Goal 7 of this rulemaking to protect privacy
and other rights (including due process) of individuals who are subject
to Part 26. At the same time, the provision permits licensees and other
entities to realize the cost efficiencies associated with the MRO
delegating some tasks to staff, consistent with Goal 3 of this
rulemaking to increase the effectiveness and efficiency of Part 26
programs. With respect to the proposed rule, the NRC has clarified this
provision to specify that the MRO staff may not report or discuss
positive, adulterated, substituted, dilute, or invalid test results
received from the HHS-certified laboratory with any individuals other
than the MRO and other MRO staff before those results have been
reviewed and confirmed by the MRO. The final rule also adds limitations
on with whom the MRO staff can discuss confirmed positive, adulterated,
substituted or invalid test results, as well as limitations on
discussion of quantitative test results and any personal medical
information. The NRC believes that only the MRO is qualified to answer
questions from FFD program personnel about the basis for his or her
decisions and the proper interpretation of test results from the HHS
lab. These changes are consistent with Goal 6 of this rulemaking to
improve clarity in the language of the rule.
Section 26.185 Determining a Fitness-for-Duty Policy Violation
Section 26.185 of the final rule contains requirements related to
the MRO's determination that a positive, adulterated, substituted,
invalid, or dilute test result constitutes an FFD policy violation.
Section 26.185(a) [MRO review required] of the final rule amends
portions of former Section 2.9(a) in Appendix A to Part 26. The former
section established requirements for the MRO's review of test results
from the HHS-certified laboratory. The final rule expands the MRO's
responsibilities to include assisting the licensee or other entity in
determining whether a donor has attempted to subvert the testing
process. These responsibilities may include, but are not limited to,
reviewing positive, adulterated, substituted, dilute, or invalid test
results and authorizing the testing at an HHS-certified laboratory of
any suspicious substance discovered in a donor's pockets that could be
used to adulterate or substitute a urine specimen. The change meets
Goal 3 of the rulemaking as it relates to improving the effectiveness
of FFD programs and is consistent with the NRC's increased concern with
potential subversion of the testing process, as discussed with respect
to Sec. 26.31(d)(3)(i). This provision also deletes the former
reference to ``nuclear power plant worker'' and replaces it with
``individual'' because persons other than nuclear power plant workers
are subject to the requirement. In addition, this provision eliminates
the former requirement for the MRO to review blood test results from
the HHS-certified laboratory because the rule no longer permits donors
to request testing of a blood specimen for alcohol, as discussed with
respect to Sec. 26.83(a). However, the provision retains the former
requirement that the MRO must complete the review of any positive,
adulterated, substituted, invalid, and, at the licensee's or other
entity's discretion, dilute test results before transmitting results to
a licensee's or other entity's designated representative.
With regard to the proposed rule, the NRC received a public comment
stating that the MRO should not be required to determine whether a
donor has violated the FFD policy because MRO expertise is exclusively
medical. The NRC believes that an MRO has the medical expertise and
detailed knowledge of possible alternate medical explanations that is
essential to the review process. Therefore, the NRC maintains that the
MRO is required to determine whether a donor has violated the FFD
policy.
Section 26.185(b) [Reporting of initial test results prohibited] of
the final rule retains the intent of the requirement in the last
sentence of former Section 2.9(a) in Appendix A to Part 26.
Specifically, this provision continues to prohibit the MRO from
communicating to licensees and other entities any positive,
adulterated, substituted, dilute, or invalid initial test results
reported by the HHS-certified laboratory before confirmatory testing
has been completed and the MRO has conducted his or her review.
However, this provision extends the prohibition to MRO staff,
consistent with Goal 7 of this rulemaking and the
[[Page 17111]]
addition of requirements related to MRO staff in Sec. 26.183(d), as
discussed with respect to that provision.
Section 26.185(c) [Discussion with the donor] of the final rule
amends former Section 2.9(c) in Appendix A to Part 26. This provision
continues to require the MRO to discuss a positive confirmatory drug
test result with the donor before determining that the FFD policy had
been violated. This provision adds a requirement for the MRO to discuss
adulterated, substituted, dilute or invalid confirmatory validity test
results with the donor as part of the review process, consistent with
the addition of requirements to conduct validity testing throughout the
rule, as discussed with respect to Sec. 26.31(d)(3)(i). This provision
also adds a reference to ``other occurrence'' to address circumstances
when the donor may have engaged in a subversion attempt that would be
detected through other means, including, but not limited to, the
specimen collection process in Subpart E [Collecting Specimens for
Testing]. This provision eliminates the former requirement for the MRO
to contact the EAP. Under this provision, referral to the EAP is at the
licensee's or other entity's discretion, as documented in FFD
procedures. The NRC has eliminated the former requirement because most
licensees terminate the employment of individuals who have a confirmed
positive, adulterated, or substituted drug test result. It is
inappropriate to require licensees and other entities to provide EAP
services to persons they will no longer employ. If a licensee or other
entity plans to consider granting authorization to the individual after
his or her authorization has been terminated unfavorably for the FFD
policy violation, this provision requires the licensee or other entity
to meet the applicable requirements of Sec. 26.69 [Authorization with
potentially disqualifying fitness-for-duty information]. The NRC has
made these changes in the paragraph for consistency with other changes
to the regulation and to meet Goal 3 of the rulemaking as it relates to
increasing efficiency in FFD programs.
The NRC has added Sec. 26.185(d) [Donor unavailability] to the
final rule to clarify the circumstances when the MRO may confirm a
positive, adulterated, substituted, dilute, or invalid test result, or
other occurrence, as an FFD policy violation without having first
discussed the test result or occurrence with the donor. These
circumstances include when--
(1) The donor expressly declines the opportunity to discuss the
possible FFD policy violation with the MRO, as specified in Sec.
26.185(d)(1);
(2) The donor fails to contact the MRO within one business day
after being contacted by the licensee or other entity, or an MRO staff
member, as specified in Sec. 26.185(d)(2); and
(3) The MRO is unable to contact the donor after making a
reasonable effort to do so as specified in Sec. 26.185(d)(2).
These provisions provide more detailed guidance than the first
sentence of former Section 2.9(c) in Appendix A to Part 26 in response
to many questions that have arisen regarding implementation of the
requirement for MROs to discuss test results with the donor. The
revisions also respond to stakeholders' requests during the public
meetings discussed in Section I.D. In questions to the NRC staff and
during the public meetings, licensees have pointed out that the former
rule made no provision for these circumstances that do occasionally
arise. Therefore, these provisions address these circumstances. The NRC
believes that these provisions give the donor adequate opportunity to
be contacted, consistent with Goal 7 of this rulemaking to protect the
rights of individuals subject to Part 26, while allowing licensees to
make ``reasonable efforts'' to contact the donor; thus meeting Goal 3
of this rulemaking as it relates to improving efficiency in the FFD
program.
For the same reasons, Sec. 26.185(e) [Additional opportunity for
discussion] of the final rule specifies procedures for addressing a
circumstance when the donor was unable to be contacted by the MRO to
discuss a positive, adulterated, substituted, dilute, or invalid test
result, or other occurrence. This provision permits the donor to
present information to the MRO documenting the circumstances that
unavoidably prevented the donor from being contacted by or from
contacting the MRO, and permits the MRO to reopen the procedure for
determining whether the donor had violated the FFD policy. This
provision also permits the MRO to modify the initial determination
based on the information that the donor provides.
The requirements in Sec. 26.185(d) and (e) incorporate the related
requirements in 49 CFR Part 40, ``Procedures for Department of
Transportation Workplace Drug and Alcohol Testing Programs'' (65 FR
41944; August 9, 2001). Therefore, in addition to responding to
implementation questions from licensees and stakeholder requests, the
provisions meet Goal 1 of this rulemaking to update and enhance the
consistency of Part 26 with advances in other relevant Federal rules
and guidelines.
The NRC has added Sec. 26.185(f) through (i) to the final rule to
establish requirements for the MRO's review of validity test results.
The NRC has added these paragraphs for consistency with the addition of
requirements to conduct validity testing throughout the rule, as
discussed with respect to Sec. 26.31(d)(3)(i) to meet Goal 3 of this
rulemaking to increase the effectiveness and efficiency of Part 26
programs.
Section 26.185(f) [Review of invalid specimens] clarifies the MRO's
responsibilities if the HHS-certified laboratory reports that a
specimen is invalid. This provision is consistent with related
provisions in the HHS Guidelines and is necessary because MRO actions
in response to an invalid specimen are not specified in the former
rule. Section 26.185(f) provides the MRO with the following several
alternative courses of action if a specimen is declared to be invalid
by the laboratory:
Section 26.185(f)(1) requires the MRO to consult with the HHS-
certified laboratory to determine whether additional testing by another
HHS-certified laboratory may be useful for completing testing of the
specimen. Another laboratory may use different testing methods that
could provide more definitive test results regarding the invalid
specimen, such as the ability to identify a new adulterant or obtain
valid drug test results despite the presence of an interfering
substance in the specimen. If the MRO and laboratory agree that
additional testing would be useful, the MRO shall direct the laboratory
to forward an aliquot of the specimen to a second HHS-certified
laboratory for further testing.
Section 26.185(f)(2) requires the MRO to contact the donor to
determine whether there is an acceptable medical explanation for the
invalid result if the MRO and HHS-certified laboratory agree that
testing at a second laboratory would not be useful. If the MRO
determines that there is an acceptable medical explanation for the
invalid result, the MRO would report to the licensee or other entity
that no FFD policy violation had occurred, but that a negative test
result had not been obtained. Because the specimen did not yield
negative test results, the licensee or other entity could not use the
invalid test result in the decision to grant or deny authorization.
However, this provision also requires the MRO to assess whether the
medical condition would similarly affect a second specimen collection.
If the MRO determines that the medical condition is temporary and would
not
[[Page 17112]]
affect a second specimen, he or she would direct the licensee or other
entity to collect another specimen from the donor. The licensee or
other entity would then rely upon the results of the second test to
make an authorization decision. This provision does not require the
second specimen to be collected under direct observation in this
situation because there is no reason to believe that the individual may
have attempted to subvert the testing process. If the MRO determines
that the medical condition would likely affect the validity of further
urine specimens, the MRO may authorize an alternative method for drug
testing. At this time, the NRC declines to specify the alternative
methods that the MRO may authorize, which may include, but are not
limited to, testing of alternate specimens, such as hair, oral fluids,
or sweat. The NRC leaves the selection of an alternative method to the
professional judgement of the MRO. This provision also prohibits
licensees and other entities from taking management actions or imposing
sanctions on the basis of an invalid test result from a medical
condition because no FFD violation would have occurred.
Section 26.185(f)(3) requires the MRO to direct the licensee or
other entity to collect another specimen under direct observation, if
testing by another laboratory would not be useful in obtaining a valid
result and the donor did not provide an acceptable medical explanation
for the invalid specimen. The invasion of privacy associated with a
directly observed collection is warranted in this situation because the
invalid specimen may be the result of a subversion attempt. This
provision requires the licensee or other entity to rely on the test
results from the directly observed collection in authorization
decision-making because the result from the invalid specimen would be
neither negative nor positive, adulterated, substituted, or invalid,
and could not meet the requirements for granting authorization to an
individual in Subpart C [Granting and Maintaining Authorization] or
serve as the basis for imposing the sanctions specified in Subpart D
[Management Actions and Sanctions].
The NRC has added Sec. 26.185(g) [Review of dilute specimens] to
the final rule to establish requirements for the MRO's review of
positive confirmatory drug test results from dilute specimens. The NRC
has added this paragraph because reviewing test results from a dilute
specimen is complex and MRO actions in response to a dilute specimen
are not addressed in the former rule.
Section 26.185(g)(1) requires the MRO to confirm a drug-positive
FFD violation for a dilute specimen in which drugs or drug metabolites
are detected, if the MRO determines that there is no legitimate medical
explanation for the presence of the drugs or metabolites in the
specimen. The final rule amends the proposed rule by clarifying that a
clinical examination is one of the criteria that must be met before the
MRO can confirm a drug-positive FFD violation, consistent with Goal 6
of this rulemaking to improve clarity in the organization and language
of the rulemaking. There are many legitimate reasons for submitting a
dilute specimen, which is the basis for omitting the submission of a
dilute specimen as one type of subversion attempt for which a permanent
denial of authorization is required in Sec. 26.75(b). Although neither
the submission of a dilute specimen nor the presence of drugs or drug
metabolites in a dilute specimen establishes that the donor has
attempted to subvert the testing process without additional evidence of
subversion, the presence of drugs or metabolites in a dilute specimen
without a legitimate medical explanation is a sufficient basis for the
MRO to confirm that the donor has violated the FFD policy.
The final rule modifies and clarifies Sec. 26.185(g)(2) of the
former and proposed rules. This provision specifies the conditions that
must be met in order for the MRO to determine whether the positive and
dilute specimen is a refusal to test. These conditions include when--
(1) The HHS-certified laboratory conducts the special analysis of
dilute specimens permitted in 26.163(a)(2) and the results show the
presence of drugs or drug metabolites in the specimen;
(2) The MRO determines there is no legitimate medical explanation
for the presence of drugs or drug metabolites in the specimen; and
(3) a clinical examination has been conducted in accordance with
this section.
The provision also specifies when the MRO shall determine that drug
test results are positive and the donor has violated FFD policy. These
changes are consistent with the changes the NRC has made to procedures
for processing dilute specimens, as discussed in Sec. 26.163(a)(2).
Section 26.185(g)(2)(i) through (g)(2)(iii) defines the
circumstances that may constitute a reason to believe that a donor may
have attempted to subvert the testing process and provide a sufficient
basis for the MRO to require the additional testing permitted in Sec.
26.185(g)(2). These circumstances are the same as those specified in
Sec. 26.115(a)(1) through (a)(3). The final rule clarifies this
provision of the proposed rule by specifying that these circumstances
must be considered by the MRO, if applicable, and are not the exclusive
grounds to believe the donor may have diluted the specimen in a
subversion attempt. This NRC has made this change in response to public
comment and to meet Goal 6 of this rulemaking to improve clarity in the
organization and language of the rule.
Section 26.185(g)(3) clarifies that the MRO may also require the
additional testing of a dilute specimen that is permitted in Sec.
26.185(g)(2) if the specimen was collected under direct observation.
This provision adds this permission for consistency with the related
provisions in the FFD rule.
Section 26.185(g)(4) requires the MRO to determine whether there is
clinical evidence of the illegal use of opiates or if opiates other
than 6-AM at any concentration are detected in a dilute specimen before
the MRO verifies that the donor has violated the FFD policy. This
provision does not require an evaluation for clinical evidence of
illegal use of opiates for 6-AM because its presence in a specimen is
proof of heroin use. However, the provision does not establish cutoff
levels below and above which an evaluation for clinical evidence of
illegal opiate use is not required (in contrast to those contained in
paragraph (j) of this section) because the concentration of opiates in
a dilute specimen does not bear any known relationship to the
concentration of opiates in vivo (i.e., in the donor's body). For
similar reasons, this provision also requires an evaluation for
clinical evidence of abuse before the MRO determines that the donor has
violated the FFD policy when drugs or drug metabolites are detected in
a dilute specimen, indicating that the donor has used prescription or
over-the-counter medications.
The NRC has added Sec. 26.185(g)(5) to the final rule, with
respect to the proposed rule, to specify the circumstances under which
MRO review is not required. This change is consistent with related
provisions in the HHS guidelines.
The NRC has added Sec. 26.185(h) [Review of substituted specimens]
to the final rule to establish requirements for the MRO review of
substituted test results. These provisions have been added because MRO
actions in determining an FFD policy violation for a substituted
specimen are consistent with the related provisions in the HHS
[[Page 17113]]
Guidelines and are not addressed in the former rule.
Section 26.185(h)(1) requires the MRO to contact the donor to
determine whether there is a legitimate medical reason for the
substituted result. This provision requires the MRO to give the donor
the opportunity to provide legitimate medical evidence, within 5
business days of being contacted by the MRO, that he or she produced
the specimen for which the HHS-certified laboratory reported a
substituted result. The final rule, with respect to the proposed rule,
specifies that a qualified and experienced physician, as verified by
the MRO, shall submit the medical evidence. The NRC has made this
change because after publishing the proposed rule, it recognized the
need for additional clarity in this provision to specify the NRC's
intent. This provision also provides examples of donor claims that the
MRO may not consider to be legitimate medical explanations, including,
but not limited to, race, gender, body weight, and dietary factors.
Section 26.185(h)(2) directs the MRO to report to the licensee or
other entity that the specimen was substituted if the MRO determines
that there is no acceptable medical explanation for the substituted
test result.
Section 26.185(h)(3) directs the MRO to report to the licensee or
other entity that no FFD policy violation has occurred if the MRO
determines that the donor has provided an acceptable medical
explanation for the substituted test result.
Section 26.185(i) [Review of adulterated specimens] of the final
rule establishes requirements for the MRO's review of adulterated test
results. This provision has been added because MRO actions in
determining an FFD policy violation for an adulterated specimen are not
addressed in the former rule. Section 26.185(i)(1) requires the MRO to
contact the donor and offer him or her the opportunity to provide an
acceptable medical explanation for the adulterated result within 5
business days after the donor produced the adulterated result. The
final rule, with respect to the proposed rule, specifies that a
qualified and experienced physician, as verified by the MRO, shall
submit the medical evidence. The NRC has made this change because after
publishing the proposed rule, it recognized the need for additional
clarity in this provision to specify the NRC's intent. If the MRO
determines that there is no legitimate acceptable medical explanation
for the adulterated result, Sec. 26.185(i)(2) requires the MRO to
report to the licensee or other entity that the specimen is
adulterated. If the donor provides an acceptable medical explanation,
Sec. 26.185(j)(3) requires the MRO to report that no FFD policy
violation had occurred. These requirements are consistent with the
related provisions in the HHS Guidelines.
Section 26.185(j) [Review for opiates, prescription and over-the-
counter medications] of the final rule amends former Section 2.9(d) in
Appendix A to Part 26. It addresses circumstances that have arisen
since Part 26 was first published and about which licensees have sought
guidance from the NRC. These changes are consistent with Goal 3 of the
rulemaking to improve the effectiveness of FFD programs. The paragraph
amends the former requirements in Section 2.9(d) in Appendix A to Part
26 and adds others, as follows:
Section 26.185(j)(1) incorporates updated requirements from the HHS
Guidelines related to the MRO's review of a positive drug test result
for opiates. The rule revises but retains the meaning of the
requirement for the MRO to determine that there is clinical evidence of
illegal use of opiates, which appeared in former Section 2.9(d) in
Appendix A to Part 26. Because some licensees and other entities rely
on MROs who work off site and are not available to conduct the required
assessment, the rule permits the MRO to designate another licensed
physician who has knowledge of the clinical signs of drug abuse to
conduct the evaluation. This change ensures that the clinical
assessment is performed by a qualified physician while reducing
unnecessary burden by permitting FFD programs to continue to rely on
off site MROs. Therefore, the change meets Goal 5 of this rulemaking to
improve Part 26 by eliminating or modifying unnecessary requirements.
This provision eliminates the examples of clinical signs of opiate
abuse in former Section 2.9(d) in Appendix A to Part 26 because these
signs are addressed as part of the training that MROs must obtain in
order to pass the comprehensive certification examination required in
Sec. 26.183(a) [Qualifications]. The rule retains the provision in
former Section 2.9(d) that permits the MRO to omit the evaluation for
clinical evidence of abuse if the laboratory identifies 6-AM in the
specimen. However, the rule adds permission for the MRO to omit the
evaluation if the morphine or codeine concentration in the specimen is
equal to or greater than 15,000 ng/mL without a legitimate medical
explanation for the presence of opiates at or above this concentration.
The NRC has made this change because, in the experience of other
Federal programs, such concentrations without a legitimate medical
explanation can only indicate substance abuse. In addition, the rule
prohibits the MRO from considering consumption of food products as a
legitimate medical explanation for the specimen having morphine or
codeine concentrations at or above 15,000 ng/mL because food
consumption could not result in a concentration at this level.
Section 26.185(j)(2) retains the last sentence of former Section
2.9(d) in Appendix A to Part 26. This provision requires the MRO to
determine whether there is clinical evidence of abuse of these
substances or their derivatives, in addition to the positive
confirmatory test result.
The NRC has added Sec. 26.185(j)(3) to the final rule to provide
greater consistency in MRO determinations related to a donor's use of
another person's prescription medication. The NRC is aware that MROs in
different FFD programs have varied in their determinations as to
whether the use of another person's prescription medication is an FFD
policy violation. The paragraph clarifies the NRC's intent with respect
to these circumstances. In the final rule, if a donor claims, and the
MRO confirms, that a positive, adulterated, substituted, or invalid
drug test result is due to the unauthorized use of another person's
prescription medication, the rule requires the MRO to evaluate or
ensure that the donor is evaluated for clinical evidence of abuse. If
no clinical evidence of abuse is identified, the MRO shall report to
the licensee or other entity that a violation of the FFD policy
regarding misuse of a prescription medication had occurred. If clinical
evidence of abuse is identified, the MRO will confirm that the test
results are positive for the drug or metabolites detected.
The NRC has added Sec. 26.185(j)(4) to the final rule to assure
greater consistency in MRO determinations related to a donor's use of a
prescription or over-the-counter medication that the donor obtained
legally in a foreign country. Again, the NRC is aware that MROs in
different FFD programs have varied in their determinations as to
whether the use of medications legally obtained in a foreign county is
an FFD policy violation. The paragraph clarifies the NRC's intent with
respect to these circumstances. At the licensee's or other entity's
discretion and in accordance with the FFD policy and procedures, the
rule permits the MRO to confirm a test result as negative if there is a
legitimate medical use for the medication that the donor obtained
legally in a foreign
[[Page 17114]]
country and the donor has used it properly for its intended medical
purpose. The rule prohibits the MRO from confirming a test result as
negative if the drug used has no legitimate medical purpose, including,
but not limited to phencyclidine and heroin.
The NRC has added Sec. 26.185(j)(5) to prohibit the MRO from
considering the consumption of food products, supplements, and other
preparations that are available over-the-counter as a legitimate
medical explanation for the specimen having drugs or drug metabolites
above the cutoff levels specified in Sec. 26.163, including, but not
limited to hemp products and coca leaf tea. In so doing, the rule
provides guidance concerning a potential subversion technique that has
become an issue for several licensees (i.e., claims of ingestion of
hemp food products as the basis for a positive marijuana test).
Ingestion of food products containing hemp seeds or extracts has
produced marijuana positive test results even though the seller claimed
that the seeds or extracts were sterilized to remove the THC
metabolite. The NRC endorses the Federal policy in this matter that was
published by the DOT, with the concurrence of the Departments of
Justice and Health and Human Services and the Office of National Drug
Control Policy. MROs must never accept an assertion of consumption of a
hemp food product as a basis for confirming that a marijuana test is
negative. Consuming a hemp food product is not a legitimate medical
explanation for a prohibited substance or metabolite in an individual's
specimen. When a specimen is positive for THC, the only legitimate
medical explanation for its presence is a prescription for marinol.
Under Sec. 26.29(a)(6) and (a)(7), individuals who are subject to Part
26 receive training in order to be able to avoid ingesting substances
that could result in positive drug test results, such as over-the-
counter medications, food products, supplements, and other
preparations.
The NRC has added Sec. 26.185(j)(6) to the final rule to prohibit
the MRO from accepting the use of any drugs that are listed in Schedule
I of section 202 of the Controlled Substances Act [21 U.S.C. 812] as a
legitimate medical explanation for a positive confirmatory drug test
result, even if the drug may be legally prescribed and used under State
law. Drugs that are listed in Schedule I of section 202 of the
Controlled Substances Act have the following characteristics:
(1) The drug or other substance has a high potential for abuse;
(2) The drug or other substance has no currently accepted medical
use in treatment in the United States; and
(3) There is a lack of accepted safety for use of the drug or other
substance under medical supervision.
The prohibition is primarily intended to address the medical use of
marijuana, which some States permit, as well as the use of certain
hallucinogenic drugs. Although some have argued that the use of such
drugs under State laws may not adversely reflect on an individual's
trustworthiness and reliability, the requirement is necessary to ensure
that individuals who are subject to this part can be trusted and relied
upon to comply with Part 26 requirements and are not impaired from
using these drugs when performing duties that require them to be
subject to this part.
Section 26.185(k) [Results consistent with legitimate drug use] of
the final rule amends former Section 2.9(f) in Appendix A to Part 26.
The former provision instructed the MRO to report to the licensee that
a drug test result is negative if, after review, the MRO determines
that there is a legitimate medical explanation for the positive test
result and that use of the substance identified through testing in the
manner and at the dosage prescribed does not reflect a lack of
reliability and is unlikely to create on-the-job impairment. However,
the former provision did not provide instructions for MRO action in the
case of an individual whose drug use is legitimate but may cause
impairment on duty. Therefore, if the MRO determines that a risk
exists, the final rule requires that a determination of fitness must be
performed. Because the MRO determined that the drug test result was
negative, the licensee or other entity shall not impose sanctions on
the individual. However, the results of the determination of fitness
may indicate a need to establish controls and conditions on the
individual's performance of certain duties in order to ensure that any
impairment from the drug use does not result in adverse impacts on
public health and safety or the common defense and security. By
providing greater assurance that individuals who are subject to the
rule are fit to safely and competently perform their duties, the
provision meets Goal 3 of this rulemaking to improve the effectiveness
of FFD programs.
Section 26.185(l) [Retesting authorized] of the final rule amends
former Section 2.9(e) in Appendix A to Part 26. This provision permits
the MRO to authorize retesting of an aliquot of a specimen or the
analysis of any split specimen (Bottle B) if there is any question
about the accuracy or scientific validity of a drug test result in
order to determine whether the FFD policy has been violated. The final
rule retains the provisions in former Section 2.9(e) that permitted a
donor to request a retest of an aliquot of a single specimen or a split
specimen if the FFD program follows split specimen procedures. However,
the final rule updates the former requirement for consistency with the
terminology used throughout the final rule (e.g., ``Bottle B'' to refer
to a split specimen), as discussed with respect to Sec. 26.5. The
final rule also includes a requirement that the retesting must be
conducted at a second HHS-certified laboratory that did not conduct the
original tests. The requirement that retesting must be performed at a
second HHS-certified laboratory ensures the independence of the second
testing and provide additional protection of donors' due process rights
under the rule. In addition, the requirement increases the consistency
of Part 26 with related provisions in the HHS Guidelines, consistent
with Goal 1 of the rulemaking to update and enhance the consistency of
Part 26 with advances in other Federal rules and guidelines.
The proposed rule required the donor to request the retest in
writing in order to ensure donors' control over the specimen and rights
to privacy under Sec. 26.135(b). However, the final rule eliminates
the provision that the donor's authorization for re-testing must be in
writing. This change is in response to public comment stating that
obtaining a written request poses an unnecessary logistical burden on
the donor and the MRO and that verbal requests are and have been
sufficient in the past. Therefore, the NRC has made this change,
consistent with other Federal regulations and Goal 1 of this rulemaking
to update and enhance the consistency of Part 26 with advances in other
relevant Federal rules and guidelines.
Section 26.185(m) [Results scientifically insufficient] of the
final rule amends the first sentence of the former Section 2.9(g) in
Appendix A to Part 26. This provision permits the MRO to determine that
a positive, adulterated, substituted or invalid test result is
scientifically insufficient for further action. The final rule
instructs the MRO to report that the drug or validity test result is
not an FFD policy violation in these circumstances, but that a negative
test result was not obtained. The NRC has made this change for
consistency with other changes in the rule related to invalid test
results (see Sec. 26.185(f)). A test result that the MRO determines to
[[Page 17115]]
be scientifically insufficient for further action (as well as an
invalid test result) could not be a basis for a licensee or other
entity to grant or deny authorization or impose sanctions because it
would be neither a negative nor positive, adulterated, or substituted
test result. Therefore, the change meets Goal 6 of this rulemaking to
improve clarity in the language of the rule. The NRC has changed some
of the terminology used in the former paragraph in the final rule for
consistency with the terminology used throughout the final rule (e.g.,
``samples'' is changed to ``specimens''). The final rule also makes the
following changes to this provision:
The final rule also adds a statement to the former paragraph to
indicate that the MRO is neither expected nor required to request
retesting of the specimen unless, in the sole opinion of the MRO, such
retesting is warranted. The final rule includes this statement because,
in the experience of other Federal agencies, some MROs have been
pressured by the organization to whom they provide services to request
retesting of specimens that the MRO has confirmed to be positive,
adulterated, substituted, or invalid. Although the NRC is not aware of
any such instances in Part 26 programs, the rule clarifies that the MRO
alone is authorized to request retesting to further protect the
independence of the MRO function.
In addition, the NRC has moved the last sentence of former Section
2.9(g), which contained records retention requirements, to Sec.
26.215(b)(11) of Subpart N [Recordkeeping and Reporting Requirements]
of the final rule. The NRC has moved this provision to group it with
other records retention requirements in the rule for organizational
clarity.
Section 26.185(n) [Evaluating results from a second laboratory]
establishes new requirements for the MRO's determination of an FFD
policy violation based on a retest of a single specimen or a test of
the specimen in Bottle B of a split specimen. This provision specifies
that the test result(s) from the second HHS-certified laboratory
supersede the confirmatory test results provided by the HHS-certified
laboratory that performed the original testing of the specimen. The
final rule incorporates these requirements from the HHS Guidelines
because the former rule did not address MRO actions in response to test
results from a second laboratory. Therefore, the provision is
consistent with the related provisions in the HHS Guidelines and meets
Goal 1 of this rulemaking to update and enhance the consistency of Part
26 with advances in other relevant Federal rules and guidelines.
The NRC has added Sec. 26.185(o) [Re-authorization after a first
violation] to the final rule. This provision addresses the MRO's review
of drug test results following a first violation of the FFD policy
based on a confirmed positive drug test result. The former rule did not
require the MRO to evaluate whether drug test results in these
instances indicated subsequent drug use after a first confirmed
positive drug test result, and MROs from different FFD programs have
implemented different policies. Specifically, the final rule requires
the MRO to determine whether subsequent drug test results indicate
further drug use since the first positive drug test result was
obtained. For example, because marijuana metabolites are fat-soluble
and may be released slowly over an extended period of time, a second
positive test result for marijuana from a test that is performed within
several weeks after a first confirmed positive test result for
marijuana may not, in fact, indicate further marijuana use. Therefore,
in this case, the provision prohibits the MRO from determining that a
second FFD policy violation for marijuana had occurred if the
quantitative results from confirmatory testing of the second specimen
are positive for marijuana metabolites, but at a concentration that is
inconsistent with additional marijuana use since the first positive,
adulterated, substituted, or invalid test result was obtained. If the
MRO concludes that the concentration of marijuana metabolites
identified by confirmatory testing is inconsistent with further
marijuana use since the first positive test result, the MRO would
declare the test result as negative, even if the quantitative test
result exceeds the 15 ng/mL confirmatory cutoff level specified in this
part or a licensee's or other entity's more stringent cutoff level. The
provision prevents individuals from being subject to a 5-year denial of
authorization for a second confirmed positive drug test result under
Sec. 26.75(e), when the donor has not engaged in further drug use,
consistent with Goal 7 of this rulemaking to protect the privacy and
other rights (including due process rights) of individuals who are
subject to Part 26.
Section 26.185(p) [Time to complete MRO review] of the final rule
amends former Sec. 26.24(e). This provision requires the MRO to
complete his or her review of test results and notify management of the
results of his or her review within 10 business days after an initial
positive, adulterated or substituted test result. The rule replaces the
former phrase, ``initial presumptive positive screening test result,''
with the phrase, ``initial positive, adulterated or substituted test
result,'' for consistency with the terminology used throughout the rule
(see Sec. 26.5). This provision also requires the MRO to report his or
her determination that a test result is an FFD policy violation in
writing to the licensee or other entity and in a manner that ensures
the confidentiality of the information. The NRC has made these changes
for consistency with the related provisions in the HHS Guidelines,
consistent with Goal 1 of this rulemaking.
Section 26.187 Substance Abuse Expert
The NRC has added Sec. 26.187 to the final rule. This section
establishes minimum requirements for a new position within FFD
programs, the ``substance abuse expert'' (SAE). These added provisions
meet Goal 3 of the rulemaking to improve the effectiveness and
efficiency of FFD programs.
The NRC has added Sec. 26.187(a) [Implementation] to the final
rule. This provision requires SAEs to meet the requirements of this
section within 2 years of the date on which the final rule is published
in the Federal Register. The NRC has imposed the 2-year period in order
to ensure that professionals who may currently be performing
determinations of fitness, but who do not meet these proposed
requirements, have the time necessary to obtain the required
credentials, knowledge, and qualification training. With respect to the
proposed rule, the final rule adds a sentence that allows an MRO who
meets the requirements of this section to serve as both an MRO and as
an SAE. The NRC has made this change in response to a public comment
suggesting that allowing the MRO, if qualified, the option to function
as the SAE would avoid any unnecessary financial burden for licensees
that have an MRO that can make SAE determinations.
The NRC has added Sec. 26.187(b) [Credentials] to the final rule
to establish the credentials required for an individual to serve as an
SAE under this part. The rule requires that the SAE must possess the
extensive education, training, and supervised clinical experience that
are prerequisites for obtaining the professional credentials listed in
Sec. 26.187(b)(1) through (b)(5). Further, Sec. 26.187(c) through (e)
requires an SAE to possess additional knowledge and experience directly
related to substance abuse disorders and the requirements of this part.
The NRC has added Sec. 26.187(c) [Basic knowledge] and (d)
[Qualification
[[Page 17116]]
training] to the final rule to establish the specific areas of
expertise and training that are required for an individual to serve as
an SAE under this part. The knowledge and training requirements in
these two paragraphs are necessary to ensure that SAEs possess the
knowledge and clinical experience required to perform the SAE function
effectively in a Part 26 program.
Section 26.187(c) requires SAEs to possess the following types of
knowledge: (1) Knowledge of and clinical experience in the diagnosis
and treatment of alcohol and controlled-substance abuse disorders, in
Sec. 26.187(c)(1); (2) knowledge of the SAE function as it relates to
individuals who perform the duties that require an individual to be
subject to this part, in Sec. 26.187(c)(2); and (3) knowledge of this
part and any changes to its requirements, in Sec. 26.187(c)(3).
Section 26.187(d) establishes the topical areas in which an SAE
must be trained. The qualification training requirements include
training in the following areas: (1) The background, rationale, and
scope of this part, in Sec. 26.187(d)(1); (2) key drug and alcohol
testing requirements of this part, in Sec. 26.187(d)(2) and (d)(3),
respectively; (3) SAE qualifications and prohibitions, in Sec.
26.187(d)(4); (4) the role of the SAE in making determinations of
fitness, and developing treatment recommendations and followup testing
plans, in Sec. 26.187(d)(5); (5) procedures for consulting and
communicating with licensee or other entity officials and the MRO, in
Sec. 26.187(d)(6); (6) reporting and recordkeeping requirements of
this part as they related to the SAE function, in Sec. 26.187(d)(7);
and (7) appropriate methods for addressing issues that SAEs confront in
carrying out their duties under this part, in Sec. 26.187(d)(8).
The NRC has added Sec. 26.187(e) [Continuing education] to the
final rule to ensure that SAEs maintain the knowledge and skills
required to perform the SAE function. The paragraph requires SAEs to
complete at least 12 continuing professional education hours relevant
to performing the SAE function during each 3-year period following
completion of initial qualification training. Section 26.187(e)(1)
describes the topics that must be covered in the continuing education
training, to include, but not limited to, new drug and alcohol testing
technologies, and any rule interpretations or new guidance, rule
changes, or other developments in SAE practice under this part since
the SAE completed the qualification training requirements in Sec.
26.187(d). Section 26.187(e)(2) requires documented assessment of the
SAE's understanding of the material presented in the continuing
education activities in order to ensure that the SAE learned the
material. These continuing education requirements are necessary to
ensure that SAEs maintain updated knowledge and skills to continue
performing the SAE function effectively under this part.
The NRC has added Sec. 26.187(f) [Documentation] to the final rule
to specify the records that the SAE must maintain in order to
demonstrate that he or she meets the requirements of this section. The
SAE is required to provide the documentation, as requested, to NRC
representatives, and to licensees or other entities who rely on the
SAE's services. Licensees and other entities who intend to rely upon a
determination of fitness that is made by an SAE under another FFD
program are also required to have access to this documentation. These
requirements are necessary to ensure that licensees and other entities,
and the NRC, have access to the documentation required to verify that
the SAE's knowledge, training, and practice meet the requirements of
this part. The final rule, with respect to the proposed rule, adds a
cross-reference to ensure that this provision is consistent with the
protection of information requirements in Sec. 26.37 of this part.
The NRC has added Sec. 26.187(g) [Responsibilities and
prohibitions] to the final rule to specify the responsibilities of SAEs
within a licensee's or other entity's FFD program and their
limitations.
Section 26.187(g)(1) specifies at least three circumstances in
which the SAE is responsible for making a determination of fitness
under the rule. In Sec. 26.187(g)(1)(i), an SAE may be called upon to
make a determination of fitness regarding an applicant for
authorization when the self-disclosure, the suitable inquiry, or other
sources of information identify potentially disqualifying FFD
information about the applicant. In Sec. 26.187(g)(1)(ii), an SAE may
be called upon to make a determination of fitness when an individual
has violated the substance abuse provisions of a licensee's or other
entity's FFD policy, including, but not limited to a first confirmed
positive drug test result. Related provisions in Sec. 26.69 require
the licensee or other entity to rely upon the results of the SAE's
determination of fitness when making a decision to grant or maintain an
individual's authorization and implement any recommendations from the
SAE for treatment and followup testing. In Sec. 26.187(g)(1)(iii), an
SAE may be called upon to make a determination of fitness when there is
a concern that an individual may be impaired as a result of the use of
prescription or over-the-counter medications or alcohol. Related
provisions in Sec. 26.77 [Management actions regarding possible
impairment] require the licensee or other entity to rely upon the
results of the SAE's determination of fitness when determining whether
an individual may perform duties that require the individual to be
subject to this part. Therefore, the NRC has added the paragraph for
consistency with other related provisions in the rule.
The NRC has added Sec. 26.187(g)(2) to the final rule to require
the SAE to act as a referral source to assist an individual's entry
into an appropriate treatment or education program. The provision also
prohibits the SAE from engaging in any activities that could create the
appearance of a conflict of interest. Section 26.187(g)(2)(i) prohibits
the SAE from referring an individual to any organization with whom the
SAE has a financial relationship, including the SAE's private practice,
to avoid creating the appearance of a conflict of interest. However,
Sec. 26.187(g)(2)(ii)(A) through (g)(2)(ii)(D) specifies circumstances
in which the prohibition in Sec. 26.187(g)(2)(i) does not apply. In
general, the rule permits the SAE to refer an individual to an entity
with whom the SAE has a financial relationship in situations where
treatment and educational resources may be limited by cost
considerations or geographical availability. These provisions are
necessary to ensure that the SAE's determinations are not influenced by
financial gain and that individuals who are subject to the rule and the
public can have confidence in the integrity and independence of the SAE
function in Part 26 programs.
Section 26.189 Determination of Fitness
The NRC has added Sec. 26.189 to the final rule to present in one
section and amend former requirements related to the determination that
an individual is fit to safely and competently perform the duties that
require individuals to be subject to this part.
The final rule replaces the terms ``medical assurance'' and
``medical determination of fitness'' used in various sections of the
former rule (e.g., Sec. 26.27(a)(3), (b)(2) and (b)(4)) with the term
``determination of fitness'' as defined in this section. The NRC has
made this change in terminology because the rule permits healthcare
professionals other than licensed physicians to conduct determinations
of fitness, as discussed with respect to Sec. 26.187 [Substance abuse
expert].
[[Page 17117]]
Therefore, the change meets Goal 6 of this rulemaking to improve
clarity in the organization and language of the rule.
The NRC has added Sec. 26.189(a) to the final rule. The first
sentence of the paragraph defines the term ``determination of
fitness.'' This term refers to the process entered when there are
indications that an individual may be in violation of the licensee's or
other entity's FFD policy or is otherwise unable to safely and
competently perform his or her duties. The final rule amends this
definition as it was proposed, due to public comment, to clarify the
intent of the provision.
In general, the final rule requires that professionals who perform
determinations of fitness must be qualified and possess the requisite
clinical experience, as verified by the licensee or other entity, to
assess the specific fitness issues presented by an individual whose
fitness may be questionable. The approach to designating the healthcare
professionals who may conduct a determination of fitness focuses on the
appropriateness of the professional's expertise for addressing the
subject individual's fitness issue, rather than on the professional's
organizational affiliation [see the discussion of Sec. 26.69(b)(4)] or
whether the individual is a licensed physician. Therefore, Sec.
26.189(a)(1) through (a)(5) provides examples of the healthcare
professionals who are qualified to address various fitness issues that
may arise in a FFD program. When a decision must be made to determine
whether an individual may be granted or maintain authorization and a
substance abuse disorder is involved, only professionals who meet the
requirements to serve as an SAE are permitted to make determinations of
fitness under Sec. 26.189(a)(1). The final rule permits other
healthcare professionals to perform determinations of fitness that
involve assessing and diagnosing impairment from causes other than
substance abuse, such as clinical psychologists in Sec. 26.189(a)(2),
psychiatrists in Sec. 26.189(a)(3), physicians in Sec. 26.189(a)(4),
or an MRO in Sec. 26.189(a)(5), consistent with their professional
qualifications. The final rule also permits other licensed and
certified professionals who are not listed in the paragraph, such as
registered nurses or physicians' assistants who have the appropriate
training and qualifications, to perform a determination of fitness
regarding specific fitness issues that are within their areas of
expertise. However, the critical tasks of assessing the presence of a
substance abuse disorder, providing input to authorization decisions,
and developing treatment plans are reserved for healthcare
professionals who have met the specific training, clinical experience,
and knowledge requirements for an SAE under Sec. 26.187 for the
reasons discussed with respect to that section.
The final rule also prohibits healthcare professionals who may
conduct a determination of fitness for a Part 26 program from
addressing fitness issues that are outside of their specific areas of
expertise, consistent with the ethical standards of healthcare
professionals' disciplines as well as State laws. The rule adds this
prohibition to clarify that the ethical standards and State laws also
apply to making determinations of fitness under Part 26 because a
determination of fitness conducted by a professional who is not
qualified to address the specific fitness issue would be of
questionable validity. Therefore, the prohibition is necessary to meet
Goal 3 of this rulemaking to improve the effectiveness and efficiency
of FFD programs, as well as Goal 7 to protect the privacy and other
rights (including due process rights) of individuals who are subject to
Part 26.
Section 26.189(b)(1) through (b)(4) of the final rule lists and
presents together the circumstances in which a determination of fitness
must be performed, as required in other sections of the rule. Although
this paragraph is redundant with other sections of the rule, these
circumstances are listed in one paragraph to meet Goal 6 of this
rulemaking to improve clarity in the organization and language of the
rule, by grouping related requirements together in the order in which
they would apply to licensees' and other entities' FFD processes.
Section 26.189(b)(1) reiterates the requirement in former Section
2.9(f) in Appendix A to Part 26 and Sec. 26.185(k) of the final rule
that a determination of fitness must be performed when there is a
medical explanation for a positive, adulterated, substituted, or
invalid test result, but a potential for impairment exists. For
example, legitimate use of some psychotropic medications or medications
for pain relief may cause impairment in some individuals and it may be
necessary to limit the types of tasks the individual performs until the
medication is no longer necessary or the person adjusts to its effects.
Section 26.189(b)(2) reiterates requirements in former Sec.
26.27(b)(1) and (b)(4) and Sec. 26.69(b) [Authorization after a first
confirmed positive drug or alcohol test result or a 5-year denial of
authorization] of the final rule that a determination of fitness must
be performed before an individual is granted authorization following an
unfavorable termination or denial of authorization for a violation of a
licensee's or other entity's FFD policy.
Section 26.189(b)(3) reiterates the requirement in Sec. 26.69(c)
[Granting authorization with other potentially disqualifying FFD
information] that a determination of fitness must be performed before
an individual is granted authorization when potentially disqualifying
FFD information is identified that has not been previously addressed
and resolved under the requirements of this subpart.
Section 26.189(b)(4) addresses other circumstances in which a
determination of fitness may be required. For example, a determination
of fitness may be necessary if an FFD concern has been raised regarding
another individual, as required in Sec. 26.27(c)(4), and if a
licensee's or other entity's reviewing official requires one, under
Sec. 26.69(c)(3) and (d)(2).
The NRC has added Sec. 26.189(c) to the final rule to establish
requirements for a determination of fitness that is conducted ``for
cause.'' Specifically, Sec. 26.189(c) requires that a determination of
fitness that is conducted for cause must be conducted through face-to-
face interaction. With respect to the proposed rule, the final rule
clarifies that a face-to-face interaction is required only when there
is observed behavior or a physical condition. This provision ensures
that the professional who is performing the determination has available
all of the sensory information that may be required for the assessment,
such as the smell of alcohol or the individual's physical appearance.
The NRC does not require a for-cause determination of fitness to be
conducted under this section if there is an absence of physical or
sensory information (i.e., based solely on receiving information that
an individual is engaging in substance abuse). The immediacy of the
decision limits the amount of information that can be gathered and made
available to the professional by others. The provision does not require
that determinations of fitness for other purposes be conducted face-to-
face. These other purposes may include, but are not limited to, the
determination of fitness that is required when an applicant for
authorization has self-disclosed potentially disqualifying FFD
information. Determinations of fitness in these other circumstances
would focus primarily on historical, rather than immediate,
information. In these cases, the professional would have access to
information that could be gathered by others about the individual,
[[Page 17118]]
and no time urgency would be involved in the evaluation. Therefore, NRC
has added the paragraph to meet Goal 3 of this rulemaking to improve
the effectiveness and efficiency of FFD programs. This provision also
requires a face-to-face assessment in some circumstances where
electronic means of communication could not provide the requisite
information for the evaluation. It also permits other means of
conducting the assessment when those means provide increased
flexibility to licensees and other entities while continuing to achieve
the goal of the evaluation.
Section 26.189(c)(1) through (c)(2) specifies the required outcomes
of a for cause determination of fitness. The final rule provides an
increased level of detail in these requirements to increase consistency
in implementing the for cause determination of fitness process among
FFD programs for the reasons discussed with respect to Sec. 26.187.
Section 26.189(c)(1) requires that, if there is neither conclusive
evidence of an FFD policy violation nor a significant basis for concern
that the individual may be impaired while on duty, then the individual
must be determined to be fit for duty. The licensee or other entity
shall permit the individual to perform the duties that require the
individual to be subject to this part.
Section 26.189(c)(2) requires that, if there is no conclusive
evidence of an FFD policy violation, but there is a significant basis
for concern that the individual may be impaired while on duty, then the
individual must be determined to be unfit for duty. Such a
determination does not constitute a violation of Part 26 or the
licensee's or other entity's FFD policy. Therefore, no sanctions shall
be applied. Examples of circumstances in which an individual may be
determined to be unfit under this paragraph could include a temporary
illness, such as a severe migraine headache, or transitory but severe
stress in a personal relationship. These circumstances may impact an
individual's ability to work safely for a short period, but would have
no implications for the individual's overall fitness to perform the
duties that require the individual to be subject to this part. In
addition, the final rule requires the professional who conducts the
determination of fitness to consult with the licensee's or other
entity's management personnel to identify and implement any necessary
limitations on the impaired individual's activities to ensure that the
individual's condition would not affect workplace or public health and
safety. If appropriate, the individual may be referred to the EAP for
assistance.
The NRC has added Sec. 26.189(d) to the final rule to prohibit
licensees and other entities from seeking a second determination of
fitness if a determination of fitness under Part 26 has already been
performed by a qualified professional who is employed by or under
contract to the licensee or other entity. The paragraph also requires
that the professional who made the initial determination must be
responsible for modifications to the initial determination based on new
or additional information. However, if the initial professional is no
longer available, then the licensee or other entity is required to
assist in arranging for consultation between a new professional and the
professional who is no longer employed by or under contract to the
licensee or other entity. The paragraph is necessary to ensure
consistency and continuity in the treatment of an individual who may be
undergoing treatment, aftercare, and followup testing. Therefore, this
addition meets Goal 3 of the rulemaking to improve the effectiveness
and efficiency of FFD programs.
Subpart I--Managing Fatigue
Section 26.201 Applicability
Section 26.201 specifies the licensees and other entities to whom
the requirements in Subpart I apply. This section replaces, with
limited editorial changes, Sec. 26.195 of the proposed rule. Subpart I
applies to licensees who are authorized to operate a nuclear power
reactor (under Sec. 50.57 [Issuance of operating license] of this
chapter) and holders of a combined license after the Commission has
made the finding under Sec. 52.103(g) [Operation under a combined
license] of this chapter, as specified in Sec. 26.3(a), and licensees
and other entities specified in Sec. 26.3(c) at the time the licensee
or other entity receives special nuclear material in the form of fuel
assemblies. Also, Subpart I applies to Contractors/Vendors (C/Vs) who
implement FFD programs or program elements upon which these licensees
rely, as specified in Sec. 26.3(d). As discussed in Section IV.D, the
final rule requires nuclear power plant licensees to implement the
requirements in Subpart I for the following reasons:
(1) Fatigue and decreased alertness can substantively degrade an
individual's ability to safely and competently perform his or her
duties.
(2) Conditions that contribute to worker fatigue are prevalent in
the U.S. nuclear power industry.
(3) With the exception of NRC orders limiting the work hours of
security personnel, the former NRC regulatory framework did not include
consistent requirements to prevent worker fatigue from adversely
impacting safe operations and the former requirements are difficult to
readily and efficiently enforce.
(4) Reviews of nuclear power plant licensees' controls on work
hours have repeatedly identified practices that are inconsistent with
the NRC Policy on Worker Fatigue, including excessive work hours and
the overuse of work hour limit deviations.
(5) The former regulatory framework was comprised of requirements
that were inadequate and incomplete for effective fatigue management.
(6) Ensuring effective management of worker fatigue through
rulemaking substantially enhances the effectiveness of FFD programs
(i.e., the new requirements are cost-justified safety enhancements)
and,
(7) Preventing the fatigue of workers in safety-critical positions
through regulation is consistent with practices in foreign countries
and other industries in the United States.
The requirements in the final rule also apply to C/Vs who implement
FFD programs or program elements, to the extent that nuclear power
plant licensees rely upon those C/V FFD programs or program elements to
meet the requirements of this part. This final rule provision permits a
licensee to rely on the fatigue management program of a C/V, which is
consistent with former Sec. 26.23(a), so long as the C/V relies on
licensee-approved FFD programs and program elements, as retained in
Sec. 26.3 [Scope].
Subpart I does not apply to the materials licensees who are
otherwise subject to Part 26 (see Sec. 26.3) for two reasons. First,
NRC analyses indicate that significant offsite radiological exposure is
not a realistic accident consequence at a materials facility that is
subject to Part 26 regulations because of the nature of the radioactive
materials that are involved and the multiple layers of controls that
NRC regulations require. Second, no analysis has been done to date to
determine if there is evidence of excessive overtime use by the
materials licensees. Therefore, at this time, the final rule does not
impose the requirements of Subpart I on materials licensees. However,
requirements to prevent fatigue from adversely affecting the job
performance of security personnel at materials facilities provide a
substantial enhancement to the security of these facilities. In SRM-
COMSECY-04-0037,
[[Page 17119]]
``Staff Requirements: Fitness-For-Duty Orders to Address Fatigue of
Nuclear Facility Security Force Personnel,'' dated September 1, 2004,
the Commission determined that FFD program enhancements related to the
fatigue of security force personnel at independent spent fuel storage
installations, decommissioning reactors, Category I fuel cycle
facilities, gaseous diffusion plants, and the natural uranium
conversion facility should be pursued as a separate rulemaking activity
with additional stakeholder interactions.
Section 26.203 General Provisions
Section 26.203 establishes fatigue management requirements for
licensees' FFD programs. This section replaces Sec. 26.197 of the
proposed rule with limited editorial changes. These editorial changes
include the addition of recordkeeping requirements under Sec.
26.197(d) and the removal of collective work hour requirements from
Sec. 26.197(e)(2) of the proposed rule. The general provisions in this
section establish requirements for licensees' fatigue management
policies, procedures, training, examinations, recordkeeping, and
reporting. The NRC's objective in establishing these general provisions
is to facilitate integrating fatigue management into licensees' FFD
programs, as discussed in Section IV.D.
Section 26.203(a) [Policy] requires each licensee to have a written
policy statement that describes its management's expectations and
methods for managing fatigue to ensure that fatigue does not adversely
affect any individual's ability to safely and competently perform his
or her duties. This section replaces Sec. 26.197(a) of the proposed
rule with limited editorial changes. The policy required in this
section will apply to all individuals subject to the licensee's FFD
program and not just those individuals subject to the work hour
requirements presented in Sec. 26.205 [Work hours], which contains the
revised work hour requirements presented in proposed Sec. 26.199. The
NRC considers the responsibility for ensuring that each individual is
fit to safely and competently perform his or her duties to be shared
between the licensee and the individuals who perform duties on the
licensee's behalf. Therefore, the final rule requires each licensee's
FFD policy to delineate the licensee's fatigue management policy. Thus,
individuals who are subject to this policy will be aware of and can
comply with the fatigue management requirements for which they will be
held accountable. The final rule requires each licensee to incorporate
the fatigue management policy statement into the written FFD policy
that is required under Sec. 26.27(b) [Policy]. As discussed with
respect to Sec. 26.27(b), the final rule requires the policy statement
to be clear, concise, and readily available, in its most current form,
to all individuals who are subject to the policy.
The NRC's past experience with worker fatigue, such as that
documented in NRC Regulatory Issue Summary (RIS) 2002-007,
``Clarification of NRC Requirements Applicable to Worker Fatigue and
Self-Declarations of Fitness-For-Duty,'' dated May 10, 2002 (referred
to in this document as RIS 2002-007), indicates that a need exists for
individuals to clearly understand their own fatigue management
responsibilities, as well as those of the licensee. These
responsibilities include the individual's duty to report FFD concerns,
including concerns related to the impact of fatigue on the individual's
ability to safely and competently perform his or her duties, as well as
concerns related to others, and the licensee's obligation to assess
such fatigue-related FFD concerns. Further, the final rule does not
prohibit licensees from imposing sanctions on individuals who fail to
comply with the portions of the licensees' fatigue management policies
that assign certain responsibilities to individuals. For example, a
licensee may impose sanctions on an individual who fails to seek
recommended treatment for a sleep disorder that, as part of a
determination of fitness performed in accordance with Sec. 26.189
[Determination of fitness], a healthcare professional has determined is
adversely affecting the individual's job performance and potentially
could be medically resolved. The final rule does not establish minimum
sanctions for specific failures to comply with such fatigue management
requirements because the reasons that an individual may report to work
in a fatigued state are varied and often highly personal. Rather, the
NRC prefers to permit licensees and the appropriate healthcare
professionals to respond to such circumstances on a case-by-case basis.
However, to protect an individual's rights under the rule, it is
necessary for a licensee's fatigue management policies to communicate
any sanctions that the licensee may impose on an individual for failing
to comply with the policy's requirements.
Section 26.203(b) [Procedures] requires each licensee to develop,
implement, and maintain procedures to carry out the fatigue management
policy that Sec. 26.203(a) [Policy] requires. Procedures are necessary
to ensure that licensees' fatigue management programs are properly and
consistently implemented. This section replaces Sec. 26.197(b) of the
proposed rule with limited editorial changes.
Section 26.203(b)(1) requires licensees to develop, implement, and
maintain procedures that describe the process that an individual
subject to the licensee's FFD program should follow when reporting to a
supervisor that he or she is unfit for duty because of fatigue (i.e.,
he or she makes a self-declaration). In RIS 2002-007, the NRC noted
that self-declaration is an important adjunct to behavioral observation
in meeting the requirements of the performance objective in former
Sec. 26.10(b) (as retained in Sec. 26.23(c)), which is ``to provide
reasonable measures for the early detection of persons who are not fit
to perform the duties that require them to be subject to this part.''
Because individuals are the first line of defense against the potential
for fatigue-related impairment to adversely affect their job
performance, it is essential that all individuals who are subject to a
licensee's FFD program understand when and how to make a self-
declaration that they are unfit for duty. Individuals must also
understand how the licensee's response to a worker's self-declaration
will differ from a licensee's response to an individual's general
statement of fatigue (e.g., casually commenting to a co-worker, ``I'm
really tired today''), if the individual does not express a concern
that is specific to his or her FFD (e.g., formally stating to a
supervisor, ``I am too tired right now to check these valve lineups
accurately'').
Section 26.203(b)(1)(i) requires the licensee's self-declaration
procedure to describe the responsibilities and rights of individuals
and licensees and the actions they must take with respect to an
individual's self-declaration of fatigue. The licensee's self-
declaration procedure may explain the employees' right to know what is
going to happen to them if they self-declare, including any sanctions
that may be imposed on them. The procedure may also describe the
employees' right to privacy regarding the causes for the self-
declaration. This section ensures that all parties involved in the
self-declaration process understand the process and responsibilities
and the extent and limitations of their rights related to self-
declaration. The NRC has considered industry experience with
individuals refusing to report to work on the basis that they were too
tired. The NRC concluded that detailed procedures are necessary to
specify (1) the individual's
[[Page 17120]]
responsibility to be available at work for a fatigue assessment, which
must be conducted face-to-face under Sec. 26.211(b) for the reasons
discussed with respect to that section, (2) the individual's
responsibility to cooperate with the fatigue assessment process by
providing the necessary information (see the discussion of Sec.
26.211(c)(2)), and (3) the licensee's responsibility for conducting a
fatigue assessment in response to an individual's self-declaration, as
required under Sec. 26.211(a)(2), to determine whether, and under what
controls and conditions if any, the individual is permitted or required
to work. Section 26.211 [Fatigue assessments] retains with, limited
editorial changes, the requirements in proposed Sec. 26.201
[Applicability].
Section 26.203(b)(1)(ii) requires the licensee's self-declaration
procedure to describe requirements for establishing controls and
conditions under which an individual is permitted or required to
perform work after that individual declares that he or she is not fit
for duty as a result of fatigue. This portion of the procedure ensures
correct and consistent implementation of the requirements in Sec.
26.211(b), which states that a supervisor or staff member of the FFD
program must conduct the fatigue assessment and determine whether, and
under what conditions, an individual who has self-declared can be
returned to duty. For example, the licensee's procedure will provide
guidance on establishing appropriate controls and conditions under
which an individual could be permitted or directed to return to work
after declaring that he or she is unfit because of fatigue. Controls
and conditions will include, but will not be limited to, (1) controls
on the type of work to be performed (e.g., physical or mental, tedious
or stimulating, individual or group, risk-significant or not), (2) the
required level of supervision (continuous or intermittent) and other
oversight (e.g., peer checks, independent verifications, quality
assurance reviews, and operability checks), and (3) the need to
implement fatigue countermeasures (e.g., naps, rest breaks). The
purpose of the controls and conditions is to mitigate the risks to
public health and safety or the common defense and security that a
fatigue-induced human error could pose, as discussed in Section IV.D.
Section 26.203(b)(1)(iii) requires licensee procedures to describe
the processes to be followed if an individual disagrees with the
results of a fatigue assessment conducted in response to the
individual's self-declaration. These procedures will address situations
in which the individual disagrees with the licensee's determination
either that the individual is capable of performing work safely (with
appropriate controls and conditions, if necessary) or that the
individual cannot safely be permitted to perform the duties listed in
Sec. 26.205(a) [Individuals subject to work hour controls] because of
fatigue. For example, the licensee's procedure may refer an individual
who disagrees with the outcome of the fatigue assessment to the
bargaining unit to initiate a grievance process, the employee concerns
program, or the corrective action program.
The final rule adds this requirement for several reasons. First, in
RIS 2002-007, the NRC documented concerns associated with past
instances of self-declaration. These instances indicate the need for
licensees to describe the processes to be followed if an individual
disagrees with the results of a fatigue assessment following a self-
declaration. In addition, at the public meetings discussed in the
preamble to the proposed rule, several stakeholders asked the NRC to
add this provision to the final rule to ensure that individuals have
recourse if they disagree with the results of a fatigue assessment
conducted in response to a self-declaration. Some of the stakeholders
expressed a concern for the potential impact on public health and
safety if an individual is convinced that he or she is too fatigued to
perform work safely, but the licensee requires the individual to work.
Other stakeholders expressed concerns that an individual may experience
adverse employment and financial consequences if he or she is prevented
from working because of fatigue.
The NRC agrees that licensee policies and procedures related to
implementing the requirements of this subpart must address these
potential issues to protect the rights of individuals subject to the
rule. However, the final rule does not establish specific requirements
for the process(es) to be followed in such instances for two reasons,
(1) licensees have already implemented a number of processes for
addressing similar safety and employment issues that provide
appropriate mechanisms for resolving fatigue-related issues, and (2)
the wide variety of possible issues that may arise limits the ability
of a single mechanism established in the final rule to appropriately
address them all. Therefore, the final rule requires licensees to have
procedures for addressing situations in which an individual who has
self-declared disagrees with the outcome of a fatigue assessment, but
it does not require a new process or specify the required
characteristics of the licensees' process(es).
Section 26.203(b)(2) requires licensees to develop, implement, and
maintain procedures that describe the process for implementing the work
hour requirements in Sec. 26.205. For example, the procedures will
detail individual and organizational responsibilities and requirements,
including items such as scheduling, tracking and calculating work
hours, granting waivers from the individual work hour requirements,
reviewing the implementation of the work hour requirements, documenting
the results of the reviews, and implementing any necessary corrective
actions. These procedures are necessary to ensure that individuals
understand the work hour requirements to which they are subject and
that licensees consistently implement the work hour requirements in
Sec. 26.205 as the NRC intends.
Section 26.203(b)(3) requires licensees to develop, implement, and
maintain procedures that describe the process(es) they will follow in
conducting a fatigue assessment, as required under Sec. 26.211(a).
These procedures will establish the methods by which the licensee will
determine whether an individual is fatigued, whether the individual
will be permitted or required to perform work, and whether controls and
conditions are necessary for the individual to be able to perform work
safely and competently. The licensee's procedure will address fatigue
assessments that are conducted following an individual's self-
declaration or an event, for cause, or to reassess an individual after
returning the individual to work despite a self-declaration of fatigue
(the situations in which the final rule requires licensees to conduct
fatigue assessments are discussed in Sec. 26.211(a)). Because of the
potentially subjective and personal nature of the fatigue assessment
task and the potential for conflict and sanctions (e.g., if an
individual is found to have been asleep while on duty), comprehensive
procedures are necessary to ensure consistent implementation of the
fatigue assessment requirements in Sec. 26.211. Therefore, the NRC
expects these procedures to describe measures to ensure that fatigue
assessments (1) are performed by properly trained personnel, (2) are
free of bias, (3) methodically address the factors that commonly
contribute to fatigue, (4) are based on complete and accurate
information, (5) protect the privacy of the individuals being assessed,
(6) recognize the fact that an individual can
[[Page 17121]]
be fatigued and unfit for duty even though he or she has not exceeded
the work hour limits, (7) are thoroughly documented, and (8) are
reviewed, as required by Sec. 26.205(e)(1)(iii). These procedures are
necessary to implement the requirements in this subpart and protect the
privacy rights and other rights of individuals, consistent with Goal 7
of this rulemaking.
Section 26.203(b)(4) requires licensees to develop, implement, and
maintain procedures that describe the disciplinary actions they may
impose on individuals, if any, following a fatigue assessment (e.g.,
termination or leave without pay) and the conditions and considerations
for imposing those disciplinary actions. In the final rule, the NRC
revised Sec. 26.203(b)(4) to replace the word ``sanctions'' with the
words ``disciplinary actions'' to avoid confusion that might develop
from the multiple meanings of the word ``sanctions.'' During the public
meetings discussed in the preamble to the proposed rule, several
industry representatives indicated that licensees may rely upon the
results of a fatigue assessment as the basis for determining that an
individual has not met management expectations for maintaining his or
her FFD. Although the NRC neither endorses nor prohibits the imposition
of disciplinary actions in cases of fatigue, clear communication
regarding possible disciplinary actions and the considerations for
taking those disciplinary actions is necessary for individuals to meet
their responsibility for self-declaration without unwarranted fear of
potential outcomes. For this reason, procedures are necessary to ensure
that licensees fully disclose the conditions under which disciplinary
actions will be considered; the nature of the possible disciplinary
actions; and the process for administering and imposing the
disciplinary actions, including management's expectations and the
individual's right to a review of the determination that he or she has
violated the FFD policy, as required under Sec. 26.39 [Review process
for fitness-for-duty policy violations].
Section 26.203(c) [Training and examinations] establishes fatigue-
related training and examination requirements in addition to those
required under Sec. 26.29(a) [Training content] and (b) [Comprehensive
examination]. This section retains without change the requirement in
Sec. 26.197(c) of the proposed rule. Several of the knowledge and
abilities (KAs) requirements listed in Sec. 26.29(a) ensure that
individuals are familiar with a licensee's or other entity's fatigue
policies and procedures. However, individuals who are subject to
Subpart I should also have a working-level knowledge of specific,
fatigue-related topics that may facilitate personal decisions and
actions that are consistent with the objective of preventing,
detecting, and mitigating the adverse effects of fatigue on worker job
performance. Individual workers typically do not possess these KAs
without training (Folkard and Tucker, 2003; Knauth and Hornberger,
2003; Monk, 2000). Therefore, the final rule requires licensee FFD
training and testing programs to address the topics specified in Sec.
26.203(c)(1) and (c)(2).
Section 26.203(c)(1) requires FFD training and examinations to
ensure that individuals who are subject to Subpart I understand the
contributors to worker fatigue, circadian variations in alertness and
performance, indications and risk factors for common sleep disorders,
shiftwork strategies for obtaining adequate rest, and the effective use
of fatigue countermeasures. Examples of topics that licensee training
and examinations will address that are related to this KA will include,
but are not limited to, (1) the principal factors that influence worker
fatigue, (2) knowledge that a worker's ability to perform and remain
alert is influenced by physiological changes that follow a daily
pattern, (3) the time periods during which workers are most likely to
exhibit degraded alertness and performance, (4) the principal symptoms
of common sleep disorders (e.g., sleep apnea and insomnia) and the
conditions that can contribute to their onset, (5) the methods for
optimizing sleep periods on a shiftwork schedule, and (6) how to safely
and effectively counteract fatigue with measures such as caffeine and
strategic napping. Knowledge of these topics is necessary to ensure
that individuals are able to (1) self-manage fatigue that is caused by
shiftwork and factors other than work hours, (2) take actions to
maintain their alertness at work, and (3) recognize and seek treatment
for sleep disorders that might be creating or exacerbating their own
fatigue. In addition, training in methods for coping with the
challenges of shiftwork may contribute to a more stable workforce by
reducing worker turnover. A Circadian Technologies, Inc. survey of 550
facilities in the United States and Canada found that turnover at
facilities with operations extending beyond 7 a.m. to 7 p.m. averaged
10 percent in 2003, compared with 3.4 percent in all U.S. companies.
Facilities offering no training on specific coping strategies had an
average turnover rate of 11.4 percent, compared to 7.6 percent for
facilities that offered such training to their employees, and 2.9
percent for those offering the training to employees and their family
members (Circadian Technologies, Inc., 2004).
Section 26.203(c)(2) requires FFD training and examinations to
ensure that individuals who are subject to Subpart I have the ability
to identify symptoms of worker fatigue and contributors to decreased
alertness in the workplace. Examples of topics that are related to this
KA will include, but are not limited to, (1) behavioral symptoms of
fatigue (e.g., yawning, red eyes, prolonged or excessive blinking,
irritability), (2) task conditions that may contribute to degraded
alertness and increased fatigue (e.g., repetitive tasks, tasks with
high cognitive or attentional demands, tasks that require the
individual to be sedentary, tasks that limit social interaction), and
(3) environmental conditions that may contribute to degraded alertness
and increased worker fatigue (e.g., high heat and humidity, low
lighting, and low-frequency noise/white noise). Requiring individuals
to be trained on this KA is necessary to ensure that an individual is
able to determine when it is appropriate to self-declare that he or she
is unfit for duty because of fatigue, as permitted under Sec. 26.209
[Self-declarations] and Sec. 26.211(a)(2), and to determine when it is
appropriate to report an FFD concern about another individual who,
based on behavioral observations, is exhibiting indications of fatigue,
as required under Sec. 26.33 [Behavioral observation].
Section 26.203(d) [Recordkeeping] establishes recordkeeping
requirements related to the implementation of Subpart I. This section
includes, with revisions, the requirements presented in Sec. 26.197(d)
of the proposed rule. Specifically, Sec. 26.203(d)(1), which retains
Sec. 26.197(d)(1) of the proposed rule without change, requires
licensees to retain records of the number of hours worked by
individuals who are subject to the work hour requirements established
in Sec. 26.205. Section 26.203(d)(2) requires licensees to retain
records of shift schedules and shift cycles of individuals who are
subject to the work hour requirements established in Sec. 26.205. The
NRC added this requirement to the final rule. Section 26.203(d)(3)
through (d)(5) retains the requirements in proposed Sec. 26.197(d)(2)
through (d)(4) without changes. Specifically, Sec. 26.203(d)(3)
requires licensees to retain records of the number of, and the bases
for, waivers they have granted, Sec. 26.203(d)(4) requires licensees
to retain documentation of the work hour reviews that are required
under Sec. 26.205(e)(3) and (e)(4), and
[[Page 17122]]
Sec. 26.203(d)(5) requires retaining documentation of any fatigue
assessments licensees conduct. The NRC removed the proposed Sec.
26.197(d)(5) from the final rule because the NRC eliminated the
collective work hour requirements. The final rule establishes these
recordkeeping requirements for four reasons: (1) These records are
necessary to ensure that documentation of the licensee's fatigue
management program is retained and available for NRC inspectors to
verify that licensees are complying with the work hour requirements and
waiver and fatigue assessment provisions, (2) the documentation is
necessary for a review process under Sec. 26.39 or in legal
proceedings related to a determination that an individual has violated
the fatigue provisions of an FFD policy, (3) the documentation is
necessary to perform the trending and self-assessments that Sec.
26.205(e) [Reviews] requires; and (4) the documentation is necessary to
meet the reporting requirements in Sec. 26.203(e) [Reporting]. To
ensure that the records remain available for NRC inspections and the
review process or legal proceedings, the final rule requires licensees
to retain these records for 3 years or until the completion of any
related legal proceedings, whichever is later.
Section 26.203(e) [Reporting] requires licensees to report to the
NRC certain data related to their fatigue management programs as part
of the annual FFD program performance report, which Sec. 26.717
[Fitness-for-duty program performance data] requires. This requirement
replaces, with revisions, Sec. 26.197(e) of the proposed rule. This
section is revised to specify that reports are required in a standard
format. The final rule requires licensees to include the following
information in the annual report: (1) Information on the number of
waivers granted from work hour requirements in the previous calendar
year, and (2) a summary of corrective actions, if any, resulting from
the analyses of these data, including fatigue assessments. This section
does not retain the requirements in the proposed Sec. 26.197(e)(2) for
the reporting of information pertaining to the control of collective
work hours because the final rule does not include collective work hour
limits. In addition, this section does not retain the proposed rule
requirement for licensees to report a summary of instances of fatigue
assessments that the licensee conducted.
The NRC considered comments that the requirements for including
fatigue management information should be deleted from the rule because
they will not provide new or unique information to the NRC, are
unnecessary to protect public health and safety, are unnecessary to
facilitate NRC oversight of the revised rule, and are unduly
burdensome. In choosing to retain reporting requirements for waiver
use, the NRC considered several aspects of the work hour requirements
in the final rule. First, the NRC established the work hour limits in
the final rule at levels such that the potential for fatigue is
substantive for individuals working in excess of those limits. Second,
the rule permits licensees to authorize waivers of the limits only for
circumstances in which the additional work hours are necessary to
prevent or mitigate a condition adverse to safety or security. Finally,
the rule only requires a waiver if the individual is operating or
maintaining an SSC that a risk-informed evaluation process has shown to
be important to the protection of public health and safety or if the
individual is performing specified functions that are essential to an
effective response to a fire, plant emergency, or implementation of the
site security plan. As a result, information concerning licensee use of
waivers indicates (1) the number of hours worked on risk-significant
activities by individuals at increased potential for impairment, and
(2) how often a licensee must mitigate or prevent a condition adverse
to safety while using individuals at increased potential for
impairment. The NRC considers this unique information, not otherwise
reported, to be relevant to the agency's mission.
The NRC similarly considered the need to retain reporting
requirements regarding fatigue assessment and any management actions in
response to the fatigue assessments. The NRC concluded that the fatigue
assessment information that would have been reported under the proposed
rule requirements are more the purview of a licensee's corrective
action program, and would have been more detailed than the program
performance data for drug and alcohol testing required under Sec.
26.717(c) of the final rule. Accordingly, the final rule requires
licensees to report a summary of corrective actions, if any, resulting
from the licensee's analysis of waiver and fatigue assessment data. As
a consequence, the required reports will provide information that will
focus more on licensee performance in managing worker fatigue and will
enable the NRC to review licensee reporting of waivers in the context
of associated corrective actions.
The NRC expects that the information provided by licensees in
response to the annual reporting requirements in Subpart I will
facilitate NRC oversight of the implementation of the requirements
through the following means:
Consistency, efficiency, and continuity of NRC oversight--
Information provided through the annual FFD program performance reports
concerning fatigue management will enable the NRC to achieve a higher
level of consistency and efficiency in the oversight of the
implementation of the requirements in Subpart I and in the enforcement
of those requirements. Without the reporting requirements, the NRC's
inspection of licensee FFD programs would likely be limited to
individual inspectors evaluating licensee fatigue management for a
sample of workers at a site for a limited time period. These
assessments would necessarily be conducted without the benefit of
broader contextual information of the site and industry normative
information that would be available through the annual reports. In
contrast, the annual reports will help ensure a common perspective and
maintain consistency among inspectors conducting the oversight process.
In addition, the annual reports can enhance the efficiency of the NRC
inspection process by providing information necessary to allow the
agency to focus inspection resources on duty groups (e.g., security or
maintenance) or issues (e.g., self-declaration) that may warrant
review. The reports will enable the NRC to be better focused in
preparing for the inspection, reduce the burden of onsite inspection
hours, and potentially reduce the total number of hours required for a
baseline inspection. Furthermore, the annual reporting will also help
to achieve a more complete and continuous assessment of licensee
performance because the NRC intends to conduct the baseline inspection
of FFD programs only once every 2 years.
Evaluation of rule implementation for lessons learned--
Although the NRC and stakeholders have made extensive efforts to ensure
clear and enforceable requirements that are effective and practical for
the management of worker fatigue, the rule introduces the potential for
unintended consequences and lessons learned. In addition, changes in
the size and composition of the nuclear industry may have unforeseen
implications for site staffing and fatigue management. The NRC expects
that the site-specific and normative information obtained through the
annual reports can provide important insights regarding opportunities
to amend the rule to
[[Page 17123]]
improve its effectiveness or reduce unnecessary burden. The NRC notes
that such information was the basis for reducing the random testing
rate for drugs and alcohol required in the final rule.
Consistent interpretation of waiver criterion--The final
rule provides licensees the discretion to use waivers to exceed the
work hour limits, thereby allowing levels of work hours that could
adversely affect worker FFD. The principal basis for allowing waivers
is to reduce the additional staffing burden that licensees would
otherwise incur if waivers were not available to address exigent
circumstances. The annual reporting of waiver use will enable the NRC
to ensure that licensees use this discretion in a manner consistent
with the objectives of the rule and not as a means to compensate for a
lack of adequate staffing. Furthermore, although the use of waivers is
limited to conditions when the work hours are ``necessary to prevent or
mitigate a condition adverse to safety or security,'' the NRC
recognizes the potential for licensees to develop different
interpretations regarding this criterion. Some industry commenters on
the proposed rule took exception to the NRC's characterization of high
levels of waiver use at some sites as abuse. These commenters suggested
that differences in licensee waiver practices could be attributed to
the policy being subject to a number of interpretations during the many
years that it has been in effect. Regardless of the cause of the
differences in licensee use of work hour control waivers, the NRC
considers it prudent to address, through rulemaking, the lessons
learned from past implementation of the policy and provide a level of
oversight through the annual reporting requirement that will ensure
consistent implementation of the waiver criteria in the future.
In addition to the reasons cited in the preceding paragraphs
explaining the need for reporting requirements to ensure the effective
and efficient oversight of the implementation of the rule, the NRC
considers the reporting requirements to be justified and beneficial for
the following additional reasons:
Consistency with Part 26 requirements and performance
objective--The final rule retains the requirement that licensees report
the results of drug and alcohol testing and the performance objective
for reasonable assurance that individuals are not impaired from any
cause (Sec. Sec. 26.719 [Reporting requirements] and 26.23(b) of the
final rule, respectively). In addition, several studies discussed in
detail in Section IV.D of this document have demonstrated that worker
fatigue can produce levels of impairment that are comparable to blood
alcohol concentrations above the levels permitted by this rule.
Furthermore, given the frequency of worker concerns regarding fatigue
and the work scheduling practices that are common during outages, the
incidence of impairment from fatigue is likely to be greater than the
very low incidence of drug and alcohol use that is detected through
testing. The NRC therefore considers the reporting of information
pertaining to licensee management of worker fatigue to be consistent
with (1) the requirements for reporting information pertaining to drug
and alcohol testing, (2) the performance objective of this rulemaking
for licensees to implement a comprehensive FFD program, and (3) the
NRC's belief that the management of worker fatigue is no less important
to worker FFD than the effective detection and deterrence of drug and
alcohol use.
Public confidence--Public interest groups such as the UCS
and the Project on Government Oversight have commented at public
meetings that relevant information regarding worker fatigue is withheld
to either protect alleger identity or, in the case of security
personnel, plant security. In addition, several public media articles
have been published during the past 2 years reporting instances of
guards sleeping and guards fearing repercussions for refusing forced
and excessive overtime. Information submitted by licensees in the
annual reports will be publicly available and will reassure public
stakeholders that the NRC is appropriately cognizant of licensee
actions regarding fatigue management and that the NRC's oversight of
these activities is transparent to all stakeholders.
The burden is limited and justified--Section 26.203(e)
requires licensees to report information concerning management of
worker fatigue as part of the annual FFD program report. As a result,
the burden associated with this reporting requirement is an incremental
change to the reporting requirement for drug and alcohol testing. In
addition, the fatigue management information required by Sec.
26.203(e) is largely information that licensees will have already
generated to demonstrate compliance with other provisions of Subpart I.
As a result, the burden associated with the report will be largely
associated with compiling the information in an appropriate form and
reviewing that compilation. The NRC has reviewed the public comments
suggesting that the agency underestimated the number of clerical and
management hours associated with this requirement and has taken these
comments into consideration in estimating the burden of the reporting
requirements in Sec. 26.203(e) of the final rule. Nevertheless, the
NRC considers the burden associated with the annual reporting
requirements to be justified for the reasons described in this and the
preceding paragraphs.
The NRC also considered comments that the reporting requirement
ignores significant duplication in licensee efforts. The NRC agrees
that Sec. 26.205(e) of the final rule requires licensees to
periodically review and assess the effectiveness of the work hour
controls and that the licensee's corrective action program, which is
routinely inspected by the NRC, will document and trend these reviews.
However, as noted previously, the NRC considers the annual reports to
be a limited burden that will enable the NRC to provide more effective
and consistent oversight and achieve other objectives for the effective
implementation of the requirements in Subpart I.
Section 26.203(e)(1) requires licensees to provide the NRC with an
annual summary of all instances during the previous calendar year in
which the licensee waived each of the work hour controls specified in
Sec. 26.205(d)(1) and (d)(2) for each of the duties listed in Sec.
26.4(a)(1) through (a)(5). This section revises the requirements in
proposed Sec. 26.197(e)(1). The agency revised this reporting
requirement in response to comments that the required information would
not provide a meaningful indication of licensee performance in managing
work hours because a number of valid conditions may warrant waivers of
work hour controls.
Section 26.203(e)(1) revises the reporting requirements in proposed
rule Sec. 26.197(e)(1) to clarify that licensees are required to
report the number of waivers for each work hour requirement and not the
sum total of all waivers for all work hour requirements. For example,
if the licensee permits an operator to work 18 hours in a 24-hour
period three times in a year, another operator to work 80 hours in a 7-
day period, and another operator to take a rest break of only 6 hours
between shifts, then the licensee will report that it granted three
waivers of Sec. 26.205(d)(1)(i), one waiver of Sec.
26.205(d)(1)(iii), and one waiver of Sec. 26.205(d)(2)(i), for the
operations group that year. This clarification ensures that the waiver
information is reported at a level of detail that will enable the NRC
to know which limits
[[Page 17124]]
are most frequently exceeded and therefore better understand the
specific scheduling challenges to licensee management of worker
fatigue.
Section 26.203(e)(1) also requires licensees to include only those
waivers under which work was actually performed in the annual report.
This section contains requirements presented in Sec. 26.197(e)(1)(i)
of the proposed rule. The final rule retains this provision of the
proposed rule because it may sometimes be unnecessary for individuals
to work the extended hours for which a licensee planned when granting a
waiver. Licensees may anticipate that it will be necessary to waive one
or more of the work hour controls listed in Sec. 26.205(d)(1) and
(d)(2) in order to complete a task and so will implement the process
specified in Sec. 26.207 [Waivers and exceptions] for granting
waivers. However, on some occasions, the work will be finished sooner
than the licensee anticipated with the result that the waiver was
granted but no one was required to work an extended work period. The
final rule requires licensees to exclude waivers under which no work
was performed from the annual report because this circumstance provides
no meaningful information about the licensee's management of fatigue
during extended work periods.
Section 26.203(e)(1) further specifies that licensees shall report
all waivers granted for each of the work hour controls in Sec.
26.205(d)(1) through (d)(5) for those instances in which a single
extended work period required a waiver of more than one work hour
control. This section contains the requirements presented in Sec.
26.197(e)(1)(ii) of the proposed rule. For example, if an individual
works 12 hours on day 1 and on day 2 the licensee needs the individual
to work more than 16 hours to resolve a condition adverse to safety,
the licensee would need to authorize and report a waiver of Sec.
26.205(d)(1)(i), for exceeding 16 hours in a 24-hour period, and
(d)(1)(ii), for exceeding 26 hours in a 48-hour period. Although this
example included only one work period, both waivers are required and
must be reported because the potential for fatigue results not only
from the length of the workday (e.g., exceeding 16 hours of work in a
24-hour period) but also the cumulative effect of prior work (e.g.,
exceeding 26 hours of work in a 48-hour period).
Section 26.203(e)(1)(i) and (e)(1)(ii) requires licensees to report
whether work hour controls are waived for individuals working on normal
plant operations or working on outage activities. In establishing this
requirement the NRC considered comments that the use of waivers should
be considered in context. Through its review of authorized waivers from
the work hour limits in plant technical specifications, the NRC has
found that waivers are most frequently associated with outage
activities. Accordingly, the NRC has revised the final rule to require
licensees to report whether a waiver of the work hour requirements in
Sec. 26.205 was associated with an outage activity. This revision will
enable the NRC to better understand a site's changes in waiver use over
time and understand why certain annual reports for a given site may
indicate a heightened level of waiver use relative to the site's other
reports.
The NRC recognizes that outages are not the only cause of waivers;
however, the agency expects that most other causes of waiver use will
be for substantially shorter periods of time or involve smaller groups
of workers and that these other conditions would not have a substantive
effect on overall waiver use. For unique causes that may have more
substantive effects (e.g., licensee response to hurricanes), the NRC is
likely to be aware of or able to identify these conditions if they were
to significantly affect waiver use. Furthermore, the NRC intends to
consider waiver use in conjunction with the reported fatigue assessment
information. Therefore, the agency will be able to determine whether
waiver use may be associated with the incidence of fatigue assessments
conducted for cause, following events, or in response to self-
declarations by individuals asserting that they are not able to safely
and competently perform their duties because of fatigue. The NRC notes
that the frequency of waiver use (i.e., how often individuals exceed
the work hour limits while performing functions important to safety and
security) indicates the potential for worker fatigue to affect the
performance of these functions, regardless of whether a waiver is the
result of an activity associated with an outage or a cause that is
beyond the licensee's control.
Section 26.203(e)(1)(i) requires licensees to report the number of
instances in which each work hour control specified in Sec.
26.205(d)(1)(i) through (d)(1)(iii), (d)(2)(i) and (d)(2)(ii), and
(d)(3)(i) through (d)(3)(iv) was waived for individuals not working on
outage activities. Section 26.203(e)(1)(ii) requires licensees to
report the number of instances in which each work hour control
specified in Sec. 26.205(d)(1)(i) through (d)(1)(iii), (d)(2)(i) and
(d)(2)(ii), (d)(3)(i) through (d)(3)(iv), and (d)(4) and (d)(5)(i) was
waived for individuals working on outage activities. The differences
between Sec. 26.205(e)(1)(i) and (e)(ii) in the work hour requirements
specified reflects whether requirements are applicable to outage
activities.
Section 26.203(e)(1)(iii) requires licensees to report a summary
that shows the distribution of waiver use among the individuals within
each category of individuals Sec. 26.4(a) identifies. This summary
will show, for example, how many individuals received only one waiver
during the reporting period, how many individuals received two waivers,
how many received three waivers, and so on. This reporting requirement
enables the NRC to determine the extent to which waivers are
concentrated among a few individuals or distributed more broadly within
a group of individuals who perform the same duties. The NRC
incorporated this requirement in the final rule in response to comments
that the rule should also require licensees to report the number of
workers covered under Sec. 26.199(a) of the proposed rule to provide
an appropriate context for the annual reporting of waivers. The NRC
understood that the intent of this comment was to provide a basis for
evaluating the number of waivers from the work hour controls relative
to the number of individuals subject to those controls. The NRC chose
not to require licensees to report the number of individuals covered
under Sec. 26.4(a) of the final rule because that number will vary
throughout the course of the reporting period, particularly when the
reporting period includes a unit outage. In addition, the NRC believes
that the required distribution of waivers more effectively provides
context to the waiver use by indicating if the waivers were
concentrated among individuals performing a certain duty and if the
waiver use in a duty group was associated with relatively few
individuals or distributed among many individuals.
The waiver data that licensees are required to report to the NRC
under Sec. 26.203(e)(1)(i) through (e)(1)(iii) are important because
waivers represent ``assumed risk.'' As discussed in Section IV.D,
fatigued workers experience impaired cognitive functioning, including
difficulties in decisionmaking and maintaining attention. If a licensee
permits an individual to work extended hours that cause the individual
to become fatigued, the individual may experience momentary lapses in
attention or degraded decisionmaking from fatigue. These performance
degradations can be mitigated by establishing controls and conditions
[[Page 17125]]
under which the individual is permitted to work, as required under
Sec. 26.211(e). However, controls and conditions can reduce, but not
eliminate, the potential risks from fatigue-induced errors. The more
often that a licensee permits individuals to exceed work hour limits,
the more risk from fatigue-induced errors a licensee is assuming. The
risk of fatigue-induced errors increases further when an individual is
permitted to exceed more than one of the work hour limits contained in
Sec. 26.205(d)(1)(i) through (d)(1)(iii) because of the potential for
the combined effects of both acute and cumulative fatigue. Any waivers
from the rest breaks that are required under Sec. 26.205(d)(2) or the
minimum day off requirements of Sec. 26.205(d)(3) through (d)(5) will
also contribute to the accumulation of a sleep deficit, especially when
inadequate rest breaks are combined with long work hours. Repeated and
continual use of waivers may indicate a staffing or other programmatic
weakness at a site that warrants additional inspection resources.
Therefore, the NRC considers the number of waivers granted from the
work hour limits to be a key element in evaluating FFD program
performance.
Section 26.203(e)(2) requires that licensees include in the annual
report the reporting of corrective actions resulting from the analyses
of waiver and fatigue assessment data. The NRC considers the reporting
of a summary of corrective actions to be consistent with the
requirement of Sec. 26.717 for reporting of drug and alcohol test
results. For example, the NRC views the number of for-cause drug and
alcohol tests that a licensee conducts each year to be one indicator of
the health of the licensee's behavioral observation program and its
effectiveness in meeting the rule's performance objective identified in
Sec. 26.23(c) to provide for the early detection of individuals who
are not fit to perform the duties that require them to be subject to
this part. The NRC similarly views the reporting of corrective actions
resulting from the analyses of these data, including fatigue
assessments, to be another indicator of the health of the licensee's
behavioral observation and self-declaration processes with respect to
fatigue. Annual reports, which will include the distribution of waiver
use among individuals performing the same duties, will enable NRC to
determine the extent to which waivers are concentrated among a few
individuals or distributed broadly among individuals within each
category specified in Sec. 26.4.
Collectively, the reporting of waivers required in Sec.
26.203(e)(1) and the reporting of corrective actions required in Sec.
26.203(e)(2) provides important information concerning the
effectiveness of fatigue management at a licensee site. The reports
permit the NRC to (1) efficiently monitor the ongoing effectiveness of
licensees' fatigue management programs by providing interpretable data,
(2) efficiently allocate inspection resources, (3) track the
effectiveness of the requirements of Subpart I in controlling the
fatigue of nuclear power plant workers, (4) assess whether the
objectives of the final rule are being achieved, and (5) determine
whether any further changes to the requirements are necessary to ensure
that worker fatigue is managed consistent with the intent of the
provisions.
Section 26.203(f) [Audits] requires the licensee to audit the
management of worker fatigue as part of the overall FFD program audits
required in Sec. 26.41 [Audits and corrective action]. This section
does not add a new requirement, but is included in Subpart I for
clarity.
Section 26.205 Work Hours
The NRC substantively revised Sec. 26.199 of the proposed rule in
response to public comments. The revised provisions are in Sec. 26.205
of the final rule and establish controls on the work hours of select
individuals who are subject to nuclear power plant licensees' FFD
programs, as follows.
Section 26.205(a) [Individuals subject to work hour controls]
establishes the scope of individuals who are subject to the work hour
requirements in Sec. 26.205. These individuals are subject to the work
hour requirements, in addition to the training, behavioral observation,
and self-declaration requirements of Subpart I that apply to all
individuals who are subject to nuclear power plant licensees' FFD
programs. In determining the scope of personnel who are subject to the
work hour controls, the NRC considered the burdens on individuals and
licensees associated with the practical control of work hours in
conjunction with the potential for individuals' work activities to
affect public health and safety or the common defense and security if
their performance is degraded by fatigue. The NRC also considered the
nature of these individuals' work activities and work environments
relative to their potential to induce or exacerbate fatigue (e.g.,
whether the work is monotonous or the environment is not stimulating),
the risk significance of the work, and the potential for other controls
to prevent or mitigate the consequences of a fatigue-related error. As
a result of these deliberations, the rule requires that individuals who
perform the duties specified in Sec. 26.4(a)(1) through (a)(5) must be
subject to work hour controls. The duties specified in Sec. 26.4(a)(1)
through (a)(5) are the same as the duties that were specified in Sec.
26.199(a)(1) through (a)(5) of the proposed rule. Rather than list the
duties in Sec. 26.205(a), the final rule references Sec. 26.4(a)
which provides a consolidated list of individuals subject to the
requirements of Part 26.
Section 26.205(a) requires that individuals identified in Sec.
26.4(a)(1) (i.e., individuals who operate or provide onsite direction
of the operation of systems and components that ``a risk informed
evaluation process has shown to be significant to public health and
safety'') must be subject to the work hour requirements in this
section. To implement the work hour requirements, nuclear power plant
licensees are required to delineate the operations personnel who are
subject to the work hour requirements, on the basis of the risk
significance of the safety SSCs being operated. At a minimum, this must
include personnel who are performing activities on SSCs that are
determined to be significant to public health and safety. To delineate
the scope of the operations duty group, licensees can use, for example,
the risk-significance determination process and criteria that they
currently employ to meet the requirements of Sec. 50.65(a)(4) of this
chapter for assessing and managing the risk associated with maintenance
activities. The work hour requirements of Sec. 26.205 would typically
apply to individuals who are operating or directing, while on site, the
operation of SSCs that are included within the scope of an assessment
required by Sec. 50.65(a)(4). Therefore, the work hour requirements
would apply to the individuals who most directly affect the operation
of those SSCs most important to the protection of public health and
safety. Controlling the work hours of these individuals would achieve
the NRC's objective to minimize the potential for fatigue-related
errors in operating these risk-significant SSCs.
Licensed operators who perform the duties specified in Sec.
26.4(a)(1) are responsible for correctly performing actions that are
necessary for the safe operation of nuclear power plants and the
mitigation of accidents at these facilities. These responsibilities
include monitoring the plant for off-normal conditions and taking
appropriate actions to prevent these conditions from challenging the
reactor core, safety systems, and fission product barriers. The
importance of licensed operator actions to the protection of public
health and safety is reflected in the 10
[[Page 17126]]
CFR Part 55, ``Operators' Licenses,'' requirements that are applicable
to these individuals, including specific licensing, examination and
testing, requalification, and FFD requirements. In addition to
performing actions that are necessary for accident mitigation, operator
actions, if performed incorrectly, can be accident initiators. Section
IV.D discussed the effects of fatigue on decisionmaking, risk-taking,
communications, and other key skills. Fatigued operators have an
increased potential to commit errors, raising the probability of
component failures, system misalignments, and incorrect execution of
accident mitigation strategies. Operator actions are highly dependent
on cognitive skills (e.g., attention, decisionmaking) that are
susceptible to fatigue, and operators are frequently exposed to
conditions that can induce fatigue (e.g., long work hours, shiftwork).
The NRC highlighted this concern in 1982 by issuing its Policy on
Worker Fatigue. The Policy specifically addressed the need for
``controls to prevent situations where fatigue could reduce the ability
of operating personnel to keep the reactor in a safe condition.''
Despite the NRC's Policy on Worker Fatigue and subsequent technical
specifications to limit operator work hours, an NRC staff review of
technical specification implementation from 1997-99 found that a
significant percentage of licensed and non-licensed operators worked
more than 600 hours of overtime in a year (Attachment 1 to SECY-01-
0113, ``Rulemaking Plan: Fatigue of Workers at Nuclear Power Plants'').
This level of overtime is two to three times the level that is
permitted for operations personnel at some foreign nuclear plants and
twice the level recommended by a 1985 expert panel (NUREG/CR-4248). In
addition, the NRC staff has noted that some licensees appeared to be
abusing the authority to permit deviations from the technical
specification limits on working hours, including deviations for
operators. For example, data provided by NEI on August 29, 2000, from
J. W. Davis, NEI, to G.T. Tracy (ADAMS Accession No. ML003746495),
indicated that during a sample of 37 refueling outages conducted in
1999, licensees authorized more than 1,800 deviations for licensed
operators and more than 1,100 deviations for non-licensed operators.
This frequency of deviations is inconsistent with the intent of the
NRC's Policy on Worker Fatigue that deviations should be authorized
only for ``very unusual circumstances.'' The failure of some licensees
to limit the work hours of operations personnel, considered together
with the risk significance of the activities performed by operators,
indicates the need for more readily enforceable work hour limits for
operators whose job duties are important to protect public health and
safety.
Further, the work hour requirements in Sec. 26.205 also apply to
individuals who direct risk-significant operations on site. These
individuals include management on shift, such as shift operations
management or special outage managers, if those individuals provide
direction to operators. Individuals to whom the work hour requirements
apply also include engineers who provide onsite technical direction to
operations, such as test directors or reactor engineers. These
individuals perform tasks that are often highly dependent on cognitive
skills (e.g., problem-solving, decisionmaking, communications) and are
susceptible to fatigue-induced errors, as described in Section IV.D.
Incorrect technical direction provided to operators can significantly
challenge licensed operators and increase the possibility of errors or
events, particularly when the direction is provided by an individual
who supervises the operators or an individual who the operator
reasonably expects to have specialized technical knowledge of the
system or component being operated.
Section 26.205(a) requires that individuals identified in Sec.
26.4(a)(2) (i.e., individuals who perform health physics or chemistry
duties that are required of the onsite emergency response organization
minimum shift complement) must be subject to the work hour requirements
of this section. Although Sec. 26.207(d) [Plant emergencies] exempts
licensees from applying the work hour controls during declared
emergencies, the intent of this provision is to provide reasonable
assurance that the work schedules of these individuals during non-
emergency conditions ensure that fatigue does not compromise their
abilities to safely and competently perform their duties should an
emergency occur. NUREG-1465, ``Accident Source Terms for Light-Water
Nuclear Power Plants,'' concluded that significant fission product
releases from the bulk of the fuel can occur within 30-60 minutes after
the onset of an accident. As a function of the accident and its
severity, certain areas within the plant, while predictable and benign
during normal operations, could present elevated levels of airborne/
external radiation levels (greater that 300 Rad/hour). Additionally,
industrial hazards (e.g., explosive mixtures, smoke, toxic gas, oxygen
deficiency) that may be immediately dangerous to life and health could
be present. In these circumstances, health physics technicians (HPTs)
support necessary plant staff actions to assess conditions, perform
search and rescue missions, and take timely mitigation actions (e.g.,
local manual operations by operators). The overall success of
responding safely and appropriately to emergencies and the protection
of public health and safety depends, in part, on the ability of HPTs to
safely and competently perform their emergency response duties.
Similarly, NUREG-0654, Revision 1, ``Criteria for Preparation and
Evaluation of Radiological Emergency Response Plans and Preparedness in
Support of Nuclear Power Plants,'' issued March 2002, identifies the
need for an on-shift chemistry/radiochemistry emergency response
capability. An on-shift chemistry technician(s) provides an important
component for a successful response at the onset of a radiological
emergency. The independent and timely actions of the chemistry
technician(s) in response to a radiological event can provide key
information for assessing core status and estimating the source term of
a potential release. By providing defense-in-depth support for
operations personnel, chemistry technicians also assist with offsite
dose calculations and ancillary radiological protection tasks, such as
sampling spaces for toxic gases or explosive mixtures. Chemistry
technicians may also be needed to conduct analyses for the detection of
hydrogen and oxygen gas concentrations in both the reactor coolant and
the containment atmosphere. These analyses support severe accident
management decisions with respect to minimizing radiological release
potential. As a consequence, ensuring that chemistry technicians are
able to safely and competently perform their emergency response duties
is essential to the overall success of responding safely and
appropriately to emergencies and to the protection of public health and
safety.
Section 26.205(a) requires that individuals identified in Sec.
26.4(a)(3) (i.e., individuals who are performing the duties of a fire
brigade member who is responsible for understanding the effects of fire
and fire suppressants on safe shutdown capability) must be subject to
the work hour requirements of this section. The work hour requirements
are applicable to the members of the fire brigade who are responsible
for providing the control room operators and fire brigade leader with
information that is critical to implementing a fire mitigation strategy
[[Page 17127]]
to maintain safe shutdown capability for the reactor. Attachment 1 to
SECY-99-140, ``Recommendation for Reactor Fire Protection
Inspections,'' dated May 20, 1999, states that ``based on IPEEE
results, fire events are important contributors to the reported core
damage frequency (CDF) for a majority of plants. The reported CDF
contribution from fire events can, in some cases, approach (or even
exceed) that from internal events.'' Fire brigade members must retain
their cognitive abilities to be able to determine the best way to
suppress a fire to prevent additional damage to safety-related
equipment, evaluate equipment affected by a fire to report to control
room operators concerning equipment availability, make decisions
concerning smoke ventilation to prevent the fire effects from affecting
other plant operations, and coordinate fire brigade activities with
control room operators.
As discussed in Section IV.D, fatigue can substantially degrade an
individual's decisionmaking and communication abilities, cause an
individual to take more risks, and maintain faulty diagnoses throughout
an event. The abilities to make accurate and conservative decisions,
communicate effectively, and accurately diagnose events are key to the
duties of the fire brigade members who are responsible for providing
the control room operators and fire brigade leader with information
that is critical to implementing a fire mitigation strategy to maintain
the safe-shutdown capability for the reactor. Degradations of these
abilities could have significant consequences on the outcome of an
event involving a fire. For instance, a fatigued individual could
incorrectly decide to vent smoke or toxic gas to an area required for
alternate shutdown, which could prevent or impair access to equipment
needed for safe shutdown of the plant. In addition, a fatigued worker
could incorrectly apply the wrong fire suppressant, which could affect
additional equipment in the plant. Further, impaired decisionmaking
could lead a worker to fail to properly control flooding, which could
impact other needed equipment, or to incorrectly determine whether an
area contains critical equipment and improperly apply a suppressant in
that area. Impaired communications could also lead to incomplete
disclosure of information to licensed operators in the control room,
which could adversely impact the decisionmaking of those operators. If
information known to the impaired fire brigade member is not properly
communicated, operators may not initiate appropriate actions to
mitigate the fire effects, or the effects of suppressant activities, on
critical equipment. As a consequence, ensuring that fire brigade
members, who are responsible for understanding the effects of fire and
fire suppressants on safe-shutdown capability, are able to safely and
competently perform their duties is essential to the overall success of
the fire mitigation strategy and the protection of public health and
safety.
In addition, the NRC periodically grants exemptions from the
requirements of Appendix R [Fire Protection Program for Nuclear Power
Facilities Operating Prior to January 1, 1979] to 10 CFR Part 50,
``Domestic Licensing of Production and Utilization Facilities,'' based
on protection of the levels of defense in depth listed in Section II(A)
of Appendix R to Part 50, which are ``To prevent fires from starting;
to detect, rapidly control, and extinguish promptly those fires that do
occur; to provide protection for structures, systems, and components
important to safety so that a fire that is not promptly extinguished by
the fire suppression activities will not prevent the safe shutdown of
the plant.'' Granting these exemptions is often predicated on effective
manual suppression of the fire by the fire brigade. Therefore, it is
necessary to ensure that fire brigade members who are responsible for
understanding the effects of fire and fire suppressants on safe-
shutdown capability remain rested so that they are able to safely and
competently perform their duties in plant events involving a fire.
Section 26.205(a) requires that individuals identified in Sec.
26.4(a)(4) (i.e., individuals who are performing maintenance or the
onsite directing of maintenance of systems, structures, or components
that ``a risk informed evaluation process has shown to be significant
to public health and safety'') must be subject to the work hour
requirements in this section. Section 26.5 [Definitions] includes a
definition of ``maintenance'' to clarify the scope of individuals
described by Sec. 26.4(a)(4). To implement this requirement, licensees
are required to delineate the maintenance personnel, as well as the
personnel who direct maintenance on site, who would be subject to the
work hour controls on the basis of the risk significance of the SSCs
that they maintain. At a minimum, this must include personnel who
maintain SSCs that are determined to be significant to public health
and safety. To delineate the scope of the maintenance job duty group,
licensees can use, for example, the risk-significance determination
process and criteria that they currently employ to meet the
requirements of Sec. 50.65(a)(4) for assessing and managing the risk
associated with maintenance activities. As a consequence, the work hour
requirements of Sec. 26.205 would typically apply to individuals who
are maintaining or directing on site the maintenance of SSCs that are
included within the scope of an assessment required by Sec.
50.65(a)(4). Therefore, the work hour requirements would apply to the
individuals who most directly affect the maintenance of SSCs that are
most important to the protection of public health and safety, which
would achieve the NRC's objective to minimize the potential for
fatigue-related errors in maintaining these risk-significant SSCs.
Nuclear power plant maintenance personnel perform tasks that are
often highly dependent on cognitive skills (e.g., the ability to
comprehend oral and written instructions, problem-solving,
communication) that are susceptible to fatigue, as described in Section
IV.D. These tasks may require extensive physical effort in high heat,
humidity, and noise conditions that can exacerbate fatigue. In
addition, maintenance personnel are subject to the work scheduling
conditions of round-the-clock operations and emergent work conditions
that also can exacerbate fatigue (e.g., long work hours, unscheduled
overtime, shiftwork). Compared to rested workers, fatigued maintenance
personnel would have a higher probability of (1) taking longer to
complete maintenance activities or using non-conservative work
practices, (2) making errors that would increase the risk of failure of
the affected SSCs to perform their functions or operate for their
required mission time during post-maintenance testing, thus delaying
their return to unrestricted service, and (3) making errors that could
introduce latent defects that may not be readily detected by post-
maintenance testing, but that may cause degraded reliability (i.e.,
degraded performance or failure of the SSCs at a later time).
Collectively, the effects of fatigue on the performance of maintenance
personnel have the potential to decrease the availability and
reliability of SSCs that are important to the protection of public
health and safety. Therefore, the rule requires these maintenance
personnel to be subject to the work hour requirements to ensure that
fatigue does not compromise their abilities to safely and competently
perform their duties relative to the maintenance of these SSCs.
The work hour requirements also apply to those who direct risk-
significant maintenance on site. For example, these individuals include
maintenance supervisors who provide
[[Page 17128]]
direction to maintenance technicians and engineers who provide onsite
technical direction to maintenance crews, during key outage maintenance
activities. These individuals perform tasks that are often highly
dependent on cognitive skills (e.g., problem solving, decisionmaking,
communications) that are susceptible to fatigue, as discussed in
Section IV.D. Incorrect technical direction provided to maintenance
technicians can significantly challenge maintenance technicians and
increase the possibility of errors or events, particularly when that
direction is provided by an individual who supervises them or an
individual who the maintenance technician reasonably expects to have
specialized technical knowledge of the system or component being
maintained.
Section 26.205(a) requires that individuals identified in Sec.
26.4(a)(5) (i.e., individuals who are performing the duties of an armed
security force officer, alarm station operator, response team leader,
or watchperson at a nuclear power plant) must be subject to the work
hour requirements of this section. Individuals who perform these duties
are the members of licensees' security forces who are responsible for
implementing the licensees' physical security plans. To ensure that
these individuals are able to meet their responsibilities for
maintaining the common defense and security, it is necessary to ensure
that they are not subject to fatigue, which could reduce their
alertness and ability to perform the critical job duties of identifying
and promptly responding to plant security threats. Security personnel
are the only individuals at nuclear power plants who are entrusted with
the authority to apply deadly force. Decisions regarding the use of
deadly force are not amenable to many of the work controls (e.g., peer
checks, independent verification, post-maintenance testing) that are
implemented for other personnel actions at a nuclear plant to ensure
correct and reliable performance. In contrast to most other nuclear
power plant job duty groups, security personnel are typically deployed
in a configuration in which some members of the security force have
very infrequent contact with other members or with other plant
personnel. A lack of social contact can exacerbate the effects of
fatigue on individuals' abilities to remain alert (Horne, 1988). In
addition, these deployment positions can be fixed posts where very
little physical activity is required, further promoting an atmosphere
in which fatigue could transition into sleep. Many security duties are
largely dependent on maintaining vigilance, and vigilance tasks are
among the most susceptible to degradation from fatigue (Rosekind, 1997;
Monk and Carrier, 2003). Finally, unlike operators, security forces
lack automated backup systems that can prevent or mitigate the
consequences of an error caused by fatigue. For these reasons, and in
light of the excessive hours that some security force personnel were
required to work following the elevated threat condition(s) in effect
after the terrorist attacks of September 11, 2001, the Commission
issued orders for Compensatory Measures Related to Fitness-for-Duty
Enhancements Applicable to Nuclear Facility Security Force Personnel on
April 23, 2003. The security force personnel who are subject to work
hour controls in the orders are the same individuals who are subject to
the work hour requirements in this section.
Section 26.205(b) [Calculating work hours] specifies the time
periods that licensees shall include when calculating the work hours of
the individuals listed in Sec. 26.205(a) for the purposes of this
subpart. This requirement replaces, with editorial and substantive
modifications, the requirements presented in Sec. 26.199(b) of the
proposed rule. The editorial changes are renumbering and reorganization
of the requirements for clarity. The substantive change is the deletion
of the provisions concerning the calculation of collective work hours
as a conforming change resulting from the deletion of the collective
work hour controls as described with respect to Sec. 26.205(d)(3).
The NRC's Policy on Worker Fatigue established guidelines for the
control of work hours but did not define the concept of ``work hours''
or establish criteria for calculating them. As a consequence, licensees
have inconsistently defined and calculated work hours when implementing
the Policy through their technical specifications and administrative
procedures. This inconsistency has contributed to some licensees
permitting individuals to work excessive hours that caused them to
become fatigued. Therefore, the rule defines work hours and
requirements for calculating them, as well as certain specific periods
that may be excluded from the calculation to ensure consistent
implementation of the work hour controls established in Sec. 26.205(d)
[Work hour controls].
The rule requires licensees to calculate work hours as the amount
of time that an individual performs duties for a licensee, including
all within-shift break times and rest periods during which there are no
reasonable opportunities or accommodations appropriate for restorative
sleep. The rule also details the periods excluded from the calculation.
The rule specifically does not limit work hours to hours that are
assigned to an individual by the licensee, that are worked on site, or
that are worked as part of a scheduled shift, but does require
licensees to include hours during which an individual performs duties
for the licensee. The rule defines hours worked in this broad manner
because the NRC is aware that some licensees permit individuals to
perform duties on behalf of the licensee from offsite locations and
during periods when the individual is not assigned to a shift or
scheduled by the licensee to be working on site. For example, because
of the large amount of administrative work that is frequently assigned
to individuals in the shift manager role, some shift managers stay at
work to review and act upon administrative matters after the end of
their scheduled shifts in order to complete the reviews and meet
deadlines. Anecdotal reports from these individuals have indicated that
they may work for 3-4 hours after going off shift to manage their
workload, with the result that the hours they have available for
personal obligations and sleep are reduced. Many licensees operate
multiple sites and at times send personnel to other sites for short
periods to fill in or to extend expertise. This time away from their
normal duty site must be included when calculating work hours. If the
rule limited the calculation of work hours to only those hours that an
individual is paid by the licensee, works on shift, works on site, and/
or is scheduled to be working by the licensee, many individuals may
continue to be permitted to work excessive hours, thereby becoming
fatigued. Therefore, Sec. 26.205(b) [Calculating work hours] requires
licensees to include these work hours in their work hour calculations.
Section 26.205(b)(1) [shift turnover] excludes the time periods
during which an individual participates in shift turnover from the
calculation of the individual's work hours. Section 26.199(b)(1) of the
proposed rule defined the specific shift turnover activities that
licensees may exclude from their work hour calculations. The final rule
defines shift turnover as only those activities that are necessary to
safely transfer information and responsibilities between two or more
individuals between shifts. Shift turnover is a vital activity, but it
also contributes to the length of the workday,
[[Page 17129]]
and therefore, to worker fatigue. The NRC understands that shift
turnovers routinely add approximately 30 minutes to the length of a
shift and typically no more than 2-2.5 hours to the length of a typical
work week. Stakeholder comments during the public meetings described in
the preamble to the proposed rule highlighted the importance of this
activity for communicating plant status information between work crews
and expressed concern that including turnover time in work hour
calculations could cause indirect pressure on individuals to abbreviate
shift turnovers in order to ensure that work hour limits would not be
violated. This pressure could compromise the quality of shift turnovers
and have unintended adverse safety consequences, such as omitting
important equipment or maintenance status information. Although some
stakeholders believe that turnover is part of the workday and,
therefore, should be included in the calculation of hours worked, the
NRC concluded that the benefit of including turnover for managing
worker fatigue would be outweighed by the potential adverse consequence
on the quality of shift turnovers.
The exclusion of shift turnover from work hour calculations is
consistent with current requirements in most licensee technical
specifications for the control of work hours for personnel performing
safety-related functions and with GL 82-12, ``Nuclear Power Plant Staff
Working Hours,'' dated June 15, 1982. For example, most technical
specifications state, ``An individual should not be permitted to work
more than 16 hours in any 24-hour period, nor more than 24 hours in any
48-hour period, nor more than 72 hours in any 7-day period, all
excluding shift turnover time'' (see SECY-01-0113, Attachment 1, Table
2). However, the final rule more clearly describes the activities that
may be included in turnover and the activities that may not be
included. This provision addresses the NRC concerns arising from
observations that some licensees have occasionally excluded 2 or more
hours from calculated work hours on the basis that the individuals were
engaged in ``turnover.'' To ensure that turnover is not hurried, the
rule does not establish a time limit for an acceptable turnover period.
However, by clearly delineating the activities that licensees may
consider to be turnover activities, the rule reduces the potential for
individuals and/or licensees to use the shift turnover exclusion to
perform other work activities.
Section 26.205(b)(2) [Within shift break and rest periods] permits
licensees to exclude within-shift breaks and rest periods from their
work hour calculations if the individual has both a reasonable
opportunity and accommodations for restorative sleep. The rule permits
licensees to exclude breaks from the accounting of work hours only when
the exclusion can be justified on the basis that the break
substantively mitigates fatigue. The exclusion allows workers to be
scheduled for round-the-clock duties (e.g., dedicated fire brigades)
during which they are on site and available to respond as needed but
the licensee provides sleeping accommodations and the individuals are
allowed periods of time to obtain restorative sleep. This exclusion
also permits licensees to make use of strategic napping, a well-proven
fatigue countermeasure (McCallum, et al., 2003; Petrie, et al., 2004;
Rosekind, et al., 1994, 1995; Dinges, et al., 1988; Kemper, 2001;
Schweitzer, et al., 1992; Sallinen, et al., 1998), without requiring
the nap period to be included in work hour calculations.
The exclusion is limited to that portion of a break or rest period
that provides a reasonable opportunity for restorative sleep. For
example, a 15-minute coffee break would not provide a reasonable
opportunity for restorative sleep. The rule limits the exclusion to the
amount of time the individual has available to actually sleep and does
not include transit time to and from the sleep accommodations. The term
``restorative sleep'' means an amount of sleep that mitigates fatigue,
which is generally considered to be a minimum of approximately 30
minutes (Buxton, et al., 2002; McCallum, et al., 2003; Sallinen, 1998;
Rosekind, 1995).
The final rule also requires that individuals must have reasonable
accommodations available for sleep in order to exclude the break period
from the calculation of the individual's work hours. Reasonable
accommodations would include a sleep surface (e.g., bed, recliner) in a
darkened, quiet room (Priest, 2000).
The degree of specificity in this section is necessary because some
licensees currently exclude within-shift breaks from the calculation of
work hours required by their technical specifications. Excluding break
periods from the calculation of work hours can add up to as many as 12
hours over the course of a week, which permits individuals to work an
additional 12-hour shift. As a consequence, licensees may assign seven
consecutive 12-hour shifts to individuals, but only include 72 hours in
their work hour calculations, rather than the 84 hours that the
individuals are actually at work. The discussion of Sec.
26.205(d)(1)(iii) details the basis for limiting individuals to 72 work
hours per week.
Although breaks without sleep have some fatigue mitigation value
(Tucker, Folkard, and Macdonald, 2003), the benefits are principally
limited to short-term improvements in vigilance. Horne (1988), Mitler
and Miller (1996), and Dinges, et al. (1997) have pointed out that the
only non-pharmacological cure for fatigue is sleep. The duration of
within-shift break times is normally insufficient to allow a worker to
obtain sleep and, consequently, these periods add to the total amount
of time an individual remains awake while at work. Time since awakening
is a principal determinant of worker fatigue (Folkard and Akerstedt,
1992; NTSB, 1994; Akerstedt, 2004) and performance generally declines
as a function of the amount of time that an individual remains awake
(Dawson and Reid, 1997). Because within-shift breaks and rest periods
provide only short-term mitigation of fatigue (Kruger, 2002; Baker, et
al., 1990), the rule requires licensees to include short breaks in the
calculation of work hours.
Section 26.205(b)(3) [Beginning or resuming duties subject to work
hour controls] permits licensees to assign individuals, who are
qualified to perform the duties listed in Sec. 26.4(a), to duties
other than those listed Sec. 26.4(a), without controlling their work
hours in accordance with the work hour controls contained in Sec.
26.205(d). However, if these individuals are assigned or returned to
performing any duties that are listed in Sec. 26.4(a) during the
calculation period, the rule requires the licensee to include all of
the hours that they worked when calculating their work hours and to
subject the individual to the work hour controls in Sec. 26.205(d).
For example, if a licensed operator was assigned to training for an
entire calculation period, then his or her work hours would not be
subject to Sec. 26.205(d) for that period because he or she would not
be performing any of the duties listed in Sec. 26.4(a). However, if
the same individual were assigned to training for only a portion of the
calculation period and performed the duties listed in Sec. 26.4(a)
during the remainder of the calculation period, all of his or her
hours, including those worked while assigned to training, would be
included in the calculation of the individual's work hours as if the
individual were performing operations duties for the entire calculation
period. Licensees would be required to count the hours that the
individual worked
[[Page 17130]]
performing other duties if an individual begins performing the duties
listed in Sec. 26.4(a) during the calculation period because the
individual's level of fatigue is largely dependent on the total number
of hours he or she has worked, regardless of where the work was
performed or the nature of the work itself. Therefore, including the
hours worked performing other duties would provide assurance that
fatigue would not compromise that individual's ability to safely and
competently perform the duties that are specified in Sec. 26.4(a).
Section 26.205(b)(4) [Unannounced emergency preparedness exercise
and drills] allows licensees to exclude certain time associated with
unannounced emergency preparedness exercises and drills from the
calculation of an individual's work hours. Only the time an individual
works unscheduled work hours for the purpose of participating in the
actual conduct of an unannounced emergency preparedness exercise or
drill can be excluded. This exclusion is incorporated in the final rule
in response to stakeholder comments that adjusting work schedules in
anticipation of an unscheduled exercise or drill would negate the
element of surprise for the individuals. The nature of such drills is
that they are relatively infrequent and short in duration. Therefore,
they would not have a major impact on individual fatigue and any impact
would be offset by the potential contribution to safety.
Section 26.205(b)(5) [Incidental duties performed off site] allows
licensees to exclude from the calculation of an individual's work hours
unscheduled work performed off site (e.g., technical assistance
provided by telephone from an individual's home) provided the total
duration of the work does not exceed a nominal 30 minutes during any
single break period. For the purposes of compliance with the minimum
break requirements of Sec. 26.205(d)(2) and the minimum day off
requirements of Sec. 26.205(d)(3) through (d)(5), such duties do not
constitute work periods or work shifts. The final rule includes this
exclusion in response to stakeholder comments regarding the necessity
of obtaining expert advice or details on recent operating experience
that may not have been included in a turnover and the burden that would
be imposed by resetting the clock to account for the disruption in a
break period. The nominal 30-minute reduction in the break period is
not expected to have a detrimental impact on the individual's overall
fatigue level and would be offset by the potential contribution to
safety.
Proposed Sec. 26.199(b)(2) would have established requirements for
calculating the collective work hours of certain job duty groups that
would have been subject to the collective work hour limits in proposed
Sec. 26.199(f). The final rule does not include these requirements
because the NRC eliminated the concept of collective work hours in the
final rule, as discussed in Sec. 26.205(d)(3) of this section-by-
section analysis. Therefore, to conform with other changes in the final
rule, Sec. 26.205(b) does not include those aspects related to
calculating collective work hours.
Section 26.205(c) [Work hours scheduling] requires licensees to
schedule the work hours of individuals who are subject to this section
in a manner that is consistent with the objective of preventing
impairment from fatigue resulting from the duration, frequency, or
sequencing of successive shifts. This section retains the requirement
presented in Sec. 26.199(c) of the proposed rule. The NRC intends for
the maximum work hour and minimum break and day off requirements
specified in Sec. 26.205(d) to apply to infrequent, temporary
circumstances and not be considered guidelines or limits for routine
work scheduling. In addition, the work hour controls in Sec. 26.205(d)
do not address several elements of routine schedules that can
significantly affect worker fatigue, such as shift length, the number
of consecutive shifts, the duration of breaks between blocks of shifts,
and the direction of shift rotation. Therefore, Sec. 26.205(c)
requires licensees to schedule personnel consistent with preventing
impairment from fatigue from these scheduling factors.
The rule requires licensees to address scheduling factors because
human alertness and the propensity to sleep vary markedly through the
course of a 24-hour period. These variations are referred to as
circadian rhythms and are the result of changes in physiology brought
about by a circadian clock or oscillator inside the human brain that is
outside the control of the individual. Work may be scheduled, and the
consequent timing of periods of sleep and wakefulness, in a manner that
either facilitates an individual's adaptation to the work schedule or
challenges the individual's ability to get adequate rest. Therefore,
the duration, frequency, and sequencing of shifts, particularly for
personnel who work rotating shifts, are critical elements of fatigue
management. Section IV.D also discusses the effects of circadian
rhythms on worker fatigue. The importance of these elements for fatigue
management is reflected in guidelines for work scheduling, such as EPRI
NP-6748 (Baker, et al., 1990), and in technical reports, such as,
NUREG/CR-4248 and the Office of Technology Assessment's report,
``Biological Rhythms: Implications for the Worker'' (Liskowsky, 1991).
For example, the EPRI guidelines address issues related to the
sequencing of day, evening, and night shifts and the use of break
periods between shifts to optimize the ability of personnel to obtain
adequate sleep and effectively transition from one shift to another.
Although research provides clear evidence of the importance of these
factors in developing schedules that support effective fatigue
management, the NRC also recognizes that the complexity of effectively
addressing and integrating each of these factors in work scheduling
decisions precludes a prescriptive requirement. Therefore, Sec.
26.205(c) establishes a non-prescriptive, performance-based
requirement.
Stakeholder interactions have interpreted this requirement as a
performance-based approach in that licensees' fatigue management
performance could be assessed in terms of adherence to the schedules
developed in response to Sec. 26.205(c). Although the NRC had intended
this requirement to be limited to the development of work schedules,
the NRC acknowledges the benefit of implementing this provision as a
performance-based requirement applicable to licensee control of the
actual hours worked by individuals performing the duties specified in
Sec. 26.4(a)(1) through (a)(5) and adopts this interpretation for the
final rule. As a consequence, this provision of the final rule requires
the work hours of individuals subject to the requirements of this
section to be controlled in a manner that prevents impairment from
fatigue resulting from elements of routine schedules that can
significantly affect worker fatigue, such as shift length, the number
of consecutive shifts, the duration of breaks between blocks of shifts,
and the direction of shift rotation.
Section 26.205(d) [Work hour controls] requires licensees to
establish work hour controls for individuals who are subject to the
requirements of Sec. 26.205. The provision requires licensees to
establish controls that limit work periods and provide for breaks that
are of sufficient length to allow the individual to obtain restorative
rest. This requirement replaces Sec. 26.199(d) of the proposed rule,
with limited editorial changes.
Section 26.205(d)(1) establishes work hour limits for consecutive,
rolling periods of 24 and 48 hours and 7 days. The majority of
licensees have incorporated the work hour controls
[[Page 17131]]
from the NRC's Policy on Worker Fatigue, as disseminated by GL 82-12,
into either their technical specifications or administrative
procedures. The Policy (including the bases for the individual
requirements) has been in place for over 20 years and was the subject
of a substantive review documented in Attachment 1 to SECY-01-0113. The
work hour limits from GL 82-12 also were the subject of substantial
stakeholder comments during the public meetings described in the
preamble of the proposed rule. In developing the requirements in this
section, the NRC staff considered the information gained through these
stakeholder interactions.
Section 26.205(d)(1)(i) limits the number of hours that an
individual may work in any 24-hour period. The section permits
individuals to work no more than 16 hours in any 24-hour period. This
provision retains without change the requirement in Sec.
26.199(d)(1)(i) of the proposed rule. This limit is identical to that
specified in GL 82-12. Attachment 1 to SECY-01-0113 provides the basis
for this limit, which is summarized as follows. Studies have shown that
task performance declines after 12 hours on a task (Folkard, 1997;
Dawson and Reid, 1997; Rosa, 1991). Other studies have shown that the
relative risk of having an accident increases dramatically after 9
consecutive hours on the job (Hanecke, et al., 1998; Colquhoun, et al.,
1996; U.S. DOT, 49 CFR Parts 350, et al., Proposed Rule, May 2, 2000,
65 FR 25544). Further, nine experts who met in 1984 to develop
recommendations for NUREG/CR-4248 recommended a maximum of 12 work
hours per day. Therefore, in originally developing its Policy on Worker
Fatigue, the NRC had planned a 12-hour maximum limit, but revised it to
16 hours in response to practical concerns raised by the industry that
the 12-hour limit required personnel who worked 8-hour shifts to split
shifts when they work overtime. Those practical concerns remain valid,
and the final rule retains a 16-hour limit.
Although the rule permits 16-hour shifts, other work hour limits in
the rule would effectively limit the number of 16-hour shifts that
licensees could assign. The NRC's response to a comment from PROS on
this issue is discussed in the preamble to the proposed rule.
Section 26.205(d)(1)(ii) limits the number of hours that an
individual may work in any 48-hour period. This provision retains
without change the requirement presented in Sec. 26.199(d)(1)(ii) of
the proposed rule. The section permits an individual to work no more
than 26 work hours in a 48-hour period; by contrast, GL 82-12 limits
individuals' work hours to 24 work hours in any 48-hour period. This
change accommodates the fact that most licensee sites are now routinely
working 12-hour shifts, rather than 8-hour shifts, as was the case when
the NRC published GL 82-12. At that time, the basis for the 24-hour
limit was to permit a worker to work one 16-hour double shift, followed
by an 8-hour break, and then start another 8-hour shift at the worker's
normal starting time, but only in very unusual circumstances. With the
majority of plants now routinely working 12-hour shifts, the rule
increases the maximum work hours in a 48-hour period from 24 to 26
hours to decrease the burden on licensees by accommodating situations
in which a worker's relief is delayed or similar circumstances. For
example, a 12-hour shift worker is able to work up to 14 hours in one
day and still return to work at his or her normal time the next day,
but can only work 12 hours that day. In the extreme, the 26-hour limit
permits an individual to work up to 16 hours one day, followed by a
minimum 10-hour break, as required in Sec. 26.205(d)(2)(i). The
individual is then limited to 10 hours of work over the next 22 hours.
When developing this requirement, which effectively relaxes by 2
hours the NRC's policy guideline in GL 82-12 for the maximum hours
individuals should work in 48 hours, the NRC considered: (1) The burden
associated with granting a waiver for the additional 2 hours; (2) the
increased stringency of the criteria for granting a waiver of the work
hour limits in Sec. 26.207 relative to those in plant technical
specifications; and (3) the increased potential for worker fatigue and
fatigue-related errors that may accrue from working 26 hours in a 48-
hour period versus working 24 hours in that same period.
The increase of 2 additional work hours during a 48-hour period
will likely contribute to some increase in fatigue and fatigue-related
errors, particularly when these hours come at the end of a work period
of 12 or more hours or coincide with a decrease in an individual's
circadian level of alertness, as might be expected at the end of a 12-
hour day shift. However, because the revised criteria for granting a
waiver of the work hour limits in Sec. 26.207 are expected to
substantially reduce the number of waivers that are granted, the
licensee will have to either delay or turn over any work that the
individual is performing when it is necessary for him or her to go off
shift. Either delaying or turning over work could contribute to errors.
In addition, licensees commonly use waivers to exceed the 24-hours of
work in any 48-hour period limit for short durations. As a result, the
NRC concluded that the relaxation will principally reduce the paperwork
burden, rather than increase the hours that individuals would have
actually worked under the proposed rule. Accordingly, the relaxation
provides a substantive reduction in burden with a limited net effect on
human performance reliability.
Section 26.205(d)(1)(iii) limits the number of hours an individual
may work in any 7-day period. This section retains without change the
requirement presented in Sec. 26.199(d)(1)(iii) of the proposed rule.
The requirement limits an individual to working no more than 72 hours
in any 7-day period. This limit is identical to the related limit
specified in GL 82-12. Attachment 1 to SECY-01-0113 provides the basis
for this limit, which is summarized in this section. In the absence of
the break and day off requirements in Sec. 26.205(d)(2) and (d)(3),
respectively, the limit would permit a worker to work six 12-hour
shifts per week continuously. Studies have shown that longer work
schedules cause fatigue (Colquhoun, 1996; Rosa, 1995). Human
reliability analysis experts have recommended that the NRC set ``a
maximum of 60 hours in any 7-day period and a maximum of 100 hours in
any 14-day period,'' noting studies indicating that fatigue from long
work hours can result in personnel developing their own subjective
standards of what is important in their jobs (NUREG/CR-1278, ``Handbook
on Human Reliability Analysis with Emphasis on Nuclear Power Plant
Applications''). Further, NUREG/CR-4248 recommends a limit of 60 hours
of work in a 7-day period. However, in its Policy on Worker Fatigue,
the NRC established a 72-hour maximum limit based on the expectation
that individuals would work up to this limit on an infrequent and
temporary basis. The rule codifies this expectation, in part, through
Sec. 26.205(d)(3), which requires licensees to ensure a minimum number
of days off per week, averaged over a shift cycle, for individuals who
are subject to the work hour controls. The rule effectively prevents an
individual from consistently working six 12-hour shifts in a week.
Section 26.205(d)(2) requires licensees to provide adequate rest
breaks for individuals who are performing the duties listed in Sec.
26.4(a). This section contains, with substantial revisions, the
requirements presented in Sec. 26.199(d)(2) of the proposed rule.
[[Page 17132]]
Although Sec. 26.205(d)(2) retains without change the requirement
presented in proposed rule Sec. 26.199(d)(2)(i) for a 10-hour break,
the final rule revises the 24-hour break requirement proposed in Sec.
26.199(d)(2)(ii) and replaces the 48-hour break requirement proposed in
Sec. 26.199(d)(2)(iii) with an alternative break requirement. The
following section-by-section discussion of Sec. 26.205(d)(2) and
(d)(3) provides a rationale for these specific changes.
Section 26.205(d)(2) is necessary to ensure that licensees provide
individuals with sufficient time off between work periods (shifts) to
permit them to recuperate from fatigue and provide reasonable assurance
that acute and cumulative fatigue do not compromise the abilities of
these individuals to safely and competently perform their duties. Acute
fatigue results from excessive cognitive work, especially if an
individual is missing significant amounts of sleep, and is readily
relieved by obtaining adequate rest and sleep. Cumulative fatigue
results from receiving inadequate amounts or poor quality sleep for
successive days. An extensive body of research has shown that a lack of
adequate days off and extended workdays result in a cumulative sleep
debt and performance impairment (Williamson and Feyer, 2000; Tucker,
1999; Colquhoun, 1996; Baker, et al., 1994; Webb and Agnew,1974; U.S.
DOT (65 FR 25546, May 2, 2000)).
Section 26.205(d)(2) defines a rest break as an interval of time
that falls between successive work periods during which the individual
does not perform any duties for the licensee. For example, individuals
would not perform work-related duties during rest breaks such as
completing paperwork reviews, mandatory reading, or required self-
study. Rest breaks could include periods during which an individual is
``on-call'' because actual demands on an individual's time while he or
she is on-call would be infrequent and of limited duration, such as
answering a phone call. However, if an individual who is ``on-call'' is
``called-in'' to report to the site, the licensee would be required to
include the hours that the individual worked as work hours, not as
break time, because the individual would be performing duties on behalf
of the licensee while on site.
Section 26.205(d)(2)(i) requires licensees to provide a 10-hour
break between successive work periods, but permits 8-hour breaks in
limited circumstances in which a shorter break is necessary for a
crew's scheduled transition between work schedules. Current licensee
technical specifications and administrative procedures that are based
on GL 82-12 require a minimum 8-hour break between work periods.
Section 26.205(d)(2)(i) increases the minimum break period from 8 hours
to 10 hours to provide greater assurance that individuals have an
adequate opportunity to obtain the 7-8 hours of sleep that is
recommended by most experts in work scheduling and fatigue. When
considering shift turnover and commute times, which do not provide
individuals with opportunities for rest and recovery, a nominal rest
break of 8 hours actually leaves the individual with approximately 6
hours available to meet personal needs, including sleep (8 hours off-
duty minus an average 1.5-hour round-trip commute minus an average 0.5
hours spent in shift turnover, equaling 6 hours available for personal
needs). However, individuals typically also require 0.5 hours for
preparing (or buying) and eating at least one meal off-shift and 0.5
hours for personal hygiene, which leaves, at best (i.e., assuming no
social or domestic commitments that day), a total of 5 hours available
for sleep. By contrast, the 10-hour break ensures that individuals
generally have 7 hours available each day for sleep, which is close to
the 7-8 hours of sleep needed by adults in the United States (National
Sleep Foundation, 2001; Monk, et al., 2000; Rosekind, et al., 1997;
Rosa, 1995).
The scientific literature provides strong evidence of the negative
effects on performance and alertness of a week when sleep is restricted
to 5 hours per day. Dinges, et al., 1997, and Belenky, et al., 2003,
who have headed key laboratories in the field of sleep deprivation (the
University of Pennsylvania and the Walter Reed Army Institute of
Research, respectively), have conducted studies in this area. Belenky,
et al. (2003) clearly demonstrates that limiting sleep to 5 hours per
night leads to significant impairment in both alertness and actual
performance, which builds up over the week, when compared to the
alertness and performance of individuals who obtain 7 hours of sleep
per night. The difference was found to be significant on all days
during which sleep was restricted to 5 hours. Compared to the research
subjects' performance after two baseline nights during which they
obtained 7 hours of sleep, the subjects' performance after nights
during which they were restricted to 5 hours of sleep showed more than
twice as many lapses (extra slow responses). Dinges, et al. (1997)
obtained similar results. From the second baseline day (the last day
during which a full 7 hours of sleep was obtained) through the 7
partial sleep restriction days, the research subjects' sleepiness and
performance became progressively worse and these effects achieved a
high level of statistical significance. The Dinges, et al. study also
concluded that ``recovery from these deficits appeared to require two
full nights of sleep.''
The importance of adequate sleep and the need to provide adequate
opportunity for sleep in work schedules are reflected in studies (e.g.,
Kecklund and Akerstedt, 1995; Wylie, et al., 1996), guidelines (Pratt,
2003; Baker, et al., 1990), handbooks (Tepas and Monk, 1987), and the
panel recommendations of sleep and fatigue experts (e.g., NUREG/CR-
4248). An EPRI/NEI Work Hours Task Force white paper, ``Managing
Fatigue in the Nuclear Energy Industry: Challenges and Opportunities''
(ADAMS Accession No. ML0221740179), also notes the importance of
providing an opportunity for at least 8 hours of sleep. The report,
prepared by Mark Rosekind, states that ``the strongest and most
extensive data demonstrate that sleep is a critical factor in promoting
alertness and performance in subsequent wakefulness. Data clearly show
that acute and cumulative sleep loss degrade subsequent alertness and
performance. Therefore, any `hours of service' policy should emphasize
the provision of an appropriate sleep opportunity prior to duty.'' More
specifically, human reliability analysis experts have recommended that
the NRC require ``a break of at least 12 hours between all work
periods'' (NUREG/CR-1278). Similarly, a panel of sleep and fatigue
experts criticized a DOT requirement for an 8-hour break for motor
carriers as inadequate because 8 hours of off-duty time does not
translate into 8 hours of sleep. The DOT has since amended its
regulations for motor carriers to require 10-hour rest breaks (68 FR
22456-22517, April 28, 2003).
Although a longer minimum rest break requirement would provide
greater assurance that individuals have adequate opportunities for
sleep, the 10-hour break requirement provides adequate opportunity for
rest when used infrequently, as is expected given other requirements in
this rule. For example, Sec. 26.205(d)(1)(ii) limits individuals to
working 26 hours in any 48-hour period. Although licensees could use
routine 10-hour breaks in conjunction with atypical shift durations
(e.g., alternating 12- and 14-hour shifts), the practical implications
of these schedules, such as varied start times, make their use
improbable. As a consequence, the 10-hour break requirement is
sufficient to
[[Page 17133]]
assure adequate rest during infrequent circumstances in which
individuals work extended hours (e.g., more hours than their typical 8-
,10-, or 12-hour shift) and that rest opportunities will typically vary
between 12 and 16 hours in duration.
The minimum 10-hour break duration also accommodates most
scheduling circumstances for the common shift durations that are
currently in use in the industry. A notable exception is that the 10-
hour break requirement could potentially prevent an individual who has
worked 16 hours straight (e.g., two consecutive 8-hour shifts) from
returning to duty at the start of his or her next regularly scheduled
shift. However, the 10-hour break requirement appropriately prevents
the individual from working in this circumstance because the potential
for degraded job performance resulting from fatigue would be
substantial given the individual's continuous hours of work and limited
opportunity to sleep.
Section 26.205(d)(2)(i) permits licensees to schedule a minimum 8-
hour break in only one circumstance: if the 8-hour break is necessary
to accommodate a crew's scheduled transition between work schedules.
During the public meetings described in the preamble of the proposed
rule, the NRC received comments that a 10-hour break requirement would
occasionally interfere with a transition from 12-hour shifts to 8-hour
shifts. This transition typically occurs at the end of an outage for
individuals who normally work an 8-hour shift, but work a 12-hour shift
during outages. Although the exception provides individuals with less
time for recovery, the shorter break is limited to one break occurring
on a very restricted frequency. Therefore, the permission for an 8-hour
break for the specific circumstances of a shift transition provides
scheduling flexibility with minimal potential to adversely affect an
individual's ability to safely and competently perform his or her
duties.
Section 26.205(d)(2)(ii) replaces and revises Sec.
26.199(d)(2)(ii) of the proposed rule which would have required a
minimum 24-hour break in any rolling 7-day period. Section
26.205(d)(2)(ii) of the final rule requires a minimum 34-hour break in
any rolling 9-day period. This provision requires a periodic long
duration break thereby preventing an excessive number of consecutive
work shifts that would not otherwise be prevented by the requirements
of Sec. 26.205 of this rule.
Break periods longer than the minimum 10 hours between shifts
required by Sec. 26.205(d)(2)(i) are necessary on a regular basis in
order to maintain reliable human performance. For example, Belenky, et
al. (2003) found that the performance of subjects whose sleep periods
were restricted to 7 hours per night over 7 consecutive days
increasingly degraded as the number of sleep-restricted days increased.
Van Dongen, et al. (2003) similarly found that the performance of
subjects whose sleep was limited to 8-hours per night also declined
over a 2-week period. The only subjects in these studies who did not
show any performance decrements were those who were permitted 9-hour
sleep periods in the Van Dongen study. These results clearly
demonstrate that individuals require more rest than a 10-hour break
provides over time to prevent performance degradation from cumulative
fatigue, including that which accrues from a series of days of mild
sleep restriction (e.g., 7 hours per night). Recent changes in the DOT
regulations for the work hours of commercial truck drivers also reflect
the need for longer breaks to mitigate fatigue. On April 28, 2003, the
DOT published final regulations (68 FR 22456-22517) for hours-of-
service for drivers of motor carriers, which amended 49 CFR Parts 385,
390, and 395. These regulations require a minimum 34-hour break after
any period of 8 consecutive days with no more than 70 hours on duty.
The intent of this 34-hour break is to provide for two consecutive
sleep periods.
Further, a 10-hour break provides an opportunity for 7 hours of
sleep only if one assumes the minimal times for meals, hygiene, and
commuting described with respect to Sec. 26.205(d)(2)(i), with no
other daily living obligations. These assumptions are realistic only
for unusual circumstances and limited periods of time during which
individuals may be able to temporarily defer their other obligations.
As the number of consecutive days increases in which individuals have
only a 10-hour break available to meet these other obligations, the
pressure on individuals to restrict sleep time in order to meet these
other obligations increases. In addition, after a series of moderately
restricted sleep periods (i.e., 6 hours per night), individuals'
subjective feelings of sleepiness stabilize and they report feeling
only mild sleepiness (Van Dongen, et al., 2003), which may further
encourage individuals to restrict their sleep periods in order to meet
daily living obligations. Van Dongen, et al. noted ``the lack of
reports of intense feelings of sleepiness during chronic sleep
restriction may explain why sleep restriction is widely practiced--
people have the subjective impression they have adapted to it because
they do not feel particularly sleepy.'' However, results of the Van
Dongen study also demonstrated that the performance of subjects in that
study continued to degrade as the number of consecutive restricted
sleep periods increased over a 2-week period, including the performance
of subjects who were permitted 6- and 8-hour sleep periods.
Section 26.199(d)(2)(ii) of the proposed rule would have
established a requirement for a minimum 24-hour break in any 7-day
period. The NRC revised the maximum number of days between the breaks
in response to stakeholder comments that the proposed requirement would
have substantially reduced licensee flexibility in scheduling 8-hour
shifts. Stakeholders noted that many licensees currently use 8-hour
schedules that include periods of 7 consecutive days. In revising the
proposed requirement, the NRC considered that, although the final rule
allows more consecutive days for 8-hour and 10-hour shifts, the final
rule allows licensees the flexibility to more readily optimize 8-hour
shift schedules to minimize the transitions between day, evening, and
night shifts that can lead to worker fatigue. Although this relaxation
also allows more consecutive shifts for individuals on 10-hour shifts,
individuals on 10-hour shifts typically do not work a rotating schedule
and thereby do not experience the disruption of their circadian cycle
that exacerbates the cumulative fatigue effects of consecutive work
shifts. The final rule also provides flexibility to accommodate other
practical considerations such as scheduling training on a Monday
through Friday basis and allows a contingency day in 8-hour shift
schedules that includes a series of seven consecutive 8-hour shifts as
part of the routine shift cycle.
The final rule also revises the minimum duration of the break
period from 24 hours, as specified in Sec. 26.199(d)(2)(ii) of the
proposed rule, to a minimum 34-hour break. The revision more clearly
states the NRC's intent to require a periodic ``day off'' in which
individuals have the opportunity for two consecutive sleep periods
without an intervening work period. The 34-hour break duration provides
opportunity for two consecutive sleep periods without an intervening
work period, supports use of forward rotating and fixed shifts, and
allows for the possibility that individuals may work 26 hours in a 48-
hour period contiguous to the break.
[[Page 17134]]
Given these considerations, the NRC concluded that Sec.
26.205(d)(2)(ii) of the final rule provides a level of assurance of
worker FFD relative to fatigue that is comparable to that which would
have been achieved through the requirement in Sec. 26.199(d)(2)(ii) of
the proposed rule. The provision for a 34-hour break in any rolling 9-
day period serves both to prevent and mitigate cumulative fatigue. The
34-hour break periods will not only provide some opportunity for
recovery sleep, but also time that individuals need to meet the many
daily living obligations that they cannot otherwise readily meet.
Without such long break opportunities, individuals must either forego
activities that can be important to general mental and physical fitness
(e.g., family interactions, exercise, recreation, doctor appointments)
or sacrifice sleep and increase their sleep debt (Presser, 2000),
resulting in impairment on the job.
Section 26.205(d)(2) of the final rule does not retain the
requirement for a minimum 48-hour break in any rolling 14-day period as
would have been required by Sec. 26.199(d)(2)(iii) of the proposed
rule. The NRC received many stakeholder comments in opposition to the
48-hour break requirement. One commenter stated that fixed break
requirements and collective work hour restrictions will lead to
significant safety implications and could affect a licensee's ability
to restore inoperable equipment in a timely manner. This view was
echoed by many other commenters. Another commenter found fault with
focusing on days off without considering the number of hours worked in
a particular day and the breaks between work periods. In addition, many
commenters raised the issue of work schedule disruption as a result of
the 48-hour break requirement. They asserted that, for workers on the
night shift, having one day off provides an additional rest period and
allows the worker to maintain a consistent pattern of work and sleep
habits, which reduces the risk of accidents on the job. Two days off,
however, may interfere with his or her sleep cycle, and as a result,
the individual would have to readjust to the night shift after the 2-
day break. According to the commenters, some workers have stated that
having 2 days off is worse than having no days off. They also argued
that a 1-day break in any 7-day period is more than adequate when
combined with other rule provisions to address cumulative fatigue.
Thus, commenters requested that the 48-hour break requirement during
outage periods be deleted.
In response to stakeholder comments, the NRC replaced the
requirement proposed in Sec. 26.199(d)(2)(iii) with alternative
requirements that ensure that each worker receives a minimum number of
days off per week, on average, while the plant is operating or receives
a minimum number of days off in each consecutive 15-day period of a
plant outage. Security personnel subject to the requirements of Sec.
26.205 are also subject to requirements for minimum days off in 15-day
periods during security system outages and increased threat conditions.
These alternative extended break requirements are in Sec. 26.205(d)(3)
through (d)(5) of the final rule and are addressed in the section-by-
section analysis applicable to those requirements. In adopting the
alternative requirement for the final rule, the NRC considered that,
whereas the alternative requirements assured that workers subject to
the requirement would receive a minimum number of days off, which would
serve to limit the potential for cumulative fatigue, the requirements
would not assure that any of the days off would be consecutive, as
would have been required by the minimum 48-hour break requirement of
proposed Sec. 26.199(d)(2)(iii). In proposing the 48-hour break
requirement, the NRC cited several studies that demonstrate the
benefits of consecutive days off, noting that one night of unrestricted
sleep is not sufficient to fully recover from the cumulative fatigue
that can result from restricted sleep and extended work hours. However,
the NRC also considered that the minimum day off requirements would, in
effect, limit each individual's average number of work hours and the
average number of consecutive work shifts between days off, thereby
reducing the potential for cumulative fatigue. As a consequence, the
final rule's requirements reduce the need for consecutive days off to
prevent or mitigate fatigue. The NRC also expects that common
scheduling constraints and worker preferences will cause licensees to
schedule days off in succession. In addition, the NRC considered that
the alternative requirements of Sec. 26.205(d)(3) and (d)(4) of the
final rule provides licensees greater flexibility in meeting scheduling
demands and minimizing circadian disruption for workers.
Section 26.205(d)(3) requires individuals subject to the
requirements of Sec. 26.205 to have a minimum average number of days
off per week. The specific number of days off depends upon the length
of shifts in the work schedule of the individual. This requirement
replaces the requirements presented in proposed Sec. 26.199(f)
[Collective work hour limits], which would have required licensees to
control the collective work hours of each group of individuals
performing the duties subject to the work hour requirements and ensure
that the collective work hours of each job duty group would not have
exceeded an average of 48 hours per person per week in any averaging
period. Section 26.205(d)(3), by requiring a minimum number of days
off, indirectly limits average weekly work hours to levels comparable
to those that would have been permitted by the collective work hour
limits of the proposed rule. Consequently, Sec. 26.205(d)(3) of the
final rule performs the same function as the requirements of proposed
Sec. 26.199(f), providing reasonable assurance that the FFD of
individuals subject to the work hour requirements is not impaired by
cumulative fatigue. As described with respect to Sec. 26.205(d)(2),
this requirement also addresses an objective of the 48-hour break
requirement of the proposed rule by limiting the potential for the
cumulative fatigue of individuals while the plant is operating. The
provision does not require that days off be provided consecutively, as
would have been required by proposed Sec. 26.199(d)(2)(iii), but
rather allows licensees discretion, within the constraints of the other
work hour limit and break requirements, in distributing days off
throughout the shift cycle. As a consequence, Sec. 26.205(d)(3), like
proposed Sec. 26.199(d)(2)(iii), is intended to ensure that
individuals receive sufficient days off on a periodic basis to prevent
cumulative fatigue.
The minimum day off requirements of Sec. 26.205(d)(3) will ensure
that licensees manage during periods of normal plant operation the
potential for cumulative fatigue (i.e., fatigue from successive weeks
of overwork or inadequate rest) to adversely affect the abilities of
individuals to perform functions that are important to maintaining the
safety and security of the plant. The requirements prevent excessive
use of the maximum work hours and minimum rest breaks that are
permitted under Sec. 26.205(d)(1) and (d)(2). In addition, proactively
controlling work hours to ensure individuals receive a minimum weekly
average number of days off while the plant is operating is likely to
reduce the need for licensees to grant waivers of the work hour
requirements in Sec. 26.205(d)(1) and (d)(2). Individuals will be
better rested and less susceptible to cumulative fatigue from the
increased work hours that are common during outages and that are
necessary to augment security
[[Page 17135]]
staffing during increased threat conditions. Therefore, the minimum day
off requirement is essential for limiting cumulative fatigue and
augments other important elements of licensees' fatigue management
programs.
Requiring a minimum number of days off that results in a maximum
average work week of approximately 48-54 hours per week helps to ensure
that licensees meet a fundamental objective of the NRC's Policy on
Worker Fatigue. The Policy, promulgated in GL 82-12, is intended to
ensure that there are a sufficient number of operating personnel
available to ``maintain adequate shift coverage without routine heavy
use of overtime.'' Routine overtime can cause cumulative fatigue,
thereby degrading workers' abilities to safely and competently perform
their tasks. Section 26.205(d)(3) establishes requirements that are
expected to result in maximum average work weeks in the range of 48-54
hours, thereby ensuring that work hours approaching the limits in Sec.
26.205(d)(1) and NRC's Policy on Worker Fatigue are the exception and
not routine.
The minimum day off requirements of Sec. 26.205(d)(3) also
address, in part, the cumulative fatigue concerns reported by security
personnel in the months following the terrorist attacks of September
11, 2001. These individuals questioned their readiness and ability to
perform their required job duties because of the adverse effects of
cumulative fatigue. The NRC reviewed the actual hours worked by
security personnel and determined that, in the vast majority of cases,
individual work hours did not exceed the guidelines specified in the
NRC's Policy on Worker Fatigue. However, the review confirmed that
individuals had been working up to 60 hours per week for extended
periods. Individual concerns regarding their FFD, in light of work
schedules that did not exceed the specific guidelines of the policy, as
well as relevant technical research supporting the basis for cumulative
fatigue, led the NRC to conclude that the work hour guidelines of the
Policy are inadequate for addressing cumulative fatigue. The NRC
obtained additional support for this conclusion following a review of
worker fatigue concerns and work hours during a long-term outage at the
Davis Besse nuclear plant (NRC Inspection Report 05000346/2004003,
dated March 31, 2004, ADAMS Accession No. ML040910335).
Through public interactions during the development of order EA-03-
038, the NRC developed a collective work hour requirement, rather than
a limit on individual work hours, in response to stakeholder comments
regarding differences among individuals in their abilities and desires
to work overtime. The proposed rule would have permitted a group of
workers who perform similar duties to average 48 hours of work over a
period not to exceed 13 weeks. Because the proposed limit would have
been imposed on a job duty group's average number of work hours during
an averaging period, licensees would have been able to distribute
overtime among their workers based on their assessment of individuals'
abilities and desires to work overtime. Stakeholder comments on the
proposed requirement for collective work hour controls raised several
concerns.
Some stakeholders expressed the concern that the collective work
hour controls were not an effective means for addressing fatigue. One
stakeholder expressed the concern that the collective work hour
controls would allow licensees to force individuals to work overtime.
Another stakeholder expressed the opinion that collective work hour
controls are not an effective means to address the known physiological
fatigue risks contributed by individual operators. Other stakeholders
expressed the concern that licensees may be able to manipulate the
collective work hour calculations. Other commenters asserted that the
collective work hour controls were unnecessary to mitigate the effects
of cumulative fatigue and that the controls would limit the flexibility
to increase work hours in a job-duty group based on operational needs.
These commenters stated that other rule provisions, such as the work
schedule, individual work hour limits, and individual break
requirements, as well as the provisions concerning fatigue assessments
and the self-declaration process adequately address cumulative fatigue.
Although the NRC acknowledges that Subpart I provisions concerning
fatigue assessment and self-declaration are important for the detection
of cumulative fatigue, these provisions, like the individual work hour
limit and break requirements of the proposed rule, do not adequately
address the prevention of cumulative fatigue. Accordingly, the final
rule addresses the comments on the limitations of the collective work
hour requirements by replacing the requirements of Sec. 26.199(f) of
the proposed rule with the minimum day off requirements in Sec.
26.205(d)(3) of the final rule. The minimum day off requirements were
largely derived from a work hour control proposal submitted by NEI as a
comment on the proposed rulemaking. Although in several instances the
NRC did not adopt the specific minimum number of days off that NEI
proposed in its comments, Sec. 26.205(d)(3) establishes requirements
similar to those proposed by NEI by requiring each individual subject
to the requirements of Sec. 26.205 to have a minimum average numbers
of days off per week.
Section 26.205(d)(3) defines, for the purposes of Subpart I, the
term day off as a calendar day in which an individual does not start a
work shift. The definition ensures consistent licensee implementation
of the requirements in Sec. 26.205(d)(3). In developing the
definition, the NRC considered the alternative of defining the
requirements of Sec. 26.205(d)(3) in terms of 24-hour break periods. A
stakeholder at the March 29, 2006, public meeting concerning this
rulemaking noted that the number of 24-hour breaks in a schedule could
be readily influenced by the number of rotations between shifts and
therefore could encourage scheduling practices that achieved compliance
with the requirement through schedules that were adverse to the
circadian adjustment of workers. As defined in the final rule, use of
the term day off does not encourage such adverse scheduling practices
and results in requirements that establish uniform limits for all
schedule designs. In addition, the definition enables workers and
schedulers to readily determine the number of days off in a schedule
without the need to calculate the duration of break periods.
Section 26.205(d)(3)(i) through (d)(3)(iv) specifies the minimum
number of days off for each individual subject to the requirements of
Sec. 26.205 in terms of a minimum number of days off per week,
averaged over the shift cycle. The requirements in this section thereby
allow the number of days off for an individual to vary from week to
week, but mandate that over the duration of the shift cycle, the
average number of days off per week meets the specified minimum.
Section 26.205(d)(3) requires that, for the purposes of calculating the
average number of days off required in this section, the duration of a
shift cycle may not exceed 6 weeks. This maximum duration of a shift
cycle limits the period over which licensees are permitted to average
the number of days off and thereby limits the potential for cumulative
fatigue by preventing an excessive number of consecutive weeks in which
individuals may be working the maximum hours allowed by Sec.
26.205(d)(1) while having only the minimum breaks required by
[[Page 17136]]
Sec. 26.205(d)(2). The 6-week maximum for shift cycles also
corresponds to the longest shift cycle commonly used in the U.S.
nuclear industry.
Section 26.205(d)(3)(i) requires individuals who are working 8-hour
shift schedules to have at least 1 day off per week, averaged over the
shift cycle. This minimum day off requirement allows an average of 48
hours of work per week, assuming individuals receive the minimum number
of days off with no work shifts extended beyond 8 hours. This
requirement is therefore generally consistent with the 48-hour
collective work hour requirement of Sec. 26.199(f) of the proposed
rule, though it imposes the requirement on an individual rather than a
group basis. This requirement is also consistent with the NEI proposal
for an average of 1 day off per week, averaged over a shift cycle, for
predominantly 8-hour shift schedules.
In developing requirements to address cumulative fatigue, the NRC
considered several types and sources of information, including (1) past
recommendations from experts and expert panels on work scheduling and
maintaining worker alertness in the nuclear industry, (2) surveys of
nuclear power plant workers on their desire and ability to work
overtime, (3) data on the amount of overtime worked by security
personnel, and (4) the requirements and practices in other industries.
EPRI NP-6748 (Baker, et al., 1990) and NUREG/CR-4248 are two of the
most comprehensive documents on worker fatigue in the U.S. nuclear
industry. Like the collective work hour limits of the proposed rule,
the minimum average number of days off requirement is a new concept
developed to meet the rule's objectives while also addressing
stakeholders' unique circumstances and specific concerns. As a
consequence, neither of the documents provides specific guidelines for
establishing collective work hour limits. Nevertheless, the documents
contain information and guidelines relevant to this requirement.
Collectively, the shift scheduling guidelines of EPRI NP-6748 and
NUREG/CR-4248 suggest a maximum routine work schedule of 44-46 hours
per week. This maximum includes an assumed turnover time of 30 minutes
per shift. The NRC also considered the recommendations of experts
concerning the use of overtime. The expert panel that developed the
guidelines for NUREG/CR-4248 also addressed overtime use and
recommended an individual limit of 213 hours per month, including shift
turnover time. The expert panel emphasized that overtime should not be
approved for an entire crew, noting that this individual maximum on
overtime should not be a group norm. Work schedules that meet the
minimum day off requirements will result in levels of individual work
hours that are typically in the middle of the range of work hours
defined by the maximum routine scheduling limits and maximum individual
overtime. The expert panel further recommended that the NRC authorize
no more than 400 hours of overtime in a year. A limit of 400 hours of
overtime annually is very similar to a 48-hour average (i.e., 52 weeks
x 8 hours = 416 hours).
In addition to considering the opinions of experts in work
scheduling and fatigue, the NRC staff also considered the opinions of
individuals who work in nuclear power plants. These opinions were
expressed in surveys conducted by PROS and EPRI.
In 2002, PROS surveyed the attitudes of its members towards work
hours and the development of a proposed rule concerning fatigue of
workers at nuclear power plants (ADAMS Accession No. ML05270310). One
of the survey questions was, ``What is your personal tolerance for
overtime?'' The responses indicated that 75 percent of the respondents
had a ``tolerance'' for up to 350 hours per year. Only 13 percent
expressed a tolerance for more than 350 hours of overtime.
The work conducted in the development of EPRI NP-6748 also included
a survey of operators. The results were consistent with the PROS
survey, indicating that the amount of overtime that operators wanted to
work ranged from 100 to 400 hours per year. A survey of nuclear power
plant personnel in the United Kingdom yielded similar results.
A minimum day off requirement will limit individuals to
approximately 400 to 500 hours of overtime in a year. Therefore, the
minimum day off requirements permit levels of overtime while the plant
is operating that are at the upper extreme of the number of overtime
hours for which nuclear power plant personnel have expressed a
tolerance. In addition, the minimum day off requirements are less
restrictive than the limit implied by worker opinions because the
minimum day off requirements of Sec. 26.205(d)(3) would not apply
during the first 60 days of plant outages, and for security personnel,
during the first 60 days of plant outages, security system outages, or
increased threat conditions.
Together with expert and worker opinions, the NRC considered
industry practices concerning the use of overtime for security
personnel. The NRC collected work scheduling data for security
personnel at all nuclear power plants following the events of September
11, 2001, as part of the process of evaluating the need to require
licensees to implement compensatory measures to address security
personnel fatigue. The NRC's analysis, as described in letters from the
NRC to licensees (e.g., ADAMS Accession No. ML031880257), indicated
that at some of the sites (31 percent), security personnel worked more
than 55 hours per week and at a few sites (11 percent) they worked 60
hours or more per week. The data also indicated that at the majority of
the sites (58 percent) security personnel typically worked 50 hours per
week or less. The NRC also reviewed work hours data collected by NEI
(ADAMS Accession No. ML003746495) and found that, although individual
sites varied substantially, the average annual overtime for licensed
operators was 375 hours and 361 hours for non-licensed operators. These
findings suggest that an average work week of approximately 48 hours is
an achievable objective for operations personnel as well, although it
was not a current practice at a small fraction of nuclear power plants.
The minimum day off requirements are comparable to, though less
restrictive than, limits on workers in other industries within the
United States and the limits imposed by other countries that regulate
overtime for nuclear power plant workers. The NRC staff noted that
several other countries address cumulative fatigue of nuclear power
plant personnel through individual monthly and/or annual work hours
limits on overtime. These limits, summarized in Table 6 of Attachment 1
to SECY-01-0113, are generally more restrictive than the minimum day
off requirements because they directly limit hours of work, rather than
work days, and permit fewer hours of work (e.g., Finland limits
overtime to 250 hours per year). Table 5 of Attachment 1 to SECY-01-
0113 includes a summary of limits on work hours in other industries in
the United States.
The NRC also considered the requirements of the European Union (EU)
Working Times Directive (WTD) (Council Directive, 1993). The WTD
establishes requirements concerning the working hours of workers across
various industries in EU member nations. The WTD establishes a
requirement that ``workers cannot be forced to work more than 48 hours
per week averaged over 17 weeks.''
Moreover, the amount of overtime permitted by the minimum day off
requirements would be greater than the
[[Page 17137]]
amount used in most continuous operations. Circadian Technologies,
Inc., a consulting firm that is expert in fatigue management, regularly
surveys U.S. and Canadian companies conducting 24/7 operations. Its
2000 survey of 550 major companies indicates that shift workers at 89
percent of the companies surveyed averaged less than 400 hours of
overtime per year (Circadian Technologies, Inc., 2000). Circadian
Technologies, Inc., noted that the average overtime for workers in
extended operations in the United States was 12.6 percent above the
standard work week in the first 8 months of 2003, with utilities
averaging 14.9 percent (Circadian Technologies, Inc., 2003).
Therefore, the minimum day off requirements establish appropriate
limits on work schedules while the plant is operating. The requirements
would ensure that individuals subject to the work hour requirements of
Sec. 26.205 have sufficient days off to prevent fatigue. The minimum
day off requirements will indirectly permit levels of overtime at the
upper extreme desired by most nuclear power plant workers while
limiting overtime to levels comparable to those recommended by work
scheduling and fatigue experts.
Section 26.205(d)(3)(ii) requires that individuals who are working
10-hour shift schedules have at least 2 days off per week, averaged
over a shift cycle. Individuals working schedules that meet the minimum
day off requirements of this section would therefore be working, on
average, five 10-hour shifts (50 hours) per week. In developing this
requirement the NRC considered the NEI proposal for a minimum of 1 day
off per week average for 10-hour shift schedules. The NRC concluded
that such a limit would allow excessive work hours (i.e., an average of
60 hours per week) for routine scheduling, thus creating the potential
for cumulative fatigue. The NRC would not expect such a limit for long-
term work hour control to prevent fatigue concerns such as those
reported by security personnel working on the order of 60 hours per
week in the months following the terrorist attacks of September 11,
2001. The section-by-section analysis for Sec. 26.205(d)(3)(i)
addresses in detail the basis for minimum day off requirements that
effectively limit work schedules to work weeks averaging approximately
48 hours per week. Section 26.205(d)(3)(i) would permit an average work
schedule of approximately 50 hours. Although this requirement for 10-
hour schedules would allow 2 more hours per week than the requirement
for 8-hour schedules, 10-hour schedules are not typically used for
rotating shift schedules. As a consequence, the individuals on those
schedules are less likely to experience the disruption of their
circadian cycles that is caused by rotating shifts and therefore better
able to cope with the additional work hours.
Section 26.205(d)(3)(iii) requires that individuals performing the
duties described in Sec. 26.4(a)(1) through (a)(3) have at least 2.5
days off per week averaged over a shift cycle and individuals described
in Sec. 26.4(a)(4) have at least 2 days off per week, averaged over a
shift cycle. In developing this requirement, the NRC considered NEI's
proposal to require a minimum of 2 days off per week for all
individuals working 12-hour shifts subject to the work hour
requirements, except security personnel. For individuals performing the
duties described in Sec. 26.4(a)(1) through (a)(3), the NRC judged 2
days off per week to be insufficient for routine scheduling of 12-hour
shifts because it would allow an average work week of 60 hours, which
the NRC expects would lead to cumulative fatigue. Furthermore, such a
requirement would ensure substantially fewer days off than would be
recommended by the scheduling guidelines contained in EPRI NP-6748
(Baker, et al., 1990) and NUREG/CR-4248.
In developing Sec. 26.205(d)(3)(iii), the NRC also considered the
effect of scheduled training weeks on the overall work hours of
operations personnel. Operators have 1 week of requalification training
in most shift cycles. The training week typically consists of four 9-
hour days or five 8-hour days. As a consequence, Sec.
26.205(d)(3)(iii) has the effect of limiting covered operations
personnel to an average work week ranging from 48.8 hours to 52 hours,
in most shift cycles (i.e., when the shift cycle contains a training
week). The specific number of hours depends on the number of weeks in
the shift cycle and the training week schedule. This estimate also
assumes that individuals do not work longer than their scheduled 12-
hour shift.
Section 26.205(d)(3)(iv) of the rule requires that licensees ensure
that individuals who are working 12-hour shifts while performing the
maintenance duties described in Sec. 26.4(a)(4) have a minimum of at
least 2 days off per week, averaged over a shift cycle. For individuals
described in Sec. 26.4(a)(4) the NRC judged 2 days off per week to be
sufficient for routine scheduling of 12-hour shifts. Relative to the
duties described in Sec. 26.4(a)(1)-(a)(3) and (a)(5), the duties
described in Sec. 26.4(a)(4) involve fewer and less prolonged periods
of sedentary activities, which can contribute to degraded alertness,
and monitoring activities, which are particularly susceptible to
degraded vigilance.
Section 26.205(d)(3)(v) of the rule requires that licensees ensure
that individuals who are working 12-hour shifts and performing the
security duties described in Sec. 26.4(a)(5) have a minimum of 3 days
off per week, averaged over a shift cycle. This requirement limits the
security personnel who are subject to this requirement to an average
work week of 48 hours. In developing this requirement the NRC
considered the technical basis described with respect to Sec.
26.205(d)(3) and public comment on the collective work hour controls of
the proposed rule. The NRC also considered its experience with
implementing the group work hour controls that were required for
security personnel by the compensatory measures of order EA-03-038. The
NRC has generally found that licensees have implemented work hour
controls consistent with the requirements of the compensatory measures.
However, the NRC has received a limited number of concerns from
security personnel stating that they are still experiencing excessive
fatigue leading to the perception that the requirements have not been
fully protective of all security personnel. The NRC also notes that it
has received numerous reports of inattentive security personnel at U.S.
nuclear powerplants within the last 2 years. In addition, the NRC
considered the critical importance of mental alertness and maintaining
vigilance to the effective performance of security personnel and the
unique challenges of security duties and work environments to meeting
these needs (see the section-by-section analysis of Sec. 26.205(a) for
a more detailed discussion of the relationship between security duties
and fatigue). Given these considerations, the NRC concluded that it is
appropriate to establish more stringent work hour requirements for
security personnel than other individuals subject to the requirements
of Sec. 26.205. Accordingly, Sec. 26.205(d)(3)(iv) requires a minimum
of 3 days off per week, averaged over a shift cycle, for individuals
working 12-hour shifts who are performing the security duties described
in Sec. 26.4(a)(5).
Section 26.205(d)(4) provides a limited exception from the minimum
day off requirements in Sec. 26.205(d)(3) for individuals performing
the duties specified in Sec. 26.4(a)(1) through (a)(4) (i.e., certain
operations, chemistry,
[[Page 17138]]
health physics, fire brigade, and maintenance personnel). The exception
from the minimum day off requirements is available during the first 60
days of a unit outage while a subject individual is working on outage
activities. In these circumstances, Sec. 26.205(d)(4) requires
licensees to ensure that individuals specified in Sec. 26.4(a)(1)
through (a)(3) have a minimum of 3 days off in each successive (i.e.,
non-rolling) 15-day period and that individuals specified in Sec.
26.4(a)(4) (maintenance personnel) have at least 1 day off in any 7-day
period. If at any time during a unit outage an individual performs
duties specified in Sec. 26.4(a)(1) through (a)(4) on or for a unit
that is not disconnected from the electrical grid, the individual is
subject to the minimum day off requirements of Sec. 26.205(d)(3) while
the individual is performing those duties, except as permitted by Sec.
26.205(d)(6). After the first 60 days of a unit outage, regardless of
whether the individual is working on unit outage activities, the
individual is again subject to the minimum day off requirements of
Sec. 26.205(d)(3), except as permitted by Sec. 26.205(d)(6).
The minimum day off requirements in Sec. 26.205(d)(3) address the
long-term control of work hours while permitting the occasional use of
extended work hours for short duration circumstances such as equipment
failure, personnel illness, or attrition. The requirements in Sec.
26.205(d)(4) address the control of work hours for unique plant
conditions (i.e., unit outages) which require extended work hours for a
more sustained period of time. In developing the minimum day off
requirements of Sec. 26.205(d)(4), the NRC considered several factors,
including current policy, the bases for the policy, lessons learned
from the policy implementation, and public comment on the proposed
rule.
The NRC's Policy on Worker Fatigue provides guidelines for
controlling work hours, ``on a temporary basis,'' during periods
requiring substantial overtime. The Policy reflects the NRC's
recognition that outages are unique, relatively short term, and involve
levels of activity that are substantially higher than most non-outage
operating periods. The policy also reflects the NRC's understanding
that, although individuals are capable of working with limited rest
without degraded performance for short periods of time, research has
shown that the ability to sustain performance without adequate rest is
clearly limited (Knauth and Hornberger, 2003; Pilcher and Huffcutt,
1996; Van Dongen, et al., 2003), as discussed in Section IV.D. However,
as noted in SECY-01-0113, Attachment 1, the NRC has never defined the
term ``temporary basis'' as used in the Policy. As a result, licensees
have relied on this phrase in the guidelines to permit extended work
hours for periods ranging from a few days to more than a year. Industry
experience with conditions such as sustained plant shutdowns and the
increased work hours of security personnel following the terrorist
attacks of September 11, 2001, have demonstrated the need for the NRC
to establish clearer and more readily enforceable requirements limiting
the sustained use of extended work hours.
Differences between individuals, job demands, and work-rest
schedules can each have a substantial effect on the period of time that
an individual can work without compromising his or her ability to
safely and competently perform duties. As a result, studies of work
scheduling and fatigue provide insights into the potential for
cumulative fatigue of workers, but do not provide a direct basis for
establishing the maximum acceptable period for excluding plant outage
work hours from the collective work hour controls. In setting the
maximum duration of the exclusion period, the NRC considered that, by
the end of 60 days of work at the limits permitted by Sec.
26.205(d)(1) and (d)(2), individuals who are performing the duties
specified in Sec. 26.4(a)(1) through (a)(4) will have (1) worked 576
hours, including more than 200 hours of overtime, and (2) missed as
many as 17 normally scheduled days off. The loss of the 17 normally
scheduled days off represents a 60-percent reduction in the time
available to recover and prevent cumulative fatigue. Further, with each
passing week of increased work hours and decreased time off, deferring
daily living obligations becomes increasingly difficult, causing
increased pressure on individuals to reduce their sleep time in order
to meet the demands of both work and daily life, resulting in an
increased potential for cumulative fatigue.
In addition to considering the potential for cumulative fatigue,
the NRC considered current industry data on the duration of unit
outages in determining whether the cost to licensees imposed by
limiting the exclusion period to 60 days is justified in terms of the
benefit. The average outage duration, as indicated by outage data from
2000-2002, is approximately 39 days (Information System on Occupational
Exposure Database, ADAMS Accession No. ML050190016). Eighty-nine
percent of plant outages during this period were less than 8 weeks in
duration. In reviewing the frequency of outages, by duration, the NRC
found that it would be necessary to increase the exclusion period
substantially to address a marginal number of additional outages of
longer lengths. Many comments on the proposed rule recommended that the
8-week exclusion period be increased to a 10-week exclusion period.
This increase in the exclusion period would substantially increase the
period of time that an individual would be working with reduced
recovery time. During the exclusion period, individuals are permitted
to work up to 72 hours in a 7-day period and are assured of just 3 days
off in each 15-day period. Individuals who work 12-hour shifts, which
is common during outages, will average up to 67.2 hours per week, which
represents 160 percent of their normally scheduled hours with less than
half of their normally scheduled days off for recovery, for a period of
up to 2 months. Extending the outage exclusion period to prolong these
conditions would substantively increase the potential for cumulative
fatigue and fatigue-related personnel errors. Therefore, the NRC did
not adopt the recommendation to increase the duration of the exclusion
period in the final rule.
The NRC also received several comments on the proposed rule which
recommended that the NRC eliminate the exclusion for outage periods. In
an early phase of developing the work hour requirements in Subpart I,
the NRC considered establishing a set of uniform requirements that
would be applicable regardless of whether a unit was operating or shut
down. However, as noted with respect to Sec. 26.205(d)(4), the NRC
recognizes that individuals are capable of working with limited rest
without degraded performance for short periods of time. As a
consequence, the NRC considers it appropriate to allow flexibility
within the work hour requirements to accommodate limited periods of
more intensive work schedules, such as unit outages. However, the NRC
limits this flexibility to infrequent circumstances, such as unit
outages, to limit the potential for cumulative fatigue. Further, the
NRC considered the substantial cost to licensees for meeting the
requirements applicable to periods of plant operation through either
increasing staffing (to minimize outage durations) or increasing outage
durations to accommodate a less intensive work schedule. Given these
considerations, the NRC concluded that a limited period of less
restrictive work hour requirements, as included in the final
[[Page 17139]]
rule, is better justified by the costs and benefits.
The 60-day exclusion period that Sec. 26.205(d)(4) permits from
the minimum day off requirements of Sec. 26.205(d)(3) replaces the 8-
week exclusion period that proposed Sec. 26.199(f) would have
permitted from the collective work hour limits. The discussion with
respect to Sec. 26.205(d)(3) presents the issues the NRC considered in
deciding to replace the collective work hour limits with minimum day
off requirements. The NRC revised the maximum duration of the permitted
exclusion period to a duration that is comparable to the 8-week (56-
day) period of the proposed rule, but better conforms with the minimum
day off requirements in Sec. 26.205(d)(4) and (d)(5). For most
categories of individuals, the final rule establishes minimum day off
requirements in terms of 15-day periods, rather than weeks, as the
proposed rule would have required. As a consequence, the NRC revised
the maximum duration of the exclusion period to 60 days (4 x 15) to
encompass four complete periods of time.
Section 26.205(d)(4) requires licensees to ensure that individuals
performing the duties specified in Sec. 26.4(a)(1) through (a)(3) have
at least 3 days off in each successive (i.e., non-rolling) 15-day
period during the first 60 days of a unit outage and that individuals
specified in Sec. 26.4(a)(4) (maintenance personnel) have at least 1
day off in any 7-day period. This requirement replaces, in part,
proposed Sec. 26.199(d)(2)(ii), which would have required that these
individuals have a minimum 24-hour break in any 7-day period. This
requirement also replaces, in part, proposed Sec. 26.199(d)(2)(iii),
which would have required that these individuals have a minimum 48-hour
break in any 14-day period, except during the first 14 days of an
outage. The NRC is replacing these requirements with Sec. 26.205(d)(4)
in response to public comment (see the discussion of public comment
with respect to Sec. 26.205(d)(2)(i) and (d)(3)). The combined effect
of Sec. 26.199(d)(2)(ii) and (d)(2)(iii) of the proposed rule would
have been to require 2 days off in the first 2 weeks of the outage and
3 days off in each subsequent 14-day period. Section 26.205(d)(4)
establishes a requirement that is similar to, though more flexible and
less complex than, the requirements it replaces.
The NRC also received stakeholder comments on the proposed rule
which recommended that the NRC eliminate the minimum day off
requirements for outage periods. In additions, the NRC received
comments asserting that attracting qualified supplemental workers is
challenging in the entire commercial reactor industry, that for many
supplemental workers the availability of overtime is a key factor in
where they decide to work, and that the industry has already
experienced cases where individuals have left during an outage to go to
a job that offered more overtime. The final rule partially addresses
these comments by requiring that maintenance personnel have at least 1
day off in any 7-day period instead of the requirement for at least 3
days off in each successive (i.e., nonrolling) 15-day period. The NRC
notes that critical maintenance tasks performed by individuals within
the scope of Sec. 26.4(a)(4) are subject to quality assurance and
corrective action programs and that these programs are subject to NRC
inspection. In addition, post-maintenance testing provides additional
assurances of equipment performance.
As described with respect to Sec. 26.205(d)(2), the NRC received
many stakeholder comments on the proposed rule regarding the 48-hour
break requirement. Several commenters asserted that, for workers on the
night shift, having 1 day off provides an additional rest period and
allows the worker to maintain a consistent pattern of work and sleep
habits, which reduces the risk of accidents on the job. However, two
days off may interfere with his or her sleep cycle and, as a result,
the individual would have to readjust to the night shift after the 2-
day break. The NRC acknowledges that these concerns may be particularly
applicable during outage periods when it is common for licensees to
schedule many individuals on a fixed night shift for the duration of an
outage. The final rule addresses this concern by providing licensees
increased flexibility in the distribution of the days off. As a
consequence, licensees may schedule single days off to limit circadian
disruption for workers on the night shift. Alternatively, they may
provide the days off in consolidated blocks to provide extended breaks
of 2 or more consecutive unrestricted sleep periods which are important
to reducing cumulative fatigue.
The objective of the requirement in Sec. 26.205(d)(4) is to ensure
that individuals performing the duties described in Sec. 26.4(a)(1)
through (a)(4) have sufficient periodic long-duration breaks to prevent
cumulative fatigue from degrading their ability to safely and
competently perform their duties. The minimum day off requirement in
Sec. 26.205(d)(4) serves the same general function as the minimum day
off requirements of Sec. 26.205(d)(3). However, whereas Sec.
26.205(d)(3) is principally applicable to extended periods while a unit
is operating, Sec. 26.205(d)(4) is applicable to periods of limited
duration during unit outages. As a consequence, the specific limits and
details of these requirements differ to accommodate these different
plant conditions and periods of applicability.
In its development of Sec. 26.205(d)(4), the NRC considered
industry work scheduling practices during outages and the applicability
of other proposed requirements during these periods. In SECY-01-0113
and NRC staff reviews of records of deviations from technical
specification work hour controls from 2003 and 2004, the most common
deviation identified was to permit individuals to work more than 72
hours in 7 days, frequently by working more than six consecutive 12-
hour days. These reviews also indicated that this practice was used
extensively at a number of sites. Industry comments at the public
meetings described in the preamble to the proposed rule also confirmed
the NRC observation that some licensees were scheduling outages with
several weeks of 12-hour shifts with no scheduled days off. The NRC
also considered industry comments submitted during the public comment
period that asserted 1 day off in 7 is adequate for maintaining worker
performance and that offering schedules that included these levels of
overtime is necessary to attract supplemental outage workers. The
minimum day off requirement of Sec. 26.205(d)(4) is the one
requirement of this final rule that prevents individuals who perform
the duties listed in Sec. 26.4(a)(1) through (a)(3) from working 72
hours per week for the entire first 8 weeks of a unit outage. In
addition, the minimum day off requirement of Sec. 26.205(d)(4) is the
one requirement of this final rule that prevents individuals from
performing the duties listed in Sec. 26.4(a)(4) with no scheduled days
off for the entire first 8 weeks of a unit outage. In this regard, the
NRC notes that the duties listed in Sec. 26.4(a)(1) through (a)(4) are
those the NRC considers most important for fatigue management because
of their relationship to the protection of public health and safety. In
particular, these duties include operating and maintaining systems and
components that a risk-informed process has shown to be significant to
public health and safety.
As described with respect to Sec. 26.205(d)(2)(ii), break periods
longer than the minimum 10 hours required by Sec. 26.205(d)(2)(i) are
necessary on a regular basis to maintain reliable human
[[Page 17140]]
performance. A 10-hour break provides an adequate opportunity to sleep
(approximately 7 hours for most individuals) only if one assumes the
minimal times for meals, hygiene, and commuting, as described with
respect to Sec. 26.205(d)(2)(i), with no other daily living
obligations. During unit outages, work schedules of 12-hour shifts and
limited days off are common. As the ratio of 12-hour work shifts to
days off increases, the pressure on individuals to restrict sleep time
in order to meet daily living obligations that cannot be deferred
increases. Without periodic days off, individuals must either forego
activities that can be important to general mental and physical fitness
(e.g., family interactions, exercise, recreation, doctor appointments)
or sacrifice sleep and increase their sleep debt (Presser, 2000). Such
sleep restriction will compound the effect of the long (12-hour) work
shift resulting in impairment on the job.
The NRC also considered ways to prevent and mitigate cumulative
fatigue in roving outage crews and other transient workers who
predominantly work during plant outages in the development of this
requirement. During the stakeholder meetings discussed in the preamble
to the proposed rule, many stakeholders expressed a strong desire for
transient workers to be subject to work hour controls. One stakeholder
observed that assuring transient outage workers are not impaired by
fatigue is particularly important because these individuals typically
do not have the extensive training in methods for maintaining reliable
human performance that is provided to permanent plant personnel.
During development of the proposed rule, the NRC staff considered
establishing long-term work hour controls. However, collective work
hour controls would not be effective because these individuals
typically work during outages when the collective work hour controls
would not be applicable or practical. The NRC staff then considered
individual long-term (quarterly and yearly) work hour limits for
transient workers. However, industry representatives strongly objected
because these transient workers move from one licensee to another, and
the burden of obtaining work hour information for all of these
individuals from other licensees would be extremely high. In part
because of the practical difficulties of controlling long-term work
hours for transient individuals, the NRC developed the 48-hour break
requirement as a replacement for long-term work hour limits for
transient individuals. As noted with respect to Sec. 26.205(d)(4), the
minimum day off requirement of this section replaces, in part, the 48-
hour break requirement of the proposed rule, and is the single
requirement that prevents individuals responsible for performing risk-
significant duties from working extended periods of 72-hour work weeks
or extended periods with no days off.
The NRC further considered that some transient personnel include
licensee employees and long-term C/Vs. Many of these individuals may
move from site to site within a fleet during plant outage periods. For
large fleets, some individuals may work much of the spring and fall
outage seasons under only the work hour limits and break requirements
applicable to unit outage periods. For these individuals, the minimum
day off requirement of Sec. 26.205(d)(4) is the single requirement
that will prevent such individuals from performing risk-significant
duties while working with no days off for substantial portions of a
year.
In developing the minimum day off requirements for the final rule,
the NRC considered scheduling practices during outages and determined
that it could not practically extend the same approach used in Sec.
26.205(d)(3) because the requirements of this section are based on
shift cycles which provide a defined period to which the average day
off requirement will apply. The length of outages and increased threat
conditions is variable and therefore does not provide a consistent
averaging period. The NRC further considered establishing a requirement
of a minimum of 3 days off in any 14-day period for individuals
specified in Sec. 26.4(a)(1) through (a)(3) because that would have
been similar to the requirements it would have replaced. However, the
NRC ultimately determined that 3 days off within a 15-day period
provides licensees scheduling flexibility (e.g., establishing a
schedule comprising a repeating series of 4 work shifts followed by 1
day off). As a consequence, the rule allows licensees the option to
establish a schedule that is predictable, a characteristic desired by
schedulers and workers, and that both mitigates and prevents cumulative
fatigue by including periodic rest breaks.
During the development of the final rule the NRC also considered a
graded approach to the minimum day off requirements for outages.
Specifically, the staff considered an option which would have allowed
licensees to defer 1 of the 3 required days off in a 15-day block to
the subsequent 15-day block (i.e., licensees could provide individuals
only 2 days off in a 15-day block but would be required to provide
those individuals 4 days off in the subsequent 15-day block). This
option would have required fewer days off for outages of less than 15
days and provided additional scheduling flexibility for longer outages.
At the March 29, 2006 public stakeholder meeting regarding this
rulemaking the staff discussed the potential of a graded approach and
solicited stakeholder comment. Only one licensee representative stated
that a graded approach may provide useful flexibility. The NRC
subsequently considered the increased potential for cumulative fatigue
that would result from deferring days off, the increased complexity of
the rule and scheduling to meet the requirements, the minimal
stakeholder interest in a graded approach, and determined that the
option for deferring a required day off to a subsequent 15-day block
was not warranted.
Section 26.205(d)(5) requires that during the first 60 days of unit
outages, security system outages, and increased threat conditions,
licensees control the hours worked by individuals performing the
security duties specified in Sec. 26.4(a)(5) in accordance with the
requirements in Sec. 26.205(d)(5)(i) and (d)(5)(ii). The effect of
this section is to provide a 60-day exception from the minimum day off
requirements in 26.205(d)(3) for these plant conditions. After the
first 60 days of these periods, these individuals are again subject to
the minimum day off requirements of Sec. 26.205(d)(3), except as
permitted by Sec. 26.205(d)(6). The purpose of this exception is to
allow licensees the flexibility provided by the less stringent day off
requirements of Sec. 26.205(d)(5)(i) and (d)(5)(ii) to provide the
increased level of security staffing that is required by these unique
circumstances. The requirements in Sec. 26.205(d)(5)(i) and (d)(5)(ii)
provide the restrictions necessary to prevent and mitigate excessive
cumulative fatigue during these periods.
Section 26.205(d)(5)(i) provides an exception from the minimum day
off requirements of Sec. 26.205(d)(3) for personnel performing the
duties described in Sec. 26.4(a)(5) during unit outages or unplanned
security system outage. The requirement limits this exception period to
60 days from the beginning of the outage and requires that individuals
performing the security duties identified in Sec. 26.4(a)(5) during
this period have a minimum of 4 days off in each non-rolling 15-day
period. This requirement replaces the collective work hour limit of 60
work hours per person per week that Sec. 26.199(f)(2)(i) of
[[Page 17141]]
the proposed rule would have required for these individuals during the
first 8 weeks of a unit outage or a planned security system outage.
Section 26.205(d)(5) permits licensees to meet the minimum day off
requirements of Sec. 26.205(d)(5)(i) as an exception to the more
stringent minimum day off requirements in Sec. 26.205(d)(3). The rule
permits this exception for a limited duration, 60 days to accommodate
the short-term demand for increased work hours associated with these
outages while limiting cumulative fatigue. Therefore, the requirement
provides reasonable assurance that security personnel will remain
capable of safely and competently responding to a security incident or
an increased security threat condition, should one occur during or
shortly after a period of increased work hours.
The basis for limiting the duration of the exception from the
requirements of Sec. 26.205(d)(3) during unit outages is described
with respect to Sec. 26.205(d)(4). In addition to establishing a
minimum day off requirement for personnel performing the security
duties identified in Sec. 26.4(a)(5) during the first 60 days of a
unit outage, Sec. 26.205(d)(5) establishes minimum day off
requirements for these individuals for the first 60 days of a planned
security system outage. Planned security system outages are typically
of very short duration relative to unit outages and the NRC does not
expect that planned security system outages will exceed 60 days.
However, the rule establishes the 60-day limit for planned security
system outages to simplify implementation of the rule by applying
identical exclusion periods for all outages and increased threat
conditions. Additionally, the ability of security personnel to perform
their duties safely and competently during these outage and increased
threat conditions is based on the length of time individuals work
additional hours, not on the nature of the site condition.
Section 26.205(d)(5)(i) replaces, in part, the requirements
limiting work hours of security personnel established by order EA-03-
038 with alternative requirements that will achieve the same objective.
Collectively, the requirements in Subpart I more effectively achieve
the objectives of the compensatory measures and therefore the NRC
intends to revoke order EA-03-038 following implementation of this
rule. This requirement limits, with the exception specified in Sec.
26.205(d)(6), the maximum duration of the outage requirements to 60
days instead of the 120-day period order EA-03-038 permits.
Since September 11, 2001, the NRC has received several reports of
nuclear security officers found asleep while on duty. In addition, the
NRC received numerous allegations from nuclear security officers that
certain licensees have required them to work excessive amounts of
overtime over long periods as a result of the post-September 11 threat
environment. The nuclear security officers questioned their readiness
and ability to perform their required job duties because of fatigue and
stated that they feared reprisal if they refused to work assigned
overtime. The NRC received similar information from newspaper articles
and from interactions with public stakeholder groups. For example, the
Project on Government Oversight (POGO) issued a report entitled,
``Nuclear Power Plant Security: Voices from Inside the Fences,'' and
submitted this report to the NRC staff (ADAMS Accession No.
ML031670987). POGO interviewed more than 20 nuclear security officers
protecting 24 nuclear reactors (at 13 plants) to obtain material for
its report. POGO reported that the security officers who were
interviewed said, ``Their plants are heavily relying on increased
overtime of the existing guard force * * *. These guards raised serious
concerns about the inability to remain alert.'' After reviewing the
work hours and FFD concerns of security personnel subsequent to
September 11, 2001, the NRC issued Order EA-03-038 to limit the work
hours of security personnel and ensure that they remain capable of
safely and competently performing their duties. The order requires
compensatory measures for limiting work hours to a collective work hour
average of 48 hours per person per week during normal operations, as
well as limiting work hours to an average of 60 hours per week for
planned plant outages and planned security system outages.
Ensuring that work schedules incorporate adequate break periods is
an important mitigation strategy for cumulative fatigue. The need for
periodic long breaks was discussed with respect to Sec. 26.205(d)(2)
and (d)(3). The NRC's initial concept for compensatory measures to
prevent fatigue of security personnel from the long work hours of
outages included a feature that required a 48-hour break in any 7-day
period for periods of increased work hours that exceeded 45 days (ADAMS
Accession No. ML030300470). Through stakeholder interactions during
development of the order, the NRC concluded that a 60-hour collective
work hour limit would be an effective alternative to meet the same
objective and would also provide more flexibility. The 60-hour limit of
the proposed rule would have ensured that security force personnel who
work a 12-hour shift receive, on average, 2 days off in every 7-day
period, thereby reducing the potential for cumulative fatigue.
As discussed with respect to Sec. 26.205(d)(3), stakeholder
comments on the proposed rule expressed a range of concerns regarding
the need for, and effectiveness of, collective work hour controls. As a
consequence, the NRC replaced the collective work hour limits of the
proposed rule with the minimum day off requirements outlined in Sec.
26.205(d)(3) through (d)(5). More specifically, the requirement for a
minimum of 4 days off in each 15-day period of the first 60 days of an
outage required in Sec. 26.205(d)(5)(i) establishes a requirement in
the final rule that is comparable to the 60-hour collective work hour
limit of the proposed rule, while addressing stakeholder comments
regarding the importance of addressing worker fatigue on an individual
basis. Although Sec. 26.205(d)(5)(i) does not directly limit work
hours, the requirement has the effect of limiting individuals to an
average work week of 61.6 hours, assuming no work shifts exceed 12
hours. The NRC established the minimum day off requirement in terms of
15-day periods to establish requirements for security personnel in time
periods consistent with the minimum day off requirements for other
personnel to simplify licensee implementation of the requirements of
this section.
For several reasons, control of work hours for security personnel
must be more stringent than for other individuals who are subject to
the work hour controls. First, security personnel are the only
individuals at nuclear powerplants who are entrusted with the authority
to apply deadly force. Decisions regarding the use of deadly force are
not amenable to many of the work controls (e.g., peer checks,
independent verification, post-maintenance testing) that are
implemented for other personnel actions at a nuclear plant to ensure
correct and reliable performance. Second, unlike most other work
groups, security personnel are typically deployed in a configuration in
which some members of the security force have very infrequent contact
with other members of the security force or with other plant personnel.
A lack of social interaction can exacerbate the effects of fatigue on
individuals' abilities to remain alert (Horne, 1988). Third, these
deployment positions can be fixed posts where very little physical
activity is
[[Page 17142]]
required, further promoting an atmosphere in which fatigue could
transition into sleep. Fourth, many security duties are largely
dependent on maintaining vigilance. Vigilance tasks are among the most
susceptible to degradation from fatigue (Rosekind, 1997; Monk and
Carrier, 2003). Finally, unlike operators, security forces lack
automated backup systems that can prevent or mitigate the consequences
of an error caused by fatigue.
Consistent with the requirements of the proposed rule, the final
rule requirement differs from that in Order EA-03-038 by establishing
more stringent work hour requirements for unplanned plant outages than
for increased threat conditions. Order EA-03-038 currently does not
impose collective work hour limits for unplanned plant outages. As
discussed in the preceding paragraph, security duties are particularly
susceptible to fatigue. Therefore, the NRC considers that the minimum
day off requirement for security personnel should only be waived in
cases in which (1) licensees would be unable to sufficiently plan for
the increased security demands, and (2) the increased potential for
fatigue-induced errors is outweighed by the need for a higher
complement of security personnel on shift to maintain the common
defense and security. In the case of unplanned plant outages, although
licensees would be unable to sufficiently plan for the increased
security demands that typically accompany plant outages, licensees can
control the demands on the work hours of security personnel by
controlling the outage activities (e.g., maintenance) that create the
increased demand for security personnel. As a consequence, work hours
that may compromise the FFD of security personnel, such as those that
would be permitted in the absence of the minimum day off requirements
of Sec. 26.205(d)(5)(i), cannot be justified. The economic benefit
gained by licensees cannot justify the increased potential for fatigue-
induced errors.
Section 26.205(d)(5)(ii) provides an exception from the minimum day
off requirements for security personnel for the first 60 days of an
unplanned security system outage or an increased threat condition. This
requirement replaces proposed Sec. 26.199(f)(2)(iii), which would have
provided an exception to the collective work hour limits for security
personnel for the first 8 weeks of an unplanned security system outage
or an increased threat condition. The exception allowed by Sec.
26.205(d)(5)(ii) is consistent with compensatory measures required by
Order EA-03-038. However, Order EA-03-038 provides an exception from
the collective work hour limits in the compensatory measures for these
conditions for a period of up to 120 days. Section 26.205(d)(5)(ii)
establishes a more stringent exception period.
Unplanned security system outages and increased threat conditions
require extensive increases in security force labor in terms of
compensatory measures. These increases can make it very difficult to
maintain work hour controls during these periods, especially because
licensees are unable to plan in advance for these circumstances.
Although the increased work hours increase the potential for cumulative
fatigue, other fatigue management requirements, including the work
hours controls in Sec. 26.205(d)(1) and (d)(2), provide reasonable
assurance of guard readiness during the exception period. Therefore,
the benefit to plant security of ensuring adequate staffing during such
unplanned conditions outweighs the potential for excessive worker
fatigue.
Staffing to a level necessary to meet the minimum day off
requirements of Sec. 26.205(d)(3) during unplanned security system
outages or increased threat conditions would not be practical because
it would require licensees to maintain security staffing in numbers
that would be excessive for the vast majority of circumstances.
Limiting periods of extended work hours for security personnel to 60
days aligns the exception period for security personnel with the
exception period for other personnel subject to the work hour
requirements, simplifying the rule and its implementation. Further, the
cost to licensees of the compensatory measures required to address
security system outages is significant, and most security systems are
modular. Therefore, an unplanned security system outage is unlikely to
exceed 60 days. Outages of this duration have been uncommon. Therefore,
reducing the exclusion period from 120 days to 60 days is not likely to
have a practical impact on licensees.
The Department of Homeland Security has refined its threat system
to compartmentalize increases in threat conditions for individual
business sectors and regions of the country. In addition, since the
inception of the system, the threat level has not been increased for
any period that exceeded 6 weeks. An event that would cause NRC-
regulated sites to maintain increased protective measures for a period
of more than 60 days would likely mean a significant domestic attack
had occurred. In this event, Sec. 26.207(c) [Common defense and
security] provides a means for extending the proposed 60-day exception
period, as discussed with respect to that provision.
Proposed Sec. 26.199(f)(2)(iv) would have clarified the instances
in which security personnel would be subject to a collective work hour
limit for certain instances in which multiple plant conditions exist.
The NRC has not retained this provision for the final rule because
Sec. 26.205(d)(ii), in conjunction with the definition of increased
threat condition as described in Sec. 26.5, adequately addresses the
applicability of the work hour requirements for circumstances in which
multiple plant conditions (e.g., a unit outage and increased threat
condition) occur simultaneously. Specifically, Sec. 26.205(d)(ii)
states that during the first 60 days of an unplanned security system
outage or increased threat condition, licensees need not meet the
requirements of either Sec. 26.205(d)(3) or (d)(5)(i). As a
consequence, should an unplanned security system outage or increased
threat condition occur at any time during a unit outage, security
personnel subject to the work hour requirements would not be required
to meet the minimum day off requirements of Sec. 26.205(d)(3) or
(d)(5)(i) during the first 60 days of the unplanned security system
outage or increased threat condition.
Proposed Sec. 26.199(f)(2)(iv) would have also clarified the
applicability of the collective work hour controls to instances in
which a threat level increases and then decreases. In the final rule,
the NRC has defined an increased threat condition in Sec. 26.5 as ``an
increase in protective measure level, relative to the lowest level
applicable to the site during the previous 60 days, as promulgated by
an NRC advisory.'' Accordingly, any time a threat level changes,
whether by increasing or decreasing, the determination of whether a
site is in an increased threat condition, for purposes of applying the
work hour requirements of Subpart I, is made by comparing the current
threat level with the lowest level applicable to the site during the
previous 60 days.
Proposed Sec. 26.199(f)(2)(v) would have clarified the
applicability of the collective work hour limits for security personnel
during multiple consecutive and concurrent plant conditions. The NRC
has not retained this provision for the final rule because the
requirements in Sec. 26.205(d)(5) and (d)(7), in conjunction with the
definition of increased threat condition as described in Sec. 26.5,
adequately define the requirements applicable to multiple
[[Page 17143]]
consecutive and concurrent plant conditions. In the case of multiple
consecutive increases in threat conditions, Sec. 26.205(d)(ii) would
permit a 60-day exception from the minimum day off requirements, with
the 60 days beginning with each increase. As described in the preceding
paragraph, should the threat level decrease, the determination of which
work hour requirements are applicable (i.e., whether the increased
threat level exception applies) depends upon a comparison of the
current threat level to the lowest level applicable in the previous 60
days.
Proposed Sec. 26.199(f)(2)(vi) would have established requirements
controlling the exception period from the collective work hour controls
when a threat condition decreases during an unplanned security system
outage or increased threat condition. In these circumstances, the
proposed rule would have established the beginning of the exception
period based upon the date upon which the current threat condition was
last entered as a result of a threat condition increase. The NRC has
not retained this provision for the final rule because the requirement
in Sec. 26.205(d)(5) in conjunction with the definition of increased
threat condition as described in Sec. 26.5, adequately define the
requirements. For example, if the threat level increases at the
beginning of week 1, increases again at the beginning of week 3, and
then decreases in week 5 to the level of week 1, the beginning of the
maximum 60-day exception period would be the beginning of week 1
because the definition of increased threat condition is based upon an
increase from the lowest level of protective measures in the past 60
days. The requirements ensure that the duration of the exception period
is no longer than necessary based upon the current threat level,
thereby providing licensees with the flexibility to respond to
increased threat conditions while minimizing the potential for
cumulative fatigue of security personnel. As a consequence, Sec.
26.205(d)(5), in conjunction with the definition of increased threat
condition in Sec. 26.5, establishes requirements applicable to changes
in threat conditions that are consistent with the work hour controls
order EA-03-038 requires.
Section 26.205(d)(6) permits licensees to extend the 60-day
exception periods in Sec. 26.205(d)(4) and (d)(5) for each individual
in 7-day increments for each non-overlapping 7-day period in which the
individual has worked not more than 48 hours during the unit or
security system outage or increased threat condition. For example,
during weeks 5 and 6 of a 10-week outage, an individual may work 42-
hour work weeks because of reduced demand for his or her skills during
those weeks of the outage. That individual would then be eligible to
work an additional 2 weeks beyond the 60-day exception period under the
minimum day off requirements applicable to the first 60 days of an
outage. The NRC added this provision to the final rule partly in
response to public comment on the proposed rule that the exception for
outage periods should be extended to 10 weeks. As described with
respect to Sec. 26.205(d)(4), the NRC does not believe it is
appropriate to extend the outage exception period to 10 weeks without
restriction because of the increased potential for cumulative fatigue
when individuals work at the limits established by Sec. 26.205(d)(4)
for extended periods of time. However, during public meetings on the
proposed rule, stakeholders also commented that during extended outages
individuals do not always work an outage schedule for the entire outage
but may have periods of reduced activity that provide opportunity for
individuals to recover from cumulative fatigue. The break requirements
exception allowed by Sec. 26.205(d)(6) acknowledges this circumstance.
The provision accommodates longer outages without increasing the risk
of worker fatigue by allowing licensees to extend the outage exception,
and therefore the reduced requirements applicable to outages, by taking
credit for these periods of reduced work hours. As a result, this
requirement also provides licensees the flexibility of planning outages
longer than the normal 60-day exception period by incorporating periods
of reduced work hours appropriate to maintaining worker FFD over an
extended duration outage. In addition, this provision also applies to
increased threat conditions and provides a mechanism for a limited
extension of the reduced requirements applicable to scheduling
individuals performing security functions during increased threat
conditions.
Proposed Sec. 26.199(f)(3) would have permitted the collective
work hours of any job duty group specified in proposed Sec. 26.199(a)
to exceed an average of 48 hours per week in one averaging period if
all of the conditions specified in Sec. 26.199(f)(3)(i) through
(f)(3)(iii) of the proposed rule were met. The criteria in proposed
Sec. 26.199(f)(3)(i) through (f)(3)(iii) would have permitted
licensees to control work hours to a higher collective work hour limit
under certain occasional, short-term exigent circumstances. The NRC has
not retained this provision for the final rule because the requirements
in Sec. 26.205(d)(3) and (d)(6), and Sec. 26.207 adequately define
the requirements applicable to these circumstances.
The objective of proposed Sec. 26.199(f)(3) would have been to
establish a regulatory framework that accommodated circumstances beyond
the reasonable control of licensees, while ensuring that licensees
continue to provide reasonable assurance that the effects of fatigue
and degraded alertness on individuals' abilities to safely and
competently perform their duties are managed commensurate with
maintaining public health and safety. The requirements of the final
rule provide licensees the flexibility to accommodate these
circumstances in a manner that is consistent with reasonable assurance
of worker FFD. Section 26.205(d)(3) establishes minimum day off
requirements that accommodate variation in workload because it does not
require a minimum number of days off each week but requires licensees
to ensure that individuals have an average number of days off over the
duration of a shift cycle of up to 6 weeks. As a consequence,
individuals are able to work up to 72 hours in a week, to the extent
that they are still able to meet the minimum days off requirement for
the shift cycle. For example, individuals on 12-hour shifts can work 72
hours per week for 2 weeks, and still have enough days off to work an
average of 45 hours per week for the remaining 4 weeks of a 6-week
cycle. Section 26.205(d)(3) also accommodates circumstances that may
require increased work hours for more extended periods of time. Again,
as an example, Sec. 26.205(d)(3)(iii) requires an average of 2.5 days
off per week for individuals performing the job duties specified in
Sec. 26.4(a)(1) through (a)(4). Individuals can meet this requirement
while working an average of 54 hours per week. This limit is comparable
to the limit that would have been required by Sec. 26.199(f)(3)(ii) of
the proposed rule, which would have restricted the exception allowed by
Sec. 26.199(f)(3) to a group collective work hour average of not more
than 54 hours per person per week. Section 26.205(d)(6) can also
accommodate limited unplanned extensions of an outage beyond the 60-day
exception period, provided individuals have periods of reduced work
hours that qualify for the 7-day extensions. Such circumstances may
arise if unexpected complications in an outage task occur that cause
the work to be deferred until later in the outage,
[[Page 17144]]
leaving the assigned work crew with a reduced period of activity.
The NRC also notes that the work hour limits of Subpart I are only
applicable to a limited scope of personnel and therefore not all
exigent circumstances would necessarily involve individuals or duties
subject to these controls. In addition, should the circumstances
require increased work hours by individuals who perform the duties
specified in Sec. 26.5(a)(1) through (a)(5), the provisions of Sec.
26.207 address waivers of the work hour requirements when necessary to
prevent or mitigate conditions adverse to safety and provide exceptions
from the requirements when necessary to ensure common defense and
security and allow adequate staffing during declared plant emergencies.
Proposed Sec. 26.199(f)(4) would have prohibited licensees from
repeatedly permitting the collective work hours of any job duty group
to exceed an average of 48 hours per person per week. The final rule
does not retain this requirement because the NRC has deleted collective
work hour control requirements from the final rule. As a consequence, a
limit on repeatedly exceeding the collective work hour limit is not
necessary for the final rule.
Proposed Sec. 26.199(f)(5) would have permitted licensees to
exceed any collective work hour limit of proposed Sec. 26.199(f) if
the licensee submitted and obtained advance approval of a written
request to the NRC that included the information in proposed Sec.
26.199(f)(5)(i) through (f)(5)(iii). The primary objective of this
provision was to provide a regulatory framework for addressing unique
and infrequent circumstances, such as steam generator replacements or
other extended outages, that would be difficult to manage within the
collective work hour controls of Sec. 26.199(f) of the proposed rule.
As described with respect to Sec. 26.205(d)(6), Sec. 26.205(d)(6)
provides a mechanism in the final rule for licensees to establish work
hour schedules for extended outages without the need for NRC approval
of a written request and therefore allows licensees to directly and
more simply address the circumstances that would have otherwise been
handled through the process that proposed Sec. 26.199(f)(5) would have
required.
Proposed Sec. 26.199(g) [Successive plant outages] would have
established requirements for the control of work hours during unit and
security system outages that follow a preceding outage by less than 2
weeks. The objective of the proposed requirements would have been to
limit the potential for cumulative fatigue that could result from
working successive outages in close succession. The final rule does not
retain these requirements.
A comment on the proposed rule noted that several companies own and
operate reactors at multiple sites and it is common for these companies
to develop outage work groups and deploy these work groups to outages
in close succession at their sites. Another comment noted that
recruiting qualified supplemental workers to support outages is
challenging for the entire commercial reactor industry and that for
many supplemental workers the availability of overtime is a key factor
in where they decide to work. This comment further stated that the
industry has already experienced cases where individuals have left
during an outage for employment that offered more overtime.
In determining to eliminate the requirements pertaining to
successive plant outages the NRC concluded that although reduced work
hours between successive outages would reduce the potential for
cumulative fatigue, the NRC expects that in many cases transient
workers would have days off between outages as they travel between
nuclear power plant sites or wait for the beginning of the next outage.
As a result, a rule requirement for reduced work hours between
successive outages would provide no or limited additional benefit in
these circumstances. The NRC also considered the limited applicability
of the requirement, i.e., the requirement would have been limited to
instances in which individuals worked successive outages for the same
licensee. As a result, the requirement would have provided a benefit
for only a limited scope of individuals in these circumstances. The NRC
also considered the increased challenge licensees would face in
retaining crews of supplemental workers between outages if these
workers were required to take a full 2 weeks off between outages. The
NRC further considered that licensees could have alternatively complied
with the requirement by employing supplemental workers for a 2 week
period at the conclusion of an initial outage or the beginning of a
successive outage at the levels applicable to an operating plant. The
NRC acknowledges that such a practice would likely extend outages and
the reduced work hours could cause some individuals to seek alternative
employment. In addition, the NRC considered the potential for the
successive outage requirements to adversely affect outage schedules.
Specifically, if a planned outage must be extended due to unforeseen
complications, the schedule for subsequent outages could be affected if
the outage extension affects the ability of individuals to have 2 weeks
of reduced work hours before the subsequent outage.
Given the limited scope of individuals that would benefit from the
requirements in proposed Sec. 26.199(g) and the potential for
substantial adverse impacts on licensee's ability to plan and conduct
outages, the NRC has not retained these requirements in the final rule.
However, the NRC notes that the final rule includes other provisions
that will reduce the potential for cumulative fatigue from successive
outages, including more stringent work hour controls, requirements for
a process through which individuals may self-declare if they believe
they are not fit for duty because of fatigue, and requirements for
training in fatigue management.
Section 26.205(e) [Reviews] has been added to require licensees to
periodically self-assess their performance with respect to controlling
the work hours of those individuals who perform the job duties
specified in proposed Sec. 26.4(a). This section replaces with
substantive changes the requirements in Sec. 26.199(j) of the proposed
rule. The NRC revised the review requirements to eliminate reviews
related to the collective work hour limits that were deleted from the
final rule and to add a review requirement for the implementation of
the requirements in Sec. 26.205(d)(3).
Work hour controls in proposed Sec. 26.205(d) would provide
licensees with substantial flexibility in controlling work hours.
Accordingly, periodic self-assessments are needed for the licensee to
maintain reasonable assurance that they are implementing the specific
work hour control provisions of Sec. 26.205(d) consistent with the
general performance objective in Sec. 26.23(e). In addition, it is
necessary for the self-assessments to be scheduled in a manner that
ensures corrective action, if necessary.
Outages and increased threat conditions increase the risk of human
error as a result of higher workload, the performance of more complex
and infrequent tasks, and the pressure to meet schedular goals.
Therefore, it is particularly important to include those periods of
time in any assessment of the effectiveness of a licensee's work hour
controls. Accordingly, licensees are required to conduct a review once
per calendar year. If any plant or security system outages or increased
threat conditions occurred since the licensee completed the most recent
review, the licensee shall include in the review an
[[Page 17145]]
evaluation of the control of work hours during the outages or increased
threat conditions. Licensees shall complete the review within 30 days
of the end of the review period.
Section 26.205(e)(1) requires licensees to review the actual work
hours and performance of individuals who are subject to this section
for consistency with the requirements of Sec. 26.205(c), so that
licensees can determine if they are scheduling individuals with the
objective of preventing impairment from fatigue due to the duration,
frequency, or sequencing of successive shifts. This review is
consistent with the performance-based approach in Sec. 26.205(c).
Section 26.205(e)(1)(i) requires the licensees to assess
individuals whose actual hours worked during the review period exceeded
an average of 54 hours per week in any shift cycle while the
individuals' work hours are subject to the requirements of Sec.
26.205(d)(3). Individuals that average more than 54 hours over a shift
cycle have a substantial number of extended work days, or have received
minimal days off, or both. Although the objective of the minimum day
off requirements of Sec. 26.205(d)(3) is a maximum average work week
of 48 hours, the requirements do not prevent individuals from exceeding
an average of 54 hours per week. The requirement is necessary to ensure
that licensees fully evaluate the work hours and performance of these
individuals. Several studies have indicated a tendency for individuals
to underestimate their levels of fatigue (Wylie, et al., 1996; Dinges,
1995; Rosekind and Schwartz, 1988). This tendency may cause an
individual to fail to recognize that his or her ability to perform is
degraded. The final rule requires licensees to independently evaluate
the performance of these individuals to determine whether their
abilities to safely and competently perform their duties had actually
been compromised.
Section 26.205(e)(1)(ii) requires that licensee assessments include
individuals who were granted more than one waiver during the review
period. This provision requires licensees to assess the work hours and
performance of these individuals to ensure that licensees adequately
evaluate whether an individual's abilities to safely and competently
perform their duties had actually been compromised while working under
a waiver. This requirement is necessary to ensure that licensees' use
of waivers did not result in degraded worker fitness-for-duty.
Section 26.205(e)(1)(iii) requires that the licensee assessments
include individuals who were assessed for fatigue in accordance with
Sec. 26.211 during the review period. This section requires licensees
to evaluate whether these individuals' abilities to safely and
competently perform their duties had actually been compromised. An
individual who has been assessed for fatigue may be working above his
or her tolerance for overtime, and it would be necessary for licensees
to fully evaluate the individual's overall performance. The requirement
is necessary to ensure that licensee fatigue assessments are consistent
with worker performance and are providing an effective basis for
licensee fatigue management decisions.
Section 26.205(e)(2) requires licensees to review each individual's
hours worked and the waivers under which work was performed to assess
staffing adequacy for all of the jobs that are subject to the work hour
controls of Sec. 26.205. The minimum day off requirements of Sec.
26.205(d)(3) through (d)(5) provide assurance that licensees are
managing cumulative fatigue at a gross level, and an indication of
whether staffing is adequate to support the objectives of the rule.
However, there is a potential that individuals with specialized skills
may work a disproportionate number of hours and, consequently, may be
more susceptible to fatigue than others. Accordingly, Sec.
26.205(e)(2) requires licensees to review work hours and waivers of the
work hour controls to provide assurance that fatigue is properly
managed for all jobs.
Section 26.205(e)(3) requires licensees to document the methods
used to conduct their reviews and the results of the reviews. The NRC
will use the documentation during site inspections as a means of
assuring compliance with the regulations. The methods and results of
the reviews are indicative of a licensee's performance in managing the
fatigue of its workers who are subject to the requirements of this
section. Irregularities in the review process may indicate a
programmatic weakness that might trigger further inspection activities.
The NRC considers the additional recordkeeping burden for documenting
this information to be outweighed by the NRC's need to ensure that
licensees are complying with the proposed requirements of this section
and maintaining effective fatigue management programs.
Section 26.205(e)(4) requires licensees to record, trend, and
correct, under the licensee's corrective action program, any problems
identified in maintaining control of work hours consistent with the
specific requirements and performance objectives of Part 26.
Accordingly, licensees are required to maintain the documentation that
is necessary for NRC reviews of licensees' compliance with the work
hour controls within the licensees' existing corrective action
programs. The requirement is in keeping with the existing requirements
in 10 CFR Part 50 Appendix B, Criterion XVII, ``Quality Assurance
Records,'' and Criterion XVI, ``Corrective Action.'' The NRC will use
the documentation during site inspections as a means of assuring
compliance with the regulations. The corrective actions and trending
would be indicative of a licensee's performance in managing the fatigue
of its workers who are subject to the requirements of this part.
Irregularities in the corrective action process may indicate a
programmatic weakness that might trigger further inspection activities.
The NRC considers the additional recordkeeping burden for documenting
this information under the existing corrective action program to be
outweighed by the NRC's need to ensure that licensees are complying
with the requirements and maintaining effective fatigue management
programs.
Section 26.207 Waivers and Exceptions
Section 26.207 permits licensees to authorize waivers from the work
hour requirements in Sec. 26.205(d)(1) through (d)(5)(i) for
conditions that meet the two criteria specified in this section.
Section 26.207 contains the revised requirements in proposed Sec.
26.199(d)(3) and 26.199(h) and (i) of the proposed rule. The final rule
consolidates these requirements into a single section to improve the
organization of Subpart I. Although the provisions are renumbered, the
NRC made only limited changes to the requirements for the final rule.
Section 26.207(a) permits licensees to grant a waiver of the work
hour controls in Sec. 26.205(d)(1) through (d)(5)(i). Exceeding the
individual work hour limits is justified for limited circumstances in
which compliance with the work hour requirements could have immediate
adverse consequences for the protection of public health and safety or
the common defense and security. Limited use of waivers is also
consistent with the Commission's position stated in the NRC's Policy on
Worker Fatigue. However, as specified in Sec. 26.207(a)(2), which
contains the requirements in proposed Sec. 26.199(d)(3)(ii), the NRC
expects a licensee to grant waivers only to address circumstances that
it cannot reasonably control.
[[Page 17146]]
Section 26.207(a)(1)(i) requires an operations shift manager to
determine that the waiver is necessary to mitigate or prevent a
condition adverse to safety, or a security shift manager to determine
that the waiver is necessary to maintain site security, or a site
senior-level manager with requisite signature authority to make either
determination. This section establishes one of two criteria in the
final rule for granting a waiver from the individual work hours
requirements. This section replaces proposed Sec. 26.199(d)(3)(i)(A),
with limited editorial revisions.
The NRC's Policy on Worker Fatigue recognized that ``very unusual
circumstances may arise requiring deviation from the above [work hour]
guidelines.'' In SECY-01-0113, the NRC noted that the frequency of
guideline deviations at a substantial proportion of sites appeared to
be inconsistent with the intent of the policy and that some licensees
abused the authority to grant deviations from the work hour guidelines.
Section 26.207(a)(1)(i) more clearly articulates the NRC's expectations
with respect to exceeding the work hour limits; licensees must limit
the granting of waivers from the work hour limits to circumstances in
which such a waiver is necessary to prevent or mitigate a condition
adverse to safety or to maintain the security of the plant. The
criterion in the final rule limits waivers to conditions that are
infrequent while still permitting waivers that are necessary for safety
or security. For example, Sec. 26.207(a)(1)(i) permits a licensee to
grant a waiver from a work hour requirement if necessary to prevent a
condition adverse to safety, if compliance with the work hour
requirement will cause the licensee to violate other NRC requirements,
such as the minimum onsite staffing requirements in 10 CFR 50.54(m), or
if a delay in the recovery of failed plant equipment that is necessary
for maintaining plant safety will occur. Similarly, the NRC considers
it appropriate to grant a waiver from the work hour requirements if
necessary to prevent a condition adverse to safety or if compliance
with the work hour requirements would cause a forced reactor shutdown,
power reduction, or other similar action, as a result of exceeding a
time limit for a technical specification limiting condition for
operation (LCO). LCOs require nuclear power plant licensees to take
certain actions to maintain the plant in a safe condition under various
conditions, including malfunctions of key safety systems.
The criterion for granting waivers in Sec. 26.207(a)(1)(i) was the
subject of considerable stakeholder comment and discussion during the
public meetings described in the preamble to the proposed rule.
Industry representatives stated that the criterion is overly
restrictive because it would prohibit the granting of waivers for
conditions that could be cost beneficial to the licensee without a
substantive decrease in safety. However, the potential for worker
fatigue in conditions that require a waiver is substantial (Baker, et
al., 1994; Dawson and Reid, 1997; Stephens, 1995; Strohl, 1999).
Therefore, the NRC does not believe that licensees can reasonably
justify the performance of risk-significant functions by individuals
who have worked hours in excess of the limits on the basis that
granting the waiver will not have an adverse impact on safety or
security. The preamble to the proposed rule details the NRC's decision
not to incorporate industry's comment on this provision.
Section 26.207(a)(1)(i) further requires that an operations shift
manager or a senior-level site manager with requisite signature
authority must make the determination that a waiver is necessary to
mitigate or prevent a condition adverse to safety. Similarly, the final
rule requires that a security shift manager, or a senior-level site
manager with requisite signature authority, must make the determination
that a waiver is necessary to maintain the security of the facility.
Operations shift managers and security shift managers have the
requisite knowledge and qualifications to make the respective safety or
security determinations and making such determinations is consistent
with the scope of duties currently performed by individuals in these
positions. The NRC considered industry stakeholder comments during the
public meetings described in the preamble to the proposed rule,
expressing concern that limiting the authority to approve waivers to
operations shift managers and security shift managers could contribute
to overburdening individuals in these positions and prevent
distributing the administrative burden of granting a waiver to other
qualified individuals. The NRC also considered other stakeholder
comments concerning the need to ensure that the individuals making
these determinations are not unduly influenced by schedule pressures.
The NRC noted that some licensees had delegated the authority to
authorize deviations to organizational levels that appeared to be
inconsistent with the guidelines in the NRC's Policy on Worker Fatigue,
which recommend that the plant manager or plant manager designee
authorize deviations from the guidelines. Accordingly, Sec.
26.207(a)(1)(i) permits senior site managers with the signature
authority of operations shift supervisors to make the safety
determinations that are required to grant waivers and senior site
managers with the signature authority of security shift supervisors to
make the security determinations required to grant waivers.
Section 26.207(a)(1)(ii) establishes the second of two criteria for
granting a waiver from the individual work hour controls of Sec.
26.205(d)(1) through (d)(5)(i). This section contains, with revision,
the requirements in Sec. 26.199(d)(3)(i)(B) of the proposed rule.
Section 26.207(a)(1)(ii) requires that a supervisor, who is qualified
to direct the work to be performed by the individual to whom the waiver
will be granted and is trained in accordance with the requirements of
Sec. Sec. 26.29 [Training] and 26.203(c) [Training and examinations],
must assess the individual face to face and be reasonably sure that the
individual will be able to safely and competently perform his or her
duties during the additional work period for which the waiver is
sought. These determinations require knowledge of the specific skills
that are necessary to perform the work and the conditions under which
the work will be performed in order to assess the potential for fatigue
to adversely affect the ability of an individual to safely and
competently perform the work. This knowledge is generally limited to
individuals who are qualified to direct the work. The training required
by Sec. Sec. 26.29 and 26.203(c) provides the KAs that are essential
for a supervisor to make valid assessments in this regard. Among other
FFD topics, the training addresses the contributors to worker fatigue
and decreased alertness in the workplace, the potential adverse effects
of fatigue on job performance, and the effective use of fatigue
countermeasures. Accordingly, the training is necessary for individuals
to perform these assessments.
The NRC revised the proposed rule to account for the situation in
which no supervisor qualified to direct the work is on site. To address
this circumstance, Sec. 26.207(a)(1)(ii) of the final rule states that
a supervisor who is qualified to provide oversight of the work to be
performed by the individual can make the assessment if he or she is
trained in accordance with the requirements of Sec. Sec. 26.29 and
26.203(c). Although this individual may be less familiar with the
details of how the work is to be performed, the exception prevents the
substantial burden of a licensee requiring a supervisor who is
qualified
[[Page 17147]]
to direct the work to report to the site to perform the assessment, as
well as preventing the potential fatigue of the supervisor if called in
during the night.
Section 26.207(a)(1)(ii) further requires that supervisors must
perform the assessment face to face with the individual to which the
waiver will apply. This requirement ensures that the supervisor who is
performing the assessment has the opportunity to observe the
individual's appearance and behavior and note any indications of
fatigue (e.g., decreased facial tone, rubbing of eyes, slowed speech).
The supervisor can also interact with the individual to assess his or
her ability to continue to safely and competently perform his or her
duties during the period for which the waiver will be granted.
Section 26.207(a)(1)(ii) also requires that the supervisory
assessment must address, at a minimum, the potential for acute and
cumulative fatigue, considering the individual's work history for at
least the past 14 days, and the potential for circadian degradations in
alertness and performance, considering the time of day for which the
waiver will be granted. The potential for acute fatigue can be
practically assessed by estimating the total number of continuous hours
that the individual will have worked by the end of the work period for
which the waiver is being considered. The potential for cumulative
fatigue can be practically assessed by reviewing the individual's work
schedule during the past 14 days to determine whether (1) the
individual had adequate opportunity to obtain sufficient rest,
considering the length and sequencing of break periods, (2) the
available sleep periods occurred during the night or at other times
when sleep quality may be degraded, and (3) the potential exists for
transitions between shifts (e.g., from days to nights) to have
interfered with the individual's ability to obtain adequate rest. The
potential for circadian degradations in alertness and performance can
be practically assessed by considering the time of day or night during
which the work would be performed, as well as the times of day of the
individual's recent shift schedules. Section 26.207(a)(1)(ii) in effect
requires supervisors to address the three work schedule factors (i.e.,
shift timing, shift duration, and speed of rotation) that are generally
considered to be the largest determinants of worker fatigue (Akerstedt,
2004; McCallum, et al., 2003; Mallis, et al., 2002; Folkard and Monk,
1980; Rosa, 1995; Rosa, et al., 1996). In determining the scope of the
assessment, the NRC also considered the need for licensees to be able
to focus the assessment on information that is readily available and
could be verified.
Section 26.207(a)(1)(ii) further requires that the supervisory
assessment for granting a waiver address the potential for fatigue-
related degradations in alertness and performance to affect risk-
significant functions and whether it is necessary to establish controls
and conditions under which the individual is permitted to perform work.
This requirement is consistent with the NRC's Policy on Worker Fatigue,
which states that ``the paramount consideration in such authorizations
shall be that significant reductions in the effectiveness of operating
personnel would be highly unlikely.'' However, Sec. 26.207(a)(1)(ii)
requires the supervisor to identify any risk-significant functions that
may be compromised by worker fatigue, thereby focusing the assessment
on worker activities that have the greatest impact on the protection of
the public, considering the types of skills and abilities that are most
sensitive to fatigue-related degradations.
Section 26.207(a)(1)(ii) also requires the supervisor to identify
any additional controls and conditions that he or she considers
necessary to grant the individual a waiver from a work hour control.
For example, applicable controls and conditions may include, but are
not limited to (1) peer review and approval of assigned job tasks, (2)
assignment of job tasks that are non-repetitive in nature, (3)
assignment of job tasks that allow the individual to be physically
active, and (4) provisions for additional rest breaks. The requirement
to consider establishing controls and conditions is necessary to ensure
that licensees take steps to mitigate fatigue from an extended work
period and reduce the likelihood of fatigue-related errors adversely
affecting public health and safety or the common defense and security.
Section 26.207(a)(2) requires licensees, to the extent practical,
to grant waivers only in circumstances that could not have been
reasonably controlled. This section contains the requirement presented
in Sec. 26.199(d)(3)(ii) of the proposed rule. This requirement is
necessary because conditions for meeting the waiver criteria that are
specified in Sec. 26.207(a)(1) could routinely result from inadequate
staffing or work planning. Licensees have authorized deviations from
their technical specification limits on work hours for such reasons in
the past. However, because of the significant adverse effects of worker
fatigue, as detailed in Section IV.D, waivers should be used
infrequently and only when necessary to protect the public. Licensees
should take all reasonable care to ensure the use of waivers is
minimized. Therefore, Sec. 26.207(a)(2) prohibits the use of waivers
in lieu of adequate staffing or proper work planning, for example, but
would permit the use of waivers for circumstances that the licensee
could not have reasonably controlled, which may include, but are not
limited to, equipment failures or a sudden increase in the personnel
attrition rate.
Section 26.207(a)(3) requires that the face-to-face supervisory
assessment required by Sec. 26.207(a)(1)(ii) be performed sufficiently
close in time to the period during which the individual will be
performing work under the waiver to ensure that the assessment will
provide a valid indication of the potential for worker fatigue during
the extended work period. This section contains the requirements
presented in Sec. 26.199(d)(3)(iii) of the proposed rule. This
requirement is needed because worker alertness and the ability to
perform can change markedly over several hours (Baker, et al., 1990;
Dawson and Reid, 1997; Frobert, 1997; Folkard and Monk, 1980; Rosa,
1995). These changes can be particularly dramatic if fatigue from
sustained wakefulness coincides with circadian periods of decreased
alertness (Baker, et al., 1990; Gander, et al., 1998; Rosekind, 1997;
Folkard and Tucker, 2003; Carrier and Monk, 2000). Therefore, the final
rule requires licensees to conduct supervisory assessments within a
time period that provides reasonable assurance that the individual's
condition will not substantively change before work is performed under
the waiver.
Section 26.207(a)(3) also establishes a period of 4 hours before
the individual begins working under the waiver as the period within
which the supervisory assessment must be performed. In establishing a
maximum time period the NRC considered several factors. Conducting the
assessment as close in time as practical to the period during which the
individual will perform work under the waiver will provide the greatest
assurance of a valid assessment. However, conducting the assessment
immediately before the individual will begin performing work under the
waiver could, in some circumstances, cause the timing of assessments to
conflict with the conduct of shift turnovers and other practical
administrative and operational constraints. Additionally, assessments
for granting waivers from the longer term individual limits (e.g., the
maximum number of work hours in 7
[[Page 17148]]
days) would be less sensitive to the specific timing of the assessment.
However, certain licensees have periodically authorized blanket
deviations from technical specification work hour limits days and weeks
in advance of the actual performance of the work. A maximum limit of 4
hours would address the need for an enforceable requirement that would
provide reasonable assurance of valid assessments and would take into
account the relevant technical and practical considerations. An added
benefit of this requirement is that it would prevent the simultaneous
granting of blanket waivers for large groups of individuals that do not
take into account each individual's level of fatigue.
Section 26.207(a)(4) requires licensees to document the bases for
granting waivers from the individual work hour controls of Sec.
26.205(d). This section contains the requirement presented in Sec.
26.199(d)(3)(iv) of the proposed rule. This section requires licensees
to document the circumstances that necessitate the waiver, a statement
of the scope of work and time period for which the waiver is approved,
and the bases for the determinations required by Sec. 26.207(a)(1).
This documentation is necessary to support NRC inspections of
compliance with requirements for granting waivers from the work hour
limits as well as for the licensee self-assessments of the
effectiveness of implementing work hour controls that would be required
under Sec. 26.205(e).
Section 26.207(b) [Force-on-force tactical exercises] of the final
rule relieves licensees from the requirements of Sec. 26.205(d)(3) by
allowing them to exclude shifts worked by security personnel during the
actual conduct of NRC-evaluated force-on-force tactical exercises when
calculating the individual's number of days off. This provision is an
addition to the requirements of the proposed rule and is similar to a
slightly different exception contained in Order EA-03-08 that applied
to group work hour controls. The NRC believes this provision is
appropriate in order to provide licensees flexibility in accommodating
the NRC-evaluated tactical exercises, which are not under a licensee's
full control. For example, it allows licensees to use security
personnel on their normally scheduled days off to support the conduct
of the exercise without violating the rule. The exception in Order EA-
03-08 also applied to other force-on-force tactical exercises (i.e.,
any not evaluated by the NRC), but the NRC believes this is not an
appropriate exception for the minimum days off requirement because
these exercises can be fully planned and scheduled by licensees in
advance in a manner that complies with the requirements. Nevertheless,
the more limited exception should provide adequate flexibility to
licensees given that (1) the final rule removes all restrictions on
group work hour controls for security personnel, and (2) the exception
applies to all security personnel working during affected shifts
(including staff that do not participate in the exercise) even though
the minimum days off requirement applies to security personnel on an
individual basis. In contrast, the group work hour controls applied to
security personnel collectively. During the limited exception period
for these triennial (every 3 years) NRC-evaluated exercises, the
requirements in Sec. 26.205(d)(1) and (d)(2) provide reasonable
assurance that fatigue does not impair the ability of these individuals
to safely and competently perform their duties.
Section 26.207(c) [Common defense and security] provides a licensee
relief from the work hour control requirements of Sec. 26.205(d) upon
written notification from the NRC, for the purpose of assuring the
common defense and security for a period the NRC defines. This section
contains the requirements presented in Sec. 26.199(h) of the proposed
rule. The exception granted by this section provides necessary relief
from the requirements of the work hour controls in cases of emergencies
that are not otherwise covered in this section, including war, in which
the increased risk from fatigue-induced errors would be outweighed by
the need to maintain the common defense and security. This section also
indicates that the NRC would provide such relief in writing.
Section 26.207(d) [Plant emergencies] adds the potential to
temporarily waive the requirements of Sec. 26.205(c) and (d) during
declared emergencies, as defined in the licensee's emergency plan. This
section contains the requirements presented in Sec. 26.199(i) of the
proposed rule. Plant emergencies are extraordinary circumstances that
may be most effectively addressed through staff augmentation that can
only be practically achieved through the use of work hours in excess of
the limits of Sec. 26.205(c) and (d). The objective of the temporary
exemption is to ensure that the control of work hours and management of
worker fatigue do not impede a licensee's ability to use whatever staff
resources may be necessary to respond to a plant emergency and ensure
that the plant reaches and maintains a safe and secure status. At the
conclusion of the declared emergency, the rule would require licensees
to again comply with the work hour controls.
Section 26.209 Self-Declarations
Section 26.209(a) retains, with limited editorial changes, the
requirements presented in Sec. 26.199(e) of the proposed rule. Section
26.209(a) requires licensees to take immediate action in response to a
self-declaration (as discussed with respect to Sec. 26.203(b)(1)) by
an individual who is working under, or being considered for, a waiver
from the work hour controls in Sec. 26.205(d)(1) through (d)(5)(i).
Licensees are required to immediately stop the individual from
performing any duties listed in Sec. 26.4(a) unless the individual is
required to continue performing those duties under other requirements
of 10 CFR Chapter I, such as the minimum control room staffing
requirements in 10 CFR 50.54(m). If other requirements make it
necessary for the individual to continue working, this section requires
the licensee to immediately take action to relieve the individual. For
example, the licensee should immediately begin a call-in procedure for
another individual to fill the required position and remove the
individual from duties as soon as relief becomes available.
The final rule retains this requirement of the proposed rule
because correct performance of the duties specified in Sec. 26.4(a) is
critical to maintaining public health and safety and the common defense
and security. In addition, there is a significantly increased potential
for fatigue-related errors when individuals work more than the maximum
work hours or obtain less rest than the minimum rest requirements of
Sec. 26.205(d)(1) through (d)(5)(i). Individuals working extended
hours under a waiver will have a clear and legitimate basis for a self-
declaration of being unfit for duty because of fatigue. Further, by
self-declaring fatigue, the individual will effectively provide an
assessment of his or her ability to continue to safely and competently
perform these critical duties. Several studies indicate a tendency for
individuals to underestimate their level of fatigue (Wylie et al.,
1996; Dinges, 1995; Rosekind and Schwartz, 1988). Therefore, it is very
likely that an individual who makes a self-declaration of fatigue is
potentially more impaired than he or she realizes.
Section 26.209(a) does not require that licensees immediately
relieve an individual who self-declares when it is necessary for the
individual to continue performing his or her duties under other
requirements of 10 CFR Chapter I. The
[[Page 17149]]
failure to meet minimum staffing or similar requirements will, in the
majority of cases, have a greater potential to adversely affect public
health and safety and the common defense and security than permitting a
fatigued individual to continue performing his or her duties for a
limited period of time. Further, in these circumstances, licensees can
implement any fatigue mitigation strategies they deem necessary while
the individual remains on duty. Fatigue mitigation measures in these
circumstances include, but are not limited to, controls on the type of
work that the individual may perform until he or she is relieved (e.g.,
physical or mental, tedious or stimulating, individual or group, risk-
significant or not) and an increased level of supervision (continuous
or intermittent) and other oversight (e.g., peer checks, independent
verifications, quality assurance reviews, and operability checks).
Section 26.209(b) establishes the requirements for returning an
individual to duty following a self-declaration under the conditions
described in Sec. 26.209(a). These provisions allow the individual to
be reassigned to duties that are not subject to work hour requirements,
if the individual is fit for such duties, and requires that the
individual have a break of at least 10 hours before returning to duties
that are subject to the work hour requirements of Subpart I.
Section 26.209(b)(1) permits licensees to reassign an individual
who has made a self-declaration of fatigue to perform other duties than
those specified in Sec. 26.4(a). This section contains with limited
editorial revisions the requirements presented in Sec. 26.199(e)(1) of
the proposed rule. The final rule includes this flexibility because,
although an individual may not be fit to perform the activities
specified in Sec. 26.4(a), he or she may be able to safely and
competently perform other duties. Other duties can include, but are not
limited to, tasks that require skills that are less susceptible to
degradation from fatigue or do not have the potential to adversely
affect public health and safety or the common defense and security if
the individual commits fatigue-related errors. The final rule permits
licensees to reassign individuals who make a self-declaration of
fatigue to other duties, if the results of a fatigue assessment (as
required under Sec. 26.211) indicate that he or she is fit to perform
them, because permitting the individual to remain at work and continue
performing such duties will not have the potential to adversely impact
public health and safety or the common defense and security.
Section 26.209(b)(2) requires licensees to permit or require an
individual who has made a self-declaration to take a rest break of at
least 10 hours before the individual returns to performing any duties
listed in Sec. 26.4(a). This section contains, with limited editorial
revisions, the requirements presented in Sec. 26.199(e)(2) of the
proposed rule. The final rule includes this requirement to ensure that
individuals who have self-declared are given an opportunity to sleep
before they are permitted to resume performing any duties that have the
potential to adversely affect public health and safety or the common
defense and security. Sleep is widely considered the only non-
pharmacological means of reducing fatigue. As discussed with respect to
Sec. 26.205(d)(2)(i), a 10-hour rest break generally allows
individuals to obtain the 7-8 hours of sleep that is recommended by
most experts for maintaining human performance (National Sleep
Foundation, 2001; Dinges et al., 1997; Belenky et al., 2003; Akerstedt,
2003; Monk et al., 2000; Rosekind et al., 1997; Rosa, 1995).
Although one sleep period of 7-8 hours may be insufficient to
ensure full recovery from excessive fatigue, nothing in the final rule
precludes an individual in this circumstance from making a second self-
declaration of fatigue if the individual believes that he or she
remains unable to safely and competently perform his or her duties
following the rest break. Section I.B of NRC RIS 2002-07 addressed the
applicability of the protections of 10 CFR 50.7, [Employee protection]
to workers who self-declare that they are unfit for duty as a result of
fatigue.
Section 26.211 Fatigue Assessments
Section 26.211 requires licensees to conduct fatigue assessments
under several conditions and contains, with limited editorial changes,
the requirements presented in proposed Sec. 26.201. The numbering and
content of the paragraphs in Sec. 26.211 remain consistent with that
of proposed Sec. 26.201. These conditions, specified in Sec.
26.211(a)(1) through (a)(4), include for cause, after a self-
declaration, after an event that requires post-event drug and alcohol
testing, and as a followup to returning an individual to work after a
self-declaration. The assessments are necessary to determine whether
individuals who are observed to be in a condition creating a reasonable
suspicion of impaired individual alertness or have indicated that they
are not fit for duty because of fatigue can, in fact, safely and
competently perform their duties. Further, in situations in which a
plant event requires drug or alcohol testing as specified in Sec.
26.31(c) [Conditions for testing], this section requires the licensee
to conduct a fatigue assessment to determine whether fatigue
contributed to the event.
Work hour requirements are necessary, but not sufficient, to manage
worker fatigue effectively. Worker fatigue, and its effects on worker
alertness and performance, can result from many causes in addition to
work hours (e.g., stress, sleep disorders, daily living obligations)
(Rosa, 1995; Presser, 2000). Further, individuals differ substantially
in their ability to work for extended periods without performance
degradation from fatigue (Gander, 1998; Jansen et al., 2003; Van Dongen
et al., 2004a; Van Dongen et al., 2004b). The work hour requirements of
Sec. 26.205 provide only partial assurance that individuals are not
fatigued. Therefore, fatigue assessments are essential.
Appropriately assessing fatigue is also important because workers
who are experiencing either acute or cumulative fatigue may not be able
to perform their duties safely and competently, as discussed in Section
IV.D. A large body of research demonstrates the negative effects of
fatigue on individuals' abilities to perform. The literature includes
studies comparing the effects of fatigue with those of alcohol
intoxication. The effects of both conditions can be expressed in the
form of performance decrements. Studies have correlated hours of
wakefulness with equivalent blood alcohol concentrations showing that
the performance decrements resulting from fatigue are at least as
severe as the performance decrements observed when individuals consume
the legal limit of alcohol (Dawson and Reid, 1997; Falleti et al.,
2003). At the extreme, workers who have acute fatigue show symptoms
that are similar to those of intoxication. Speech is less precise,
attention may be lacking, and normal body movements and posture may be
absent. Therefore, it is just as important for a worker to be assessed
to determine if he or she is unduly impaired from fatigue as it is for
the worker to be evaluated to determine whether he or she is impaired
from consuming alcohol.
The objective of the assessments required by Sec. 26.211(a)(1)
through (a)(4) is for licensees to address instances of worker fatigue
appropriately, including those that are not prevented by the work hour
requirements, regardless of the number of hours that the subject
individual has worked or rested. As discussed with respect to Sec.
26.211(c),
[[Page 17150]]
these assessments provide the basis for subsequent management actions
for fatigue management (e.g., relieving an individual of duties or
requiring additional fatigue mitigation actions). Therefore, fatigue
assessments are important for effective fatigue management because they
provide the basis for any short-term corrective actions that may be
necessary to ensure that individuals are able to safely and competently
perform their duties and any long-term corrective actions that may be
necessary to address individual or programmatic issues contributing to
recurring instances of fatigue.
Section 26.211(a)(1) specifies that licensees must perform a
fatigue assessment, in addition to any other testing that is required
under Sec. Sec. 26.31(c) and 26.77, if a worker is observed to be in a
condition of impaired alertness and there is a reasonable suspicion
that he or she may not be fit to safely and competently perform his or
her duties. The objective of the requirement is to ensure that fatigue
is considered, in addition to drugs or alcohol, as a cause for impaired
alertness. As noted in SECY-01-0113, approximately 80 percent of all
for-cause FFD tests conducted annually yield negative results for drugs
and alcohol. A fatigue assessment will help to determine if fatigue was
the cause for the perceived impairment when testing does not support
drugs or alcohol as the probable cause.
Common indications of impaired alertness include yawning, red eyes,
prolonged or excessive blinking, rubbing of the face with the hands,
and gross body movements to maintain alertness. Individuals may take
substantially longer to complete routine tasks, exhibit difficultly
processing written or oral communications, and may become less
talkative. At the extreme, workers who are experiencing acute fatigue
have symptoms that are similar to those of intoxication. Individuals
who are fatigued are more likely to complain of illness, pain, or
discomfort. In addition to decreased vigor, fatigued individuals may be
more irritable, engage in inappropriate humor, exhibit less
conservative decisionmaking, and persevere in using ineffective problem
solutions (Horne, 1988; Harrison and Horne, 2000; Dinges et al., 1997;
Pilcher and Huffcutt, 1996; Belenky et al., 2003; Monk, 2003).
Section 26.211(a)(1) does not require licensees to conduct a
fatigue assessment if indications of impaired individual alertness are
observed during an individual's break period. The NRC considered a
comment from the IBEW at a September 14, 2004, public meeting
expressing concern with for-cause assessments for work performed
outside of the protected area (PA). Although whether a worker is inside
the PA is not a criterion for being subject to Part 26 requirements,
the NRC recognizes that napping is an effective means for reducing
worker fatigue. Therefore, Sec. 26.211(a)(1) excludes napping during a
break period as a condition for which the final provision requires a
for-cause fatigue assessment.
Section 26.211(a)(1) also permits licensees to conduct a fatigue
assessment, without drug and alcohol testing, if the observed condition
is impaired alertness with no other indication of possible substance
abuse. In developing the requirement related to for-cause fatigue
assessments, the NRC considered stakeholder comments during the public
meetings described in the preamble to the proposed rule. Stakeholders
expressed concern that testing for drugs and alcohol, in addition to
fatigue, when the only apparent cause of impairment was decreased
alertness, would cause stigma, burden, and reluctance to raise FFD
concerns that may result in for-cause testing. Accordingly, the
requirement permits licensees to assess only fatigue if there are no
indications of possible substance abuse.
Section 26.211(a)(1) also permits licensees to conduct drug and
alcohol testing, without a fatigue assessment, when the licensee has
reason to believe that the observed condition is not caused by fatigue.
The NRC considered stakeholder comments at the public meetings
described in the preamble to the proposed rule that a requirement to
perform a fatigue assessment when the licensee has a reasonable basis
for believing that the condition is from causes other than fatigue is
an undue burden. In many cases, an observed condition may clearly
relate to drugs or alcohol only (such as the smell of alcohol on an
individual), and in such cases, a fatigue assessment will have no
benefit.
Section 26.211(a)(2) requires licensees to conduct a fatigue
assessment if an individual makes a self-declaration that he or she is
not fit to safely and competently perform his or her duties because of
fatigue, except if the licensee permits or requires the individual to
take a rest break of at least 10 hours. Self-declarations provide
assurance that instances of worker fatigue, including those that are
not prevented by the work hour requirements in Sec. 26.205, are
appropriately addressed, regardless of the number of hours the
individual has worked or rested. Former Sec. 26.27(b)(1) required that
``impaired workers, or those whose fitness may be questionable, shall
be removed from activities within the scope of this part, and may be
returned only after determined to be fit to safely and competently
perform activities within the scope of this part.'' A statement by an
individual to his or her supervisor that he or she is not fit to safely
and competently perform his or her duties because of fatigue is an
indication that the individual's FFD is questionable, and that an
assessment, or a rest break of at least 10 hours, is necessary before
the individual may be returned to duty. Therefore, in circumstances in
which an individual requests to be relieved of duties because of
fatigue and the individual is relieved of duties for at least 10 hours,
the final rule does not require the licensee to conduct another fatigue
assessment before permitting the individual to return to duty,
consistent with current industry practice. Providing a 10-hour break is
consistent with Sec. 26.205(d)(2)(i), which establishes required break
times between work periods, and is generally considered sufficient to
address most acute fatigue conditions.
As discussed with respect to Sec. 26.211(c), a fatigue assessment
provides a basis for a licensee to determine whether the individual is
able to safely and competently perform his or her duties and what, if
any, subsequent management actions for fatigue management are necessary
(e.g., relieving an individual of duties or requiring additional
fatigue mitigation actions). As discussed with respect to Sec.
26.203(b)(1)(ii), licensees are required to establish controls and
conditions under which an individual may be permitted or required to
perform work after that individual declares that he or she is not fit
because of fatigue.
In developing the final requirement for fatigue assessments of
individuals who have self-declared, the NRC considered research on
subjective assessments of alertness. Self-declarations are generally
based on an individual's subjective evaluation of his or her alertness.
Studies have indicated that individuals often misjudge their own
fatigue, typically by underestimating their level of fatigue and
propensity for uncontrolled sleep episodes. This effect is widely
recognized by scientists who study sleep and fatigue. Rosekind, et al.
(1997) noted that ``An important phenomenon, highly relevant to
operational environments, is that there is a discrepancy between
subjective reports of sleepiness/alertness and physiological measures.
In general, individuals will report higher levels of
[[Page 17151]]
alertness than indicated by physiological measures.'' As a consequence,
individuals who self-declare will tend to be more impaired than they
realize. An exception to this tendency has been noted by Dinges, et al.
(1988) who noted that naps can benefit the performance of those
experiencing sleep loss, without that benefit being apparent in
subjective measures. Therefore, it is not only important to assess
self-declarations as an indicator that an individual may not be able to
safely and competently perform his or her duties, but also to consider
factors in addition to a self-declaration as part of the fatigue
assessment.
Section 26.211(a)(2) also specifies that licensees must perform
fatigue assessments for self-declarations made to an individual's
supervisor. The NRC considered stakeholder comments at public meetings
that the final rule should be clear with respect to the behavior that
constitutes a self-declaration. For example, stakeholders expressed
concern that an individual's off-hand remark to a co-worker that he or
she is groggy would be considered a self-declaration under the final
rule and, therefore, require a fatigue assessment in conditions that
could be satisfactorily addressed through less formal processes. The
NRC's objective is not to supplant these normal processes for licensee
workforce management, but to ensure that formal declarations of fatigue
are appropriately evaluated and addressed. Therefore, the requirement
specifies that fatigue assessments must be conducted for self-
declarations concerning an individual's ability to ``safely and
competently perform his or her duties'' and require that the self-
declaration must be made to the individual's supervisor. However, as
discussed with respect to Sec. 26.211(a)(1), a fatigue assessment must
be performed in response to an observed condition of impaired
alertness. If, in the preceding example, the groggy individual remains
on duty and is observed to exhibit impaired alertness, a fatigue
assessment is required for cause in accordance with Sec. 26.211(a)(1).
Section 26.211(a)(3) specifies that licensees must perform a
fatigue assessment after an event that requires drug or alcohol
testing, as required in Sec. 26.31(c)(3). Section 26.31(c)(3)(i)
through (c)(3)(iii) specifies the events and conditions requiring post-
event drug and alcohol testing. A fatigue assessment is also necessary
in these circumstances to determine whether worker fatigue contributed
to the event and, if so, to identify the need for any corrective
actions to prevent similar future events. The assessment will also
provide the basis for subsequent management actions for fatigue
management, as required by Sec. 26.211(c) (e.g., relieving an
individual of duties or requiring additional fatigue mitigation
actions). Further, the fatigue assessment will provide insights
concerning the effectiveness of the licensee's fatigue management
program.
Consistent with Sec. 26.31(d)(5)(ii), the requirement specifies
that licensees may not delay necessary medical treatment in order to
conduct a fatigue assessment, if the event involved physical harm to
the individual. The NRC considers the immediate medical needs of the
individual to be paramount. In these circumstances, it is reasonable to
presume that the individual has been removed from duty and consequently
the individual's level of fatigue is irrelevant to the immediate
protection of public health and safety or the common defense and
security.
Section 26.211(a)(4) requires licensees to perform a followup
fatigue assessment if an individual is returned to work after a break
of fewer than 10 hours following a fatigue assessment that was
performed for cause or in response to a self-declaration. Although
sleep periods of less than 8 hours (e.g., naps) can mitigate some
effects of fatigue, such sleep periods are typically insufficient to
provide complete recovery from fatigue (McCallum, et al., 2003; Dinges,
et al., 1997; Totterdell, et al., 1995). As a consequence, the
objective of this provision is to ensure that, in circumstances of
sleep periods of less than 8 hours (e.g., if a licensee provides an
individual an opportunity for a nap rather than a 10-hour break), the
short rest break has provided sufficient rest to mitigate the
individual's fatigue and that the individual is not still groggy from
sleep inertia. Sleep inertia is the grogginess that an individual
experiences in the transition from sleep to wakefulness that can
temporarily affect an individual's ability to safely and competently
perform his or her duties (Bruck and Pisani, 1999; Sallinen, et al.,
1998). Further, the assessment ensures that the individual is capable
of performing his or her duties safely and competently during the
upcoming work period. It also provides the information necessary for
the licensee to determine whether any controls or conditions must be
implemented during the work period (Priest, 2000; Baker, et al., 1990;
Sallinen, 1998; Kruger, 2002).
Section 26.211(b) requires that either a supervisor or a staff
member of the FFD program, who is trained in accordance with the
requirements of Sec. Sec. 26.29 and 26.203(c), must conduct any
fatigue assessment that is required under Sec. 26.211. Under Sec.
26.211(c), fatigue assessments provide the basis for subsequent actions
for fatigue management (e.g., relieving an individual of duties or
requiring additional fatigue mitigation actions). In addition, the NRC
recognizes that fatigue assessments may be used by some licensees as a
basis for imposing sanctions on individuals. Therefore, the authority
to perform fatigue assessments should be limited to supervisors or
staff members of the FFD program. The training required by Sec. Sec.
26.29 and 26.203(c) provides the KAs that are essential to a
supervisor's or FFD program staff member's ability to make valid
assessments in this regard. Among other FFD program topics, the
training addresses (1) the contributors to worker fatigue and decreased
alertness in the workplace, (2) symptoms of worker fatigue, (3)
indications and risk factors for common sleep disorders, and (4) the
effective use of fatigue countermeasures. Section 26.29(b) [Policy]
also requires individuals to demonstrate successful completion of the
training by passing a comprehensive examination that addresses the KAs.
Section 26.211(b) further requires that supervisors or FFD program
staff members must perform the fatigue assessment face to face with the
subject individual. This requirement ensures that the individual
performing the assessment has the opportunity to (1) observe the
subject individual's appearance and behavior to note indications of
fatigue (e.g., decreased facial tone, rubbing of eyes, slowed speech),
(2) interact with the individual to understand the individual's self-
assessment of his or her ability to safely and competently perform his
or her duties, and (3) understand any factors in addition to the
individual's work schedule that may have contributed to fatigue.
Section 26.211(b)(1) prohibits individuals who observe another
individual exhibiting indications of impaired alertness from performing
the for-cause fatigue assessment of that individual. Without this
prohibition, a single supervisor could potentially both observe a
worker exhibiting indications of impairment from fatigue and also
conduct the for-cause assessment of that worker. In accordance with
Sec. 26.211(c), fatigue assessments provide the basis for subsequent
management actions for fatigue management. In addition, some licensees
may use fatigue assessments as a basis for imposing sanctions on
individuals, if, for example, a licensee believes that an individual
has been
[[Page 17152]]
negligent in maintaining his or her FFD. Therefore, in the case of
fatigue assessments that are conducted for cause, an independent third
party shall perform the fatigue assessment to provide reasonable
assurance of an objective assessment.
Section 26.211(b)(2) prohibits individuals from performing a post-
event fatigue assessment in those circumstances specified in Sec.
26.211(b)(2)(i) through (b)(2)(iii), in which a conflict of interest
may be present. An individual who has a conflict of interest may not
provide an objective assessment of the subject individual's fatigue.
This requirement provides assurance of an objective fatigue assessment
by prohibiting individuals from performing the assessment who were
directly responsible for performing the work or assessing the
individuals who were involved in the event.
Section 26.211(b)(2)(i) prohibits individuals from performing a
post-event fatigue assessment if they performed or directed the work
activities during which the event occurred. A supervisor who performed
some of the work activities during which the event occurred may benefit
from either positive or negative results from a fatigue assessment of
another individual, depending on the circumstances. Similarly, a
supervisor who directed the work activities of an individual may avoid
an adverse action against himself or herself for the actions of a
fatigued individual under his or her supervision if the supervisor
erroneously assessed the individual as not fatigued. Therefore, the
final rule prohibits these individuals from performing fatigue
assessments under the specified conditions.
Section 26.211(b)(2)(ii) prohibits individuals from performing a
post-event fatigue assessment if they performed a fatigue assessment of
the individuals who were performing or directing the work activities
during which the event occurred within 24 hours before the event
occurred. These individuals may have a conflict of interest. For
example, if an individual previously self-declared fatigue, but a
fatigue assessment determined he or she was fit to continue work and an
event subsequently occurred that required the subject individual to be
assessed again, then the supervisor who performed the first assessment
may avoid adverse action for the previous determination by performing
the post-event fatigue assessment and erroneously determining that the
individual was not fatigued. The final rule prohibits these individuals
from performing fatigue assessments under the specified conditions.
Section 26.211(b)(2)(iii) prohibits individuals from performing a
post-event fatigue assessment if they evaluated or approved a waiver of
the limits specified in Sec. 26.205(d)(1) through (d)(5)(i) for any of
the individuals who were performing or directing the work activities
during which the event occurred if the event occurred while such
individuals were performing work under that waiver. This provision
limits the potential for bias in assessments that can result from prior
involvement in assessing the individual or responsibility for the work
activities associated with the event.
Section 26.211(c) requires that fatigue assessments must provide
the information necessary for management decisions and actions in
response to the circumstance that initiated the assessment. This
information is necessary to determine the subject individual's ability
to safely and competently perform his or her duties, as well as any
controls or conditions that must be implemented. Section 26.211(c)
provides assurance that fatigue assessments include sufficient and
appropriate information to support a valid assessment of the individual
relative to fatigue and therefore an appropriate basis for management
decisions and actions. The criteria listed in Sec. 26.211(c)(1)(i)
through (c)(1)(iii) specify the minimum considerations for fatigue
assessments.
In determining the scope of the assessments, the NRC considered the
need for licensees to be able to focus the assessment on information
that is readily available and verifiable. Section 26.211(c) requires
the assessment to address the three work schedule factors described in
Sec. 26.211(c)(1) through (c)(3), which are generally considered to be
the largest determinants of worker fatigue (Akerstedt, 2003, 2004;
McCallum, et al., 2003; Mallis, et al., 2002; Folkard and Monk, 1980;
Rosa, 1995; Rosa, et al., 1996), as follows.
Section 26.211(c)(1)(i) specifies the first criterion that fatigue
assessments will address, acute fatigue. Acute fatigue directly affects
an individual's ability to safely and competently perform his or her
duties, as discussed in Section IV.D. Licensees will assess the
potential for acute fatigue by estimating, at a minimum, the total
number of continuous hours the individual has been awake, as well as
considering other individual factors or information provided by the
individual (such as his or her ability to obtain rest during break
periods).
Section 26.211(c)(1)(ii) specifies the second criterion that
fatigue assessments will address, cumulative fatigue. Cumulative
fatigue also directly affects an individual's ability to safely and
competently perform his or her duties, as discussed in Section IV.D.
Licensees will assess the potential for cumulative fatigue by
reviewing, at a minimum, (1) the individual's work schedule during the
past 14 days to assess whether the individual had adequate opportunity
to obtain sufficient rest, considering the length and sequencing of
break periods, (2) whether the available sleep periods occurred during
the night or at other times when sleep quality may be degraded, (3) the
potential for transitions between shifts (e.g., from days to nights) to
have interfered with the ability of the individual to obtain adequate
rest, and (4) other individual factors or information provided by the
individual (such as any personal issues that may impact his or her
ability to obtain adequate sleep). For cumulative fatigue, the sleep
medicine scientific establishment uses the concept of a ``sleep debt,''
which is analogous to a bank account becoming overdrawn, and is a
measure of how much an individual's sleep is being cumulatively reduced
from his or her everyday sleep need. Many individuals build up a slight
sleep debt during the working week, dissipating it by ``catch-up''
sleep on weekends (National Sleep Foundation, 2000; Monk, et al.,
2001). Therefore, in evaluating cumulative fatigue, how much of a
``sleep debt'' the worker has accrued in the preceding week needs to be
evaluated. Dinges and colleagues (1997) noted a five- to seven-fold
increase in the percentage of subjects noting a significant ``illness,
infection, pain, discomfort, worry or problem'' in their daily logs as
they progressed from baseline through the 7 nights of restricted sleep.
In addition to the expected decrements in vigor over the restricted
sleep days, subjects' ratings indicated increases in confusion-
bewilderment, tension-anxiety, and total mood disturbance.
Symptoms of cumulative fatigue are in some ways similar to those of
acute fatigue, but in other ways quite different. The term ``burnout''
has been used to describe workers experiencing cumulative fatigue.
Similar to burnout from other sources, burnout from cumulative fatigue
is often characterized by a lack of initiative and/or creativity, with
the individual just ``going through the motions like a zombie'' without
being actively engaged or involved in the job he or she is being asked
to
[[Page 17153]]
perform. Harrison and Horne (2000) advanced the view that the more
creative thought processes are those most likely to be impaired by the
individual receiving insufficient amounts of the ``core'' sleep needed
for cognitive restitution. They note ``[sleep deprivation] presents
particular difficulties for decisionmaking involving the unexpected,
innovation, revising plans, competing distraction and effective
communication.''
Section 26.211(c)(1)(iii) specifies the third criterion that
fatigue assessments will address, circadian variations in alertness and
performance. Section IV.D discusses the impact of such variations on an
individual's ability to safely and competently perform his or her
duties. Licensees can assess the potential for circadian degradations
in alertness and performance by considering the time of day or night
during which the work was or will be performed and whether the time
period coincides with a circadian variation through in the individual's
level of alertness.
Section 26.211(c)(2) requires that individuals must provide
complete and accurate information that may be required by the licensee
to address the factors listed in Sec. 26.20(c)(1) (i.e., acute
fatigue, cumulative fatigue, and circadian variations in alertness and
performance). Although work hours are an important determinant of
worker fatigue, many other factors can affect worker fatigue, not all
of which may be readily apparent to a licensee. As a consequence,
individuals and licensees share the responsibility for effective
assessment and management of fatigue which depends upon complete and
accurate communication between the individual and the licensee
concerning matters that may influence an individual's level of fatigue.
For example, licensees may be able to estimate the total number of
continuous hours that an individual has been awake through review of
the individual's work schedule and assumptions regarding typical waking
times for individuals on that schedule. However, individuals can
provide information to better approximate the number of hours they have
been continuously awake and facilitate a more accurate assessment of
acute fatigue. Additionally, individuals may be able to provide
information about their general level of work- and non-work-related
activities, as well as opportunities for rest during the period
addressed in the fatigue assessment.
Licensees can practically assess the potential for cumulative
fatigue by reviewing the individual's work schedule during the past 14
days to identify schedule features that typically influence whether an
individual has had adequate opportunity to obtain sufficient rest.
However, individuals differ substantially in their ability to adapt to
various schedules (Monk and Folkard, 1985). Therefore, individuals can
provide general information related to the quality and quantity of
sleep that they actually obtained during this period, which
substantively improves the licensee's assessment of the potential for
cumulative fatigue.
Licensees can practically assess the potential for circadian
degradations in alertness and performance by considering the time of
day or night during which the work is or will be performed and whether
the time period coincides with a circadian trough in alertness for the
individual. However, individuals differ in the extent and rate at which
they adapt to work during periods in which they would otherwise be
asleep (Folkard and Tucker, 2003; Carrier and Monk, 2000) and can
provide information (e.g., the timing of their sleep periods) that can
better inform a licensee's assessment of the potential for circadian
degradations in alertness.
Section 26.211(c)(2) also limits licensees' inquiries to only
obtaining information from the subject individual that is necessary to
assess the factors listed in Sec. 26.211(c)(1). The fatigue assessment
will provide a valid basis for licensee decisions and actions for
fatigue management without undue invasion of an individual's privacy.
For example, inquiries limited to the amount, quality, and timing of
sleep and general activity level of the individual can support an
accurate fatigue assessment without the need for an individual to
divulge personal details about the reasons for missed sleep or abnormal
timings for sleep. Consistent with Sec. 26.37 [Protection of
information], licensees are required to keep any information from the
individual's self-disclosures confidential.
Section 26.211(d) prohibits licensees from concluding that fatigue
had not or will not degrade the individual's ability to safely and
competently perform his or her duties solely on the basis that the
individual's work hours have not exceeded any of the limits specified
in Sec. 26.205(d)(1) or that the individual has had the minimum rest
breaks required in Sec. 26.205(d)(2) or the minimum days off required
in 26.205(d)(3) through (d)(5). The work hour controls of Sec.
26.205(d)(1) and (d)(2) provide reasonable measures to prevent fatigue
resulting from excessive work hours. However, these controls address
only work hours and work schedules, and as a consequence, compliance
with these controls may not prevent an individual from experiencing
fatigue from one or more of the many other factors that can cause
fatigue, some of which may not be readily apparent to an employer.
Workload and the type of work an individual performs, home stresses,
sleep disorders, and differences in an individual's ability to work
extended hours or adapt to certain schedules can all substantively
affect worker fatigue (Rosa, 1995; Totterdell, et al., 1995; Knauth and
Hornberger, 2003). Although the NRC considered the findings from
studies of work hours and worker fatigue in developing the work hours
requirements of Sec. 26.205(d)(1) through (d)(5), it is neither
practical nor possible to establish limits that will prevent fatigue
for all individuals. Therefore, the final rule requires licensees to
consider factors in addition to work hours and rest breaks when
determining whether an individual is fit to safely and competently
perform duties.
Section 26.211(e) requires that, following a fatigue assessment,
the licensee must decide whether the individual may perform duties
without a rest break, and, if so, whether controls and conditions must
be established under which the individual may perform those duties.
Examples of controls and conditions include, but are not limited to (1)
a rest break, (2) peer review and approval of assigned job tasks, (3)
assignment of job tasks that are non-repetitive in nature, (4)
assignment of job tasks that are simple in nature, and (5) assignment
to duties that are not important to the protection of public health and
safety or common defense and security. Section 26.211(e) also requires
licensees to ensure that any controls and conditions that they
determine to be necessary to return an individual to duty will be
implemented.
Section 26.211(f) requires that licensees document the results of
any fatigue assessments that were performed, the circumstances that
necessitated the fatigue assessments, and any controls and conditions
that were implemented. The documentation is necessary for NRC
inspectors to evaluate the fatigue assessment component of licensees'
FFD programs and for the licensee to conduct the reviews required under
Sec. 26.205(e). The information that the final rule requires licensees
to document will indicate how well a licensee's fatigue mitigation
program at a site is performing.
Section 26.211(g) requires that licensees prepare an annual summary
for each nuclear power plant site of instances of fatigue assessments
that were conducted during the previous
[[Page 17154]]
calendar year for any individual identified in Sec. 26.4(a) through
(c). The NRC revised the reporting provisions in Sec. 26.197(e)(3) of
the proposed rule to eliminate the requirement to include information
regarding fatigue assessments in an annual report to the NRC. However,
the NRC concluded that the fatigue assessment information that would
have been required in the annual report should be documented in an
annual summary available on site for NRC inspection. Specifically,
Sec. 26.211(g)(1) requires that the summary include the conditions
under which each fatigue assessment was conducted (i.e., whether the
assessment was conducted for cause, for a self-declaration, after an
event, or as a followup, as described in Sec. 26.211(a)(1) through
(a)(4)). As a result, the annual reports will indicate the means by
which licensees are identifying potential instances of worker
impairment from fatigue, including whether these instances are
identified through plant events. Section 26.211(g)(2) requires that the
annual summaries include a statement for each fatigue assessment of
whether or not the assessed individual was working on outage activities
at the time of the self-declaration or condition resulting in the
fatigue assessment. The annual summaries will therefore show the
incidence of fatigue assessments during known periods of increased work
hours (i.e., outage periods) relative to other times during the
reporting period. Section 26.211(g)(3) requires that the annual summary
indicate for each fatigue assessment the category of duties that the
individual was performing, if the individual was performing the duties
described in Sec. 26.4(a)(1) through (a)(5) at the time of the self-
declaration or condition resulting in the fatigue assessment.
Accordingly, the annual summaries will show the relative incidence of
fatigue assessments for each category of duties subject to the work
hour requirements of Sec. 26.205 in addition to the incidence of
fatigue assessments for individuals subject to the FFD requirements of
Part 26 but not subject to the work hour controls of Sec. 26.205.
Section 26.211(g)(4) requires that the annual summaries include for
each fatigue assessment the management actions, if any, resulting from
each fatigue assessment. The annual summaries will therefore show the
incidence of fatigue assessments that warranted management actions, and
the nature of those actions.
Subpart J--[Reserved]
As a result of reorganization of the proposed rule, the provisions
contained in Subpart J of the proposed rule have been moved to Subpart
N of the final rule. This section is currently reserved.
Subpart K--FFD Programs for Construction
Section 26.401 General
Section 26.401(a) provides that a licensee or other entity
specified in Sec. 26.3(c) may, at its discretion, establish,
implement, and maintain an FFD program that meets the requirements of
Subpart K for those individuals who are specified in Sec. 26.4(f).
Alternatively, if an FFD program for those individuals that meets the
requirements of Subpart K is not established, those individuals must be
subject to an FFD program that meets the requirements of Subparts A
[Administrative Provisions] through H [Determining Fitness-for-Duty
Policy Violations and Determining Fitness], N [Recordkeeping and
Reporting Requirements], and O [Inspections, Violations, and Penalties]
of Part 26. The NRC recognizes that some new plants will be constructed
near existing nuclear power plants, and it may be more efficient for
the licensees of those plants to extend their existing FFD programs to
cover the individuals specified in Sec. 26.4(f). Therefore, this
section of the final rule provides licensees and other entities
flexibility to implement either the Subpart K program or a program
meeting all of the requirements of Subparts A through H, N, and O.
Subparts A through H, N, and O include all elements of the FFD program
that apply to operating nuclear power plant licensees, except fatigue
management requirements. This section meets Goal 3 of this rulemaking
to improve the effectiveness and efficiency of FFD programs. It also
meets Goal 6 to improve clarity in the organization and language of the
rule.
This section of the final rule differs in several respects from
those sections of the former rule and the proposed rule that
established the general applicability requirements for FFD programs
during construction. The former rule did not specify the construction
activities that would be subject to the FFD program. Consequently, it
applied to all workers performing any construction activities, whether
or not the SSCs under construction could have an impact on public
health and safety or the common defense and security. In addition, it
did not provide a choice between applying the FFD program in Sec.
26.2(c) of the former rule or a complete Part 26 program to the new
reactor construction workforce (although the former Sec. 26.2(c) could
have been interpreted as requiring a complete Part 26 program). The
proposed rule also did not specify the individuals to whom the program
would apply, thus making it applicable to the entire new reactor
construction workforce. The proposed rule also did not provide the
option that is included in Sec. 26.401(a) of the final rule. The final
rule provides greater flexibility to licensees and other entities than
either the former rule or the proposed rule by giving them an option
concerning the type of FFD program to apply. It also clarifies and
narrows the scope of the group to which Subpart K applies. This is
consistent with Goal 6 of this rulemaking to improve clarity in the
organization and language of the rule.
The former rule in Sec. 26.2(c) imposed FFD requirements on
construction permit holders ``with a plant under active construction''
but did not define that term. The proposed rule in Sec. 26.3(e) would
have required an FFD program for construction following NRC
authorization to construct, and the Part 52 final rule made these
changes to the former Sec. 26.2(c). However, the NRC recognizes that
there may be a period of time that elapses between the authorization to
construct and the commencement of specific construction activities that
have the potential to affect public health and safety and the common
defense and security when the nuclear power plant begins operations.
Therefore, the final rule clarifies that an FFD program for
construction is not required until a licensee or other entity begins
``fabricating, erecting, integrating, and testing safety- and security-
related SSCs, and the installation of their foundations, including the
placement of concrete.''
In addition, the FFD program for construction in the final rule
applies only to construction activities that are performed at the
location where the new plant will be constructed and operated. The NRC
added this phrase to the definition of construction activities in Sec.
26.5 of the final rule to clarify that any fabrication, integration, or
testing of safety- or security-related SSCs that is not performed
within or near the licensee's or other entity's owner-controlled area
in which the new plant will be operated would not be subject to Subpart
K. For example, fabricating, integrating, and testing safety- or
security-related SSCs at a vendor's or manufacturer's facility that is
located in another city, state, or country would not be subject to
Subpart K, whereas producing (i.e., ``fabricating'') the concrete to be
used for the foundation of the reactor building in a facility located
on the site where the nuclear power plant will be constructed and
operated would be subject to Subpart K
[[Page 17155]]
(although the construction of the cement mixing facility would not).
The NRC anticipates that the focus of the Subpart K program on
construction activities performed at the location where the new plant
will be constructed and operated will lead licensees and other entities
to ensure that the program covers all those individuals who perform
construction activities within the footprint of the new power reactor
(e.g., the exterior boundary of the reactor building once it is
completed) as well as the nearby areas where safety- and security-
related SSCs will be installed and operated when the plant begins
operations.
The NRC considered whether the FFD program for construction should
also cover individuals who construct safety- and security-related SSCs
at a vendor's or manufacturer's facility that is geographically remote
from the location where the new plant will be operated. Because of the
modular design of new reactors, many of the safety-related SSCs that
will be relied on to protect public health and safety will be
fabricated by vendor personnel at remote locations and transported to
the site for installation and integration. Similarly, the small,
complete nuclear reactors that may be constructed by manufacturing
licensees under Part 52 will also be constructed at remote locations
and transported to the site for installation and integration. However,
because of the complexity of the technical and regulatory issues raised
by imposing FFD requirements on these entities, the staff has decided
to defer adopting requirements for reactor manufacturing facilities,
which were included in the proposed rule, and has declined to impose a
Subpart K program on modular fabrication facilities located at a
distance from the site where the nuclear power plant will be
constructed and operated at this time. Although the Part 52 final rule
added manufacturing licensees to the scope of Part 26, this final rule
removes holders of manufacturing licenses from regulation under Part
26.
The former rule and the proposed rule also did not limit the
applicability of the FFD program to individuals who are constructing
only safety- or security-related SSCs. However, the NRC recognizes that
there will be other construction work being performed at the location
where a new plant will be constructed and operated that will not have
the potential to affect public health and safety or the common defense
and security when the nuclear power plant begins operations, such as
constructing a building that will be used only for training or
administration purposes. The NRC does not intend that individuals who
are performing these other construction activities must be subject to
the FFD program. Therefore, the final rule also limits the scope of the
requirements to cover only those individuals who are constructing
(i.e., fabricating, erecting, integrating, testing, and installing
foundations of) these specific SSCs. Thus, as one example of a safety-
related SSC, the rule requires individuals who are constructing the
containment structure that surrounds the reactor to be subject to an
FFD program because the containment is relied on to mitigate the
consequences of accidents that could result in potential offsite
exposure. Similarly, individuals who are constructing security-related
SSCs, such as the central and secondary alarm stations, physical
barriers, communications systems, guard towers, surveillance and
detection systems, or installing locks and illumination systems, that
will be necessary to implement the physical security and safeguards
contingency plans that are required under 10 CFR Part 73 also are
subject to an FFD program for construction.
Section 26.401(b) provides that licensees and other entities who
intend to implement an FFD program under Subpart K shall submit a
description of the FFD program and its implementation as part of the
license, permit, or limited work authorization application. The former
rule and the proposed rule did not contain a reference to a limited
work authorization application, because the requirements in 10 CFR
parts 50 and 52 pertaining to limited work authorization had not yet
been developed. The reference to a limited work authorization
application in Sec. 26.401(b) is consistent with Goal 6 of this
rulemaking to improve clarity in the organization and language of the
rule.
Licensees and other entities who intend to implement an FFD program
for construction that meets all of the requirements of Subparts A
through H, N, and O are not required under Part 26 to submit a
description of their FFD program and its implementation because the
details of the program are specified by 10 CFR Part 26, Subparts A
through H, N, and O.
Submittal of a description of the FFD program and its
implementation was not required by Sec. 26.2(c) of the former rule or
Sec. 26.3(e) of the proposed rule, but is a logical and necessary
component of Subpart K because of the flexibility that Subpart K
provides in Sec. 26.401(a) and (d). The description of the FFD program
and its implementation will provide the information that the NRC needs
to enable it to review as a part of the license, permit, or limited
work authorization application the particular FFD requirements that are
selected for implementation by licensees and other entities. Subpart K
provides licensees and other entities substantial flexibility in the
design of the program to accommodate local circumstances and the
logistical challenges associated with construction. The NRC believes
this flexibility is necessary because it cannot reasonably anticipate
all of the circumstances that may affect implementation of an FFD
program for construction (e.g., proximity to a licensee testing
facility, proximity to a population center that offers alternative
collection sites, stability in the composition of the workforce at a
specific site, variations in the need for an FFD program during
different construction stages based on the potential risks imposed by
the construction activities at each stage) and, therefore, could not
develop prescriptive requirements that would be appropriate for all
potential circumstances. However, because Subpart K is not prescriptive
and includes several new concepts (e.g., the fitness monitoring
program, permission to use specimens other than urine for drug
testing), the NRC believes that it is necessary to verify that a
licensee or other entity has understood the intent of the Subpart K
provisions and will implement a program that meets that intent,
including ensuring that any procedures used for testing specimens other
than urine for drugs will be scientifically sound and legally
defensible.
Requiring a Part 50 applicant to submit a description of its FFD
program for construction and its implementation is also consistent with
the Part 52 license application requirements. In the Part 52
rulemaking, the NRC implemented the Commission's SRM-SECY-02-0067,
dated September 11, 2002, in which the Commission disapproved the use
of ITAAC for operational programs such as FFD as long as combined
license applicants provide descriptions of the operational programs in
their applications:
[A]n ITAAC for a program should not be necessary if the program
and its implementation are fully described in the application and
found to be acceptable by the NRC at the COL stage. The burden is on
the applicant to provide the necessary and sufficient programmatic
information for approval of the COL without ITAAC.
This requirement to include descriptions of operational programs in
combined license applications was reiterated in the Commission's SRM-
SECY-04-0032, ``Programmatic
[[Page 17156]]
Information Needed for Approval of a Combined License Application
Without Inspections, Tests, Analyses, and Acceptance Criteria,'' dated
May 14, 2004:
In this context, ``fully described'' should be understood to
mean that the program is clearly and sufficiently described in terms
of the scope and level of detail to allow a reasonable assurance
finding of acceptability. Required programs should always be
described at a functional level and at an increased level of detail
where implementation choices could materially and negatively affect
the program effectiveness and acceptability.
Accordingly, Part 52 requires a combined license applicant to include a
description of its FFD program and its implementation, including the
FFD program to be implemented during construction. Similarly, Sec.
26.401(b) requires license, permit, or LWA applicants under Part 50 to
submit a description of their FFD programs during construction and
their implementation. The NRC believes that prior review of the
description of the FFD program for construction and its implementation
will be more efficient than inspecting FFD programs for construction
because it will significantly reduce the inspection resources necessary
to ensure proper program implementation once construction has begun. In
addition, delaying an evaluation of the program until an inspection can
be scheduled, which may occur after construction has begun, could mean
that an ineffective FFD program may be in place during early
construction, when important tasks are being performed and errors
resulting in faults could not be easily detected and corrected (e.g.,
the pouring of concrete). Finally, the emphasis on performance
objectives in Subpart K, compared to the specific, prescriptive
requirements in the remainder of the rule, means that the Subpart K
requirements will be difficult to enforce without prior NRC knowledge
of a licensee's FFD program secured through the description of the FFD
program and its implementation.
Consistent with the Part 52 final rule, the NRC expects a Part 50
applicant's FFD program for construction and its implementation to be
``fully described,'' as explained by the Commission in SRM-SECY-04-
0032. The applicant should provide a description of the FFD policy and
procedures prepared by licensees or other entities, including, but not
limited to, procedures for implementing either random testing or
fitness monitoring and for performing drug and alcohol testing, and
identification of the personnel covered by the FFD program. This
requirement meets Goal 3 of the rulemaking to improve the effectiveness
and efficiency of FFD programs.
Section 26.401(c) provides that nothing prohibits the licensees and
other entities listed in Sec. 26.3(c) from subjecting the individuals
described in Sec. 26.4(f) to an FFD program that meets all of the
requirements of Part 26, or program elements that meet all of the
applicable requirements of Part 26. This provision provides flexibility
to licensees and other entities to cover all individuals with an FFD
program that includes all the requirements of Part 26 or to adopt
certain FFD requirements for individuals described in Sec. 26.4(f)
from Subpart K and certain FFD requirements from other subparts of Part
26, as long as the latter meet all of the applicable requirements of
Part 26. In either case, workers conducting preliminary work that does
not involve building any safety-or security-related SSCs of a facility
are not required to be subject to an FFD program. This section allows
licensees and other entities, if they so choose, to include fatigue
management requirements under Subpart I in their FFD programs for
reactor construction. It also allows licensees to mingle elements of
the requirements of Subpart K and program elements under Subparts A
through H, N, and O, as long as the elements selected from Subparts A
through H, N, and O meet all of the requirements in Part 26 for that
element. Because neither the former rule nor the proposed rule included
this provision, the final rule provides greater flexibility than either
the former rule or the proposed rule. This section achieves Goals 3 and
5 of the rulemaking to improve the effectiveness and efficiency of FFD
programs and to improve consistency between FFD requirements and access
authorization requirements established in 10 CFR 73.56, as supplemented
by orders to nuclear power plant licensees dated January 7, 2003.
Section 26.403 Written Policy and Procedures
Section 26.403 addresses the requirements related to the FFD policy
for personnel listed in Sec. 26.4(f) and the requirements related to
the procedures for such FFD programs. These requirements are presented
in separate sections to ensure that the requirements related to FFD
policy and procedures are easy to locate within this section. This is
consistent with Goal 6 of this rulemaking to improve clarity in the
organization and language of the rule.
Section 26.403(a) requires FFD programs under Subpart K to ensure
that a clear, concise, written FFD policy statement is provided to
individuals who are subject to the program. Section 26.403(a) specifies
that the policy statement must be written in sufficient detail to
provide affected individuals with information on the program's
expectations of them and the consequences that may result from a lack
of adherence to the policy. Because Subpart K does not require
licensees and other entities to provide site-specific FFD training to
individuals, the FFD policy statement will be the primary means for
communicating information with respect to, for example, the sanctions
that are applied for confirmed positive, adulterated, substituted, or
invalid test results, the types of specimens and cutoff levels used in
drug or alcohol testing, or the time periods within which an individual
who has been selected for random testing must report to the collection
site, if the program includes random testing. Because of the likely
large numbers and transient nature of construction workers involved in
new reactor plant construction, requiring each of them to be provided
with a copy of the FFD policy statement is the most effective and
efficient means of ensuring that each individual listed under Sec.
26.4(f) is informed of the contents of the policy. A clear and concise
FFD policy statement that is provided to individuals subject to the
program will promote their awareness of the site-specific FFD policy to
which they are subject. This section satisfies Goal 3 of the rulemaking
to improve the effectiveness and efficiency of FFD programs, as well as
Goal 7 to protect the privacy and other rights (including due process)
of individuals who are subject to the rule.
If a licensee or other entity chooses, under Sec. 26.401(d), to
adopt FFD elements from Subparts A through H, N, and O of Part 26, the
requirements established by those elements will need to be documented
in the FFD policy and procedures, and in the FFD program plan. Also,
notice will need to be provided to the relevant workers falling under
the scope of the program, as required by this section of the rule.
The final rule differs in several other respects from the former
rule and the proposed rule. The former rule contained a simple cross-
reference to the section of the former rule pertaining to the
requirement to adopt an FFD policy and procedures in writing and did
not describe or circumscribe the requirement. Thus, the policy and
procedures requirement for FFD programs applicable to only the reactor
construction workforce was the same as
[[Page 17157]]
the requirement for other FFD programs. In contrast, the proposed rule
did not contain any explicit cross-reference to the requirement
pertaining to FFD program and procedures. However, the program and
procedures section could be interpreted to apply to FFD programs
applicable to the reactor construction workforce. The final rule both
clarifies and adds flexibility to the requirement for an FFD policy
statement and FFD procedures for FFD programs for construction by
explaining the limited nature of the Subpart K FFD policy and
procedures and indicating that they need to be provided only to those
persons subject to the Subpart K FFD program. This is consistent with
Goal 6 of this rulemaking to improve clarity in the organization and
language of the rule.
Section 26.403(b) requires FFD programs under Subpart K to develop,
implement, and maintain written procedures that address the topics
specified in section (b)(1) through (b)(3). However, the procedures
must address a more limited set of topics than specified in Sec. 26.27
[Written policy and procedures], the section of Part 26 that deals with
policy and procedures for FFD programs generally. Thus, the final rule
reduces the scope of the FFD procedures that are required for FFD
programs applicable to the individuals listed in Sec. 26.4(f),
compared to the scope of the former rule and the proposed rule. This
section implements Goal 3 of the rulemaking to improve the
effectiveness and efficiency of FFD programs.
Section 26.403(b)(1) requires the written procedures to address the
methods and techniques to be used in testing for drugs and alcohol,
including procedures for protecting the privacy of the individual who
provides a specimen, procedures for protecting the integrity of the
specimen, and procedures for ensuring that the test results are valid
and attributable to the correct individual.
Section 26.403(b)(2) requires the procedures to describe the
immediate and followup actions that must be taken if an individual is
determined to have: (1) Been involved in the use, sale, or possession
of illegal drugs; (2) consumed alcohol to excess before or while
constructing safety-or security-related SSCs, as determined by a test
that accurately measures BAC; (3) attempted to subvert the testing
process by adulterating or diluting specimens (in vivo or in vitro),
substituting specimens, or by any other means; (4) refused to provide a
specimen for testing; or (5) had legal action taken relating to drug or
alcohol use.
Section 26.403(b)(3) requires the procedures to describe the
process to be followed if an individual's behavior raises a concern
regarding the possible use, sale, or possession of illegal drugs on or
off site; the possible possession or consumption of alcohol while
constructing safety-or security-related SSCs; or impairment from any
cause which in any way could adversely affect the individual's ability
to safely and competently perform his or her duties.
The NRC considers the procedures specified in Sec. 26.403(b)(1) to
(b)(3) to be the minimum set of procedures necessary to implement an
effective FFD program meeting the requirements of Subpart K. Those
sections clarify the requirements in the former rule and the proposed
rule for FFD policy and procedures by explaining what is meant by the
requirements and limiting them to the listed topics. The section
satisfies Goal 3 of the rulemaking to improve the effectiveness and
efficiency of FFD programs, and Goal 6 of the rulemaking to improve
clarity in the organization and language of the rule. As specified in
Sec. 26.401(c), licensees and other entities are free to adopt
procedures for other aspects of their FFD programs that are applicable
to the individuals listed in Sec. 26.4(f).
Section 26.405 Drug and Alcohol Testing
The former rule required reactor construction permit holders to
implement a chemical testing program, including random tests. The
proposed rule made the requirement more explicit, by requiring the
implementation of a drug and alcohol testing program, including random
testing, during construction. The final rule requires pre-assignment,
for-cause, post-accident, and followup testing, as discussed with
respect to Sec. 26.405(c), but does not require random testing of all
individuals who are constructing safety- or security-related SSCs, as
discussed with respect to Sec. 26.405(b), if a licensee or other
entity implements a fitness monitoring program, as discussed with
respect to Sec. 26.406.
The NRC concludes that there is a strong empirical basis for
requiring drug and alcohol testing for construction. SAMHSA conducts
annual surveys that investigate the prevalence, patterns, and
consequences of alcohol and illegal drug use and abuse in the general
U.S. civilian population. Its National Household Survey on Drug Abuse
(NHSDA) covering the years 2000-2001, for example, indicated that over
23 percent of male construction workers aged 18-24 and over 11 percent
of those 25 and older admitted to the use of an illicit drug within the
month previous to the survey, while over 75 percent of the 18-24 age
group and almost 55 percent of the over 25 group admitted to binge
drinking or heavy use of alcohol at least once during the prior month.
Because of the relatively small number of female construction workers,
the data pertain only to male construction workers. A study based on
the results of the SAMHSA NHSDA conducted in 1994 and in 1997 showed
that in 1994 15.6 percent of full-time construction workers, ages 18-
49, reported current illicit drug use and 17.6 percent reported heavy
alcohol use, while in 1997 14.1 percent and 12.4 percent reported such
drug and alcohol use, respectively. The report of the 2000 SAMHSA NHSDA
stated that ``workers in the construction and mining industries
reported the highest rates'' of heavy alcohol use, illicit drug use,
dependence on or abuse of alcohol, and dependence on or abuse of
illicit drugs among full time workers aged 18 through 49 in the U.S.
labor force. SMHSA's 2004 National Survey on Drug Use and Health
indicated that from 2002-2004, past month illicit drug use among full-
time construction and extraction workers aged 18 to 64 was 15.1
percent, and past month heavy alcohol use among this same group was
17.8 percent, which was the highest level among surveyed occupational
groups. Also, construction industry groups, such as the Construction
Safety and Drug Abuse Executive Roundtable, also have concluded that
``drug abuse continues to be widespread in the construction industry,''
affecting up to 25 percent of the workforce. Finally, data collected
annually through the FFD program performance reports and evaluated by
the NRC show a consistent pattern of substantially higher incidence of
detections of drugs and/or alcohol in the population of short-term
contractors, which includes construction workers who seek employment or
are employed during outages, who are given pre-access, random, for-
cause, and post-event drug and alcohol tests by the FFD programs of
reactor licensees, compared to long-term permanent employees at
reactors.
To clarify that the drug and alcohol testing requirements under
Subpart K are not intended to incorporate all of the requirements in
Subparts C [Granting and Maintaining Authorization], E [Collecting
Specimens for Testing], F [Licensee Testing Facilities], and G
[Laboratories Certified by the Department of Health and Human Services]
of Part 26, but at the same time to ensure that the drug and alcohol
[[Page 17158]]
testing requirements of Subpart K are clear, the final rule clarifies
the proposed rule by substantially expanding the description of the
program requirements in Sec. 26.405. This section meets Goal 3 of the
rulemaking to improve the effectiveness and efficiency of FFD programs,
and Goal 6 to improve clarity in the organization and language of the
rule.
Section 26.405(a) requires Subpart K FFD programs to provide a
means to deter and detect substance abuse. The FFD programs must
include drug and alcohol testing that complies with the requirements of
Sec. 26.405. The final rule clarifies that if a licensee or other
entity complies with the requirements of Sec. 26.405 with respect to
drug and alcohol testing, it is not required to meet the drug and
alcohol testing requirements in the balance of Part 26.
Section 26.405(b) specifies that if the licensee or other entity
elects to impose random testing for drugs and alcohol on individuals
who are constructing safety- or security-related SSCs, the random
testing must meet the requirements specified in Sec. 26.405(b)(1)
through (b)(4). Random testing must--
(1) Be administered in a manner that provides reasonable assurance
that individuals are unable to predict the time periods during which
specimens will be collected.
(2) Require individuals who are selected for random testing to
report to the collection site as soon as reasonably practicable after
notification, within the time period specified in the FFD program
policy.
(3) Ensure that all individuals in the population that is subject
to testing on a given day have an equal probability of being selected
and tested.
(4) Provide that an individual completing a test is immediately
eligible for another unannounced test.
The random testing requirements in Subpart K are considerably more
flexible than the random testing requirements in Sec. 26.31 [Drug and
alcohol testing]. These requirements represent those elements of the
random testing requirements under Sec. 26.31 that the NRC has
concluded are necessary and appropriate for random testing of
individuals identified in Sec. 26.4(f). They are intended to ensure
randomness of selection for testing but also take into account the
potentially difficult logistical problems associated with testing at
such large and diverse locations. Licensees and other entities who
adopt random testing will need, in particular, to develop a system for
tracking individuals who are subject to the random testing program to
identify when they are physically present and therefore available and
eligible for testing. Licensees and other entities may also need to
develop programs to ensure that subcontractors who operate
independently also implement random testing programs, and it will be
necessary for licensees and other entities to conduct audits of
subcontractor programs. Section 26.405 provides licensees and other
entities flexibility to design their random testing programs to address
those problems. For example, the final rule in Subpart K does not
specify that random testing must take place at times including
weekends, backshifts, and holidays, and at various times during a shift
because the construction schedule may not in all cases include work
during those periods. The final rule also provides flexibility for
licensees and other entities to determine the number of random tests to
be performed annually and the probability that a member of the
population that is subject to the FFD program will be selected for
random testing. Because of the likely fluctuations in the numbers of
reactor construction workers over the course of a year, the NRC cannot
specify that the number of random tests performed annually must be
equal to at least 50 percent of the population that is subject to the
FFD program, as it does under Sec. 26.31. Finally, Subpart K provides
licensees and other entities with the flexibility to adopt a fitness
monitoring program under Sec. 26.406 to detect and deter substances
abuse, rather than conducting random testing of individuals identified
in Sec. 26.4(f).
Section 26.405(c) specifies that the individuals who are
constructing safety- and security-related SSCs shall be subject to drug
and alcohol testing under the following four conditions: (1) Before
assignment to construct safety-or security-related SSCs; (2) When the
licensee or other entity has adequate cause, arising either in response
to an individual's observed behavior or physical condition indicating
possible substance abuse or after the licensee or other entity has
received credible information that an individual is engaging in
substance abuse, as defined in Sec. 26.5; (3) Following an accident in
which the individual was involved. Post-accident testing should be
conducted as soon as practical after an event involving a human error
that was committed by an individual specified in Sec. 26.4(f), where
the human error may have caused or contributed to the accident. The
licensee or other entity is not required to test individuals who were
affected by the event but whose actions likely did not cause or
contribute to the event. Post-accident testing may involve more than
one individual, and should be conducted if the event resulted in
either: (i) A significant illness or personal injury to the individual
to be tested or another individual, which within 4 hours after the
event is recordable under the U.S. Department of Labor standards
contained in 29 CFR 1904.7, and subsequent amendments, and results in
death, days away from work, restricted work, transfer to another job,
medical treatment beyond first aid, loss of consciousness, or other
significant illness or injury as diagnosed by a physician or other
licensed health care professional, even if it does not result in death,
days away from work, restricted work or job transfer, medical treatment
beyond first aid, or loss of consciousness; or (ii) Significant damage
to any safety-related SSC of a facility that is required by the
Commission's rules and regulations to be described in the site safety
analysis report or preliminary or final safety analysis report.
Finally, (4) followup testing should be conducted as part of a followup
plan to verify an individual's continued abstinence from substance
abuse.
The conditions that can lead to drug and alcohol testing of an
individual specified in Sec. 26.405(c)(1) through (c)(4) parallel
generally the conditions listed in Sec. 26.31(c)(1) through (c)(4),
with changes to reflect the different reasons for testing individuals
identified in Sec. 26.4(f) under Subpart K and testing individuals at
an operating nuclear reactor under Part 26. Thus, pre-assignment
testing is limited to those individuals who will construct safety-or
security-related SSCs. Because the NRC has concluded that there is no
basis to distinguish between for-cause testing under Subpart K and for-
cause testing under Part 26 generally, the final rule in Subpart K and
Sec. 26.31(c)(2) provide the same basis for for-cause testing.
Similarly, Sec. 26.405(c)(3)(i) requires post-accident testing for
exactly the same significant illness and personal injury situations as
required under Sec. 26.31(c)(3)(i). However, the Subpart K post-
accident testing requirement that is triggered by property damage is
limited to damage to any safety-or security-related SSC of a facility.
The NRC recognizes that in the context of reactor plant construction,
damage incidents can occur in a number of contexts that are not related
to the impairment or potential sabotage bases for FFD programs under
Subpart K (e.g., vehicle accidents, injuries to persons not working on
safety-or security-related
[[Page 17159]]
SSCs). Followup testing under Sec. 26.405(c)(4) is defined exactly the
same as followup testing under Sec. 26.31(c)(4). In the NRC's view,
the purpose of the testing, to verify an individual's continued
abstinence from substance abuse, is exactly the same in both cases.
These requirements meet Goal 3 of the rulemaking to improve the
effectiveness and efficiency of FFD programs, and Goal 6 to improve
clarity in the organization and language of the rule.
Section 26.405(d) specifies that, at a minimum, FFD programs under
Subpart K shall test specimens for marijuana metabolite, cocaine
metabolite, opiates (codeine, morphine, 6-acetylmorphine), amphetamines
(amphetamine, methamphetamine), phencyclidine, adulterants, and alcohol
at the cutoff levels specified in this part for testing the respective
specimens, or comparable cutoff level, if alternate specimens, such as
oral fluids, are used for drug screening. The list of substances for
which testing must be conducted under Subpart K exactly parallels the
list in Sec. 26.31(d)(1). The NRC considers this the minimum set of
substances that an effective and adequate FFD program must include for
both construction and operation. However, this section does not
prohibit Subpart K programs from testing for additional drugs,
consistent with the permission in Sec. 26.31(d)(1)(i)(A) for licensees
and other entities who are implementing an FFD program for operating
plants to test for additional drugs.
The NRC is not prohibiting drug testing of specimens other than
urine under Subpart K because it recognizes that there may be
circumstances during construction where waiting for the results of
urine drug tests could unacceptably delay the assignment of individuals
to construct safety-or security-related SSCs. For example, for some
construction activities or in some locations, licensees and other
entities may rely on craftspersons from a local union hall and may not
know in advance which specific individuals will be assigned to work on
a particular day. If the union local does not offer pre-employment
testing to its members, a licensee or other entity may elect to conduct
an oral fluids drug screen, for example, that provides very rapid
results, as long as the collection procedures and testing of oral
fluids meet the criteria established in Sec. 26.405(e) by protecting
the donor's privacy and the integrity of the specimen, and stringent
quality controls are implemented to ensure that test results are valid
and attributable to the correct individual. The NRC does not permit
testing of oral fluids for drugs in FFD programs for other licensees
and entities who are subject to Part 26 because the window of detection
for marijuana use when testing for oral fluids is very short compared
to the window of detection for marijuana use when testing urine
specimens, and the NRC has a higher expectation that individuals will
be trustworthy and reliable, as demonstrated by the avoidance of
substance abuse, for the categories of individuals who are subject to
Part 26 under the licensees' and entities' FFD program for operating
plants. However, the NRC believes that oral fluids drug test results
would be adequate to demonstrate that an individual who will be
constructing safety- and security-related SSCs is not impaired that day
from recent marijuana use or the other substances for which testing is
required under Sec. 26.405(d). Permitting testing of alternate
specimens under FFD programs for construction is consistent with Goal 3
of the rulemaking to improve the effectiveness and efficiency of FFD
programs. This permission is also consistent with Sec. 26.2(c) of the
former rule and Sec. 26.3(e)(2) of the proposed rule that required
drug and alcohol testing during construction, but did not specify the
specimens to be tested.
Section 26.405(d) also requires that urine specimens collected for
drug testing must be subject to validity testing. Although Sec.
26.405(d) specifies that urine specimens collected for drug testing
must be subject to validity testing and does not further elaborate on
the validity testing requirement, the NRC considers the regulatory
detail found in Sec. 26.31 to provide useful guidance to licensees and
other entities on the agency's expectations. However, Subpart K also
provides flexibility to licensees and other entities with respect to
this requirement by not specifying that they are required to meet the
standards of Sec. 26.31. This section limits the requirement for
validity testing to urine specimens because the final rule does not
prohibit the use of specimens other than urine for drug testing under
Subpart K and scientifically sound and legally defensible means of
testing the validity of other types of specimens are not yet available
for some alternate specimens. The requirements in this section meet
Goal 3 of the rulemaking to improve the effectiveness and efficiency of
FFD programs, and Goal 6 to improve clarity in the organization and
language of the rule.
Section 26.405(e) specifies that the specimen collection and drug
and alcohol testing procedures of FFD programs under this subpart must
protect the donor's privacy and the integrity of the specimen and
implement stringent quality controls to ensure that test results are
valid and attributable to the correct individual. At the licensee's or
other entity's discretion, specimen collections and alcohol testing may
be conducted at a local hospital or other facility in accordance with
the specimen collection and alcohol testing requirements of 49 CFR Part
40, ``Procedures for Department of Transportation Workplace Drug and
Alcohol Testing Programs'' (65 FR 41944; August 9, 2001), and
subsequent amendments. This section of the final rule is intended to
provide licensees and other entities with additional flexibility about
the locations where specimen collections and alcohol testing may be
carried out and to help ensure that licensees will not be required,
before construction can begin, to build specimen collection and alcohol
testing facilities at sites that are distant from a current licensee's
specimen collection facilities for drug and alcohol testing. This
provision is consistent with the former and proposed rules, which also
did not require the construction of specimen collection and alcohol
testing facilities. This requirement meets Goal 3 of the rulemaking to
improve the effectiveness and efficiency of FFD programs, and Goal 6 to
improve clarity in the organization and language of the rule.
Section 26.405(f) specifies that testing of urine specimens for
drugs and validity, except validity screening and initial drug and
validity tests that may be performed by licensee testing facilities,
must be performed in a laboratory that is certified by HHS for that
purpose, consistent with its standards and procedures for
certification. This section requires that urine specimens collected for
drug testing must be subject to initial validity and drug testing by
the laboratory because means to attempt to adulterate or substitute a
urine specimen are readily available, but does not apply these
requirements to drug testing of other specimens for two reasons: (1)
Some HHS-certified laboratories may not have the capability to perform
tests of alternate specimens, such as oral fluids, or validity testing
of alternate specimens, and (2) means for attempting to adulterate or
substitute some alternative specimens (e.g., oral fluids) are not
readily available. However, any initial drug test performed by a
licensee or other entity subject to Subpart K, including tests of
alternate specimens, must use an immunoassay that meets
[[Page 17160]]
the requirements of the Food and Drug Administration for commercial
distribution. Urine specimens that yield positive, adulterated,
substituted, or invalid initial validity or drug test results must be
subject to confirmatory testing by an HHS-certified laboratory, except
for invalid specimens that cannot be tested. Alternate specimens that
yield positive drug test results must be subject to confirmatory
testing by a laboratory that meets quality control requirements that
are at least as stringent as the requirements those laboratories are
required to meet for HHS-certification, such as the accreditation
process of the American College of Pathologists. These requirements
constitute the general administrative procedures that the NRC considers
necessary for drug testing. Licensees and other entities would be
allowed to conduct initial testing of urine or alternate specimens at a
licensee testing facility, provided that the licensee testing facility
staff members possess the necessary training and skills for the tasks
assigned, the staff's qualifications are documented, and adequate
quality controls for testing are implemented. However, in parallel with
Sec. 26.31, Subpart K requires licensees and other entities to use
only HHS-certified laboratories to perform drug testing of urine
specimens, except if a licensee testing facility performs initial
tests. This requirement is consistent with the former and proposed
rules, which also required the use of only HHS-certified laboratories
for testing urine specimens for drugs.
Section 26.405(g) requires FFD programs under Subpart K to provide
for an MRO review of positive, adulterated, substituted, and invalid
drug and validity test results from confirmatory testing to determine
whether the donor has violated the FFD policy, before reporting the
results to the individual designated by the licensee or other entity to
perform the suitability and fitness evaluations required under Sec.
26.419. This requirement in Subpart K parallels the requirement in
Sec. 26.169 [Reporting results] of the final rule. This requirement is
an integral component of all Federally-mandated drug and alcohol
testing programs, and required by the Department of Health and Human
Services Mandatory Guidelines for Federal Workplace Drug Testing
Programs. It is fully consistent with the former and proposed rules,
which also followed the HHS Guidelines. This requirement meets Goal 3
of the rulemaking to improve the effectiveness and efficiency of FFD
programs, and Goal 6 to improve clarity in the organization and
language of the rule.
Section 26.406 Fitness Monitoring
Section 26.406(a) of Subpart K specifies that the requirements in
Sec. 26.406 apply only if a licensee or other entity does not elect to
subject the individuals specified in Sec. 26.4(f) to random testing
for drugs and alcohol under Sec. 26.405(b). The NRC considers fitness
monitoring of the individuals who are constructing safety- and
security-related SSCs, as specified in Sec. 26.406, to be a means of
detecting and deterring substance abuse that can function as
effectively as random testing, given the logistical and other issues
associated with random testing. Daily monitoring of individuals by
trained personnel provides a constant source of information about their
fitness, in contrast to the sporadic information provided by random
testing during construction. Fitness monitoring can immediately detect
situations where for-cause testing is required as well as provide a
degree of deterrence comparable to the deterrence provided by the
potential for a random test. Subpart K gives a licensee or other entity
the flexibility to adopt either random testing under Sec. 26.405(b),
or fitness monitoring under Sec. 26.406, or to implement both if the
licensee or other entity chooses. Neither the former rule nor the
proposed rule explicitly required fitness monitoring. However, both
listed the performance objective standards section as one of the
specific rule sections that an FFD program applicable to individuals
involved with the construction of a new reactor plant was required to
satisfy. Attainment of the performance objectives clearly implied that
licensees and other entities would undertake a program to deter
substance abuse and detect impairment. Section 26.406(b) described
below contains a similar performance objective. The requirement for
fitness monitoring in Sec. 26.406, if a licensee or other entity does
not implement random testing of individuals who construct safety- and
security-related SSCs, meets Goal 3 of the rulemaking to improve the
effectiveness and efficiency of FFD programs and Goal 6 to improve
clarity in the organization and language of the rule.
Section 26.406(b) establishes the performance objective for a
fitness monitoring program. It requires licensees and other entities to
implement a program to deter substance abuse and detect indications of
possible use, sale, or possession of illegal drugs, use or possession
of alcohol while constructing safety-or security-related SSCs, and
impairment from any cause that if left unattended may result in a risk
to public health and safety or the common defense and security. Both
the former rule and the proposed rule included a cross-reference to the
performance objectives standard. Thus, Sec. 26.406(b) of the final
rule extends and clarifies the former and proposed rules.
Section 26.406(c) requires licensees and other entities to
establish procedures that fitness monitors shall follow in response to
the indications and actions specified in Sec. 26.406(b) and to train
the monitors to implement the program. Section 26.406(d) provides
licensees and other entities with significant flexibility in
determining the number of individuals required to monitor fitness and
the procedures they are required to follow, commensurate with the
potential risk. Development of fitness monitoring procedures and
training of monitors in those procedures as well as the licensee's or
other entity's requirements for program implementation will ensure that
fitness monitors know what is meant by the requirement and are informed
about the procedures for implementing this requirement.
Section 26.406(d) requires licensees and other entities to ensure
that the fitness of individuals who are constructing safety- and
security-related SSCs is monitored effectively, commensurate with the
potential risk to public health and safety and the common defense and
security imposed by the construction activity. To achieve this
objective, the rule requires licensees and other entities to consider
the number and placement of monitors required, the necessary ratio of
monitors to individuals specified in Sec. 26.4(f), and the frequency
with which the individuals shall be monitored while performing each
construction activity. The NRC does not expect that the individuals
designated as fitness monitors will be dedicated solely to the task of
fitness monitoring. Licensees and other entities may assign fitness
monitoring responsibilities to first-line supervisors, security
personnel, and others who are performing other activities for the
licensee or other entity while monitoring the fitness of individuals
who are constructing safety- and security-related SSCs. In determining
the number of such monitors licensees and other entities may need to
consider how to ensure that equipment, walls, and other temporary or
permanent barriers do not interfere with the monitors' abilities to
maintain visual contact with individuals performing the construction
activity and whether monitoring will be conducted
[[Page 17161]]
continuously until completion of the construction activity,
continuously only at critical points during a construction activity,
once at the beginning of a shift and again after a lunch break, or at a
frequency of every few hours on an irregular schedule. Licensees and
other entities thus have considerable flexibility in designing their
fitness monitoring program. However, they must ensure that the program
meets the performance objective stated in Sec. 26.406(b). This
requirement is consistent with the requirement in the former rule that
FFD programs pertaining to licensees actively constructing nuclear
power plants satisfy former Sec. 26.10(b), calling for measures for
the early detection of persons who are not fit to perform activities
within the scope of Part 26.
Section 26.407 Behavioral Observation
Section 26.407 provides that individuals in Sec. 26.4(f) shall be
subject to behavioral observation while they are constructing safety-
and security-related SSCs at the location where a nuclear power plant
is under construction and will be operated. However, if these
individuals are subject to a fitness monitoring program under Sec.
26.406, they are not required to be subject to behavioral observation
under Sec. 26.407. Thus, this section provides licensees and other
entities with the flexibility of subjecting the individuals specified
in Sec. 26.4(f) to either fitness monitoring under Sec. 26.406 or to
a combination of random drug and alcohol testing under Sec. 26.405(b)
and behavioral observation under Sec. 26.407.
Behavioral observation is an important component of an FFD program
because it increases the likelihood that the licensees and other
entities who are subject to the rule detect and appropriately address
impairment and other adverse behaviors. The individuals listed under
Sec. 26.4(e) will be trained in behavioral observation, because Sec.
26.4(e) specifies that they shall be subject to an FFD program that
meets all of the requirements of Part 26, except Subparts I and K, and
such a program includes behavioral observation training. The
individuals who will perform the behavioral observation are specified
under Sec. 26.4(e) as including any individual whose duties for the
licensees and other entities in Sec. 26.3(c) require him or her to
perform the following activities at the location where the nuclear
power plant will be constructed and operated: (1) Serves as a security
officer under NRC requirements; (2) performs quality assurance
activities, as specified in Appendix B to Part 50; (3) based on a
designation under Sec. 26.406 by a licensee or other entity, monitors
the fitness of the individuals specified in Sec. 26.4(f) (and thus has
also received fitness monitoring training); (4) determines that
inspections, tests, and analyses, or parts thereof, required under 10
CFR Part 52 have been successfully completed; (5) supervises or manages
the construction of safety-or security-related SSCs; or (6) directs, as
defined in Sec. 26.5, or implements the licensee's or other entity's
access authorization program. Because of their important oversight
responsibilities, these individuals will be subject to an FFD program
that meets the requirements for Subparts A through H, N, and O of
Subpart 26. In addition to behavioral observation training, they will
be subject to random testing at the 50 percent annual rate and a
suitable inquiry/employment history check.
Neither the former rule nor the proposed rule explicitly required
behavioral observation. However, both listed the performance objective
standards section as one of the specific rule sections that an FFD
program applicable to individuals involved with the construction of a
new reactor plant was required to satisfy, and attainment of the
performance objectives clearly implied the use of behavioral
observation. The final rule clarifies the requirement and adds
flexibility. This requirement is consistent with the requirement in the
former rule that FFD programs pertaining to licensees actively
constructing nuclear power plants satisfy former Sec. 26.10(b),
calling for measures for the early detection of persons who are not fit
to perform activities within the scope of Part 26. Section 26.407 meets
Goal 3, to improve the effectiveness and efficiency of FFD programs,
and Goal 6 to improve clarity in the organization and language of the
rule.
Section 26.409 Sanctions
Section 26.409 requires FFD programs under Subpart K to establish
sanctions for FFD policy violations that, at a minimum, prohibit the
individuals specified in Sec. 26.4(f) from being assigned to or
performing the duties specified in that section until the licensee or
other entity determines that the individual's behavior does not pose a
threat to public health and safety or the common defense and security.
This section meets Goal 3 of this rulemaking to improve the
effectiveness and efficiency of FFD programs and Goal 6 to improve
clarity in the organization and language of the rule.
The former rule provided for flexibility in the development and
application of sanctions by specifying only that an FFD program
applicable to individuals involved in the construction of a new reactor
plant should make provision for the imposition of sanctions but did not
otherwise specify the level or type of sanctions to be applied. The
proposed rule, in Sec. 26.3(e)(3), included an identical provision,
also without specifying the level or type of sanctions to be included
in the FFD program. By adding explicit criteria for the types of FFD
policy violations to which sanctions shall be applied, the final rule
clarifies the sanctions provision of the former and proposed rules.
This provision in the final rule adds flexibility because it does not
require FFD programs under Subpart K to implement the minimum
requirements for sanctions in Sec. 26.75 [Sanctions] or to apply the
specific procedures for conducting a determination of fitness in Sec.
26.189. Subpart K also allows licensees and other entities the
flexibility to assign individuals who violate the FFD policy under
Subpart K to other duties at the site not covered by the FFD program,
depending on the licensee's assessment of the violation and the other
duties involved.
Section 26.411 Protection of Information
Section 26.411(a) requires FFD programs that collect personal
information about an individual for the purpose of complying with
Subpart K to establish and maintain a system of files and procedures to
protect the personal information. It also requires FFD programs to
maintain and use such records with the highest regard for individual
privacy. This requirement exactly parallels the requirement in Sec.
26.37 [Protection of information] of the final rule pertaining to
protection of information under Part 26 generally. The NRC does not
believe that any lesser standard of protection can be justified for
personal information collected under Subpart K than is required for
personal information collected under Part 26 generally. This section
meets Goal 3 of this rulemaking to improve the effectiveness and
efficiency of FFD programs, Goal 6 to improve clarity in the
organization and language of the rule, and Goal 7 to protect the
privacy of individuals.
The final Subpart K rule parallels the requirements in the former
rule and in the proposed rule. Both included a requirement that FFD
programs applicable to individuals involved with the construction of a
new reactor plant make provisions for the protection of information.
Section 26.411(a) provides
[[Page 17162]]
additional detail about the level of protection (the highest regard for
individual privacy) required of FFD programs that maintain and use
records of personal information. Thus, this final rule provides
additional clarity, compared to the former rule or the proposed rule,
that the program should achieve the necessary protection through a
system of files and procedures.
Section 26.411(b) requires licensees and other entities to obtain a
signed consent that authorizes the disclosure of the personal
information collected and maintained under Subpart K before disclosing
the personal information, except for disclosures to the individuals and
entities specified in Sec. 26.37(b)(1) through (b)(6), (b)(8), and
persons deciding matters under review in Sec. 26.413 [Review process].
These persons include the subject individual or his or her
representative, when the individual has designated the representative
in writing for specified FFD matters; assigned MROs and MRO staff; NRC
representatives; appropriate law enforcement officials under court
order; a licensee's or other entity's representatives who have a need
to access the information to perform assigned duties, including
determinations of fitness, audits of FFD programs, and human resources
functions; the presiding officer in a judicial or administrative
proceeding that the subject individual initiates; and other persons
pursuant to court order. The NRC did not include a reference to Sec.
26.37(b)(7) because it refers to persons deciding matters under another
section of Part 26 that Subpart K does not include. Instead, this
section adds a new reference to persons deciding matters under review
in Sec. 26.413. The requirement to obtain permission to release the
personal information to individuals who are not specified in Sec.
26.37(b)(1) through (b)(6), (b)(8), and persons deciding matters under
review in Sec. 26.413 is necessary because licensees have
misinterpreted the former requirement as prohibiting them from
releasing the personal information under any circumstances. In some
instances, such failures to release information have inappropriately
inhibited an individual's ability to obtain information that was
necessary for a review or appeal of the licensee's determination that
the individual had violated the FFD policy. Therefore, the final rule
includes the explicit permission for licensees and other entities to
release personal information when an individual consents to the
release, in writing. This requirement precisely parallels the
requirement in Sec. 26.37, except for the differences noted, because
the NRC does not believe that any different procedures for handling
personal information can be justified for personal information
collected under Subpart K than are required for personal information
collected under Part 26 generally.
Section 26.413 Review Process
Section 26.413 requires FFD programs under Subpart K to establish
and implement procedures for the review of a determination that an
individual listed in Sec. 26.4(f) has violated the FFD policy. The
procedure must provide for an objective and impartial review of the
facts related to the determination that the individual has violated the
FFD policy. This requirement parallels the one in Sec. 26.39(a) of the
final rule. Because the NRC recognizes that much of the construction
workforce will be transient and rapidly changing, it is leaving
licensees and other entities the flexibility to adopt the additional
review procedures found in Sec. 26.39(b) through (e), but is not
mandating their adoption by including them in the review process
requirements in Sec. 26.413. This section meets Goal 3 of this
rulemaking to improve the effectiveness and efficiency of FFD programs
and Goal 6 to improve clarity in the organization and language of the
rule.
The final rule is more explicit than the former rule, which
specified only that the FFD program for the reactor construction
workforce should make provisions for appeals procedures. The proposed
rule in Sec. 26.3(e)(3) similarly required FFD program for
construction to make provisions for procedures for the objective and
impartial review of authorization decisions. This final rule more
clearly requires FFD programs under Subpart K to establish and
implement procedures and more clearly specifies that the procedures are
for the review of the facts related to the determination that an
individual has violated the FFD policy. However, the basic requirement
in this final rule is the same as that in the former rule and the
proposed rule. The requirement for an objective and impartial review
establishes the same criteria for the review as did the proposed rule,
which also mandated an impartial and objective review.
Section 26.415 Audits
Section 26.415 establishes audit requirements for Subpart K FFD
programs. Section 26.415(a) requires licensees and other entities to
ensure that audits are performed to assure the continuing effectiveness
of the FFD program, including FFD program elements that C/Vs provide,
and the FFD programs of C/Vs that are accepted by the licensee or other
entity. This requirement parallels the audit requirement in Sec.
26.41(a) of the final rule. The agency has not identified any
circumstances relating to the reactor construction workforce that would
support different auditing requirements for Subpart K FFD programs than
for FFD programs under the other subparts of Part 26. The criterion to
be applied for each audit program is that it must assure the continuing
effectiveness of the FFD program. Although the former rule did not
contain a requirement for audits of the FFD programs for construction,
the proposed rule referred explicitly to Sec. 26.41 [Audits and
corrective action] as one of the requirements to be complied with by
licensees authorized to construct a nuclear power plant. Thus, Sec.
26.415 extends and clarifies the requirement in the proposed rule,
meets Goal 3 of this rulemaking to improve the effectiveness and
efficiency of FFD programs, and satisfies Goal 6 to improve clarity in
the organization and language of the rule.
Section 26.415(b) requires each licensee and other entity who
implements an FFD program under Subpart K to ensure that these programs
are audited at a frequency that ensures their continuing effectiveness
and that corrective actions are taken to resolve any problems
identified. The section also provides that licensees and entities may
conduct joint audits, or accept audits of C/Vs conducted by others, so
long as the audit addresses the relevant services of the C/V. The NRC
expects that in determining the frequency of audits, licensees and
other entities will consider the frequency, nature, and severity of
discovered problems, testing errors, personnel or procedural changes,
previous audit findings, and lessons learned. The requirement is
intended to promote performance-based rather than compliance-based
audit activities. By allowing joint audits, the final rule creates
additional flexibility for Subpart K FFD programs.
Section 26.415(c) provides that licensees and other entities who
implement FFD programs under Subpart K need not audit the HHS-certified
laboratories or specimen collection and alcohol testing services that
meet the requirements of 49 CFR Part 40, ``Procedures for Department of
Transportation Workplace Drug and Alcohol Testing Programs'' (65 FR
41944, August 9, 2001) upon which licensees and other entities may rely
to meet the drug and alcohol testing requirements of Subpart K. Because
the
[[Page 17163]]
DOT conducts audits of collection sites that the agency's grantees use,
the NRC has concluded that audits of those sites when they are used by
NRC licensees and other entities are unnecessary.
Section 26.417 Recordkeeping and Reporting
Section 26.417(a) of the final rule provides that FFD programs
shall ensure that records pertaining to the administration of the
program, which may be stored and archived electronically, are
maintained so that they are available for NRC inspection purposes and
for any legal proceedings resulting from the administration of the
program. This recordkeeping provision provides more extensive detail
than the equivalent recordkeeping sections of the former rule or the
proposed rule, both of which provided only that the FFD program for the
reactor construction workforce should make provisions for
recordkeeping. This final rule provides notice that records may be
stored and archived electronically, which clarifies the requirement and
provides flexibility to licensees and other entities. This rule also
incorporates standard language pertaining to the availability of
records for NRC inspection purposes and for any legal proceedings
resulting from the administration of the program. These provisions are
inherent to the NRC's recordkeeping requirements. While adding clarity,
they do not significantly change the recordkeeping requirement from
that in the former or proposed rule. Both the former rule and the
proposed rule contained an explicit requirement for recordkeeping by
the FFD program applicable to reactor construction workers. This
section meets Goal 3 of this rulemaking to improve the effectiveness
and efficiency of FFD programs, and Goal 6 to improve clarity in the
organization and language of the rule.
Section 26.417(b) requires licensees and other entities that
implement FFD programs under Subpart K to make the reports described in
Sec. 26.417(b)(1) and (b)(2). Section 26.417(b)(1) requires reports to
the NRC Operations Center by telephone within 24 hours after the
licensee or other entity discovers any intentional act that casts doubt
on the integrity of the FFD program and any programmatic failure,
degradation, or discovered vulnerability of the FFD program that may
permit undetected drug or alcohol use or abuse by individuals who are
subject to Subpart K. This provision also specifies that these events
must be reported under Subpart K, rather than under the provisions of
10 CFR 73.71 [Reporting of safeguards events]. Section 26.417(b)(2)
requires annual program performance reports for the FFD program. The
former rule contained detailed reporting requirements similar to those
in the final rule. In addition, the NRC considers the reporting of acts
that cast doubt on the integrity of the FFD program and any
programmatic failure, degradation, or discovered vulnerability of the
FFD program that may permit undetected drug or alcohol use or abuse by
individuals subject to Subpart K, as well as annual program performance
reports, to be clearly logical and necessary components of the program
and outgrowths of the recordkeeping requirements.
Section 26.419 Suitability and Fitness Evaluations
Section 26.419 requires licensees and other entities who implement
FFD programs under Subpart K to develop, implement, and maintain
procedures for evaluating whether to assign individuals to the duties
specified in Sec. 26.4(f). These procedures must provide reasonable
assurance that such individuals are fit to safely and competently
perform their duties and are trustworthy and reliable, as demonstrated
by the avoidance of substance abuse. This section provides flexibility
for Subpart K programs to develop procedures for determining
suitability. The requirement that licensees and other entities develop,
implement, and maintain procedures for evaluating whether to assign
individuals to the duties specified in Sec. 26.4(f) is necessary to
enable licensees and other entities to implement Subpart K. These
procedures will allow licensees, other entities, and the individuals
who are subject to the FFD program to know who the Subpart K
requirements cover. This section meets Goal 3 of this rulemaking to
improve the effectiveness and efficiency of FFD programs, and Goal 6 to
improve clarity in the organization and language of the rule.
Although neither the former rule nor the proposed rule contained an
explicit requirement for suitability and fitness evaluations, each
contained a cross-reference to the general performance objectives
sections of their respective rules (Sec. 26.10 of the former rule and
Sec. 26.23 of the proposed rule). Section 26.10 required the FFD
programs applicable to reactor construction workers to provide
reasonable assurance that personnel would perform their tasks in a
reliable and trustworthy manner and that they are not under the
influence of any substance, legal or illegal, or mentally or physically
impaired from any cause, which in any way would affect their ability to
safely and competently perform their duties. Section 26.23 of the
proposed rule used language similar to that in this final rule,
requiring FFD programs to provide reasonable assurance that individuals
who are subject to Part 26 are trustworthy and reliable, as
demonstrated by the avoidance of substance abuse, and to provide
reasonable assurance that individuals who are subject to Part 26 are
not under the influence of any substance, legal or illegal, or mentally
or physically impaired from any cause, which in any way adversely
impairs their ability to safely and competently perform their duties.
Subpart L--[Reserved]
Subpart M--[Reserved]
Subpart N--Recordkeeping and Reporting Requirements
As a result of the reorganization of the proposed rule, the NRC has
moved the provisions from Subpart J of the proposed rule to a new
Subpart N of the final rule. The final rule includes minor
clarifications of the language of the proposed rule that are discussed
with respect to those sections. The NRC has also made more substantive
changes to the proposed rule in Sec. 26.711(c) and (d). Otherwise, the
provisions in this subpart have been adopted as proposed without
change.
Section 26.709 Applicability
The NRC has added Sec. 26.709 to the final rule to specify the
licensees and other entities to whom the requirements of this subpart
apply.
Section 26.711 General Provisions
The NRC has added Sec. 26.711 to the final rule to define general
requirements related to recordkeeping and reporting under Part 26.
Section 26.711(a) of the final rule establishes a requirement that
licensees and other entities must maintain records and submit certain
reports to the NRC, consistent with Goal 6 of this rulemaking to
improve clarity in the organization and language of the rule. In
addition, this section requires that licensees and other entities
retain the records required under this part for either the periods that
are specified in Subpart N or for the life of the facility's license,
certificate, or other regulatory approval, if no records retention
requirement is specified. This general records retention requirement
clarifies the language of the rule and is a standard administrative
provision that is used in all other parts of 10 CFR that contain
substantive requirements applicable to licensees and applicants, such
as 10 CFR 50.71(c).
[[Page 17164]]
The NRC has added Sec. 26.711(b) to the final rule to permit
records to be stored and archived electronically if the method used to
create the electronic records (1) provides an accurate representation
of the original records, (2) prevents the alteration of any archived
information and/or data once it has been committed to storage, and (3)
allows easy retrieval and re-creation of the original records. This
provision recognizes that most records are now stored electronically
and must be protected to ensure the integrity of the data. The
requirements are consistent with related requirements in the access
authorization orders issued to nuclear power plant licensees dated
January 7, 2003. Therefore, these requirements meet Goal 4 of this
rulemaking to improve consistency between FFD requirements and access
authorization requirements established in 10 CFR 73.56 [Personal access
authorization requirements for nuclear power plants], as supplemented
by orders to nuclear power plant licensees dated January 7, 2003.
In the final rule, the NRC has added a new provision in Sec.
26.711(c). This provision requires licensees and other entities to
inform individuals of the right to review and correct the records
maintained about the individual under this part and imposes a
requirement on licensees and other entities to ensure that the
information they maintain and share with other licensees and entities
is correct and complete. The NRC added this provision to provide
further assurance that individuals who are subject to an FFD program
under this part are not unjustly or inaccurately portrayed as having
violated FFD requirements in any written documentation that licensees
and other entities rely on when making authorization decisions. This
provision meets Goal 7 of this rulemaking to protect the privacy and
other rights (including due process) of individuals who are subject to
Part 26. This provision is also meets Goal 4 of this rulemaking to
improve consistency between this rule and access authorization
requirements established in 10 CFR 73.56, as supplemented by orders to
nuclear power plant licensees dated January 7, 2003.
The NRC has also added Sec. 26.711(d) to the final rule to require
licensees and other entities to ensure that only correct and complete
information about individuals is retained and shared. This provision
specifies that licensees and other entities shall correct or augment
shared information contained in the records if this information changes
or new information is developed. Also, if the changed or new
information has implications for adversely affecting an individual's
eligibility for authorization, the final rule requires that the
licensee or other entity who discovers the incorrect information or
developed new information shall inform the reviewing official of the
updated information. The NRC has added this provision to meet Goal 7 of
this rulemaking to protect the privacy and other rights (including due
process) of individuals who are subject to Part 26. This provision also
meets Goal 4 of this rulemaking to improve consistency between this
rule and access authorization requirements established in 10 CFR 73.56,
as supplemented by orders to nuclear power plant licensees dated
January 7, 2003.
Section 26.713 Recordkeeping Requirements for Licensees and Other
Entities
Section 26.713 of the final rule amends former Sec. 26.71
[Recordkeeping requirements]. Former Sec. 26.71(d), which established
requirements for FFD program performance reports, is retained in Sec.
26.717 [Fitness-for-duty program performance data], a separate section
that focuses only on those reports. Section 26.713 retains but amends
former Sec. 26.71(a) through (c) and adds other requirements that are
interspersed throughout the former rule. The NRC has made these changes
to meet Goal 6 of this rulemaking to improve clarity in the
organization and language of the rule by grouping recordkeeping
requirements that apply to licensees and other entities in one section.
Section 26.713(a) of the final rule requires licensees and other
entities to retain certain records related to authorization
decisionmaking for at least 5 years after an individual's authorization
has been terminated or denied, or until the completion of all related
legal proceedings, whichever is later. The agency has added the
requirement to retain records until the completion of all related legal
proceedings at the suggestion of stakeholders during the public
meetings discussed in Section I.D. The stakeholders noted that some
legal proceedings involving records of the type specified in the
paragraph have continued longer than the 5 years that the former rule
required these records to be retained and that adding a requirement in
the final rule to retain the records until all legal proceedings are
complete protects an individual's right to due process under the rule.
This provision is consistent with Goal 7 of this rulemaking to protect
the privacy and other rights (including due process) of individuals who
are subject to Part 26 and Goal 3 to improve the effectiveness and
efficiency of FFD programs.
Section 26.713(a)(1) amends former Sec. 26.71(a). Former Sec.
26.71(a) required licensees to retain records of the inquiries that
licensees conduct in granting unescorted access to an individual for 5
years following the termination of such access authorizations. The
final rule updates the terminology used in the former paragraph for
consistency with the revised language used throughout the rule. For
example, the paragraph refers to ``self-disclosures,'' ``employment
histories,'' ``suitable inquiries,'' and ``granting authorization,''
but retains the intent of the former paragraph. The NRC has made the
changes in terminology for the reasons discussed with respect to
Sec. Sec. 26.61 [Self-disclosure and employment history] and 26.63
[Suitable inquiry]. In addition, the agency has updated the former
cross-reference to Sec. 26.27(a) to reflect the new organization of
the rule.
Section 26.713(a)(2) amends former Sec. 26.71(b). Former Sec.
26.71(b) required licensees to retain records that are related to
positive drug test results that the MRO has confirmed. The final rule
revises the former requirement by mandating that licensees and other
entities retain records related to any violation of the FFD policy,
which includes confirmed positive drug and alcohol test results. This
change ensures that licensees and other entities who may be considering
granting authorization to an individual who has previously violated any
aspect of an FFD policy can obtain these records for review as part of
the authorization decisionmaking process specified in Sec. 26.69
[Authorization with potentially disqualifying fitness-for-duty
information].
The NRC has added Sec. 26.713(a)(3) to the final rule to require
licensees and other entities to retain records that are related to the
granting and termination of an individual's authorization. This
provision ensures that licensees and other entities who may be
considering granting authorization to an individual under Subpart C
[Granting and Maintaining Authorization] can determine which category
of authorization requirements in Subpart C applies to the individual,
based upon the length of time that has elapsed since the termination of
the individual's last period of authorization and whether it was
terminated favorably. The new section discusses the categories of
authorization requirements with respect to Sec. Sec. 26.55 [Initial
authorization], 26.57
[[Page 17165]]
[Authorization update], 26.59 [Authorization reinstatement], and 26.69.
The NRC has added Sec. 26.713(a)(4) to the final rule to require
licensees and other entities to retain records that are related to any
determination of fitness that was conducted under Sec. 26.189
[Determination of fitness]. The final rule, with respect to the
proposed rule, clarifies that the records to be retained include any
recommendations for treatment and followup testing plans. This
provision ensures that licensees and other entities who may be
considering granting authorization to an individual who has previously
undergone a determination of fitness can obtain these records for
review as part of the authorization decisionmaking process specified in
Sec. 26.69. In addition, if an individual who is subject to followup
testing and a treatment plan transfers to another FFD program, the
reviewing official and SAE of the receiving FFD program, which takes
responsibility for implementing the testing and treatment plans, are
required to have access to this information under Sec. 26.69(e).
Section 26.713(b)(1) and (b)(2) of the final rule requires
licensees and other entities to retain records related to FFD training,
examinations, audits, audit findings, and corrective actions for at
least 3 years, or until the completion of all related legal
proceedings, whichever is later. These paragraphs retain the 3-year
recordkeeping requirements of the former rule in Sec. Sec. 26.21(b)
and 26.22(c) for training records, and Sec. 26.80(c) for audit
findings and corrective action records.
Section 26.713(c) of the final rule amends former Sec. 26.71(c).
Former Sec. 26.71(c) required licensees to retain records related to
any individual who was made ineligible for authorization for 3 years or
longer under former Sec. 26.27 [Management actions and sanctions to be
imposed] until the Commission terminates each license under which the
records were created. However, the final rule requires licensees and
other entities to retain records concerning 5-year and permanent
denials of authorization for 40 years or until, upon application, the
NRC determines that the records are no longer needed. The requirement
to retain records related to 5-year denials of authorization is
consistent with the more stringent sanctions established in Sec.
26.75(c), (d), and (e)(2), in which the NRC has eliminated the sanction
of a 3-year denial of authorization, as discussed with respect to those
paragraphs. The 40-year retention requirement is based on the longest
expected working life of an individual, rather than on the period of
the license. The termination of a license by the Commission does not
mean that individuals whose authorizations were denied for 5 years or
permanently denied under the licensee' FFD program would necessarily
leave the industry. Requiring retention of the records pertaining to
those individuals ensures that the records of the 5-year and permanent
denials are available, should the individual seek authorization from
another licensee or other entity. This amendment is consistent with
Goal 7 of this rulemaking to protect the privacy and other rights
(including due process) of individuals who are subject to Part 26 and
Goal 3 to improve the effectiveness and efficiency of FFD programs.
Section 26.713(d) of the final rule replaces the recordkeeping
requirement in former Sec. 26.20 [Written policy and procedures]. This
paragraph requires licensees and other entities to retain superseded
FFD policies and procedures for at least 5 years, or until completion
of all legal proceedings related to an FFD violation that may have
occurred under the policy and procedures, whichever is later. The NRC
has increased the required period for retaining superseded materials
from 3 to 5 years to ensure that the materials are available if
subsequent licensees and other entities require the information in
making a determination of fitness. The requirement to retain the policy
and procedures related to any matter under legal challenge until the
matter is resolved ensures that the materials remain available if an
individual, the NRC, a licensee, or another entity who is subject to
this rule require access to them in a legal or regulatory proceeding.
This provision is consistent with Goal 7 of this rulemaking to protect
the privacy and other rights (including due process) of individuals who
are subject to Part 26, and Goal 3 to improve the effectiveness and
efficiency of FFD programs.
Section 26.713(e) of the final rule amends the requirement in
former Sec. 26.23(a) pertaining to the retention of written agreements
for the provision of FFD program services. This provision requires
licensees and other entities to retain the written agreement for the
life of the agreement (as in the former rule), or until completion of
all legal proceedings related to an FFD violation that involved the
services, whichever is later. This requirement ensures that the
materials remain available should an individual, the NRC, a licensee,
or another entity who is subject to the rule require access to them in
a legal or regulatory proceeding. This amendment is consistent with
Goal 7 of this rulemaking to protect the privacy and other rights
(including due process) of individuals who are subject to Part 26, and
Goal 3 to improve the effectiveness and efficiency of FFD programs.
The NRC has added Sec. 26.713(f) to the final rule to require
licensees and other entities to retain records related to the
background investigations, credit and criminal history checks, and
psychological assessments of FFD program personnel, conducted under
Sec. 26.31(b)(1)(i), for the length of the individual's employment by
or contractual relationship with the licensee or other entity, or until
the completion of all related legal proceedings, whichever is later.
This requirement is consistent with the last phrase of former Section
2.6(c) in Appendix A to Part 26, which required licensee testing
facilities to retain personnel files that include ``appropriate data to
support determinations of honesty and integrity conducted in accordance
with Section 2.3 of this appendix.'' The required period during which
these records must be maintained is based on the NRC's need to have
access to the records for inspection purposes and the potential need
for the records to remain available if an individual, the NRC, a
licensee, or another entity who is subject to this rule requires access
to them in a legal or regulatory proceeding. However, the final rule
establishes a new limit on the period during which the records must be
retained in order to reduce the burden associated with storing such
records indefinitely. This new provision is consistent with Goal 7 of
this rulemaking to protect the privacy and other rights (including due
process) of individuals who are subject to Part 26, and Goal 3 to
improve the effectiveness and efficiency of FFD programs.
The NRC has added Sec. 26.713(g) to the final rule to require
licensees and other entities to retain records of the certification,
provided by a qualified forensic toxicologist, as required under Sec.
26.31(d)(1)(i) and (d)(3)(iii)(C), of the scientific and technical
suitability of any assays and cutoff levels used for drug testing that
this part does not address. This provision requires the licensee or
other entity to retain these records for the period of time during
which the FFD program continues to test for drugs for which this part
does not require testing, uses more stringent cutoff levels than those
specified in this part, or until the completion of all related legal
proceedings, whichever is later. This new requirement ensures that the
NRC has access to the records for inspection purposes and that the
[[Page 17166]]
records remain available if an individual, the NRC, a licensee, or
another entity who is subject to this rule requires access to them in a
legal or regulatory proceeding. This provision is consistent with Goal
7 of this rulemaking to protect the privacy and other rights (including
due process) of individuals who are subject to Part 26, and Goal 3 to
improve the effectiveness and efficiency of FFD programs.
Section 26.715 Recordkeeping Requirements for Collection Sites,
Licensee Testing Facilities, and Laboratories Certified by The
Department of Health and Human Services
The NRC has added Sec. 26.715 to the final rule to group together
in one section the recordkeeping requirements that apply to collection
sites, licensee testing facilities, and HHS-certified laboratories.
Section 26.715(a) of the final rule retains the requirement in
former Section 2.7(n) in Appendix A to Part 26. This provision mandates
that collection sites, HHS-certified laboratories and licensee testing
facilities must maintain documentation of all aspects of the testing
process for at least two years. The final rule includes collection
sites within this provision because licensee testing facilities and
collection sites may not be co-located, as was typically the case when
the former rule was first published. This section retains the provision
in former Section 2.7(n) that the two-year period may be extended upon
written notification by the NRC or any licensee or other entity for
whom services are being provided. The final rule also adds a
requirement to retain the documentation until completion of all legal
proceedings related to an FFD violation to ensure that the records
remain available if an individual, the NRC, a licensee, or another
entity who is subject to this rule requires access to them in a legal
or regulatory proceeding. This change is consistent with Goal 7 of this
rulemaking to protect the privacy and other rights (including due
process) of individuals who are subject to Part 26, and Goal 3 to
improve the effectiveness and efficiency of FFD programs.
The NRC has added Sec. 26.715(b)(1) through (b)(14) to the final
rule to list in a single paragraph the documents that collection sites,
licensee testing facilities, and HHS-certified laboratories must
retain. Specifically, those documents include personnel files of
individuals who are no longer working at a collection site, licensee
testing facility, or HHS-certified laboratory; on chain-of-custody
documents; quality assurance/quality control records; superseded
procedures; all test data; test reports; records on performance
testing; records on testing errors or unsatisfactory performance, and
the investigation and correction of the errors or unsatisfactory
performance; performance records on certification inspections; records
on preventative maintenance; records on negative test results based on
scientific insufficiency; computer-generated data, printed or
electronic copies of computer-generated data; records of individuals
accessing secured areas in licensee testing facilities and HHS-
certified laboratories; and records of EBT maintenance, inspection, and
calibration. This listing of records to be retained comes from
provisions of the former rule in Sec. Sec. 26.20 and 26.71(a) and
Sections 2.7(a)(1), 2.7(f)(2), 2.7(g)(8), 2.7(n), 2.7(o)(1), 2.7(o)(3),
2.8(e)(4), 2.9(g), and 3.1 of Appendix A to Part 26. The final rule
groups them together in a single paragraph to make them easier to
locate within the rule, consistent with Goal 6 of this rulemaking to
improve clarity in the organization and language of the rule.
Section 26.717 Fitness-for-Duty Program Performance Data
The NRC has added Sec. 26.717 to the final rule to amend the
requirements in former Sec. 26.71(d) for collecting, compiling, and
submitting FFD program performance data to reduce the burden on
licensees and other entities and to make the reporting time consistent
with the NRC's need for the information. Specifically, this paragraph
requires licensees and other entities to submit program performance
data to the NRC every 12 months, rather than every 6 months. The NRC
has made the additional conforming changes described below to former
Sec. 26.71 for consistency with other revisions to the rule.
Section 26.717(a) of the final rule retains the requirement in
former Sec. 26.71(d) that each FFD program subject to Part 26 must
collect and compile FFD performance data.
Section 26.717(b)(1) through (b)(9) of the final rule amends the
second sentence of former Sec. 26.71(d). The provision specifies the
FFD program performance data that a licensee or other entity must
report, including the random testing rate, the drugs for which testing
is conducted and their cutoff levels, workforce populations tested,
numbers of tests administered and results, conditions under which the
tests were performed, substances identified, number of subversion
attempts by type, summary of management actions; and the information
required under Sec. 26.203(e)(1) and (e)(2). With respect to the
proposed rule, the final rule clarifies Sec. 26.717(b)(2) to be
consistent with the changes the NRC has made to procedures for dilute
specimens, as discussed with regard to Sec. 26.163(a)(2). This
paragraph is identical to the requirements of the former provision with
two exceptions: (1) the final rule requires reporting the number of
subversion attempts by type, and (2) does not require a list of events
reported during the reporting period.
Concerning the first exception, the final rule adds a requirement
for licensees and other entities to report the number of subversion
attempts by type. This new requirement is necessary to enable the NRC
to monitor the ongoing integrity and effectiveness of FFD programs in
detecting subversion attempts, consistent with the NRC's heightened
concern with this issue, as discussed with respect to Sec. Sec.
26.31(d)(3)(i) and 26.75(b). Although this information is available to
NRC inspection personnel at each site, it would be costly and an
inefficient use of resources for inspectors to aggregate and report it
annually. Under the former rule, licensees typically reported
subversion attempts they detected under the requirement to summarize
``events reported'' in former Sec. 26.71(d). Therefore, the NRC
expects that the reporting requirement imposes minimal additional
burden. The agency has added this requirement to meet Goal 3 of the
rulemaking to improve the effectiveness and efficiency of FFD programs.
Second, the final rule eliminates the former requirement to include
the number of events reported to the NRC during the reporting period.
The NRC eliminated the former reporting requirement because it has
access to this information through other avenues and reporting it twice
is unnecessary. Eliminating this requirement meets Goal 5 of the
rulemaking to improve Part 26 by eliminating or modifying unnecessary
requirements.
The final rule also adds a requirement in Sec. 26.717(b)(9) that
the FFD program performance data must include the information required
under Sec. 26.203(e)(1) and (e)(2), which includes (1) a summary of
all instances during the past calendar year when certain work hour
controls were waived, and (2) a summary of corrective actions taken,
resulting from the analysis of the data collected under Sec.
26.203(e), respectively.
Section 26.717(c) of the final rule amends the portions of former
Sec. 26.71(d)
[[Page 17167]]
that required licensees and other entities to analyze the FFD program
performance data semiannually. Instead, this provision requires
licensees and other entities to analyze FFD program performance data
annually and retains the requirement that actions must be taken to
correct program weaknesses. NRC experience in reviewing FFD program
performance reports since it first promulgated the rule has shown that
reporting twice per year is unnecessary to ensure the continuing
effectiveness of FFD programs. Therefore, the final rule relaxes the
semiannual analysis and reporting requirement, consistent with Goal 5
of the rulemaking to improve Part 26 by eliminating or modifying
unnecessary requirements. Furthermore, the provision requires licensees
and other entities to retain for 3 years records of the data, analysis,
and corrective actions taken, which is the same as the former
requirement in Sec. 26.71(d). However, the rule adds a requirement to
retain the documentation until completion of any legal proceedings
related to an FFD violation to ensure that the records remain available
if an individual, the NRC, a licensee, or another entity who is subject
to this rule requires access to them in a legal or regulatory
proceeding. The agency has added this requirement to meet Goal 3 of the
rulemaking to improve the effectiveness and efficiency of FFD programs.
Section 26.717(d) of the final rule retains the last sentence of
former Sec. 26.71(d). The former provision required any licensee who
temporarily suspends an individual's authorization or takes
administrative actions on the basis of an initial positive marijuana or
cocaine drug test result (under the provisions of former Sec.
26.24(d)) to report the results in the annual summary by processing
stage (i.e., initial testing at the licensee testing facility, testing
at the HHS-certified laboratory, MRO determination). The final rule
continues to require that the report include the number of
administrative actions taken against individuals for the reporting
period. However, the agency has eliminated the term ``temporarily
suspend'' from the provision and replaced it with the term
``administratively withdraw authorization,'' in response to stakeholder
requests at the public meetings discussed in Section I.D. The
stakeholders noted that an individual is either authorized to perform
job duties under Part 26 or not, and that the concept of suspending an
individual's authorization is conceptually inconsistent. The NRC
concurred with this observation and, therefore, has eliminated the
inaccurate phrase from the final rule. The agency made this change to
meet Goal 6 of the rulemaking relating to improving clarity in the
language of the rule.
Section 26.717(e) of the final rule amends portions of former Sec.
26.71(d). It requires licensees and other entities to submit the annual
summary to the NRC by March 1 of the following year, rather than the
former requirement to provide a semiannual summary within 60 days of
the end of each six-month reporting period. The agency made this change
for consistency with the requirement in Sec. 26.717(c) to submit the
report annually, as discussed with respect to that paragraph, and to
meet Goal 5 of the rulemaking to improve Part 26 by eliminating or
modifying unnecessary requirements.
Section 26.717(f) of the final rule retains the requirement in
former Sec. 26.71(d) that program performance data may be submitted in
a consolidated report as long as the data are reported separately for
each site.
The NRC has added Sec. 26.717(g) to the final rule to require that
C/Vs who maintain an approved drug and alcohol testing program must
submit to the NRC the same program performance data that are required
from licensees and other entities who are subject to the final rule,
either directly or via the licensee or other entity to whom the C/V
provides services, ensuring that duplicate reports are not provided to
the NRC. This requirement is necessary because the final rule applies
directly to C/Vs who maintain licensee-approved programs, rather than
applying only to licensees under the former rule, as discussed with
respect to Sec. 26.3(d). The agency has added this requirement to meet
Goal 3 of the rulemaking to improve the effectiveness and efficiency of
FFD programs.
Section 26.719 Reporting Requirements
The NRC has added Sec. 26.719 to the final rule to replace former
Sec. 26.73 and combines it with former Section 2.8(e)(4), (e)(5), and
(e)(6) in Appendix A to Part 26. The final rule groups into one section
reporting requirements that are interspersed throughout the former rule
to meet Goal 6 of this rulemaking to improve clarity in the
organization and language of the rule.
The NRC added Sec. 26.719(a) to the final rule to introduce the
section, consistent with Goal 6 of this rulemaking to improve clarity
in the organization and language of the rule. This provision specifies
the categories of significant events that licensees and other entities
must report to the NRC (i.e., significant violations of the FFD policy,
significant FFD program failures, and errors in drug and alcohol
testing). The second sentence of the paragraph retains the requirement
in former Sec. 26.73(c) that significant events must be reported under
this section, rather than under the provisions of 10 CFR 73.71
[Reporting of safeguards events].
Section 26.719(b) of the final rule reorganizes and amends former
Sec. 26.73(a)(1), (a)(2), and (b), consistent with Goal 6 of this
rulemaking to improve clarity in the organization and language of the
rule. Paragraph 26.719(b) retains the requirement in former Sec.
26.73(b) that notifications of events must be made to the NRC
Operations Center within 24 hours of their discovery. However, the
final rule presents this requirement at the beginning of the paragraph
to clarify that it applies to all of the events that are listed in the
paragraph.
Section 26.719(b)(1) amends former Sec. 26.73(a)(1). The former
provision required licensees to report the sale, use, or possession of
illegal drugs within a protected area. The final rule adds a
requirement for licensees and other entities also to report the
consumption or presence of alcohol in a protected area. This change is
consistent with the NRC's increased concern with the adverse effects of
alcohol abuse on safe performance, as discussed with respect to Sec.
26.75(e). The agency has made the change for consistency with the
performance objective in Sec. 26.23(d), which is to provide reasonable
assurance that the workplaces subject to this part are free from the
presence and effects of illegal drugs and alcohol, as discussed with
respect to that paragraph. This change also meets Goal 3 of the
rulemaking to improve the effectiveness and efficiency of FFD programs,
as the consumption or presence of alcohol in a protected area
constitutes a significant programmatic failure in achieving this
performance objective.
Section 26.719(b)(2) amends former Sec. 26.73(a)(2). Former Sec.
26.73(a)(2) required licensees to report any acts by licensed operators
and supervisory personnel involving the sale, use, or possession of a
controlled substance; resulting in confirmed positive test results for
such persons; involving the use of alcohol within the protected area;
or resulting in a determination of unfitness for scheduled work because
of the consumption of alcohol. The final rule expands the former
reporting requirement to include SSNM transporter personnel and FFD
program personnel. The NRC has made this
[[Page 17168]]
change to ensure that it is informed of events involving these
individuals because of the important roles they play in assuring public
health and safety and the common defense and security, in the former
case, and the integrity of the FFD program, in the latter. The agency's
change meets Goal 3 of the rulemaking to improve the effectiveness and
efficiency of FFD programs.
Section 26.719(b)(2)(i) retains former Sec. 26.73(a)(2)(i). The
provision requires licensees and other entities to report any acts by
the subject individuals that involve the use, sale, or possession of a
controlled substance.
Section 26.719(b)(2)(ii) combines and amends former Sec.
26.73(a)(2)(ii) and (a)(2)(iv). The former section required licensees
and other entities to report any confirmed positive test results for
such persons and any acts by the subject individuals that result in a
determination of unfitness for scheduled work because of the
consumption of alcohol, respectively. The final rule amends the former
requirements by mandating that licensees and other entities report any
acts by the subject individuals that result in a determination that the
individual has violated the licensee's or other entity's FFD policy
(including subversion as defined in Sec. 26.5 [Definitions]). This
change is consistent with two other changes to the rule: (1) the
addition of validity testing requirements to the final rule, as
discussed with respect to Sec. 26.31(d)(3)(i), and (2) the addition of
new requirements in Subpart D [Management Actions and Sanctions to be
Imposed] that impose the same sanctions for confirmed positive alcohol
test results as those required for confirmed positive drug test
results, as discussed with respect to Sec. 26.75(e). Therefore, the
final rule requires licensees and other entities to report confirmed
positive drug test results, any other acts to subvert or attempt to
subvert the testing process, and confirmed positive alcohol test
results for these individuals.
Section 26.719(b)(2)(iii) amends former Sec. 26.73(a)(2)(iii). The
former provision required licensees and other entities to report any
events involving the consumption of alcohol within the protected area
by the subject individuals. The final rule adds the requirement to
report any acts involving the consumption of alcohol while performing
the duties that require these individuals to be subject to this part.
This change is consistent with the addition of SSNM transporters and
FFD program personnel to this paragraph, as discussed with respect to
Sec. 26.719(b)(2), because transporter and FFD program personnel
typically do not work within a protected area. However, the NRC
maintains an interest in the consumption of alcohol by the individuals
listed in Sec. 26.719(b)(2) while they are performing the duties
specified in Sec. 26.4 at any location.
Section 26.719(b)(3) establishes a new requirement for licensees
and other entities to report any intentional act that casts doubt on
the integrity of the FFD program. Because of the wide array of possible
acts that could fit this definition and be of concern to the NRC, the
final rule does not specify the acts that licensees and other entities
must report. However, such intentional acts may include, but are not
limited to:
(1) Notifying individuals, outside of the FFD program's normal
notification procedures, that they will be selected for random or
followup testing on a particular date or at a specific time so that the
individuals have sufficient time available to attempt to mask drug use
by, for example, obtaining a substitute urine specimen or an
adulterant, drinking large amounts of liquid in order to provide a
dilute urine specimen, or leaving the site to avoid testing;
(2) Attempting to divert or tamper with urine specimens that are
being prepared for transfer to a licensee testing facility or HHS-
certified laboratory by stealing the specimens, substituting specimens
in the package, or altering the specimens' custody-and-control
documentation;
(3) Attempting to tamper with testing instruments so that they
provide false negative test results;
(4) Collusion by collection site personnel, an MRO, or MRO staff
with an individual who is subject to testing to alter the individual's
test results; and
(5) Attempts by information technology personnel to alter the
software that the FFD program uses to randomly select individuals for
testing to ensure that specific individuals are not selected.
The intentional acts that this final rule requires licensees and
other entities to report could involve any aspect of the operations of
the FFD program and the testing process.
The final rule adds this reporting requirement because of other
changes to the final rule that permit licensees and other entities to
rely on other Part 26 programs to a much greater extent than under the
former requirement. The final rule permits licensees and other entities
to rely on testing performed by another Part 26 program, FFD training,
other programs' suitable inquiries and determinations of fitness, and
audits. Therefore, intentional acts that cast doubt on the integrity of
one FFD program may also indirectly affect the integrity and
effectiveness of other FFD programs. The NRC requires reporting of
these acts in order to monitor their impacts and ensure that other FFD
programs that may be affected are informed of the problem so that they
can take corrective actions, if necessary. The agency has made this
change to meet Goal 3 of the rulemaking to improve the effectiveness
and efficiency of FFD programs.
The NRC has added Sec. 26.719(b)(4) to the final rule to require
licensees and other entities to report any programmatic failure,
degradation, or discovered vulnerability of an FFD program that may
permit undetected drug or alcohol use or abuse by individuals within a
protected area, or by individuals who are assigned to perform the
duties that require them to be subject to the FFD program. In Item 10.1
of NUREG-1385, ``Fitness for Duty in the Nuclear Power Industry:
Responses to Implementation Questions,'' the NRC emphasized that it
expects licensees to exercise prudent judgment in determining whether
to report unusual situations and that the significant events the
licensees must report are not limited to the examples contained in the
rule. However, the NRC understands that licensees have not reported
many significant events that would be useful for formulating public
policy or that the NRC should respond to in a timely fashion because
licensee management decided not to do so unless the rule specifically
required this reporting. Therefore, this final rule adds Sec.
26.719(b)(4) to clarify that significant events and programmatic
failures are not limited to those listed in Sec. 26.719(b), but
include any programmatic failures or weaknesses that potentially could
permit substance abuse to be undetected. The agency has made this
change to meet Goal 3 of the rulemaking to improve the effectiveness
and efficiency of FFD programs.
Section 26.719(c) of the final rule reorganizes and amends former
requirements for reporting errors in drug and alcohol testing,
consistent with Goal 6 of the rulemaking to improve clarity in the
organizational of the rule. The final rule retains the former
requirements for licensees and other entities to investigate and take
corrective actions for drug and alcohol testing errors in Sec. Sec.
26.137(f) and 26.167(g) for licensee testing facilities and HHS-
certified laboratories, respectively, but moves the reporting
requirements to this section.
[[Page 17169]]
Section 26.719(c)(1) updates the portion of former Sec. 2.8(e)(4)
in Appendix A to Part 26 that mandated that licensees and other
entities must report within 30 days of completing an investigation any
testing errors or unsatisfactory performance in performance testing at
either a licensee testing facility or an HHS-certified laboratory. This
section amends the former requirement by specifying that the report of
the incident must describe the corrective actions taken or planned.
Although licensees and other entities have consistently described
corrective actions in such reports, the agency has added this new
requirement to meet Goal 6 of the rulemaking to improve clarity in the
language of the rule.
In addition, this section adds cross-references to other sections
of the final rule that define processes that may also result in the
identification of errors, including the reviews required under Sec.
26.39 [Review process for fitness-for-duty policy violations] and Sec.
26.185 [Determining a fitness-for-duty policy violation]. In the
original rule, the NRC intended that testing or process errors
discovered in any part of the program, including these review
processes, would be investigated as an unsatisfactory performance of a
test. Thorough investigation and reporting of such test results will
continue to assist the NRC, the licensees, HHS, and the HHS-certified
laboratories in preventing future occurrences. Therefore, this change,
consistent with Goal 6 of the rulemaking to improve clarity in the
language of the rule, clarifies that the requirement to investigate,
correct, and report errors is not limited only to errors identified
through blind performance testing in licensee testing facilities and
HHS-certified laboratories but also applies to errors identified
through any means.
Section 26.719(c)(2) amends the portion of former Section 2.8(e)(5)
in Appendix A to Part 26 that required licensees to promptly notify the
NRC if a false positive error occurs on a blind performance test
sample. This section replaces the former requirement that the report
must be made ``promptly'' with one to report the false positive error
within 24 hours of the discovery. The agency has made this change as a
result of the public meetings discussed in Section I.D, during which
the stakeholders noted that the term ``promptly'' is vague. Therefore,
the final rule clarifies the former requirement by establishing a 24-
hour time limit for the notification, consistent with Goal 6 of this
rulemaking to improve clarity in the language of the rule.
The rule establishes a 24-hour time limit because false positive
test results would cause licensees and other entities to impose
sanctions on individuals who have not, in fact, abused drugs and/or
attempted to subvert the testing process. HHS may decertify a
laboratory as a result of false positive test results. The 24-hour time
limit ensures that the NRC can quickly notify HHS of the problem so
that HHS may initiate the applicable steps required under its
guidelines for such circumstances. In addition, the NRC may use the
information to inform other licensees and entities who rely on the same
HHS-certified laboratory of the problem, so that they may determine
whether to require the laboratory or a second laboratory to retest any
specimens a licensee or other entity has submitted. The agency has
established the 24-hour time limit to meet Goal 7 of the rulemaking to
protect the privacy and other rights (including due process) of
individuals who are subject to Part 26.
The NRC has added Sec. 26.719(c)(3) to the final rule to require
licensees and other entities to report any false negative errors
identified through quality assurance checks of validity screening tests
within 24 hours of the discovery if the licensee or other entity uses
these tests for validity screening at a licensee testing facility. This
reporting requirement ensures that the NRC is aware of any testing
failures, so that other Part 26 programs that rely on the tests may be
informed of the error and stop using them until the cause of the error
is identified and the problem is resolved. Continued use of unreliable
tests may permit attempts to subvert the testing process to go
undetected, with the result that individuals who have engaged in a
subversion attempt may be granted or allowed to maintain authorization.
The agency has added this requirement to meet Goal 3 of the rulemaking
to improve the effectiveness and efficiency of FFD programs.
The final rule does not require licensees and other entities to
report false positive errors identified through quality assurance
checks of validity screening tests for two reasons. First, other
provisions of the rule prohibit licensees and other entities from
taking management actions or imposing sanctions on individuals on the
basis of validity screening test results, as discussed with respect to
Sec. 26.75(h). Second, donors are protected from the adverse
consequences of false positive validity screening test results because
these specimens are forwarded to an HHS-certified laboratory for
initial and confirmatory testing, if required, before a licensee or
other entity is permitted to act, as discussed with respect to Sec.
26.137(c). Therefore, reporting of false positive errors is unnecessary
to protect the interests of either donors or the public.
The NRC has added Sec. 26.719(d) to the final rule to require
licensees and other entities to document, trend, and correct
nonreportable FFD issues that identify programmatic weaknesses under
the licensee's or other entity's corrective action program. The final
rule includes this requirement because some licensees have not
documented, trended, or corrected programmatic weaknesses, while others
have created separate systems, with the result that corrective actions
for FFD program weaknesses have not been timely or effective.
Therefore, the final rule adds these requirements for consistency with
Criterion XVI in Appendix B to 10 CFR Part 50 [Domestic licensing of
production and utilization facilities] and to meet Goal 3 of this
rulemaking to improve the effectiveness and efficiency of FFD programs.
This section also requires licensees and other entities to
document, trend, and correct any programmatic weaknesses in a manner
that protects individuals' privacy. For example, this section prohibits
licensees and other entities from documenting a single confirmed
positive, adulterated, substituted, or invalid drug test result in the
corrective action program, because such documentation, along with other
cues in the work environment, may permit any individual who has access
to the corrective action system easily to identify the donor. However,
under the final rule, the NRC expects licensees and other entities to
document, trend, analyze, and take corrective actions for an increase
in the rate of confirmed positive, adulterated, substituted, or invalid
test results in the aggregate if the licensee or other entity
determines that the increasing trend indicates programmatic weaknesses
rather than improved effectiveness of the FFD program or some other
factor. The agency has added the requirement to protect individuals'
privacy within the corrective action program to meet Goal 7 of this
rulemaking to protect the privacy and other rights (including due
process) of individuals who are subject to Part 26.
Subpart O--Inspections, Violations, and Penalties
As a result of the reorganization of the proposed rule, the
provisions contained in Subpart K of the proposed rule have been moved
to Subpart O of the final rule. The NRC received no public comment on
Subpart O, and the final
[[Page 17170]]
rule adopts the provisions in Subpart O as proposed without change.
The NRC added Subpart O to the final rule to combine into one
subpart former Sec. Sec. 26.70 [Inspections], 26.90 [Violations], and
26.91 [Criminal penalties], consistent with Goal 6 of the rulemaking to
improve clarity in the organization of the rule, by grouping related
sections into one subpart. Section 26.821 [Inspections] retains the
requirements in former Sec. 2626.70. Section 26.823 [Violations]
retains the requirements in former Sec. 2626.90. Section 26.825
[Criminal penalties] retains the requirements in former Sec. 2626.91.
The NRC has deleted Appendix A to Part 26 ``Guidelines for Drug and
Alcohol Testing Programs'' in its entirety and has incorporated its
requirements into Subparts E [Collecting Specimens for Testing], F
[Licensee Testing Facilities], and G [Laboratories Certified by the
Department of Health and Human Services].
VII. Availability of Documents
The NRC is making the documents identified below available to
interested persons through one or more of the following methods as
indicated.
Public Document Room (PDR). The NRC Public Document Room is located
at 11555 Rockville Pike, Rockville, Maryland.
Regulations.gov Web site (Web). The federal government's rulemaking
portal is located at http://www.regulations.gov/.
NRC's Public Electronic Reading Room (EPDR). The NRC's electronic
public reading room is located at http://www.nrc.gov/reading-rm.html.
The NRC staff contact. David Diec, Mail Stop O-12D3, Washington, DC
20555-0001, 301-415-2834.
----------------------------------------------------------------------------------------------------------------
Document PDR Web EPDR NRC staff
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Part 26 Derivation and Distribution X ........................ ML080570421............ X
Tables.
Comments received.................... X NRC--2002--0002......... ....................... X
Analysis of comments received (when X ........................ X...................... X
available).
Regulatory Analysis.................. X ........................ ML080580135............ X
----------------------------------------------------------------------------------------------------------------
VIII. Criminal Penalties
For the purpose of Section 223 of the Atomic Energy Act (AEA), the
Commission is amending 10 CFR Part 26 under one or more of Sections
161b, 161i, or 161o of the AEA. Willful violations of the rule are
subject to criminal enforcement.
IX. Agreement State Compatibility
Under the ``Policy Statement on Adequacy and Compatibility of
Agreement State Programs'' approved by the Commission on June 30, 1997,
and published in the Federal Register on September 3, 1997 (62 FR
46517), this rule is classified as Compatibility Category ``NRC.''
Compatibility is not required for Category ``NRC'' regulations. The NRC
program elements in this category are those that relate directly to
areas of regulation reserved to the NRC by the Atomic Energy Act of
1954, as amended (AEA), or the provisions of Title 10 of the Code of
Federal Regulations. Although an Agreement State may not adopt program
elements reserved to the NRC, it may wish to inform its licensees of
certain requirements via a mechanism that is consistent with the
particular States's administrative procedure laws but does not confer
regulatory authority on the State.
X. Plain Language
The Presidential memorandum dated June 1, 1998, entitled ``Plain
Language in Government Writing'' directed that the Government's writing
be in plain language. This memorandum was published on June 10, 1998
(63 FR 31883). In complying with this directive, editorial changes have
been made in these revisions to improve the organization and
readability of the former language of the paragraphs being revised.
XI. Voluntary Consensus Standards
The National Technology Transfer and Advancement Act of 1995, Pub.
L. 104-113, requires that Federal agencies use technical standards
developed or adopted by voluntary consensus standards bodies unless the
use of such a standard is inconsistent with applicable law or otherwise
impractical. There are no consensus standards regarding the methods for
performing drug and alcohol testing, fatigue assessments, or other
aspects of FFD programs, that would apply to the requirements imposed
by this rule, with the exception of short-term work hour limits for
licensed operators, senior operators, and the shift technical advisor.
The NRC notes the inclusion of these limits in a 1988 American Nuclear
Society standard on administrative controls and quality assurance for
the operational phase of nuclear power plants, ANSI/ANS-3.2-1998.
The NRC does not believe that this standard is sufficient, as it
does not apply to other categories of workers who would be subject to
the provisions of this rule, such as maintenance, health physics,
chemistry, fire brigade, and security force personnel. Additionally,
the standard is insufficient because it does not provide the
comprehensive fatigue management approach that this rule does, and
lacks provisions to mitigate long-term fatigue, provide a process for
self-declarations of fatigue by workers, and provide for rest breaks.
Further, the standard does not adequately mitigate short-term
fatigue, because it does not restrict deviations from the short-term
limits to only those unique instances necessary for the safety and
security of the plant. The standard only requires that exceptions be
minimized and that they be approved by the plant manager or designee.
The provisions in the standard are identical to those currently
incorporated as requirements in some nuclear power plants' technical
specifications. Section IV.D explains that enforcement of the technical
specification requirements is complicated by the fact that the language
is largely advisory, and key terms have not been defined, with the
result that the requirements have been interpreted inconsistently.
For the reasons noted above, the ANS standard cannot be used in
lieu of the provisions of this rule to meet the objective of
comprehensive fatigue management.
XII. Finding of No Significant Environmental Impact: Environmental
Assessment
The Commission has determined under the National Environmental
Policy Act of 1969, as amended, and the Commission's regulations in
Subpart A of 10 CFR Part 51, that this rule is not a major Federal
action significantly affecting the quality of the human environment
and, therefore, an environmental impact statement is not required. The
basis for this determination reads as follows:
[[Page 17171]]
The final rule amends the NRC's requirements for FFD programs which
are contained in 10 CFR Part 26 to address the following needs: (1)
Update and enhance the consistency of 10 CFR Part 26 with advances in
other relevant Federal rules and guidelines, including the HHS
Guidelines and other Federal drug and alcohol testing programs (e.g.,
those required by DOT) that impose similar requirements on the private
sector; (2) strengthen the effectiveness of FFD programs at nuclear
power plants in ensuring against worker fatigue adversely affecting
public health and safety and the common defense and security by
establishing clear and enforceable requirements for the management of
worker fatigue; (3) improve the effectiveness and efficiency of FFD
programs; (4) improve consistency between FFD requirements and access
authorization requirements established in 10 CFR 73.56, as supplemented
by orders to nuclear power plant licensees dated January 7, 2003; (5)
improve 10 CFR Part 26 by eliminating or modifying unnecessary
requirements; (6) improve clarity in the organization and language of
the rule; and (7) protect the privacy rights and other rights
(including due process) of individuals who are subject to 10 CFR Part
26.
It also grants, in part, a December 30, 1993, petition for
rulemaking (PRM-26-1) from Virginia Electric and Power Company (now
Dominion Virginia Power) which requested a relaxation in required audit
frequencies, and a petition for rulemaking (PRM-26-2), dated December
28, 1999, from Barry Quigley, by establishing clear and enforceable
requirements concerning the management of worker fatigue. In addition,
the rule continues to apply to all personnel with unescorted access to
the protected area of a nuclear power plant, consistent with the
Commission's denial (SRM-SECY-04-0229) of an exemption request by IBEW
Local 1245 dated March 13, 1990, and renewed on January 26 and December
6, 1993.
This rule does not significantly increase the probability or
consequences of an accident. No changes have been made in the types or
quantities of radiological effluents that may be released offsite, and
there is no significant increase in public or occupational radiation
exposure since there is no change to facility operations that could
create a new or affect a previously analyzed accident or release path.
With regard to non-radiological impacts, no changes have been made
to non-radiological plant effluents and there are no changes in
activities that would adversely affect the environment. Therefore,
there are no significant non-radiological impacts associated with this
action.
The primary alternative to this action is the no action
alternative. The no action alternative would result in continued
inconsistencies between FFD and access authorization requirements,
continued difficulties in implementation of the regulation due to the
current organization of the rule, continued use of less current
technologies and advances in testing and a continued lack of a
comprehensive fatigue management program. The no action alternative
would provide little or no safety, risk, or environmental benefit.
No outside agencies or persons were consulted, or outside sources
used or relied upon, in the preparation of this environmental
assessment. The NRC received no comments on this environmental
assessment.
The determination of this environmental assessment is that there
will be no significant environmental impact from this action.
XIII. Paperwork Reduction Act Statement
The final rule contains new or amended information collection
requirements that are subject to the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.). These requirements were approved by the
Office of Management and Budget, approval number 3150-0146.
The burden to the public for these information collections is
estimated to average 1.5 hours per response, including the time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
information collection. Send comments on any aspect of these
information collections, including suggestions for reducing the burden,
to the Records and FOIA/Privacy Services Branch (T-5 F52), U.S. Nuclear
Regulatory Commission, Washington DC 20555-0001, or by Internet
electronic mail to [email protected]; and to the Desk Officer,
Office of Information and Regulatory Affairs, NEOB-10202, (3150-0146),
Office of Management and Budget, Washington, DC 20503.
Public Protection Notification
The NRC may not conduct or sponsor, and a person is not required to
respond to, a request for information or an information collection
requirement unless the requesting document displays a currently valid
OMB control number.
XIV. Regulatory Analysis
The NRC has prepared a final Regulatory Analysis on this
regulation. The final regulatory analysis was prepared under the NRC's
Regulatory Analysis Guidelines (RA Guidelines), NUREG/BR-0058, Revision
4, dated September 2004. The Regulatory Analysis consists of three
parts. First, an aggregate analysis of the entire rule was performed.
Second, a screening review for disaggregation was performed to identify
any individual provisions that could impose costs disproportionate to
the benefits attributable to each provision. Finally, a separate
analysis of the rule's provisions addressing worker fatigue was
performed. A description of each of these three elements is discussed
below. Single copies may be obtained from the contact listed above
under the FOR FURTHER INFORMATION CONTACT heading.
A. Aggregate Analysis
Consistent with the RA Guidelines, an aggregate analysis of the
entire rulemaking was performed. The provisions of the rule relating to
drug and alcohol testing (and other general FFD program requirements)
are estimated to result in net present value savings to industry of
$129 million-$204 million (using 7 percent and 3 percent real discount
rates), consisting of $2 million in one-time costs and $10 million in
annual net savings. The worker fatigue portions of the final rule are
estimated to cost industry $439 million--$685 million net present value
(using the 7 percent and 3 percent real discount rates, respectively),
consisting of $12 million in one-time costs and $32 million in annual
net costs. The net present value of the entire rule, including both the
worker fatigue and drug and alcohol testing portions, is estimated to
be a cost to industry of $310 million--$481 million (using 7 percent
and 3 percent real discount rates), which consists of $14 million in
one-time costs and $22 million in annual costs. In addition, the rule
is estimated to be a cost to the NRC of $665,000--$1,025,000 net
present value (using 7 percent and 3 percent real discount rates),
consisting of $28,000 in one-time costs and $47,000 in annual net
costs.
The NRC concludes that the costs of the rule are justified in view
of the qualitative benefits evaluated in Section 4.1.2 of the
Regulatory Analysis. The basic analysis measures the incremental
impacts of the rule relative to a baseline that assumes full licensee
compliance
[[Page 17172]]
with existing NRC requirements, including current regulations and any
relevant orders or enforcement discretion. The aggregate analysis is
contained in Section 4.1 of the regulatory analysis.
B. Screening Review for Disaggregation
The regulatory analysis also discusses the screening review for
disaggregation performed by the staff. The analysis was performed
consistent with Section 4.3.2 of the RA Guidelines to determine if
there are provisions whose costs are disproportionate to the benefits
and whose inclusion in the aggregate analysis could obscure their
impact, but also responds to the Commission's direction in SRM-01-0134
dated July 23, 2001, that, ``If there is a reasonable indication that a
change imposes costs disproportionate to the safety benefit
attributable to that change, as part of the final rule package the
Commission will perform an analysis of that change in addition to the
aggregate analysis of the entire rulemaking to determine whether this
change should be aggregated with the other change for the purposes of
the backfit analysis. That analysis will need to show that the
individual change is integral to achieving the purpose of the rule, has
costs that are justified in view of the benefits that would be provided
or qualifies for one of the exceptions in 10 CFR Sec. 50.109(a)(4).''
These results are described in Sections 4.1.4.1 and 4.4.2 of the
regulatory analysis.
C. Dissaggregation of Worker Fatigue Provisions
Section 4.1.4.2 of the Regulatory Analysis summarizes the division
of costs and savings of the fatigue management portions of the rule, in
comparison with the rest of the rule. The worker fatigue portions of
the rule are estimated to cost industry $439 million--$685 million net
present value (using the 7 percent and 3 percent real discount rates,
respectively), consisting of $12 million in one-time costs and $32
million in annual net costs. The NRC considers fatigue management to be
an integral and necessary aspect of FFD. Fatigue was considered to be
part of FFD under former Sec. 26.10(a) and Sec. 26.20(a)(2). However,
the NRC included a summary of the costs associated with the fatigue
management requirements in the aggregate as a courtesy to stakeholders
in Section 4.1.4.2 of the Regulatory Analysis.
XV. Regulatory Flexibility Act Certification
As required by the Regulatory Flexibility Act, as amended, 5 U.S.C.
605(b), the Commission certifies that this rule will not have a
significant economic impact on a substantial number of small entities.
This rule affects only licensees authorized to operate nuclear power
reactors; licensees authorized to possess, use, or transport formula
quantities of SSNM; corporations who obtain certificates of compliance
or approved compliance plans under Part 76 involving formula quantities
of SSNM; combined license holders; holders of construction permits;
combined license and construction permit holders and combined license
and construction permit applicants with authorization to construct; and
C/Vs who implement FFD programs or program elements, to the extent that
licensees and other entities rely upon those C/V FFD programs or
program elements to meet the requirements of Part 26. Those above do
not fall within the scope of the definition of ``small entities'' set
forth in the Regulatory Flexibility Act, or the Size Standards
established by the Nuclear Regulatory Commission (10 CFR 2.810).
XVI. Backfit Analysis
The rule constitutes backfitting as defined in 10 CFR 50.109(a)(1).
The NRC has performed a backfit analysis, as described in Sec.
50.109(c) [which applies to power reactors], Sec. 70.76(b) [which
applies to formula quantity strategic special nuclear material
licensees], and Sec. 76.76(b) [which applies to gaseous diffusion
plants], consistent with the NRC's Regulatory Analysis Guidelines (RA
Guidelines) in NUREG/BR-0058, Revision 4, dated September 2004. The
Backfit Analysis is included in the Regulatory Analysis.
A. Consideration of Fuel Fabrication Facilities and Gaseous Diffusion
Plants
The backfit provision of 10 CFR 70.76 applies to currently licensed
fuel fabrication facilities. Although gas centrifuge facilities are
licensed under Part 70, these facilities have not been considered in
the analysis because NRC has not granted authorization to possess
formula quantities of SSNM at these facilities. These facilities have
been considered in the aggregate backfit analysis. The planned mixed-
oxide fuel fabrication facility also would be licensed under Part 70,
but has not yet submitted a Part 26 program description. Therefore, the
consideration of the costs to the mixed-oxide fuel fabrication facility
in the regulatory analysis is sufficient for consideration of the
impacts to that facility. Although the backfit provision of 10 CFR
76.76 applies to gaseous diffusion plants, there are no backfit impacts
because the gaseous diffusion plants certified by the NRC are not
currently authorized to possess formula quantities of strategic special
nuclear material.
B. Aggregate Backfit Analysis
The NRC performed an aggregate backfit analysis of all backfits
consistent with Section 4.3.2 of the RA Guidelines. Because the changes
associated with the rule are interrelated and deal with a single
subject area (FFD), the NRC followed its ordinary practice of assessing
the backfitting implications in an aggregate manner, consistent with
the RA Guidelines. The aggregate analysis is provided in Section 4.4.1
of the Part 26 Regulatory Analysis. The aggregate analysis also
includes a list of all changes that constitute backfits, in Exhibits 4-
14 and 4-15 of the analysis. Exhibit 4-16 of the analysis also includes
a list of all changes that were evaluated for potential cost
implications, but were determined to not constitute backfits, as well
as a list of the reasons those changes were determined to not
constitute backfits. In addition, the NRC prepared a supplemental
backfit analysis for the requirements in Subpart K of Part 26. A
summary of the results of the aggregate analysis follows.
The NRC determined the backfitting is justified under Sec.
50.109(a)(3) and Sec. 70.76(a)(3) because: (1) There is a substantial
increase in the overall level of protection afforded for the public
health and safety or the common defense and security to be derived from
the backfitting; and (2) the costs of implementation and the annual
costs are justified in view of this increase. The estimated cost of
implementation would be $14 million and the annual net costs would be
$42 million, resulting in a net present value cost of $582 million-$911
million (using 7 percent and 3 percent real discount rates,
respectively).
In determining that the substantial increase standard is met, the
NRC considered safety benefits qualitatively. In this qualitative
consideration, the NRC determined that the FFD rule, considered in the
aggregate, constitutes a substantial increase in protection to public
health and safety by addressing the following six key areas that have
been identified as posing recurring and, in some cases, significant
problems with respect to the effectiveness, integrity, and efficiency
of FFD programs at nuclear facilities.
1. Subversion of the detection/testing process;
[[Page 17173]]
2. Regulatory efficiency between 10 CFR Part 26 and other related
Federal rules and guidelines;
3. Ineffective/unnecessary FFD requirements;
4. Ambiguous or imprecise regulatory language in 10 CFR Part 26;
5. Technical developments; and
6. FFD program integrity and protection of individual rights.
In addition to the six areas above, the NRC noted in its analysis a
significant qualitative benefit in the management of worker fatigue for
key personnel at nuclear power plants.
C. Screening Review for Disaggregation
The NRC also performed a screening review, consistent with Section
4.3.2 of the RA Guidelines, to determine if there are provisions
constituting backfits whose costs are disproportionate to the benefits
and whose inclusion in the aggregate analysis could obscure their
impact. The NRC identified 17 backfits with reasonable indications that
the costs associated with the backfit may be disproportional to the
safety benefit attributable to the change. The NRC determined that all
of the 17 backfits were necessary to meet the objectives of the rule.
Therefore, the staff did not disaggregate any of those individual
provisions and perform a separate backfit analysis for each provision.
A detailed discussion of the screening review, including the reasons
why each of the 17 backfits were determined to be necessary to meet the
objectives of the rule is described in Section 4.4.2 of the Regulatory
Analysis.
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Developing Implementation Guidance for the Fatigue Management
Provisions,'' September 2, 2005, ML052420363.
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Copies of publicly available reference items are available for
inspection and/or copying for a fee in the NRC Public Document Room,
One White Flint North, 11555 Rockville Pike, Room O-F21, Rockville, MD
20852-2738. Copyrighted materials may be viewed at the NRC Public
Document Room, but may not be copied.
List of Subjects in 10 CFR Part 26
Alcohol abuse, Alcohol testing, Appeals, Chemical testing, Drug
abuse, Drug testing, Employee assistance programs, Fitness for duty,
Management actions, Nuclear power reactors, Protection of information,
Reporting and recordkeeping requirements.
0
For the reasons set out in the preamble and under the authority of the
Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of
1974, as amended; and 5 U.S.C. 552 and 553; the NRC is revising 10 CFR
Part 26.
0
1. 10 CFR Part 26 is revised to read as follows:
PART 26--FITNESS FOR DUTY PROGRAMS
Subpart A--Administrative Provisions
Sec.
26.1 Purpose.
26.3 Scope.
26.4 FFD program applicability to categories of individuals.
26.5 Definitions.
26.7 Interpretations.
26.8 Information collection requirements: OMB approval.
26.9 Specific exemptions.
26.11 Communications.
Subpart B--Program Elements
26.21 Fitness-for-duty program.
26.23 Performance objectives.
26.25 [Reserved]
26.27 Written policy and procedures.
26.29 Training.
26.31 Drug and alcohol testing.
26.33 Behavioral observation.
26.35 Employee assistance programs.
26.37 Protection of information.
26.39 Review process for fitness-for-duty policy violations.
26.41 Audits and corrective action.
Subpart C--Granting and Maintaining Authorization
26.51 Applicability.
26.53 General provisions.
26.55 Initial authorization.
26.57 Authorization update.
26.59 Authorization reinstatement.
26.61 Self-disclosure and employment history.
26.63 Suitable inquiry.
26.65 Pre-access drug and alcohol testing.
26.67 Random drug and alcohol testing of individuals who have
applied for authorization.
26.69 Authorization with potentially disqualifying fitness-for-duty
information.
26.71 Maintaining authorization.
Subpart D--Management Actions and Sanctions To Be Imposed
26.73 Applicability.
26.75 Sanctions.
26.77 Management actions regarding possible impairment.
Subpart E--Collecting Specimens for Testing
26.81 Purpose and applicability.
26.83 Specimens to be collected.
26.85 Collector qualifications and responsibilities.
26.87 Collection sites.
26.89 Preparing to collect specimens for testing.
26.91 Acceptable devices for conducting initial and confirmatory
tests for alcohol and methods of use.
26.93 Preparing for alcohol testing.
26.95 Conducting an initial test for alcohol using a breath
specimen.
26.97 Conducting an initial test for alcohol using a specimen of
oral fluids.
26.99 Determining the need for a confirmatory test for alcohol.
26.101 Conducting a confirmatory test for alcohol.
26.103 Determining a confirmed positive test result for alcohol.
26.105 Preparing for urine collection.
26.107 Collecting a urine specimen.
26.109 Urine specimen quantity.
26.111 Checking the acceptability of the urine specimen.
26.113 Splitting the urine specimen.
26.115 Collecting a urine specimen under direct observation.
26.117 Preparing urine specimens for storage and shipping.
26.119 Determining ``shy'' bladder.
Subpart F--Licensee Testing Facilities
26.121 Purpose.
26.123 Testing facility capabilities.
26.125 Licensee testing facility personnel.
26.127 Procedures.
26.129 Assuring specimen security, chain of custody, and
preservation.
26.131 Cutoff levels for validity screening and initial validity
tests.
26.133 Cutoff levels for drugs and drug metabolites.
26.135 Split specimens.
26.137 Quality assurance and quality control.
[[Page 17177]]
26.139 Reporting initial validity and drug test results.
Subpart G--Laboratories Certified by the Department of Health and Human
Services
26.151 Purpose.
26.153 Using certified laboratories for testing urine specimens.
26.155 Laboratory personnel.
26.157 Procedures.
26.159 Assuring specimen security, chain of custody, and
preservation.
26.161 Cutoff levels for validity testing.
26.163 Cutoff levels for drugs and drug metabolites.
26.165 Testing split specimens and retesting single specimens.
26.167 Quality assurance and quality control.
26.168 Blind performance testing.
26.169 Reporting results.
Subpart H--Determining Fitness-for-Duty Policy Violations and
Determining Fitness
26.181 Purpose.
26.183 Medical review officer.
26.185 Determining a fitness-for-duty policy violation.
26.187 Substance abuse expert.
26.189 Determination of fitness.
Subpart I--Managing Fatigue.
26.201 Applicability.
26.203 General provisions.
26.205 Work hours.
26.207 Waivers and exceptions.
26.209 Self-declarations.
26.211 Fatigue assessments.
Subpart J--[Reserved]
Subpart K--FFD Programs for Construction
26.401 General.
26.403 Written policy and procedures.
26.405 Drug and alcohol testing.
26.406 Fitness monitoring.
26.407 Behavioral observation.
26.409 Sanctions.
26.411 Protection of information.
26.413 Review process.
26.415 Audits.
26.417 Recordkeeping and reporting.
26.419 Suitability and fitness evaluations.
Subpart L--[Reserved]
Subpart M--[Reserved]
Subpart N--Recordkeeping and Reporting Requirements
26.709 Applicability.
26.711 General provisions.
26.713 Recordkeeping requirements for licensees and other entities.
Sec. 26.715 Recordkeeping requirements for collection sites, licensee
testing facilities, and laboratories certified by the Department of
Health and Human Services.
Sec. 26.717 Fitness-for-duty program performance data.
Sec. 26.719 Reporting requirements.
Subpart O--Inspections, Violations, and Penalties
Sec. 26.821 Inspections.
Sec. 26.823 Violations.
Sec. 26.825 Criminal penalties.
Authority: Secs. 53, 81, 103, 104, 107, 161, 68 Stat. 930, 935,
936, 937, 948, as amended, sec. 1701, 106 Stat. 2951, 2952, 2953 (42
U.S.C. 2073, 2111, 2112, 2133, 2134, 2137, 2201, 2297f); secs. 201,
202, 206, 88 Stat. 1242, 1244, 1246, as amended (42 U.S.C. 5841,
5842, 5846).
Subpart A--Administrative Provisions
Sec. 26.1 Purpose.
This part prescribes requirements and standards for the
establishment, implementation, and maintenance of fitness-for-duty
(FFD) programs.
Sec. 26.3 Scope.
(a) Licensees who are authorized to operate a nuclear power reactor
under 10 CFR 50.57, and holders of a combined license under 10 CFR Part
52 after the Commission has made the finding under 10 CFR 52.103(g)
shall comply with the requirements of this part, except for subpart K
of this part. Licensees who receive their authorization to operate a
nuclear power reactor under 10 CFR 50.57 after the date of publication
of this final rule in the Federal Register and holders of a combined
license under 10 CFR Part 52 after the Commission has made the finding
under 10 CFR 52.103(g) shall implement the FFD program before the
receipt of special nuclear material in the form of fuel assemblies.
(b) Licensees who are authorized to possess, use, or transport
formula quantities of strategic special nuclear material (SSNM) under
Part 70 of this chapter, and any corporation, firm, partnership,
limited liability company, association, or other organization who
obtains a certificate of compliance or an approved compliance plan
under Part 76 of this chapter, only if the entity elects to engage in
activities involving formula quantities of SSNM shall comply with the
requirements of this part, except for subparts I and K of this part.
(c) Before the receipt of special nuclear material in the form of
fuel assemblies, the following licensees and other entities shall
comply with the requirements of this part, except for subpart I of this
part; and, no later than the receipt of special nuclear material in the
form of fuel assemblies, the following licensees and other entities
shall comply with the requirements of this part:
(1) Combined license applicants (under Part 52 of this chapter) who
have been issued a limited work authorization under Sec. 50.10(e), if
the limited work authorization authorizes the applicant to install the
foundations, including the placement of concrete, for safety- and
security-related structures, systems, and components (SSCs) under the
limited work authorization;
(2) Combined license holders (under Part 52 of this chapter) before
the Commission has made the finding under Sec. 52.103(g);
(3) Construction permit applicants (under Part 50 of this chapter)
who have been issued a limited work authorization under Sec. 50.10(e),
if the limited work authorization authorizes the applicant to install
the foundations, including the placement of concrete, for safety- and
security-related SSCs under the limited work authorization;
(4) Construction permit holders (under Part 50 of this chapter);
and
(5) Early site permit holders who have been issued a limited work
authorization under Sec. 50.10(e), if the limited work authorization
authorizes the early site permit holder to install the foundations,
including the placement of concrete, for safety- and security-related
SSCs under the limited work authorization.
(d) Contractor/vendors (C/Vs) who implement FFD programs or program
elements, to the extent that the licensees and other entities specified
in paragraphs (a) through (c) of this section rely on those C/V FFD
programs or program elements to meet the requirements of this part,
shall comply with the requirements of this part.
(e) This part does not apply to either spent fuel storage facility
licensees or non-power reactor licensees who possess, use, or transport
formula quantities of irradiated SSNM.
Sec. 26.4 FFD program applicability to categories of individuals.
(a) All persons who are granted unescorted access to nuclear power
reactor protected areas by the licensees in Sec. 26.3(a) and, as
applicable, (c) and perform the following duties shall be subject to an
FFD program that meets all of the requirements of this part, except
subpart K of this part:
(1) Operating or onsite directing of the operation of systems and
components that a risk-informed evaluation process has shown to be
significant to public health and safety;
(2) Performing health physics or chemistry duties required as a
member of the onsite emergency response organization minimum shift
complement;
(3) Performing the duties of a fire brigade member who is
responsible for understanding the effects of fire and fire suppressants
on safe shutdown capability;
(4) Performing maintenance or onsite directing of the maintenance
of SSCs that a risk-informed evaluation process
[[Page 17178]]
has shown to be significant to public health and safety; and
(5) Performing security duties as an armed security force officer,
alarm station operator, response team leader, or watchperson,
hereinafter referred to as security personnel.
(b) All persons who are granted unescorted access to nuclear power
reactor protected areas by the licensees in Sec. 26.3(a) and, as
applicable, (c) and who do not perform the duties described in
paragraph (a) of this section shall be subject to an FFD program that
meets all of the requirements of this part, except Sec. Sec. 26.205
through 26.209 and subpart K of this part.
(c) All persons who are required by a licensee in Sec. 26.3(a)
and, as applicable, (c) to physically report to the licensee's
Technical Support Center or Emergency Operations Facility by licensee
emergency plans and procedures shall be subject to an FFD program that
meets all of the requirement of this part, except Sec. Sec. 26.205
through 26.209 and subpart K of this part.
(d) Any individual whose duties for the licensees and other
entities in Sec. 26.3(b) require him or her to have the following
types of access or perform the following activities shall be subject to
an FFD program that meets all of the requirements of this part, except
subparts I and K of this part:
(1) All persons who are granted unescorted access to Category IA
material;
(2) All persons who create or have access to procedures or records
for safeguarding SSNM;
(3) All persons who measure Category IA material;
(4) All persons who transport or escort Category IA material; and
(5) All persons who guard Category IA material.
(e) When construction activities begin, any individual whose duties
for the licensees and other entities in Sec. 26.3(c) require him or
her to have the following types of access or perform the following
activities at the location where the nuclear power plant will be
constructed and operated shall be subject to an FFD program that meets
all of the requirements of this part, except subparts I and K of this
part:
(1) Serves as security personnel required by the NRC, until the
licensees or other entities receive special nuclear material in the
form of fuel assemblies, at which time individuals who serve as
security personnel required by the NRC must meet the requirements
applicable to security personnel in paragraph (a)(5) of this section;
(2) Performs quality assurance, quality control, or quality
verification activities related to safety- or security-related
construction activities;
(3) Based on a designation under Sec. 26.406 by a licensee or
other entity, monitors the fitness of the individuals specified in
paragraph (f) of this section;
(4) Witnesses or determines inspections, tests, and analyses
certification required under Part 52 of this chapter;
(5) Supervises or manages the construction of safety- or security-
related SSCs; or
(6) Directs, as defined in Sec. 26.5, or implements the access
authorization program, including--
(i) Having access to the information used by the licensee or other
entity to make access authorization determinations, including
information stored in electronic format;
(ii) Making access authorization determinations;
(iii) Issuing entry-control picture badges in accordance with
access authorization determinations;
(iv) Conducting background investigations or psychological
assessments used by the licensee or other entity to make access
authorization determinations, except that he or she shall be subject to
behavioral observation only when he or she is present at the location
where the nuclear power plant will be constructed and operated, and
licensees and other entities may rely on a local hospital or other
organization that meets the requirements of 49 CFR Part 40,
``Procedures for Department of Transportation Workplace Drug and
Alcohol Testing Programs'' (65 FR 41944; August 9, 2001) to collect his
or her specimens for drug and alcohol testing;
(v) Adjudicating reviews or appeals of access authorization
determinations;
(vi) Auditing the access authorization program; or
(vii) Performing any of the activities or having any of the duties
listed in paragraph (e)(6) of this section for any C/V upon whom the
licensee's or other entity's access authorization program will rely.
(f) Any individual who is constructing or directing the
construction of safety- or security-related SSCs shall be subject to an
FFD program that meets the requirements of subpart K of this part,
unless the licensee or other entity subjects these individuals to an
FFD program that meets all of the requirements of this part, except for
subparts I and K of this part.
(g) All FFD program personnel who are involved in the day-to-day
operations of the program, as defined by the procedures of the
licensees and other entities in Sec. 26.3(a) through (c), and, as
applicable, (d), and whose duties require them to have the following
types of access or perform the following activities shall be subject to
an FFD program that meets all of the requirements of this part, except
subparts I and K of this part, and, at the licensee's or other entity's
discretion, subpart C of this part:
(1) All persons who can link test results with the individual who
was tested before an FFD policy violation determination is made,
including, but not limited to the MRO;
(2) All persons who make determinations of fitness;
(3) All persons who make authorization decisions;
(4) All persons involved in selecting or notifying individuals for
testing; and
(5) All persons involved in the collection or onsite testing of
specimens.
(h) Individuals who have applied for authorization to have the
types of access or perform the activities described in paragraphs (a)
through (d) of this section shall be subject to Sec. Sec. 26.31(c)(1),
26.35(b), 26.37, 26.39, and the applicable requirements of subparts C,
and E through H of this part.
(i) The following individuals are not subject to an FFD program
under this part:
(1) Individuals who are not employed by a licensee or other entity
in this part, who do not routinely provide FFD program services to a
licensee or other entity in this part, and whose normal workplace is
not at the licensee's or other entity's facility, but who may be called
on to provide an FFD program service, including, but not limited to,
collecting specimens for drug and alcohol testing, performing
behavioral observation, or providing input to a determination of
fitness. Such individuals may include, but are not limited to,
hospital, employee assistance program (EAP) or substance abuse
treatment facility personnel, or other medical professionals;
(2) NRC employees, law enforcement personnel, or offsite emergency
fire and medical response personnel while responding on site;
(3) SSNM transporter personnel who are subject to U.S. Department
of Transportation drug and alcohol FFD programs that require random
testing for drugs and alcohol; and
(4) The FFD program personnel of a program that is regulated by
another Federal agency or State on which a licensee or other entity
relies to meet the requirements of this part, as
[[Page 17179]]
permitted under Sec. Sec. 26.4(j), 26.31(b)(2), and 26.405(e), if the
FFD program personnel are not employed by the licensee or other entity
and their normal workplace is not at the licensee's or other entity's
facility.
(j) Individuals who are subject to this part and who are also
subject to a program regulated by another Federal agency or State need
be covered by only those elements of an FFD program that are not
included in the Federal agency or State program, as long as all of the
following conditions are met:
(1) The individuals are subject to pre-access (or pre-employment),
random, for-cause, and post-event testing for the drugs and drug
metabolites specified in Sec. 26.31(d)(1) at or below the cutoff
levels specified in Sec. 26.163(a)(1) for initial drug testing and in
Sec. 26.163(b)(1) for confirmatory drug testing;
(2) The individuals are subject to pre-access (or pre-employment),
random, for-cause, and post-event testing for alcohol at or below the
cutoff levels specified in Sec. 26.103(a) and breath specimens are
subject to confirmatory testing, if required, with an EBT that meets
the requirements specified in Sec. 26.91;
(3) Urine specimens are tested for validity and the presence of
drugs and drug metabolites at a laboratory certified by the Department
of Health and Human Services (HHS);
(4) Training is provided to address the knowledge and abilities
(KAs) listed in Sec. 26.29(a)(1) through (a)(10); and
(5) Provisions are made to ensure that the testing agency or
organization notifies the licensee or other entity granting
authorization of any FFD policy violation.
Sec. 26.5 Definitions.
Acute fatigue means fatigue from causes (e.g., restricted sleep,
sustained wakefulness, task demands) occurring within the past 24
hours.
Adulterated specimen means a urine specimen that has been altered,
as evidenced by test results showing either a substance that is not a
normal constituent of urine or showing an abnormal concentration of an
endogenous substance.
Alertness means the ability to remain awake and sustain attention.
Aliquot means a portion of a specimen that is used for testing. It
is taken as a sample representing the whole specimen.
Analytical run means the process of testing a group of urine
specimens for validity or for the presence of drugs and/or drug
metabolites. For the purposes of defining the periods within which
performance testing must be conducted by any licensee testing facility
or HHS-certified laboratory that continuously processes specimens, an
analytical run is defined as no more than an 8-hour period. For a
facility that analyzes specimens in batches, an analytical run is
defined as a group of specimens that are handled and tested together.
Authorization means that a licensee or other entity in Sec. 26.3
has determined that an individual has met the requirements of this part
to be granted or maintain the types of access or perform the duties
specified in Sec. 26.4(a) through (e), and, at the licensee's or other
entity's discretion, Sec. 26.4(f) or (g).
Best effort means documented actions that a licensee or other
entity who is subject to subpart C of this part takes to obtain
suitable inquiry and employment information in order to determine
whether an individual may be granted authorization, when the primary
source of information refuses or indicates an inability or
unwillingness to provide the information within 3 business days of the
request and the licensee or other entity relies on a secondary source
to meet the requirement.
Blood alcohol concentration (BAC) means the mass of alcohol in a
volume of blood.
Calibrator means a solution of known concentration which is used to
define expected outcomes of a measurement procedure or to compare the
response obtained with the response of a test specimen/sample. The
concentration of the analyte of interest in the calibrator is known
within limits ascertained during its preparation. Calibrators may be
used to establish a cutoff concentration and/or a calibration curve
over a range of interest.
Category IA material means SSNM that is directly usable in the
manufacture of a nuclear explosive device, except if the material meets
any of the following criteria:
(1) The dimensions are large enough (at least 2 meters in one
dimension, greater than 1 meter in each of two dimensions, or greater
than 25 centimeters in each of three dimensions) to preclude hiding the
item on an individual;
(2) The total weight of an encapsulated item of SSNM is such that
it cannot be carried inconspicuously by one person (i.e., at least 50
kilograms gross weight); or
(3) The quantity of SSNM (less than 0.05 formula kilograms) in each
container requires protracted diversions to accumulate 5 formula
kilograms.
Chain of custody means procedures to account for the integrity of
each specimen or aliquot by tracking its handling and storage from the
point of specimen collection to final disposition of the specimen and
its aliquots. ``Chain of custody'' and ``custody and control'' are
synonymous and may be used interchangeably.
Circadian variation in alertness and performance means the
increases and decreases in alertness and cognitive/motor functioning
caused by human physiological processes (e.g., body temperature,
release of hormones) that vary on an approximately 24-hour cycle.
Collection site means a designated place where individuals present
themselves for the purpose of providing a specimen of their urine, oral
fluids, and/or breath to be analyzed for the presence of drugs or
alcohol.
Collector means a person who is trained in the collection
procedures of subpart E, instructs and assists a specimen donor at a
collection site, and receives and makes an initial examination of the
specimen(s) provided by the donor.
Commission means the U.S. Nuclear Regulatory Commission (NRC) or
its duly authorized representatives.
Confirmatory drug or alcohol test means a second analytical
procedure to identify the presence of alcohol or a specific drug or
drug metabolite in a specimen. The purpose of a confirmatory test is to
ensure the reliability and accuracy of an initial test result.
Confirmatory validity test means a second test performed on a
different aliquot of the original urine specimen to further support a
validity test result.
Confirmed test result means a test result that demonstrates that an
individual has used drugs and/or alcohol in violation of the
requirements of this part or has attempted to subvert the testing
process by submitting an adulterated or substituted urine specimen. For
drugs, adulterants, and substituted specimens, a confirmed test result
is determined by the Medical Review Officer (MRO), after discussion
with the donor subsequent to the MRO's receipt of a positive
confirmatory drug test result from the HHS-certified laboratory and/or
a confirmatory substituted or adulterated validity test result from the
HHS-certified laboratory for that donor. For alcohol, a confirmed test
result is based on a positive confirmatory alcohol test result from an
evidential breath testing device (EBT) without MRO review of the test
result.
Constructing or construction activities mean, for the purposes of
this part, the tasks involved in building a nuclear power plant that
are performed at the location where the nuclear power plant will be
constructed and operated. These
[[Page 17180]]
tasks include fabricating, erecting, integrating, and testing safety-
and security-related SSCs, and the installation of their foundations,
including the placement of concrete.
Contractor/vendor (C/V) means any company, or any individual not
employed by a licensee or other entity specified in Sec. 26.3(a)
through (c), who is providing work or services to a licensee or other
entity covered in Sec. 26.3(a) through (c), either by contract,
purchase order, oral agreement, or other arrangement.
Control means a sample used to monitor the status of an analysis to
maintain its performance within predefined limits.
Cumulative fatigue means the increase in fatigue over consecutive
sleep-wake periods resulting from inadequate rest.
Cutoff level means the concentration or decision criteria
established for designating and reporting a test result as positive, of
questionable validity (referring to validity screening or initial
validity test results from a licensee testing facility), or
adulterated, substituted, dilute, or invalid (referring to initial or
confirmatory test results from an HHS-certified laboratory).
Dilute specimen means a urine specimen with creatinine and specific
gravity concentrations that are lower than expected for human urine.
Directing means the exercise of control over a work activity by an
individual who is directly involved in the execution of the work
activity, and either makes technical decisions for that activity
without subsequent technical review, or is ultimately responsible for
the correct performance of that work activity.
Donor means the individual from whom a specimen is collected.
Eight (8)-hour shift schedule means a schedule that averages not
more than 9 hours per workday over the entire shift cycle.
Employment action means a change in job responsibilities or removal
from a job, or the employer-mandated implementation of a plan for
substance abuse treatment in order to avoid a change in or removal from
a job, because of the individual's use of drugs or alcohol.
Fatigue means the degradation in an individual's cognitive and
motor functioning resulting from inadequate rest.
Formula quantity means SSNM in any combination in a quantity of
5000 grams or more computed by the formula, grams=(grams contained U-
235)+2.5 (grams U-233+grams plutonium). This class of material is
sometimes referred to as a Category I quantity of material.
HHS-certified laboratory means a laboratory that is certified to
perform urine drug testing under the Department of Health and Human
Services Mandatory Guidelines for Federal Workplace Drug Testing
Programs (the HHS Guidelines), which were published in the Federal
Register on April 11, 1988 (53 FR 11970), and as amended, June 9, 1994
(59 FR 29908), November 13, 1998 (63 FR 63483), and April 13, 2004 (69
FR 19643).
Illegal drug means, for the purposes of this regulation, any drug
that is included in Schedules I to V of section 202 of the Controlled
Substances Act [21 U.S.C. 812], but not when used pursuant to a valid
prescription or when used as otherwise authorized by law.
Increased threat condition means an increase in the protective
measure level, relative to the lowest protective measure level
applicable to the site during the previous 60 days, as promulgated by
an NRC Advisory.
Initial drug test means a test to differentiate ``negative''
specimens from those that require confirmatory drug testing.
Initial validity test means a first test used to determine whether
a specimen is adulterated, dilute, substituted, or invalid, and may
require confirmatory validity testing.
Invalid result means the result reported by an HHS-certified
laboratory for a specimen that contains an unidentified adulterant,
contains an unidentified interfering substance, has an abnormal
physical characteristic, contains inconsistent physiological
constituents, or has an endogenous substance at an abnormal
concentration that prevents the laboratory from completing testing or
obtaining a valid drug test result.
Legal action means a formal action taken by a law enforcement
authority or court of law, including an arrest, an indictment, the
filing of charges, a conviction, or the mandated implementation of a
plan for substance abuse treatment in order to avoid a permanent record
of an arrest or conviction, in response to any of the following
activities:
(1) The use, sale, or possession of illegal drugs;
(2) The abuse of legal drugs or alcohol; or
(3) The refusal to take a drug or alcohol test.
Licensee testing facility means a drug and specimen validity
testing facility that is operated by a licensee or other entity who is
subject to this part to perform tests of urine specimens.
Limit of detection (LOD) means the lowest concentration of an
analyte that an analytical procedure can reliably detect, which could
be significantly lower than the established cutoff levels.
Limit of quantitation (LOQ) means the lowest concentration of an
analyte at which the concentration of the analyte can be accurately
determined under defined conditions.
Maintenance means, for the purposes of Sec. 26.4(a)(4), the
following onsite maintenance activities: Modification, surveillance,
post-maintenance testing, and corrective and preventive maintenance.
Medical Review Officer (MRO) means a licensed physician who is
responsible for receiving laboratory results generated by a Part 26
drug testing program and who has the appropriate medical training to
properly interpret and evaluate an individual's drug and validity test
results together with his or her medical history and any other relevant
biomedical information.
Nominal means the limited flexibility that is permitted in meeting
a scheduled due date for completing a recurrent activity that is
required under this part, such as the nominal 12-month frequency
required for FFD refresher training in Sec. 26.29(c)(2) and the
nominal 12-month frequency required for certain audits in Sec.
26.41(c)(1). Completing a recurrent activity at a nominal frequency
means that the activity may be completed within a period that is 25
percent longer or shorter than the period required in this part. The
next scheduled due date would be no later than the current scheduled
due date plus the required frequency for completing the activity.
Other entity means any corporation, firm, partnership, limited
liability company, association, C/V, or other organization who is
subject to this part under Sec. 26.3(a) through (c), but is not
licensed by the NRC.
Oxidizing adulterant means a substance that acts alone or in
combination with other substances to oxidize drugs or drug metabolites
to prevent the detection of the drugs or drug metabolites, or a
substance that affects the reagents in either the initial or
confirmatory drug test. Examples of these agents include, but are not
limited to, nitrites, pyridinium chlorochromate, chromium (VI), bleach,
iodine/iodide, halogens, peroxidase, and peroxide.
Positive result means, for drug testing, the result reported by a
licensee testing facility or HHS-certified laboratory when a specimen
contains a drug or drug metabolite equal to or greater than the cutoff
concentration. A result reported by an HHS-certified laboratory
[[Page 17181]]
that a specimen contains a drug or drug metabolite below the cutoff
concentration is also a positive result when the laboratory has
conducted the special analysis permitted in Sec. 26.163(a)(2). For
alcohol testing, a positive result means the result reported by a
collection site when the BAC indicated by testing a specimen exceeds
the cutoff concentrations established in this part.
Potentially disqualifying FFD information means information
demonstrating that an individual has--
(1) Violated a licensee's or other entity's FFD policy;
(2) Had authorization denied or terminated unfavorably under
Sec. Sec. 26.35(c)(2), 26.53(i), 26.63(d), 26.65(g), 26.67(c),
26.69(f), or 26.75(b) through (e);
(3) Used, sold, or possessed illegal drugs;
(4) Abused legal drugs or alcohol;
(5) Subverted or attempted to subvert a drug or alcohol testing
program;
(6) Refused to take a drug or alcohol test;
(7) Been subjected to a plan for substance abuse treatment (except
for self-referral); or
(8) Had legal action or employment action, as defined in this
section, taken for alcohol or drug use.
Protected area has the same meaning as in Sec. 73.2(g) of this
chapter: An area encompassed by physical barriers and to which access
is controlled.
Quality control sample means a sample used to evaluate whether an
analytical procedure is operating within predefined tolerance limits.
Calibrators, controls, negative samples, and blind samples are
collectively referred to as ``quality control samples'' and each is
individually referred to as a ``sample.''
Questionable validity means the results of validity screening or
initial validity tests at a licensee testing facility indicating that a
urine specimen may be adulterated, substituted, dilute, or invalid.
Reviewing official means an employee of a licensee or other entity
specified in Sec. 26.3(a) through (c), who is designated by the
licensee or other entity to be responsible for reviewing and evaluating
any potentially disqualifying FFD information about an individual,
including, but not limited to, the results of a determination of
fitness, as defined in Sec. 26.189, in order to determine whether the
individual may be granted or maintain authorization.
Safety-related structures, systems, and components (SSCs) mean, for
the purposes of this part, those structures, systems, and components
that are relied on to remain functional during and following design
basis events to ensure the integrity of the reactor coolant pressure
boundary, the capability to shut down the reactor and maintain it in a
safe shutdown condition, or the capability to prevent or mitigate the
consequences of accidents that could result in potential offsite
exposure comparable to the guidelines in 10 CFR 50.34(a)(1).
Security-related SSCs mean, for the purposes of this part, those
structures, systems, and components that the licensee will rely on to
implement the licensee's physical security and safeguards contingency
plans that either are required under Part 73 of this chapter if the
licensee is a construction permit applicant or holder or an early site
permit holder, as described in Sec. 26.3(c)(3) through (c)(5),
respectively, or are included in the licensee's application if the
licensee is a combined license applicant or holder, as described in
Sec. 26.3(c)(1) and (c)(2), respectively.
Shift cycle means a series of consecutive work shifts and days off
that is planned by the licensee or other entity to repeat regularly,
thereby constituting a continuous shift schedule.
Standard means a reference material of known purity or a solution
containing a reference material at a known concentration.
Strategic special nuclear material (SSNM) means uranium-235
(contained in uranium enriched to 20 percent or more in the uranium-235
isotope), uranium-233, or plutonium.
Substance abuse means the use, sale, or possession of illegal
drugs, or the abuse of prescription and over-the-counter drugs, or the
abuse of alcohol.
Substituted specimen means a specimen with creatinine and specific
gravity values that are so diminished or so divergent that they are not
consistent with normal human physiology.
Subversion and subvert the testing process mean a willful act to
avoid being tested or to bring about an inaccurate drug or alcohol test
result for oneself or others at any stage of the testing process
(including selection and notification of individuals for testing,
specimen collection, specimen analysis, and test result reporting), and
adulterating, substituting, or otherwise causing a specimen to provide
an inaccurate test result.
Supervises or manages means the exercise of control over a work
activity by an individual who is not directly involved in the execution
of the work activity, but who either makes technical decisions for that
activity without subsequent technical review, or is ultimately
responsible for the correct performance of that work activity.
Ten (10)-hour shift schedule means a schedule that averages more
than 9 hours, but not more than 11 hours, per workday over the entire
shift cycle.
Transporter means a general licensee, under 10 CFR 70.20(a), who is
authorized to possess formula quantities of SSNM, in the regular course
of carriage for another or storage incident thereto, and includes the
driver or operator of any conveyance, and the accompanying guards or
escorts.
Twelve (12)-hour shift schedule means a schedule that averages more
than 11 hours, but not more than 12 hours, per workday over the entire
shift cycle.
Unit outage means, for the purposes of this part, that the reactor
unit is disconnected from the electrical grid.
Validity screening test means a test to determine the need for
initial validity testing of a urine specimen, using a non-instrumented
test in which the endpoint result is obtained by visual evaluation
(read by the human eye), or a test that is instrumented to the extent
that results are machine-read.
Validity screening test lot means a group of validity screening
tests that were made from the same starting material.
Sec. 26.7 Interpretations.
Except as specifically authorized by the Commission in writing, no
interpretation of the meaning of the regulations in this part by any
officer or employee of the Commission other than a written
interpretation by the General Counsel will be recognized to be binding
on the Commission.
Sec. 26.8 Information collection requirements: OMB approval.
(a) The NRC has submitted the information collection requirements
contained in this part for approval by the Office of Management and
Budget (OMB), as required by the Paperwork Reduction Act (44 U.S.C.
3501 et seq.). The NRC may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number. OMB has approved the information
collection requirements contained in this part under control number
3150-0146.
(b) The approved information collection requirements contained in
this part appear in Sec. Sec. 26.9, 26.27, 26.29, 26.31, 26.33, 26.35,
26.37, 26.39, 26.41, 26.53, 26.55, 26.57, 26.59, 26.61, 26.63, 26.65,
26.67, 26.69, 26.75, 26.77, 26.85, 26.87, 26.89, 26.91, 26.93, 26.95,
26.97, 26.99, 26.101, 26.103, 26.107, 26.109,
[[Page 17182]]
26.111, 26.113, 26.115, 26.117, 26.119, 26.125, 26.127, 26.129, 26.135,
26.137, 26.139, 26.153, 26.155, 26.157, 26.159, 26.163, 26.165, 26.167,
26.168, 26.169, 26.183, 26.185, 26.187, 26.189, 26.203, 26.205, 26.207,
26.211, 26.401, 26.403, 26.405, 26.406, 26.407, 26.411, 26.413, 26.415,
26.417, 26.711, 26.713, 26.715, 26.717, 26.719, and 26.821.
Sec. 26.9 Specific exemptions.
Upon application of any interested person or on its own initiative,
the Commission may grant such exemptions from the requirements of the
regulations in this part as it determines are authorized by law and
will not endanger life or property or the common defense and security,
and are otherwise in the public interest.
Sec. 26.11 Communications.
Except where otherwise specified in this part, all communications,
applications, and reports concerning the regulations in this part must
be sent either by mail addressed to ATTN: NRC Document Control Desk,
U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; by hand
delivery to the NRC's offices at 11555 Rockville Pike, Rockville,
Maryland, between the hours of 8:15 a.m. and 4 p.m. eastern time; or,
where practicable, by electronic submission, for example, via
Electronic Information Exchange, e-mail, or CD-ROM. Electronic
submissions must be made in a manner that enables the NRC to receive,
read, authenticate, distribute, and archive the submission, and process
and retrieve it a single page at a time. Detailed guidance on making
electronic submissions can be obtained by visiting the NRC's Web site
at http://www.nrc.gov/site-help/eie.html, by calling (301) 415-6030, by
e-mail to [email protected], or by writing to the Office of Information
Services, U.S. Nuclear Regulatory Commission, Washington, DC 20555-
0001. The guidance discusses, among other topics, the formats the NRC
can accept, the use of electronic signatures, and the treatment of
nonpublic information. Copies of all communications must be sent to the
appropriate regional office and resident inspector (addresses for the
NRC Regional Offices are listed in Appendix D to Part 20 of this
chapter).
Subpart B--Program Elements
Sec. 26.21 Fitness-for-duty program.
The licensees and other entities specified in Sec. 26.3(a) through
(c) shall establish, implement, and maintain FFD programs that, at a
minimum, comprise the program elements contained in this subpart. The
individuals specified in Sec. 26.4(a) through (e) and (g), and, at the
licensee's or other entity's discretion, Sec. 26.4(f), and, if
necessary, Sec. 26.4(j) shall be subject to these FFD programs.
Licensees and other entities may rely on the FFD program or program
elements of a C/V, as defined in Sec. 26.5, if the C/V's FFD program
or program elements meet the applicable requirements of this part.
Sec. 26.23 Performance objectives.
Fitness-for-duty programs must--
(a) Provide reasonable assurance that individuals are trustworthy
and reliable as demonstrated by the avoidance of substance abuse;
(b) Provide reasonable assurance that individuals are not under the
influence of any substance, legal or illegal, or mentally or physically
impaired from any cause, which in any way adversely affects their
ability to safely and competently perform their duties;
(c) Provide reasonable measures for the early detection of
individuals who are not fit to perform the duties that require them to
be subject to the FFD program;
(d) Provide reasonable assurance that the workplaces subject to
this part are free from the presence and effects of illegal drugs and
alcohol; and
(e) Provide reasonable assurance that the effects of fatigue and
degraded alertness on individuals' abilities to safely and competently
perform their duties are managed commensurate with maintaining public
health and safety.
Sec. 26.25 [Reserved]
Sec. 26.27 Written policy and procedures.
(a) General. Each licensee and other entity shall establish,
implement, and maintain written policies and procedures to meet the
general performance objectives and applicable requirements of this
part.
(b) Policy. The FFD policy statement must be clear, concise, and
readily available, in its most current form, to all individuals who are
subject to the policy. Methods of making the statement readily
available include, but are not limited to, posting the policy in
multiple work areas, providing individuals with brochures, or allowing
individuals to print the policy from a computer. The policy statement
must be written in sufficient detail to provide affected individuals
with information on what is expected of them and what consequences may
result from a lack of adherence to the policy. At a minimum, the
written policy statement must--
(1) Describe the consequences of the following actions:
(i) The use, sale, or possession of illegal drugs on or off site;
(ii) The abuse of legal drugs and alcohol; and
(iii) The misuse of prescription and over-the-counter drugs;
(2) Describe the requirement that individuals who are notified that
they have been selected for random testing must report to the
collection site within the time period specified by the licensee or
other entity;
(3) Describe the actions that constitute a refusal to provide a
specimen for testing, the consequences of a refusal to test, as well as
the consequences of subverting or attempting to subvert the testing
process;
(4) Prohibit the consumption of alcohol, at a minimum--
(i) Within an abstinence period of 5 hours preceding the
individual's arrival at the licensee's or other entity's facility,
except as permitted in Sec. 26.27(c)(3); and
(ii) During the period of any tour of duty;
(5) Convey that abstinence from alcohol for the 5 hours preceding
any scheduled tour of duty is considered to be a minimum that is
necessary, but may not be sufficient, to ensure that the individual is
fit for duty;
(6) Address other factors that could affect FFD, such as mental
stress, fatigue, or illness, and the use of prescription and over-the-
counter medications that could cause impairment;
(7) Provide a description of any program that is available to
individuals who are seeking assistance in dealing with drug, alcohol,
fatigue, or other problems that could adversely affect an individual's
ability to safely and competently perform the duties that require an
individual to be subject to this subpart;
(8) Describe the consequences of violating the policy;
(9) Describe the individual's responsibility to report legal
actions, as defined in Sec. 26.5;
(10) Describe the responsibilities of managers, supervisors, and
escorts to report FFD concerns; and
(11) Describe the individual's responsibility to report FFD
concerns.
(c) Procedures. Each licensee and other entity shall prepare,
implement, and maintain written procedures that describe the methods to
be used in implementing the FFD policy and the requirements of this
part. The procedures must--
(1) Describe the methods and techniques to be used in testing for
drugs and alcohol, including procedures for protecting the privacy and
other rights (including due process) of an individual who provides a
specimen, procedures for protecting the integrity of
[[Page 17183]]
the specimen, and procedures used to ensure that the test results are
valid and attributable to the correct individual;
(2) Describe immediate and followup actions that will be taken, and
the procedures to be used, in those cases in which individuals are
determined to have--
(i) Been involved in the use, sale, or possession of illegal drugs;
(ii) Consumed alcohol to excess before the mandatory pre-work
abstinence period, or consumed any alcohol during the mandatory pre-
work abstinence period or while on duty, as determined by a test that
measures BAC;
(iii) Attempted to subvert the testing process by adulterating or
diluting specimens (in vivo or in vitro), substituting specimens, or by
any other means;
(iv) Refused to provide a specimen for analysis; or
(v) Had legal action taken relating to drug or alcohol use, as
defined in Sec. 26.5;
(3) Describe the process that the licensee or other entity will use
to ensure that individuals who are called in to perform an unscheduled
working tour are fit for duty. At a minimum--
(i) The procedure must require the individual who is called in to
state whether the individual considers himself or herself fit for duty
and whether he or she has consumed alcohol within the pre-duty
abstinence period stated in the policy;
(ii) If the individual has consumed alcohol within this period and
the individual is called in for an unscheduled working tour, including
an unscheduled working tour to respond to an emergency, the procedure
must--
(A) Require a determination of fitness by breath alcohol analysis
or other means;
(B) Permit the licensee or other entity to assign the individual to
duties that require him or her to be subject to this subpart, if the
results of the determination of fitness indicate that the individual is
fit to safely and competently perform his or her duties;
(C) Prohibit the licensee or other entity from assigning the
individual to duties that require him or her to be subject to this
subpart, if the individual is not required to respond to an emergency
and the results of the determination of fitness indicate that the
individual may be impaired;
(D) State that consumption of alcohol during the 5-hour abstinence
period required in paragraph (b)(4)(i) of this section may not by
itself preclude a licensee or other entity from using individuals who
are needed to respond to an emergency. However, if the determination of
fitness indicates that an individual who has been called in for an
unscheduled working tour to respond to an emergency may be impaired,
the procedure must require the establishment of controls and conditions
under which the individual who has been called in can perform work, if
necessary; and
(E) State that no sanctions may be imposed on an individual who is
called in to perform any unscheduled working tour for having consumed
alcohol within the pre-duty abstinence period stated in the policy.
(iii) If the individual reports that he or she considers himself or
herself to be unfit for duty for other reasons, including illness,
fatigue, or other potentially impairing conditions, and the individual
is called in, the procedure must require the establishment of controls
and conditions under which the individual can perform work, if
necessary;
(4) Describe the process to be followed if an individual's behavior
raises a concern regarding the possible use, sale, or possession of
illegal drugs on or off site; the possible possession or consumption of
alcohol on site; or impairment from any cause which in any way could
adversely affect the individual's ability to safely and competently
perform his or her duties. The procedure must require that individuals
who have an FFD concern about another individual's behavior shall
contact the personnel designated in the procedures to report the
concern.
(d) Review. The NRC may, at any time, review the written policy and
procedures to assure that they meet the performance objectives and
requirements of this part.
Sec. 26.29 Training.
(a) Training content. Licensees and other entities shall ensure
that the individuals who are subject to this subpart have the following
KAs:
(1) Knowledge of the policy and procedures that apply to the
individual, the methods that will be used to implement them, and the
consequences of violating the policy and procedures;
(2) Knowledge of the individual's role and responsibilities under
the FFD program;
(3) Knowledge of the roles and responsibilities of others, such as
the MRO and the human resources, FFD, and EAP staffs;
(4) Knowledge of the EAP services available to the individual;
(5) Knowledge of the personal and public health and safety hazards
associated with abuse of illegal and legal drugs and alcohol;
(6) Knowledge of the potential adverse effects on job performance
of prescription and over-the-counter drugs, alcohol, dietary factors,
illness, mental stress, and fatigue;
(7) Knowledge of the prescription and over-the-counter drugs and
dietary factors that have the potential to affect drug and alcohol test
results;
(8) Ability to recognize illegal drugs and indications of the
illegal use, sale, or possession of drugs;
(9) Ability to observe and detect performance degradation,
indications of impairment, or behavioral changes; and
(10) Knowledge of the individual's responsibility to report an FFD
concern and the ability to initiate appropriate actions, including
referrals to the EAP and person(s) designated by the licensee or other
entity to receive FFD concerns.
(b) Comprehensive examination. Individuals who are subject to this
subpart shall demonstrate the successful completion of training by
passing a comprehensive examination that addresses the KAs in paragraph
(a) of this section. The examination must include a comprehensive
random sampling of all KAs with questions that test each KA, including
at least one question for each KA. The minimum passing score required
must be 80 percent. Remedial training and testing are required for
individuals who fail to answer correctly at least 80 percent of the
test questions. The examination may be administered using a variety of
media, including, but not limited to, hard-copy test booklets with
separate answer sheets or computer-based questions.
(c) Training administration. Licensees and other entities shall
ensure that individuals who are subject to this subpart are trained, as
follows:
(1) Training must be completed before the licensee or other entity
grants initial authorization, as defined in Sec. 26.55, and must be
current before the licensee or other entity grants an authorization
update, as defined in Sec. 26.57, or authorization reinstatement, as
defined in Sec. 26.59;
(2) Individuals shall complete refresher training on a nominal 12-
month frequency, or more frequently where the need is indicated.
Indications of the need for more frequent training include, but are not
limited to, an individual's failure to properly implement FFD program
procedures and the frequency, nature, or severity of problems
discovered through audits or the administration of the program.
Individuals who pass a comprehensive annual examination that meets the
requirements in paragraph (b) of this
[[Page 17184]]
section may forgo the refresher training; and
(3) Initial and refresher training may be delivered using a variety
of media (including, but not limited to, classroom lectures, required
reading, video, or computer-based training systems). The licensee or
other entity shall monitor the completion of training and provide a
qualified instructor or designated subject matter expert to answer
questions during the course of training.
(d) Acceptance of training. Licensees and other entities may accept
training of individuals who have been subject to another training
program that meets the requirements of this section and who have,
within the past 12 months, either had initial or refresher training, or
have successfully passed a comprehensive examination that meets the
requirements in paragraph (b) of this section.
Sec. 26.31 Drug and alcohol testing.
(a) General. To provide a means to deter and detect substance
abuse, licensees and other entities who are subject to this part shall
implement drug and alcohol testing programs for individuals who are
subject to this subpart.
(b) Assuring the honesty and integrity of FFD program personnel.
(1) Licensees and other entities who are subject to this subpart shall
carefully select and monitor FFD program personnel, as defined in Sec.
26.4(g), based on the highest standards of honesty and integrity, and
shall implement measures to ensure that these standards are maintained.
The measures must ensure that the honesty and integrity of these
individuals are not compromised and that FFD program personnel are not
subject to influence attempts attributable to personal relationships
with any individuals who are subject to testing, an undetected or
untreated substance abuse problem, or other factors. At a minimum,
these measures must include the following considerations:
(i) Licensees and other entities shall complete appropriate
background investigations, credit and criminal history checks, and
psychological assessments of FFD program personnel before assignment to
tasks directly associated with administration of the FFD program. The
background investigations, credit and criminal history checks, and
psychological assessments that are conducted to grant unescorted access
authorization to individuals under a nuclear power plant licensee's
access authorization program are acceptable to meet the requirements of
this paragraph. The credit and criminal history checks and
psychological assessments must be updated nominally every 5 years;
(ii) Individuals who have personal relationships with a donor may
not perform any assessment or evaluation procedures, including, but not
limited to, determinations of fitness. These personal relationships may
include, but are not limited to, supervisors, coworkers within the same
work group, and relatives of the donor;
(iii) Except if a directly observed collection is required, a
collector who has a personal relationship with the donor may collect
specimens from the donor only if the integrity of specimen collections
in these instances is assured through the following means:
(A) The collection must be monitored by an individual who does not
have a personal relationship with the donor and who is designated by
the licensee or other entity for this purpose, including, but not
limited to, security force or quality assurance personnel; and
(B) Individuals who are designated to monitor collections in these
instances shall be trained to monitor specimen collections and the
preparation of specimens for transfer or shipping under the
requirements of this part;
(iv) If a specimen must be collected under direct observation, the
collector or an individual who serves as the observer, as permitted
under Sec. 26.115(e), may not have a personal relationship with the
donor; and
(v) FFD program personnel shall be subject to a behavioral
observation program designed to assure that they continue to meet the
highest standards of honesty and integrity. When an MRO and MRO staff
are on site at a licensee's or other entity's facility, the MRO and MRO
staff shall be subject to behavioral observation.
(2) Licensees and other entities may rely on a local hospital or
other organization that meets the requirements of 49 CFR Part 40,
``Procedures for Department of Transportation Workplace Drug and
Alcohol Testing Programs'' (65 FR 41944; August 9, 2001) to collect
specimens for drug and alcohol testing from the FFD program personnel
listed in Sec. 26.4(g).
(c) Conditions for testing. Licensees and other entities shall
administer drug and alcohol tests to the individuals who are subject to
this subpart under the following conditions:
(1) Pre-access. In order to grant initial, updated, or reinstated
authorization to an individual, as specified in subpart C of this part;
(2) For cause. In response to an individual's observed behavior or
physical condition indicating possible substance abuse or after
receiving credible information that an individual is engaging in
substance abuse, as defined in Sec. 26.5;
(3) Post-event. As soon as practical after an event involving a
human error that was committed by an individual who is subject to this
subpart, where the human error may have caused or contributed to the
event. The licensee or other entity shall test the individual(s) who
committed the error(s), and need not test individuals who were affected
by the event whose actions likely did not cause or contribute to the
event. The individual(s) who committed the human error(s) shall be
tested if the event resulted in--
(i) A significant illness or personal injury to the individual to
be tested or another individual, which within 4 hours after the event
is recordable under the Department of Labor standards contained in 29
CFR 1904.7, ``General Recording Criteria,'' and subsequent amendments
thereto, and results in death, days away from work, restricted work,
transfer to another job, medical treatment beyond first aid, loss of
consciousness, or other significant illness or injury as diagnosed by a
physician or other licensed health care professional, even if it does
not result in death, days away from work, restricted work or job
transfer, medical treatment beyond first aid, or loss of consciousness;
(ii) A radiation exposure or release of radioactivity in excess of
regulatory limits; or
(iii) Actual or potential substantial degradations of the level of
safety of the plant;
(4) Followup. As part of a followup plan to verify an individual's
continued abstinence from substance abuse; and
(5) Random. On a statistically random and unannounced basis, so
that all individuals in the population subject to testing have an equal
probability of being selected and tested.
(d) General requirements for drug and alcohol testing. (1)
Substances tested. At a minimum, licensees and other entities shall
test for marijuana metabolite, cocaine metabolite, opiates (codeine,
morphine, 6-acetylmorphine), amphetamines (amphetamine,
methamphetamine), phencyclidine, adulterants, and alcohol.
(i) In addition, licensees and other entities may consult with
local law enforcement authorities, hospitals, and drug counseling
services to determine whether other drugs with abuse potential are
being used in the
[[Page 17185]]
geographical locale of the facility and by the local workforce that may
not be detected in the panel of drugs and drug metabolites specified in
paragraph (d)(1) of this section.
(A) When appropriate, the licensee or other entity may add other
drugs identified under paragraph (d)(1)(i) of this section to the panel
of substances for testing, but only if the additional drugs are listed
in Schedules I through V of section 202 of the Controlled Substances
Act [21 U.S.C. 812].
(B) The licensee or other entity shall establish appropriate cutoff
limits for these substances.
(C) The licensee or other entity shall establish rigorous testing
procedures for these substances that are consistent with the intent of
this part, so that the MRO can evaluate the use of these substances.
(D) The licensee or other entity may not conduct an analysis for
any drug or drug metabolites except those identified in paragraph
(d)(1) of this section unless the assay and cutoff levels to be used
are certified in writing as scientifically sound and legally defensible
by an independent, qualified forensic toxicologist who has no
relationships with manufacturers of the assays or instruments to be
used or the HHS-certified laboratory that will conduct the testing for
the licensee or other entity, which could be construed as a potential
conflict of interest. The forensic toxicologist may not be an employee
of the licensee or entity, and shall either be a Diplomate of the
American Board of Forensic Toxicology or currently holds, has held, or
is eligible to hold, the position of Responsible Person at an HHS-
certified laboratory, as specified in Sec. 26.155(a). All new assays
and cutoff levels must be properly validated consistent with
established forensic toxicological standards before implementation.
Certification of the assay and cutoff levels is not required if the HHS
Guidelines are revised to authorize use of the assay in testing for the
additional drug or drug metabolites and the licensee or other entity
uses the cutoff levels established in the HHS Guidelines for the drug
or drug metabolites, or if the licensee or other entity received
written approval of the NRC to test for the additional drug or drug
metabolites before April 30, 2008.
(ii) When conducting post-event, followup, and for-cause testing,
as defined in Sec. 26.31(c), licensees and other entities may test for
any drugs listed on Schedules I through V of section 202 of the
Controlled Substances Act [21 U.S.C. 812] that an individual is
suspected of having abused, and may consider any drugs or metabolites
so detected when determining appropriate action under subpart D of this
part. If the drug or metabolites for which testing will be performed
under this paragraph are not included in the FFD program's drug panel,
the assay and cutoff levels to be used in testing for the additional
drugs must be certified by a forensic toxicologist under paragraph
(d)(1)(i)(D) of this section. Test results that fall below the
established cutoff levels may not be considered when determining
appropriate action under subpart D of this part, except if the specimen
is dilute and the licensee or other entity has requested the HHS-
certified laboratory to evaluate the specimen under Sec. Sec.
26.163(a)(2) or 26.185(g)(3).
(iii) The licensee or other entity shall document the additional
drug(s) for which testing will be performed in written policies and
procedures in which the substances for which testing will be performed
are described.
(2) Random testing. Random testing must--
(i) Be administered in a manner that provides reasonable assurance
that individuals are unable to predict the time periods during which
specimens will be collected. At a minimum, the FFD program shall--
(A) Take reasonable steps to either conceal from the workforce that
collections will be performed during a scheduled collection period or
create the appearance that specimens are being collected during a
portion of each day on at least 4 days in each calendar week at each
site. In the latter instance, the portions of each day and the days of
the week must vary in a manner that cannot be predicted by donors; and
(B) Collect specimens on an unpredictable schedule, including
weekends, backshifts, and holidays, and at various times during a
shift;
(ii) At a minimum, be administered by the FFD program on a nominal
weekly frequency;
(iii) Require individuals who are selected for random testing to
report to the collection site as soon as reasonably practicable after
notification, within the time period specified in the FFD program
policy;
(iv) Ensure that all individuals in the population subject to
testing have an equal probability of being selected and tested;
(v) Require that individuals who are off site when selected for
testing, or who are on site and are not reasonably available for
testing when selected, shall be tested at the earliest reasonable and
practical opportunity when both the donor and collectors are available
to collect specimens for testing and without prior notification to the
individual that he or she has been selected for testing;
(vi) Provide that an individual completing a test is immediately
eligible for another unannounced test; and
(vii) Ensure that the sampling process used to select individuals
for random testing provides that the number of random tests performed
annually is equal to at least 50 percent of the population that is
subject to the FFD program.
(3) Drug testing. (i) Testing of urine specimens for drugs and
validity, except validity screening and initial drug and validity tests
performed by licensee testing facilities under paragraph (d)(3)(ii) of
this section, must be performed in a laboratory that is certified by
HHS for that purpose, consistent with its standards and procedures for
certification. Specimens sent to HHS-certified laboratories must be
subject to initial validity and initial drug testing by the laboratory.
Specimens that yield positive initial drug test results or are
determined by initial validity testing to be of questionable validity
must be subject to confirmatory testing by the laboratory, except for
invalid specimens that cannot be tested. Licensees and other entities
shall ensure that laboratories report results for all specimens sent
for testing, including blind performance test samples.
(ii) Licensees and other entities may conduct validity screening,
initial validity, and initial drug tests of urine aliquots to determine
which specimens are valid and negative and need no further testing,
provided that the licensee's or other entity's staff possesses the
necessary training and skills for the tasks assigned, the staff's
qualifications are documented, and adequate quality controls for the
testing are implemented.
(iii) At a minimum, licensees and other entities shall apply the
cutoff levels specified in Sec. 26.163(a)(1) for initial drug testing
at either the licensee testing facility or HHS-certified laboratory,
and in Sec. 26.163(b)(1) for confirmatory drug testing at the HHS-
certified laboratory. At their discretion, licensees and other entities
may implement programs with lower cutoff levels in testing for drugs
and drug metabolites.
(A) If a licensee or other entity implements lower cutoff levels,
and the MRO determines that an individual has violated the FFD policy
using the licensee's or other entity's more stringent cutoff levels,
the individual shall be subject to all management actions and sanctions
required by the licensee's or other entity's FFD policy
[[Page 17186]]
and this part, as if the individual had a confirmed positive drug test
result using the cutoff levels specified in this subpart. The licensee
or other entity shall document the more stringent cutoff levels in any
written policies and procedures in which cutoff levels for drug testing
are described.
(B) The licensee or other entity shall uniformly apply the cutoff
levels listed in Sec. 26.163(a)(1) for initial drug testing and in
Sec. 26.163(b)(1) for confirmatory drug testing, or any more stringent
cutoff levels implemented by the FFD program, to all tests performed
under this part and equally to all individuals who are tested under
this part, except as permitted in Sec. Sec. 26.31(d)(1)(ii),
26.163(a)(2), and 26.165(c)(2).
(C) In addition, the scientific and technical suitability of any
more stringent cutoff levels must be evaluated and certified, in
writing, by a forensic toxicologist who meets the requirements set
forth in Sec. 26.31(d)(1)(i)(D). Certification of the more stringent
cutoff levels is not required if the HHS Guidelines are revised to
lower the cutoff levels for the drug or drug metabolites in Federal
workplace drug testing programs and the licensee or other entity
implements the cutoff levels published in the HHS Guidelines, or if the
licensee or other entity received written approval of the NRC to test
for lower cutoff levels before April 30, 2008.
(4) Alcohol testing. Initial tests for alcohol must be administered
by breath or oral fluids analysis using alcohol analysis devices that
meet the requirements of Sec. 26.91(a). If the initial test shows a
BAC of 0.02 percent or greater, a confirmatory test for alcohol must be
performed. The confirmatory test must be performed with an EBT that
meets the requirements of Sec. 26.91(b).
(5) Medical conditions. (i) If an individual has a medical
condition that makes collection of breath, oral fluids, or urine
specimens difficult or hazardous, the MRO may authorize an alternative
evaluation process, tailored to the individual case, to meet the
requirements of this part for drug and alcohol testing. The alternative
process must include measures to prevent subversion and achieve results
that are comparable to those produced by urinalysis for drugs and
breath analysis for alcohol.
(ii) If an individual requires medical attention, including, but
not limited to, an injured worker in an emergency medical facility who
is required to have a post-event test, treatment may not be delayed to
conduct drug and alcohol testing.
(6) Limitations of testing. Specimens collected under NRC
regulations may only be designated or approved for testing as described
in this part and may not be used to conduct any other analysis or test
without the written permission of the donor. Analyses and tests that
may not be conducted include, but are not limited to, DNA testing,
serological typing, or any other medical or genetic test used for
diagnostic or specimen identification purposes.
Sec. 26.33 Behavioral observation.
Licensees and other entities shall ensure that the individuals who
are subject to this subpart are subject to behavioral observation.
Behavioral observation must be performed by individuals who are trained
under Sec. 26.29 to detect behaviors that may indicate possible use,
sale, or possession of illegal drugs; use or possession of alcohol on
site or while on duty; or impairment from fatigue or any cause that, if
left unattended, may constitute a risk to public health and safety or
the common defense and security. Individuals who are subject to this
subpart shall report any FFD concerns about other individuals to the
personnel designated in the FFD policy.
Sec. 26.35 Employee assistance programs.
(a) Each licensee and other entity who is subject to this part
shall maintain an EAP to strengthen the FFD program by offering
confidential assessment, short-term counseling, referral services, and
treatment monitoring to individuals who have problems that could
adversely affect the individuals' abilities to safely and competently
perform their duties. Employee assistance programs must be designed to
achieve early intervention and provide for confidential assistance.
(b) Licensees and other entities need not provide EAP services to a
C/V's employees, including those whose work location is a licensee's or
other entity's facility, or to individuals who have applied for, but
have not yet been granted, authorization under subpart C of this part.
(c) The EAP staff shall protect the identity and privacy of any
individual (including those who have self-referred) seeking assistance
from the EAP, except if the individual waives the right to privacy in
writing or a determination is made that the individual's condition or
actions pose or have posed an immediate hazard to himself or herself or
others.
(1) Licensees and other entities may not require the EAP to
routinely report the names of individuals who self-refer to the EAP or
the nature of the assistance the individuals sought.
(2) If EAP personnel determine that an individual poses or has
posed an immediate hazard to himself or herself or others, EAP
personnel shall so inform FFD program management, and need not obtain a
written waiver of the right to privacy from the individual. The
individual conditions or actions that EAP personnel shall report to FFD
program management include, but are not limited to, substantive reasons
to believe that the individual--
(i) Is likely to commit self-harm or harm to others;
(ii) Has been impaired from using drugs or alcohol while in a work
status and has a continuing substance abuse disorder that makes it
likely he or she will be impaired while in a work status in the future;
or
(iii) Has ever engaged in any acts that would be reportable under
Sec. 26.719(b)(1) through (b)(3).
(3) If a licensee or other entity receives a report from EAP
personnel under paragraph (c)(2) of this section, the licensee or other
entity shall ensure that the requirements of Sec. Sec. 26.69(d) and
26.77(b) are implemented, as applicable.
Sec. 26.37 Protection of information.
(a) Each licensee or other entity who is subject to this subpart
who collects personal information about an individual for the purpose
of complying with this part, shall establish, use, and maintain a
system of files and procedures that protects the individual's privacy.
(b) Licensees and other entities shall obtain a signed consent that
authorizes the disclosure of the personal information collected and
maintained under this part before disclosing the personal information,
except for disclosures to the following individuals:
(1) The subject individual or his or her representative, when the
individual has designated the representative in writing for specified
FFD matters;
(2) Assigned MROs and MRO staff;
(3) NRC representatives;
(4) Appropriate law enforcement officials under court order;
(5) A licensee's or other entity's representatives who have a need
to have access to the information to perform their assigned duties
under the FFD program, including determinations of fitness, FFD program
audits, or some human resources functions;
(6) The presiding officer in a judicial or administrative
proceeding that is initiated by the subject individual;
(7) Persons deciding matters under review in Sec. 26.39; and
(8) Other persons pursuant to court order.
(c) Personal information that is collected under this subpart must
be
[[Page 17187]]
disclosed to other licensees and entities, including C/Vs, or their
authorized representatives, who are legitimately seeking the
information for authorization decisions as required by this part and
who have obtained a signed release from the subject individual.
(d) Upon receipt of a written request by the subject individual or
his or her designated representative, the FFD program, including but
not limited to, the collection site, HHS-certified laboratory,
substance abuse expert (SAE), or MRO, possessing such records shall
promptly provide copies of all FFD records pertaining to the
individual, including, but not limited to, records pertaining to a
determination that the individual has violated the FFD policy, drug and
alcohol test results, MRO reviews, determinations of fitness, and
management actions pertaining to the subject individual. The licensee
or other entity shall obtain records related to the results of any
relevant laboratory certification, review, or revocation-of-
certification proceedings from the HHS-certified laboratory and provide
them to the subject individual on request.
(e) A licensee's or other entity's contracts with HHS-certified
laboratories and C/Vs providing specimen collection services, and
licensee testing facility procedures, must require test records to be
maintained in confidence, except as provided in paragraphs (b), (c),
and (d) of this section.
(f) This section does not authorize the licensee or other entity to
withhold evidence of criminal conduct from law enforcement officials.
Sec. 26.39 Review process for fitness-for-duty policy violations.
(a) Each licensee and other entity who is subject to this subpart
shall establish procedures for the review of a determination that an
individual who they employ or who has applied for authorization has
violated the FFD policy. The procedure must provide for an objective
and impartial review of the facts related to the determination that the
individual has violated the FFD policy.
(b) The procedure must provide notice to the individual of the
grounds for the determination that the individual has violated the FFD
policy, and must provide an opportunity for the individual to respond
and submit additional relevant information.
(c) The procedure must ensure that the individual who conducts the
review is not associated with the administration of the FFD program
[see the description of FFD program personnel in Sec. 26.4(g)].
Individuals who conduct the review may be management personnel.
(d) If the review finds in favor of the individual, the licensee or
other entity shall update the relevant records to reflect the outcome
of the review and delete or correct all information the review found to
be inaccurate.
(e) When a C/V is administering an FFD program on which licensees
and other entities rely, and the C/V determines that its employee,
subcontractor, or applicant has violated its FFD policy, the C/V shall
ensure that the review procedure required in this section is provided
to the individual. Licensees and other entities who rely on a C/V's FFD
program need not provide the review procedure required in this section
to a C/V's employee, subcontractor, or applicant when the C/V is
administering its own FFD program and the FFD policy violation was
determined under the C/V's program.
Sec. 26.41 Audits and corrective action.
(a) General. Each licensee and other entity who is subject to this
subpart is responsible for the continuing effectiveness of the FFD
program, including FFD program elements that are provided by C/Vs, the
FFD programs of any C/Vs that are accepted by the licensee or other
entity, any FFD program services that are provided to the C/V by a
subcontractor, and the programs of the HHS-certified laboratories on
whom the licensee or other entity and its C/Vs rely. Each licensee and
other entity shall ensure that these programs are audited and that
corrective actions are taken to resolve any problems identified.
(b) FFD program. Each licensee and other entity who is subject to
this subpart shall ensure that the entire FFD program is audited as
needed, but no less frequently than nominally every 24 months.
Licensees and other entities are responsible for determining the
appropriate frequency, scope, and depth of additional auditing
activities within the nominal 24-month period based on the review of
FFD program performance, including, but not limited to, the frequency,
nature, and severity of discovered problems, testing errors, personnel
or procedural changes, and previous audit findings.
(c) C/Vs and HHS-certified laboratories. (1) FFD services that are
provided to a licensee or other entity by C/V personnel who are off
site or are not under the direct daily supervision or observation of
the licensee's or other entity's personnel and HHS-certified
laboratories must be audited on a nominal 12-month frequency.
(2) Audits of HHS-certified laboratories that are conducted for
licensees and other entities who are subject to this subpart need not
duplicate areas inspected in the most recent HHS certification
inspection. However, the licensee and other entity shall review the HHS
certification inspection records and reports to identify any areas in
which the licensee or other entity uses services that the HHS
certification inspection did not address. The licensee or other entity
shall ensure that any such areas are audited on a nominal 12-month
frequency. Licensees and other entities need not audit organizations
and professionals who may provide an FFD program service to the
licensee or other entity, but who are not routinely involved in
providing services to a licensee's or other entity's FFD program, as
specified in Sec. 26.4(i)(1).
(d) Contracts. (1) The contracts of licensees and other entities
contracts with C/Vs and HHS-certified laboratories must reserve the
right to audit the C/V, the C/V's subcontractors providing FFD program
services, and the HHS-certified laboratories at any time, including at
unannounced times, as well as to review all information and
documentation that is reasonably relevant to the audits.
(2) Licensees' and other entities' contracts with C/Vs and HHS-
certified laboratories must also permit the licensee or other entity to
obtain copies of and take away any documents, including reviews and
inspections pertaining to a laboratory's certification by HHS, and any
other data that may be needed to assure that the C/V, its
subcontractors, or the HHS-certified laboratory are performing their
functions properly and that staff and procedures meet applicable
requirements. In a contract with a licensee or other entity who is
subject to this subpart, an HHS-certified laboratory may reasonably
limit the use and dissemination of any documents copied or taken away
by the licensee's or other entity's auditors in order to ensure the
protection of proprietary information and donors' privacy.
(3) In addition, before awarding a contract, the licensee or other
entity shall ensure completion of pre-award inspections and/or audits
of the procedural aspects of the HHS-certified laboratory's drug-
testing operations, except as provided in paragraph (g)(5) of this
section.
(e) Conduct of audits. Audits must focus on the effectiveness of
the FFD program or program element(s), as appropriate, and must be
conducted by individuals who are qualified in the
[[Page 17188]]
subject(s) being audited. The individuals performing the audit of the
FFD program or program element(s) shall be independent from both the
subject FFD program's management and from personnel who are directly
responsible for implementing the FFD program.
(f) Audit results. The result of the audits, along with any
recommendations, must be documented and reported to senior corporate
and site management. Each audit report must identify conditions that
are adverse to the proper performance of the FFD program, the cause of
the condition(s), and recommended corrective actions. The licensee or
other entity shall review the audit findings and take corrective
actions, including re-auditing of the deficient areas where indicated,
to preclude, within reason, repetition of the condition. The resolution
of the audit findings and corrective actions must be documented.
(g) Sharing of audits. Licensees and other entities may jointly
conduct audits, or may accept audits of C/Vs and HHS-certified
laboratories that were conducted by other licensees and entities who
are subject to this subpart, if the audit addresses the services
obtained from the C/V or HHS-certified laboratory by each of the
sharing licensees and other entities.
(1) Licensees and other entities shall review audit records and
reports to identify any areas that were not covered by the shared or
accepted audit.
(2) Licensees and other entities shall ensure that FFD program
elements and services on which the licensee or entity relies are
audited, if the program elements and services were not addressed in the
shared audit.
(3) Sharing licensees and other entities need not re-audit the same
C/V or HHS-certified laboratory for the same period of time.
(4) Each sharing licensee and other entity shall maintain a copy of
the shared audit and HHS certification inspection records and reports,
including findings, recommendations, and corrective actions.
(5) If an HHS-certified laboratory loses its certification, in
whole or in part, a licensee or other entity is permitted to
immediately use another HHS-certified laboratory that has been audited
within the previous 12 months by another NRC licensee or entity who is
subject to this subpart. Within 3 months after the change, the licensee
or other entity shall ensure that an audit is completed of any areas
that have not been audited by another licensee or entity who is subject
to this subpart within the past 12 months.
Subpart C--Granting and Maintaining Authorization
Sec. 26.51 Applicability.
The requirements in this subpart apply to the licensees and other
entities identified in Sec. 26.3(a), (b), and, as applicable, (c) for
the categories of individuals in Sec. 26.4(a) through (d), and, at the
licensee's or other entity's discretion, in Sec. 26.4(g) and, if
necessary, Sec. 26.4(j). The requirements in this subpart also apply
to the licensees and other entities specified in Sec. 26.3(c), as
applicable, for the categories of individuals in Sec. 26.4(e). At the
discretion of a licensee or other entity in Sec. 26.3(c), the
requirements of this subpart also may be applied to the categories of
individuals identified in Sec. 26.4(f). In addition, the requirements
in this subpart apply to the entities in Sec. 26.3(d) to the extent
that a licensee or other entity relies on the C/V to meet the
requirements of this subpart. Certain requirements in this subpart also
apply to the individuals specified in Sec. 26.4(h).
Sec. 26.53 General provisions.
(a) In order to grant authorization to an individual, a licensee or
other entity shall ensure that the requirements in this subpart have
been met for either initial authorization, authorization update,
authorization reinstatement, or authorization with potentially
disqualifying FFD information, as applicable.
(b) For individuals who have previously held authorization under
this part but whose authorization has since been favorably terminated,
the licensee or other entity shall implement the requirements for
either initial authorization, authorization update, or authorization
reinstatement, based on the total number of days that the individual's
authorization is interrupted, to include the day after the individual's
last period of authorization was terminated and the intervening days
until the day on which the licensee or other entity grants
authorization to the individual. If potentially disqualifying FFD
information is disclosed or discovered about an individual, licensees
and other entities shall implement the applicable requirements in Sec.
26.69 in order to grant or maintain an individual's authorization.
(c) The licensee or other entity shall ensure that an individual
has met the applicable FFD training requirements in Sec. Sec. 26.29
and 26.203(c) before granting authorization to the individual.
(d) Licensees and other entities who are seeking to grant
authorization to an individual who is maintaining authorization under
another FFD program that is implemented by a licensee or entity who is
subject to this subpart may rely on the transferring FFD program to
satisfy the requirements of this subpart. The individual may maintain
his or her authorization if he or she continues to be subject to either
the receiving FFD program or the transferring FFD program, or a
combination of elements from both programs that collectively satisfy
the applicable requirements of this part. The receiving FFD program
shall ensure that the program elements to which the individual is
subject under the transferring FFD program remain current.
(e) Licensees and other entities in Sec. 26.3(a) through (c) may
also rely on a C/V's FFD program or program elements when granting or
maintaining the authorization of an individual who is or has been
subject to the C/V's FFD program, if the C/V's program or program
elements meet the applicable requirements of this part.
(1) A C/V's FFD program may grant and maintain an individual's
authorization, as defined in Sec. 26.5, under the C/V's FFD program.
However, only a licensee or other entity in Sec. 26.3(a) through (c)
may grant or maintain an individual's authorization to have the types
of access or perform the duties specified in Sec. 26.4(a) through (e)
and (g), and, at the licensee's or other entity's discretion, Sec.
26.4(f).
(2) If a C/V's FFD program denies or unfavorably terminates an
individual's authorization, and the individual is performing any duties
for a licensee or other entity that are specified in Sec. 26.4(a)
through (e) and (g), or, at the licensee's or other entity's
discretion, Sec. 26.4(f), then the C/V shall inform the affected
licensee or other entity of the denial or unfavorable termination. The
licensee or other entity shall deny or unfavorably terminate the
individual's authorization to perform those duties on the day that the
licensee or other entity receives the information from the C/V, or
implement the applicable process in Sec. 26.69 to maintain the
individual's authorization.
(3) If an individual is maintaining authorization under a C/V's FFD
program, a licensee or other entity in Sec. 26.3(a) through (c) may
grant authorization to the individual to have the types of access and
perform the duties specified in Sec. 26.4(a) through (e) and (g), and,
at the licensee's or other entity's discretion, Sec. 26.4(f), and
maintain his or her authorization, if the individual continues to be
subject to either the receiving FFD program or a combination of
elements from the
[[Page 17189]]
receiving FFD program and the C/V's program that collectively satisfy
the applicable requirements of this part. The receiving licensee's or
other entity's FFD program shall ensure that the program elements to
which the individual is subject under the C/V's FFD program remain
current.
(f) Licensees and other entities who are seeking to grant
authorization to an individual who has been subject to an FFD program
under subpart K may not rely on that program or its program elements to
meet the requirements of this subpart, except if the program or program
element(s) of the FFD program for construction satisfy the applicable
requirements of this part.
(g) The licensees and other entities specified in Sec. 26.3(a)
and, as applicable, (c) and (d), shall identify any violation of any
requirement of this part to any licensee who has relied on or intends
to rely on the FFD program element that is determined to be in
violation of this part.
(h) The licensees and other entities specified in Sec. 26.3(a)
and, as applicable, (c) and (d), may not initiate any actions under
this subpart without the knowledge and written consent of the subject
individual. The individual may withdraw his or her consent at any time.
If an individual withdraws his or her consent, the licensee or other
entity may not initiate any elements of the authorization process
specified in this subpart that were not in progress at the time the
individual withdrew his or her consent, but shall complete and document
any elements that are in progress at the time consent is withdrawn. The
licensee or other entity shall record the individual's application for
authorization; his or her withdrawal of consent; the reason given by
the individual for the withdrawal, if any; and any pertinent
information gathered from the elements that were completed (e.g., the
results of pre-access drug tests, information obtained from the
suitable inquiry). The licensee or other entity to whom the individual
has applied for authorization shall inform the individual that--
(1) Withdrawal of his or her consent will withdraw the individual's
current application for authorization under the licensee's or other
entity's FFD program; and
(2) Other licensees and entities will have access to information
documenting the withdrawal as a result of the information sharing that
is required under this part.
(i) The licensees and other entities specified in Sec. 26.3(a)
and, as applicable, (c) and(d), shall inform, in writing, any
individual who is applying for authorization that the following actions
related to providing and sharing the personal information required
under this subpart are sufficient cause for denial or unfavorable
termination of authorization:
(1) Refusal to provide written consent for the suitable inquiry;
(2) Refusal to provide or the falsification of any personal
information required under this part, including, but not limited to,
the failure to report any previous denial or unfavorable termination of
authorization;
(3) Refusal to provide written consent for the sharing of personal
information with other licensees or other entities required under this
part; and
(4) Failure to report any legal actions, as defined in Sec. 26.5.
Sec. 26.55 Initial authorization.
(a) Before granting authorization to an individual who has never
held authorization under this part or whose authorization has been
interrupted for a period of 3 years or more and whose last period of
authorization was terminated favorably, the licensee or other entity
shall ensure that--
(1) A self-disclosure has been obtained and reviewed under the
applicable requirements of Sec. 26.61;
(2) A suitable inquiry has been completed under the applicable
requirements of Sec. 26.63;
(3) The individual has been subject to pre-access drug and alcohol
testing under the applicable requirements of Sec. 26.65; and
(4) The individual is subject to random drug and alcohol testing
under the applicable requirements of Sec. 26.67.
(b) If potentially disqualifying FFD information is disclosed or
discovered, the licensee or other entity may not grant authorization to
the individual, except under Sec. 26.69.
Sec. 26.57 Authorization update.
(a) Before granting authorization to an individual whose
authorization has been interrupted for more than 365 days but less than
3 years and whose last period of authorization was terminated
favorably, the licensee or other entity shall ensure that--
(1) A self-disclosure has been obtained and reviewed under the
applicable requirements of Sec. 26.61;
(2) A suitable inquiry has been completed under the applicable
requirements of Sec. 26.63;
(3) The individual has been subject to pre-access drug and alcohol
testing under the applicable requirements of Sec. 26.65; and
(4) The individual is subject to random drug and alcohol testing
under the applicable requirements of Sec. 26.67.
(b) If potentially disqualifying FFD information is disclosed or
discovered, the licensee or other entity may not grant authorization to
the individual, except under Sec. 26.69.
Sec. 26.59 Authorization reinstatement.
(a) In order to grant authorization to an individual whose
authorization has been interrupted for a period of more than 30 days
but no more than 365 days and whose last period of authorization was
terminated favorably, the licensee or other entity shall ensure that--
(1) A self-disclosure has been obtained and reviewed under the
applicable requirements of Sec. 26.61;
(2) A suitable inquiry has been completed under the requirements of
Sec. 26.63 within 5 business days of reinstating authorization. If the
suitable inquiry is not completed within 5 business days due to
circumstances that are outside of the licensee's or other entity's
control and the licensee or other entity is not aware of any
potentially disqualifying information regarding the individual within
the past 5 years, the licensee or other entity may maintain the
individual's authorization for an additional 5 business days. If the
suitable inquiry is not completed within 10 business days of
reinstating authorization, the licensee or other entity shall
administratively withdraw the individual's authorization until the
suitable inquiry is completed;
(3) The individual has been subject to pre-access drug and alcohol
testing under the applicable requirements of Sec. 26.65; and
(4) The individual is subject to random drug and alcohol testing
under the applicable requirements of Sec. 26.67.
(b) If a licensee or other entity administratively withdraws an
individual's authorization under paragraph (a)(2) of this section, and
until the suitable inquiry is completed, the licensee or other entity
may not record the administrative action to withdraw authorization as
an unfavorable termination and may not disclose it in response to a
suitable inquiry conducted under the provisions of Sec. 26.63, a
background investigation conducted under the provisions of this
chapter, or any other inquiry or investigation. The individual may not
be required to disclose the administrative action in response to
requests for self-disclosure of potentially disqualifying FFD
information, except if the individual's authorization was subsequently
denied or terminated unfavorably by the licensee or other entity.
(c) Before granting authorization to an individual whose
authorization has
[[Page 17190]]
been interrupted for a period of no more than 30 days and whose last
period of authorization was terminated favorably, the licensee or other
entity shall ensure that--
(1) A self-disclosure has been obtained and reviewed under the
applicable requirements of Sec. 26.61;
(2) The individual has been subject to pre-access drug and alcohol
testing under the applicable requirements of Sec. 26.65, if the
individual's authorization was interrupted for more than 5 days; and
(3) The individual is subject to random drug and alcohol testing
under the applicable requirements of Sec. 26.67.
(d) If potentially disqualifying FFD information is disclosed or
discovered, the licensee or other entity may not grant authorization to
the individual, except under Sec. 26.69.
Sec. 26.61 Self-disclosure and employment history.
(a) Before granting authorization, the licensee or other entity
shall ensure that a written self-disclosure and employment history has
been obtained from the individual who is applying for authorization,
except as follows:
(1) If an individual previously held authorization under this part,
and the licensee or other entity has verified that the individual's
last period of authorization was terminated favorably, and the
individual has been subject to a behavioral observation program that
includes arrest reporting, which meets the requirements of this part,
throughout the period since the individual's last authorization was
terminated, the granting licensee or other entity need not obtain the
self-disclosure or employment history in order to grant authorization;
and
(2) If the individual's last period of authorization was terminated
favorably within the past 30 days, the licensee or other entity need
not obtain the employment history.
(b) The written self-disclosure must--
(1) State whether the individual has--
(i) Violated a licensee's or other entity's FFD policy;
(ii) Had authorization denied or terminated unfavorably under
Sec. Sec. 26.35(c)(2), 26.53(i), 26.63(d), 26.65(g), 26.67(c),
26.69(f), or 26.75(b) through (e);
(iii) Used, sold, or possessed illegal drugs;
(iv) Abused legal drugs or alcohol;
(v) Subverted or attempted to subvert a drug or alcohol testing
program;
(vi) Refused to take a drug or alcohol test;
(vii) Been subject to a plan for substance abuse treatment (except
for self-referral); or
(viii) Had legal action or employment action, as defined in Sec.
26.5, taken for alcohol or drug use;
(2) Address the specific type, duration, and resolution of any
matter disclosed, including, but not limited to, the reason(s) for any
unfavorable termination or denial of authorization; and
(3) Address the shortest of the following periods:
(i) The past 5 years;
(ii) Since the individual's eighteenth birthday; or
(iii) Since the individual's last period of authorization was
terminated, if authorization was terminated favorably within the past 3
years.
(c) The individual shall provide a list of all employers, including
the employer by whom the individual claims to have been employed on the
day before he or she completes the employment history, if any, with
dates of employment, for the shortest of the following periods:
(1) The past 3 years;
(2) Since the individual's eighteenth birthday; or
(3) Since authorization was last terminated, if authorization was
terminated favorably within the past 3 years.
Sec. 26.63 Suitable inquiry.
(a) In order to grant authorization, licensees and other entities
shall ensure that a suitable inquiry has been conducted, on a best
effort basis, to verify the individual's self-disclosed information and
determine whether any potentially disqualifying FFD information is
available, except if all of the following conditions are met:
(1) The individual previously held authorization under this part;
(2) The licensee or other entity has verified that the individual's
last period of authorization was terminated favorably; and
(3) The individual has been subject to a behavioral observation
program that includes arrest reporting, which meets the requirements of
this part, throughout the period of interruption.
(b) To meet the suitable inquiry requirement, licensees and other
entities may rely on the information that other licensees and entities
who are subject to this subpart have gathered for previous periods of
authorization. Licensees and other entities may also rely on those
licensees' and entities' determinations of fitness that were conducted
under Sec. 26.189, as well as their reviews and resolutions of
potentially disqualifying FFD information, for previous periods of
authorization.
(c) The licensee or other entity shall ensure that the suitable
inquiry has been conducted, on a best effort basis, by questioning
former employers, and the employer by whom the individual claims to
have been employed on the day before he or she completes the employment
history, if an employment history is required under Sec. 26.61.
(1) For the claimed employment period, the suitable inquiry must
ascertain the reason for termination, eligibility for rehire, and other
information that could reflect on the individual's fitness to be
granted authorization.
(2) If the claimed employment was military service, the licensee or
other entity who is conducting the suitable inquiry shall request a
characterization of service, reason for separation, and any
disciplinary actions related to potentially disqualifying FFD
information. If the individual's last duty station cannot provide this
information, the licensee or other entity may accept a hand-carried
copy of the DD 214 presented by the individual which on face value
appears to be legitimate. The licensee or other entity may also accept
a copy of a DD 214 provided by the custodian of military records.
(3) If a company, previous employer, or educational institution to
whom the licensee or other entity has directed a request for
information refuses to provide information or indicates an inability or
unwillingness to provide information within 3 business days of the
request, the licensee or other entity shall document this refusal,
inability, or unwillingness in the licensee's or other entity's record
of the investigation, and obtain a confirmation of employment or
educational enrollment and attendance from at least one alternate
source, with suitable inquiry questions answered to the best of the
alternate source's ability. This alternate source may not have been
previously used by the licensee or other entity to obtain information
about the individual's character. If the licensee or other entity uses
an alternate source because employer information is not forthcoming
within 3 business days of the request, the licensee or other entity
need not delay granting authorization to wait for any employer
response, but shall evaluate and document the response if it is
received.
(d) When any licensee or other entity in Sec. 26.3(a) through (d)
is legitimately seeking the information required for an authorization
decision under this subpart and has obtained a signed release from the
subject individual authorizing the disclosure of information, any
licensee or other entity who is subject to this part shall disclose
whether the subject individual's authorization was denied or terminated
[[Page 17191]]
unfavorably as a result of a violation of an FFD policy and shall make
available the information on which the denial or unfavorable
termination of authorization was based, including, but not limited to,
drug or alcohol test results, treatment and followup testing
requirements or other results from a determination of fitness, and any
other information that is relevant to an authorization decision.
(e) In conducting a suitable inquiry, a licensee or other entity
may obtain information and documents by electronic means, including,
but not limited to, telephone, facsimile, or e-mail. The licensee or
other entity shall make a record of the contents of the telephone call
and shall retain that record, and any documents or electronic files
obtained electronically, under Sec. Sec. 26.711 and 26.713(a), (b),
and (c), as applicable.
(f) For individuals about whom no potentially disqualifying FFD
information is known (or about whom potentially disqualifying FFD
information is known, but it has been resolved by a licensee or other
entity who is subject to this subpart) at the time at which the
suitable inquiry is initiated, the licensee or other entity shall
ensure that a suitable inquiry has been conducted as follows:
(1) Initial authorization. The period of the suitable inquiry must
be the past 3 years or since the individual's eighteenth birthday,
whichever is shorter. For the 1-year period immediately preceding the
date on which the individual applies for authorization, the licensee or
other entity shall ensure that the suitable inquiry has been conducted
with every employer, regardless of the length of employment. For the
remaining 2-year period, the licensee or other entity shall ensure that
the suitable inquiry has been conducted with the employer by whom the
individual claims to have been employed the longest within each
calendar month, if the individual claims employment during the given
calendar month.
(2) Authorization update. The period of the suitable inquiry must
be the period since authorization was terminated. For the 1-year period
immediately preceding the date on which the individual applies for
authorization, the licensee or other entity shall ensure that the
suitable inquiry has been conducted with every employer, regardless of
the length of employment. For the remaining period since authorization
was terminated, the licensee or other entity shall ensure that the
suitable inquiry has been conducted with the employer by whom the
individual claims to have been employed the longest within each
calendar month, if the individual claims employment during the given
calendar month.
(3) Authorization reinstatement after an interruption of more than
30 days. The period of the suitable inquiry must be the period since
authorization was terminated. The licensee or other entity shall ensure
that the suitable inquiry has been conducted with the employer by whom
the individual claims to have been employed the longest within the
calendar month, if the individual claims employment during the given
calendar month.
Sec. 26.65 Pre-access drug and alcohol testing.
(a) Purpose. This section contains pre-access testing requirements
for granting authorization to an individual who either has never held
authorization or whose last period of authorization was terminated
favorably and about whom no potentially disqualifying FFD information
has been discovered or disclosed that was not previously reviewed and
resolved by a licensee or other entity under the requirements of this
subpart.
(b) Accepting tests conducted within the past 30 days. If an
individual has negative results from drug and alcohol tests that were
conducted under the requirements of this part before the individual
applied for authorization from the licensee or other entity, and the
specimens for such testing were collected within the 30-day period
preceding the day on which the licensee or other entity grants
authorization to the individual, the licensee or other entity may rely
on the results of those drug and alcohol tests to meet the requirements
for pre-access testing in this section.
(c) Initial authorization and authorization update. Before granting
authorization to an individual who has never held authorization or
whose authorization has been interrupted for a period of more than 365
days, the licensee or other entity shall verify that the results of
pre-access drug and alcohol tests, which must be performed within the
30-day period preceding the day the licensee or other entity grants
authorization to the individual, are negative. The licensee or other
entity need not conduct pre-access testing if--
(1) The individual previously held authorization under this part
and has been subject to a drug and alcohol testing program that
includes random testing and a behavioral observation program that
includes arrest reporting, which both meet the requirements of this
part, from the date the individual's last authorization was terminated
through the date the individual is granted authorization; or
(2) The licensee or other entity relies on negative results from
drug and alcohol tests that were conducted under the requirements of
this part at any time before the individual applied for authorization,
and the individual has remained subject to a drug and alcohol testing
program that includes random testing and a behavioral observation
program that includes arrest reporting, which both meet the
requirements of this part, beginning on the date the drug and alcohol
testing was conducted through the date the individual is granted
authorization and thereafter.
(d) Authorization reinstatement after an interruption of more than
30 days. (1) To reinstate authorization for an individual whose
authorization has been interrupted for a period of more than 30 days
but no more than 365 days, except as permitted in paragraph (d)(2) of
this section, the licensee or other entity shall--
(i) Verify that the individual has negative results from alcohol
testing and collect a specimen for drug testing within the 30-day
period preceding the day the licensee reinstates the individual's
authorization; and
(ii) Verify that the drug test results are negative within 5
business days of specimen collection or administratively withdraw
authorization until the drug test results are received.
(2) The licensee or other entity need not conduct pre-access
testing of these individuals if--
(i) The individual previously held authorization under this part
and has been subject to a drug and alcohol testing program that
includes random testing and a behavioral observation program that
includes arrest reporting, which both meet the requirements of this
part, beginning on the date the individual's last authorization was
terminated through the date the individual is granted authorization; or
(ii) The licensee or other entity relies on negative results from
drug and alcohol tests that were conducted under the requirements of
this part at any time before the individual applied for authorization,
and the individual remains subject to a drug and alcohol testing
program that includes random testing and a behavioral observation
program that includes arrest reporting, which both meet the
requirements of this part, beginning on the date the drug and alcohol
testing was conducted through the date the individual is granted
authorization.
[[Page 17192]]
(e) Authorization reinstatement after an interruption of 30 or
fewer days. (1) The licensee or other entity need not conduct pre-
access testing before granting authorization to an individual whose
authorization has been interrupted for 5 or fewer days. In addition,
the licensee or other entity need not conduct pre-access testing if the
individual has been subject to a drug and alcohol testing program that
includes random testing and a behavioral observation program that
includes arrest reporting, which both meet the requirements of this
part, from the date the individual's last authorization was terminated
through the date the individual is granted authorization.
(2) In order to reinstate authorization for an individual whose
authorization has been interrupted for a period of more than 5 days but
not more than 30 days, except as permitted in paragraph (e)(1) of this
section, the licensee or other entity shall take the following actions:
(i) The licensee or other entity shall subject the individual to
random selection for pre-access drug and alcohol testing at a one-time
probability that is equal to or greater than the normal testing rate
specified in Sec. 26.31(d)(2)(vii) calculated for a 30-day period;
(ii) If the individual is not selected for pre-access testing under
paragraph (e)(2)(i) of this section, the licensee or other entity need
not perform pre-access drug and alcohol tests; or
(iii) If the individual is selected for pre-access testing under
this paragraph, the licensee or other entity shall--
(A) Verify that the individual has negative results from alcohol
testing and collect a specimen for drug testing before reinstating
authorization; and
(B) Verify that the drug test results are negative within 5
business days of specimen collection or administratively withdraw
authorization until negative drug test results are received.
(f) Administrative withdrawal of authorization. If a licensee or
other entity administratively withdraws an individual's authorization
under paragraphs (d)(1)(ii) or (e)(2)(iii)(B) of this section, and
until the drug test results are known, the licensee or other entity may
not record the administrative action to withdraw authorization as an
unfavorable termination. The individual may not be required to disclose
the administrative action in response to requests for self-disclosure
of potentially disqualifying FFD information, except if the
individual's authorization was subsequently denied or terminated
unfavorably by a licensee or entity. Immediately on receipt of negative
test results, the licensee or other entity shall ensure that any matter
that could link the individual to the temporary administrative action
is eliminated from the donor's personnel record and other records.
(g) Sanctions. If an individual has confirmed positive,
adulterated, or substituted test results from any drug, validity, or
alcohol tests that may be required in this section, the licensee or
other entity shall, at a minimum and as appropriate--
(1) Deny authorization to the individual, as required by Sec.
26.75(b), (d), (e)(2), or (g);
(2) Terminate the individual's authorization, if it has been
reinstated, under Sec. 26.75(e)(1) or (f); or
(3) Grant authorization to the individual under Sec. 26.69.
Sec. 26.67 Random drug and alcohol testing of individuals who have
applied for authorization.
(a) When the licensee or other entity collects specimens from an
individual for any pre-access testing that may be required under
Sec. Sec. 26.65 or 26.69, and thereafter, the licensee or other entity
shall subject the individual to random testing under Sec. 26.31(d)(2),
except if--
(1) The licensee or other entity does not grant authorization to
the individual; or
(2) The licensee or other entity relies on drug and alcohol tests
that were conducted before the individual applied for authorization to
meet the applicable requirements for pre-access testing. If the
licensee or other entity relies on drug and alcohol tests that were
conducted before the individual applied for authorization, the licensee
or other entity shall subject the individual to random testing when the
individual arrives at a licensee's or other entity's facility for in-
processing and thereafter.
(b) If an individual is selected for one or more random tests after
any applicable requirement for pre-access testing in Sec. Sec. 26.65
or 26.69 has been met, the licensee or other entity may grant
authorization before random testing is completed, if the individual has
met all other applicable requirements for authorization.
(c) If an individual has confirmed positive, adulterated, or
substituted test results from any drug, validity, or alcohol test
required in this section, the licensee or other entity shall, at a
minimum and as appropriate--
(1) Deny authorization to the individual, as required by Sec.
26.75(b), (d), (e)(2), or (g);
(2) Terminate the individual's authorization, if it has been
granted, as required by Sec. 26.75(e)(1) or (f); or
(3) Grant authorization to the individual under Sec. 26.69.
Sec. 26.69 Authorization with potentially disqualifying fitness-for-
duty information.
(a) Purpose. This section defines the management actions that
licensees and other entities who are subject to this subpart shall take
to grant or maintain, at the licensee's or other entity's discretion,
the authorization of an individual who is in the following
circumstances:
(1) Potentially disqualifying FFD information within the past 5
years has been disclosed or discovered about the individual by any
means, including, but not limited to, the individual's self-disclosure,
the suitable inquiry, drug and alcohol testing, the administration of
any FFD program under this part, a self-report of a legal action,
behavioral observation, or other sources of information, including, but
not limited to, any background investigation or credit and criminal
history check conducted under the requirements of this chapter; and
(2) The potentially disqualifying FFD information has not been
reviewed and favorably resolved by a previous licensee or other entity
under this section.
(b) Authorization after a first confirmed positive drug or alcohol
test result or a 5-year denial of authorization. The requirements in
this paragraph apply to individuals whose authorization was denied or
terminated unfavorably for a first violation of an FFD policy involving
a confirmed positive drug or alcohol test result and individuals whose
authorization was denied for 5 years under Sec. 26.75(c), (d), (e)(2),
or (f). To grant, and subsequently maintain, the individual's
authorization, the licensee or other entity shall--
(1) Obtain and review a self-disclosure and employment history from
the individual that addresses the shorter period of either the past 5
years or since the individual's last period of authorization was
terminated, and verify that the self-disclosure does not contain any
previously undisclosed potentially disqualifying FFD information before
granting authorization;
(2) Complete a suitable inquiry with every employer by whom the
individual claims to have been employed during the period addressed in
the employment history obtained under paragraph (b)(1) of this section,
and obtain and review any records that other licensees or entities who
are subject to this part may have developed related to the unfavorable
termination or denial of authorization;
[[Page 17193]]
(3) If the individual was subject to a 5-year denial of
authorization under this part, verify that he or she has abstained from
substance abuse for at least the past 5 years;
(4) Ensure that an SAE has conducted a determination of fitness and
concluded that the individual is fit to safely and competently perform
his or her duties.
(i) If the individual's authorization was denied or terminated
unfavorably for a first confirmed positive drug or alcohol test result,
ensure that clinically appropriate treatment and followup testing plans
have been developed by an SAE before granting authorization;
(ii) If the individual was subject to a 5-year denial of
authorization, ensure that any recommendations for treatment and
followup testing from an SAE's determination of fitness are initiated
before granting authorization; and
(iii) Verify that the individual is in compliance with, and
successfully completes, any followup testing and treatment plans.
(5) Within 10 business days before granting authorization, perform
a pre-access alcohol test, collect a specimen for drug testing under
direct observation, and ensure that the individual is subject to random
testing thereafter. Verify that the pre-access drug and alcohol test
results are negative before granting authorization.
(6) If the individual's authorization was denied or terminated
unfavorably for a first confirmed positive drug or alcohol test result
and a licensee or other entity grants authorization to the individual,
ensure that the individual is subject to unannounced testing at least
quarterly for 3 calendar years after the date the individual is granted
authorization. Both random and followup tests, as defined in Sec.
26.31(c), satisfy this requirement. Verify that the individual has
negative test results from a minimum of 15 tests distributed over the
3-year period, except as follows:
(i) If the individual does not continuously hold authorization
during the 3-year period, the licensee or other entity shall ensure
that at least one unannounced test is conducted in any quarter during
which the individual holds authorization;
(ii) If the 15 tests are not completed within the 3-year period
specified in this paragraph due to periods during which the individual
does not hold authorization, the followup testing program may be
extended up to 5 calendar years to complete the 15 tests;
(iii) If the individual does not hold authorization during the 5-
year period a sufficient number of times or for sufficient periods of
time to complete the 15 tests required in this paragraph, the licensee
or other entity shall ensure that an SAE conducts a determination of
fitness to assess whether further followup testing is required and
implement the SAE's recommendations; and
(7) Verify that any drug and alcohol tests required in this
paragraph, and any other drug and alcohol tests that are conducted
under this part since authorization was terminated or denied, yield
results indicating no further drug abuse, as determined by the MRO
after review, or alcohol abuse, as determined by the result of
confirmatory alcohol testing.
(c) Granting authorization with other potentially disqualifying FFD
information. The requirements in this paragraph apply to an individual
who has applied for authorization, and about whom potentially
disqualifying FFD information has been discovered or disclosed that is
not a first confirmed positive drug or alcohol test result or a 5-year
denial of authorization. If potentially disqualifying FFD information
is obtained about an individual by any means, including, but not
limited to, the individual's self-disclosure, the suitable inquiry, the
administration of any FFD program under this part, a self-report of a
legal action, behavioral observation, or other sources of information,
including, but not limited to, any background investigation or credit
and criminal history check conducted under the requirements of this
chapter, before granting authorization to the individual, the licensee
or other entity shall--
(1) Obtain and review a self-disclosure and employment history that
addresses the shortest of the following periods:
(i) The past 5 years;
(ii) Since the individual's eighteenth birthday; or
(iii) Since the individual's last period of authorization was
terminated;
(2) Complete a suitable inquiry with every employer by whom the
individual claims to have been employed during the period addressed in
the employment history required under paragraph (c)(1) of this section.
If the individual held authorization within the past 5 years, obtain
and review any records that other licensees or entities who are subject
to this part may have developed with regard to potentially
disqualifying FFD information about the individual from the past 5
years;
(3) If the designated reviewing official determines that a
determination of fitness is required, verify that a professional with
the appropriate qualifications, as specified in Sec. 26.187(a), has
indicated that the individual is fit to safely and competently perform
his or her duties;
(4) Ensure that the individual is in compliance with, or has
completed, any plans for treatment and drug and alcohol testing from
the determination of fitness, which may include the collection of a
urine specimen under direct observation; and
(5) Verify that the results of pre-access drug and alcohol tests
are negative before granting authorization, and that the individual is
subject to random testing after the specimens have been collected for
pre-access testing and thereafter.
(d) Maintaining authorization with other potentially disqualifying
FFD information. If an individual is authorized when other potentially
disqualifying FFD information is disclosed or discovered, in order to
maintain the individual's authorization, the licensee or other entity
shall--
(1) Ensure that the licensee's or other entity's designated
reviewing official completes a review of the circumstances associated
with the information;
(2) If the designated reviewing official concludes that a
determination of fitness is required, verify that a professional with
the appropriate qualifications, as specified in Sec. 26.187(a), has
indicated that the individual is fit to safely and competently perform
his or her duties; and
(3) If the reviewing official determines that maintaining the
individual's authorization is warranted, implement any recommendations
for treatment and followup drug and alcohol testing from the
determination of fitness, which may include the collection of urine
specimens under direct observation, and ensure that the individual
complies with and successfully completes the treatment plans.
(e) Accepting followup testing and treatment plans from another FFD
program. Licensees and other entities may rely on followup testing,
treatment plans, and determinations of fitness that meet the
requirements of Sec. 26.189 and were conducted under the FFD program
of another licensee or entity who is subject to this subpart.
(1) If an individual leaves the FFD program in which a treatment
and/or followup testing plan was required under paragraphs (b), (c), or
(d) of this section, the licensee or other entity who imposed the
treatment and/or followup testing plan shall ensure that information
documenting the treatment and/or followup testing plan is identified to
any subsequent licensee or other entity who seeks to grant
[[Page 17194]]
authorization to the individual. If the individual is granted
authorization by the same or another licensee or entity, the licensee
or other entity who grants authorization to the individual shall ensure
that any followup testing requirements are met and that the individual
complies with any treatment plan, with accountability assumed by the
granting licensee or other entity. If it is impractical for the
individual to comply with a treatment plan that was developed under
another FFD program because of circumstances that are outside of the
individual's or licensee's or other entity's control (e.g.,
geographical distance, closure of a treatment facility), then the
granting FFD program shall ensure that an SAE develops a comparable
treatment plan, with accountability for monitoring the individual's
compliance with the plan assumed by the granting licensee or other
entity.
(2) If the previous licensee or other entity determined that the
individual successfully completed any required treatment and followup
testing, and the individual's last period of authorization was
terminated favorably, the receiving licensee or entity may rely on the
previous determination of fitness and no further review or followup is
required.
(f) Sanctions. If an individual has confirmed positive,
adulterated, or substituted test results from any drug, validity, or
alcohol test required in this section, the licensee or other entity
shall, at a minimum and as appropriate--
(1) Deny authorization to the individual, as required by Sec.
26.75(b), (d), (e)(2), or (g); or
(2) Terminate the individual's authorization, if it has been
granted, as required by Sec. 26.75(e)(1) or (f).
Sec. 26.71 Maintaining authorization.
(a) Individuals may maintain authorization under the following
conditions:
(1) The individual complies with the licensee's or other entity's
FFD policies and procedures, as described in Sec. 26.27, including the
responsibility to report any legal actions, as defined in Sec. 26.5;
(2) The individual remains subject to a drug and alcohol testing
program that meets the requirements of Sec. 26.31, including random
testing;
(3) The individual remains subject to a behavioral observation
program that meets the requirements of Sec. 26.33; and
(4) The individual successfully completes required FFD training on
the schedule specified in Sec. 26.29(c).
(b) If an authorized individual is not subject to an FFD program
that meets the requirements of this section for more than 30 continuous
days, then the licensee or other entity shall terminate the
individual's authorization and the individual shall meet the
requirements in this subpart, as applicable, to regain authorization.
Subpart D--Management Actions and Sanctions To Be Imposed
Sec. 26.73 Applicability.
The requirements in this subpart apply to the licensees and other
entities identified in Sec. 26.3(a), (b), and, as applicable, (c) for
the categories of individuals specified in Sec. 26.4(a) through (d)
and (g). The requirements in this subpart also apply to the licensees
and other entities specified in Sec. 26.3(c), as applicable, for the
categories of individuals in Sec. 26.4(e). At the discretion of a
licensee or other entity in Sec. 26.3(c), the requirements of this
subpart also may be applied to the categories of individuals identified
in Sec. 26.4(f). In addition, the requirements in this subpart apply
to the entities in Sec. 26.3(d) to the extent that a licensee or other
entity relies on the C/V to meet the requirements of this subpart. The
regulations in this subpart also apply to the individuals specified in
Sec. 26.4(h) and (j), as appropriate.
Sec. 26.75 Sanctions.
(a) This section defines the minimum sanctions that licensees and
other entities shall impose when an individual has violated the drug
and alcohol provisions of an FFD policy. A licensee or other entity may
impose more stringent sanctions, except as specified in paragraph (h)
of this section.
(b) Any act or attempted act to subvert the testing process,
including, but not limited to, refusing to provide a specimen and
providing or attempting to provide a substituted or adulterated
specimen, for any test required under Sec. 26.31(c) must result in the
immediate unfavorable termination of the individual's authorization and
permanent denial of authorization thereafter.
(c) Any individual who is determined to have been involved in the
sale, use, or possession of illegal drugs or the consumption of alcohol
within a protected area of any nuclear power plant, within a facility
that is licensed to possess or use formula quantities of SSNM, within a
transporter's facility or vehicle, or while performing the duties that
require the individual to be subject to this subpart shall immediately
have his or her authorization unfavorably terminated and denied for a
minimum of 5 years from the date of the unfavorable termination of
authorization.
(d) Any individual who resigns or withdraws his or her application
for authorization before authorization is terminated or denied for a
first violation of the FFD policy involving a confirmed positive drug
or alcohol test result shall immediately have his or her authorization
denied for a minimum of 5 years from the date of termination or denial.
If an individual resigns or withdraws his or her application for
authorization before his or her authorization is terminated or denied
for any violation of the FFD policy, the licensee or other entity shall
record the resignation or withdrawal, the nature of the violation, and
the minimum sanction that would have been required under this section
had the individual not resigned or withdrawn his or her application for
authorization.
(e) Lacking any other evidence to indicate the use, sale, or
possession of illegal drugs or consumption of alcohol on site, a
confirmed positive drug or alcohol test result must be presumed to be
an indication of offsite drug or alcohol use in violation of the FFD
policy.
(1) The first violation of the FFD policy involving a confirmed
positive drug or alcohol test result must, at a minimum, result in the
immediate unfavorable termination of the individual's authorization for
at least 14 days from the date of the unfavorable termination.
(2) Any subsequent confirmed positive drug or alcohol test result,
including during an assessment or treatment period, must result in the
denial of authorization for a minimum of 5 years from the date of
denial.
(f) Paragraph (e) of this section does not apply to the misuse of
prescription and over-the-counter drugs, except if the MRO determines
that misuse of the prescription or over-the-counter drug represents
substance abuse. Sanctions for misuse of prescription and over-the-
counter drugs must be sufficient to deter misuse of those substances.
(g) For individuals whose authorization was denied for 5 years
under paragraphs (c), (d), (e)(2), or (f) of this section, any
subsequent violation of the drug and alcohol provisions of an FFD
policy must immediately result in permanent denial of authorization.
(h) A licensee or other entity may not terminate an individual's
authorization and may not subject the individual to other
administrative action based solely on a positive test result from any
initial drug test, other than positive initial test results for
marijuana or cocaine metabolites from a specimen that is
[[Page 17195]]
reported to be valid on the basis of either validity screening or
initial validity testing performed at a licensee testing facility,
unless other evidence, including information obtained under the process
set forth in Sec. 26.189, indicates that the individual is impaired or
might otherwise pose a safety hazard. The licensee or other entity may
not terminate an individual's authorization or subject an individual to
any other administrative action under this section based on the results
of validity screening or initial validity testing performed at a
licensee testing facility indicating that a specimen is of questionable
validity.
(i) With respect to positive initial drug test results from a
licensee testing facility for marijuana and cocaine metabolites from a
valid specimen, licensee testing facility personnel may inform licensee
or other entity management of the positive initial drug test result and
the specific drugs or metabolites identified, and licensees or other
entities may administratively withdraw the donor's authorization or
take lesser administrative actions against the donor, provided that the
licensee or other entity complies with the following conditions:
(1) For the drug for which action will be taken, at least 85
percent of the specimens that were determined to be positive as a
result of initial drug tests at the licensee testing facility during
the past 12-month data reporting period submitted to the NRC under
Sec. 26.717 were subsequently reported as positive by the HHS-
certified laboratory as the result of confirmatory testing;
(2) There is no loss of compensation or benefits to the donor
during the period of temporary administrative action;
(3) Immediately on receipt of a negative report from the HHS-
certified laboratory or MRO, any matter that could link the donor to
the temporary administrative action is eliminated from the donor's
personnel record and other records; and
(4) Licensees and other entities may not disclose the temporary
administrative action against an individual whose initial drug test
result is not subsequently confirmed by the MRO as a violation of the
FFD policy in response to a suitable inquiry conducted under the
provisions of Sec. 26.63, a background investigation conducted under
the provisions of this chapter, or to any other inquiry or
investigation.
(i) To ensure that no records are retained, access to the system of
files and records must be provided to personnel who are conducting
reviews, inquiries into allegations, or audits under the provisions of
Sec. 26.41, and to NRC inspectors.
(ii) The licensee or other entity shall provide the donor with a
written statement that the records specified in Sec. Sec. 26.713 and
26.715 have not been retained with respect to the temporary
administrative action and shall inform the donor in writing that the
temporary administrative action that was taken will not be disclosed
and need not be disclosed by the individual in response to requests for
self-disclosure of potentially disqualifying FFD information.
Sec. 26.77 Management actions regarding possible impairment.
(a) This section defines management actions that licensees and
other entities who are subject to this subpart must take when an
individual who is subject to this subpart shows indications that he or
she may not be fit to safely and competently perform his or her duties.
(b) If an individual appears to be impaired or the individual's
fitness is questionable, except as permitted under Sec. Sec.
26.27(c)(3), 26.207, and 26.209, the licensee or other entity shall
take immediate action to prevent the individual from performing the
duties that require him or her to be subject to this subpart.
(1) If an observed behavior or physical condition creates a
reasonable suspicion of possible substance abuse, the licensee or other
entity shall perform drug and alcohol testing. The results must be
negative before the individual returns to performing the duties that
require the individual to be subject to this subpart. However, if the
physical condition is the smell of alcohol with no other behavioral or
physical indications of impairment, then only an alcohol test is
required and the results must be negative before the individual returns
to performing his or her duties.
(2) If a licensee or C/V who is subject to subpart I of this part
is certain that the observed behavior or physical condition is the
result solely of fatigue, the licensee or C/V shall ensure that a
fatigue assessment is conducted under Sec. 26.211. If the results of
the fatigue assessment confirm that the observed behavior or physical
condition is the result solely of fatigue, the licensee or C/V need not
perform drug and alcohol tests or implement the determination of
fitness process otherwise required by Sec. 26.189.
(3) For other indications of possible impairment that do not create
a reasonable suspicion of substance abuse (or fatigue, in the case of
licensees and C/Vs who are subject to subpart I of this part), the
licensee or other entity may permit the individual to return to
performing his or her duties only after the impairing or questionable
conditions are resolved and a determination of fitness indicates that
the individual is fit to safely and competently perform his or her
duties.
(c) If a licensee or other entity has a reasonable belief that an
NRC employee or NRC contractor may be under the influence of any
substance, or is otherwise unfit for duty, the licensee or other entity
may not deny access but shall escort the individual. In any such
instance, the licensee or other entity shall immediately notify the
appropriate Regional Administrator by telephone, followed by written
notification (e.g., e-mail or fax) to document the oral notification.
If the Regional Administrator cannot be reached, the licensee or other
entity shall notify the NRC Operations Center.
Subpart E--Collecting Specimens for Testing
Sec. 26.81 Purpose and applicability.
This subpart contains requirements for collecting specimens for
drug testing and conducting alcohol tests by or on behalf of the
licensees and other entities in Sec. 26.3(a) through (d) for the
categories of individuals specified in Sec. 26.4(a) through (d) and
(g). At the discretion of a licensee or other entity in Sec. 26.3(c),
specimen collections and alcohol tests must be conducted either under
this subpart for the individuals specified in Sec. 26.4(e) and (f) or
the licensee or other entity may rely on specimen collections and
alcohol tests conducted under the requirements of 49 CFR Part 40 for
the individuals specified in Sec. 26.4(e) and (f). The requirements of
this subpart do not apply to specimen collections and alcohol tests
that are conducted under the requirements of 49 CFR Part 40, as
permitted in this paragraph and under Sec. Sec. 26.4(j) and
26.31(b)(2) and Subpart K.
Sec. 26.83 Specimens to be collected.
Except as permitted under Sec. 26.31(d)(5), licensees and other
entities who are subject to this subpart shall--
(a) Collect either breath or oral fluids for initial tests for
alcohol. Breath must be collected for confirmatory tests for alcohol;
and
(b) Collect only urine specimens for both initial and confirmatory
tests for drugs.
Sec. 26.85 Collector qualifications and responsibilities.
(a) Urine collector qualifications. Urine collectors shall be
knowledgeable of the requirements of this part and the FFD policy and
procedures of the
[[Page 17196]]
licensee or other entity for whom collections are performed, and shall
keep current on any changes to urine collection procedures. Collectors
shall receive qualification training that meets the requirements of
this paragraph and demonstrate proficiency in applying the requirements
of this paragraph before serving as a collector. At a minimum,
qualification training must provide instruction on the following
subjects:
(1) All steps necessary to complete a collection correctly and the
proper completion and transmission of the custody-and-control form;
(2) Methods to address ``problem'' collections, including, but not
limited to, collections involving ``shy bladder'' and attempts to
tamper with a specimen;
(3) How to correct problems in collections; and
(4) The collector's responsibility for maintaining the integrity of
the specimen collection and transfer process, carefully ensuring the
modesty and privacy of the donor, and avoiding any conduct or remarks
that might be construed as accusatorial or otherwise offensive or
inappropriate.
(b) Alcohol collector qualifications. Alcohol collectors shall be
knowledgeable of the requirements of this part and the FFD policy and
procedures of the licensee or other entity for whom collections are
performed, and shall keep current on any changes to alcohol collection
procedures. Collectors shall receive qualification training meeting the
requirements of this paragraph and demonstrate proficiency in applying
the requirements of this paragraph before serving as a collector. At a
minimum, qualification training must provide instruction on the
following subjects:
(1) The alcohol testing requirements of this part;
(2) Operation of the particular alcohol testing device(s) [i.e.,
the alcohol screening devices (ASDs) or EBTs] to be used, consistent
with the most recent version of the manufacturers' instructions;
(3) Methods to address ``problem'' collections, including, but not
limited to, collections involving ``shy lung'' and attempts to tamper
with a specimen;
(4) How to correct problems in collections; and
(5) The collector's responsibility for maintaining the integrity of
the specimen collection process, carefully ensuring the privacy of the
donor, and avoiding any conduct or remarks that might be construed as
accusatorial or otherwise offensive or inappropriate.
(c) Alternative collectors. A medical professional, technologist,
or technician may serve as a collector without meeting the collector
qualification requirements in paragraphs (a) or (b) of this section, as
applicable, only if all of the following conditions are met:
(1) A collector who meets the requirements of paragraphs (a) or (b)
of this section cannot reasonably be made available at the time the
collection must occur;
(2) The individual is not employed by the licensee's or other
entity's FFD program and his or her normal workplace is not at the
licensee's or other entity's facility;
(3) The individual does not routinely provide FFD program services
to the licensee or other entity;
(4) The individual is licensed or otherwise approved to practice in
the jurisdiction in which the collection occurs; and
(5) The individual is provided with detailed, clearly-illustrated,
written instructions for collecting specimens under this subpart and
follows those instructions.
(d) Personnel available to testify at proceedings. The licensee or
other entity shall ensure that qualified collection site personnel,
when required, are available to testify in an administrative or
disciplinary proceeding against an individual when that proceeding is
based on positive drug or alcohol test results or adulterated or
substituted test results from specimens collected by or under contract
to the licensee or other entity.
(e) Files. Collection site personnel files must include each
individual's resume of training and experience; certification or
license, if any; references; job descriptions; records of performance
evaluations and advancement; incident reports, if any; results of tests
to establish employee competency for the position he or she holds,
including, but not limited to, certification that collectors are
proficient in administering alcohol tests consistent with the most
recent manufacturer's instructions for the instruments and devices
used; and appropriate data to support determinations of honesty and
integrity conducted under Sec. 26.31(b).
Sec. 26.87 Collection sites.
(a) Each FFD program must have one or more designated collection
sites that have all necessary personnel, materials, equipment,
facilities, and supervision to collect specimens for drug testing and
to perform alcohol testing. Each collection site must provide for the
collection, security, temporary storage, and shipping or transportation
of urine specimens to a drug testing laboratory; the collection of oral
fluids or breath specimens; and the security of alcohol testing devices
and test results. A properly equipped mobile facility that meets the
requirements of this section is an acceptable collection site.
(b) The collection site must provide for the donor's visual privacy
while the donor and collector are viewing the results of an alcohol
test, and for individual privacy while the donor is submitting a urine
specimen, except if a directly observed urine specimen collection is
required. Unauthorized personnel may not be present for the specimen
collection.
(c) Contracts for collection site services must permit
representatives of the NRC, licensee, or other entity to conduct
unannounced inspections and audits and to obtain all information and
documentation that is reasonably relevant to the inspections and
audits.
(d) Licensees and other entities shall take the following measures
to prevent unauthorized access to the collection site that could
compromise the integrity of the collection process or the specimens.
(1) Unauthorized personnel may not be permitted in any part of the
designated collection site where specimens are collected or stored;
(2) A designated collection site must be secure. If a collection
site is dedicated solely to specimen collection, it must be secure at
all times. Methods of assuring security may include, but are not
limited to, physical measures to control access, such as locked doors,
alarms, or visual monitoring of the collection site when it is not
occupied; and
(3) If a collection site cannot be dedicated solely to collecting
specimens, the portion of the facility that is used for specimen
collection must be secured and, during the time period during which a
specimen is being collected, a sign must be posted to indicate that
access is permitted only for authorized personnel.
(e) The following steps must be taken to deter the dilution and
adulteration of urine specimens at the collection site:
(1) Agents that color any source of standing water in the stall or
room in which the donor will provide a specimen, including, but not
limited to, the toilet bowl or tank, must be placed in the source of
standing water, so that the reservoirs of water are neither yellow nor
colorless;
(2) There must be no other source of water (e.g., no shower or
sink) in the enclosure where urination occurs, or the source of water
must be rendered unusable; and
[[Page 17197]]
(3) Chemicals or products that could be used to contaminate or
otherwise alter the specimen must be removed from the collection site
or secured. The collector shall inspect the enclosure in which
urination will occur before each collection to ensure that no materials
are available that could be used to subvert the testing process.
(f) In the exceptional event that a designated collection site is
inaccessible and there is an immediate requirement to collect a urine
specimen, including, but not limited to, an event investigation, then
the licensee or other entity may use a public rest room, onsite rest
room, or hospital examining room according to the following procedures:
(1) The facility must be secured by visual inspection to ensure
that no unauthorized persons are present, and that undetected access
(e.g., through a rear door not in the view of the collector) is
impossible. Security during the collection may be maintained by
restricting access to collection materials and specimens. In the case
of a public rest room, a sign must be posted or an individual assigned
to ensure that no unauthorized personnel are present during the entire
collection procedure to avoid embarrassment of the donor and
distraction of the collector.
(2) If practical, a water coloring agent that meets the
requirements of Sec. 26.87(e)(1) must be placed in the toilet bowl to
be used by the donor and in any other accessible source of standing
water, including, but not limited to, the toilet tank. The collector
shall instruct the donor not to flush the toilet.
(3) A collector of the same gender as the donor shall accompany the
donor into the area that will be used for specimen collection, but
remain outside of the stall, if it is a multi-stalled rest room, or
outside of the door to the room, if it is a single rest room, in which
the donor will provide the specimen. If a collector of the same gender
is not available, the collector shall select a same-gender person to
accompany the donor. This person shall be instructed on the collection
procedures specified in this subpart and his or her identity must be
documented on the custody-and-control form.
(4) After the collector has possession of the specimen, the
collector shall inspect the toilet bowl and area to ensure that there
is no evidence of a subversion attempt and shall then flush the toilet.
The collector shall instruct the donor to participate with the
collector in completing the chain-of-custody procedures.
(5) If it is impractical to maintain continuous physical security
of a collection site from the time a urine specimen is presented until
the sealed container is transferred for shipment, the specimen must
remain under the direct control of an individual who is authorized by
the licensee or other entity until the specimen is prepared for
transfer, storage, or shipping, as required by Sec. 26.117. The
authorized individual shall be instructed on his or her
responsibilities for maintaining custody and control of the specimen
and his or her custody of the specimen must be documented on the
custody-and-control form.
Sec. 26.89 Preparing to collect specimens for testing.
(a) When an individual has been notified of a requirement for
testing and does not appear at the collection site within the time
period specified by FFD program procedures, the collector shall inform
FFD program management that the individual has not reported for
testing. FFD program management shall ensure that the necessary steps
are taken to determine whether the individual's undue tardiness or
failure to appear for testing constitutes a violation of the licensee's
or other entity's FFD policy. If FFD program management determines that
the undue tardiness or failure to report for testing represents an
attempt to subvert the testing process, the licensee or other entity
shall impose on the individual the sanctions in Sec. 26.75(b). If FFD
program management determines that the undue tardiness or failure to
report does not represent a subversion attempt, the licensee or other
entity may not impose sanctions but shall ensure that the individual is
tested at the earliest reasonable and practical opportunity after
locating the individual.
(b) Donors shall provide acceptable identification before testing.
(1) Acceptable identification includes photo-identification issued
by a licensee or other entity who is subject to this part, or by the
Federal, State, or local government. Licensees and other entities may
not accept faxes or photocopies of identification.
(2) If the donor cannot produce acceptable identification before
any testing that is required under this part other than pre-access
testing, the collector shall proceed with the test and immediately
inform FFD program management that the donor did not present acceptable
identification. When so informed, FFD program management shall contact
the individual's supervisor to verify in-person the individual's
identity, or, if the supervisor is not available, take other steps to
establish the individual's identity and determine whether the lack of
identification was an attempt to subvert the testing process. The donor
may not leave the collection site except under supervision until his or
her identity has been established.
(3) If the donor is scheduled for pre-access testing and cannot
produce acceptable identification, the collector may not proceed with
the collection, and shall inform FFD program management that the
individual did not present acceptable identification. When so informed,
FFD program management will take the necessary steps to determine
whether the lack of identification was an attempt to subvert the
testing process.
(4) The collector shall explain the testing procedure to the donor,
show the donor the form(s) to be used, and ask the donor to sign a
consent-to-testing form. The donor may not be required to list
prescription medications or over-the-counter preparations that he or
she has recently used.
(c) The collector shall inform the donor that, if the donor refuses
to cooperate in the specimen collection process (including, but not
limited to, behaving in a confrontational manner that disrupts the
testing process; admitting to the collector that he or she adulterated,
diluted, or adulterated the specimen; is found to have a device, such
as a prosthetic appliance, the purpose of which is to interfere with
providing an actual urine specimen; or leaving the collection site
before all of the collection procedures are completed), it will be
considered a refusal to test, and sanctions for subverting the testing
process will be imposed under Sec. 26.75(b). If the donor refuses to
cooperate in the collection procedures, the collector shall inform FFD
program management to obtain guidance on the actions to be taken.
(d) In order to promote the security of specimens, avoid
distraction of the collector, and ensure against any confusion in the
identification of specimens, a collector shall conduct only one
collection procedure at any given time. For this purpose, a urine
collection procedure is complete when the urine specimen container has
been sealed and initialed, the chain-of-custody form has been executed,
and the donor has departed the collection site.
Sec. 26.91 Acceptable devices for conducting initial and confirmatory
tests for alcohol and methods of use.
(a) Acceptable alcohol screening devices. Alcohol screening devices
(ASDs), including devices that test specimens of oral fluids or breath,
must be approved by the National Highway
[[Page 17198]]
Traffic Safety Administration (NHTSA) and listed in the most current
version of NHTSA's Conforming Products List (CPL) for such devices. An
ASD that is listed in the NHTSA CPL may be used only for initial tests
for alcohol, and may not be used for confirmatory tests.
(b) Acceptable evidential breath testing devices. Evidential breath
testing devices listed in the NHTSA CPL for evidential devices that
meet the requirements of paragraph (c) of this section must be used to
conduct confirmatory alcohol tests, and may be used to conduct initial
alcohol tests. Note that, among the devices listed in the CPL for EBTs,
only those devices listed without an asterisk (*) may be used for
confirmatory alcohol testing under this subpart.
(c) EBT capabilities. An EBT that is listed in the NHTSA CPL for
evidential devices that has the following capabilities may be used for
conducting initial alcohol tests and must be used for confirmatory
alcohol tests under this subpart:
(1) Provides a printed result of each breath test;
(2) Assigns a unique number to each completed test, which the
collector and donor can read before each test and which is printed on
each copy of the test result;
(3) Prints, on each copy of the test result, the manufacturer's
name for the device, its serial number, and the time of the test;
(4) Distinguishes alcohol from acetone at the 0.02 alcohol
concentration level;
(5) Tests an air blank; and
(6) Permits performance of an external calibration check.
(d) Quality assurance and quality control of ASDs. (1) Licensees
and other entities shall implement the most recent version of the
quality assurance plan submitted to NHTSA for any ASD that is used for
initial alcohol testing.
(2) Licensees and other entities may not use an ASD that fails the
specified quality control checks or that has passed its expiration
date.
(3) For ASDs that test breath specimens and meet EBT requirements
for confirmatory testing, licensees and other entities shall also
follow the device use and care requirements specified in paragraph (e)
of this section.
(e) Quality assurance and quality control of EBTs. (1) Licensees
and other entities shall implement the most recent version of the
manufacturer's instructions for the use and care of the EBT
consistently with the quality assurance plan submitted to NHTSA for the
EBT, including performing external calibration checks no less
frequently than at the intervals specified in the manufacturer's
instructions.
(2) When conducting external calibration checks, licensees and
other entities shall use only calibration devices appearing on NHTSA's
CPL for ``Calibrating Units for Breath Alcohol Tests.''
(3) If an EBT fails an external check of calibration, the licensee
or other entity shall take the EBT out of service. The EBT may not be
used again for alcohol testing under this subpart until it is repaired
and passes an external calibration check.
(4) In order to ensure that confirmed positive alcohol test results
are derived from an EBT that is calibrated, the licensee or other
entity shall implement one of the following procedures:
(i) If an EBT fails any external check of calibration, cancel every
confirmed positive test result that was obtained using the EBT from any
tests that were conducted after the EBT passed the last external
calibration check; or
(ii) After every confirmed positive test result obtained from using
an EBT, conduct an external check of calibration of the EBT in the
presence of the donor. If the EBT fails the external calibration check,
cancel the donor's test result and conduct another initial and
confirmatory test on a different EBT as soon as practicable.
(5) Inspection, maintenance, and calibration of the EBT must be
performed by its manufacturer or a maintenance representative or other
individual who is certified either by the manufacturer or by a State
health agency or other appropriate State agency.
Sec. 26.93 Preparing for alcohol testing.
(a) Immediately before collecting a specimen for alcohol testing,
the collector shall--
(1) Ask the donor whether he or she, in the past 15 minutes, has
had anything to eat or drink, belched, or put anything into his or her
mouth (including, but not limited to, a cigarette, breath mint, or
chewing gum), and instruct the donor that he or she should avoid these
activities during the collection process;
(2) If the donor states that he or she has not engaged in the
activities listed in paragraph (a)(1) of this section, alcohol testing
may proceed;
(3) If the donor states that he or she has engaged in any of the
activities listed in paragraph (a)(1) of this section, inform the donor
that a 15-minute waiting period is necessary to prevent an accumulation
of mouth alcohol from leading to an artificially high reading;
(4) Explain that it is to the donor's benefit to avoid the
activities listed in paragraph (a)(1) of this section during the
collection process;
(5) Explain that the initial and confirmatory tests, if a
confirmatory test is necessary, will be conducted at the end of the
waiting period, even if the donor has not followed the instructions;
and
(6) Document that the instructions were communicated to the donor.
(b) With the exception of the 15-minute waiting period, if
necessary, the collector shall begin for-cause alcohol and/or drug
testing as soon as reasonably practical after the decision is made that
for-cause testing is required. When for-cause alcohol testing is
required, alcohol testing may not be delayed by collecting a specimen
for drug testing.
Sec. 26.95 Conducting an initial test for alcohol using a breath
specimen.
(a) The collector shall perform the initial breath test as soon as
practical after the donor indicates that he or she has not engaged in
the activities listed in Sec. 26.93(a)(1) or after the 15-minute
waiting period has elapsed, if required.
(b) To perform the initial test, the collector shall--
(1) Select, or allow the donor to select, an individually wrapped
or sealed mouthpiece from the testing materials;
(2) Open the individually wrapped or sealed mouthpiece in view of
the donor and insert it into the device as required by the
manufacturer's instructions;
(3) Instruct the donor to blow steadily and forcefully into the
mouthpiece for at least 6 seconds or until the device indicates that an
adequate amount of breath has been obtained;
(4) Show the donor the displayed or printed test result; and
(5) Ensure that the test result record can be associated with the
donor and is maintained secure.
(c) Unless problems in administering the breath test require an
additional collection, only one breath specimen may be collected for
the initial test. If an additional collection(s) is required, the
collector shall rely on the test result from the first successful
collection to determine the need for confirmatory testing.
Sec. 26.97 Conducting an initial test for alcohol using a specimen of
oral fluids.
(a) To perform the initial test, the collector shall--
(1) Check the expiration date on the device and show it to the
donor (the device may not be used after its expiration date);
(2) Open an individually wrapped or sealed package containing the
device in the presence of the donor;
[[Page 17199]]
(3) Offer the donor the choice of using the device or having the
collector use it. If the donor chooses to use it, instruct the donor to
insert the device into his or her mouth and use it in the manner
described by the device's manufacturer;
(4) If the donor chooses not to use the device, or in all cases
when a new test is necessary because the device failed to activate,
insert the device into the donor's mouth, and gather oral fluids in the
manner described by the device's manufacturer (wear single-use
examination or similar gloves while doing so and change them following
each test); and
(5) When the device is removed from the donor's mouth, follow the
manufacturer's instructions regarding necessary next steps to ensure
that the device has activated.
(b) If the steps in paragraph (a) of this section could not be
completed successfully (e.g., the device breaks, the device is dropped
on the floor, the device fails to activate), the collector shall--
(1) Discard the device and conduct a new test using a new device.
The new device must be one that has been under the collector's control
before the test;
(2) Record the reason for the new test;
(3) Offer the donor the choice of using the device or having the
collector use it unless the donor, in the opinion of the collector, was
responsible for the new test needing to be conducted. If the collector
concludes that the donor was responsible, then the collector shall use
the device to conduct the test; and
(4) Repeat the procedures in paragraph (a) of this section.
(c) If the second collection attempt in paragraph (b) of this
section could not be completed, the collector shall--
(1) End the collection of oral fluids and document the reason(s)
that the collection could not be completed; and
(2) Immediately conduct another initial test using an EBT.
(d) The collector shall read the result displayed on the device no
sooner than the device's manufacturer instructs. In all cases, the
collector shall read the result within 15 minutes of the test. The
collector shall then show the device and its reading to the donor,
record the result, and record that an ASD was used.
(e) Devices, swabs, gloves, and other materials used in collecting
oral fluids may not be re-used.
Sec. 26.99 Determining the need for a confirmatory test for alcohol.
(a) If the initial test result is less than 0.02 percent BAC, the
collector shall declare the test result as negative.
(b) If the initial test result is 0.02 percent BAC or higher, the
collector shall ensure that the time at which the test was concluded
(i.e., the time at which the test result was known) is recorded and
inform the donor that a confirmatory test for alcohol is required.
Sec. 26.101 Conducting a confirmatory test for alcohol.
(a) The confirmatory test must begin as soon as possible, but no
more than 30 minutes after the conclusion of the initial test.
(b) To complete the confirmatory test, the collector shall--
(1) In the presence of the donor, conduct an air blank on the EBT
before beginning the confirmatory test and show the result to the
donor;
(2) Verify that the reading is 0.00. If the reading is 0.00, the
test may proceed. If not, then conduct another air blank;
(3) If the reading on the second air blank is 0.00, the test may
proceed. If the reading is greater than 0.00, take the EBT out of
service and proceed with the test using another EBT. If an EBT is taken
out of service for this reason, the EBT may not be used for further
testing until it is found to be within tolerance limits on an external
check of calibration;
(4) Open an individually wrapped or sealed mouthpiece in view of
the donor and insert it into the device as required by the
manufacturer's instructions;
(5) Read the unique test number displayed on the EBT, and ensure
that the donor reads the same number;
(6) Instruct the donor to blow steadily and forcefully into the
mouthpiece for at least 6 seconds or until the device indicates that an
adequate amount of breath has been obtained; and
(7) Show the donor the result displayed on or printed by the EBT,
record the result, and document the time at which the confirmatory test
result was known.
(c) Unless there are problems in administering the breath test that
require an additional collection, the collector shall collect only one
breath specimen for the confirmatory test. If an additional
collection(s) is required because of problems in administering the
breath test, the collector shall rely on the breath specimen from the
first successful collection to determine the confirmatory test result.
Collection procedures may not require collectors to calculate an
average or otherwise combine results from two or more breath specimens
to determine the confirmatory test result.
(d) If an EBT that meets the requirements of Sec. 26.91(b) and (c)
was used for the initial alcohol test, the same EBT may be used for
confirmatory testing.
Sec. 26.103 Determining a confirmed positive test result for alcohol.
(a) A confirmed positive test result for alcohol must be declared
under any of the following conditions:
(1) When the result of the confirmatory test for alcohol is 0.04
percent BAC or higher;
(2) When the result of the confirmatory test for alcohol is 0.03
percent BAC or higher and the donor had been in a work status for at
least 1 hour at the time the initial test was concluded (including any
breaks for rest, lunch, dental/doctor appointments, etc.); or
(3) When the result of the confirmatory test for alcohol is 0.02
percent BAC or higher and the donor had been in a work status for at
least 2 hours at the time the initial test was concluded (including any
breaks for rest, lunch, dental/doctor appointments, etc.).
(b) When the result of the confirmatory test for alcohol is equal
to or greater than 0.01 percent BAC but less than 0.02 percent BAC and
the donor has been in a work status for 3 hours or more at the time the
initial test was concluded (including any breaks for rest, lunch,
dental/doctor appointments, etc.), the collector shall declare the test
result as negative and inform FFD program management. The licensee or
other entity shall prohibit the donor from performing any duties that
require the individual to be subject to this subpart and may not return
the individual to performing such duties until a determination of
fitness indicates that the donor is fit to safely and competently
perform his or her duties.
Sec. 26.105 Preparing for urine collection.
(a) The collector shall ask the donor to remove any unnecessary
outer garments, such as a coat or jacket, which might conceal items or
substances that the donor could use to tamper with or adulterate his or
her urine specimen. The collector shall ensure that all personal
belongings such as a purse or briefcase remain with the outer garments
outside of the room or stall in which the urine specimen is collected.
The donor may retain his or her wallet.
(b) The collector shall also ask the donor to empty his or her
pockets and display the items in them to enable the collector to
identify items that the donor could use to adulterate or substitute his
or her urine specimen. The donor shall permit the collector to make
this observation. If the donor refuses to show the collector the items
in his or her
[[Page 17200]]
pockets, this is considered a refusal to test. If an item is found that
appears to have been brought to the collection site with the intent to
adulterate or substitute the specimen, the collector shall contact the
MRO or FFD program manager to determine whether a directly observed
collection is required. If the item appears to have been inadvertently
brought to the collection site, the collector shall secure the item and
continue with the normal collection procedure. If the collector
identifies nothing that the donor could use to adulterate or substitute
the specimen, the donor may place the items back into his or her
pockets.
(c) The collector shall instruct the donor to wash and dry his or
her hands before urinating.
(d) After washing his or her hands, the donor shall remain in the
presence of the collector and may not have access to any water
fountain, faucet, soap dispenser, cleaning agent, or other materials
that he or she could use to adulterate the urine specimen.
(e) The collector may select, or allow the donor to select, an
individually wrapped or sealed collection container from the collection
kit materials. Either the collector or the donor, with both present,
shall unwrap or break the seal of the collection container. With the
exception of the collection container, the donor may not take anything
from the collection kit into the room or stall used for urination.
Sec. 26.107 Collecting a urine specimen.
(a) The collector shall direct the donor to go into the room or
stall used for urination, provide a specimen of the quantity that has
been predetermined by the licensee or other entity, as defined in Sec.
26.109(a), not flush the toilet, and return with the specimen as soon
as the donor has completed the void.
(1) The donor shall provide his or her urine specimen in the
privacy of a room, stall, or otherwise partitioned area (private area)
that allows for individual privacy, except if a directly observed
collection is required, as described in Sec. 26.115;
(2) Except in the case of a directly observed collection, no one
may go with the donor into the room or stall in which the donor will
provide his or her specimen; and
(3) The collector may set a reasonable time limit for voiding.
(b) The collector shall pay careful attention to the donor during
the entire collection process to note any conduct that clearly
indicates an attempt to tamper with a specimen (e.g., substitute urine
is in plain view or an attempt to bring an adulterant or urine
substitute into the private area used for urination). If any such
conduct is detected, the collector shall document the conduct on the
custody-and-control form and contact FFD program management to
determine whether a directly observed collection is required, as
described in Sec. 26.115.
(c) After the donor has provided the urine specimen and submitted
it to the collector, the donor shall be permitted to wash his or her
hands. The collector shall inspect the toilet bowl and room or stall in
which the donor voided to identify any evidence of a subversion
attempt, and then flush the toilet.
Sec. 26.109 Urine specimen quantity.
(a) Licensees and other entities who are subject to this subpart
shall establish a predetermined quantity of urine that donors are
requested to provide when submitting a specimen. At a minimum, the
predetermined quantity must include 30 milliliters (mL) to ensure that
a sufficient quantity of urine is available for initial and
confirmatory validity and drug tests at an HHS-certified laboratory,
and for retesting of an aliquot of the specimen if requested by the
donor under Sec. 26.165(b). The licensee's or other entity's
predetermined quantity may include more than 30 mL, if the testing
program follows split specimen procedures, tests for additional drugs,
or performs initial testing at a licensee testing facility. Where
collected specimens are to be split under the provisions of this
subpart, the predetermined quantity must include an additional 15 mL.
(b) If the quantity of urine in the first specimen provided by the
donor is less than 30 mL, the collector shall take the following steps:
(1) The collector shall encourage the donor to drink a reasonable
amount of liquid (normally, 8 ounces of water every 30 minutes, but not
to exceed a maximum of 40 ounces over 3 hours) until the donor provides
a specimen containing at least 30 mL. The collector shall provide the
donor with a separate collection container for each successive
specimen;
(2) Once the donor provides a specimen of at least 30 mL, the
collection must end. If the specimen quantity is at least 30 mL but is
less than the licensee's or other entity's predetermined quantity, the
licensee or other entity may not require the donor to provide
additional specimens and may not impose any sanctions on the donor. If
the donor provides a specimen of 30 mL or more, but the specimen
quantity is less than the predetermined quantity, the collector shall
forward the specimen to the HHS-certified laboratory for testing. If
the donor provides a specimen of at least the predetermined quantity,
the specimen may be processed under the FFD program's usual testing
procedures;
(3) If the donor has not provided a specimen of at least 30 mL
within 3 hours of the first unsuccessful attempt to provide a specimen
of the predetermined quantity, the collector shall discontinue the
collection and notify the FFD program manager or MRO to initiate the
``shy bladder'' procedures in Sec. 26.119; and
(4) Neither the donor nor the collector may combine specimens. The
collector shall discard specimens of less than 30 mL, except if there
is reason to believe that the donor has diluted, adulterated,
substituted, or otherwise tampered with the specimen, based on the
collector's observations of the donor's behavior during the collection
process or the specimen's characteristics, as specified in Sec.
26.111. If the collector has a reason to believe that a specimen that
is 15 mL or more, but less than 30 mL, has been diluted, adulterated,
substituted, or altered, the collector shall prepare the suspect
specimen for shipping to the HHS-certified laboratory and contact FFD
program management to determine whether a directly observed collection
is required, as described in Sec. 26.115.
Sec. 26.111 Checking the acceptability of the urine specimen.
(a) Immediately after the donor provides the urine specimen to the
collector, including specimens of less than 30 mL but greater than 15
mL, the collector shall measure the temperature of the specimen. The
temperature-measuring device used must accurately reflect the
temperature of the specimen and not contaminate the specimen. The time
from urination to temperature measurement may not exceed 4 minutes. If
the temperature of a urine specimen is outside the range of 90 [deg]F
to 100 [deg]F (32 [deg]C to 38 [deg]C), that is a reason to believe the
donor may have altered or substituted the specimen.
(b) Immediately after the donor provides a urine specimen,
including specimens of less than 30 mL but equal to or greater than 15
mL, the collector shall also inspect the specimen to determine its
color and clarity and look for any signs of contaminants or
adulteration. The collector shall note any unusual findings on the
custody-and-control form.
(c) If there is reason to believe that the donor may have attempted
to dilute, substitute, or adulterate the specimen based on specimen
temperature or other observations made during the collection, the
collector shall contact the
[[Page 17201]]
designated FFD program manager, who may consult with the MRO, to
determine whether the donor has attempted to subvert the testing
process or whether other circumstances may explain the observations.
The FFD program manager or MRO may require the donor to provide a
second specimen as soon as possible under direct observation. In
addition, the collector shall inform the donor that he or she may
volunteer to submit a second specimen under direct observation to
counter the reason to believe the donor may have altered or substituted
the specimen.
(d) Any specimen of 15 mL or more that the collector suspects has
been diluted, substituted, or adulterated, and any specimen of 15 mL or
more that has been collected under direct observation under paragraph
(c) of this section, must be sent directly to the HHS-certified
laboratory for initial and, if required, confirmatory testing, and may
not be subject to initial testing at a licensee testing facility.
(e) As much of the suspect specimen as possible must be preserved.
(f) An acceptable specimen is free of any apparent contaminants,
meets the required basic quantity of at least 30 mL, and is within the
acceptable temperature range.
Sec. 26.113 Splitting the urine specimen.
(a) Licensees and other entities may, but are not required to, use
split-specimen methods of collection.
(b) If the urine specimen is to be split into two specimen bottles,
hereinafter referred to as Bottle A and Bottle B, the collector shall
take the following steps:
(1) The collector shall instruct the donor to urinate into a
specimen container;
(2) The collector, in the presence of the donor and after
determining specimen temperature as described in Sec. 26.111(a), shall
split the urine specimen. The collector shall pour 30 mL of urine into
Bottle A and a minimum of 15 mL of urine into Bottle B. If the quantity
of urine available for Bottle B is less than 15 mL, the collector shall
pour the remaining urine into Bottle B and forward the specimens in
Bottles A and B to the HHS-certified laboratory for drug and validity
testing; and
(3) The collector shall ask the donor to observe the splitting of
the urine specimen and to maintain visual contact with both specimen
bottles until the custody-and-control form(s) for both specimens are
completed, the specimens are sealed, and the specimens and form(s) are
prepared for secure storage or shipping.
(c) Licensees and other entities may use aliquots of the specimen
collected for validity screening and initial validity and drug testing
at the licensee testing facility, as permitted under Sec.
26.31(d)(3)(ii), or to test for additional drugs, as permitted under
Sec. 26.31(d)(1)(i)(A), but only if sufficient urine is available for
this testing after the specimen has been split into Bottle A and Bottle
B.
Sec. 26.115 Collecting a urine specimen under direct observation.
(a) Procedures for collecting urine specimens must provide for the
donor's privacy unless directed by this subpart or the MRO or FFD
program manager determines that a directly observed collection is
warranted. The following circumstances constitute the exclusive grounds
for performing a directly observed collection:
(1) The donor has presented, at this or a previous collection, a
urine specimen that the HHS-certified laboratory reported as being
substituted, adulterated, or invalid to the MRO and the MRO reported to
the licensee or other entity that there is no adequate medical
explanation for the result;
(2) The donor has presented, at this collection, a urine specimen
that falls outside the required temperature range;
(3) The collector observes conduct clearly and unequivocally
indicating an attempt to dilute, substitute, or adulterate the
specimen; and
(4) A directly observed collection is required under Sec. 26.69.
(b) Before collecting a urine specimen under direct observation,
the collector shall obtain the agreement of the FFD program manager or
MRO to obtain a urine specimen under direct observation. After
obtaining agreement, the collector shall ensure that a specimen is
collected under direct observation as soon as reasonably practicable.
(c) The collector shall explain to the donor the reason for direct
observation of the collection under paragraph (a) of this section.
(d) The collector shall complete a new custody-and-control form for
the specimen that is obtained from the directly observed collection.
The collector shall record that the collection was observed and the
reason(s) for the directly observed collection on the form.
(e) The collector shall ensure that the observer is the same gender
as the individual. A person of the opposite gender may not act as the
observer under any conditions. The observer may be a different person
from the collector and need not be a qualified collector.
(f) If someone other than the collector is to observe the
collection, the collector shall instruct the observer to follow the
procedures in this paragraph. The individual who observes the
collection shall follow these procedures:
(1) The observer shall instruct the donor to adjust his or her
clothing to ensure that the area of the donor's body between the waist
and knees is exposed;
(2) The observer shall watch the donor urinate into the collection
container. Specifically, the observer shall watch the urine go from the
donor's body into the collection container;
(3) If the observer is not the collector, the observer may not take
the collection container from the donor, but shall observe the specimen
as the donor takes it to the collector; and
(4) If the observer is not the collector, the collector shall
record the observer's name on the custody-and-control form.
(g) If a donor declines to allow a directly observed collection
that is required or permitted under this section, the donor's refusal
constitutes an act to subvert the testing process.
(h) If a collector learns that a directly observed collection
should have been performed but was not, the collector shall inform the
FFD program manager, or his or her designee. The FFD program manager or
designee shall ensure that a directly observed collection is
immediately performed.
Sec. 26.117 Preparing urine specimens for storage and shipping.
(a) Both the donor and the collector shall keep the donor's urine
specimen(s) in view at all times before the specimen(s) are sealed and
labeled. If any specimen or aliquot is transferred to another
container, the collector shall ask the donor to observe the transfer
and sealing of the container with a tamper-evident seal.
(b) Both the collector and the donor shall be present (at the same
time) during the procedures outlined in this section.
(c) The collector shall place an identification label securely on
each container. The label must contain the date, the donor's specimen
number, and any other identifying information provided or required by
the FFD program. The collector shall also apply a tamper-evident seal
on each container if it is separate from the label. The specimen bottle
must be securely sealed to prevent undetected tampering.
(d) The donor shall initial the identification label(s) on the
specimen bottle(s) for the purpose of certifying that the specimen was
collected from him or her. The collector shall also ask
[[Page 17202]]
the donor to read and sign a statement on the custody-and-control form
certifying that the specimen(s) identified as having been collected
from the donor is, in fact, the specimen(s) that he or she provided.
(e) The collector shall complete the custody-and-control form(s)
and shall certify proper completion of the collection.
(f) The specimens and chain-of-custody forms must be packaged for
transfer to the HHS-certified laboratory or the licensee's testing
facility. If the specimens are not immediately prepared for transfer,
they must be appropriately safeguarded during temporary storage.
(g) While any part of the chain-of-custody procedures is being
performed, the specimens and custody documents must be under the
control of the involved collector. The collector may not leave the
collection site during the interval between presentation of the
specimen by the donor and securing of the specimens with identifying
labels bearing the donor's specimen identification numbers and seals
initialed by the donor. If the involved collector momentarily leaves
his or her workstation, the sealed specimens and custody-and-control
forms must be secured or taken with him or her. If the collector is
leaving for an extended period of time, the specimens must be packaged
for transfer to the HHS-certified laboratory or the licensee testing
facility and secured before the collector leaves the collection site.
(h) The specimen(s) sealed in a shipping container must be
immediately transferred, appropriately safeguarded during temporary
storage, or kept under the personal control of an authorized individual
until transferred. These minimum procedures apply to the transfer of
specimens to licensee testing facilities from collection sites (except
where co-located) as well as to the shipping of specimens to HHS-
certified laboratories. As an option, licensees and other entities may
ship several specimens via courier in a locked or sealed shipping
container.
(i) Collection site personnel shall ensure that a custody-and-
control form is packaged with its associated urine specimen bottle.
Unless a collection site and a licensee testing facility are co-
located, the sealed and labeled specimen bottles, with their associated
custody-and-control forms that are being transferred from the
collection site to the drug testing laboratory must be placed in a
second, tamper-evident shipping container. The second container must be
designed to minimize the possibility of damage to the specimen during
shipment (e.g., specimen boxes, shipping bags, padded mailers, or bulk
insulated shipping containers with that capability), so that the
contents of the shipping containers are no longer accessible without
breaking a tamper-evident seal.
(j) Collection site personnel shall arrange to transfer the
collected specimens to the HHS-certified laboratory or the licensee
testing facility. Licensees and other entities shall take appropriate
and prudent actions to minimize false negative results from specimen
degradation. Specimens that have not been shipped to the HHS-certified
laboratory or the licensee testing facility within 24 hours of
collection and any specimen that is suspected of having been
substituted, adulterated, or tampered with in any way must be
maintained cooled to not more than 6[deg]C (42.8 [deg]F) until they are
shipped to the HHS-certified laboratory. Specimens must be shipped from
the collection site to the HHS-certified laboratory or the licensee
testing facility as soon as reasonably practical but, except under
unusual circumstances, the time between specimen shipment and receipt
of the specimen at the licensee testing facility or HHS-certified
laboratory should not exceed 2 business days.
(k) Couriers, express carriers, and postal service personnel do not
have direct access to the custody-and-control forms or the specimen
bottles. Therefore, there is no requirement that such personnel
document chain of custody on the custody-and-control forms during
transit. Custody accountability of the shipping containers during
shipment must be maintained by a tracking system provided by the
courier, express carrier, or postal service.
Sec. 26.119 Determining ``shy'' bladder.
(a) When a donor has not provided a specimen of at least 30 mL
within the 3 hours permitted for urine collection, FFD program
personnel shall direct the donor to obtain, within 5 business days, an
evaluation from a licensed physician who is acceptable to the MRO and
has expertise in the medical issues raised by the donor's failure to
provide a sufficient specimen. The MRO may perform this evaluation if
the MRO has the appropriate expertise.
(b) If another physician will perform the evaluation, the MRO shall
provide the other physician with the following information and
instructions:
(1) The donor was required to take a drug test, but was unable to
provide a sufficient quantity of urine to complete the test;
(2) The potential consequences of refusing to take the required
drug test; and
(3) The physician must agree to follow the requirements of
paragraphs (c) through (f) of this section.
(c) The physician who conducts this evaluation shall make one of
the following determinations:
(1) A medical condition has, or with a high degree of probability
could have, precluded the donor from providing a sufficient amount of
urine; or
(2) There is an inadequate basis for determining that a medical
condition has, or with a high degree of probability could have,
precluded the donor from providing a sufficient quantity of urine.
(d) For purposes of this section, a medical condition includes an
ascertainable physiological condition (e.g., a urinary system
dysfunction) or a medically documented pre-existing psychological
disorder, but does not include unsupported assertions of ``situational
anxiety'' or dehydration.
(e) The physician who conducts this evaluation shall provide a
written statement of his or her determination and the basis for it to
the MRO. This statement may not include detailed information on the
donor's medical condition beyond what is necessary to explain the
determination.
(f) If the physician who conducts this evaluation determines that
the donor's medical condition is a serious and permanent or long-term
disability that is highly likely to prevent the donor from providing a
sufficient amount of urine for a very long or indefinite period of
time, the physician shall set forth this determination and the reasons
for it in the written statement to the MRO.
(g) The MRO shall seriously consider and assess the information
provided by the physician in deciding whether the donor has a medical
condition that has, or with a high degree of probability could have,
precluded the donor from providing a sufficient amount of urine, as
follows:
(1) If the MRO concurs with the physician's determination, then the
MRO shall declare that the donor has not violated the FFD policy and
the licensee or other entity shall take no further action with respect
to the donor;
(2) If the MRO determines that the medical condition has not, or
with a high degree of probability could not have, precluded the donor
from providing a sufficient amount of urine, then the MRO shall declare
that there has been a refusal to test; or
(3) If the MRO determines that the medical condition is highly
likely to prevent the donor from providing a sufficient amount of urine
for a very
[[Page 17203]]
long or indefinite period of time, then the MRO shall authorize an
alternative evaluation process, tailored to the individual case, for
drug testing.
Subpart F--Licensee Testing Facilities
Sec. 26.121 Purpose.
This subpart contains requirements for facilities that are operated
by licensees and other entities who are subject to this part to perform
initial tests of urine specimens for validity, drugs, and drug
metabolites.
Sec. 26.123 Testing facility capabilities.
Each licensee testing facility shall have the capability, at the
same premises, to perform either validity screening tests or initial
validity tests or both, and initial drug tests for each drug and drug
metabolite for which testing is conducted.
Sec. 26.125 Licensee testing facility personnel.
(a) Each licensee testing facility shall have one or more
individuals who are responsible for day-to-day operations and
supervision of the testing technicians. The designated individual(s)
shall have at least a bachelor's degree in the chemical or biological
sciences, medical technology, or equivalent. He or she shall also have
training and experience in the theory and practice of the procedures
used in the licensee testing facility, and a thorough understanding of
quality control practices and procedures, the review, interpretation,
and reporting of test results, and proper remedial actions to be taken
in response to detection of abnormal test or quality control results.
(b) Other technicians or non-technical staff shall have the
necessary training and skills for their assigned tasks. Technicians who
perform urine specimen testing shall have documented proficiency in
operating the testing instruments and devices used at the licensee
testing facility.
(c) Licensee testing facility personnel files must include each
individual's resume of training and experience; certification or
license, if any; references; job descriptions; records of performance
evaluations and advancement; incident reports, if any; results of tests
that establish employee competency for the position he or she holds,
including, but not limited to, certification that personnel are
proficient in conducting testing in accordance with manufacturer's most
recent instructions for the instruments and devices used and tests for
color blindness; and appropriate data to support determinations of
honesty and integrity required by this part.
Sec. 26.127 Procedures.
(a) Licensee testing facilities shall develop, implement, and
maintain clear and well-documented procedures for accession, shipment,
and testing of urine specimens.
(b) Written chain-of-custody procedures must describe the methods
to be used to maintain control and accountability of specimens from
receipt through completion of testing and reporting of results, during
storage and shipping to the HHS-certified laboratory, and continuing
until final disposition of the specimens.
(c) Licensee testing facilities shall develop, implement, and
maintain written standard operating procedures for each assay performed
for drug and specimen validity testing. If a licensee testing facility
performs validity screening tests, the licensee testing facility shall
develop, implement, and maintain written standard operating procedures
for each test. The procedures must include, but are not limited to,
detailed descriptions of--
(1) The principles of each test;
(2) Preparation of reagents, standards, and controls;
(3) Calibration procedures;
(4) Derivation of results;
(5) Linearity of the methods;
(6) Sensitivity of the methods;
(7) Cutoff values;
(8) Mechanisms for reporting results;
(9) Controls;
(10) Criteria for unacceptable specimens and results;
(11) Reagents and expiration dates; and
(12) References.
(d) Licensee testing facilities shall develop, implement, and
maintain written procedures for instrument and test setup and normal
operation, including the following:
(1) A schedule for checking critical operating characteristics for
all instruments and validity screening tests;
(2) Tolerance limits for acceptable function checks; and
(3) Instructions for major troubleshooting and repair.
(e) Licensee testing facilities shall develop, implement, and
maintain written procedures for remedial actions to be taken when
systems, and instrumented and non-instrumented tests are out of
acceptable limits or errors are detected. Each facility shall maintain
documentation that these procedures are followed and that all necessary
corrective actions are taken. In addition, each facility shall have
systems in place to verify all stages of testing and reporting and to
document the verification.
Sec. 26.129 Assuring specimen security, chain of custody, and
preservation.
(a) Each licensee testing facility must be secure at all times.
Each licensee or other entity shall have sufficient security measures
in place to control access to the licensee testing facility and to
ensure that no unauthorized personnel handle specimens or gain access
to the licensee testing facility's processes or areas where records are
stored. Access to these secured areas must be limited to specifically
authorized individuals whose authorization is documented. All
authorized visitors and maintenance and service personnel shall be
escorted at all times while in the licensee testing facility.
(b) When specimens are received, licensee testing facility
personnel shall inspect each package for evidence of possible tampering
and shall compare information on the specimen containers within each
package to the information on the accompanying custody-and-control
forms. Licensee testing facility personnel shall attempt to resolve any
discrepancies identified in the information on specimen bottles or on
the accompanying custody-and-control forms. When resolving any
discrepancies, licensee testing facility personnel shall obtain a
memorandum for the record from the specimen collector involved in the
discrepancy to document correction of the discrepancy. This memorandum
must accompany the specimen(s) and custody-and-control forms to the
HHS-certified laboratory if the specimen(s) must be transferred.
(1) Indications of tampering with specimens in transit from the
collection site, or at a licensee testing facility, must be reported to
senior licensee or other entity management as soon as practical and no
later than 8 hours after the indications are identified. In response to
a report, licensee or other entity management personnel shall initiate
an investigation to determine whether tampering has occurred.
(i) If the investigation determines that tampering has occurred,
licensee or other entity management shall ensure that corrective
actions are taken.
(ii) If there is reason to believe that the integrity or identity
of a specimen is in question (as a result of tampering or discrepancies
between the information on the specimen bottle and on the accompanying
custody-and-control forms that cannot be resolved), the specimen may
not be tested and the licensee or other entity shall ensure that
another collection occurs as soon as reasonably practical, except if a
split specimen collection was performed, either the Bottle A or Bottle
B seal
[[Page 17204]]
remains intact, and the intact specimen contains at least 15 mL of
urine. In this instance, the licensee testing facility shall forward
the intact specimen for testing to the HHS-certified laboratory and may
not conduct any testing at the licensee testing facility.
(2) The following are exclusive grounds requiring the MRO to cancel
the testing of a donor's urine specimen:
(i) The custody-and-control form does not contain information to
identify the specimen collector and the collection site cannot provide
conclusive evidence of the collector's identity;
(ii) The identification numbers on the specimen bottle seal(s) do
not match the identification numbers on the custody-and-control form;
(iii) A specimen bottle seal is broken or shows evidence of
tampering and an intact specimen, as specified in paragraph (b)(1)(ii)
of this section, does not exist;
(iv) The specimen appears to have leaked out of its sealed bottle
and there is less than 15 mL remaining, and an intact specimen, as
specified in paragraph (b)(1)(ii) of this section, does not exist; or
(v) As required under Sec. 26.165(f)(2).
(c) The licensee testing facility shall retain specimen containers
within the testing facility's accession area until all analyses have
been completed. Testing facility personnel shall use aliquots of the
specimen and licensee testing facility chain-of-custody forms, or other
appropriate methods of tracking aliquot custody and control, when
conducting validity screening and initial validity and drug tests. The
original specimen bottles and the original custody-and-control forms
must remain in secure storage. Licensee testing facility personnel may
discard specimens and aliquots as soon as practical after validity
screening or initial validity tests have demonstrated that the specimen
appears valid and initial test results for drugs and drug metabolites
are negative.
(d) The licensee testing facility's procedure for tracking custody
and control of specimens and aliquots must protect the identity of the
donor, and provide documentation of the testing process and transfers
of custody of the specimen and aliquots. Each time a specimen or
aliquot is handled or transferred within the licensee testing facility,
testing facility personnel shall document the date and purpose and
every individual in the chain of custody must be identified.
(e) Urine specimens identified as positive or of questionable
validity at a licensee testing facility must be shipped to an HHS-
certified laboratory for testing as soon as reasonably practical.
(f) Licensee testing facility personnel shall take appropriate and
prudent actions to minimize false negative results from specimen
degradation. If validity screening or initial validity testing indicate
that the specimen is of questionable validity, or initial drug test
results are positive, or if a specimen has not been tested within 24
hours of receipt at the licensee testing facility, then the facility
shall maintain the specimen cooled to not more than 6 [deg]C (42.8
[deg]F) until it is forwarded to the HHS-certified laboratory for
further testing, if required. Split specimens in Bottle B that are
associated with positive specimens or specimens of questionable
validity in Bottle A must also be maintained cooled (as previously
specified) until test results from the HHS-certified laboratory are
known to be negative for Bottle A; until the MRO informs the licensee
testing facility that Bottle B must be forwarded to an HHS-certified
laboratory for testing; or until the specimen is moved to long-term,
frozen storage, under Sec. 26.135(c).
(g) Licensee testing facility personnel shall ensure that the
original custody-and-control form is packaged with its associated urine
specimen bottle. Sealed and labeled specimen bottles, with their
associated custody-and-control forms, being transferred from the
licensee testing facility to the HHS-certified laboratory must be
placed in a second, tamper-evident shipping container designed to
minimize the possibility of damage to the specimen during shipment
(e.g., specimen boxes, padded mailers, or bulk insulated shipping
containers with that capability) so that the contents of the shipping
containers are no longer accessible without breaking a tamper-evident
seal.
(h) Couriers, express carriers, and postal service personnel do not
have direct access to the custody-and-control forms or the specimen
bottles. Therefore, such personnel are not required to document chain
of custody on the custody-and-control forms during transit. Custody
accountability of the shipping containers during shipment must be
maintained by a tracking system provided by the courier, express
carrier, or postal service.
Sec. 26.131 Cutoff levels for validity screening and initial validity
tests.
(a) Each validity test result from the licensee testing facility
must be based on performing either a validity screening test or an
initial validity test, or both, on one or more aliquots of a urine
specimen. The licensee testing facility shall forward any specimen that
yields a questionable validity screening or initial validity test
result to the HHS-certified laboratory for further testing. Licensee
testing facilities need not perform validity screening tests before
conducting initial validity tests of a specimen.
(b) At a minimum, the licensee testing facility shall test each
urine specimen for creatinine, pH, and one or more oxidizing
adulterants. Licensees and other entities may not specify more
stringent cutoff levels for validity screening and initial validity
tests than those specified in this section. If tests or observations
indicate one or more of the following from either a validity screening
test or an initial validity test, the licensee testing facility shall
forward the specimen to the HHS-certified laboratory for additional
testing:
(1) Creatinine is less than 20 milligrams (mg) per deciliter (dL);
(2) The pH of the specimen is either less than 4.5 or equal to or
greater than 9, using either a colorimetric pH test with a dynamic
range of 2 to 12 or pH meter that is capable of measuring pH to one
decimal place (for initial validity tests), or colorimetric pH tests,
dipsticks, and pH paper (for pH validity screening tests) that have a
narrow dynamic range;
(3) Nitrite or other oxidant concentration is equal to or greater
than 200 micrograms (mcg) per mL or equal to or greater than 200 mcg/mL
nitrite-equivalents using either a nitrite colorimetric test or a
general oxidant colorimetric test;
(4) The possible presence of an oxidizing adulterant (e.g.,
chromium (VI), pyridine (pyridinium chlorochromate)) is determined
using either a general oxidant colorimetric test (with a cutoff equal
to or greater than 50 mcg/mL chromium (VI)-equivalents) or a chromium
(VI) colorimetric test (chromium (VI) concentration equal to or greater
than 50 mcg/mL);
(5) The possible presence of halogen (e.g., bleach, iodine,
fluoride) is determined using a general oxidant colorimetric test (with
a cutoff equal to or greater than 200 mcg/mL nitrite-equivalents or
equal to or greater than 50 mcg/mL chromium (VI)-equivalents), a
halogen colorimetric test (halogen concentration equal to or greater
than the limit of detection (LOD)), or the odor of the specimen;
(6) The possible presence of glutaraldehyde is determined using
either an aldehyde test (aldehyde present) or the characteristic
immunoassay response is observed on one or more drug immunoassay tests;
(7) The possible presence of a surfactant is determined by using a
surfactant colorimetric test with a cutoff
[[Page 17205]]
equal to or greater than 100 mcg/mL dodecylbenzene sulfonate-equivalent
or a foam/shake test; or
(8) The specimen shows evidence of adulterants, including, but not
limited to, the following:
(i) Abnormal physical characteristics;
(ii) Reactions or responses characteristic of an adulterant
obtained during the validity screening or initial test; or
(iii) A possible unidentified interfering substance or adulterant,
demonstrated by interference occurring on the immunoassay drug tests on
two separate aliquots (i.e., valid immunoassay drug test results cannot
be obtained).
Sec. 26.133 Cutoff levels for drugs and drug metabolites.
Subject to the provisions of Sec. 26.31(d)(3)(iii), licensees and
other entities may specify more stringent cutoff levels for drugs and
drug metabolites than those in the table below and, in such cases, may
report initial test results for only the more stringent cutoff levels.
Otherwise, the following cutoff levels must be used for initial testing
of urine specimens to determine whether they are negative for the
indicated drugs and drug metabolites:
Initial Test Cutoff Levels for Drugs and Drug Metabolites
------------------------------------------------------------------------
Cutoff level
Drug or metabolites [nanograms
(ng)/mL]
------------------------------------------------------------------------
Marijuana metabolites................................... 50
Cocaine metabolites..................................... 300
Opiate metabolites...................................... 2000
Phencyclidine (PCP)..................................... 25
Amphetamines............................................ 1000
------------------------------------------------------------------------
Sec. 26.135 Split specimens.
(a) If the FFD program follows split-specimen procedures, as
described in Sec. 26.113, the licensee testing facility shall analyze
aliquots of the specimen for the licensee's or other entity's purposes
as described in this part. Except as provided in paragraph (b) in this
section, the licensee testing facility shall store Bottles A and B of
the specimen in a secure manner until the facility has finished
testing. If the initial validity and drug test results are negative and
the specimen in Bottle A will not be forwarded to the HHS-certified
laboratory, the licensee testing facility may discard both Bottle A and
Bottle B. If any test results are positive or indicate that the
specimen is of questionable validity, the licensee testing facility
shall forward Bottle A to the HHS-certified laboratory for testing and
shall retain Bottle B in secure storage, under the requirements of
Sec. 26.159(i), or may forward it to the HHS-certified laboratory for
storage.
(b) If the MRO confirms any positive, adulterated, or substituted
result for a specimen in Bottle A, based on the results of confirmatory
testing at an HHS-certified laboratory, and the licensee testing
facility has elected to retain Bottle B of the specimen, and the donor
requests testing of the specimen in Bottle B, as permitted under Sec.
26.165(b), the MRO shall ensure that Bottle B is forwarded to an HHS-
certified laboratory other than the laboratory that tested the specimen
in Bottle A, under the procedures specified in Sec. 26.165(b).
(c) If the MRO confirms that the specimen in Bottle A is positive,
adulterated, substituted, or invalid and the donor does not request
that Bottle B be tested, the licensee or other entity shall ensure that
Bottle B is maintained in long-term, frozen storage (-20 [deg]C/-68
[deg]F or less) for a minimum of 1 year. If a licensee testing facility
elects to retain the specimen in Bottle B, rather than forwarding it to
the HHS-certified laboratory with Bottle A, the licensee testing
facility shall ensure proper storage conditions in the event of a
prolonged power failure. After the end of 1 year, the licensee or other
entity may discard Bottle B, with the exception that the licensee
testing facility shall retain any specimens under legal challenge, or
as requested by the NRC, until the specimen is no longer needed.
Sec. 26.137 Quality assurance and quality control.
(a) Quality assurance program. Each licensee testing facility shall
have a quality assurance program that encompasses all aspects of the
testing process including, but not limited to, specimen acquisition,
chain of custody, security and reporting of results, validity screening
(if validity screening tests are performed), initial validity and drug
testing, and validation of analytical procedures. Quality assurance
procedures must be designed, implemented, and reviewed to monitor the
conduct of each step of the process of validity testing and testing for
drugs and drug metabolites.
(b) Performance testing and quality control requirements for
validity screening tests. (1) Licensee testing facilities may rely on
validity screening tests to determine the need for initial tests of
specimen validity either at the licensee testing facility or HHS-
certified laboratory. Licensees and other entities shall ensure that
the HHS-certified laboratory is capable of conducting confirmatory
testing for any adulterant for which the licensee testing facility
conducts validity screening tests. Licensee testing facilities shall
use only validity screening tests that meet the following criteria:
(i) Either the test, by lot number, has been placed on the
Substance Abuse and Mental Health Services Administration (SAMHSA) list
of point-of-collection tests that are approved for use in the Federal
Workplace Drug Testing Program; or
(ii) Before using the test, the licensee or other entity has
ensured that the validity screening test, by lot number, effectively
identifies specimens of questionable validity by meeting the following
performance testing and quality control requirements:
(A) The creatinine validity screening test must use a 20 mg/dL
cutoff concentration;
(B) A pH specimen validity screening test must be able to determine
if pH is less than 4.5 and if pH is equal to or greater than 9; and
(C) An oxidant validity screening test must be able to determine if
an oxidant concentration is equal to or greater than a 200 mcg/mL
nitrite-equivalent cutoff, and/or a chromium screening test must be
able to determine concentrations equal to or greater than a 50 mcg/mL
chromium(VI)-equivalent cutoff, and/or a halogen screening test must be
able to determine the halogen concentration is equal to or greater than
the LOD. Licensees and other entities who use validity screening tests
for additional adulterants shall establish performance testing
requirements to challenge the licensee testing facility and the HHS-
certified laboratory for the additional validity screening test(s);
(D) The manufacturer has conducted validation studies to document
the validity screening test's performance characteristics around each
applicable cutoff specified in this section, using performance testing
samples that have been formulated to challenge the validity screening
test around the applicable cutoffs. These validation studies must
demonstrate the validity screening test's ability to differentiate
valid samples from those of questionable validity and the performance
of the validity screening test(s) around the applicable cutoffs
specified in this section; and
(E) The licensee testing facility shall submit three consecutive
sets of performance testing samples to the manufacturer, using
performance testing samples that have been formulated to challenge the
validity screening test around the applicable cutoffs specified
[[Page 17206]]
in this paragraph and whose formulation levels have been confirmed by
an HHS-certified laboratory. For example, one set of performance
testing samples used to challenge a creatinine validity screening test
must include at least six samples formulated at different
concentrations ranging from 0 to 20 mg/dL. A set of performance testing
samples used to challenge a pH validity screening test must include at
least six samples formulated with different pH levels that are equal to
or less than 4.5, and six samples formulated with different pH levels
that are equal to or greater than 9. And, a set of performance testing
samples used to challenge an oxidizing adulterant validity screening
test must include at least six samples to challenge each validity
screening test used. The performance testing samples for oxidizing
adulterants must contain nitrite and other oxidizing adulterant
concentrations in a range of less than or equal to a 200 mcg/mL
nitrite-equivalent cutoff to a 500 mcg/mL nitrite-equivalent cutoff;
chromium samples formulated in a range less than or equal to a 50 mcg/
mL chromium(VI)-equivalent cutoff to 100 mcg/mL chromium(VI)-equivalent
cutoff; or halogen samples formulated in a concentration at or near the
LOD and 25 percent above the LOD. The results of analyzing the three
consecutive sets of performance test samples for each validity
screening test (i.e., creatinine, pH, nitrite and general oxidants,
chromium, or halogen) must demonstrate that the validity screening
test, by lot number, correctly identified at least 90 percent of the
total validity performance test challenges on each of three sets of
performance testing samples, and, for each individual specimen validity
screening test, the test, by lot number, correctly identified at least
90 percent of the validity performance test challenges on each of three
sets of performance testing samples; and
(iii) After the licensee testing facility has placed a validity
screening test in service, the licensee or other entity shall verify
that the test, by lot number, remains on the SAMHSA-approved list. Or,
if the SAMHSA-approved list is unavailable, the licensee or other
entity shall ensure that the test continues to identify specimens of
questionable validity, as demonstrated by documentation from the
manufacturer that a set of validity screening tests from each lot in
use by the licensee testing facility correctly identified at least 90
percent of the total validity test challenges on a set of performance
testing samples, and, for each individual specimen validity screening
test, that the test, by lot number, correctly identified at least 90
percent of the validity test challenges. This performance testing must
be performed at a nominal annual frequency after the date on which the
manufacturer completed the initial validation studies required under
paragraph (b)(1)(ii)(D) of this section. The performance testing
samples used must be formulated to challenge the validity screening
test around the applicable cutoffs of this subpart.
(2) In addition, licensee testing facility personnel who perform
the validity screening tests shall conduct quality control testing of
validity screening tests as follows:
(i) At the beginning of any 8-hour period during which the licensee
testing facility will perform validity screening tests, licensee
testing facility personnel shall test a minimum of one quality control
sample that is negative for each specific validity test to be performed
(e.g., creatinine, pH, nitrites, chromium) during the 8-hour period,
and one quality control sample that is formulated to challenge the
validity screening test(s) around the cutoffs specified in this subpart
for each specific validity test to be performed during the 8-hour
period. The results of these quality control tests must be correct
before any donor specimens may be tested.
(ii) After screening every ten donor specimens during the 8-hour
period, licensee testing facility personnel shall also challenge each
validity screening test with at least one quality control sample that
is formulated to challenge the validity screening test(s) around the
cutoffs specified in this subpart. If fewer than ten donor specimens
were screened during the 8-hour period or the number of donor specimens
tested exceeds a multiple of ten but is less than the next multiple of
ten (e.g., 24 donor specimens, 48 donor specimens), licensee testing
facility personnel shall challenge each validity screening test at the
end of the 8-hour period during which the validity screening tests were
performed.
(3) The licensee testing facility shall also submit at least one
specimen out of every ten donor specimens that test negative using each
validity screening test that the licensee testing facility uses to an
HHS-certified laboratory as part of the licensee testing facility's
quality assurance program.
(4) Licensee testing facilities shall store specimen validity tests
as specified by the manufacturer's instructions and may not use such
tests after the manufacturer's expiration date.
(c) Validity screening test results. If the results of a validity
screening test indicate that the specimen is of questionable validity,
the licensee testing facility may either perform initial validity
testing or shall forward the specimen to the HHS-certified laboratory
for further testing.
(d) Quality control requirements for performing initial validity
tests. Licensees and other entities shall ensure that the HHS-certified
laboratory is capable of conducting confirmatory testing for any
adulterant for which the licensee testing facility conducts initial
validity tests.
(1) Creatinine. Creatinine concentration must be measured to 1
decimal place. The initial creatinine test must have a control in the
range of 3 to 20 mg/dL and a control in the range of 21 to 25 mg/dL.
(2) Requirements for performing initial pH tests are as follows:
(i) Colorimetric pH tests that have a dynamic range of 2 to 12 and
pH meters and must be capable of measuring pH to one decimal place.
(ii) An initial colorimetric pH test must have the following
calibrators and controls:
(A) One calibrator at 3;
(B) One calibrator at 11;
(C) One control in the range of 2 to 2.8;
(D) One control in the range of 3.2 to 4;
(E) One control in the range of 4.5 to 9;
(F) One control in the range of 10 to 10.8; and
(G) One control in the range of 11.2 to 12.
(iii) If a pH screening test is not used, an initial pH meter test
must have the following calibrators and controls:
(A) One calibrator at 4;
(B) One calibrator at 7;
(C) One calibrator at 10;
(D) One control in the range of 2 to 2.8;
(E) One control in the range of 3.2 to 4;
(F) One control in the range of 10 to 10.8; and
(G) One control in the range of 11.2 to 12.
(iv) If a pH screening test is used, an initial pH meter test must
have the following calibrators and controls when the screening result
indicates that the pH is below the lower decision point in use:
(A) One calibrator at 4;
(B) One calibrator at 7;
(C) One control in the range of 2 to 2.8; and
(D) One control in the range of 3.2 to 4.
[[Page 17207]]
(v) If a pH screening test is used, an initial pH meter test must
have the following calibrators and controls when the screening test
result indicates that the pH is above the upper decision point in use:
(A) One calibrator at 7;
(B) One calibrator at 10;
(C) One control in the range of 10 to 10.8; and
(D) One control in the range of 11.2 to 12.
(3) Oxidizing adulterants. Initial tests for oxidizing adulterants
must include a calibrator at the appropriate cutoff concentration for
the compound of interest, a control without the compound of interest
(i.e., a certified negative control), and a control with at least one
of the compounds of interest at a measurable concentration. For
nitrite, the licensee testing facility shall have one control in the
range of 200 to 400 mcg/mL, one control in the range of 500 to 625 mcg/
mL, and a control without nitrite (i.e., a certified negative control).
(4) Other adulterants. Initial tests for other adulterants must
include an appropriate calibrator, a control without the compound of
interest (i.e., a certified negative control), and a control with the
compound of interest at a measurable concentration.
(5) Each analytical run performed to conduct initial validity
testing shall include at least one quality control sample that appears
to be a donor specimen to the laboratory analysts.
(6) The licensee testing facility shall also submit at least one
specimen out of every 10 donor specimens that test negative on the
initial validity tests performed by the licensee testing facility to an
HHS-certified laboratory as part of the licensee testing facility's
quality assurance program.
(e) Quality control requirements for initial drug tests. (1) Any
initial drug test performed by a licensee testing facility must use an
immunoassay that meets the requirements of the Food and Drug
Administration for commercial distribution. Licensee testing facilities
may not use non-instrumented immunoassay testing devices that are
pending HHS/SAMHSA review and approval for initial drug testing under
this part. In addition, licensees and other entities may not take
management actions on the basis of any drug test results obtained from
non-instrumented devices that may be used for validity screening tests.
(2) Licensee testing facilities shall discard negative specimens or
may pool them for use in the licensee testing facility's internal
quality control program after certification by an HHS-certified
laboratory that the specimens are negative and valid. Licensee testing
facilities may not retain any information linking donors to specimens
that are pooled for use in the internal quality control program.
(3) Licensee testing facilities may perform multiple initial drug
tests for the same drug or drug class, provided that all tests meet the
cutoffs and quality control requirements of this part. For example, a
licensee testing facility may use immunoassay technique ``A'' for all
drugs using the licensee's or other entity's cutoff levels, but
specimens testing positive for amphetamines may also be tested using
immunoassay technique ``B'' to eliminate any possible positives due to
structural analogues; or, a valid analytical result cannot be obtained
using immunoassay technique ``A'' and immunoassay technique ``B'' is
used in an attempt to obtain a valid analytical result.
(4) Licensee testing facilities need not assess their false
positive testing rates for drugs, because all specimens that test as
positive on the initial tests for drugs and drug metabolites must be
forwarded to an HHS-certified laboratory for initial and confirmatory
testing.
(5) To ensure that the rate of false negative drug tests is kept to
the minimum that the immunoassay technology supports, licensee testing
facilities shall submit to the HHS-certified laboratory a minimum of 5
percent (or at least one) of the donor specimens screened as negative
from every analytical run.
(6) A minimum of 10 percent of all specimens in each analytical run
of specimens to be initially tested for drugs by the licensee testing
facility must be quality control samples, which the licensee testing
facility shall use for internal quality control purposes. (These
samples are not forwarded to the HHS-certified laboratory for further
testing, other than for performance testing of the samples.) Licensee
testing facilities shall ensure that quality control samples that are
positive for each drug and metabolite for which the FFD program
conducts testing are included in at least one analytical run each
calendar quarter. The quality control samples for each analytical run
must include--
(i) Sample(s) certified by an HHS-certified laboratory to contain
no drugs or drug metabolites (i.e., negative urine samples);
(ii) At least one positive control with drug(s) or drug
metabolite(s) targeted at 25 percent above the cutoff;
(iii) At least one positive control with drug(s) or drug
metabolite(s) targeted at 25 percent below the cutoff;
(iv) A sufficient number of calibrators to ensure and document the
linearity of the assay method over time in the concentration area of
the cutoff (after acceptable values are obtained for the known
calibrators, those values will be used to calculate sample data); and
(v) At least one positive control, certified to be positive by an
HHS-certified laboratory, that appears to be a donor specimen to the
laboratory analysts.
(7) Licensee testing facilities shall document the implementation
of procedures to ensure that carryover does not contaminate the testing
of a donor's specimen.
(f) Errors in testing. Each licensee testing facility shall
investigate any testing errors or unsatisfactory performance discovered
in the testing of quality control samples, in the testing of actual
specimens, or through the processing of management reviews and/or MRO
reviews, as well as any other errors or matters that could adversely
reflect on the licensee testing facility's testing process.
(1) Whenever possible, the investigation must determine relevant
facts and identify the root cause(s) of the testing or process error.
(2) The licensee testing facility shall take action to correct the
cause(s) of any errors or unsatisfactory performance that are within
the licensee testing facility's control.
(3) If false negative results are obtained in any analytical run
from testing the quality control samples specified in paragraphs (b),
(d), and (e) of this section at the licensee testing facility, the
licensee testing facility shall forward all donor specimens from that
analytical run to the HHS-certified laboratory for additional testing
and implement corrective actions before resuming testing of donor
specimens for the drug(s), drug metabolite(s), adulterant(s), or other
specimen characteristics (i.e., creatinine, pH) associated with the
quality control sample that yielded the false negative result(s).
(4) If a donor specimen that yielded negative validity or drug test
results at the licensee testing facility yields positive, substituted,
adulterated, or invalid results after confirmatory testing by the HHS-
certified laboratory under paragraphs (b)(3), (d)(6), or (e)(5) of this
section, the licensee or other entity shall implement corrective
actions before resuming testing of donor specimens for the drug(s),
drug metabolite(s), adulterant(s), or other specimen
[[Page 17208]]
characteristics (i.e., creatinine, pH) associated with the donor
specimen that yielded the false negative result(s). In addition to
resolving any technical, methodological, or administrative errors in
the licensee testing facility's testing process, the licensee or other
entity may re-collect and test specimens from any donor whose test
results from the licensee testing facility may have been inaccurate.
(5) A record of the investigative findings and the corrective
actions taken, where applicable, must be dated and signed by the
individuals who are responsible for the day-to-day management of the
licensee testing facility and reported to appropriate levels of
management.
(g) Accuracy. Volumetric pipettes and measuring devices must be
certified for accuracy or be checked by gravimetric, colorimetric, or
other verification procedure. Automatic pipettes and dilutors must be
checked for accuracy and reproducibility before being placed in
service, and periodically thereafter.
(h) Calibrators and controls. Calibrators and controls must be
prepared using pure drug reference materials, stock standard solutions
obtained from other laboratories, or standard solutions that are
obtained from commercial manufacturers and are properly labeled as to
content and concentration. Calibrators and controls may not be prepared
from the same stock solution. The standards and controls must be
labeled with the following dates: when received; when prepared or
opened; when placed in service; and when scheduled for expiration.
Sec. 26.139 Reporting initial validity and drug test results.
(a) The licensee testing facility shall report as negative all
specimens that are valid on the basis of validity screening or initial
validity tests, or both, and are negative on the initial tests for
drugs and drug metabolites. Except as permitted under Sec. 26.75(h),
positive test results from initial drug tests at the licensee testing
facility may not be reported to licensee or other entity management. In
addition, the licensee testing facility may not report results from
validity screening or initial validity testing indicating that a
specimen is of questionable validity or positive initial drug test
results from specimens that are of questionable validity.
(b) Except as provided in Sec. Sec. 26.37 and 26.75(h), access to
the results of initial tests must be limited to the licensee testing
facility's staff, the MRO and MRO staff, the FFD program manager, and,
when appropriate, EAP staff and the SAE.
(c) The licensee testing facility shall provide qualified
personnel, when required, to testify in an administrative or
disciplinary proceeding against an individual when that proceeding is
based on urinalysis results reported by the licensee testing facility.
(d) The licensee testing facility shall prepare the information
required for the annual report to the NRC, as required in Sec. 26.717.
(e) The data in the annual report to the NRC must be presented for
either the cutoff levels specified in this part, or for more stringent
cutoff levels, if the FFD program uses more stringent cutoff levels for
drugs and drug metabolites. If the FFD program tests for drugs and drug
metabolites that are not specified in Sec. 26.31(d)(1), the summary
must also include the number of positive test results and the cutoff
levels used for those drugs and drug metabolites.
(f) The designated FFD program official shall use the available
information from the licensee testing facility's validity and drug test
results, the results of quality control testing performed at the
licensee testing facility, and the results from testing the quality
control samples that the licensee testing facility submits to the HHS-
certified laboratory to evaluate continued testing program
effectiveness and detect any local trends in drugs of abuse that may
require management action or FFD program adjustments. FFD program
adjustments may include, but are not limited to, training enhancements,
procedure changes, the expansion of the FFD program's drug panel to
include additional drugs to be tested, or changes in the types of
assays, validity screening tests, or instruments used.
Subpart G--Laboratories Certified by the Department of Health and
Human Services
Sec. 26.151 Purpose.
This subpart contains requirements for the HHS-certified
laboratories that licensees and other entities who are subject to this
part use for testing urine specimens for validity and the presence of
drugs and drug metabolites.
Sec. 26.153 Using certified laboratories for testing urine specimens.
(a) Licensees and other entities who are subject to this part shall
use only laboratories certified under the Department of Health and
Human Services (HHS) Mandatory Guidelines for Federal Workplace Drug
Testing Programs [published in the Federal Register on April 11, 1988
(53 FR 11970), and as amended, June 9, 1994 (59 FR 29908), November
13,1998 (63 FR 63483), and April 13, 2004 (69 FR 19643)] for specimen
validity and drug testing, except as permitted under Sec.
26.31(d)(3)(ii). Information concerning the current certification
status of laboratories is available from the Division of Workplace
Programs, Center for Substance Abuse Prevention, Substance Abuse and
Mental Health Services Administration, Room 815, 5600 Fishers Lane,
Rockwall 2 Bldg., Rockville, Maryland 20857.
(b) HHS-certified laboratories shall have the capability, at the
same premises, to perform both initial and confirmatory tests for
specimen validity and for each drug and drug metabolite for which the
HHS-certified laboratory provides services to the licensee or other
entity.
(c) An HHS-certified laboratory may not subcontract and shall
perform all work with its own personnel and equipment unless otherwise
authorized by the licensee or other entity.
(d) Licensees and other entities shall use only HHS-certified
laboratories that agree to follow the same rigorous specimen testing,
quality control, and chain-of-custody procedures when testing for more
stringent cutoff levels as may be specified by licensees and other
entities for the classes of drugs identified in this part, and for any
other substances included in the licensees' or other entities' panels.
(e) Before awarding a contract to an HHS-certified laboratory, the
licensee or other entity shall ensure that qualified personnel conduct
a pre-award inspection and evaluation of the procedural aspects of the
laboratory's drug testing operations. However, if an HHS-certified
laboratory loses its certification, in whole or in part, a licensee or
other entity may immediately begin using another HHS-certified
laboratory that is being used by another licensee or entity who is
subject to this part, as permitted by Sec. 26.41(g)(5).
(f) All contracts between licensees or other entities who are
subject to this part and HHS-certified laboratories must require the
laboratory to implement all applicable requirements of this part. At a
minimum, licensees' and other entities' contracts with HHS-certified
laboratories must include the following requirements:
(1) Laboratory facilities shall comply with the applicable
provisions of any State licensor requirements;
(2) The laboratory shall make available qualified personnel to
testify in an administrative or disciplinary
[[Page 17209]]
proceeding against an individual when that proceeding is based on
urinalysis results reported by the HHS-certified laboratory;
(3) The laboratory shall maintain test records in confidence,
consistent with the requirements of Sec. 26.39, and use them with the
highest regard for individual privacy;
(4) Consistent with the principles established in section 503 of
Public Law 100-71, any employee of a licensee or other entity who is
the subject of a drug test (or his or her representative designated
under Sec. 26.37(d)) shall, on written request, have access to the
laboratory's records related to his or her validity and drug test and
any records related to the results of any relevant certification,
review, or revocation-of-certification proceedings;
(5) The laboratory may not enter into any relationship with the
licensee's or other entity's MRO(s) that may be construed as a
potential conflict of interest, including, but not limited to, the
relationships described in Sec. 26.183(b), and may not derive any
financial benefit by having a licensee or other entity use a specific
MRO; and
(6) The laboratory shall permit representatives of the NRC and any
licensee or other entity using the laboratory's services to inspect the
laboratory at any time, including unannounced inspections.
(g) If licensees or other entities use a form other than the
current Federal custody-and-control form, licensees and other entities
shall provide a memorandum to the laboratory explaining why a non-
Federal form was used, but must ensure, at a minimum, that the form
used contains all the required information on the Federal custody-and-
control form.
Sec. 26.155 Laboratory personnel.
(a) Day-to-day management of the HHS-certified laboratory. HHS-
certified laboratories shall have a responsible person to assume
professional, organizational, educational, and administrative
responsibility for the laboratory's drug testing facilities.
(1) This individual shall have documented scientific qualifications
in analytical forensic toxicology. Minimum qualifications are as
follows:
(i) Certification by the appropriate State as a laboratory director
in forensic or clinical laboratory toxicology; or
(ii) A PhD in one of the natural sciences with an adequate
undergraduate and graduate education in biology, chemistry, and
pharmacology or toxicology; or
(iii) Training and experience comparable to a Ph.D. in one of the
natural sciences, such as a medical or scientific degree with
additional training and laboratory/research experience in biology,
chemistry, and pharmacology or toxicology; and
(iv) In addition to the requirements in paragraphs (a)(1)(i)
through (a)(1)(iii) of this section, the responsible person shall also
have the following minimum qualifications:
(A) Appropriate experience in analytical forensic toxicology
including experience with the analysis of biological material for drugs
of abuse; and
(B) Appropriate training and/or experience in forensic applications
of analytical toxicology (e.g., publications, court testimony, research
concerning analytical toxicology of drugs of abuse, or other factors
that qualify the individual as an expert witness in forensic
toxicology).
(2) This individual shall be engaged in and responsible for the
day-to-day management of the testing laboratory, even if another
individual has overall responsibility for an entire multi-specialty
laboratory.
(3) This individual shall be responsible for ensuring that there
are enough personnel with adequate training and experience to supervise
and conduct the work of the drug testing laboratory. He or she shall
ensure the continued competency of laboratory personnel by documenting
their in-service training, reviewing their work performance, and
verifying their skills.
(4) This individual shall be responsible for ensuring that the
laboratory has a manual of standard operating procedures that are
complete, up-to-date, available for personnel performing tests, and
followed by those personnel. The procedures must be reviewed, signed,
and dated by this responsible person whenever the procedures are first
placed into use or changed or when a new individual assumes
responsibility for management of the laboratory. This individual shall
ensure that copies of all procedures and records of the dates on which
they are in effect are maintained. (Specific contents of the procedures
are described in Sec. 26.157.)
(5) This individual shall be responsible for maintaining a quality
assurance program to assure the proper performance and reporting of all
test results; maintaining acceptable analytical performance for all
controls and standards; maintaining quality control testing; and
assuring and documenting the validity, reliability, accuracy,
precision, and performance characteristics of each test and test
system.
(6) This individual shall be responsible for taking all remedial
actions that may be necessary to maintain satisfactory operation and
performance of the laboratory in response to quality control systems
not being within performance specifications, including errors in result
reporting or in the analysis of performance testing results. This
individual shall ensure that test results are not reported until all
corrective actions have been taken and he or she can assure that the
test results provided are accurate and reliable.
(b) Certifying scientist. (1) HHS-certified laboratories shall have
one or more certifying scientists who review all pertinent data and
quality control results to certify the laboratory's test results.
(2) A certifying scientist shall be an individual with at least a
bachelor's degree in the chemical or biological sciences, medical
technology, or an equivalent field who reviews all pertinent data and
quality control results. The individual shall have training and
experience in the theory and practice of all methods and procedures
used in the laboratory, including a thorough understanding of chain-of-
custody procedures, quality control practices, and analytical
procedures relevant to the results that the individual certifies.
Relevant training and experience must also include the review,
interpretation, and reporting of test results; maintenance of chain of
custody; and proper remedial action to be taken in response to aberrant
test or quality control results, or a determination that test systems
are out of control limits.
(3) A laboratory may designate certifying scientists who only
certify results that are reported negative and certifying scientists
who certify results that are reported both negative and adulterated,
substituted, dilute, or invalid.
(c) Day-to-day operations and supervision of analysts. HHS-
certified laboratories shall assign one or more individuals who are
responsible for day-to-day operations and supervision of the technical
analysts. The designated individual(s) shall have at least a bachelor's
degree in the chemical or biological sciences, medical technology, or
an equivalent field. The individual(s) shall also have training and
experience in the theory and practice of the procedures used in the
laboratory, resulting in his or her thorough understanding of quality
control practices and procedures; review, interpretation, and reporting
of test results; maintenance of the chain of
[[Page 17210]]
custody; and proper remedial actions to be taken in response to
aberrant test or quality control results, or the finding that test
systems are out of control limits.
(d) Other personnel. Other technicians or nontechnical staff shall
have the necessary training and skills for their assigned tasks.
(e) Training. HHS-certified laboratories shall make available
continuing education programs to meet the needs of laboratory
personnel.
(f) Files. At a minimum, each laboratory personnel file must
include a r[eacute]sum[eacute], any professional certification(s) or
license(s), a job description, and documentation to show that the
individual has been properly trained to perform his or her job.
Sec. 26.157 Procedures.
(a) HHS-certified laboratories shall develop, implement, and
maintain clear and well-documented procedures for accession, receipt,
shipment, and testing of urine specimens.
(b) Written chain-of-custody procedures must describe the methods
to be used to maintain control and accountability of specimens from
receipt through completion of testing and reporting of results, during
storage and shipping to another HHS-certified laboratory, if required,
and continuing until final disposition of specimens.
(c) HHS-certified laboratories shall develop, implement, and
maintain a written manual of standard operating procedures for each
assay performed for licensees and other entities for drug and specimen
validity testing. The procedures must include, but are not limited to,
detailed descriptions of--
(1) The principles of each test;
(2) Preparation of reagents, standards, and controls;
(3) Calibration procedures;
(4) Derivation of results;
(5) Linearity of methods;
(6) Sensitivity of the methods;
(7) Cutoff values;
(8) Mechanisms for reporting results;
(9) Controls;
(10) Criteria for unacceptable specimens and results;
(11) Reagents and expiration dates; and
(12) References.
(d) HHS-certified laboratories shall develop, implement, and
maintain written procedures for instrument setup and normal operation,
including the following:
(1) A schedule for checking critical operating characteristics for
all instruments;
(2) Tolerance limits for acceptable function checks; and
(3) Instructions for major troubleshooting and repair.
(e) HHS-certified laboratories shall develop, implement, and
maintain written procedures for remedial actions to be taken when
errors are detected or systems are out of acceptable limits.
The laboratory shall maintain documentation that its personnel follow
these procedures and take all necessary corrective actions. In
addition, the laboratory shall have systems in place to verify all
stages of testing and reporting and to document the verification.
Sec. 26.159 Assuring specimen security, chain of custody, and
preservation.
(a) The HHS-certified laboratories performing services for
licensees and other entities under this part shall be secure at all
times. Each laboratory shall have in place sufficient security measures
to control access to the premises and to ensure that no unauthorized
personnel handle specimens or gain access to the laboratory processes
or areas where records are stored. Access to these secured areas must
be limited to specially authorized individuals whose authorization is
documented. All authorized visitors, and maintenance and service
personnel, shall be escorted at all times in the laboratory, except
personnel who are authorized to conduct inspections and audits on
behalf of licensees, other entities, the NRC, or the HHS Secretary, and
emergency personnel (including but not limited to firefighters and
medical rescue teams).
(b) When a shipment of specimens is received, laboratory personnel
shall inspect each package for evidence of possible tampering and shall
compare information on specimen bottles within each package to the
information on the accompanying custody-and-control forms.
(1) Any direct evidence of tampering or discrepancies in the
information on the specimen bottles and the custody-and-control forms
attached to the shipment must be reported to the licensee or other
entity within 24 hours of the discovery and must be noted on the
custody-and-control forms for each specimen contained in the package.
When notified, the licensee or other entity shall ensure that an
investigation is initiated to determine whether tampering has occurred.
(i) If the investigation determines that tampering has occurred,
the licensee or other entity shall ensure that corrective actions are
taken.
(ii) If the licensee or other entity has reason to question the
integrity and identity of the specimens, the specimens may not be
tested and the licensee or other entity shall ensure that another
collection occurs as soon as reasonably practical, except if a split
specimen collection was performed, either the Bottle A or Bottle B seal
remains intact, and the intact specimen contains at least 15 mL of
urine. In this instance, if the licensee testing facility has retained
the specimen in Bottle B, the licensee testing facility shall forward
the intact specimen for testing to the HHS-certified laboratory and may
not conduct any testing at the licensee testing facility.
(2) The following are exclusive grounds requiring the MRO to cancel
the testing of a donor's urine specimen:
(i) The custody-and-control form does not contain information to
identify the specimen collector and the collection site cannot provide
conclusive evidence of the collector's identity;
(ii) The identification numbers on the specimen bottle seal(s) do
not match the identification numbers on the custody-and-control form;
(iii) A specimen bottle seal is broken or shows evidence of
tampering and an intact specimen, as specified in paragraph (b)(1)(ii)
of this section, does not exist;
(iv) The specimen appears to have leaked out of its sealed bottle
and there is less than 15 mL remaining, and an intact specimen, as
specified in paragraph (b)(1)(ii) of this section, does not exist; or
(v) As required under Sec. 26.165(f)(2).
(c) The HHS-certified laboratory shall retain specimen bottles
within the laboratory's accession area until all analyses have been
completed. Laboratory personnel shall use aliquots and laboratory
internal custody-and-control forms when conducting initial and
confirmatory tests. The original specimen and the original custody-and-
control form must remain in secure storage.
(d) The laboratory's internal custody-and-control form must allow
for identification of the donor, and documentation of the testing
process and transfers of custody of the specimen.
(e) Each time a specimen is handled or transferred within the
laboratory, laboratory personnel shall document the date and purpose on
the custody-and-control form and every individual in the chain shall be
identified. Authorized technicians are responsible for each urine
specimen or aliquot in their possession and shall sign and complete
custody-and-control forms for those specimens or aliquots as they are
received.
[[Page 17211]]
(f) If a specimen is to be transferred to a second HHS-certified
laboratory, laboratory personnel shall ensure that a copy of the
custody-and-control form is packaged with the aliquot of a single
specimen or Bottle B of a split specimen, as appropriate. Sealed and
labeled specimen bottles and aliquots, with their associated custody-
and-control forms, being transferred from one laboratory to another
must be placed in a second, tamper-evident shipping container designed
to minimize the possibility of damage to the specimen during shipment
(e.g., specimen boxes, padded mailers, or bulk insulated shipping
containers with that capability) so that the contents of the shipping
containers are inaccessible without breaking a tamper-evident seal.
(g) Couriers, express carriers, and postal service personnel do not
have direct access to the custody-and-control forms or the specimen
bottles. Therefore, such personnel are not required to document chain
of custody on the custody-and-control forms during transit. Custody
accountability of the shipping containers during shipment must be
maintained by a tracking system provided by the courier, express
carrier, or postal service.
(h) Specimens that do not receive an initial test within 7 days of
arrival at the laboratory must be placed in secure refrigeration units
for short-term storage. Temperatures may not exceed 6 [deg]C (42.8
[deg]F). The laboratory shall ensure proper storage conditions in the
event of a prolonged power failure.
(i) Long-term frozen storage at a temperature of -20 [deg]C (-68
[deg]F) or less ensures that positive, adulterated, substituted, and
invalid urine specimens and Bottle B of a split specimen will be
available for any necessary retests. Unless otherwise authorized in
writing by the licensee or other entity, laboratories shall retain and
place in properly secured long-term frozen storage all specimens
reported as positive, adulterated, substituted, or invalid. At a
minimum, such specimens must be stored for 1 year. Within this 1-year
period, a licensee, other entity, or the NRC may ask the laboratory to
retain the specimen for an additional period of time. If no retention
request is received, the laboratory may discard the specimen after the
end of 1 year. However, the laboratory shall retain any specimens under
review or legal challenge until they are no longer needed.
(j) The laboratory shall discard a valid specimen that tests
negative on initial or confirmatory drug tests or may pool such
specimens for use in the laboratory's internal quality control program
after certifying that the specimens are negative and valid. The
laboratory may not retain any information linking donors to specimens
that are pooled for use in the internal quality control program.
Sec. 26.161 Cutoff levels for validity testing.
(a) Validity test results. Each validity test result for a specimen
that the HHS-certified laboratory reports to the MRO as adulterated,
substituted, dilute, or invalid must be based on performing an initial
validity test on one aliquot and a confirmatory validity test on a
second aliquot. Licensees and other entities shall ensure that the HHS-
certified laboratory is capable of conducting, and conducts,
confirmatory testing for at least one oxidizing adulterant and any
other adulterants specified by the licensee's or other entity's testing
program. If initial validity test results indicate that the specimen is
valid under the criteria in paragraphs (c) through (f) of this section,
the HHS-certified laboratory need not perform confirmatory validity
testing of the specimen.
(b) Initial validity testing. The HHS-certified laboratory shall
perform initial validity testing of each specimen as follows:
(1) Determine the creatinine concentration;
(2) Determine the specific gravity of every specimen for which the
creatinine concentration is less than 20 mg/dL;
(3) Determine the pH;
(4) Perform one or more initial validity tests for oxidizing
adulterants; and
(5) Perform additional validity tests, the choice of which depends
on the observed indicators or characteristics below, when the following
conditions are observed:
(i) Abnormal physical characteristics;
(ii) Reactions or responses characteristic of an adulterant
obtained during initial or confirmatory drug tests (e.g., non-recovery
of internal standards, unusual response); or
(iii) Possible unidentified interfering substance or adulterant.
(c) Results indicating an adulterated specimen. The laboratory
shall report a specimen as adulterated when the specimen yields any one
or more of the following validity testing results:
(1) The pH is less than 3, or equal to or greater than 11, using
either a pH meter or a colorimetric pH test for the initial test on the
first aliquot and a pH meter for the confirmatory test on the second
aliquot;
(2) The nitrite concentration is equal to or greater than 500 mcg/
mL using either a nitrite colorimetric test or a general oxidant
colorimetric test for the initial test on the first aliquot and a
different confirmatory test (e.g., multi-wavelength spectrophotometry,
ion chromatography, capillary electrophoresis) on the second aliquot;
(3) The presence of chromium (VI) is verified using either a
general oxidant colorimetric test (with a cutoff equal to or greater
than 50 mcg/mL chromium (VI)-equivalents) or a chromium (VI)
colorimetric test (chromium (VI) concentration equal to or greater than
50 mcg/mL) for the initial test on the first aliquot and a different
confirmatory test (e.g., multi-wavelength spectrophotometry, ion
chromatography, atomic absorption spectrophotometry, capillary
electrophoresis, inductively coupled plasma-mass spectrometry) with the
chromium (VI) concentration equal to or greater than the LOD of the
confirmatory test on the second aliquot;
(4) The presence of halogen (e.g., bleach, iodine, fluoride) is
verified using either a general oxidant colorimetric test (with a
cutoff equal to or greater than 200 mcg/mL nitrite-equivalents or a
cutoff equal to or greater than 50 mcg/mL chromium (VI)-equivalents) or
a halogen colorimetric test (halogen concentration equal to or greater
than the LOD) for the initial test on the first aliquot and a different
confirmatory test (e.g., multi-wavelength spectrophotometry, ion
chromatography, inductively coupled plasma-mass spectrometry) with a
specific halogen concentration equal to or greater than the LOD of the
confirmatory test on the second aliquot;
(5) The presence of glutaraldehyde is verified using either an
aldehyde test (aldehyde present) or the specimen yields the
characteristic immunoassay response on one or more drug immunoassay
tests for the initial test on the first aliquot and gas chromatography/
mass spectrometry (GC/MS) for the confirmatory test with the
glutaraldehyde concentration equal to or greater than the LOD of the
analysis on the second aliquot;
(6) The presence of pyridine (pyridinium chlorochromate) is
verified using either a general oxidant colorimetric test (with a
cutoff equal to or greater than 200 mcg/mL nitrite-equivalents or a
cutoff equal to or greater than 50 mcg/mL chromium (VI)-equivalents) or
a chromium (VI) colorimetric test (chromium (VI) concentration equal to
or greater than 50 mcg/mL) for the initial test on the first aliquot
and GC/MS for the confirmatory test with the pyridine concentration
equal to or greater than the LOD of the analysis on the second aliquot;
[[Page 17212]]
(7) The presence of a surfactant is verified by using a surfactant
colorimetric test with a cutoff equal to or greater than 100 mcg/mL
dodecylbenzene sulfonate-equivalent for the initial test on the first
aliquot and a different confirmatory test (e.g., multi-wavelength
spectrophotometry) with a cutoff equal to or greater than 100 mcg/mL
dodecylbenzene sulfonate equivalent on the second aliquot; or
(8) The presence of any other adulterant not specified in
paragraphs (c)(3) through (c)(7) of this section is verified using an
initial test on the first aliquot and a different confirmatory test on
the second aliquot.
(d) Results indicating a substituted specimen. The laboratory shall
report a specimen as substituted when the specimen's creatinine
concentration is less than 2 mg/dL and its specific gravity is less
than or equal to 1.0010, or equal to or greater than 1.0200, on both
the initial and confirmatory creatinine tests (i.e., the same
colorimetric test may be used to test both aliquots) and on both the
initial and confirmatory specific gravity tests (i.e., a refractometer
is used to test both aliquots) on two separate aliquots.
(e) Results indicating a dilute specimen. The laboratory shall
report a specimen as dilute when the specimen's creatinine
concentration is equal to or greater than 2 mg/dL but less than 20 mg/
dL and its specific gravity is greater than 1.0010 but less than 1.0030
on a single aliquot.
(f) Results indicating an invalid specimen. The laboratory shall
report a specimen as invalid when the laboratory obtains any one or
more of the following validity testing results:
(1) Inconsistent creatinine concentration and specific gravity
results are obtained (i.e., the creatinine concentration is less than 2
mg/dL on both the initial and confirmatory creatinine tests and the
specific gravity is greater than 1.0010 but less than 1.0200 on the
initial and/or confirmatory specific gravity test, the specific gravity
is less than or equal to 1.0010 on both the initial and confirmatory
specific gravity tests and the creatinine concentration is equal to or
greater than 2 mg/dL on either or both the initial or confirmatory
creatinine tests);
(2) The pH is equal to or greater than 3 and less than 4.5, or
equal to or greater than 9 and less than 11, using either a
colorimetric pH test or pH meter for the initial test and a pH meter
for the confirmatory test on two separate aliquots;
(3) The nitrite concentration is equal to or greater than 200 mcg/
mL using a nitrite colorimetric test, or equal to or greater than the
equivalent of 200 mcg/mL nitrite using a general oxidant colorimetric
test for both the initial test and the confirmatory test, or, using
either initial test, the nitrite concentration is equal to or greater
than 200 mcg/mL but less than 500 mcg/mL using a different confirmatory
test (e.g., multi-wavelength spectrophotometry, ion chromatography,
capillary electrophoresis) on two separate aliquots;
(4) The possible presence of chromium (VI) is determined using the
same chromium (VI) colorimetric test with a cutoff equal to or greater
than 50 mcg/mL chromium (VI) for both the initial test and the
confirmatory test on two separate aliquots;
(5) The possible presence of a halogen (e.g., bleach, iodine,
fluoride) is determined using the same halogen colorimetric test with a
cutoff equal to or greater than the LOD for both the initial test and
the confirmatory test on two separate aliquots or relying on the odor
of the specimen as the initial test;
(6) The possible presence of glutaraldehyde is determined using the
same aldehyde test (aldehyde present) or the characteristic immunoassay
response is observed on one or more drug immunoassay tests for both the
initial test and the confirmatory test on two separate aliquots;
(7) The possible presence of an oxidizing adulterant is determined
by using the same general oxidant colorimetric test (with cutoffs equal
to or greater than 200 mcg/mL nitrite-equivalents, equal to or greater
than 50 mcg/mL chromium (VI)-equivalents, or a halogen concentration
equal to or greater than the LOD) for both the initial test and the
confirmatory test on two separate aliquots;
(8) The possible presence of a surfactant is determined using the
same surfactant colorimetric test with a cutoff equal to or greater
than 100 mcg/mL dodecylbenzene sulfonate-equivalent for both the
initial test and the confirmatory test on two separate aliquots or a
foam/shake test for the initial test;
(9) Interference occurs on the immunoassay drug tests on two
separate aliquots (i.e., valid immunoassay drug test results cannot be
obtained);
(10) Interference with the drug confirmation assay occurs on at
least two separate aliquots of the specimen, and the laboratory is
unable to identify the interfering substance;
(11) The physical appearance of the specimen indicates that testing
may damage the laboratory's equipment; or
(12) The physical appearances of Bottles A and B (when a split
specimen collection is used) are clearly different, and either the test
result for Bottle A indicated it is an invalid specimen or the specimen
in Bottle A was screened negative for drugs, or both.
(g) Additional testing by a second laboratory. If the presence of
an interfering substance/adulterant is suspected that could make a test
result invalid, but it cannot be identified (e.g., a new adulterant),
laboratory personnel shall consult with the licensee's or other
entity's MRO and, with the MRO's agreement, shall send the specimen to
another HHS-certified laboratory that has the capability to identify
the suspected substance.
(h) More stringent validity test cutoff levels are prohibited.
Licensees and other entities may not specify more stringent cutoff
levels for validity tests than those specified in this section.
Sec. 26.163 Cutoff levels for drugs and drug metabolites.
(a) Initial drug testing. (1) HHS-certified laboratories shall
apply the following cutoff levels for initial testing of specimens to
determine whether they are negative for the indicated drugs and drug
metabolites, except if validity testing indicates that the specimen is
dilute or the licensee or other entity has established more stringent
cutoff levels:
Initial Test Cutoff Levels for Drugs and Drug Metabolites
------------------------------------------------------------------------
Cutoff level
Drug or metabolites [nanograms
(ng)/mL]
------------------------------------------------------------------------
Marijuana metabolites................................... 50
Cocaine metabolites..................................... 300
Opiate metabolites...................................... 2000
Phencyclidine (PCP)..................................... 25
Amphetamines............................................ 1000
------------------------------------------------------------------------
(2) At the licensee's or other entity's discretion, as documented
in the FFD program policies and procedures, the licensee or other
entity may require the HHS-certified laboratory to conduct special
analyses of dilute specimens as follows:
(i) If initial validity testing indicates that a specimen is
dilute, the HHS-certified laboratory shall compare the responses of the
dilute specimen to the cutoff calibrator in each of the drug classes;
(ii) If any response is equal to or greater than 50 percent of the
cutoff, the HHS-certified laboratory shall conduct confirmatory testing
of the specimen down to the LOD for those drugs and/or drug
metabolites; and
(iii) The laboratory shall report the numerical values obtained
from this special analysis to the MRO.
[[Page 17213]]
(b) Confirmatory drug testing. (1) A specimen that is identified as
positive on an initial drug test must be subject to confirmatory
testing for the class(es) of drugs for which the specimen initially
tested positive. The HHS-certified laboratory shall apply the
confirmatory cutoff levels specified in this paragraph, except if the
licensee or other entity requires the special analysis of dilute
specimens permitted in paragraph (a)(2) of this section or the licensee
or other entity has established more stringent cutoff levels.
Confirmatory Test Cutoff Levels for Drugs and Drug Metabolites
------------------------------------------------------------------------
Cutoff
Drug or metabolites level
(ng/mL)
------------------------------------------------------------------------
Marijuana metabolite\1\...................................... 15
Cocaine metabolite \2\....................................... 150
Opiates:
Morphine................................................. 2000
Codeine.................................................. 2000
6-acetylmorphine \3\..................................... 10
Phencyclidine (PCP).......................................... 25
Amphetamines:
Amphetamine.............................................. 500
Methamphetamine \4\...................................... 500
------------------------------------------------------------------------
\1\ As delta-9-tetrahydrocannabinol-9-carboxylic acid.
\2\ As benzoylecgonine.
\3\ Test for 6-AM when the confirmatory test shows a morphine
concentration exceeding 2,000 ng/mL.
\4\ Specimen must also contain amphetamine at a concentration equal to
or greater than 200 ng/mL.
(2) Each confirmatory drug test must provide a quantitative result.
When the concentration of a drug or metabolite exceeds the linear range
of the standard curve, the laboratory may record the result as
``exceeds the linear range of the test'' or as ``equal to or greater
than ,'' or
may dilute an aliquot of the specimen to obtain an accurate
quantitative result when the concentration is above the upper limit of
the linear range.
Sec. 26.165 Testing split specimens and retesting single specimens.
(a) Testing split specimens. (1) If a specimen has been split into
Bottle A and Bottle B at the collection site, and the specimen was not
initially tested at a licensee testing facility, then the HHS-certified
laboratory shall perform initial and confirmatory validity and drug
testing, if required, of the specimen in Bottle A.
(2) If a specimen was initially tested at a licensee testing
facility and positive or questionable validity test results were
obtained, then the HHS-certified laboratory shall perform initial and
confirmatory testing, if required, of the specimen in Bottle A.
(3) At the licensee's or other entity's discretion, Bottle B must
either be forwarded to the HHS-certified laboratory or maintained in
secure storage at the licensee testing facility, as required by Sec.
26.135(a) and (c), as applicable. If the specimen in Bottle A is free
of any evidence of drugs or drug metabolites, and is a valid specimen,
then the licensee testing facility or HHS-certified laboratory may
discard the specimens in Bottles A and B.
(b) Donor request to MRO for a retest of a single specimen or
testing Bottle B of a split specimen. (1) For a confirmed positive,
adulterated, or substituted result reported on a single specimen of 30
mL or more, or a specimen in Bottle A of a split specimen which the
donor submitted to the licensee or other entity, a donor may request
(through the MRO) that an aliquot from the single specimen or the split
(Bottle B) specimen be tested by a second HHS-certified laboratory to
verify the result reported by the first laboratory. For an invalid test
result, a donor may not request that an aliquot from the single
specimen or the split specimen in Bottle B be tested by a second HHS-
certified laboratory.
(2) The MRO shall inform the donor that he or she may, within 3
business days of notification by the MRO of the confirmed positive,
adulterated, or substituted test result, request the retesting of an
aliquot of the single specimen or the testing of the Bottle B split
specimen. The MRO shall provide the donor with specific instructions
for making this request (i.e., providing telephone numbers or other
contact information). The MRO shall have the ability to receive the
donor's calls at all times during the 3-day period (e.g., by use of an
answering machine with a ``time stamp'' feature when there is no one in
the MRO's office to answer the phone). The donor's request may be oral
or in writing.
(3) The donor shall provide his or her permission for retesting an
aliquot of the single specimen or the testing of Bottle B. Neither the
licensee, MRO, NRC, nor any other entity may order retesting of the
single specimen or testing of the specimen in Bottle B without the
donor's written permission, except as permitted in Sec. 26.185(l).
(4) If the donor has not requested a retest of an aliquot of a
single specimen or a test of the split specimen (Bottle B) within 3
business days, the donor may present to the MRO information documenting
that serious injury, illness, lack of actual notice of the confirmed
test result, inability to contact the MRO (e.g., there was no one in
the MRO's office and the answering machine was not working), or other
circumstances unavoidably prevented the donor from making a timely
request. If the MRO concludes from the donor's information that there
was a legitimate reason for the donor's failure to contact the MRO
within the 3 business days permitted, the MRO shall direct the
retesting of an aliquot of the single specimen or the test of the split
specimen (Bottle B) take place, as if the donor had made a timely
request.
(5) As soon as reasonably practical and not more than 1 business
day following the day of the donor's request, as permitted in paragraph
(b)(3) or (b)(4) of this section, the MRO shall ensure that the HHS-
certified laboratory forwards an aliquot of a single specimen, or that
the HHS-certified laboratory (or licensee testing facility, as
appropriate) forwards Bottle B of a split specimen, to a second HHS-
certified laboratory that did not test the specimen in Bottle A.
(6) The HHS-certified laboratory that retests an aliquot of a
single specimen or tests the specimen in Bottle B shall provide
quantitative test results to the MRO and the MRO shall provide them to
the donor.
(c) Retesting a specimen for drugs. (1) The second laboratory shall
use its confirmatory drug test when retesting an aliquot of a single
specimen or testing Bottle B of a split specimen for the drug(s) or
drug metabolite(s) for which the first laboratory reported a positive
result(s), including retesting specimens that have been subject to the
special analysis permitted in Sec. 26.163(a)(2).
(2) Because some drugs or drug metabolites may deteriorate during
storage, the retest by the second laboratory is not subject to a
specific drug cutoff level, but must provide data sufficient to
reconfirm the presence of the drug(s) or drug metabolite(s) down to the
assay's LOD.
(3) If the second laboratory fails to reconfirm the presence of the
drug(s) or drug metabolite(s) for which the first laboratory reported a
positive result(s), the second laboratory shall attempt to determine
the reason for not reconfirming the first laboratory's findings by
conducting specimen validity tests. The second laboratory shall conduct
the same specimen validity tests it would conduct on a single specimen
or the specimen in Bottle A of a split specimen.
(4) The second laboratory shall report all results to the
licensee's or other entity's MRO.
(d) Retesting a specimen for adulterants. A second laboratory shall
use the required confirmatory validity
[[Page 17214]]
test and criteria in Sec. 26.161(c) to reconfirm an adulterant result
when retesting an aliquot from a single specimen or when testing Bottle
B of a split specimen. The second laboratory may only conduct the
confirmatory validity test needed to reconfirm the adulterant result
reported by the first laboratory.
(e) Retesting a specimen for substitution. A second laboratory
shall use its confirmatory creatinine and confirmatory specific gravity
tests, when retesting an aliquot of a single specimen or testing Bottle
B of a split specimen, to reconfirm that the creatinine concentration
was less than 2 mg/dL and the specific gravity was less than or equal
to 1.0010 or equal to or greater than 1.0200. The second laboratory may
only conduct the confirmatory creatinine and specific gravity tests to
reconfirm the substitution result reported by the first laboratory.
(f) Management actions and sanctions. (1) If the MRO confirms a
positive, adulterated, or substituted test result(s) from the first
HHS-certified laboratory and the donor requests testing of Bottle B of
a split specimen or retesting of an aliquot from a single specimen, the
licensee or other entity shall administratively withdraw the
individual's authorization on the basis of the first confirmed
positive, adulterated, or substituted test result until the results of
testing Bottle B or retesting an aliquot of the single specimen are
available and have been reviewed by the MRO. If the MRO reports that
the results of testing Bottle B or retesting the aliquot of a single
specimen reconfirm any of the original positive, adulterated, or
substituted test result(s), the licensee or other entity shall impose
the appropriate sanctions specified in subpart D. If the results of
testing Bottle B or retesting the aliquot of a single specimen are
negative, the licensee or other entity--
(i) May not impose any sanctions on the individual;
(ii) Shall eliminate from the donor's personnel file and other
records any matter that could link the individual to the temporary
administrative action;
(iii) May not disclose the temporary administrative action in
response to a suitable inquiry conducted under the provisions of Sec.
26.63 or to any other inquiry or investigation required in this
chapter. To ensure that no records have been retained, access to the
system of files and records must be provided to personnel conducting
reviews, inquiries into allegations, or audits under the provisions of
Sec. 26.41, or to NRC inspectors; and
(iv) Shall provide the tested individual with a written statement
that the records specified in Sec. Sec. 26.713 and 26.715 have not
been retained and shall inform the individual in writing that the
temporary administrative action that was taken will not be disclosed
and need not be disclosed by the individual in response to requests for
self-disclosure of potentially disqualifying FFD information.
(2) If a donor requests that Bottle B be tested or that an aliquot
of a single specimen be retested, and either Bottle B or the single
specimen are not available due to circumstances outside of the donor's
control (including, but not limited to, circumstances in which there is
an insufficient quantity of the single specimen or the specimen in
Bottle B to permit retesting, either Bottle B or the original single
specimen is lost in transit to the second HHS-certified laboratory, or
Bottle B has been lost at the HHS-certified laboratory or licensee
testing facility), the MRO shall cancel the test and inform the
licensee or other entity that another collection is required under
direct observation as soon as reasonably practical. The licensee or
other entity shall eliminate from the donor's personnel and other
records any matter that could link the donor to the original positive,
adulterated, or substituted test result(s) and any temporary
administrative action, and may not impose any sanctions on the donor
for a cancelled test. If test results from the second specimen
collected are positive, adulterated, or substituted and the MRO
determines that the donor has violated the FFD policy, the licensee or
other entity shall impose the appropriate sanctions specified in
subpart D of this part, but may not consider the original confirmed
positive, adulterated, or substituted test result in determining the
appropriate sanctions.
Sec. 26.167 Quality assurance and quality control.
(a) Quality assurance program. Each HHS-certified laboratory shall
have a quality assurance program that encompasses all aspects of the
testing process, including, but not limited to, specimen accessioning,
chain of custody, security and reporting of results, initial and
confirmatory testing, certification of calibrators and controls, and
validation of analytical procedures. The performance characteristics
(e.g., accuracy, precision, LOD, limit of quantitation (LOQ),
specificity) of each test must be validated and documented for each
test. Validation of procedures must document that carryover does not
affect the donor's specimen results. Periodic re-verification of
analytical procedures is required. Quality assurance procedures must be
designed, implemented, and reviewed to monitor the conduct of each step
of the testing process.
(b) Calibrators and controls required. Each analytical run of
specimens for which an initial or confirmatory validity test, or an
initial or confirmatory drug test, is being performed must include the
appropriate calibrators and controls.
(c) Quality control requirements for performing initial and
confirmatory validity tests. (1) Requirements for performing creatinine
tests:
(i) The creatinine concentration must be measured to one decimal
place on both the initial and the confirmatory creatinine tests;
(ii) The initial creatinine test must have a calibrator at 2 mg/dL;
(iii) The initial creatinine test must have a control in the range
of 1 to 1.5 mg/dL, a control in the range of 3 to 20 mg/dL, and a
control in the range of 21 to 25 mg/dL; and
(iv) The confirmatory creatinine test (performed on those specimens
with a creatinine concentration less than 2 mg/dL on the initial test)
must have a calibrator at 2 mg/dL, a control in the range of 1.0 to 1.5
mg/dL, and a control in the range of 3 to 4 mg/dL.
(2) Requirements for performing specific gravity tests:
(i) The refractometer must report and display the specific gravity
to four decimal places, and must be interfaced with a laboratory
information management system, or computer, and/or generate a hard copy
or digital electronic display to document the numerical result;
(ii) The initial and confirmatory specific gravity tests must have
a calibrator or control at 1.0000; and
(iii) The initial and confirmatory specific gravity tests must have
the following controls:
(A) One control targeted at 1.0020;
(B) One control in the range of 1.0040 to 1.0180; and
(C) One control equal to or greater than 1.0200 but not greater
than 1.0250.
(3) Requirements for performing pH tests:
(i) Colorimetric pH tests that have the dynamic range of 2 to 12 to
support the 3 and 11 pH cutoffs and pH meters must be capable of
measuring pH to one decimal place. Dipsticks, colorimetric pH tests,
and pH paper that have a narrow dynamic range and do not support the 2
to 12 pH cutoffs may be used only to determine whether initial validity
tests must be performed;
(ii) At a minimum, pH screening tests must have the following
controls:
[[Page 17215]]
(A) One control below the lower decision point in use;
(B) One control between the decision points in use; and
(C) One control above the upper decision point in use;
(iii) If a pH screening test is not used, an initial pH meter test
must have the following calibrators and controls:
(A) One calibrator at 4;
(B) One calibrator at 7;
(C) One calibrator at 10;
(D) One control in the range of 2 to 2.8;
(E) One control in the range of 3.2 to 4;
(F) One control in the range of 10 to 10.8; and
(G) One control in the range of 11.2 to 12;
(iv) If a pH screening test is used, an initial or confirmatory pH
meter test must have the following calibrators and controls when the
screening result indicates that the pH is below the lower decision
point in use:
(A) One calibrator at 4;
(B) One calibrator at 7;
(C) One control in the range of 2 to 2.8; and
(D) One control in the range of 3.2 to 4;
(v) If a pH screening test is used, an initial or confirmatory pH
meter test must have the following calibrators and controls when the
screening result indicates that the pH is above the upper decision
point in use:
(A) One calibrator at 7;
(B) One calibrator at 10;
(C) One control in the range of 10 to 10.8; and
(D) One control in the range of 11.2 to 12; and
(vi) An initial colorimetric pH test must have the following
calibrators and controls:
(A) One calibrator at 3;
(B) One calibrator at 11;
(C) One control in the range of 2 to 2.8;
(D) One control in the range of 3.2 to 4;
(E) One control in the range of 4.5 to 9;
(F) One control in the range of 10 to 10.8;
(G) One control in the range of 11.2 to 12.
(4) Requirements for performing oxidizing adulterant tests:
(i) Initial tests for oxidizing adulterants must include a
calibrator at the appropriate cutoff concentration for the compound of
interest as specified in Sec. 26.161(c) and (f), a control without the
compound of interest (i.e., a certified negative control), and at least
one control with one of the compounds of interest at a measurable
concentration; and
(ii) A confirmatory test for a specific oxidizing adulterant must
use a different analytical method than that used for the initial test.
Each confirmatory analytical run must include a calibrator at the
appropriate cutoff concentration for the compound of interest as
specified in Sec. 26.161(c) and (f), a control without the compound of
interest (i.e., a certified negative control), and a control with the
compound of interest at a measurable concentration.
(5) Requirements for performing nitrite tests: The initial and
confirmatory nitrite tests must have a calibrator at the cutoff
concentration, a control without nitrite (i.e., certified negative
urine specimen), one control in the range of 200 to 400 mcg/mL, and one
control in the range of 500 to 625 mcg/mL.
(6) Requirements for performing ``other'' adulterant tests:
(i) The initial and confirmatory tests for any ``other'' adulterant
that may be identified in the future must satisfy the requirements in
Sec. 26.161(a);
(ii) The confirmatory test for ``other'' adulterants must use a
different analytical principle or chemical reaction than that used for
the initial test; and
(iii) The initial and confirmatory tests for ``other'' adulterants
must include an appropriate calibrator, a control without the compound
of interest (i.e., a certified negative control), and a control with
the compound of interest at a measurable concentration.
(d) Quality control requirements for performing initial drug tests.
(1) Any initial drug test performed by an HHS-certified laboratory must
use an immunoassay that meets the requirements of the Food and Drug
Administration for commercial distribution. Non-instrumented
immunoassay testing devices that are pending HHS/SAMHSA review and
approval may not be used for initial drug testing under this part.
(2) HHS-certified laboratories may perform multiple initial drug
tests for the same drug or drug class, provided that all tests meet the
cutoffs and quality control requirements of this part. For example, an
HHS-certified laboratory may use immunoassay technique ``A'' for all
drugs using the licensee's or other entity's cutoff levels, but
specimens testing positive for amphetamines may also be tested using
immunoassay technique ``B'' to eliminate any possible positives due to
structural analogues; or, a valid analytical result cannot be obtained
using immunoassay technique ``A'' and immunoassay technique ``B'' is
used in an attempt to obtain a valid analytical result.
(3) Quality control samples for each analytical run of specimens
for initial testing must include--
(i) Sample(s) certified to contain no drugs or drug metabolites
(i.e., negative urine samples);
(ii) At least one positive control with a drug(s) or drug
metabolite(s) targeted at 25 percent above the cutoff;
(iii) At least one positive control with a drug(s) or drug
metabolite(s) targeted at 25 percent below the cutoff;
(iv) A sufficient number of calibrators to ensure and document the
linearity of the assay method over time in the concentration area of
the cutoff (after acceptable values are obtained for the known
calibrators, those values will be used to calculate sample data); and
(v) At least one control that appears to be a donor specimen to the
laboratory analysts.
(4) A minimum of 10 percent of the total specimens in each
analytical run must be quality control samples, as defined by
paragraphs (d)(3)(i) through (iv) of this section.
(e) Quality control requirements for performing confirmatory drug
tests. (1) Confirmatory tests for drugs and drug metabolites must be
performed using gas chromatography/mass spectrometry (GC/MS) or other
confirmatory test methodologies that HHS-certified laboratories are
permitted to use in Federal workplace drug testing programs for this
purpose.
(2) At least 10 percent of the samples in each analytical run of
specimens must be calibrators and controls.
(3) Each analytical run of specimens that are subjected to
confirmatory testing must include--
(i) Sample(s) certified to contain no drug (i.e., negative urine
samples);
(ii) Positive calibrator(s) and control(s) with a drug(s) or drug
metabolite(s);
(iii) At least one positive control with a drug(s) or drug
metabolite(s) targeted at 25 percent above the cutoff; and
(iv) At least one calibrator or control that is targeted at or
below 40 percent of the cutoff.
(f) Errors in testing. The licensee or other entity shall ensure
that the HHS-certified laboratory investigates any testing errors or
unsatisfactory performance discovered in blind performance testing, as
required under Sec. 26.168, in the testing of actual specimens, or
through the processing of reviews, as well as any other errors or
matters that could adversely reflect on the testing process.
(1) Whenever possible, the investigation must determine relevant
[[Page 17216]]
facts and identify the root cause(s) of the testing or process error.
The licensee or other entity, and the HHS-certified laboratory, shall
take action to correct the causes of any errors or unsatisfactory
performance that are within each entity's control. Sufficient records
shall be maintained to furnish evidence of activities affecting
quality. The licensee or other entity shall assure that the cause of
the condition is determined and that corrective action is taken to
preclude repetition. The identification of the significant condition,
the cause of the condition, and the corrective action taken shall be
documented and reported to appropriate levels of management.
(2) If a false positive error occurs on a blind performance test
sample or on a regular specimen, the licensee or other entity shall
require the laboratory to take corrective action to minimize the
occurrence of the particular error in the future. If there is reason to
believe that the error could have been systematic, the licensee or
other entity may also require review and re-analysis of previously run
specimens.
(3) If a false positive error occurs on a blind performance test
sample and the error is determined to be technical or methodological,
the licensee or other entity shall instruct the laboratory to provide
all quality control data from the batch or analytical run of specimens
that included a false positive sample. In addition, the licensee or
other entity shall require the laboratory to retest all specimens that
analyzed as positive for that drug or metabolite, or as adulterated,
substituted, dilute, or invalid in validity testing, from the time of
final resolution of the error back to the time of the last satisfactory
performance test cycle. This retesting must be documented by a
statement signed by the laboratory's responsible person. The licensee
or other entity and the NRC also may require an onsite review of the
laboratory, which may be conducted unannounced during any hours of
operation of the laboratory.
(g) Accuracy. Volumetric pipettes and measuring devices must be
certified for accuracy or be checked by gravimetric, colorimetric, or
other verification procedures. Automatic pipetttes and dilutors must be
checked for accuracy and reproducibility both before being placed in
service and periodically thereafter.
(h) Calibrators and controls. Laboratory calibrators and controls
must be prepared using pure drug reference materials, stock standard
solutions obtained from other laboratories, or standard solutions that
are obtained from commercial manufacturers and are properly labeled as
to content and concentration. Calibrators and controls may not be
prepared from the same stock solution. The standards and controls must
be labeled with the following dates: when received; when prepared or
opened; when placed in service; and when scheduled for expiration.
Sec. 26.168 Blind performance testing.
(a) Each licensee and other entity shall submit blind performance
test samples to the HHS-certified laboratory.
(1) During the initial 90-day period of any contract with an HHS-
certified laboratory (not including rewritten or renewed contracts),
each licensee or other entity shall submit blind performance test
samples to each HHS-certified laboratory with whom it contracts in the
amount of at least 20 percent of the total number of specimens
submitted (up to a maximum of 100 blind performance specimens) or 30
blind performance test samples, whichever is greater.
(2) Following the initial 90-day period, the number of blind
performance test samples submitted per quarter must be a minimum of one
percent of all specimens (up to a maximum of 100) or ten blind
performance test samples, whichever is greater.
(3) Both during the initial 90-day period and quarterly thereafter,
licensees and other entities should attempt to submit blind performance
test samples at a frequency that corresponds to the submission
frequency for other specimens.
(b) Approximately 60 percent of the blind performance test samples
submitted to the laboratory must be positive for one or more drugs or
drug metabolites per sample and submitted so that all of the drugs for
which the FFD program is testing are included at least once each
calendar quarter, except as follows:
(1) Licensees and other entities shall submit blind performance
test samples that are positive for marijuana metabolite at least two
times each quarter; and
(2) In at least two quarters each year, licensees and other
entities shall submit an additional blind performance test sample that
is positive for cocaine instead of the required sample that is positive
for PCP.
(c) The positive blind performance test samples must be positive
for only those drugs for which the FFD program is testing and
formulated at concentrations established in paragraph (g)(2) of this
section.
(d) To challenge the HHS-certified laboratory's ability to limit
false negatives, approximately 10 percent of the blind performance test
samples submitted to the laboratory each quarter must be formulated at
the concentrations established in paragraph (g)(3) of this section.
(e) To challenge the HHS-certified laboratory's ability to
determine specimen validity, the licensee or other entity shall submit
blind samples each quarter that are appropriately adulterated, diluted,
or substituted, in the amount of 20 percent of the specimens submitted
that quarter or at least three samples per quarter (one each that is
adulterated, diluted, or substituted), whichever is greater. These
samples must be formulated at the concentrations established in
paragraphs (g)(4) through (g)(6) of this section.
(f) Approximately 10 percent of the blind performance test samples
submitted to the laboratory each quarter must be negative, as specified
in paragraph (g)(1) of this section.
(g) Licensees and other entities shall use only blind performance
test samples that have been certified by the supplier to be--
(1) Negative. A negative blind performance test sample may not
contain a measurable amount of a target drug analyte and must be
certified by immunoassay and confirmatory testing;
(2) Drug positive. These samples must contain a measurable amount
of the target drug or analyte in concentrations ranging between 150 and
200 percent of the initial cutoff values and be certified by
immunoassay and confirmatory testing to contain one or more drug(s) or
drug metabolite(s);
(3) A false negative challenge. This blind performance test sample
must contain a measurable amount of the target drug or analyte in
concentrations ranging between 130 and 155 percent of the initial
cutoff values;
(4) Adulterated. The adulterated blind performance test sample must
have a pH of less than or equal to 2, or greater than or equal to 12,
or a nitrite or other oxidant concentration equal to or greater than
500 mcg/mL, equal to or greater than 50 mcg/mL chromium (VI)-
equivalents, or a halogen concentration equal to or greater than the
LOD. Blind performance test samples for other adulterants must have
adulterant concentrations equal to or greater than (or equal to or less
than, as appropriate) the initial cutoff levels used by the licensee's
or other entity's HHS-certified laboratory;
(5) Dilute. The dilute blind performance test sample must contain a
[[Page 17217]]
creatinine concentration that is equal to or greater than 5 mg/dL but
less than 20 mg/dL, and the specific gravity must be greater than
1.0010 but less than 1.0030; or
(6) Substituted. The substituted blind performance test sample must
contain less than 2 mg/dL of creatinine, and the specific gravity must
be less than or equal to 1.0010, or equal to or greater than 1.0200.
(h) In order to ensure that blind performance test samples continue
to meet the criteria set forth in paragraph (g) of this section,
licensees and other entities shall--
(1) Ensure that all blind performance test sample lots are placed
in service by the supplier only after confirmation by an HHS-certified
laboratory, and for no more than 6 months;
(2) Ensure that the supplier provides the expiration date for each
blind performance test sample to ensure that each sample will have the
expected value when it is submitted to and tested by a laboratory; and
(3) At a minimum, require the supplier to check each open lot bi-
monthly (i.e., every two months) to ensure that samples remaining in
the lot do not fall below 130 percent of the initial cutoff test
concentration established by the assay manufacturer. Thus, for example,
a lot that was certified by an HHS-certified laboratory at 155 percent
of the manufacturer's assay cutoff level, and was reported by the
licensee's or other entity's HHS-certified laboratory to be at or above
130 percent of that standard is acceptable. A test that indicated a
result below 130 percent of that standard would be unacceptable.
Licensees and other entities shall discard blind performance test
samples from any lot that is outside of these parameters and may not
use any further samples from that lot.
(i) Licensees and other entities shall ensure that each blind
performance test sample is indistinguishable to laboratory personnel
from a donor's specimen, as follows:
(1) The licensee or other entity shall submit blind performance
test samples to the laboratory using the same channels (i.e., from the
licensee's or other entity's collection site or licensee testing
facility, as appropriate) through which donors' specimens are sent to
the laboratory;
(2) The collector and licensee testing facility personnel, as
appropriate, shall use a custody-and-control form, place fictional
initials on the specimen bottles' labels/seals, and indicate for the
MRO on the MRO's copy that the specimen is a blind performance test
sample; and
(3) The licensee or other entity shall ensure that all blind
performance test samples include split samples, when the FFD program
includes split specimen procedures.
Sec. 26.169 Reporting Results.
(a) The HHS-certified laboratory shall report test results to the
licensee's or other entity's MRO within 5 business days after receiving
the specimen from the licensee or other entity. Before reporting any
test result to the MRO, the laboratory's certifying scientist shall
certify the result as correct. The report must identify the substances
for which testing was performed; the results of the validity and drug
tests; the cutoff levels for each; any indications of tampering,
adulteration, or substitution that may be present; the specimen
identification number assigned by the licensee or other entity; and the
specimen identification number assigned by the laboratory.
(b) If licensees or other entities specify cutoff levels for drugs
or drug metabolites that are more stringent than those specified in
this part, the laboratory need only conduct the more stringent tests
and shall report the results of the initial and confirmatory tests only
for the more stringent cutoff levels.
(c) The HHS-certified laboratory shall report as negative all
specimens that are negative on the initial or confirmatory drug and
validity tests. Specimens that test as positive, adulterated,
substituted, dilute, or invalid on the confirmatory analysis must be
reported to the MRO as positive for a specific drug(s) or drug
metabolite(s), or as meeting the criteria for an adulterated,
substituted, dilute, or invalid specimen.
(1) The laboratory shall report all positive, adulterated,
substituted, dilute, and invalid test results for each specimen to the
MRO. For example, a specimen may be both adulterated and positive for
one or more specific drugs.
(2) For a specimen that has a positive test result, the laboratory
shall provide numerical values if the MRO requests such information.
The MRO's request for positive confirmatory test results may be either
a general request covering all such results or a specific case-by-case
request. The laboratory shall routinely provide quantitative values for
confirmatory opiate test results for morphine or codeine that are
greater than or equal to 15,000 ng/mL, even if the MRO has not
requested quantitative values for the test result.
(3) For a specimen that has an adulterated or substituted test
result, the laboratory shall provide the MRO with the numerical values
that support the reported result. The MRO may not disclose the
numerical values to the licensee or other entity, except as permitted
in Sec. 26.37(b). If the numerical values for creatinine are below the
LOD, the laboratory shall report to the MRO ``creatinine: none
detected'' (i.e., substituted) along with the numerical values of the
specific gravity test.
(4) For a specimen that has an invalid result, the laboratory shall
contact the MRO and both will decide whether testing by another
certified laboratory would be useful in being able to report a positive
or adulterated result. This contact may occur through any secure
electronic means (e.g., telephone, fax, e-mail). If no further testing
is necessary, the laboratory shall report the invalid result to the
MRO.
(5) When the concentration of a drug, metabolite, or adulterant
exceeds the linear range of the standard curve, the laboratory may
report to the MRO that the quantitative value ``exceeds the linear
range of the test,'' that the quantitative value is ``equal to or
greater than ,'' or may report an accurate quantitative value above the upper
limit of the linear range that was obtained by diluting an aliquot of
the specimen.
(d) The MRO and MRO staff may not disclose quantitative test
results to a licensee or other entity, but shall report only whether
the specimen was positive (and for which analyte), adulterated,
substituted, dilute, invalid, or negative, except as permitted under
Sec. 26.37(b). This paragraph does not preclude either the HHS-
certified laboratory or the MRO from providing program performance
data, as required under Sec. 26.717.
(e) The laboratory may transmit results to the MRO by various
electronic means (e.g., teleprinters, facsimile, or computer) in a
manner designed to ensure the confidentiality of the information. The
laboratory may not provide results orally by telephone. The licensee or
other entity, directly or through the HHS-certified laboratory, shall
ensure the security of the data transmission and ensure only authorized
access to any data transmission, storage, and retrieval system.
(f) For negative test results, the HHS-certified laboratory may
fax, courier, mail, or electronically transmit a computer-generated
electronic report and/or a legible image or copy of the completed
custody-and-control form to the MRO. However, for positive,
adulterated, substituted, dilute, and invalid results, the laboratory
shall fax, courier, mail, or electronically transmit
[[Page 17218]]
a legible image or copy of the completed custody-and-control form to
the MRO.
(g) For a specimen that has a positive, adulterated, substituted,
dilute, or invalid result, the laboratory shall retain the original
custody-and-control form and transmit to the MRO a copy of the original
custody-and-control form signed by a certifying scientist.
(h) The HHS-certified laboratory shall provide to the licensee's or
other entity's official responsible for coordination of the FFD program
an annual statistical summary of urinalysis testing, which may not
include any personal identifying information. To avoid sending data
from which it is likely that information about a donor's test result
can be readily inferred, the laboratory may not send a summary report
if the licensee or other entity has fewer than 10 specimen test results
in a 1-year period. The summary report must include test results that
were reported within the year period. The laboratory shall send the
summary report to the licensee or other entity within 14 calendar days
after the end of the 1-year period covered by the report. The
statistics must be presented either for the cutoff levels specified in
this part or for any more stringent cutoff levels that the licensee or
other entity may specify. The HHS-certified laboratory shall make
available quantitative results for all specimens tested when requested
by the NRC, licensee, or other entity for whom the laboratory is
performing drug-testing services. If the FFD program tests for
additional drugs beyond those listed in Sec. 26.31(d), the summary
must include drug test results for the additional drugs. The summary
report must contain the following information:
(1) Total number of specimens received;
(2) Number of specimens reported as--
(i) Negative, and
(ii) Negative and dilute;
(3) Number of specimens reported as positive on confirmatory tests
by drug or drug metabolite for which testing is conducted, including,
but not limited to--
(i) Marijuana metabolite;
(ii) Cocaine metabolite;
(iii) Opiates (total);
(A) Codeine;
(B) Morphine; and
(C) 6-AM;
(iv) Phencyclidine;
(v) Amphetamines (total);
(A) Amphetamine; and
(B) Methamphetamine;
(4) Total number of specimens reported as adulterated;
(5) Total number of specimens reported as substituted;
(6) Total number of specimens reported as positive and dilute
[including an indication as to whether the specimen was subject to the
special analysis permitted in Sec. 26.163(a)(2)];
(7) Total number of specimens reported as invalid; and
(8) Number of specimens reported as rejected for testing and the
reason for the rejection.
Subpart H--Determining Fitness-for-Duty Policy Violations and
Determining Fitness
Sec. 26.181 Purpose.
This subpart contains requirements for determining whether a donor
has violated the FFD policy and for making a determination of fitness.
Sec. 26.183 Medical review officer.
(a) Qualifications. The MRO shall be knowledgeable of this part and
of the FFD policies of the licensees and other entities for whom the
MRO provides services. The MRO shall be a physician holding either a
Doctor of Medicine or Doctor of Osteopathy degree who is licensed to
practice medicine by any State or Territory of the United States, the
District of Columbia, or the Commonwealth of Puerto Rico. By March 31,
2010, the MRO shall have passed an examination administered by a
nationally-recognized MRO certification board or subspecialty board for
medical practitioners in the field of medical review of Federally
mandated drug tests.
(b) Relationships. The MRO may be an employee of the licensee or
other entity or a contractor. However, the MRO may not be an employee
or agent of, or have any financial interest in, an HHS-certified
laboratory or a contracted operator of a licensee testing facility for
whom the MRO reviews drug test results. Additionally, the MRO may not
derive any financial benefit by having the licensee or other entity use
a specific drug testing laboratory or licensee testing facility
operating contractor and may not have any agreement with such parties
that may be construed as a potential conflict of interest. Examples of
relationships between laboratories and MROs that create conflicts of
interest, or the appearance of such conflicts, include, but are not
limited to--
(1) The laboratory employs an MRO who reviews test results produced
by the laboratory;
(2) The laboratory has a contract or retainer with the MRO for the
review of test results produced by the laboratory;
(3) The laboratory designates which MRO the licensee or other
entity is to use, gives the licensee or other entity a slate of MROs
from which to choose, or recommends certain MROs;
(4) The laboratory gives the licensee or other entity a discount or
other incentive to use a particular MRO;
(5) The laboratory has its place of business co-located with that
of an MRO or MRO staff who review test results produced by the
laboratory; or
(6) The laboratory permits an MRO, or an MRO's organization, to
have a financial interest in the laboratory.
(c) Responsibilities. The primary role of the MRO is to review and
interpret positive, adulterated, substituted, invalid, and at the
licensee's or other entity's discretion, dilute test results obtained
through the licensee's or other entity's testing program and to
identify any evidence of subversion of the testing process. The MRO is
also responsible for identifying any issues associated with collecting
and testing specimens, and for advising and assisting FFD program
management in planning and overseeing the overall FFD program.
(1) In carrying out these responsibilities, the MRO shall examine
alternate medical explanations for any positive, adulterated,
substituted, invalid, or, at the licensee's or other entity's
discretion, dilute test result. This action may include, but is not
limited to, conducting a medical interview with the donor, reviewing
the donor's medical history, or reviewing any other relevant biomedical
factors. The MRO shall review all medical records that the donor may
make available when a positive, adulterated, substituted, invalid, or
dilute test result could have resulted from responsible use of legally
prescribed medication, a documented condition or disease state, or the
demonstrated physiology of the donor.
(2) The MRO may only consider the results of tests of specimens
that are collected and processed under this part, including the results
of testing split specimens, in making his or her determination, as long
as those split specimens have been stored and tested under the
procedures described in this part.
(d) MRO staff. Individuals who provide administrative support to
the MRO may be employees of a licensee or other entity, employees of
the MRO, or employees of an organization with whom a licensee or other
entity contracts for MRO services. Employees of a licensee or other
entity who serve MRO staff functions may also perform other duties for
the licensee or other entity and need not be under the
[[Page 17219]]
direction of the MRO while performing those other duties.
(1) Direction of MRO staff activities. MROs shall be directly
responsible for all administrative, technical, and professional
activities of individuals who are serving MRO staff functions while
they are performing those functions, and those functions must be under
the MRO's direction.
(i) The duties of MRO staff must be maintained independent from any
other activity or interest of a licensee or other entity, in order to
protect the integrity of the MRO function and donors' privacy.
(ii) An MRO's responsibilities for directing MRO staff must
include, but are not limited to, ensuring that--
(A) The procedures being performed by MRO staff meet NRC
regulations and HHS' and professional standards of practice;
(B) Records and other donor personal information are maintained
confidential by MRO staff and are not released to other individuals or
entities, except as permitted under this part;
(C) Data transmission is secure; and
(D) Drug test results are reported to the licensee's or other
entity's designated reviewing official only as required by this part.
(iii) The MRO may not delegate any of his or her responsibilities
for directing MRO staff to any other individual or entity, except
another MRO.
(2) MRO staff responsibilities. MRO staff may perform routine
administrative support functions, including receiving test results,
reviewing negative test results, and scheduling interviews for the MRO.
(i) The staff under the direction of the MRO may receive, review,
and report negative test results to the licensee's or other entity's
designated representative.
(ii) The staff reviews of positive, adulterated, substituted,
invalid, and, at the licensee's or other entity's discretion, dilute
test results must be limited to reviewing the custody-and-control form
to determine whether it contains any errors that may require corrective
action and to ensure that it is consistent with the information on the
MRO's copy. The staff may resolve errors in custody-and-control forms
that require corrective action(s), but shall forward the custody-and-
control forms to the MRO for review and approval of the resolution.
(iii) The staff may not conduct interviews with donors to discuss
positive, adulterated, substituted, invalid, or dilute test results nor
request medical information from a donor. Only the MRO may request and
review medical information related to a positive, adulterated,
substituted, or invalid test result or other matter from a donor.
(iv) Staff may not report nor discuss with any individuals other
than the MRO and other MRO staff any positive, adulterated,
substituted, invalid, or dilute test results received from the HHS-
certified laboratory before those results have been reviewed and
confirmed by the MRO. Any MRO staff discussions of confirmed positive,
adulterated, substituted, invalid, or dilute test results must be
limited to discussions only with the licensee's or other entity's FFD
program personnel and may not reveal quantitative test results or any
personal medical information about the donor that the MRO may have
obtained in the course of reviewing confirmatory test results from the
HHS-certified laboratory.
Sec. 26.185 Determining a fitness-for-duty policy violation.
(a) MRO review required. A positive, adulterated, substituted,
dilute, or invalid drug test result does not automatically identify an
individual as having used drugs in violation of the NRC's regulations,
or the licensee's or other entity's FFD policy, or as having attempted
to subvert the testing process. An individual who has a detailed
knowledge of possible alternate medical explanations is essential to
the review of the results. The MRO shall review all positive,
adulterated, substituted, and invalid test results from the HHS-
certified laboratory to determine whether the donor has violated the
FFD policy before reporting the results to the licensee's or other
entity's designated representative.
(b) Reporting of initial test results prohibited. Neither the MRO
nor MRO staff may report positive, adulterated, substituted, dilute, or
invalid initial test results that are received from the HHS-certified
laboratory to the licensee or other entity.
(c) Discussion with the donor. Before determining that a positive,
adulterated, substituted, dilute, or invalid test result or other
occurrence is an FFD policy violation and reporting it to the licensee
or other entity, the MRO shall give the donor an opportunity to discuss
the test result or other occurrence with the MRO, except as described
in paragraph (d) of this section. After this discussion, if the MRO
determines that a positive, adulterated, substituted, dilute, or
invalid test result or other occurrence is an FFD policy violation, the
MRO shall immediately notify the licensee's or other entity's
designated representative.
(d) Donor unavailability. The MRO may determine that a positive,
adulterated, substituted, dilute, or invalid test result or other
occurrence is an FFD policy violation without having discussed the test
result or other occurrence directly with the donor in the following
three circumstances:
(1) The MRO has made and documented contact with the donor and the
donor expressly declined the opportunity to discuss the test result or
other occurrence that may constitute an FFD policy violation;
(2) A representative of the licensee or other entity, or an MRO
staff member, has successfully made and documented contact with the
donor and has instructed him or her to contact the MRO, and more than 1
business day has elapsed since the date on which the licensee's
representative or MRO's staff member successfully contacted the donor;
or
(3) The MRO, after making all reasonable efforts and documenting
the dates and time of those efforts, has been unable to contact the
donor. Reasonable efforts include, at a minimum, three attempts, spaced
reasonably over a 24-hour period, to reach the donor at the day and
evening telephone numbers listed on the custody-and-control form.
(e) Additional opportunity for discussion. If the MRO determines
that the donor has violated the FFD policy without having discussed the
positive, adulterated, substituted, dilute, or invalid test result or
other occurrence directly with the donor, the donor may, on subsequent
notification of the MRO determination and within 30 days of that
notification, present to the MRO information documenting the
circumstances, including, but not limited to, serious illness or
injury, which unavoidably prevented the donor from being contacted by
the MRO or a representative of the licensee or other entity, or from
contacting the MRO in a timely manner. On the basis of this
information, the MRO may reopen the procedure for determining whether
the donor's test result or other occurrence is an FFD policy violation
and permit the individual to present information related to the issue.
The MRO may modify the initial determination based on an evaluation of
the information provided.
(f) Review of invalid specimens. (1) If the HHS-certified
laboratory reports an invalid result, the MRO shall consult with the
laboratory to determine whether additional testing by another HHS-
certified laboratory may be useful in determining and reporting a
positive or adulterated test result. If the MRO and the laboratory
agree that further
[[Page 17220]]
testing would be useful, the HHS-certified laboratory shall forward the
specimen to a second laboratory for additional testing.
(2) If the MRO and the laboratory agree that further testing would
not be useful and there is no technical explanation for the result, the
MRO shall contact the donor and determine whether there is an
acceptable medical explanation for the invalid result. If there is an
acceptable medical explanation, the MRO shall report to the licensee or
other entity that the test result is not an FFD policy violation, but
that a negative test result was not obtained. If the medical reason for
the invalid result is, in the opinion of the MRO, a temporary
condition, the licensee or other entity shall collect a second urine
specimen from the donor as soon as reasonably practical and rely on the
MRO's review of the test results from the second collection. The second
specimen collected for the purposes of this paragraph may not be
collected under direct observation. If the medical reason for the
invalid result would similarly affect the testing of another urine
specimen, the MRO may authorize an alternative method for drug testing.
Licensees and other entities may not impose sanctions for an invalid
test result due to a medical condition.
(3) If the MRO and the laboratory agree that further testing would
not be useful and there is no legitimate technical or medical
explanation for the invalid test result, the MRO shall require that a
second collection take place as soon as practical under direct
observation. The licensee or other entity shall rely on the MRO's
review of the test results from the directly observed collection.
(g) Review of dilute specimens. (1) If the HHS-certified laboratory
reports that a specimen is dilute and that drugs or drug metabolites
were detected in the specimen at or above the cutoff levels specified
in this part or the licensee's or other entity's more stringent cutoff
levels, and the MRO determines that there is no legitimate medical
explanation for the presence of the drugs or drug metabolites in the
specimen, and a clinical examination, if required under paragraph
(g)(4) of this section, has been conducted, the MRO shall determine
that the drug test results are positive and that the donor has violated
the FFD policy.
(2) If the licensee or other entity requires the HHS-certified
laboratory to conduct the special analysis of dilute specimens
permitted in Sec. 26.163(a)(2), the results of the special analysis
are positive, the MRO determines that there is no legitimate medical
explanation for the presence of the drug(s) or drug metabolite(s) in
the specimen, and a clinical examination, if required under paragraph
(g)(4) of this section, has been conducted under paragraph (j) of this
section, the MRO shall determine whether the positive and dilute
specimen is a refusal to test. If the MRO does not have sufficient
reason to believe that the positive and dilute specimen is a subversion
attempt, he or she shall determine that the drug test results are
positive and that the donor has violated the FFD policy. When
determining whether the donor has diluted the specimen in a subversion
attempt, the MRO shall also consider the following circumstances, if
applicable:
(i) The donor has presented, at this or a previous collection, a
urine specimen that the HHS-certified laboratory reported as being
substituted, adulterated, or invalid to the MRO and the MRO determined
that there is no adequate technical or medical explanation for the
result;
(ii) The donor has presented a urine specimen of 30 mL or more that
falls outside the required temperature range, even if a subsequent
directly observed collection was performed; or
(iii) The collector observed conduct clearly and unequivocally
indicating an attempt to dilute the specimen.
(3) If a dilute specimen was collected under direct observation,
the MRO may require the laboratory to conduct confirmatory testing at
the LOD for any drugs or drug metabolites, as long as each drug class
is evaluated as required by Sec. 26.31(d)(1)(ii).
(4) If the drugs detected in a dilute specimen are any opium,
opiate, or opium derivative (e.g., morphine/codeine), or if the drugs
or metabolites detected indicate the use of prescription or over-the-
counter medications, before determining that the donor has violated the
FFD policy under paragraph (a) of this section, the MRO or his/her
designee, who shall also be a licensed physician with knowledge of the
clinical signs of drug abuse, shall conduct the clinical examination
for abuse of these substances that is required in paragraph (j) of this
section. An evaluation for clinical evidence of abuse is not required
if the laboratory confirms the presence of 6-AM (i.e., the presence of
this metabolite is proof of heroin use) in the dilute specimen.
(5) An MRO review is not required for specimens that the HHS-
certified laboratory reports as negative and dilute. The licensee or
other entity may not take any administrative actions or impose any
sanctions on a donor who submits a negative and dilute specimen.
(h) Review of substituted specimens. (1) If the HHS-certified
laboratory reports a specimen as substituted (i.e., the creatinine
concentration is less than 2 mg/dL and the specific gravity is less
than or equal to 1.0010 or equal to or greater than 1.0200), the MRO
shall contact the donor and offer the donor an opportunity to provide a
legitimate medical explanation for the substituted result. The burden
of proof resides solely with the donor, who must provide legitimate
medical evidence within 5 business days that he or she produced the
specimen for which the HHS-certified laboratory reported a substituted
result. Any medical evidence must be submitted through a physician who
is experienced and qualified in the medical issues involved, as
verified by the MRO. Claims of excessive hydration, or claims based on
unsubstantiated personal characteristics, including, but not limited
to, race, gender, diet, and body weight, are not acceptable evidence
without medical studies which demonstrate that the donor did produce
the laboratory result.
(2) If the MRO determines that there is no legitimate medical
explanation for the substituted test result, the MRO shall report to
the licensee or other entity that the specimen was substituted.
(3) If the MRO determines that there is a legitimate medical
explanation for the substituted test result and no drugs or drug
metabolites were detected in the specimen, the MRO shall report to the
licensee or other entity that no FFD policy violation has occurred.
(i) Review of adulterated specimens. (1) If the HHS-certified
laboratory reports a specimen as adulterated with a specific substance,
the MRO shall contact the donor and offer the donor an opportunity to
provide a legitimate medical explanation for the adulterated result.
The burden of proof resides solely with the donor, who must provide
legitimate medical evidence within 5 business days that he or she
produced the adulterated result. Any medical evidence must be submitted
through a physician experienced and qualified in the medical issues
involved, as verified by the MRO.
(2) If the MRO determines there is no legitimate medical
explanation for the adulterated test result, the MRO shall report to
the licensee or other entity that the specimen is adulterated.
(3) If the MRO determines that there is a legitimate medical
explanation for the adulterated test result and no drugs or drug
metabolites were detected in the specimen, the MRO shall report to the
[[Page 17221]]
licensee or other entity that no FFD policy violation has occurred.
(j) Review for opiates, prescription and over-the-counter
medications. (1) If the MRO determines that there is no legitimate
medical explanation for a positive confirmatory test result for opiates
and before the MRO determines that the test result is a violation of
the FFD policy, the MRO or his/her designee, who shall also be a
licensed physician with knowledge of the clinical signs of drug abuse,
shall determine that there is clinical evidence, in addition to the
positive confirmatory test result, that the donor has illegally used
opium, an opiate, or an opium derivative (e.g., morphine/codeine). This
requirement does not apply if the laboratory confirms the presence of
6-AM (i.e., the presence of this metabolite is proof of heroin use), or
the morphine or codeine concentration is equal to or greater than
15,000 ng/mL and the donor does not present a legitimate medical
explanation for the presence of morphine or codeine at or above this
concentration. The MRO may not determine that the consumption of food
products is a legitimate medical explanation for the presence of
morphine or codeine at or above this concentration.
(2) If the MRO determines that there is no legitimate medical
explanation for a positive confirmatory test result for drugs other
than opiates that are commonly prescribed or included in over-the-
counter preparations (e.g., benzodiazepines in the first case,
barbiturates in the second) and are listed in the licensee's or other
entity's panel of substances to be tested, the MRO shall determine
whether there is clinical evidence, in addition to the positive
confirmatory test result, of abuse of any of these substances or their
derivatives.
(3) If the MRO determines that the donor has used another
individual's prescription medication, including a medication containing
opiates, and no clinical evidence of drug abuse is found, the MRO shall
report to the licensee or other entity that the donor has misused a
prescription medication. If the MRO determines that the donor has used
another individual's prescription medication and clinical evidence of
drug abuse is found, the MRO shall report to the licensee that the
donor has violated the FFD policy.
(4) In determining whether a legitimate medical explanation exists
for a positive confirmatory test result for opiates or prescription or
over-the-counter medications, the MRO may consider the use of a
medication from a foreign country. The MRO shall exercise professional
judgment consistently with the following principles:
(i) There can be a legitimate medical explanation only with respect
to a drug that is obtained legally in a foreign country;
(ii) There can be a legitimate medical explanation only with
respect to a drug that has a legitimate medical use. Use of a drug of
abuse (e.g., heroin, PCP) or any other substance that cannot be viewed
as having a legitimate medical use can never be the basis for a
legitimate medical explanation, even if the drug is obtained legally in
a foreign country; and
(iii) Use of the drug can form the basis of a legitimate medical
explanation only if it is used consistently with its proper and
intended medical purpose.
(5) The MRO may not consider consumption of food products,
supplements, or other preparations containing substances that may
result in a positive confirmatory drug test result, including, but not
limited to supplements containing hemp products or coca leaf tea, as a
legitimate medical explanation for the presence of drugs or drug
metabolites in the urine specimen above the cutoff levels specified in
Sec. 26.163 or a licensee's or other entity's more stringent cutoff
levels.
(6) The MRO may not consider the use of any drug contained in
Schedule I of section 202 of the Controlled Substances Act [21 U.S.C.
812] as a legitimate medical explanation for a positive confirmatory
drug test result, even if the drug may be legally prescribed and used
under State law.
(k) Results consistent with legitimate drug use. If the MRO
determines that there is a legitimate medical explanation for a
positive confirmatory drug test result, and that the use of a drug
identified through testing was in the manner and at the dosage
prescribed, and the results do not reflect a lack of reliability or
trustworthiness, then the donor has not violated the licensee's or
other entity's FFD policy. The MRO shall report to the licensee or
other entity that no FFD policy violation has occurred. The MRO shall
further evaluate the positive confirmatory test result and medical
explanation to determine whether use of the drug and/or the medical
condition poses a potential risk to public health and safety as a
result of the individual being impaired while on duty. If the MRO
determines that such a risk exists, he or she shall ensure that a
determination of fitness is performed.
(l) Retesting authorized. Should the MRO question the accuracy or
scientific validity of a positive, adulterated, substituted, or invalid
test result, only the MRO is authorized to order retesting of an
aliquot of the original specimen or the analysis of any split specimen
(Bottle B) in order to determine whether the FFD policy has been
violated. Retesting must be performed by a second HHS-certified
laboratory. The MRO is also the only individual who may authorize a
reanalysis of an aliquot of the original specimen or an analysis of any
split specimen (Bottle B) in response to a request from the donor
tested.
(m) Result scientifically insufficient. Based on the review of
inspection and audit reports, quality control data, multiple specimens,
and other pertinent results, the MRO may determine that a positive,
adulterated, substituted or invalid test result is scientifically
insufficient for further action and may declare that a drug or validity
test result is not an FFD policy violation, but that a negative test
result was not obtained. In this situation, the MRO may request
retesting of the original specimen before making this decision. The MRO
is neither expected nor required to request such retesting, unless in
the sole opinion of the MRO, such retesting is warranted. The MRO may
request that the reanalysis be performed by the same laboratory, or
that an aliquot of the original specimen be sent for reanalysis to
another HHS-certified laboratory. The licensee testing facility and the
HHS-certified laboratory shall assist in this review process, as
requested by the MRO, by making available the individual(s) responsible
for day-to-day management of the licensee testing facility or the HHS-
certified laboratory, or other individuals who are forensic
toxicologists or who have equivalent forensic experience in urine drug
testing, to provide specific consultation as required by the MRO.
(n) Evaluating results from a second laboratory. After a second
laboratory tests an aliquot of a single specimen or the split (Bottle
B) specimen, the MRO shall take the following actions if the second
laboratory reports the following results:
(1) If the second laboratory reconfirms any positive test results,
the MRO may report an FFD policy violation to the licensee or other
entity;
(2) If the second laboratory reconfirms any adulterated,
substituted, or invalid validity test results, the MRO may report an
FFD policy violation to the licensee or other entity;
(3) If the second laboratory does not reconfirm the positive test
results, the MRO shall report that no FFD policy violation has
occurred; or
(4) If the second laboratory does not reconfirm the adulterated,
substituted,
[[Page 17222]]
or invalid validity test results, the MRO shall report that no FFD
policy violation has occurred.
(o) Re-authorization after a first violation for a positive test
result. The MRO is responsible for reviewing drug test results from an
individual whose authorization was terminated or denied for a first
violation of the FFD policy involving a confirmed positive drug test
result and who is being considered for re-authorization. In order to
determine whether subsequent positive confirmatory drug test results
represent new drug use or remaining metabolites from the drug use that
initially resulted in the FFD policy violation, the MRO shall request
from the HHS-certified laboratory, and the laboratory shall provide,
quantitation of the test results and other information necessary to
make the determination. If the drug for which the individual first
tested positive was marijuana and the confirmatory assay for delta-9-
tetrahydrocannabinol-9-carboxylic acid yields a positive result, the
MRO shall determine whether the confirmatory test result indicates
further marijuana use since the first positive test result, or whether
the test result is consistent with the level of delta-9-
tetrahydrocannabinol-9-carboxylic acid that would be expected if no
further marijuana use had occurred. If the test result indicates that
no further marijuana use has occurred since the first positive test
result, then the MRO shall declare the drug test result as negative.
(p) Time to complete MRO review. The MRO shall complete his or her
review of positive, adulterated, substituted, and invalid test results
and, in instances when the MRO determines that there is no legitimate
medical explanation for the test result(s), notify the licensee's or
other entity's designated representative within 10 business days of an
initial positive, adulterated, substituted, or invalid test result. The
MRO shall notify the licensee or other entity of the results of his or
her review in writing and in a manner designed to ensure the
confidentiality of the information.
Sec. 26.187 Substance abuse expert.
(a) Implementation. By March 31, 2010, any SAEs on whom licensees
and other entities rely to make determinations of fitness under this
part shall meet the requirements of this section. An MRO who meets the
requirements of this section may serve as both an MRO and as an SAE.
(b) Credentials. An SAE shall have at least one of the following
credentials:
(1) A licensed physician;
(2) A licensed or certified social worker;
(3) A licensed or certified psychologist;
(4) A licensed or certified employee assistance professional; or
(5) An alcohol and drug abuse counselor certified by the National
Association of Alcoholism and Drug Abuse Counselors Certification
Commission or by the International Certification Reciprocity
Consortium/Alcohol and Other Drug Abuse.
(c) Basic knowledge. An SAE shall be knowledgeable in the following
areas:
(1) Demonstrated knowledge of and clinical experience in the
diagnosis and treatment of alcohol and controlled-substance abuse
disorders;
(2) Knowledge of the SAE function as it relates to the public's
interests in the duties performed by the individuals who are subject to
this subpart; and
(3) Knowledge of this part and any changes thereto.
(d) Qualification training. SAEs shall receive qualification
training on the following subjects:
(1) Background, rationale, and scope of this part;
(2) Key drug testing requirements of this part, including specimen
collection, laboratory testing, MRO review, and problems in drug
testing;
(3) Key alcohol testing requirements of this part, including
specimen collection, the testing process, and problems in alcohol
tests;
(4) SAE qualifications and prohibitions;
(5) The role of the SAE in making determinations of fitness and the
return-to-duty process, including the initial evaluation, referrals for
education and/or treatment, the followup evaluation, continuing
treatment recommendations, and the followup testing plan;
(6) Procedures for SAE consultation and communication with
licensees or other entities, MROs, and treatment providers;
(7) Reporting and recordkeeping requirements of this part; and
(8) Issues that SAEs confront in carrying out their duties under
this part.
(e) Continuing education. During each 3-year period following
completion of initial qualification training, the SAE shall complete
continuing education consisting of at least 12 continuing professional
education hours relevant to performing SAE functions.
(1) This continuing education must include material concerning new
technologies, interpretations, recent guidance, rule changes, and other
information about developments in SAE practice pertaining to this part,
since the time the SAE met the qualification training requirements of
this section.
(2) Continuing education activities must include documented
assessment tools to assist in determining that the SAE has learned the
material.
(f) Documentation. The SAE shall maintain documentation showing
that he or she currently meets all requirements of this section. The
SAE shall provide this documentation on request to NRC representatives,
licensees, or other entities who are relying on or contemplating
relying on the SAE's services, and to other individuals and entities,
as required by Sec. 26.37.
(g) Responsibilities and prohibitions. The SAE shall evaluate
individuals who have violated the substance abuse provisions of an FFD
policy and make recommendations concerning education, treatment, return
to duty, followup drug and alcohol testing, and aftercare. The SAE is
not an advocate for the licensee or other entity, or the individual.
The SAE's function is to protect public health and safety and the
common defense and security by professionally evaluating the individual
and recommending appropriate education/treatment, follow-up tests, and
aftercare.
(1) The SAE is authorized to make determinations of fitness in at
least the following three circumstances:
(i) When potentially disqualifying FFD information has been
identified regarding an individual who has applied for authorization
under this part;
(ii) When an individual has violated the substance abuse provisions
of a licensee's or other entity's FFD policy; and
(iii) When an individual may be impaired by alcohol, prescription
or over-the-counter medications, or illegal drugs.
(2) After determining the best recommendation for assisting the
individual, the SAE shall serve as a referral source to assist the
individual's entry into an education and/or treatment program.
(i) To prevent the appearance of a conflict of interest, the SAE
may not refer an individual requiring assistance to his or her private
practice or to a person or organization from whom the SAE receives
payment or in which the SAE has a financial interest. The SAE is
precluded from making referrals to entities with whom the SAE is
financially associated.
(ii) There are four exceptions to the prohibitions contained in the
preceding paragraph. The SAE may refer an individual to any of the
following providers of assistance, regardless of his or her
relationship with them:
[[Page 17223]]
(A) A public agency (e.g., treatment facility) operated by a state,
county, or municipality;
(B) A person or organization under contract to the licensee or
other entity to provide alcohol or drug treatment and/or education
services (e.g., the licensee's or other entity's contracted treatment
provider);
(C) The sole source of therapeutically appropriate treatment under
the individual's health insurance program (e.g., the single substance
abuse in-patient treatment program made available by the individual's
insurance coverage plan); or
(D) The sole source of therapeutically appropriate treatment
reasonably available to the individual (e.g., the only treatment
facility or education program reasonably located within the general
commuting area).
Sec. 26.189 Determination of fitness.
(a) A determination of fitness is the process entered when there
are indications that an individual specified in Sec. 26.4(a) through
(e), and at the licensee's or other entity's discretion as specified in
Sec. 26.4(f) and (g), may be in violation of the licensee's or other
entity's FFD policy or is otherwise unable to safely and competently
perform his or her duties. A determination of fitness must be made by a
licensed or certified professional who is appropriately qualified and
has the necessary clinical expertise, as verified by the licensee or
other entity, to evaluate the specific fitness issues presented by the
individual. A professional called on by the licensee or other entity
may not perform a determination of fitness regarding fitness issues
that are outside of his or her specific areas of expertise. The types
of professionals and the fitness issues for which they are qualified to
make determinations of fitness include, but are not limited to, the
following:
(1) An SAE who meets the requirements of Sec. 26.187 may determine
the fitness of an individual who may have engaged in substance abuse
and shall determine an individual's fitness to be granted authorization
following an unfavorable termination or denial of authorization under
this part, but may not be qualified to assess the fitness of an
individual who may have experienced mental illness, significant
emotional stress, or other mental or physical conditions that may cause
impairment but are unrelated to substance abuse, unless the SAE has
additional qualifications for addressing those fitness issues;
(2) A clinical psychologist may determine the fitness of an
individual who may have experienced mental illness, significant
emotional stress, or cognitive or psychological impairment from causes
unrelated to substance abuse, but may not be qualified to assess the
fitness of an individual who may have a substance abuse disorder,
unless the psychologist is also an SAE;
(3) A psychiatrist may determine the fitness of an individual who
is taking psychoactive medications consistently with one or more valid
prescription(s), but may not be qualified to assess potential
impairment attributable to substance abuse, unless the psychiatrist has
had specific training to diagnose and treat substance abuse disorders;
(4) A physician may determine the fitness of an individual who may
be ill, injured, fatigued, taking medications in accordance with one or
more valid prescriptions, or using over-the-counter medications, but
may not be qualified to assess the fitness of an individual who may
have a substance abuse disorder, unless the physician is also an SAE;
and
(5) As a physician with specialized training, the MRO may determine
the fitness of an individual who may have engaged in substance abuse or
may be ill, injured, fatigued, taking medications under one or more
valid prescriptions, and/or using over-the-counter medications, but may
not be qualified to assess an individual's fitness to be granted
authorization following an unfavorable termination or denial of
authorization under this part, unless the MRO is also an SAE.
(b) A determination of fitness must be made in at least the
following circumstances:
(1) When there is an acceptable medical explanation for a positive,
adulterated, substituted, or invalid test result, but there is a basis
for believing that the individual could be impaired while on duty;
(2) Before making return-to-duty recommendations after an
individual's authorization has been terminated unfavorably or denied
under a licensee's or other entity's FFD policy;
(3) Before an individual is granted authorization when potentially
disqualifying FFD information is identified that has not previously
been evaluated by another licensee or entity who is subject to this
subpart; and
(4) When potentially disqualifying FFD information is otherwise
identified and the licensee's or other entity's reviewing official
concludes that a determination of fitness is warranted under Sec.
26.69.
(c) A determination of fitness that is conducted for cause (i.e.,
because of observed behavior or a physical condition) must be conducted
through face-to-face interaction between the subject individual and the
professional making the determination. Electronic means of
communication may not be used.
(1) If there is neither conclusive evidence of an FFD policy
violation nor a significant basis for concern that the individual may
be impaired while on duty, then the individual must be determined to be
fit for duty.
(2) If there is no conclusive evidence of an FFD policy violation
but there is a significant basis for concern that the individual may be
impaired while on duty, then the subject individual must be determined
to be unfit for duty. This result does not constitute a violation of
this part nor of the licensee's or other entity's FFD policy, and no
sanctions may be imposed. However, the professional who made the
determination of fitness shall consult with the licensee's or other
entity's management personnel to identify the actions required to
ensure that any possible limiting condition does not represent a threat
to workplace or public health and safety. Licensee or other entity
management personnel shall implement the required actions. When
appropriate, the subject individual may also be referred to the EAP.
(d) Neither the individual nor licensees and other entities may
seek a second determination of fitness if a determination of fitness
under this part has already been performed by a qualified professional
employed by or under contract to the licensee or other entity. After
the initial determination of fitness has been made, the professional
may modify his or her evaluation and recommendations based on new or
additional information from other sources including, but not limited
to, the subject individual, another licensee or entity, or staff of an
education or treatment program. Unless the professional who made the
initial determination of fitness is no longer employed by or under
contract to the licensee or other entity, only that professional is
authorized to modify the evaluation and recommendations. When
reasonably practicable, licensees and other entities shall assist in
arranging for consultation between the new professional and the
professional who is no longer employed by or under contract to the
licensee or other entity, to ensure continuity and consistency in the
recommendations and their implementation.
[[Page 17224]]
Subpart I--Managing Fatigue
Sec. 26.201 Applicability.
The requirements in this subpart apply to the licensees and other
entities identified in Sec. 26.3(a), and, if applicable, (c) and (d).
The requirements in Sec. Sec. 26.203 and 26.211 apply to the
individuals identified in Sec. 26.4 (a) through (c). In addition, the
requirements in Sec. 26.205 through Sec. 26.209 apply to the
individuals identified in Sec. 26.4(a).
Sec. 26.203 General provisions.
(a) Policy. Licensees shall establish a policy for the management
of fatigue for all individuals who are subject to the licensee's FFD
program and incorporate it into the written policy required in Sec.
26.27(b).
(b) Procedures. In addition to the procedures required in Sec.
26.27(c), licensees shall develop, implement, and maintain procedures
that--
(1) Describe the process to be followed when any individual
identified in Sec. 26.4(a) through (c) makes a self-declaration that
he or she is not fit to safely and competently perform his or her
duties for any part of a working tour as a result of fatigue. The
procedure must--
(i) Describe the individual's and licensee's rights and
responsibilities related to self-declaration;
(ii) Describe requirements for establishing controls and conditions
under which an individual may be permitted or required to perform work
after that individual declares that he or she is not fit due to
fatigue; and
(iii) Describe the process to be followed if the individual
disagrees with the results of a fatigue assessment that is required
under Sec. 26.211(a)(2);
(2) Describe the process for implementing the controls required
under Sec. 26.205 for the individuals who are performing the duties
listed in Sec. 26.4(a);
(3) Describe the process to be followed in conducting fatigue
assessments under Sec. 26.211; and
(4) Describe the disciplinary actions that the licensee may impose
on an individual following a fatigue assessment, and the conditions and
considerations for taking those disciplinary actions.
(c) Training and examinations. Licensees shall add the following
KAs to the content of the training that is required in Sec. 26.29(a)
and the comprehensive examination required in Sec. 26.29(b):
(1) Knowledge of the contributors to worker fatigue, circadian
variations in alertness and performance, indications and risk factors
for common sleep disorders, shiftwork strategies for obtaining adequate
rest, and the effective use of fatigue countermeasures; and
(2) Ability to identify symptoms of worker fatigue and contributors
to decreased alertness in the workplace.
(d) Recordkeeping. Licensees shall retain the following records for
at least 3 years or until the completion of all related legal
proceedings, whichever is later:
(1) Records of work hours for individuals who are subject to the
work hour controls in Sec. 26.205;
(2) Records of shift schedules and shift cycles of individuals who
are subject to the work hour controls in Sec. 26.205;
(3) The documentation of waivers that is required in Sec.
26.207(a)(4), including the bases for granting the waivers;
(4) The documentation of work hour reviews that is required in
Sec. 26.205(e)(3) and (e)(4); and
(5) The documentation of fatigue assessments that is required in
Sec. 26.211(g).
(e) Reporting. Licensees shall include the following information in
a standard format in the annual FFD program performance report required
under Sec. 26.717:
(1) A summary for each nuclear power plant site of all instances
during the previous calendar year when the licensee waived the work
hour controls specified in Sec. 26.205(d)(1) through (d)(5)(i) for
individuals described in Sec. 26.4(a). The summary must include only
those waivers under which work was performed. If it was necessary to
waive more than one work hour control during any single extended work
period, the summary of instances must include each of the work hour
controls that were waived during the period. For each category of
individuals specified in Sec. 26.4(a), the licensee shall report--
(i) The number of instances when each applicable work hour control
specified in Sec. 26.205(d)(1)(i) through (d)(1)(iii), (d)(2)(i) and
(d)(2)(ii), and (d)(3)(i) through (d)(3)(v) was waived for individuals
not working on outage activities;
(ii) The number of instances when each applicable work hour control
specified in Sec. 26.205(d)(1)(i) through (d)(1)(iii), (d)(2)(i) and
(d)(2)(ii), (d)(3)(i) through (d)(3)(v), and (d)(4) and (d)(5)(i) was
waived for individuals working on outage activities; and
(iii) A summary that shows the distribution of waiver use among the
individuals within each category of individuals identified in Sec.
26.4(a) (e.g., a table that shows the number of individuals who
received only one waiver during the reporting period, the number of
individuals who received a total of two waivers during the reporting
period).
(2) A summary of corrective actions, if any, resulting from the
analyses of these data, including fatigue assessments.
(f) Audits. Licensees shall audit the management of worker fatigue
as required by Sec. 26.41.
Sec. 26.205 Work hours.
(a) Individuals subject to work hour controls. Any individual who
performs duties identified in Sec. 26.4(a)(1) through (a)(5) shall be
subject to the requirements of this section.
(b) Calculating work hours. For the purposes of this section, a
licensee shall calculate the work hours of individuals who are subject
to this section as the amount of time the individuals perform duties
for the licensee. Except as permitted by paragraphs (b)(1) through
(b)(5) of this section, the calculated work hours must include all time
performing duties for the licensee, including all within-shift break
times and rest periods during which there are no reasonable
opportunities or accommodations appropriate for restorative sleep.
(1) Shift turnover. Licensees may exclude shift turnover from the
calculation of an individual's work hours. Shift turnover includes only
those activities that are necessary to safely transfer information and
responsibilities between two or more individuals between shifts. Shift
turnover activities may include, but are not limited to, discussions of
the status of plant equipment, and the status of ongoing activities,
such as extended tests of safety systems and components. Licensees may
not exclude work hours worked during turnovers between individuals
within a shift period due to rotations or relief within a shift.
Activities that licensees may not exclude from work hours calculations
also include, but are not limited to, shift holdovers to cover for late
arrivals of incoming shift members; early arrivals of individuals for
meetings, training, or pre-shift briefings for special evolutions; and
holdovers for interviews needed for event investigations.
(2) Within-shift break and rest periods. Licensees may exclude from
the calculation of an individual's work hours only that portion of a
break or rest period during which there is a reasonable opportunity and
accommodations for restorative sleep (e.g., a nap).
[[Page 17225]]
(3) Beginning or resuming duties subject to work hour controls. If
an individual begins or resumes performing for the licensee any of the
duties listed in Sec. 26.4(a) during the calculation period, the
licensee shall include in the calculation of the individual's work
hours all work hours worked for the licensee, including hours worked
performing duties that are not listed in Sec. 26.4(a), and control the
individual's work hours under the requirements of paragraph (d) of this
section.
(4) Unannounced emergency preparedness exercises and drills.
Licensees may exclude from the calculation of an individual's work
hours the time the individual works unscheduled work hours for the
purpose of participating in the actual conduct of an unannounced
emergency preparedness exercise or drill.
(5) Incidental duties performed off site. Licensees may exclude
from the calculation of an individual's work hours unscheduled work
performed off site (e.g., technical assistance provided by telephone
from an individual's home) provided the total duration of the work does
not exceed a nominal 30 minutes during any single break period. For the
purposes of compliance with the minimum break requirements of paragraph
(d)(2) of this section and the minimum day off requirements of
paragraph (d)(3) through (d)(5) of this section, such duties do not
constitute work periods or work shifts.
(c) Work hours scheduling. Licensees shall schedule the work hours
of individuals who are subject to this section consistent with the
objective of preventing impairment from fatigue due to the duration,
frequency, or sequencing of successive shifts.
(d) Work hour controls. Licensees shall control the work hours of
individuals who are subject to this section.
(1) Except as permitted in Sec. 26.207, licensees shall ensure
that any individual's work hours do not exceed the following limits:
(i) 16 work hours in any 24-hour period;
(ii) 26 work hours in any 48-hour period; and
(iii) 72 work hours in any 7-day period.
(2) Licensees shall ensure that individuals have, at a minimum, the
rest breaks specified in this paragraph. For the purposes of this
subpart, a break is defined as an interval of time that falls between
successive work periods, during which the individual does not perform
any duties for the licensee other than one period of shift turnover at
either the beginning or end of a shift but not both. Except as
permitted in Sec. 26.207, licensees shall ensure that individuals
have, at a minimum--
(i) A 10-hour break between successive work periods or an 8-hour
break between successive work periods when a break of less than 10
hours is necessary to accommodate a crew's scheduled transition between
work schedules or shifts; and
(ii) A 34-hour break in any 9-day period.
(3) Licensees shall ensure that individuals have, at a minimum, the
number of days off specified in this paragraph. For the purposes of
this subpart, a day off is defined as a calendar day during which an
individual does not start a work shift. For the purposes of calculating
the average number of days off required in this paragraph, the duration
of the shift cycle may not exceed 6 weeks.
(i) Individuals who are working 8-hour shift schedules shall have
at least 1 day off per week, averaged over the shift cycle;
(ii) Individuals who are working 10-hour shift schedules shall have
at least 2 days off per week, averaged over the shift cycle;
(iii) Individuals who are working 12-hour shift schedules while
performing the duties described in Sec. 26.4(a)(1) through (a)(3)
shall have at least 2.5 days off per week, averaged over the shift
cycle;
(iv) Individuals who are working 12-hour shift schedules while
performing the duties described in Sec. 26.4(a)(4) shall have at least
2 days off per week, averaged over the shift cycle; and
(v) Individuals who are working 12-hour shift schedules while
performing the duties described in Sec. 26.4(a)(5) shall have at least
3 days off per week, averaged over the shift cycle.
(4) During the first 60 days of a unit outage, licensees need not
meet the requirements of paragraph (d)(3) of this section for
individuals specified in Sec. 26.4(a)(1) through (a)(4), while those
individuals are working on outage activities. However, the licensee
shall ensure that the individuals specified in Sec. 26.4(a)(1) through
(a)(3) have at least 3 days off in each successive (i.e., non-rolling)
15-day period and that the individuals specified in Sec. 26.4(a)(4)
have at least 1 day off in any 7-day period;
(5) During the first 60 days of a unit outage, security system
outage, or increased threat condition, licensees shall control the
hours worked by individuals specified in Sec. 26.4(a)(5) as follows:
(i) During the first 60 days of a unit outage or a planned security
system outage, licensees need not meet the requirements of paragraph
(d)(3) of this section. However, licensees shall ensure that these
individuals have at least 4 days off in each successive (i.e., non-
rolling) 15-day period; and
(ii) During the first 60 days of an unplanned security system
outage or increased threat condition, licensees need not meet the
requirements of either paragraph (d)(3) or (d)(5)(i) of this section.
(6) The 60-day periods in paragraphs (d)(4) and (d)(5) of this
section may be extended for each individual in 7-day increments for
each non-overlapping 7-day period the individual has worked not more
than 48 hours during the unit or security system outage or increased
threat condition, as applicable.
(e) Reviews. Licensees shall evaluate the effectiveness of their
control of work hours of individuals who are subject to this section.
Licensees shall conduct the reviews once per calendar year. If any
plant or security system outages or increased threat conditions
occurred since the licensee completed the most recent review, the
licensee shall include in the review an evaluation of the control of
work hours during the outages or increased threat conditions. Licensees
shall complete the review within 30 days of the end of the review
period. Licensees shall--
(1) Review the actual work hours and performance of individuals who
are subject to this section for consistency with the requirements of
Sec. 26.205(c). At a minimum, this review must address--
(i) Individuals whose actual hours worked during the review period
exceeded an average of 54 hours per week in any shift cycle while the
individuals' work hours are subject to the requirements of Sec.
26.205(d)(3);
(ii) Individuals who were granted more than one waiver during the
review period; and
(iii) Individuals who were assessed for fatigue under Sec. 26.211
during the review period.
(2) Review individuals' hours worked and the waivers under which
work was performed to evaluate staffing adequacy for all jobs subject
to the work hour controls of this section;
(3) Document the methods used to conduct the review and the results
of the review; and
(4) Record, trend, and correct, under the licensee's corrective
action program, any problems identified in maintaining control of work
hours consistent with the specific requirements and performance
objectives of this part.
[[Page 17226]]
Sec. 26.207 Waivers and exceptions.
(a) Waivers. Licensees may grant a waiver of the work hour controls
in Sec. 26.205(d)(1) through (d)(5)(i), as follows:
(1) To grant a waiver, the licensee shall meet both of the
following requirements:
(i) An operations shift manager determines that the waiver is
necessary to mitigate or prevent a condition adverse to safety, or a
security shift manager determines that the waiver is necessary to
maintain site security, or a site senior-level manager with requisite
signature authority makes either determination; and
(ii) A supervisor assesses the individual face to face and
determines that there is reasonable assurance that the individual will
be able to safely and competently perform his or her duties during the
additional work period for which the waiver will be granted. The
supervisor performing the assessment shall be trained as required by
Sec. Sec. 26.29 and 26.203(c) and shall be qualified to direct the
work to be performed by the individual. If there is no supervisor on
site who is qualified to direct the work, the assessment may be
performed by a supervisor who is qualified to provide oversight of the
work to be performed by the individual. At a minimum, the assessment
must address the potential for acute and cumulative fatigue considering
the individual's work history for at least the past 14 days, the
potential for circadian degradations in alertness and performance
considering the time of day for which the waiver will be granted, the
potential for fatigue-related degradations in alertness and performance
to affect risk-significant functions, and whether any controls and
conditions must be established under which the individual will be
permitted to perform work.
(2) To the extent practicable, licensees shall rely on the granting
of waivers only to address circumstances that could not have been
reasonably controlled;
(3) Licensees shall ensure that the timing of the face-to-face
supervisory assessment that is required by paragraph (a)(1)(ii) of this
section supports a valid assessment of the potential for worker fatigue
during the time the individual will be performing work under the
waiver. Licensees may not perform the face-to-face assessment more than
4 hours before the individual begins performing any work under the
waiver; and
(4) Licensees shall document the bases for individual waivers. The
documented basis for a waiver must include a description of the
circumstances that necessitate the waiver, a statement of the scope of
work and time period for which the waiver is approved, and the bases
for the determinations required in paragraphs (a)(1)(i) and (ii) of
this section.
(b) Force-on-force tactical exercises. For the purposes of
compliance with the minimum days off requirements of Sec.
26.205(d)(3), licensees may exclude shifts worked by security personnel
during the actual conduct of NRC-evaluated force-on-force tactical
exercises when calculating the individual's number of days off.
(c) Common defense and security. When informed in writing by the
NRC that the requirements of Sec. 26.205, or any subset thereof, are
waived for security personnel to ensure the common defense and
security, licensees need not meet the specified requirements of Sec.
26.205 for the duration of the period defined by the NRC.
(d) Plant emergencies. Licensees need not meet the requirements of
Sec. 26.205(c) and (d) during declared emergencies, as defined in the
licensee's emergency plan.
Sec. 26.209 Self-declarations.
(a) If an individual is performing, or being assessed for, work
under a waiver of the requirements contained in Sec. 26.205(d)(1)
through (d)(5)(i) and declares that, due to fatigue, he or she is
unable to safely and competently perform his or her duties, the
licensee shall immediately stop the individual from performing any
duties listed in Sec. 26.4(a), except if the individual is required to
continue performing those duties under other requirements of this
chapter. If the subject individual must continue performing the duties
listed in Sec. 26.4(a) until relieved, the licensee shall immediately
take action to relieve the individual.
(b) Following a self-declaration, as described in paragraph (a) of
this section, the licensee--
(1) May reassign the individual to duties other than those listed
in Sec. 26.4(a), but only if the results of a fatigue assessment,
conducted under the requirements of Sec. 26.211, indicate that the
individual is fit to safely and competently perform those other duties;
and
(2) Shall permit or require the individual to take a break of at
least 10 hours before the individual returns to performing any duties
listed in Sec. 26.4(a).
Sec. 26.211 Fatigue assessments.
(a) Licensees shall ensure that fatigue assessments are conducted
under the following conditions:
(1) For cause. In addition to any other test or determination of
fitness that may be required under Sec. Sec. 26.31(c) and 26.77, a
fatigue assessment must be conducted in response to an observed
condition of impaired individual alertness creating a reasonable
suspicion that an individual is not fit to safely and competently
perform his or her duties, except if the condition is observed during
an individual's break period. If the observed condition is impaired
alertness with no other behaviors or physical conditions creating a
reasonable suspicion of possible substance abuse, then the licensee
need only conduct a fatigue assessment. If the licensee has reason to
believe that the observed condition is not due to fatigue, the licensee
need not conduct a fatigue assessment;
(2) Self-declaration. A fatigue assessment must be conducted in
response to an individual's self-declaration to his or her supervisor
that he or she is not fit to safely and competently perform his or her
duties for any part of a working tour because of fatigue, except if,
following the self-declaration, the licensee permits or requires the
individual to take a rest break of at least 10 hours before the
individual returns to duty;
(3) Post-event. A fatigue assessment must be conducted in response
to events requiring post-event drug and alcohol testing as specified in
Sec. 26.31(c). Licensees may not delay necessary medical treatment in
order to conduct a fatigue assessment; and
(4) Followup. If a fatigue assessment was conducted for cause or in
response to a self-declaration, and the licensee returns the individual
to duty following a break of less than 10 hours in duration, the
licensee shall reassess the individual for fatigue as well as the need
to implement controls and conditions before permitting the individual
to resume performing any duties.
(b) Only supervisors and FFD program personnel who are trained
under Sec. Sec. 26.29 and 26.203(c) may conduct a fatigue assessment.
The fatigue assessment must be conducted face to face with the
individual whose alertness may be impaired.
(1) In the case of a fatigue assessment conducted for cause, the
individual who observed the condition of impaired alertness may not
conduct the fatigue assessment.
(2) In the case of a post-event fatigue assessment, the individual
who conducts the fatigue assessment may not have--
[[Page 17227]]
(i) Performed or directed (on site) the work activities during
which the event occurred;
(ii) Performed, within 24 hours before the event occurred, a
fatigue assessment of the individuals who were performing or directing
(on site) the work activities during which the event occurred; and
(iii) Evaluated or approved a waiver of the limits specified in
Sec. 26.205(d)(1) through (d)(5)(i) for any of the individuals who
were performing or directing (on site) the work activities during which
the event occurred, if the event occurred while such individuals were
performing work under that waiver.
(c) A fatigue assessment must provide the information necessary for
management decisions and actions in response to the circumstance that
initiated the assessment.
(1) At a minimum, the fatigue assessment must address the following
factors:
(i) Acute fatigue;
(ii) Cumulative fatigue; and
(iii) Circadian variations in alertness and performance.
(2) Individuals shall provide complete and accurate information
that may be required by the licensee to address the factors listed in
paragraph (c)(1) of this section. Licensees shall limit any inquiries
to obtaining from the subject individual only the personal information
that may be necessary to assess the factors listed in paragraph (c)(1)
of this section.
(d) The licensee may not conclude that fatigue has not or will not
degrade the individual's ability to safely and competently perform his
or her duties solely on the basis that the individual's work hours have
not exceeded any of the limits specified in Sec. 26.205(d)(1) or that
the individual has had the minimum breaks required in Sec.
26.205(d)(2) or minimum days off required in Sec. 26.205(d)(3) through
(d)(5), as applicable.
(e) Following a fatigue assessment, the licensee shall determine
and implement the controls and conditions, if any, that are necessary
to permit the individual to resume performing duties for the licensee,
including the need for a break.
(f) Licensees shall document the results of any fatigue assessments
conducted, the circumstances that necessitated the fatigue assessment,
and any controls and conditions that were implemented.
(g) Licensees shall also prepare an annual summary for each nuclear
power plant site of instances of fatigue assessments that were
conducted during the previous calendar year for any individual
identified in Sec. 26.4(a) through (c). Each summary must include--
(1) The conditions under which each fatigue assessment was
conducted (i.e., self-declaration, for cause, post-event, followup);
(2) A statement of whether or not the individual was working on
outage activities at the time of the self-declaration or condition
resulting in the fatigue assessment;
(3) The category of duties the individual was performing, if the
individual was performing the duties described in Sec. 26.4(a)(1)
through (a)(5) at the time of the self-declaration or condition
resulting in the fatigue assessment; and
(4) The management actions, if any, resulting from each fatigue
assessment.
Subpart J--[Reserved]
Subpart K--FFD Program for Construction
Sec. 26.401 General.
(a) At the licensee's or other entity's discretion, a licensee or
other entity in Sec. 26.3(c) may establish, implement, and maintain an
FFD program that meets the requirements of this subpart to apply to the
individuals specified in Sec. 26.4(f). If a licensee or other entity
in Sec. 26.3(c) does not elect to implement an FFD program that meets
the requirements of this subpart, the individuals specified in Sec.
26.4(f) shall be subject to an FFD program that meets the requirements
of subparts A through H, N, and O of this part.
(b) Entities who intend to implement an FFD program under this
subpart shall submit a description of the FFD program and its
implementation as part of the license, permit, or limited work
authorization application.
(c) Nothing in this subpart prohibits the licensees and other
entities in Sec. 26.3(c) from subjecting the individuals in Sec.
26.4(f) to an FFD program that meets all of the requirements of this
part or FFD program elements that meet all of the applicable
requirements of this part.
Sec. 26.403 Written policy and procedures.
(a) Licensees and other entities who implement an FFD program under
this subpart shall ensure that a clear, concise, written FFD policy
statement is provided to individuals who are subject to the program.
The policy statement must be written in sufficient detail to provide
affected individuals with information on what is expected of them and
what consequences may result from a lack of adherence to the policy.
(b) Licensees and other entities shall develop, implement, and
maintain written procedures that address the following topics:
(1) The methods and techniques to be used in testing for drugs and
alcohol, including procedures for protecting the privacy of an
individual who provides a specimen, procedures for protecting the
integrity of the specimen, and procedures used to ensure that the test
results are valid and attributable to the correct individual;
(2) The immediate and followup actions that will be taken, and the
procedures to be used, in those cases in which individuals who are
subject to the FFD program are determined to have--
(i) Been involved in the use, sale, or possession of illegal drugs;
(ii) Consumed alcohol to excess before or while constructing
safety-or security-related SSCs, as determined by a test that
accurately measures BAC;
(iii) Attempted to subvert the testing process by adulterating or
diluting specimens (in vivo or in vitro), substituting specimens, or by
any other means;
(iv) Refused to provide a specimen for analysis; or
(v) Had legal action taken relating to drug or alcohol use.
(3) The process to be followed if an individual's behavior or
condition raises a concern regarding the possible use, sale, or
possession of illegal drugs on or off site; the possible use or
possession of alcohol while constructing safety-or security-related
SSCs; or impairment from any cause which in any way could adversely
affect the individual's ability to safely and competently perform his
or her duties.
Sec. 26.405 Drug and alcohol testing.
(a) To provide means to deter and detect substance abuse, licensees
and other entities who implement an FFD program under this subpart
shall perform drug and alcohol testing that complies with the
requirements of this section.
(b) If the licensee or other entity elects to impose random testing
for drugs and alcohol on the individuals identified in Sec. 26.4(f),
random testing must--
(1) Be administered in a manner that provides reasonable assurance
that individuals are unable to predict the time periods during which
specimens will be collected;
(2) Require individuals who are selected for random testing to
report to the collection site as soon as reasonably practicable after
notification, within the time period specified in the FFD program
policy;
(3) Ensure that all individuals in the population that is subject
to random
[[Page 17228]]
testing on a given day have an equal probability of being selected and
tested; and
(4) Provide that an individual completing a test is immediately
eligible for another random test.
(c) Individuals identified in Sec. 26.4(f) shall be subject to
drug and alcohol testing under the following conditions:
(1) Pre-assignment. Before assignment to construct safety-or
security-related SSCs;
(2) For-cause. In response to an individual's observed behavior or
physical condition indicating possible substance abuse or after
receiving credible information that an individual is engaging in
substance abuse, as defined in Sec. 26.5;
(3) Post-accident. As soon as practical after an event involving a
human error that was committed by an individual specified in Sec.
26.4(f), where the human error may have caused or contributed to the
accident. The licensee or other entity shall test the individual(s) who
committed the error(s), and need not test individuals who were affected
by the event but whose actions likely did not cause or contribute to
the event. The individual(s) who committed the human error(s) shall be
tested if the event resulted in--
(i) A significant illness or personal injury to the individual to
be tested or another individual, which within 4 hours after the event
is recordable under the Department of Labor standards contained in 29
CFR 1904.7, and subsequent amendments thereto, and results in death,
days away from work, restricted work, transfer to another job, medical
treatment beyond first aid, loss of consciousness, or other significant
illness or injury as diagnosed by a physician or other licensed health
care professional, even if it does not result in death, days away from
work, restricted work or job transfer, medical treatment beyond first
aid, or loss of consciousness; or
(ii) Significant damage, during construction, to any safety-or
security-related SSC; and
(4) Followup. As part of a followup plan to verify an individual's
continued abstinence from substance abuse.
(d) At a minimum, licensees and other entities shall test specimens
for marijuana metabolite, cocaine metabolite, opiates (codeine,
morphine, 6-acetylmorphine), amphetamines (amphetamine,
methamphetamine), phencyclidine, adulterants, and alcohol at the cutoff
levels specified in this part, or comparable cutoff levels if specimens
other than urine are collected for drug testing. Urine specimens
collected for drug testing must be subject to validity testing.
(e) The specimen collection and drug and alcohol testing procedures
of FFD programs under this subpart must protect the donor's privacy and
the integrity of the specimen, and implement stringent quality controls
to ensure that test results are valid and attributable to the correct
individual. At the licensee's or other entity's discretion, specimen
collections and alcohol testing may be conducted at a local hospital or
other facility under the specimen collection and alcohol testing
requirements of 49 CFR Part 40 and subsequent amendments thereto.
(f) Testing of urine specimens for drugs and validity, except
validity screening and initial drug and validity tests that may be
performed by licensee testing facilities, must be performed in a
laboratory that is certified by HHS for that purpose, consistent with
its standards and procedures for certification. Any initial drug test
performed by a licensee or other entity subject to this subpart must
use an immunoassay that meets the requirements of the Food and Drug
Administration for commercial distribution. Urine specimens that yield
positive, adulterated, substituted, or invalid initial validity or drug
test results must be subject to confirmatory testing by the HHS-
certified laboratory, except for invalid specimens that cannot be
tested. Other specimens that yield positive initial drug test results
must be subject to confirmatory testing by a laboratory that meets
stringent quality control requirements that are comparable to those
required for certification by the HHS.
(g) Licensees and other entities shall provide for an MRO review of
positive, adulterated, substituted, and invalid confirmatory drug and
validity test results to determine whether the donor has violated the
FFD policy, before reporting the results to the individual designated
by the licensee or other entity to perform the suitability and fitness
evaluations required under Sec. 26.419.
Sec. 26.406 Fitness monitoring.
(a) The requirements in this section apply only if a licensee or
other entity does not elect to subject the individuals specified in
Sec. 26.4(f) to random testing for drugs and alcohol under Sec.
26.405(b).
(b) Licensees and other entities shall implement a fitness
monitoring program to deter substance abuse and detect indications of
possible use, sale, or possession of illegal drugs; use or possession
of alcohol while constructing safety-or security-related SSCs; or
impairment from any cause that if left unattended may result in a risk
to public health and safety or the common defense and security.
(c) Licensees and other entities shall establish procedures that
monitors shall follow in response to the indications and actions
specified in paragraph (b) of this section and train the monitors to
implement the program.
(d) Licensees and other entities shall ensure that the fitness of
individuals specified in Sec. 26.4(f) is monitored effectively while
the individuals are constructing safety- and security-related SSCs,
commensurate with the potential risk to public health and safety and
the common defense and security imposed by the construction activity.
To achieve this objective, licensees and other entities shall consider
the number and placement of monitors required, the necessary ratio of
monitors to individuals specified in Sec. 26.4(f), and the frequency
with which the individuals specified in Sec. 26.4(f) shall be
monitored while constructing each safety- or security-related SSC.
Sec. 26.407 Behavioral observation.
While the individuals specified in Sec. 26.4(f) are constructing
safety- or security-related SSCs, licensees and other entities shall
ensure that these individuals are subject to behavioral observation,
except if the licensee or other entity has implemented a fitness
monitoring program under Sec. 26.406.
Sec. 26.409 Sanctions.
Licensees and other entities who implement an FFD program under
this subpart shall establish sanctions for FFD policy violations that,
at a minimum, prohibit the individuals specified in Sec. 26.4(f) from
being assigned to construct safety- or security-related SSCs unless or
until the licensee or other entity determines that the individual's
condition or behavior does not pose a potential risk to public health
and safety or the common defense and security.
Sec. 26.411 Protection of information.
(a) Licensees and other entities who collect personal information
about an individual for the purpose of complying with this subpart
shall establish and maintain a system of files and procedures to
protect the personal information. FFD programs must maintain and use
such records with the highest regard for individual privacy.
(b) Licensees and other entities shall obtain a signed consent that
authorizes the disclosure of the personal information collected and
maintained under this subpart before disclosing the
[[Page 17229]]
personal information, except for disclosures to the individuals and
entities specified in Sec. 26.37(b)(1) through (b)(6), (b)(8), and
persons deciding matters under review in Sec. 26.413.
Sec. 26.413 Review process.
Licensees and other entities who implement an FFD program under
this subpart shall establish and implement procedures for the review of
a determination that an individual in Sec. 26.4(f) has violated the
FFD policy. The procedure must provide for an objective and impartial
review of the facts related to the determination that the individual
has violated the FFD policy.
Sec. 26.415 Audits.
(a) Licensees and other entities who implement an FFD program under
this subpart shall ensure that audits are performed to assure the
continuing effectiveness of the FFD program, including FFD program
elements that are provided by C/Vs, and the FFD programs of C/Vs that
are accepted by the licensee or other entity.
(b) Each licensee and other entity shall ensure that these programs
are audited at a frequency that assures their continuing effectiveness
and that corrective actions are taken to resolve any problems
identified. Licensees and entities may conduct joint audits, or accept
audits of C/Vs conducted by others, so long as the audit addresses the
relevant C/Vs' services.
(c) Licensees and other entities need not audit HHS-certified
laboratories or the specimen collection and alcohol testing services
that meet the requirements of 49 CFR Part 40, ``Procedures for
Department of Transportation Workplace Drug and Alcohol Testing
Programs'' (65 FR 41944; August 9, 2001), on which licensees and other
entities may rely to meet the drug and alcohol testing requirements of
this subpart.
Sec. 26.417 Recordkeeping and reporting.
(a) Licensees and other entities who implement FFD programs under
this subpart shall ensure that records pertaining to the administration
of the program, which may be stored and archived electronically, are
maintained so that they are available for NRC inspection purposes and
for any legal proceedings resulting from the administration of the
program.
(b) Licensees and other entities shall make the following reports:
(1) Reports to the NRC Operations Center by telephone within 24
hours after the licensee or other entity discovers any intentional act
that casts doubt on the integrity of the FFD program and any
programmatic failure, degradation, or discovered vulnerability of the
FFD program that may permit undetected drug or alcohol use or abuse by
individuals who are subject to this subpart. These events must be
reported under this subpart, rather than under the provisions of 10 CFR
73.71; and
(2) Annual program performance reports for the FFD program.
Sec. 26.419 Suitability and fitness evaluations.
Licensees and other entities who implement FFD programs under this
subpart shall develop, implement, and maintain procedures for
evaluating whether to assign individuals to construct safety- and
security-related SSCs. These procedures must provide reasonable
assurance that the individuals are fit to safely and competently
perform their duties, and are trustworthy and reliable, as demonstrated
by the avoidance of substance abuse.
Subpart L--[Reserved]
Subpart M--[Reserved]
Subpart N--Recordkeeping and Reporting Requirements
Sec. 26.709 Applicability.
The requirements of this subpart apply to the FFD programs of
licensees and other entities specified in Sec. 26.3, except for FFD
programs that are implemented under subpart K of this part.
Sec. 26.711 General provisions.
(a) Each licensee and other entity shall maintain records and
submit certain reports to the NRC. Records that are required by the
regulations in this part must be retained for the period specified by
the appropriate regulation. If a retention period is not otherwise
specified, these records must be retained until the Commission
terminates the facility's license, certificate, or other regulatory
approval.
(b) All records may be stored and archived electronically, provided
that the method used to create the electronic records meets the
following criteria:
(1) Provides an accurate representation of the original records;
(2) Prevents the alteration of any archived information and/or data
once it has been committed to storage; and
(3) Permits easy retrieval and re-creation of the original records.
(c) The licensees and other entities specified in Sec. 26.3(a)
and, as applicable, (c) and (d), shall inform each individual of his or
her right to review information about the individual that is collected
and maintained under this part to assure its accuracy. Licensees and
other entities shall provide the individual with an opportunity to
correct any inaccurate or incomplete information that is documented by
licensees and other entities about the individual.
(d) Licensees and other entities shall ensure that only correct and
complete information about individuals is retained and shared with
other licensees and entities. If, for any reason, the shared
information used for determining an individual's eligibility for
authorization under this part changes or new information is developed
about the individual, licensees and other entities shall correct or
augment the shared information contained in the records. If the changed
or developed information has implications for adversely affecting an
individual's eligibility for authorization, a licensee and other entity
specified in Sec. 26.3(a) and, as applicable, (c) and (d), who has
discovered the incorrect information, or develops new information,
shall inform the reviewing official of any FFD program under which the
individual is maintaining authorization of the updated information on
the day of discovery. The reviewing official shall evaluate the
information and take appropriate actions, which may include denial or
unfavorable termination of the individual's authorization.
Sec. 26.713 Recordkeeping requirements for licensees and other
entities.
(a) Each licensee and other entity who is subject to this subpart
shall retain the following records for at least 5 years after the
licensee or other entity terminates or denies an individual's
authorization or until the completion of all related legal proceedings,
whichever is later:
(1) Records of self-disclosures, employment histories, and suitable
inquiries that are required under Sec. Sec. 26.55, 26.57, 26.59, and
26.69 that result in the granting of authorization;
(2) Records pertaining to the determination of a violation of the
FFD policy and related management actions;
(3) Documentation of the granting and termination of authorization;
and
(4) Records of any determinations of fitness conducted under Sec.
26.189, including any recommendations for treatment and followup
testing plans.
(b) Each licensee and other entity who is subject to this subpart
shall retain the following records for at least 3 years or until the
completion of all related legal proceedings, whichever is later:
[[Page 17230]]
(1) Records of FFD training and examinations conducted under Sec.
26.29; and
(2) Records of audits, audit findings, and corrective actions taken
under Sec. 26.41.
(c) Licensees and other entities shall ensure the retention and
availability of records pertaining to any 5-year denial of
authorization under Sec. 26.75(c), (d), or (e)(2) and any permanent
denial of authorization under Sec. 26.75(b) and (g) for at least 40
years or until, on application, the NRC determines that the records are
no longer needed.
(d) Licensees and other entities shall retain any superseded
versions of the written FFD policy and procedures required under
Sec. Sec. 26.27, 26.39, and 26.203(b) for at least 5 years or until
completion of all legal proceedings related to an FFD violation that
may have occurred under the policy and procedures, whichever is later.
(e) Licensees and other entities shall retain written agreements
for the provision of services under this part for the life of the
agreement or until completion of all legal proceedings related to an
FFD policy violation that involved those services, whichever is later.
(f) Licensees and other entities shall retain records of the
background investigations, credit and criminal history checks, and
psychological assessments of FFD program personnel, conducted under
Sec. 26.31(b)(1)(i), for the length of the individual's employment by
or contractual relationship with the licensee or other entity, or until
the completion of all related legal proceedings, whichever is later.
(g) If a licensee's or other entity's FFD program includes tests
for drugs in addition to those specified in this part, as permitted
under Sec. 26.31(d)(1), or uses more stringent cutoff levels than
those specified in this part, as permitted under Sec. 26.31(d)(3), the
licensee or other entity shall retain documentation certifying the
scientific and technical suitability of the assays and cutoff levels
used, as required under Sec. 26.31(d)(1)(i) and (d)(3)(iii)(C),
respectively, for the time the FFD program follows these practices or
until the completion of all related legal proceedings, whichever is
later.
Sec. 26.715 Recordkeeping requirements for collection sites, licensee
testing facilities, and laboratories certified by the Department of
Health and Human Services.
(a) Collection sites providing services to licensees and other
entities who are subject to this subpart, licensee testing facilities,
and HHS-certified laboratories shall maintain and make available
documentation of all aspects of the testing process for at least 2
years or until the completion of all legal proceedings related to a
determination of an FFD violation, whichever is later. This 2-year
period may be extended on written notification by the NRC or by any
licensee or other entity for whom services are being provided.
(b) Documentation that must be retained includes, but is not
limited to, the following:
(1) Personnel files, including training records, for all
individuals who have been authorized to have access to specimens, but
are no longer under contract to or employed by the collection site,
licensee testing facility, or HHS-certified laboratory;
(2) Chain-of-custody documents (other than forms recording
specimens with negative test results and no FFD violations or
anomalies, which may be destroyed after appropriate summary information
has been recorded for program administration purposes);
(3) Quality assurance and quality control records;
(4) Superseded procedures;
(5) All test data (including calibration curves and any
calculations used in determining test results);
(6) Test reports;
(7) Records pertaining to performance testing;
(8) Records pertaining to the investigation of testing errors or
unsatisfactory performance discovered in quality control or blind
performance testing, in the testing of actual specimens, or through the
processing of appeals and MRO reviews, as well as any other errors or
matters that could adversely reflect on the integrity of the testing
process, investigation findings, and corrective actions taken, where
applicable;
(9) Performance records on certification inspections;
(10) Records of preventative maintenance on licensee testing
facility instruments;
(11) Records that summarize any test results that the MRO
determined to be scientifically insufficient for further action;
(12) Either printed or electronic copies of computer-generated
data;
(13) Records that document the dates, times of entry and exit,
escorts, and purposes of entry of authorized visitors, maintenance
personnel, and service personnel who have accessed secured areas of
licensee testing facilities and HHS-certified laboratories; and
(14) Records of the inspection, maintenance, and calibration of
EBTs.
Sec. 26.717 Fitness-for-duty program performance data.
(a) Licensees and other entities shall collect and compile FFD
program performance data for each FFD program that is subject to this
subpart.
(b) The FFD program performance data must include the following
information:
(1) The random testing rate;
(2) Drugs for which testing is conducted and cutoff levels,
including results of tests using lower cutoff levels, tests for drugs
not included in the HHS panel, and any special analyses of dilute
specimens permitted under Sec. 26.163(a)(2);
(3) Populations tested (i.e., individuals in applicant status,
permanent licensee employees, C/Vs);
(4) Number of tests administered and results of those tests sorted
by population tested (i.e., individuals in applicant status, permanent
licensee employees, C/Vs);
(5) Conditions under which the tests were performed, as defined in
Sec. 26.31(c);
(6) Substances identified;
(7) Number of subversion attempts by type;
(8) Summary of management actions; and
(9) The information required under Sec. 26.203(e)(1) and (e)(2).
(c) Licensees and other entities who have a licensee-approved FFD
program shall analyze the data at least annually and take appropriate
actions to correct any identified program weaknesses. Records of the
data, analyses, and corrective actions taken must be retained for at
least 3 years or until the completion of any related legal proceedings,
whichever is later.
(d) Any licensee or other entity who terminates an individual's
authorization or takes administrative action on the basis of the
results of a positive initial drug test for marijuana or cocaine shall
also report these test results in the annual summary by processing
stage (i.e., initial testing at the licensee testing facility, testing
at the HHS-certified laboratory, and MRO determinations). The report
must also include the number of terminations and administrative actions
taken against individuals for the reporting period.
(e) Licensees and other entities shall submit the FFD program
performance data (for January through December) to the NRC annually,
before March 1 of the following year.
(f) Licensees and other entities may submit the FFD program
performance data in a consolidated report, as long as the report
presents the data separately for each site.
[[Page 17231]]
(g) Each C/V who maintains a licensee-approved drug and alcohol
testing program is subject to the reporting requirements of this
section and shall submit the required information either directly to
the NRC or through the licensee's) or other entities to whom the C/V
provided services during the year. Licensees, other entities, and C/Vs
shall share information to ensure that the information is reported
completely and is not duplicated in reports submitted to the NRC.
Sec. 26.719 Reporting requirements.
(a) Required reports. Each licensee and entity who is subject to
this subpart shall inform the NRC of significant violations of the FFD
policy, significant FFD program failures, and errors in drug and
alcohol testing. These events must be reported under this section,
rather than under the provisions of 10 CFR 73.71.
(b) Significant FFD policy violations or programmatic failures. The
following significant FFD policy violations and programmatic failures
must be reported to the NRC Operations Center by telephone within 24
hours after the licensee or other entity discovers the violation:
(1) The use, sale, distribution, possession, or presence of illegal
drugs, or the consumption or presence of alcohol within a protected
area;
(2) Any acts by any person licensed under 10 CFR parts 52 and/or 55
to operate a power reactor, as well as any acts by SSNM transporters,
FFD program personnel, or any supervisory personnel who are authorized
under this part, if such acts--
(i) Involve the use, sale, or possession of a controlled substance;
(ii) Result in a determination that the individual has violated the
licensee's or other entity's FFD policy (including subversion as
defined in Sec. 26.5); or
(iii) Involve the consumption of alcohol within a protected area or
while performing the duties that require the individual to be subject
to the FFD program;
(3) Any intentional act that casts doubt on the integrity of the
FFD program; and
(4) Any programmatic failure, degradation, or discovered
vulnerability of the FFD program that may permit undetected drug or
alcohol use or abuse by individuals within a protected area, or by
individuals who are assigned to perform duties that require them to be
subject to the FFD program.
(c) Drug and alcohol testing errors. (1) Within 30 days of
completing an investigation of any testing errors or unsatisfactory
performance discovered in performance testing at either a licensee
testing facility or an HHS-certified laboratory, in the testing of
quality control or actual specimens, or through the processing of
reviews under Sec. 26.39 and MRO reviews under Sec. 26.185, as well
as any other errors or matters that could adversely reflect on the
integrity of the random selection or testing process, the licensee or
other entity shall submit to the NRC a report of the incident and
corrective actions taken or planned. If the error involves an HHS-
certified laboratory, the NRC shall ensure that HHS is notified of the
finding.
(2) If a false positive error occurs on a blind performance test
sample submitted to an HHS-certified laboratory, the licensee or other
entity shall notify the NRC within 24 hours after discovery of the
error.
(3) If a false negative error occurs on a quality assurance check
of validity screening tests, as required in Sec. 26.137(b), the
licensee or other entity shall notify the NRC within 24 hours after
discovery of the error.
(d) Indicators of programmatic weaknesses. Licensees and other
entities shall document, trend, and correct non-reportable indicators
of FFD programmatic weaknesses under the licensee's or other entity's
corrective action program, but may not track or trend drug and alcohol
test results in a manner that would permit the identification of any
individuals.
Subpart O--Inspections, Violations, and Penalties
Sec. 26.821 Inspections.
(a) Each licensee and other entity who is subject to this part
shall permit duly authorized NRC representatives to inspect, copy, or
take away copies of its records and to inspect its premises,
activities, and personnel as may be necessary to accomplish the
purposes of this part.
(b) Written agreements between licensees or other entities and
their C/Vs must clearly show that--
(1) The licensee or other entity is responsible to the NRC for
maintaining an effective FFD program under this part; and
(2) Duly authorized NRC representatives may inspect, copy, or take
away copies of any licensee's, other entity's, or C/V's documents,
records, and reports related to implementation of the licensee's or
other entity's FFD program under the scope of the contracted
activities.
Sec. 26.823 Violations.
(a) An injunction or other court order may be obtained to prohibit
a violation of any provision of--
(1) The Atomic Energy Act of 1954, as amended;
(2) Title II of the Energy Reorganization Act of 1974; or
(3) Any regulation or order issued under these Acts.
(b) A court order may be obtained for the payment of a civil
penalty imposed under section 234 of the Atomic Energy Act of 1954, for
violations of--
(1) Section 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of
the Act;
(2) Section 206 of the Energy Reorganization Act of 1974;
(3) Any rule, regulation, or order issued under these sections;
(4) Any term, condition, or limitation of any license issued under
these sections; or
(5) Any provisions for which a license may be revoked under section
186 of the Atomic Energy Act of 1954.
26.825 Criminal penalties.
(a) Section 223 of the Atomic Energy Act of 1954, as amended,
provides for criminal sanctions for willful violation of, attempted
violation of, or conspiracy to violate, any regulation issued under
sections 161b, 161i, or 161o of the Act. For the purposes of section
223, all of the regulations in Part 26 are issued under one or more of
sections 161b, 161i, or 161o, except for the sections listed in
paragraph (b) of this section.
(b) The regulations in Part 26 that are not issued under sections
161b, 161i, or 161o for the purposes of section 223 are as follows:
Sec. Sec. 26.1, 26.3, 26.5, 26.7, 26.8, 26.9, 26.11, 26.51, 26.81,
26.121, 26.151, 26.181, 26.201, 26.823, and 26.825.
* * * * *
Dated at Rockville, Maryland, this 7th day of March, 2008.
For the Nuclear Regulatory Commission.
Annette Vietti-Cook,
Secretary of the Commission.
Note: This Appendix will not appear in The Code of Federal
Regulations.
Appendix A to This Document--Derivation and Distribution Tables for
Part 26.
Table 1.--Derivation Table for Part 26
------------------------------------------------------------------------
New section Based on
------------------------------------------------------------------------
26.1...................................... 26.1 first sentence.
26.3(a)................................... 26.2(a).
26.3(b)................................... 26.1 (2nd sentence) and
26.2(a) (1st sentence).
[[Page 17232]]
26.3(c)................................... 26.2(c).
26.3(d)................................... 26.23(a)(1).
26.3(e)................................... 26.2(b).
26.4(a)................................... 26.2(a) and 26.2(d).
26.4(b)................................... 26.2(a) and 26.2(d).
26.4(c)................................... 26.2(a) and 26.2(d).
26.4(d)................................... 26.2(a) and 26.2(d).
26.4(e)................................... NEW.
26.4(f)................................... NEW.
26.4(g)................................... NEW.
26.4(h)................................... NEW.
26.4(i)(1)................................ 26.20(a).
26.4(i)(2)................................ 26.2(b) first sentence.
26.4(i)(3)................................ 26.2(b) first sentence.
26.4(i)(4)................................ NEW.
26.4(j)................................... NEW.
26.5...................................... 26.3 and Appendix A Subpart
1.2.
26.7...................................... 26.4.
26.8...................................... 26.8.
26.9...................................... 26.6.
26.11..................................... NEW.
26.21..................................... 26.23(b).
26.23(a).................................. 26.10(a).
26.23(b).................................. 26.10(a).
26.23(c).................................. 26.10(b).
26.23(d).................................. 26.10(c).
26.23(e).................................. NEW.
26.27(a).................................. 26.20 1st paragraph.
26.27(b)(1)............................... 26.20(a).
26.27(b)(2)............................... NEW.
26.27(b)(3)............................... NEW.
26.27(b)(4)(i)............................ 26.20(a)(1).
26.27(b)(4)(ii)........................... 26.20(a)(2).
26.27(b)(5)............................... NEW.
26.27(b)(6)............................... 26.20(a).
26.27(b)(7)............................... 26.20(b).
26.27(b)(8)............................... 26.20(d).
26.27(b)(9)............................... NEW.
26.27(b)(10).............................. NEW.
26.27(b)(11).............................. NEW.
26.27(c)(1)............................... 26.20(c).
26.27(c)(2)............................... 26.20(d).
26.27(c)(3)............................... 26.20(e).
26.27(c)(4)............................... NEW.
26.27(d).................................. 26.20(f).
26.29(a).................................. 26.21(a)(1)-(5); 26.22(a)(1)-
(5); 26.22(b).
26.29(b).................................. NEW.
26.29(c).................................. 26.21(b) and 26.21(c).
26.31..................................... 26.24.
26.31(a).................................. 26.24(a).
26.31(b).................................. Section 2.3 in Appendix A to
Part 26.
26.31(b)(1)............................... First paragraph, Section 2.3
in Appendix A to Part 26.
26.31(b)(1)(i)............................ Section 2.3(2).
26.31(b)(1)(ii)........................... Section 2.3(1).
26.31(b)(1)(iii).......................... Section 2.3(1).
26.31(b)(1)(iv)........................... NEW.
26.31(b)(1)(v)............................ Section 2.3(3).
26.31(b)(2)............................... NEW.
26.31(c).................................. 26.24(a)(1)-(4).
26.31(c)(1)............................... 26.24(a)(1).
26.31(c)(2)............................... 26.24(a)(3).
26.31(c)(3)............................... 26.24(a)(3).
26.31(c)(4)............................... 26.24(a)(4).
26.31(c)(5)............................... 26.24(a)(2).
26.31(d).................................. NEW.
26.31(d)(1)............................... Section 2.1(a) in Appendix A
to Part 26.
26.31(d)(1)(i)(A)......................... 26.24(c).
26.31(d)(1)(i)(B)......................... 26.24(c).
26.31(d)(1)(i)(C)......................... Section 2.1(c).
26.31(d)(1)(i)(D)......................... 26.31(d)(1)(i)(C).
26.31(d)(1)(ii)........................... Section 2.1(b) and
26.31(d)(1)(i)(D).
26.31(d)(1)(iii).......................... NEW.
26.31(d)(2)............................... 26.24(a).
26.31(d)(3)............................... NEW.
26.31(d)(3)(i)............................ Appendix A Subpart A 1.1(3);
26.24(f); Appendix A
Subpart B 2.8(e); 2.8(a)
and (b).
26.31(d)(3)(ii)........................... 26.24(d)(1).
26.31(d)(3)(iii).......................... Sections 2.7(e)(1) and
(f)(2).
26.31(d)(3)(iii)(A)....................... 26.24(b).
26.31(d)(3)(iii)(B)....................... NEW.
26.31(d)(3)(iii)(C)....................... NEW.
26.31(d)(4)............................... 26.24(g).
26.31(d)(5)............................... NEW.
26.31(d)(6)............................... Section 2.1(d).
26.33..................................... 26.22.
26.35..................................... 26.25.
26.37..................................... 26.29.
26.39..................................... 26.27.
26.41(a).................................. 26.80(a).
26.41(b).................................. 26.80(a).
26.41(c).................................. 26.80(a); Appendix A Subpart
B 2.7(m).
26.41(d).................................. Section 2.7(m).
26.41(e).................................. 26.80(b).
26.41(f).................................. 26.80(c).
26.41(g).................................. 26.80(a).
26.51..................................... 26.1.
26.53..................................... NEW.
26.55(a).................................. NEW.
26.55(b).................................. NEW.
26.57(a).................................. NEW.
26.57(b).................................. NEW.
26.59..................................... NEW.
26.61..................................... 26.27(a)(1).
26.61(a).................................. NEW.
26.61(b).................................. NEW.
26.61(c).................................. NEW.
26.61(d).................................. 26.27(a)(4).
26.63..................................... 26.27(a)(2).
26.63(a).................................. NEW.
26.63(b).................................. NEW.
26.63(c).................................. NEW.
26.63(d).................................. NEW.
26.63(e).................................. NEW.
26.63(f)(1)............................... 26.71(c) and
26.27(b)(2)(vii).
26.63(f)(2)............................... NEW.
26.63(f)(3)............................... NEW.
26.65..................................... 26.24(a)(1).
26.65(a).................................. NEW.
26.65(b).................................. NEW.
26.65(c).................................. NEW.
26.65(d).................................. NEW.
26.65(e).................................. NEW.
26.65(f).................................. NEW.
26.65(g).................................. NEW.
26.67(a).................................. NEW.
26.67(b).................................. NEW.
26.67(c).................................. NEW.
26.69..................................... 26.27(b)(4).
26.69(a).................................. NEW. 26.27(b)(2).
26.69(b)(1)............................... NEW.
26.69(b)(2)............................... NEW. 26.27(b)(2).
26.69(b)(3)............................... 26.27(b)(4).
26.69(b)(4)............................... 26.27(b)(2).
26.69(b)(5)............................... NEW.
26.69(b)(6)............................... 26.27(b)(4).
26.69(b)(7)............................... NEW.
26.69(c)(1)............................... NEW.
26.69(c)(2)............................... NEW.
26.69(c)(3)............................... NEW.
26.69(c)(4)............................... NEW.
26.69(c)(5)............................... NEW.
26.69(d).................................. NEW.
26.69(e).................................. NEW.
26.69(f).................................. 26.27(a)(2).
26.71..................................... NEW.
26.73..................................... NEW.
26.75(a) (1st sentence)................... NEW.
26.75(a) (2nd sentence)................... 26.27(b) (1st sentence).
26.75(b).................................. NEW.
26.75(c).................................. 26.27(b)(3).
26.75(d).................................. 26.27(c).
26.75(e).................................. 26.27(b)(2).
26.75(f).................................. 26.27(b)(5).
26.75(g).................................. 26.27(b)(4).
26.75(h).................................. 26.24(d)(2).
26.75(i).................................. 26.24(d)(2).
26.77..................................... 26.26(b)(1).
26.77(a).................................. NEW.
26.77(b)(1)............................... 26.27(b)(1).
26.77(b)(2)............................... NEW.
26.77(b)(3)............................... NEW.
26.77(c).................................. 26.27(d).
26.83(b).................................. 26.24(b).
26.85(a).................................. Appendix A Subpart B 2.2(d).
26.85(b).................................. NEW.
26.85(c).................................. Appendix A Subpart B
2.2(d)(2) (last sentence).
26.85(d).................................. Appendix A Subpart B
2.7(o)(5).
26.85(e).................................. NEW.
26.87(a).................................. Appendix A Subpart B 2.4(a).
26.87(b).................................. Appendix A Subpart B 2.4(f)
(1st sentence).
26.87(c).................................. Appendix A Subpart B 2.7(m).
26.87(d).................................. Appendix A Subpart B 2.4(c).
26.87(d)(1)............................... Appendix A Subpart B 2.4(e).
26.87(d)(2)............................... Appendix A Subpart B 2.4(c)
(2nd sentence).
26.87(d)(3)............................... Appendix A Subpart B 2.4(c).
26.87(e).................................. NEW.
26.87(e)(2)............................... Appendix A Subpart B
2.4(g)(1) (2nd sentence).
26.87(e)(3)............................... NEW.
26.87(f)(1)............................... Appendix A Subpart B
2.4(c)(1).
[[Page 17233]]
26.87(f)(2)............................... Appendix A Subpart B
2.4(g)(10) (3rd sentence).
26.87(f)(3)............................... Appendix A Subpart B
2.4(g)(10) (2nd sentence).
26.87(f)(4)............................... Appendix A Subpart B
2.4(g)(10) and new
material.
26.87(f)(5)............................... Appendix A Subpart B
2.4(c)(2).
26.89(a).................................. Appendix A Subpart B
2.4(g)(3).
26.89(b).................................. Appendix A Subpart B
2.4(g)(2).
26.89(b)(1)............................... Appendix A Subpart B
2.4(g)(2).
26.89(b)(2)............................... Appendix A Subpart B
2.4(g)(2).
26.89(b)(3)............................... NEW.
26.89(b)(4)............................... Appendix A Subpart B
2.4(g)(4) and (g)(23)(ii).
26.89(c).................................. NEW.
26.89(d).................................. Appendix A Subpart B 2.4(e).
26.91(a).................................. Appendix A Subpart B
2.7(o)(3)(ii).
26.91(b).................................. Appendix A Subpart B
2.7(o)(3)(ii).
26.91(c).................................. NEW.
26.91(d).................................. NEW.
26.91(e).................................. NEW.
26.93..................................... Appendix A Subpart B
2.4(g)(18) and new
material.
26.95..................................... Appendix A Subpart B
2.4(g)(18) and new
material.
26.97..................................... NEW.
26.99..................................... 26.24(g) and Appendix A
Subpart B 2.7(e)(1).
26.101.................................... Appendix A Subpart B
2.4(g)(18) and new
material.
26.103.................................... 26.24(g), Appendix A Subpart
B 2.7(f)(2), and new
material.
26.105(a)................................. Appendix A Subpart B
2.4(g)(5).
26.105(b)................................. NEW.
26.105(c)................................. Appendix A Subpart B
2.4(g)(6).
26.105(d)................................. Appendix A Subpart B
2.4(g)(7).
26.105(e)................................. NEW.
26.107.................................... Appendix A Subpart B 2.4(g)
and new material.
26.109.................................... Appendix A Subpart B 2.4 and
new material.
26.111(a)................................. Appendix A Subpart B
2.4(g)(13) and (g)(14).
26.111(b)................................. Appendix A Subpart B
2.4(g)(15).
l26.111(c)................................ NEW.
26.111(d)................................. Appendix A Subpart B
2.4(g)(16).
26.111(e)................................. NEW.
26.111(f)................................. NEW.
26.113(a)................................. NEW.
26.113(b)................................. Appendix A Subpart B
2.4(g)(20) and 2.7(j).
26.113(c)................................. NEW.
26.115(a)(1).............................. Appendix A Subpart B
2.4(f)(2).
26.115(a)(2).............................. Appendix A Subpart B
2.4(f)(1) and (g)(14).
26.115(a)(3).............................. Appendix A Subpart B
2.4(f)(3).
26.115(a)(4).............................. Appendix A Subpart B
2.4(f)(4).
26.115(b)................................. Appendix A Subpart B
2.4(g)(25).
26.115(c)................................. NEW.
26.115(d)................................. NEW.
26.115(e)................................. Appendix A Subpart A 1.2 and
Subpart B 2.4.
26.115(f)................................. NEW.
26.117(a)................................. Appendix A Subpart B
2.4(g)(20).
26.117(b)................................. Appendix A Subpart B
2.4(g)(21).
26.117(c)................................. Appendix A Subpart B
2.4(g)(22).
26.117(d)................................. Appendix A Subpart B
2.4(g)(23).
26.117(e)................................. Appendix A Subpart B
2.4(g)(26).
26.117(f)................................. Appendix A Subpart B
2.4(g)(27).
26.117(g)................................. Appendix A Subpart B
2.4(g)(28).
26.117(h)................................. Appendix A Subpart B
2.4(c)(2).
26.117(i)................................. Appendix A Subpart B 2.7(i).
26.117(j)................................. Appendix A Subpart B 2.4(1)
and 2.7(c).
26.117(k)................................. Appendix A Subpart B 2.4(h).
26.119.................................... NEW.
26.121.................................... NEW.
26.123.................................... Appendix A Subpart B
2.7(l)(2).
26.125(a)................................. Appendix A Subpart B 2.6(a).
26.125(b)................................. Appendix A Subpart B 2.6(b).
26.125(c)................................. Appendix A Subpart B 2.6(c).
26.127(a)................................. Appendix A Subpart B 2.2 1st
paragraph.
26.127(b)................................. Appendix A Subpart B
2.7(a)(2) and 2.4(d).
26.127(c)................................. Appendix A Subpart B
2.7(o)(1).
26.127(d)................................. Appendix A Subpart B
2.7(o)(3)(iii).
26.127(e)................................. Appendix A Subpart B
2.7(o)(4).
26.129(a)................................. Appendix A Subpart B
2.7(a)(1).
26.129(b)................................. Appendix A Subpart B
2.2(b)(1).
26.129(c)................................. Appendix A Subpart B
2.7(b)(2).
26.129(d)................................. Appendix A Subpart B
2.7(a)(2).
26.129(e)................................. Appendix A Subpart B 2.7(d)
1st sentence.
26.129(f)................................. Appendix A Subpart B 2.7(c).
26.129(g)................................. Appendix A Subpart B 2.4(i).
26.129(h)................................. Appendix A Subpart B 2.4(i).
26.131.................................... NEW.
26.133.................................... Appendix A Subpart B
2.7(e)(1).
26.135(a)................................. Appendix A Subpart B 2.7(j).
26.135(b)................................. Appendix A Subpart B 2.7(j).
25.135(c)................................. Appendix A Subpart B 2.7(h).
26.137.................................... Appendix A Subpart B 2.8(a).
26.137(e)(4-5)............................ Appendix A Subpart B 2.8(b).
26.137(e)(6-7)............................ Appendix A Subpart B 2.8(c).
26.137(f)................................. NEW.
26.137(g)................................. Appendix A Subpart B
2.7(o)(3)(i).
26.137(h)................................. Appendix A Subpart B
2.7(o)(2).
26.139(a)................................. Appendix A Subpart B
2.7(g)(2).
26.139(b)................................. 26.24(d)(1).
26.139(c)................................. Appendix A Subpart B
2.7(o)(5).
26.139(d)................................. Appendix A Subpart B
2.7(g)(6).
26.139(e)................................. Appendix A Subpart B
2.7(g)(7).
26.139(f)................................. NEW.
26.151.................................... NEW.
26.153(a)................................. 26.24(f), Appendix A Subpart
A 1.1(3) and Subpart D
4.1(a).
26.153(b)................................. Appendix A Subpart B
2.7(l)(2).
26.153(c)................................. Appendix A Subpart B 2.7(k).
26.153(d)................................. Appendix A Subpart D 4.1(b).
26.153(e)................................. Appendix A Subpart B 2.7(m).
26.153(f)(1).............................. Appendix A Subpart B
2.7(l)(1).
26.153(f)(2).............................. Appendix A Subpart B
2.7(o)(5).
26.153(f)(3).............................. Appendix A Subpart C 3.1.
26.153(f)(4).............................. Appendix A Subpart C 3.2.
26.153(f)(5).............................. NEW.
26.153(f)(6).............................. Appendix A Subpart B 2.7(m).
26.153(g)................................. NEW.
[[Page 17234]]
26.155.................................... Appendix A Subpart B 2.5.
26.157(a)................................. Appendix A Subpart B 2.2 1st
paragraph.
26.157(b)................................. Appendix A Subpart B 2.4(d)
and 2.7(a)(2).
26.157(c)................................. Appendix A Subpart B
2.7(o)(1).
26.157(d)................................. Appendix A Subpart B
2.2(o)(3)(iii).
26.157(e)................................. Appendix A Subpart B
2.7(o)(4).
26.159(a)................................. Appendix A Subpart B
2.7(a)(1).
26.159(b)................................. Appendix A Subpart B
2.7(b)(1).
26.159(c)................................. Appendix A Subpart B
2.7(b)(2).
26.159(d)................................. Appendix A Subpart B
2.7(a)(2).
26.159(e)................................. Appendix A Subpart B
2.7(a)(2).
26.159(f)................................. Appendix A Subpart B 2.4(i).
26.159(g)................................. Appendix A Subpart B 2.4(i).
26.159(h)................................. NEW.
26.159(i)................................. Appendix A Subpart B 2.7(h).
26.159(j)................................. NEW.
26.161.................................... NEW.
26.163(a)................................. Appendix A Subpart B 2.7(e).
26.163(a)(2).............................. NEW.
26.163(b)................................. Appendix A Subpart B 2.7(f).
26.165(a)................................. 26.24(f) and Appendix A
Subpart B 2.7(j).
26.165(b)................................. Appendix A Subpart B 2.7(j)
and new material.
26.165(c)................................. Appendix A Subpart B 2.7(i).
26.165(c)(1).............................. NEW.
26.165(c)(2).............................. Appendix A Subpart B 2.7(i).
26.165(c)(3).............................. NEW.
26.165(c)(4).............................. Appendix A Subpart B 2.7(j)
(last sentence).
26.165(d)................................. NEW.
26.165(e)................................. NEW.
26.165(f)................................. NEW.
26.167(a)................................. Appendix A Subpart B 2.8(a)
and (d).
26.167(b)................................. Appendix A Subpart B 2.8(c)
and (d) and new material.
26.167(c)................................. NEW.
26.167(d)(1).............................. Appendix A Subpart B
2.7(e)(1).
26.167(d)(2).............................. NEW.
26.167(d)(3).............................. Appendix A Subpart B 2.8(c).
26.167(e)................................. Appendix A Subpart B
2.7(f)(2) and 2.8(d).
26.167(f)................................. Appendix A Subpart B
2.8(e)(4)-(e)(6).
26.167(g)................................. Appendix A Subpart B
2.7(o)(3)(i).
26.167(h)................................. Appendix A Subpart B
2.7(o)(2).
26.168.................................... Appendix A Subpart B 2.8(e)
and new material.
26.169.................................... Appendix A Subpart B 2.7(g)
(substantially revised).
26.181.................................... NEW.
26.183(a)................................. 26.3 and Appendix A Subpart
A 1.2 and Appendix A
Subpart B 2.9(b).
26.183(b)................................. Appendix A Subpart B 2.9(b).
26.183(c)................................. 26.3 and Appendix A Subparts
A 1.2, B 2.4(j), B 2.9(a),
and B 2.9(b).
26.183(d)................................. NEW.
26.185(a)................................. Appendix A Subpart B 2.9(a).
26.185(b)................................. Appendix A Subpart B 2.9(b).
26.185(c)................................. Appendix A Subpart B 2.9(c).
26.185(d)................................. NEW.
26.185(e)................................. NEW.
26.185(f)................................. NEW.
26.185(g)................................. NEW.
26.185(h)................................. NEW.
26.185(i)................................. NEW.
26.185(j)(1).............................. Appendix A Subpart B 2.9(d).
26.185(j)(2).............................. Appendix A Subpart B 2.9(d).
26.185(j)(3).............................. NEW.
26.185(j)(4).............................. NEW.
26.185(j)(5).............................. NEW.
26.185(j)(6).............................. NEW.
26.185(k)................................. Appendix A Subpart B 2.9(f).
26.185(l)................................. Appendix A Subpart B 2.9(e).
26.185(m)................................. Appendix A Subpart B 2.9(g).
26.185(n)................................. NEW.
26.185(o)................................. NEW.
26.185(p)................................. 26.24(e).
26.187.................................... NEW.
26.189.................................... NEW.
26.201.................................... NEW.
26.203.................................... NEW.
26.205.................................... NEW.
26.207.................................... NEW.
26.209.................................... NEW.
26.211.................................... NEW.
26.401.................................... 26.2(c).
26.403.................................... 26.2(c).
26.405.................................... 26.2(c).
26.407.................................... 26.2(c).
26.409.................................... 26.2(c).
26.411.................................... 26.2(c).
26.413.................................... 26.2(c).
26.415.................................... 26.2(c).
26.417.................................... 26.2(c).
26.419.................................... 26.2(c).
26.709.................................... NEW.
26.711.................................... NEW.
26.713(a)(1).............................. 26.71(a).
26.713(a)(2).............................. 26.71(b).
26.713(a)(3).............................. NEW.
26.713(a)(4).............................. NEW.
26.713(b)................................. 26.21(b); 26.22(c);
26.80(c).
26.713(c)................................. 26.71(c).
26.713(d)................................. 26.20.
26.713(e)................................. 26.23(a).
26.713(f)................................. NEW.
26.713(g)................................. NEW.
26.715(a)................................. Appendix A, Section 2.7(n).
26.715(b)(1)-(14)......................... NEW.
26.717.................................... 26.71(d).
26.719(a)-(b)............................. 26.73.
26.719(c)(1).............................. Appendix A Subpart B
2.8(e)(4).
26.719(c)(2).............................. Appendix A Subpart B
2.8(e)(5).
26.719(c)(3).............................. NEW.
26.719(d)................................. NEW.
26.821.................................... 26.70.
26.823.................................... 26.90.
26.825.................................... 26.91.
------------------------------------------------------------------------
Table 2.--Distribution Table for Part 26
------------------------------------------------------------------------
Former section Replaced by
------------------------------------------------------------------------
26.1 (from beginning to ``programs'')..... 26.1.
26.1 (following ``programs'')............. Deleted.
26.2(a) (first clause).................... 26.3(a).
26.2(a) (balance of 1st sentence)......... 26.3(b) first clause.
26.2(a) (2nd sentence).................... 26.21 (1st sentence).
26.2(a) (3rd sentence to end)............. 26.4(a), (b), (c), and (d).
26.2(b) (1st sentence).................... 26.4(i) (2) and (3).
26.2(b) (2nd sentence to end)............. 26.3(e).
26.2(c) (1st sentence).................... 26.3(c); Subpart K.
26.2(c) (from ``shall implement'' to end). Subpart K.
26.2(d)................................... 26.3(c).
26.3...................................... 26.5.
26.4...................................... 26.7.
26.6...................................... 26.9.
26.8...................................... 26.13.
26.10(a) (from beginning through 26.23(a).
``manner'').
26.10(a) (balance of 1st sentence)........ 26.23(b).
26.10(b).................................. 26.23(c).
26.10(c).................................. 26.23(d).
26.20 (introductory paragraph, 1st 26.27(a).
sentence).
26.20 (introductory paragraph, 2nd 26.713(d).
sentence).
[[Page 17235]]
26.20 (introductory paragraph, final 26.27(b) (sentence before
sentence). ``(1)'').
26.20(a).................................. 26.27(b).
26.20(b).................................. 26.27(b)(7).
26.20(c).................................. 26.27(c)(1).
26.20(d).................................. 26.27(c)(2).
26.20(e).................................. 26.27(c)(3).
26.20(f).................................. 26.27(d).
26.21(a).................................. 26.29(a).
26.21(b).................................. 26.29(c).
26.21(b) (last sentence).................. 26.713(b)(1).
26.22..................................... Deleted.
26.23(a).................................. 26.3(d) and 26.21.
26.23(b).................................. 26.21.
26.24(a) (first sentence to ``(1)'')...... 26.31(a).
26.24(a)(1)-(4)........................... 26.31(c) (substantially
revised).
26.24(b).................................. Subparts E, F, and G.
26.24(c).................................. 26.31(d).
26.24(d).................................. Subparts E, F, and G.
26.24(e).................................. Subpart H.
26.24(f).................................. 26.31(d)(2) and requirements
in Subpart G.
26.24(g).................................. 26.31(d)(4) and Subparts E,
F, and G.
26.25..................................... 26.35.
26.27(a).................................. Subpart C.
26.27(b).................................. Subpart D.
26.27(c).................................. Subpart D.
26.27(d).................................. 26.77(c).
26.28..................................... 26.39.
26.29..................................... 26.37.
26.70..................................... 26.721.
26.71..................................... 26.711, 26.713, and 26.715.
26.73..................................... 26.719 (substantially
revised).
26.80..................................... 26.41 (substantially
revised).
26.90..................................... 26.723.
26.91..................................... 26.725.
Appendix A Subpart A, 1.1(1).............. 26.3.
Appendix A Subpart A, 1.1(3).............. Subparts F and G.
Appendix A Subpart A, 1.2................. 26.5, and 26.115(e).
Appendix A Subpart B, 2.1(a).............. 26.31(d)(1).
Appendix A Subpart B, 2.1(b).............. 26.31(d)(1)(ii).
Appendix A Subpart B.2.1(c)............... Subparts E, F, and G.
Appendix A Subpart B.2.1(d)............... 26.31(d)(6).
Appendix A Subpart B.2.1(e)............... 26.31.
Appendix A Subpart B.2.2 (Initial Subparts F and G.
paragraph).
Appendix A Subpart B.2.2 (a), (b), and (c) 26.115, 26.117, 26.129,
26.159, 26.169.
Appendix A Subpart B.2.2 (d)(1), (2), and 26.85 and 26.157(b).
(3).
Appendix A Subpart B.2.2(d)(4)............ Deleted.
Appendix A Subpart B.2.3.................. 26.31(b), and requirements
in Subparts E, F, and G.
Appendix A Subpart B.2.4(a)............... 26.87(a).
Appendix A Subpart B.2.4(b)............... 26.85 and 26.115(e).
Appendix A Subpart B.2.4(c)............... 26.87 (d) and (f),
26.117(h).
Appendix A Subpart B 2.4(d)............... 26.117 and 26.127(b).
Appendix A Subpart B 2.4(e)............... 26.87(d)(1).
Appendix A Subpart B 2.4(f) 1st sentence.. 26.87(b).
Appendix A Subpart B 2.4(f)(1) through 26.95 through 26.115 and
(f)(4). Subparts Fand G.
Appendix A Subpart B 2.4(g)(1) through Subparts E, F, and G.
(g)(25).
Appendix A Subpart B 2.4(h) (1st sentence) 26.87(f)(5).
Appendix A Subpart B 2.4(h) (balance of 26.129(d) and 26.157.
section).
Appendix A Subpart B 2.4(i)............... 26.117(j), 26.129(h) and
26.159.
Appendix A Subpart B 2.4(j) (first two 26.115 and 26.185.
sentences).
Appendix A Subpart B 2.4(j) (final Deleted.
sentence).
Appendix A Subpart B 2.5(a)............... 26.155(a).
Appendix A Subpart B 2.5(b)............... 26.153(c) and 26.155(c).
Appendix A Subpart B 2.5(c)............... 26.155(c).
Appendix A Subpart B 2.5(d)............... 26.155(d).
Appendix A Subpart B 2.5(e)............... 26.155(e).
Appendix A Subpart B 2.5(f)............... 26.155(f).
Appendix A Subpart B 2.6(a)............... 26.125(a).
Appendix A Subpart B 2.6(b)............... 26.125(b).
Appendix A Subpart B 2.6(c)............... 26.125(c).
Appendix A Subpart B 2.7(a)............... 26.127, 26.129, 26.157, and
26.159.
Appendix A Subpart B 2.7(b)............... 26.129(b) and 26.159.
Appendix A Subpart B 2.7(c)............... 26.117(j), 26.129(f) and
26.159(h).
Appendix A Subpart B 2.7(d)............... 26.157 and 26.159.
Appendix A Subpart B 2.7(e)............... Validity screening and
initial validity test
requirements in 26.131 and
26.161 and initial cutoff
levels in 26.133 and
26.163(a).
Appendix A Subpart B 2.7(f)............... 26.103, 26.115(a),
26.163(b), 26.167 and
26.169.
Appendix A Subpart B 2.7(g)(1) through (5) 26.169.
Appendix A Subpart B 2.7(g)(6) and (7).... Requirement for annual
summary in 26.169(h).
Appendix A Subpart B 2.7(g)(8)............ 26.215.
Appendix A Subpart B 2.7(h)............... 26.159(i) and by 26.135(c).
Appendix A Subpart B 2.7(i)............... 26.117(i) and Subparts F and
G.
Appendix A Subpart B 2.7(j)............... 26.113, 26.135, 26.165.
Appendix A Subpart B 2.7(k)............... 26.153(c).
Appendix A Subpart B 2.7(l)............... 26.123 and 26.153.
Appendix A Subpart B 2.7(m)............... 26.87(c), 26.153 and 26.221.
Appendix A Subpart B 2.7(n)............... 26.215(a).
Appendix A Subpart B 2.7(o)(1)............ 26.127(c) and 26.157(c).
Appendix A Subpart B 2.7(o)(2), (o)(3), 26.91, 26.127, 26.137,
and (o)(4). 26.157 and 26.167.
Appendix A Subpart B 2.7(o)(5)............ 26.85(d), 26.139(c) and
26.153(f)(2).
Appendix A Subpart B 2.8(a)............... 26.137(a) and 26.167(a).
Appendix A Subpart B 2.8(b)............... 26.137.
Appendix A Subpart B 2.8(c)............... 26.167.
Appendix A Subpart B 2.8(d)............... 26.137 and 26.167.
Appendix A Subpart B 2.8(e)(1) to (e)(3).. 26.137 and 26.167.
Appendix A Subpart B 2.8(e)(4), (e)(5), 26.137, 26.167, and 26.219.
and (e)(6).
Appendix A Subpart B 2.9 (a) and (b) 26.183.
(through ``contract employee'').
Appendix A Subpart B 2.9(b) (balance of 26.185.
section), (c), (d), (e), (f), and (g).
Appendix A Subpart C 3.1.................. 26.37(e) and 26.153(f)(3).
Appendix A Subpart C 3.2.................. 26.75(I)(4), 26.153(f)(4),
and 26.165(f).
Appendix A Subpart D 4.1.................. 26.153(d).
------------------------------------------------------------------------
[FR Doc. E8-4998 Filed 3-28-08; 8:45 am]
BILLING CODE 7590-01-P