[Federal Register: March 31, 2008 (Volume 73, Number 62)]
[Rules and Regulations]
[Page 16965-17235]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31mr08-14]
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Part II
Nuclear Regulatory Commission
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10 CFR Part 26
Fitness for Duty Programs; Final Rule
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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
FITNESSFORDUTY@NRC.GOV.
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
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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
cag@nrc.gov.
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
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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
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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