[Federal Register Volume 73, Number 231 (Monday, December 1, 2008)]
[Proposed Rules]
[Pages 73129-73147]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-28172]
Federal Register / Vol. 73, No. 231 / Monday, December 1, 2008 /
Proposed Rules
[[Page 73129]]
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DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety Administration
49 CFR Parts 390 and 391
[Docket No. FMCSA-2008-0363]
RIN 2126-AA97
National Registry of Certified Medical Examiners
AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.
ACTION: Notice of proposed rulemaking (NPRM); request for comments.
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SUMMARY: The FMCSA proposes to establish and maintain a National
Registry of Certified Medical Examiners (NRCME) and to require that all
medical examiners who conduct medical examinations for interstate
commercial motor vehicle drivers complete certain training concerning
FMCSA physical qualification standards, pass a test to verify an
understanding of those standards, and maintain competence by periodic
training and testing. Following establishment of the NRCME and a
transition period, FMCSA would accept as valid only medical examiners'
certificates issued by medical examiners listed on the NRCME. The FMCSA
is developing the NRCME program to improve highway safety and driver
health by requiring that medical examiners be trained and certified to
determine effectively whether a commercial motor vehicle driver's
health meets FMCSA standards. The program implements requirements in 49
U.S.C. 31149 and supports FMCSA's goal to improve safety and reduce
fatalities on our Nation's highways.
DATES: Send your comments on or before January 30, 2009.
ADDRESSES: You may submit comments [identified by DOT Docket ID Number
FMCSA-2008-0363] by any of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
Mail: Docket Management Facility: U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building, Ground
Floor, Room W12-140, Washington, DC 20590-0001.
Hand Delivery or Courier: West Building, Ground Floor,
Room W12-140, 1200 New Jersey Avenue, SE., between 9 a.m. and 5 p.m.
E.T., Monday through Friday, except Federal holidays.
Fax: 202-493-2251.
Instructions: For detailed instructions on submitting comments and
additional information on the rulemaking process, see the Public
Participation heading of the SUPPLEMENTARY INFORMATION section of this
document. Note that all comments received will be posted without change
to http://www.regulations.gov, including any personal information
provided. Please see the Privacy Act heading below.
Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov, and follow the
online instructions for accessing the dockets, or go to the street
address listed above.
Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19476) or you may visit http://DocketInfo.dot.gov.
Public participation: The Federal eRulemaking Portal is available
24 hours each day, 365 days each year. You can get electronic
submission and retrieval help and guidelines under the ``help'' section
of the Federal eRulemaking Portal Web site. If you want us to notify
you that we received your comments, please include a self-addressed,
stamped envelope or postcard, or print the acknowledgement page that
appears after submitting comments on-line.
Comments received after the comment closing date will be included
in the docket and we will consider late comments to the extent
practicable. The FMCSA may, however, issue a final rule at any time
after the close of the comment period.
FOR FURTHER INFORMATION CONTACT: Linda Phillips, Physical
Qualifications Division (MC-PSP), Federal Motor Carrier Safety
Administration, 1200 New Jersey Avenue, SE., Washington, DC 20590-0001.
Telephone (202) 366-4001. E-mail: [email protected].
SUPPLEMENTARY INFORMATION: This document is organized as follows:
I. Legal Basis for the Rulemaking
II. Background
A. Role of Medical Examiners
B. Prior Developments Related to Medical Examiners
III. General Discussion of the Proposals
A. Existing Medical Requirements and the Role of the Proposed
NRCME Program
B. Major Elements of the Proposed NRCME Program
C. Medical Examiner Training
D. Medical Examiner Certification Testing
E. Listing on the NRCME
F. Implementation of the NRCME Program
G. Changes in Medical Examination Procedures
H. Removal from the NRCME and Appeal Process
IV. Section-by-Section Discussion of the Proposals
A. Section 390.5, Definitions
B. Subpart D of part 390, National Registry of Certified Medical
Examiners
1. Section 390.101, Scope
2. Section 390.103, Eligibility requirements for medical
examiner certification
3. Section 390.105, Medical examiner training programs
4. Section 390.107, Medical examiner certification testing
5. Section 390.109, Issuance of the FMCSA medical examiner
certification credential
6. Section 390.111, Requirements for continued listing on the
NRCME
7. Section 390.113, Reasons for removal from the NRCME
8. Section 390.115, Procedure for removal from the NRCME
9. Appendix A to part 390, Medical examiner application data
elements
C. Section 391.42, Schedule for use of medical examiners listed
on the National Registry of Certified Medical Examiners
D. Section 391.43, Medical examination; certificate of physical
examination
V. Regulatory Analyses and Notices
I. Legal Basis for the Rulemaking
The primary legal basis for the National Registry of Certified
Medical Examiners (NRCME) program comes from 49 U.S.C. 31149, enacted
by section 4116(a) of the Safe, Accountable, Flexible, Efficient
Transportation Equity Act: A Legacy for Users, Pub. L. 109-59, 119
Stat. 1726 (Aug. 10, 2005) (SAFETEA-LU). Subsection (d) of this section
provides that:
The Secretary, acting through the Federal Motor Carrier Safety
Administration--
(1) shall establish and maintain a current national registry of
medical examiners who are qualified to perform examinations and
issue medical certificates;
(2) shall remove from the registry the name of any medical
examiner that fails to meet or maintain the qualifications
established by the Secretary for being listed in the registry or
otherwise does not meet the requirements of this section or
regulation issued under this section;
(3) shall accept as valid only medical certificates issued by
persons on the national registry of medical examiners; and
(4) may make participation of medical examiners in the national
registry voluntary if such a change will enhance the safety of
operators of commercial motor vehicles.
In addition to implementing the provisions in subsection (d), which
specifically directs the establishment of a national registry of
qualified medical examiners, FMCSA proposes to implement through this
rulemaking certain other provisions from new section 31149 related to a
national
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registry. First, subsection (c) requires FMCSA, with the advice of the
Medical Review Board and Chief Medical Examiner (established by
subsections (a) and (b), respectively), to develop, as appropriate,
specific courses and materials for training required for medical
examiners to be listed on a national registry. Medical examiners would
be required to undergo initial and periodic training and testing in
order to be listed on the national registry. (Section
31149(c)(1)(A)(ii) and (D)). Second, FMCSA would also implement
requirements for medical examiners to transmit to FMCSA on a monthly
basis certain information about completed Medical Examination Reports
of commercial motor vehicle (CMV) drivers. (Section 31149(c)(1)(E)).
Third, the proposed rule would require medical examiners to provide to
FMCSA copies of Medical Examination Reports and medical examiner's
certificates within 48 hours of the request, to enable FMCSA to
investigate patterns of errors or improper certification by medical
examiners, in accordance with 49 U.S.C. 31149(c)(2). Finally, the
proposed rule would establish the procedures and grounds for removal of
medical examiners from the national registry, as authorized by section
31149(c)(2) and (d)(2).
SAFETEA-LU also revised the statutory minimum standards for the
regulation of CMV safety to ensure that medical examinations of CMV
drivers are ``performed by medical examiners who have received training
in physical and medical examination standards and, after the national
registry maintained by the Department of Transportation * * * is
established, are listed on such registry.'' (49 U.S.C. 31136(a)(3), as
amended by section 4116(b) of SAFETEA-LU). The statute continues to
require FMCSA, in developing its regulations, to consider both the
effect of driver health on the safety of CMV operations and the effect
of such operations on driver health (49 U.S.C. 31136(a)).
In addition to its general rulemaking authority in 49 U.S.C.
31136(a), FMCSA is specifically authorized by section 31149(e) to
``issue such regulations as may be necessary to carry out this
section.'' Authority to establish and implement the NRCME program has
been delegated to the Administrator of FMCSA. (Section 1.73(g) of Title
49, Code of Federal Regulations (49 CFR)).
II. Background
A. Role of Medical Examiners
The FMCSA's primary mission is to reduce crashes, injuries, and
fatalities involving large trucks and buses. In carrying out its safety
mandate, FMCSA develops and enforces regulations that enhance safety in
the operation of CMVs. The FMCSA proposes to develop the NRCME program
to improve highway safety and driver health by requiring that medical
examiners be trained and certified to determine effectively whether an
interstate CMV driver meets FMCSA physical qualification standards
under 49 CFR part 391. Medical examiners are health care professionals
who conduct the medical examinations as specified in subpart E of part
391.
With limited exceptions, all drivers who operate CMVs, as defined
in 49 CFR 390.5, in interstate commerce must comply with the
qualification requirements of part 391 (Sec. 391.1). Each driver
subject to the physical qualification requirements must be examined and
certified by a medical examiner, as defined in Sec. 390.5, at least
once every 2 years. For certain drivers, such as those with severe
cases of hypertension or other acute medical conditions, more frequent
medical reexamination by a medical examiner may be required to
determine whether the driver can still be certified.
A medical examiner documents the results of the examination on a
Medical Examination Report specified in Sec. 391.43(f) (also referred
to as the ``long form''). If the medical examiner determines that a
driver is physically qualified in accordance with Sec. 391.41(b), the
examiner certifies that the driver meets the physical qualification
standards by completing a medical examiner's certificate that complies
with Sec. 391.43(g) and (h). This certificate also contains check
boxes to indicate whether the driver is subject to any restrictions
while operating a CMV, such as wearing corrective lenses or a hearing
aid, or whether the driver has been granted a medical variance
requiring the certificate to be accompanied by a medical exemption
document or a skill performance evaluation (SPE) certificate.
B. Prior Developments Related to Medical Examiners
National Highway Traffic Safety Administration (NHTSA) Study.
Interest in certifying medical examiners to evaluate interstate CMV
drivers dates back to 1978, when NHTSA commissioned a feasibility study
on the issue [Feasibility of Certifying (Designating) Medical Examiners
for Interstate Commercial Vehicle Drivers, National Highway Traffic
Safety Administration, Final Report--June 1978].\1\ This study
addressed the primary weakness in the overall medical program for CMV
drivers--the lack of understanding by medical examiners of the
relationship between the driver's physical condition and the task of
operating CMVs.
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\1\ Because of its age, FMCSA is not relying on this study in
developing the proposed rule. However, because it is only available
from the National Technical Information Service (NTIS Order No. PB-
293 809/0), a copy has been placed in the docket solely for the
limited purpose of convenient access by interested parties.
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Amendment of the Definition of ``Medical Examiner.'' In 1992, the
Federal Highway Administration (FHWA) (which was responsible for motor
carrier safety until the fall of 1999) amended the Federal Motor
Carrier Safety Regulations (FMCSRs) to expand the definition of
``medical examiner'' to allow other medical professionals such as
physician assistants, advanced practice nurses, and doctors of
chiropractic, in addition to medical doctors and doctors of osteopathy
authorized previously, to perform medical examinations of CMV drivers
(57 FR 33276; July 28, 1992). As a result of this action, the number of
potential medical examiners increased. All medical examiners were
required to be licensed, registered, or certified by their States to
perform physical examinations, and to be proficient in the use of, and
to use, medical protocols necessary to perform the examination in
accordance with the FMCSRs.
Merger of Medical Certification and Commercial Drivers License
(CDL) Processes Negotiated Rulemaking. In 1996-97, FHWA convened a
negotiated rulemaking committee to consider merging the medical
certification with the CDL function. Several of the proposals submitted
included models for a national registry and for certification of
medical examiners. (See 61 FR 18713, April 29, 1996, and 61 FR 38133,
July 23, 1996.) However, the negotiated rulemaking committee was unable
to reach a consensus and no rulemaking relating to a national registry
resulted.
Motor Carrier Safety Improvement Act of 1999. When the Motor
Carrier Safety Improvement Act of 1999 (MCSIA) (Pub. L. 106-159, 113
Stat. 1748 (Dec. 9, 1999)), established FMCSA in the Department of
Transportation (DOT), the idea of a national registry was again raised.
A Senate version of MCSIA directed the Secretary of Transportation to
initiate rulemaking to establish a national registry of preferred
medical providers. However, the enacted legislation did not retain this
language. MCSIA did direct the Secretary to
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initiate rulemaking for the required medical certification to be made
part of the CDL. The FMCSA published an NPRM to accomplish this
combination on November 16, 2006 (71 FR 66723). The NPRM comment period
closed on February 14, 2007, and a final rule is in development.
National Transportation Safety Board (NTSB) Public Hearing. The
idea of a national registry was again discussed during a January 21,
2000, public hearing conducted by the NTSB concerning a 1999 multiple-
fatality crash. It was determined that the CMV driver in this incident
had several life-threatening and disqualifying medical conditions. The
NTSB concluded that medical examiners might not have the knowledge and
information necessary to make appropriate decisions about driver
fitness. In its ``Highway Accident Report, Motorcoach Run-Off-The-Road
Accident, New Orleans, Louisiana, May 9, 1999'' (NTSB/HAR-01/01, PB
2001--916201, Notation 7381, August 28, 2001), the NTSB recommended
that FMCSA ``develop a comprehensive medical oversight program for
interstate drivers * * * '' that includes requirements to ensure
``individuals performing medical examinations for drivers are qualified
to do so and are educated about occupational issues for drivers.''
(Recommendations H-01-017 through H-01-024)
In 2003, NTSB added these recommendations for medical certification
of commercial drivers to its ``Most Wanted'' list of Transportation
Safety Improvements. In subsequent updates to this list, NTSB provided
additional details regarding the recommendations. According to the 2008
NTSB Most Wanted Transportation Safety Improvements brochure, FMCSA
should act to prevent medically unqualified drivers from operating
commercial vehicles. This task includes: Establishing a comprehensive
medical oversight program for interstate commercial drivers; ensuring
that examiners are qualified and know what to look for; tracking all
medical certificate applications; enhancing oversight and enforcement
of invalid certificates; and providing mechanisms for reporting medical
conditions.
SAFETEA-LU. Congress included a number of provisions in SAFETEA-LU
to improve the quality of the medical certification of CMV drivers.
Among those provisions is the establishment of a Medical Review Board
and appointment of a Chief Medical Examiner to advise FMCSA on the
qualifications and training for medical examiners to be listed on a
national registry. When the prescribed provisions are fulfilled, all
required medical examinations of CMV drivers would be performed only by
trained and qualified medical examiners listed on the national
registry, and their performance would be monitored by FMCSA. S. Rep.
No. 109-120, at 2, 22 (2005) and H. R. Rep. No. 109-12, at 434 (2005).
Public meetings and listening sessions. During FMCSA's 2005 and
2006 public meetings and listening sessions,\2\ a number of medical
providers and industry representatives expressed concern about the idea
of an NRCME, and about the current quality of the CMV driver medical
examinations. Representatives provided anecdotal evidence about drivers
qualified by health care providers who were clearly unaware of the
medical standards, guidelines, and other information needed to properly
determine whether a driver can safely operate a CMV.
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\2\ Notices published May 18, 2005 (70 FR 28596), and May 18,
2006 (71 FR 28912).
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Informal State analyses. In August 2005, informal FMCSA staff
contacts with the State of California Department of Motor Vehicles
(CDMV) revealed that of the 66,000 Medical Examination Reports received
by CDMV between January and June of 2005, 10% of the drivers were
issued certificates as physically qualified by the medical examiner
even though the Medical Examination Report indicated that the driver
should not have been qualified or should have received a medical
certificate valid for a shorter time period than the certificate the
medical examiner granted to the driver. Additionally, information
obtained in July 2005 from the State of Indiana's CDL program indicated
a general finding of mistakes on 28% of all Medical Examination Reports
collected. These findings may be an indicator that some unqualified
drivers are inappropriately being determined physically qualified.
III. General Discussion of the Proposals
A. Existing Medical Requirements and the Role of the Proposed NRCME
Program
The physical qualification standards and medical examination
process currently required under Sec. Sec. 391.41 and 391.43 apply to
drivers who operate CMVs, as defined in Sec. 390.5. In other words,
the medical requirements apply to drivers who operate: Trucks with a
gross vehicle weight rating or gross combination weight rating, or
gross vehicle weight or gross combination weight, whichever is greater,
of 10,001 pounds or more; passenger-carrying vehicles (either nine or
more passengers for compensation or 16 or more passengers not for
compensation); and vehicles used to transport hazardous materials that
require placards on the vehicle.\3\ After a transition period to
establish the NRCME program, this proposal would require interstate
drivers of CMVs who are required by the FMCSRs to receive medical
examinations to obtain them from examiners listed on the NRCME. Under
current rules, all such CMV drivers are required to obtain medical
certification at least once every 2 years, although drivers with
certain medical conditions must obtain medical certification more
frequently. This requirement is unchanged by the proposed rule.
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\3\ There are several limited exceptions and exemptions from the
medical certification requirement provided by Sec. Sec. 390.3(f),
391.2, 391.62, and 391.68(c). However, future implementation of
section 4136 of SAFETEA-LU limits the exception in Sec.
390.3(f)(6)(ii) for drivers of small passenger-carrying vehicles
within a 75 air-mile radius of the driver's normal work reporting
location. Canadian and Mexican drivers operating in the United
States will continue to be governed by the provisions of existing
reciprocity agreements with Canada and Mexico, because they are not
in conflict with 49 U.S.C. 31136(a)(3) and 31149. See 67 FR 61818,
61819 (October 2, 2002) and 57 FR 31454, 31455 (July 16, 1992).
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The Agency estimates that there are 3.1 million interstate CDL
holders currently working as CMV drivers, and 1.3 million interstate
CMV drivers who are not required to hold a CDL. The proposed rule
applies to both categories, and would therefore apply directly to
approximately 4.4 million active interstate commercial drivers.
All CMV drivers must be certified at least every 2 years, and as
previously mentioned, some drivers are certified more frequently. For
example, some carriers contract with occupational health clinics to
examine the drivers they employ, and these carriers often insist that
newly-hired drivers receive an examination from one of their medical
examiners, even if the newly-hired driver already has a current valid
medical certification. In addition, the FMCSRs advise medical examiners
that drivers with certain medical conditions should receive more
frequent monitoring, and drivers who have these conditions may be
required to be examined more frequently than every 2 years (for
example, 49 CFR 391.43(f) and instructions on high blood pressure and
neurological disorders). Finally, drivers whose ability to perform
their normal driving duties has been impaired by injury or disease are
required by Sec. 391.45 to be reexamined before resuming such duties.
The FMCSA estimates that these exceptions to the
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biennial examination schedule increase the total number of examinations
conducted per year by 31 percent over that which would result if all
drivers were examined every 2 years. This increase in examinations due
to exceptions to the biennial certification requirement is based on
limited industry data on driver turnover and medical certifications
issued for time periods of less than 2 years. If we assume that half of
the 4.4 million drivers described previously in this section would
require examination each year, that is, 2.2 million drivers, and
increase this number by 31 percent to account for drivers who are
examined more frequently than every 2 years, an estimated 3 million
examinations would be conducted annually. The FMCSA requests comment on
how frequently drivers are examined more often than every 2 years.
Health care professionals in a general practice setting commonly
examine 8 to 10 patients per day, and the Agency is aware of medical
examiners who currently conduct over 1,000 medical certifications of
drivers per year. The FMCSA estimates that 40,000 certified medical
examiners would be sufficient to perform the estimated 3 million
medical examinations per year. Each of these examiners would conduct an
average of 75 examinations per year, which is a feasible volume for
examiners in all types of practices.
Drivers are permitted by current regulations to be examined and
certified by medical examiners in any State, and FMCSA does not propose
to remove this flexibility with the implementation of the NRCME
program.
B. Major Elements of the Proposed NRCME Program
In general, under this proposal, FMCSA would develop core
curriculum specifications and administrative requirements for medical
examiner training and provide these to private-sector training
providers for their use. It would also develop a certification test for
medical examiners and provide it to private-sector testing
organizations. Under this proposal, training and testing would be
delivered by these private organizations to medical examiners who meet
specified eligibility requirements.
After a qualified applicant completes required medical examiner
training and passes an FMCSA certification test, FMCSA would certify
the applicant as a medical examiner and list that person on the NRCME.
To ensure that medical examiners remain knowledgeable about driver
qualification requirements as they are updated, examiners would be
required to comply with periodic training and recertification
requirements in order to remain listed on the NRCME. When the NRCME
program is fully implemented, FMCSA would accept as valid only medical
certificates issued to CMV drivers by medical examiners listed on the
NRCME.
By implementing the NRCME program, FMCSA believes that it would
improve the knowledge and capabilities of certified medical examiners
about FMCSA's physical qualifications standards and guidelines for
operators of CMVs. Medical examiners would also be more aware of the
demands that operating a CMV can make on drivers and the impact such
demands can have on their health. A CMV operator who does not meet the
physical qualifications standards can have a direct impact on the
safety of CMV operations. In addition, the demands of such operations
may impact the health of CMV drivers. Based on its own knowledge and
experience, FMCSA believes that the enhancement of the knowledge and
capabilities of medical examiners would have a clear and direct
positive impact on both safety of CMV operations and driver health. The
FMCSA encourages commenters on this proposal to provide additional
examples of such impacts, derived from their knowledge and experience.
Information for drivers, employers, and medical examiners about the
NRCME program would be available primarily through an NRCME Web site,
and a resource center with a toll-free phone number would also be
available. On the Web site, drivers and employers could find names and
addresses of nearby certified medical examiners listed on the NRCME.
The NRCME Web site would also provide program information about
training and testing requirements to certified medical examiners and
medical examiners who wish to become certified. The NRCME Web site
would also disseminate information to practitioners on new medical
discoveries, policies, or requirements relevant to the examinations.
FMCSA seeks comment on how the NRCME Web site and toll-free phone
number could potentially be used to deliver and/or administer medical
examiner testing and/or examination certification.
The FMCSA is developing the certification component of the NRCME
program using the accreditation standards of the National Commission of
Certifying Agencies (NCCA). NCCA is the accreditation body of the
National Organization for Competency Assurance (NOCA). NOCA is the
oldest and largest accreditation body for the certification industry,
and is nationally recognized as the leader in setting quality standards
for credentialing organizations, particularly in the healthcare
industry. The FMCSA is considering applying for accreditation for the
certification component of the NRCME program to demonstrate: Ongoing
quality management for certification test development and security;
fairness of test administration; appropriate use of test and candidate
data; and consistency with private-sector best practices in the
certification industry. FMCSA seeks comment on the criteria that should
be in place for private organizations to be certified for
administration of training and testing. FMCSA also seeks comment on
alternative training, testing, and certification methods--taking into
consideration applicable Federal requirements, cost-effectiveness,
administrative simplification, and meeting performance based standards.
A new certification program (one that has not previously received
NCCA accreditation) may apply for accreditation either after 1 year of
administration of the certification test or when at least 500
candidates have been assessed with that test instrument, whichever
comes first. The primary rationale for this requirement is that
compliance with accreditation standards cannot be determined until
after the program has demonstrated completion of all critical program
activities, including development and implementation of policies and
procedures and development, administration and scoring of the
certification test. The FMCSA must also consider other programmatic and
legal issues prior to making a decision to apply for accreditation.
FMCSA seeks comment on this proposal for certification and
accreditation, and seeks potential alternatives.
C. Medical Examiner Training
This NPRM would require that all medical examiners complete
training conducted by a private-sector training provider accredited by
a nationally-recognized medical profession accrediting organization to
provide continuing education credits. The FMCSA would develop the core
curriculum specifications and administrative requirements with the
advice of the Medical Review Board and the Chief Medical Examiner, and
provide these to the training providers to develop and deliver training
for medical examiners. The FMCSA would initially base the core
curriculum specifications on the current regulations and guidelines for
conducting CMV driver medical examinations and would periodically
review and update the
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requirements and core curriculum. A training provider could expand its
course content to tailor the training to the needs of its target
audience, but the course must include the FMCSA core curriculum
specifications. The length of the training would vary among providers
depending on whether a training provider expands its course to include
additional scope and depth. The FMCSA projects that it would take one
day to teach the FMCSA core curriculum specifications. Current private-
sector medical examiner training programs are generally one day in
length and use the traditional classroom-based model. However, the
training delivery method could also vary among providers and include
self-paced, on-line training; the traditional classroom model; or a
blended format that combines more than one model. FMCSA seeks comment
on potential training delivery methods. FMCSA also seeks comment on how
FMCSA could offer training directly to medical examiners in a cost-
effective manner.
The FMCSA plans to require accreditation of the FMCSA medical
examiner training programs because it would maximize consistency and
quality assurance for the training and would be consistent with
practices already embraced by the medical professions for continuing
education. Each of the primary professions that currently perform
medical examinations under part 391 (that is, doctors of medicine,
doctors of osteopathy, physician assistants, advanced practice nurses,
and doctors of chiropractic) utilizes nationally-recognized
organizations that accredit training programs providing continuing
education credits to licensed medical professionals. FMCSA seeks
comment on the costs of training certification programs, and whether
there are any alternatives to ensure consistency and quality. In
addition, we seek comment on how certification and accreditation
requirements would impact the cost of training for medical examiners.
FMCSA also seeks comment on whether existing certified medical training
programs would be able to adapt their continuing education programs to
meet these needs.
After the initial training, a medical examiner would be required to
complete periodic retraining at least every 3 years to refresh his or
her knowledge of both the medical standards for CMV drivers and any
changes to FMCSA examination standards or guidelines. It is anticipated
that FMCSA would provide this periodic retraining at no charge to the
examiner, and that the retraining would be Web-based, allowing the
medical examiner to verify completion of the training on-line. The
proposed rule would also require the medical examiner to repeat once
every 12 years, at a cost to be borne by the examiner, the complete
initial training program (instead of the periodic retraining). FMCSA
seeks comment on the cost to medical examiners, and potential training
and re-training alternatives which would be more cost-effective.
D. Medical Examiner Certification Testing
The FMCSA would base the medical examiner certification test on the
results of a Role Delineation Study, a rigorous methodology regularly
employed in the certification and medical fields when developing a
valid, reliable, and fair certification test. The FMCSA conducted an
initial Role Delineation Study (the Study) that identified content for
the certification test, which is intended to focus on competencies
common to FMCSA medical examiners from a variety of professional
backgrounds and work settings. It was completed in April 2007. The task
list was validated and rated, according to importance of the task, by
surveying more than 4,000 medical examiners who currently perform CMV
driver medical examinations. The final report on the initial Study,
when completed, will be made publicly available. The Study provided an
assessment of the knowledge, skills, and abilities necessary for an
FMCSA medical examiner to competently perform CMV driver medical
examinations in accordance with current FMCSA standards and guidelines.
The most important information derived from the Study--identification
of critical tasks--is necessary to create specifications for the
certification test and forms the basis of a professionally-sound
quality management system that would support possible future
accreditation for the certification component of the NRCME program.
Therefore, a Role Delineation Study will be conducted periodically to
capture relevant changes in medical practice, standards, and guidelines
that affect the examination of CMV drivers in order to maintain a
current and relevant certification test.
After completing the mandatory training, a medical examiner
applying to be listed on the NRCME would have to pass the FMCSA medical
examiner certification test. In addition to the initial certification
test, medical examiners would be required to recertify by passing the
medical examiner certification test every 6 years in order to remain
listed on the registry.
Before taking the certification test, an applicant would provide
the testing organization with information such as the applicant's
medical profession, State medical license or certificate number,
business address and phone number, and medical examiner training
provider. In addition, the applicant would provide several statements,
including a statement that the applicant is capable and willing to
comply with FMCSA requirements; that upon request he or she would
provide copies of documents showing evidence of completion of training,
States licenses, etc.; and an affirmation that all of the information
provided is true. Proposed Appendix A to part 390 contains a list of
the minimum information and statements required of an applicant. The
testing organization would review this information to ensure that the
applicant provided all of the required information. After an applicant
completed the test, the testing organization would forward to FMCSA the
results (that is, the test scores and responses) along with the
applicant's application package information. The FMCSA would
periodically audit a percentage of medical examiners to obtain
verification of eligibility (for example, proof of current State
medical licensure, registration, or certification to perform physical
examinations, and proof of completion of required training).
Under the proposed NRCME program model, an applicant would take a
certification test provided by a private-sector professional testing
organization that meets all testing criteria proposed in this NPRM,
including test delivery and secure data handling criteria. The FMCSA
expects that an applicant would have to travel to a testing center to
take a proctored, secure certification test. FMCSA seeks comment on
alternatives which would allow medical examiners to complete the
testing requirements on-line, or in a manner which would meet testing
criteria while reducing the cost and time burden on the medical
examiner. FMCSA also seeks comment on whether the proposed requirements
may deter otherwise qualified medical examiners from performing these
types of examinations.
E. Listing on the NRCME
The FMCSA would issue an FMCSA medical examiner certification
credential with a unique identification number and list on the NRCME at
least the contact information of all medical examiners that meet FMCSA
eligibility requirements, successfully complete required training, and
pass the FCMSA medical examiner certification test. The certification
and listing on the NRCME would expire 6 years after the date of
issuance of the certification credential.
[[Page 73134]]
The FMCSA would maintain the NRCME on the Web, and drivers and
employers of drivers would be able to access, by state or zip code, the
names and contact information (from the information provided by the
medical examiner under proposed Appendix A to part 390) for medical
examiners listed on the NRCME. A communications resource center created
to support medical examiners, drivers, and motor carriers--both with
and without Internet access--would also be available. The FMCSA
requests public comment on what types of medical examiner information
should or should not be made available to the public by the NRCME
program.
F. Implementation of the NRCME Program
The FMCSA proposes a phased approach to the required use of medical
examiners listed on the NRCME. In the first phase, FMCSA proposes to
require drivers who work for larger employers to have their medical
examinations performed by medical examiners listed on the NRCME,
because these drivers are less likely to have problems locating a
medical examiner. The second phase would expand the requirement to the
remaining drivers not covered in phase one. The additional time allowed
for other drivers would allow for growth in the number of medical
examiners who have completed the proposed certification process and
have been listed on the NRCME. FMCSA seeks comment on ways to ensure
that certified medical examiners are accessible to drivers in rural
areas and areas where the demand for certification may be low, so that
drivers do not have to travel excessive distances to locate a certified
medical examiner. FMCSA also seeks comment on additional costs drivers
may incur to locate and travel to a certified medical examiner for
their periodic examinations.
For purposes of phase one, FMCSA proposes to define large employers
as motor carriers that employ 50 or more CMV drivers. The FMCSA
proposes that phase one begin 2 years after the effective date of the
final rule. Any medical examination conducted for a CMV driver employed
by a large employer under this phase must be conducted by a medical
examiner listed on the NRCME. The second phase would begin 3 years
after the effective date of the final rule, would apply to all CMV
drivers, and would expand the requirement for medical examinations to
be conducted by medical examiners listed on the NRCME to all CMV
drivers regardless of the size of the employer. After the applicable
compliance dates for the affected drivers, FMCSA would accept as valid
only medical certificates issued by medical examiners listed on the
NRCME.
G. Changes in Medical Examination Procedures
This NPRM also proposes implementation of the SAFETEA-LU
requirement that medical examiners electronically transmit to the FMCSA
Chief Medical Examiner on a monthly basis the name of the CMV driver
and a numerical identifier for any completed Medical Examination Report
required under Sec. 391.43. (49 U.S.C. 31149(c)(1)(E)) Additionally,
the proposed rule would require medical examiners to retain for 3 years
the Medical Examination Report for each examination performed. It would
also require medical examiners to provide copies of the Medical
Examination Reports and medical examiner's certificates to FMCSA or to
authorized Federal, State and local enforcement agency personnel,
within 48 hours of the request, in order to allow for investigation of
errors and improper certification of CMV drivers (49 U.S.C.
31149(c)(2)).
These requirements also establish the basis for future
implementation of other statutory requirements for monitoring medical
examiner performance. For example, although this rulemaking does not
propose collection of a representative sample and storage of Medical
Examination Reports and medical certificates in a central database (49
U.S.C. 31149(c)(1)(E)), in the future FMCSA could begin reviewing a
representative sample of Medical Examination Reports and medical
certificates for errors, omissions, or other indications of improper
certification.
H. Removal From the NRCME and Appeal Process
This NPRM proposes to define the standards and process by which a
medical examiner would be removed from the NRCME and the procedures
provided for appealing such action within the Agency. Under 49 U.S.C.
31149(c)(2), if a medical examiner issues a medical examiner's
certificate to a driver who fails to meet the applicable standards at
the time of the examination or falsely claims to have completed
required training in the physical qualification standards and medical
certification process, FMCSA may remove the medical examiner from the
NRCME. In addition, the statute requires FMCSA to monitor medical
examiner performance and investigate patterns of errors or improper
certification of CMV drivers by a medical examiner (49 U.S.C.
31149(c)(2)). The FMCSA also may remove from the NRCME any medical
examiner who does not meet the qualification standards or otherwise
fails to comply with section 31149 or the implementing regulations (49
U.S.C. 31149(d)(2)).
To monitor compliance with these statutory requirements, FMCSA may
investigate whether medical examiners are complying with the
requirement that they electronically transmit each month the name of
the driver, an FMCSA numerical identifier for the driver, and the
results of the examination to FMCSA (via an FMCSA-designated Web site,
e-mail address, or facsimile number that will be published in the
Federal Register) for each completed Medical Examination Report
(including for individuals who failed to meet FMCSA medical standards).
The proposed rule would also require the medical examiner to
provide to an authorized representative of FMCSA or to an authorized
State or local enforcement agency representative, a copy of any Medical
Examination Report or medical examiner's certificate, within 48 hours
of the request, so that enforcement personnel can identify errors,
omissions, or other indications of improper certification by medical
examiners.
In addition, FMCSA would review changes submitted by medical
examiners to their application information. These reviews, along with
other mechanisms to be developed, would potentially identify medical
examiners for removal from the NRCME.
The following are some examples of grounds for removal from the
NRCME: The medical examiner no longer has at least one valid license,
registration, or certification to perform physical examinations in any
State; failure to comply with training requirements; failure to comply
with FMCSA requirements for electronic transmittal of medical
examination information to FMCSA; a demonstrated pattern of errors,
omissions, or other indications of improper certification; and failure
to provide copies of Medical Examination Reports and medical examiner's
certificates upon demand. There may also be situations where a medical
examiner would be voluntarily removed for personal reasons, such as
health, travel, or retirement.
The proposed appeal process provides an opportunity for a medical
examiner who has been proposed to be removed to correct an identified
deficiency or request administrative review by FMCSA.
[[Page 73135]]
IV. Section-by-Section Discussion of the Proposals
A. Section 390.5, Definitions
Section 390.5 currently defines ``medical examiner'' as a person
licensed by a State to perform physical examinations and lists examples
of types of medical professions authorized to perform examinations of
CMV drivers under part 391. Section 4116(c) of SAFETEA-LU adds a
statutory definition of ``medical examiner'' to 49 U.S.C. 31132(6) as
``an individual licensed, certified, or registered in accordance with
regulations issued by the Federal Motor Carrier Safety Administration
as a medical examiner.'' The proposed revision of the definition of
medical examiner in Sec. 390.5 in this NPRM provides for the new
statutory definition to replace the current regulatory definition once
the final rule is completely implemented as provided in proposed Sec.
391.42. The eligibility requirements regarding State medical licensure,
registration, or certification would also appear in proposed Sec.
390.103(a), covering eligibility requirements for medical examiner
certification.
B. Subpart D of Part 390, National Registry of Certified Medical
Examiners
The FMCSA proposes to establish a new subpart D in part 390 that
would include the requirements for training and testing of medical
examiners for listing on, and removal from, the NRCME, including appeal
provisions. The requirements for medical examinations would remain in
part 391.
1. Section 390.101, Scope
Proposed Sec. 390.101 states that the new subpart would establish
the minimum qualifications for FMCSA certification of medical examiners
and for listing medical examiners on the NRCME. It also describes the
NRCME program and explains that the registry itself is the component of
the program that would provide the public with a national database
listing certified medical examiners.
2. Section 390.103, Eligibility requirements for medical examiner
certification
Section Sec. 390.103 proposes the eligibility requirements for
medical examiner certification. Paragraph (a)(1) incorporates the
requirements from current Sec. 390.5 that applicants must be licensed,
certified, or registered under the applicable State requirements to
perform physical examinations. Paragraphs (a)(2) and (a)(3) state that
applicants must also obtain training and pass a certification test, as
specified in proposed Sec. Sec. 390.105 and 390.107, respectively.
Proposed paragraph (b) states that to renew the certification, a
medical examiner would have to remain licensed, registered, or
certified by his or her State and complete additional testing and
training as required by proposed Sec. 390.111(a)(5).
3. Section 390.105, Medical examiner training programs
Proposed Sec. 390.105 would require an applicant for medical
examiner certification to complete an accredited training program that
meets the core curriculum specifications and administrative
requirements established by FMCSA for medical examiner training. The
training program would have to be accredited by a nationally-recognized
medical profession accrediting organization to provide continuing
education courses. There is at least one such accrediting organization
for each medical specialty.
This section clarifies that it is the sole responsibility of
medical examiners to ensure their training meets these requirements.
The FMCSA would maintain on the NRCME Web site a list of all training
providers that have submitted for FMCSA review their course
documentation that includes, but is not limited to, the course
syllabus, sample slides, sample handouts, and a sample training module.
A training provider included on the NRCME Web site would have to agree
to submit documentation for future reviews to ensure continuing
compliance with FMCSA requirements. If FMCSA finds that a particular
training provider does not meet the core curriculum specifications and
administrative requirements, the name of the training provider would be
removed from the NRCME Web site. A medical examiner could arrange for
training by an organization not included in the Web site, but the
medical examiner would need to ensure that the training program meets
FMCSA requirements.
4. Section 390.107, Medical examiner certification testing
Section 390.107 contains the proposed requirements for the medical
examiner certification test. An applicant would take the certification
test from a private-sector professional testing organization. As part
of the testing process, the applicant would have to provide information
to a private-sector testing organization. Proposed Appendix A to part
390 would list the minimum information that the applicants would be
required to provide. The applicant would take the test at a testing
center provided by a testing organization that meets FMCSA standards
for delivering these tests. The testing organization would supply the
applicant's personal application information and test results to FMCSA.
The testing organization would: (1) Submit for FMCSA review its
documented policies and procedures to ensure they meet FMCSA criteria;
and (2) agree to future FMCSA reviews to ensure continuing compliance.
The FMCSA is considering the option of listing on the NRCME Web site
testing organizations that meet FMCSA standards. However, the medical
examiner would need to ensure that the testing organization he or she
chooses to use meets FMCSA requirements.
5. Section 390.109, Issuance of the FMCSA medical examiner
certification credential
Proposed Sec. 390.109 states that FMCSA would issue an FMCSA
medical examiner certification credential with a unique identification
number to each applicant found to be in compliance with the
requirements of Sec. Sec. 390.103-390.107, and would list the medical
examiner's name on the NRCME. In accordance with the phased-in schedule
proposed in Sec. 391.42, FMCSA proposes to accept as valid only
medical certificates issued by medical examiners listed on the NRCME.
In addition, proposed Sec. 390.109 specifies that the
certification credential and the listing on the NRCME would expire 6
years after issuance. To maintain a listing on the NRCME and to receive
a new credential, the medical examiner would need to comply with the
training, testing, and other requirements of proposed Sec. 390.111.
6. Section 390.111, Requirements for continued listing on the NRCME
Proposed Sec. 390.111 explains how a medical examiner retains a
listing on the NRCME. Each medical examiner must continue to be
licensed, registered, or certified, and be authorized to perform
physical examinations in accordance with the applicable State laws and
regulations of each State in which the examiner performs examinations.
For continued listing on the NRCME, the medical examiner would have to
report to FMCSA changes to any information that the examiner previously
provided to FMCSA, for example, any information related to any
termination, suspension, or withdrawal of the medical examiner's
license, registration, or certificate under State law.
The medical examiner must maintain documentation of his/her: (1)
State
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licensing, registration, or certification; and (2) completion of all
training required under this notice. In addition the medical examiner
would have to make this documentation available to an authorized
representative of FMCSA, or an authorized representative of Federal,
State or local government. The medical examiner would have to make the
documentation available within 48 hours of a request for investigations
and within 10 days of a request for regular audits.
The medical examiner also would have to complete periodic training
and testing according to a schedule specified in paragraph (a)(5) of
proposed Sec. 390.111:
Within 3 years of receiving the credential, the medical
examiner must complete periodic training. The purpose of this training
would be to refresh the medical examiner's knowledge of the medical
standards for CMV drivers and to inform the medical examiner of any
changes to FMCSA examination standards or guidelines. The FMCSA would
monitor the results of the certification tests to identify gaps in
knowledge, and analyze enforcement and crash data to identify other
areas where additional training may improve the medical certification
process.
Within 6 years of receiving the credential, the medical
examiner must complete the periodic training, plus repeat and pass the
test taken for initial certification, under Sec. 390.103(a)(3).
However, in alternating 6 year periods, instead of taking the periodic
training, the medical examiner would need to repeat the training taken
for initial certification, under Sec. 390.103(a)(2).
If a medical examiner complies with the proposed training and
testing schedule and meets the other maintenance requirements of
proposed Sec. 390.111, FMCSA would issue a new medical examiner
certification credential. It would be the responsibility of the medical
examiner to ensure that he or she receives the new credential before
the previous one expires.
7. Section 390.113, Reasons for removal from the NRCME
Section 390.113 proposes the reasons for removal of a medical
examiner from the NRCME. The reasons include, but are not limited to,
the following: The medical examiner's failure to continue compliance
with the basic requirements for inclusion on the NRCME, such as
maintaining a current State medical license, certification, or
registration, receiving required periodic training, or renewing the
FMCSA certification; the medical examiner's failure to comply with the
FMCSA operational requirements, such as issuing a certificate to
someone not medically qualified, failure to accurately complete the
Medical Examination Report or medical examiner's certificate, or
failure to regularly transmit the names and other information about the
results of examinations conducted; false claims by the medical examiner
of completion of any required training; and failure to provide access
to examination data upon request.
8. Section 390.115, Procedure for removal from the NRCME
Section 390.115 proposes procedures for removal of a medical
examiner from the NRCME, as well as the due process protections
afforded to medical examiners subject to proposed involuntary removal.
Any involuntary removal action must be undertaken by the FMCSA Director
of Medical Programs (a new position to be established by the Agency).
The proposal states that a medical examiner could be removed
voluntarily by submitting a request to the FMCSA Director of Medical
Programs. Such a request could be submitted either in writing or
through a proposed secure information system. The FMCSA is considering
developing a secure information system through Web interface in which
each medical examiner listed on the NRCME would receive a unique login
identification and password upon their acceptance into the NRCME. The
unique login ID and password would be used to authenticate each request
for voluntary removal from the NRCME. A request for voluntary removal
would be effective immediately.
The proposal then describes the process by which FMCSA would
initiate and then complete the involuntary removal of a medical
examiner from the NRMCE at the Agency's discretion. The FMCSA would
issue to the medical examiner a notice of proposed removal, stating:
(1) The reasons upon which the proposed removal is based under proposed
Sec. 390.113; and (2) any corrective actions necessary, if applicable,
for the medical examiner to remain listed on the NRCME, if he/she so
chooses. The medical examiner would have an opportunity to submit a
response in writing no later than 30 days after the date of issuance of
the notice. The medical examiner could submit to the Director of
Medical Programs an explanation of any error(s) committed in proposing
to remove the medical examiner from the NRCME. The Director of Medical
Programs would review the explanation and could withdraw, modify, or
affirm the notice of proposed removal. Alternatively, the medical
examiner could submit to the Director of Medical Programs a written
response indicating that he or she will come into compliance, if
possible, and complete the corrective actions identified in the notice
of proposed removal.
The medical examiner would have 60 days from either the date of
issuance of the notice of proposed removal or the date the notice is
affirmed or modified, whichever is later, to comply with the
requirements of this subpart and complete the applicable corrective
actions specified in the notice, as modified or affirmed. If the
medical examiner fails to take these necessary actions, the proposed
removal becomes effective. Additionally, if the medical examiner does
not submit a written response in the 30-day period following issuance
of the original notice of proposed removal, the medical examiner would
be removed from the NRCME at the end of that 30-day period.
Although a person may voluntarily request to be removed from the
NRCME under proposed Sec. 390.115(a), a person may not request a
voluntary removal from the NRCME after receiving a notice of proposed
removal from the Director of Medical Programs. This proposed provision
is intended to prevent the medical examiner from leaving the NRCME and
later attempting reinstatement without meeting conditions for
reinstatement and compliance identified in the notice of proposed
removal. However, at any time before a notice of proposed removal
becomes effective, the medical examiner could resolve the matter by
mutual agreement with the Director of Medical Programs.
A person who has been removed from the NRCME could request an
administrative review by submitting to the FMCSA Associate
Administrator for Policy and Program Development a written request no
later than 30 days after the date the removal becomes final. The
Associate Administrator may request additional data or a conference to
discuss the removal. After completing the review, the Associate
Administrator would issue a written decision.
Under proposed Sec. 390.115(e), and as authorized by the
Administrative Procedure Act, 5 U.S.C. 558(c), the Director of Medical
Programs would reserve the right to remove a medical examiner from the
NRCME immediately, either in cases of willfulness or cases in which
public health, interest, or safety requires. In these cases, the
provisions for the medical examiner to submit a response
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and take corrective action would not apply. However, the medical
examiner could submit to the Associate Administrator for Policy and
Program Development a request for administrative review of the
emergency removal. The medical examiner must request such a review no
later than 30 days after the date of removal from the NRCME.
Proposed Sec. 390.115(f) describes how a person removed from the
NRCME would request reinstatement. Such a request must be submitted no
sooner than 30 days after removal from the NRCME. The person must
provide documentation demonstrating he or she has taken whatever
action(s) is necessary to correct the deficiencies that resulted
initially in removal from the NRCME, and demonstrate he or she is in
compliance with the eligibility requirements of Sec. 390.103(a). The
Director of Medical Programs may specify additional requirements for
reinstatement in the notice of proposed removal. In the case of a
voluntary removal, the person could be reinstated after providing
documentary proof of satisfying the requirements to be listed on the
NRCME.
If FMCSA removes a medical examiner from the NRCME, except at the
request of the medical examiner, the certification credential issued
under proposed Sec. 390.109 would no longer be valid. If a medical
examiner requests voluntary removal from the NRCME, the certification
credential would remain valid until it expires, but that person would
not be permitted to conduct FMCSA medical examinations until that
person provided documentation showing proof of satisfying the
requirements for continued listing on the NRCME. In either case, the
removed person's information would still be publicly available on the
NRCME Web site. A record of the removed person's previous certification
would remain on the NRCME Web site, with the date of removal, so that
enforcement personnel and employers of drivers could verify whether a
medical examiner's certificate was issued by a person listed on the
NRCME at the time of issuance.
9. Appendix A to part 390, Medical examiner application data elements
Proposed Appendix A shows the information applicants must provide
when they arrange with a testing organization to take the FMCSA medical
examiner certification test. The professional testing organization
would provide this information to FMCSA along with the results of the
certification test. When a medical examiner is added to the NRCME,
FMCSA would post the person's name, business address, telephone number,
and other contact information on the NRCME Web site. The applicant
would need to supply a street address for the business location--not a
post office box, although a post office box could be used for the
mailing address. The Web site would contain a search function allowing
drivers to locate certified medical examiners in a particular location.
The other information required from applicants by Appendix A would be
used to document a medical examiner's eligibility to be listed on the
NRCME or to facilitate contact with the applicant by FMCSA.
C. Section 391.42, Schedule for Use of Medical Examiners Listed on the
National Registry of Certified Medical Examiners
Under Sec. 391.42, FMCSA proposes a schedule for implementation of
the requirement that drivers must be examined only by persons who have
been trained, tested, certified, and are listed on the NRCME, as set
out in proposed subpart D of part 390. Specifically, beginning on a
date 2 years after the effective date of the final rule, each medical
examination required under subpart E of part 391 must be conducted by a
medical examiner who is listed on the NRCME if the person is employed
by a motor carrier that employs 50 or more drivers of CMVs.
Subsequently, beginning on a date 3 years after the effective date of
the final rule, every medical examination required under subpart E of
part 391 must be conducted by a medical examiner who is listed on the
NRCME. The FMCSA requests specific comments on the proposed compliance
schedule and on the proposed threshold of 50 CMV drivers for the first
phase of implementation.
D. Section 391.43, Medical Examination; Certificate of Physical
Examination
Current Sec. 391.43 contains the requirements for performing the
medical examination, including instructions for the medical examiner, a
sample Medical Examination Report form, and a sample medical examiner's
certificate form. The NPRM contains several proposed amendments to
Sec. 391.43, including an addition to the information required on a
medical examiner's certificate.
First, under the proposal, paragraph (a) would be revised to
specify that, in accordance with the compliance schedule proposed in
Sec. 391.42, the medical examination must be performed by a medical
examiner listed on the NRCME under proposed subpart D of part 390 of
this chapter.
Second, paragraph (g) would be revised to add the new requirement
that once every calendar month the medical examiner must electronically
transmit certain information to the FMCSA Medical Program. For each
medical examination of an interstate CMV driver performed during the
previous month, the required information to be transmitted would be the
driver's name, the driver's FMCSA numerical identifier, the date of the
examination, the date of expiration of the medical examiner's
certificate (the so-called ``medical card''), if issued, and the
results of the medical examination. The FMCSA proposes to create a
secure electronic transmission process that medical examiners could use
to provide the information, such as a secure Web interface, e-mail
address, or facsimile number. The medical examiner would be required to
transmit this information not only for persons found to be medically
qualified, but also for persons found to be medically unqualified or
temporarily disqualified. Additionally, paragraph (g)(1) repeats part
of the ``Instructions for Performing and Recording Physical
Examinations'' in current Sec. 391.43 that requires the medical
examiner to date and sign the Medical Examination Report and provide
the medical examiner's full name, office address, and telephone number.
Third, under the proposal the Medical Examiner's Certificate
included in paragraph (h) would be revised to add a field for the
medical examiner to enter the medical examiner's unique National
Registry Number. Adding the National Registry Number allows FMCSA to
identify medical examinations performed by particular medical examiners
and to monitor compliance with these rules. Medical examiners would be
allowed to use printed certificates they have on hand until 4 years
after the effective date of the final rule.
Finally, paragraph (i) would be added to specify that the medical
examiner must retain the original (paper or electronic) completed
Medical Examination Report and a copy or electronic version of the
medical examiner's certificate for 3 years and make them available,
along with related medical documentation, to an authorized
representative of the FMCSA or an authorized Federal, State or local
enforcement agency representative, within 48 hours of the request. The
requirement for retaining the Medical Examination Report already exists
under the heading, ``Instructions for
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Performing and Recording Physical Examinations'' in Sec. 391.43.
V. Regulatory Analyses and Notices
Executive Order 12866 (Regulatory Planning and Review) and DOT
Regulatory Policies and Procedures
The FMCSA has determined that this action is a significant
regulatory action within the meaning of Executive Order 12866 and the
Department of Transportation regulatory policies and procedures. This
NPRM includes a summary of the Agency's preliminary regulatory analysis
of the costs and benefits of this undertaking. A copy of the complete
preliminary analysis is included in the docket referenced at the
beginning of this notice. FMCSA seeks comment on the costs and benefits
of this proposal as outlined, as well as alternatives to current cost-
benefit data collection methods currently used to quantify the costs
and benefits. FMCSA is particularly interested in developing a solid
estimate of the cost-effectiveness, if not the benefits, of this rule.
For example, it would be helpful to know what fraction of crashes
involve drivers without a valid medical certificate and which aspects
of this rule would be most effective at reducing both of those numbers.
Alternatives
This regulatory evaluation considers three alternatives for
implementing this program. One alternative, referred to as the Public-
Private Partnership Model or Alternative 1, would involve a partnership
between the Agency and various private-sector training and testing
organizations that currently exist to provide continuing professional
education and credentialing to medical professionals. Under this
partnership, the Agency would develop and provide core curriculum
specifications and the certification test and protocols, and any
interested organization that can meet FMCSA requirements would be
eligible to deliver training or testing. Training would be delivered by
private-sector professional associations, health care organizations,
and other for-profit and non-profit training providers. Testing would
be delivered by private-sector professional testing organizations.
After completing required training, passing the certification test, and
agreeing to comply with FMCSA administrative requirements, a medical
examiner would be added to the NRCME, and would be authorized to
conduct CMV driver physical examinations. After the NRCME is fully
implemented, only physical examinations conducted by medical examiners
listed on the NRCME would be recognized by FMCSA and enforcement
personnel as proof of driver physical qualification.
Alternative 2 is based on the Federal Aviation Administration's
(FAA) Aviation Medical Examiner Program (Government Model). This
alternative would require the Agency to establish its own centralized
training and testing program. All medical examiners would have to
attend this Agency-run program and pass the test in order to be
eligible for listing on the NRCME. This program's components are
essentially the same as Alternative 1, but all training and testing
would be conducted by the Agency rather than private-sector training
and testing organizations. This alternative would also require all
medical examiners to travel to the FMCSA facility to receive the FMCSA
training, which involves greater travel expenses on the part of medical
examiners when compared to Alternative 1, which has training programs
distributed throughout the country. However, this option would give
FMCSA optimal control over the quality and content of training provided
to medical examiners.
Alternative 3 would be based on the current Department of
Transportation (DOT) Medical Review Officer (MRO) program requirements.
The MRO training program grew out of the DOT testing program that
monitors use of controlled substances and alcohol. MROs are trained and
certified by accredited training programs operated by professional
associations in cooperation with DOT. Only licensed Medical Doctors
(MD) or Doctors of Osteopathy (DO) are eligible to be MROs. MROs also
review test results for other safety sensitive occupations such as
airline mechanics, train operators, and ships' pilots.
The existing program specifies that MROs who oversee testing for
commercial drivers must attend training and certification programs that
satisfy the Department's requirements. Each of these programs maintains
its own registry of graduates rather than contributing names to a
single Federal database. DOT does not have direct control over the
training curriculum or testing protocols for these programs. Thus, the
Agency would exert less control over the program under a similar
option. In addition, due to the limited number of organizations issuing
MRO credentials, these programs are able to charge a higher fee for
certification testing than would be the case under a more competitive
atmosphere. Long distance travel for the initial training and testing
could also be required under this alternative.
Summary of Costs and Benefits
The costs and benefits for all three alternatives are analyzed in
this regulatory evaluation. It is anticipated that approximately 40,000
medical examiners would be needed for the NRCME to accommodate the
demand for an estimated 3 million medical examinations per year. All
alternatives involve an initial training phase in which the 40,000
medical examiners receive training. This phase is expected to last 3
years. Beginning with the third year, the Agency would require all
drivers to be examined by medical examiners listed on the NRCME. Under
Alternatives 1 and 3, medical examiners would be required to attend
training conducted by a private-sector organization. The training and
testing costs would be borne by medical examiners. Under Alternative 2,
no training or testing fees would be incurred by medical examiners, but
the Agency would bear the costs of providing the training and testing
services. Long distance travel to the FMCSA training center would be
required under Alternative 2. Long distance travel to a designated
training program is also anticipated under Alternative 3. Under
Alternative 1--the Public-Private Partnership Model--it is anticipated
that training programs would be available throughout the country, and
that some programs would offer on-line training courses, which would
minimize the need for long distance travel.
By screening out physically unqualified drivers, this rule may
impact the labor market in the motor carrier industry. Some commercial
drivers may have to find alternative occupations because they cannot
meet the FMCSA physical qualification standards. These alternatives are
likely to pay less than commercial driving, and this loss of income
represents the main cost of this impact. Motor carriers would also have
to bear the burden of hiring new drivers. Each alternative is expected
to have an equivalent impact on the quality of driver medical
certification screening, and hence the impacts on the industry are
likely to be the same for all alternatives.
The ten year total cost of Alternative 1 is estimated at $587
million, when discounted at a 7 percent rate. Alternative 2 has a total
discounted ten year cost of $658 million. Alternative 3 has a total 10
year discounted cost of $617 million. In all alternatives, the lost
income to disqualified drivers is the largest portion of cost. The
costs of the training/testing, including lost time to medical
examiners, is estimated to vary
[[Page 73139]]
between $31 million and $44 million (undiscounted) during the initial
training phase, depending on the alternative, with Alternative 1 having
the lowest cost. The lower cost associated with Alternative 1 is due to
its minimization of travel and associated costs, both in expenses and
lost time, to medical examiners.
Because all three alternatives are expected to improve the
performance of medical examiners by equivalent amounts, total benefits
are expected to be equivalent for all programs. These benefits are
based on the reduction in CMV crashes that is likely to result from
improved medical screening of drivers. It is estimated that physically
impaired drivers operating in interstate commerce are responsible for
approximately 5,800 of the roughly 420,000 CMV crashes that occur
annually. Although it is not anticipated that this program would
completely eliminate these crashes, it is expected to prevent a portion
of them. Due to data limitations, we are unable to develop a precise
estimate of the potential benefits of this rule. If this program were
to prevent 25 percent of these crashes annually, it would eliminate
approximately 1,451 crashes per year. The estimated annual benefit
associated with avoiding these crashes would be $206 million per year.
At a 7 percent discount rate, the 10 year net benefits under this
assumption would be between $376--$447 million, depending on the
alternative chosen.
Regulatory Flexibility Act
In compliance with the Regulatory Flexibility Act (5 U.S.C. 601-
612), FMCSA has considered the effects of this proposed regulatory
action on small entities and determined that it is not likely to have a
significant impact on a substantial number of small entities, as
defined by the U.S. Small Business Administration's Office of Size
Standards.
The Small Business Administration (SBA) regulations (13 CFR part
121) require Federal agencies to analyze the impact of proposed and
final rules on small entities. The regulations define a ``small
entity'' in the motor carrier industry by average annual receipts,
which are currently set at $21.5 million per firm.\4\ The FMCSA has
developed a model that uses data from the Economic Census (U.S. Census
Bureau), North American Industrial Classification System (NAICS) Code
484 ``Truck Transportation'' segments, to assist us in determining the
number of small trucking entities potentially affected by our proposed
rules. Examining all property carriers within NAICS Code 484, roughly
75 percent had annual receipts of less than $21.5 million. Of the
475,500 current active, interstate motor carriers in the Motor Carrier
Management Information System (MCMIS), approximately 356,625 are
considered small entities, and this proposed rule would affect all of
them. In the Regulatory Evaluation we estimated that the improvements
in the screening of drivers that would result from the NRCME training
program would result in some drivers being screened out of the
occupation due to untreatable disqualifying medical conditions. Motor
carriers would incur costs to replace these drivers. In the Regulatory
Evaluation we estimated these costs as $1,600 per replaced driver.
---------------------------------------------------------------------------
\4\ Small Business Administration Table of Size Standards.
Available online at: http://www.sba.gov/services/contractingopportunities/sizestandardstopics/tableofsize/SERV_TABLE_HTML.html.
---------------------------------------------------------------------------
Although smaller carriers make up the majority of the carrier
population by number of firms, these firms only employ 20 percent of
the driver population. In the regulatory evaluation, we estimated that
approximately 44,000 drivers would be screened out of the CMV driving
occupation and would have to be replaced. Since there is no reason to
suspect that drivers for smaller firms are any more or less healthy
than drivers for larger firms, we assume that 20 percent (8,800) of the
drivers that would need to be replaced work for smaller carriers,
resulting in a total cost to small businesses in this industry of $14.1
million. Spreading this cost among the carriers that qualify as small
businesses results in a per-carrier cost of $39.48.
While these amounts do not represent a significant cost to the
industry as a whole, or even the small business portion of it, it
should be noted that the impacts are not spread evenly among all small
businesses in the industry. Many small businesses in the industry would
bear no additional costs from this rule, but a subset that employs
drivers who do not meet current physical qualification standards would
bear a cost of $1,600 for each driver they would have to replace. This
may represent a significant cost to a small motor carrier employing
only one or two drivers operating on a slim margin. However, the
alternative is to continue allowing drivers who do not meet current
FMCSA physical qualification requirements to operate CMVs in commerce,
which would compromise public safety. The FMCSA does not see a way to
reduce the impacts of this requirement to small businesses in the
industry without compromising public safety.
The rule would, at a maximum, affect 8,800 motor carriers that
qualify as small businesses. These carriers represent approximately 2.5
percent of small entities in the industry. While the costs to affected
motor carriers may be significant, the total number of affected small
entities does not appear to be significant when compared to the size of
the industry and the number of small entities in the industry.
Furthermore, this rule does not impose new physical requirements on
drivers, but only enhances detection of drivers who do not meet current
physical qualification requirements. These drivers are out of
compliance with current requirements, and therefore should not be
operating CMVs in commerce. Whether the cost of replacing these drivers
should be considered as a cost of this rule is therefore debatable.
However, the improvement in enforcement would impact the industry, so
we have accounted for it here.
Another group of businesses that may be impacted by this rule
change are the offices of health care providers who currently conduct
driver medical examinations. Driver examinations would be conducted
primarily by nurse practitioners, general internal and family
physicians, and physician's assistants. Combining these groups yields a
total of 317,000 health care providers who might perform driver
physical examinations on a regular basis. In order to qualify as a
small business, a physician's office must bring in $9 million or less
in revenue annually.\5\ The small-business threshold for nurse
practitioners and physician assistants is $6.5 million. According to
the American Academy of Family Physicians, the average gross revenue of
family medical practices is $360,000 per year. However, it should be
noted that many physicians and other medical professionals work for
larger health care organizations such as HMOs and hospital outpatient
care facilities. These larger organizations would have revenues
exceeding the threshold for small businesses established by the Small
Business Administration. Still, the vast majority of family care
practices are likely to qualify as small businesses. Our best estimate
is that 90 percent of the firms in this subset of the health care
industry are small businesses. We estimate that these private health
care practices have an average of 5 health care providers per firm.
Given this average, there are likely to be in the neighborhood of
317,000/5 = 63,400
[[Page 73140]]
firms. Ninety percent of this number is 57,060. This is the number of
firms that could potentially be impacted by this rule. We do not
anticipate that the effects of this rule on firms in the health care
industry would be large enough to be considered significant.
---------------------------------------------------------------------------
\5\ Ibid.
---------------------------------------------------------------------------
Unfunded Mandates Reform Act of 1995
This rulemaking would not impose an unfunded Federal mandate, as
defined by the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1532, et
seq.), that would result in the expenditure by State, local, and tribal
governments, in the aggregate, or by the private sector, of $128.2
(2005 dollars) million or more in any 1 year.\6\
---------------------------------------------------------------------------
\6\ The accompanying Regulatory Evaluation for this NPRM
presents costs and benefits in inflation-adjusted 2005 dollars. The
$128.2 million figure was derived by inflation adjusting the $100
million cap in the original Act from 1995 to 2005 dollars using the
Consumer Price Index.
---------------------------------------------------------------------------
Executive Order 12988 (Civil Justice Reform)
This proposed action would meet applicable standards in sections
3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to
minimize litigation, eliminate ambiguity, and reduce burden.
Executive Order 13045 (Protection of Children)
The FMCSA has analyzed this proposed action under Executive Order
13045, Protection of Children from Environmental Health Risks and
Safety Risks. We have determined preliminarily that this rulemaking
would not concern an environmental risk to health or safety that may
disproportionately affect children.
Executive Order 12630 (Taking of Private Property)
This proposed rulemaking would not effect a taking of private
property or otherwise have taking implications under Executive Order
12630, Governmental Actions and Interference with Constitutionally
Protected Property Rights.
Executive Order 13132 (Federalism)
This proposed action has been analyzed in accordance with the
principles and criteria contained in Executive Order 13132. The FMCSA
has preliminarily determined that this rulemaking would have no
significant cost or other effect on or for States. States would have
policy-making discretion. Nothing in this document would preempt any
State law or regulation.
Executive Order 12372 (Intergovernmental Review)
The regulations implementing Executive Order 12372 regarding
intergovernmental consultation on Federal programs and activities do
not apply to this program.
Privacy Impact Assessment
FMCSA conducted a privacy impact assessment of this proposed rule
as required by section 522(a)(5) of division H of the FY 2005 Omnibus
Appropriations Act, Public Law 108-447, 118 Stat. 2809, 3268 (Dec. 8,
2004) [set out as a note to 5 U.S.C. Sec. 552a]. The assessment
considers any impacts of the proposed rule on the privacy of
information in an identifiable form and related matters. The entire
privacy impact assessment for this proposal is available for review in
the docket.
Paperwork Reduction Act
This proposal contains the following new information collection
requirements. As required by the Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3507(d)), FMCSA has submitted the information requirements
associated with this proposal to the Office of Management and Budget
for its review.
Title: National Registry of Certified Medical Examiners (NRCME).
Summary: Under SAFETEA-LU, the Secretary of Transportation is
required to establish and maintain a current national registry of
medical examiners who are qualified to perform examinations and issue
medical certificates that verify whether a CMV driver's health meets
FMCSA standards. In addition, section 4116(b) of SAFETEA-LU requires
that the medical examinations of CMV operators be performed by medical
examiners who have received training in physical and medical
examination standards, and, after the NRCME is established, are listed
on the NRCME. SAFETEA-LU also requires medical examiners to
electronically transmit the name of the applicant and FMCSA numerical
identifier for any completed Medical Examination Report required under
Sec. 391.43 to the Chief Medical Examiner on a monthly basis.
Once the NRCME program is implemented, FMCSA would accept medical
examinations performed only by certified medical examiners listed on
the NRCME, as required by law. The NRCME program would require medical
examiners to complete training developed from standardized curriculum
specifications and pass a national certification test. The procedures
used to develop and maintain the quality of the program are expected to
be in accordance with national accreditation standards for
certification programs established by the National Commission of
Certifying Agencies (NCCA), the accreditation arm of the National
Organization for Competency Assurance (NOCA).
Third-party requirements of this information collection are being
considered since State laws are generally in substantial conformity
with the Federal regulations for medical qualifications of commercial
drivers. Consequently, the estimate of the number of CMV drivers
(respondents) covered by this information collection reflects both
interstate drivers subject to the Federal Motor Carrier Safety
Regulations (FMCSRs) and intrastate drivers subject to compatible State
regulations. Although Federal regulations do not require States to
comply with the medical requirements in the FMCSRs, most States do
mirror the Federal requirements; therefore, we are including intrastate
drivers, which is consistent with other FMCSA information collections,
to accurately reflect the burden of this information collection.
Close tracking and monitoring of certification activities and
medical outcomes are crucial, and the NPRM addresses the information
collection aspects of NRCME implementation.
To this end, the NPRM requires medical examiners to submit three
types of data:
(1) Medical Examiner Application and Test Results Data: To be
listed on the NRCME, medical examiners must first pass a certification
test to ensure that they demonstrate an established level of
competency. Private-sector testing organizations would collect data
from medical examiners as the medical professionals apply to take this
certification test. Data elements required of medical examiners at the
time of application would include (but not be limited to) professional
contact and identifying information such as job title, address, and
training and State licenses obtained. This information would be
collected each time the medical examiner applies to sit for the
certification test, and updated with FMCSA as needed. Test results data
would include total test score and responses for each test item.
Private-sector testing organizations would regularly transmit medical
examiner application and test results data electronically to FMCSA for
inclusion in a centralized, confidential database.
(2) CMV Driver Examination Data: Once every calendar month, each
[[Page 73141]]
medical examiner listed on the NRCME would be required to transmit to
FMCSA (via the Chief Medical Examiner) the following information about
each CMV driver examined during the previous month: name, FMCSA
numerical identifier, date of examination, an indication of the
examination outcome (for example, ``medically qualified''), and date of
expiration of the driver's medical certification, if issued. Data would
be submitted electronically via a secure FMCSA-designated Web site, e-
mail address, or facsimile number. In order to be listed on and to
continue participation in the NRCME, medical examiners would need to
comply with this requirement on a monthly basis.
(3) Medical Examination Reports and Medical Examiner's
Certificates: This NPRM would require medical examiners to provide
copies of Medical Examination Reports and medical examiner's
certificates to authorized representatives of FMCSA or authorized State
or local enforcement agency representatives. These documents contain
the driver's social security number, date of birth, driver license
number, and health and medical information.
Use of information collected: This proposal would support the
information needs of the FMCSA in three different ways:
(1) Medical Examiner Test Application Data: These data would allow
for the matching of documentation with verification of identity and
testing eligibility (for example, proof of State licensure,
registration or certification that allows performance of medical
examinations, and completion of training by an accredited training
provider. This information would also be utilized to track participant
test taking trends as well as provide respondents with test results and
follow-up information.
It is important to note that there is currently no mechanism for
identifying medical examiners conducting CMV driver medical
examinations. The size of this population, as well as characteristics
related to their training and location, for example, is not known. This
database would therefore serve as the only resource containing this
information for all certified medical examiners in the United States.
Ultimately, these data would therefore be used to provide CMV
drivers with contact information for those medical professionals who
have passed the certification test; that is, this information would
provide the content for the actual NRCME listing. In some cases, this
medical examiner information would be needed to address removals from
the NRCME.
(2) CMV Driver Examination Data: CMV driver examination data are
intended to serve a monitoring function. First, these would be the only
centralized, consistent national data that would enable FMCSA to link
medical examiners to the examinations they have conducted. In addition,
this would be the first national database that would, after several
years of implementation, contain CMV driver medical examination
certification outcomes.
(3) Medical Examination Reports and Medical Examiner's
Certificates: Medical Examination Reports and medical examiner's
certificates must be available to an authorized representative of FMCSA
or an authorized Federal, State or local enforcement agency
representative in order to determine whether a medical examiner has
issued a medical certificate to a driver who fails to meet the
applicable FMCSA medical standards. Failure to properly apply FMCSA
medical standards may result in removal from the NRCME. Medical
examiner's certificates provide additional documentation to determine
proper application of FMCSA medical standards by linking the medical
examiner to both the medical examination and the driver medical
certification decision, and to ensure the certification decision
matches the information in the medical examination and the certificate
is completed correctly.
Respondents (including number of): The likely respondents to this
proposed information requirement are 40,000 medical examiners from
medical professions who are believed to conduct the majority of current
CMV driver medical examinations (advanced practice nurses, doctors of
chiropractic, doctors of osteopathy, medical doctors and physician
assistants) and one or more national private-sector testing
organizations that deliver the certification test. We are unable to
estimate the number of private-sector organizations that might wish to
perform testing.
Frequency: FMCSA estimates each of the respondents would provide
medical examiner test application data every 6 years and updated
information as needed, and would provide CMV driver examination data a
maximum of 12 times per year. It is estimated that an average of
approximately 13,333 medical examiners will apply to take the
certification test annually for the first 3 years of NRCME
implementation. It is estimated that one or more testing organizations
will deliver the FMCSA medical examiner certification test to 13,333
medical examiners annually for the first 3 years following
implementation of the NRCME program. It is projected that medical
examiners would file 4,600,000 medical examiner's certificates per year
and that authorized representatives of FMCSA or authorized State or
local enforcement agency representatives would request medical
examiners to provide copies of the Medical Report Form and the medical
examiner's certificate 2,100 times a year.
Annual Burden Estimate: This proposal would result in an annual
recordkeeping and reporting burden as follows:
FMCSA estimates that the total annual burden hours for the
collection of the medical examiner test application data is 1,111 hours
[13,333 applicants x 5 minutes/60 minutes per response = 1,111 hours].
This annual burden includes medical examiner time for submitting the
application data to the private-sector testing organizations.
It is estimated that it will take private-sector testing
organization personnel 5 minutes per medical examiner to collect and
upload to FMCSA application data and test results. FMCSA estimates that
the total annual burden hours for private-sector testing organizations
to collect medical examiner application data and send medical examiner
application and test results data to FMCSA is 1,111 hours [13,333
applicants x 5 minutes/60 minutes per medical examiner = 1,111 hours].
The transmission of CMV driver examination data would require
approximately 46,000 hours of medical examiner administrative personnel
time on a yearly basis, consisting of 8,000 hours for report filing
(40,000 registered medical examiners x 1 minute/60 minutes to file a
report x 12 reports per year = 8,000 hours) and 38,000 hours for data
entry (4,600,000 reports x 30 seconds/3600 seconds to enter each
driver's examination data elements = approximately 38,000 hours). Total
hours for report filing and data entry is 8,000 hours + 38,000 hours =
46,000 hours]. It is estimated that it would take medical examiner
administrative personnel 30 seconds to file the medical examiner's
certificate. This would require approximately 38,000 hours of medical
examiner administrative personnel time on a yearly basis [4,600,000
examinations x 30 seconds/3600 seconds per certificate = 38,000 hours].
It is estimated that it will take medical examiner administrative
personnel 5 minutes to provide both the Medical Examination Report and
the medical examiner's certificate to FMCSA or an
[[Page 73142]]
authorized State or local enforcement agency representative upon
request, so this would require approximately 175 hours of
administrative personnel time on a yearly basis [2,100 requests x 5
minutes/60 minutes per response = 175 hours].
The total estimated annual recordkeeping and time burden for these
medical requirement components is approximately 86,397 hours.
The agency is soliciting comments to--
(1) Evaluate whether the proposed information requirement is
necessary for the proper performance of the functions of the Agency,
including whether the information would have practical utility;
(2) Evaluate the accuracy of the Agency's estimate of the burden;
(3) Enhance the quality, utility, and clarity of the information to
be collected; and
(4) Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology.
Individuals and organizations may submit comments on the
information collection requirement by January 30, 2009, and should
direct them to the address listed in the ADDRESSES section of this
document. Comments also should be submitted to the Office of
Information and Regulatory Affairs, Office of Management and Budget,
New Executive Building, Room 10202, 725 17th Street, NW., Washington,
DC 20053, Attention: Desk Officer for the Department of Transportation.
According to the 1995 amendments to the Paperwork Reduction Act
(implemented by 5 CFR 1320.8(b)(2)(vi)), an agency may not collect or
sponsor the collection of information, nor may it impose an information
collection requirement unless it displays a currently valid OMB control
number. The OMB control number for this information collection would be
published in the Federal Register, after the Office of Management and
Budget approves it.
National Environmental Policy Act
The Agency analyzed this proposed rule for the purpose of the
National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321 et
seq.) and determined under our environmental procedures Order 5610.1,
issued March 1, 2004 (69 FR 9680), that this action requires an
Environmental Assessment (EA) to determine if a more extensive
Environmental Impact Statement (EIS) will be required. The FMCSA
prepared an EA and placed it in the docket for this rulemaking. The EA
found that there are no significant negative impacts expected from the
result of the proposed actions. Although minor congestion and air
emission impacts are discussed in the EA, the impacts are minimal and
are not expected to alter the Nation's highway congestion or air
emissions from roadway or air transportation vehicles. In addition,
while not quantified in this analysis, minor benefits to the
environment from reducing CMV crashes are expected.
We have also analyzed this rule under the Clean Air Act, as amended
(CAA), section 176(c) (42 U.S.C. 7401 et seq.), and implementing
regulations promulgated by the Environmental Protection Agency.
Approval of this action is exempt from the CAA's General conformity
requirement since it involves rulemaking and policy development and
issuance.
Executive Order 13211 (Energy Effects)
We have analyzed this proposed action under Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution or Use. We have determined preliminarily that it would not
be a ``significant energy action'' under that Executive Order because
it would not likely have a significant adverse effect on the supply,
distribution, or use of energy.
List of Subjects
49 CFR Part 390
Highway safety, Intermodal transportation, Motor carriers, Motor
vehicle safety, Reporting and recordkeeping requirements.
49 CFR Part 391
Alcohol abuse, Drug abuse, Drug testing, Highway safety, Motor
carriers, Reporting and recordkeeping requirements, Safety,
Transportation.
In consideration of the foregoing, FMCSA proposes to amend title
49, Code of Federal Regulations, parts 390 and 391, as follows:
PART 390--FEDERAL MOTOR CARRIER SAFETY REGULATIONS; GENERAL
1. The authority citation for part 390 is revised to read as
follows:
Authority: 49 U.S.C. 508, 13301, 13902, 31132, 31133, 31136,
31149, 31502, 31504, and sec. 204, Pub. L. 104-88, 109 Stat. 803,
941 (49 U.S.C. 701 note); sec. 114, Pub. L. 103-311, 108 Stat. 1673,
1677; sec. 217, Pub. L. 106-159, 113 Stat. 1748, 1767; and 49 CFR
1.73.
2. Amend Sec. 390.5 by revising the definition of ``medical
examiner'' to read as follows:
Sec. 390.5 Definitions.
* * * * *
Medical examiner means the following:
(1) Except as provided in paragraph (2) of this definition, for
medical examinations conducted before [Date 3 years after the effective
date of the final rule], a person who is licensed, certified, and/or
registered, in accordance with applicable State laws and regulations,
to perform physical examinations. The term includes but is not limited
to, doctors of medicine, doctors of osteopathy, physician assistants,
advanced practice nurses, and doctors of chiropractic.
(2) For medical examinations conducted on and after [Date 2 years
after the effective date of the final rule] and for medical examination
of persons employed by motor carriers who employ 50 or more CMV
drivers, an individual certified by FMCSA and listed on the National
Registry of Certified Medical Examiners in accordance with subpart D of
this part.
(3) For medical examinations conducted on and after [Date 3 years
after the effective date of the final rule], an individual certified by
FMCSA and listed on the National Registry of Certified Medical
Examiners in accordance with subpart D of this part.
* * * * *
3. Add subpart D, consisting of Sec. Sec. 390.101 through 390.115,
to read as follows:
Subpart D--National Registry of Certified Medical Examiners
390.101 Scope.
390.103 Eligibility requirements for medical examiner certification.
390.105 Medical examiner training programs.
390.107 Medical examiner certification testing.
390.109 Issuance of the FMCSA medical examiner certification
credential.
390.111 Requirements for continued listing on the National Registry
of Certified Medical Examiners.
390.113 Reasons for removal from the National Registry of Certified
Medical Examiners.
390.115 Procedure for removal from the National Registry of
Certified Medical Examiners.
Subpart D--National Registry of Certified Medical Examiners
Sec. 390.101 Scope.
The rules in this subpart establish the minimum qualifications for
FMCSA certification of a medical examiner and
[[Page 73143]]
for listing the examiner on the FMCSA's National Registry of Certified
Medical Examiners. The National Registry of Certified Medical Examiners
program is designed to improve highway safety and driver health by
requiring that medical examiners be trained and certified to determine
effectively whether an interstate CMV driver meets FMCSA physical
qualification standards under part 391 of this chapter. One component
of the National Registry of Certified Medical Examiners program is the
registry itself, which is a national database of names and contact
information for medical examiners who are authorized by FMCSA to
perform CMV driver medical examinations.
Sec. 390.103 Eligibility requirements for medical examiner
certification.
(a) To receive medical examiner certification from FMCSA a person
must--
(1) Be licensed, certified, or registered in accordance with
applicable State laws and regulations to perform physical examinations.
The applicant may be an advanced practice nurse, doctor of
chiropractic, doctor of medicine, doctor of osteopathy, physician
assistant, or other medical professional authorized by applicable State
laws and regulations to perform physical examinations.
(2) Have completed a training program that meets the requirements
of Sec. 390.105.
(3) Have passed the FMCSA medical examiner certification test
administered by a testing organization that meets the requirements of
Sec. 390.107 and that has electronically forwarded to FMCSA the
applicant's completed test and application information contained in
appendix A of this part.
(b) To renew medical examiner certification a medical examiner must
remain qualified under paragraph (a)(1) of this section and complete
additional testing and training as required by Sec. 390.111(a)(5).
Sec. 390.105 Medical examiner training programs.
An applicant for medical examiner certification must complete a
training program that:
(a) Is conducted by a training provider that:
(1) Is accredited by a nationally-recognized medical profession
accrediting organization to provide continuing education units; and
(2) Meets the following administrative requirements:
(i) Provides training participants with proof of participation.
(ii) Provides FMCSA point of contact information to training
participants.
(iii) Complies with section 508 of the Rehabilitation Act (29
U.S.C. 794d).
(b) Meets the core curriculum specifications established by FMCSA
for medical examiner training. The curriculum must, at a minimum,
include the following topics:
(1) Background, rationale, mission, and goals of the FMCSA medical
examiner's role in reducing crashes, injuries, and fatalities involving
commercial motor vehicles.
(2) Familiarization with the responsibilities and work environment
of commercial motor vehicle operation.
(3) Identification of the driver and obtaining, reviewing, and
documenting driver medical history, including prescription and over-
the-counter medications.
(4) Performing, reviewing, and documenting the driver's medical
examination.
(5) Performing, obtaining, and documenting additional diagnostic
tests or medical opinion from a medical specialist or treating
physician.
(6) Informing and educating the driver about medications and non-
disqualifying medical conditions that require remedial care.
(7) Determining driver certification outcome and period for which
certification should be valid.
(8) FMCSA reporting and documentation requirements.
Sec. 390.107 Medical examiner certification testing.
An applicant for medical examiner certification or recertification
must apply, in accordance with the minimum specifications identified in
the list of application data elements in appendix A of this part, to a
testing organization that meets the following criteria:
(a) The testing organization has documented policies and procedures
to:
(1) Use secure protocols to access, process, store, and transmit
all test items, test forms, test data, and candidate information and
ensure access by authorized personnel only.
(2) Ensure testing environments are reasonably comfortable and have
minimal distractions.
(3) Prevent to the greatest extent practicable the opportunity for
a test taker to attain a passing score by fraudulent means.
(4) Ensure that test center staff who interact with and proctor
examinees or provide technical support have completed formal training,
demonstrate competency, and are monitored periodically for quality
assurance in testing procedures.
(5) Accommodate testing of individuals with disabilities or
impairments to minimize the effect of the disabilities or impairments
while maintaining the security of the test and data.
(b) The testing organization has submitted its documented policies
and procedures as defined in paragraph (a) of this section to FMCSA;
and agreed to future reviews by FMCSA to ensure compliance with the
criteria listed in this section.
Sec. 390.109 Issuance of the FMCSA medical examiner certification
credential.
Upon compliance with the requirements of Sec. Sec. 390.103-
390.107, FMCSA will issue to a medical examiner an FMCSA medical
examiner certification credential with a unique National Registry
Number and will add the medical examiner's name to the National
Registry of Certified Medical Examiners. The certification and the
listing on the National Registry of Certified Medical Examiners will
expire 6 years after the date of issuance of the certification
credential.
Sec. 390.111 Requirements for continued listing on the National
Registry of Certified Medical Examiners.
(a) To continue to be listed on the National Registry of Certified
Medical Examiners, each medical examiner must:
(1) Continue to meet the requirements of this subpart and the
applicable requirements of part 391 of this chapter.
(2) Report to FMCSA any changes in the information submitted under
Sec. 390.107 within 30 days of the change.
(3) Continue to be licensed, certified, or registered, and
authorized to perform physical examinations, in accordance with the
applicable laws and regulations of each State in which the medical
examiner performs examinations.
(4) Maintain documentation of State licensing, registration, or
certification to perform physical examinations for each State in which
the examiner performs examinations and completion of all training
required by this section and Sec. 390.105, and make this documentation
available to an authorized representative of the FMCSA or an authorized
representative of Federal, State or local government. The medical
examiner must provide this documentation within 48 hours of the request
for investigations and within 10 days of request for regular audits of
eligibility.
(5) Maintain medical examiner certification by completing training
and testing according to the following schedule:
(i) No sooner than 2 years and no later than 3 years after the date
of issuance of the medical examiner certification
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credential, complete periodic training as specified by FMCSA.
(ii) No sooner than 5 years and no later than 6 years after the
date of issuance of the medical examiner certification credential:
(A) Complete periodic training as specified by FMCSA, except, in
alternating 6 year periods, complete the training required by Sec.
390.103(a)(2); and
(B) Pass the test required by Sec. 390.103(a)(3).
(b) FMCSA will issue a new medical examiner certification
credential to a medical examiner who complies with paragraphs (a)(1)
through (4) of this section and who successfully completes the training
and testing as required by paragraphs (a)(5)(i) and (ii) of this
section.
Sec. 390.113 Reasons for removal from the National Registry of
Certified Medical Examiners.
The FMCSA may remove a medical examiner from the National Registry
of Certified Medical Examiners. The reasons for removal may include,
but are not limited to:
(a) The medical examiner fails to comply with the requirements for
continued listing on the National Registry of Certified Medical
Examiners, as described in Sec. 390.111.
(b) The FMCSA finds the medical examiner has made errors or
omissions, or finds other indications of improper certification in
completed Medical Examination Reports or medical examiner's
certificates.
(c) The FMCSA determines the medical examiner issued a medical
examiner's certificate to an operator of a commercial motor vehicle who
failed to meet the applicable standards at the time of the examination.
(d) The medical examiner fails to comply with the examination
requirements in Sec. 391.43 of this chapter.
(e) The medical examiner falsely claims to have completed training
in physical and medical examination standards as required by this
subpart.
Sec. 390.115 Procedure for removal from the National Registry of
Certified Medical Examiners.
(a) Voluntary removal. To be voluntarily removed from the National
Registry of Certified Medical Examiners, a medical examiner must submit
a request to the FMCSA Director of Medical Programs. Except as provided
in paragraph (b) of this section, the Director will accept the request
and the removal will become effective immediately. However, on and
after the date of issuance of a notice of proposed removal from the
National Registry, as described in paragraph (b) of this section, the
Director will not approve the medical examiner's request for voluntary
removal from the National Registry.
(b) Notice of proposed removal. Except as provided by paragraphs
(a) and (e) of this section, FMCSA initiates the process for removal of
a medical examiner from the National Registry of Certified Medical
Examiners by issuing a written notice of proposed removal to the
medical examiner, stating the reasons that removal is proposed under
Sec. 390.113 and any corrective actions necessary for the medical
examiner to remain listed on the National Registry.
(c) Response to notice of proposed removal and corrective action. A
medical examiner who has received a notice of proposed removal from the
National Registry of Certified Medical Examiners must submit any
written response to the Director of Medical Programs, no later than 30
days after the date of issuance of the notice of proposed removal. The
response must indicate either that the medical examiner believes FMCSA
has relied on erroneous reasons, in whole or in part, in proposing
removal from the National Registry, as described in paragraph (c)(1) of
this section, or that the medical examiner will comply and take any
corrective action specified in the notice of proposed removal, as
described in paragraph (c)(2) of this section.
(1) Opposing a notice of proposed removal. If the medical examiner
believes FMCSA to have relied on an erroneous reason, in whole or in
part, in proposing removal from the National Registry of Certified
Medical Examiners, the medical examiner must explain why an erroneous
reason has been relied on in proposing the removal. The Director will
review the explanation.
(i) If the Director finds FMCSA has relied on a wholly erroneous
reason for proposing removal from the National Registry, the Director
will withdraw the notice of proposed removal and notify the medical
examiner in writing of the determination. If the Director finds FMCSA
has relied on a partly erroneous reason for proposing removal from the
National Registry, the Director will modify the notice of proposed
removal and notify the medical examiner in writing of the
determination. No later than 60 days after the date the Director
modifies a notice of proposed removal, the medical examiner must comply
with this subpart and correct the deficiencies identified in the
modified notice of proposed removal as described in paragraph (c)(2) of
this section.
(ii) If the Director finds FMCSA has not relied on an erroneous
reason in proposing removal, the Director will affirm the notice of
proposed removal and notify the medical examiner in writing of the
determination. No later than 60 days after the date the Director
affirms the notice of proposed removal, the medical examiner must
comply with this subpart and correct the deficiencies identified in the
notice of proposed removal as described in paragraph (c)(2) of this
section.
(iii) If the medical examiner does not submit a written response
within 30 days of the date of issuance of a notice of proposed removal,
the removal becomes effective and the medical examiner is immediately
removed from the National Registry of Certified Medical Examiners.
(2) Compliance and corrective action. (i) The medical examiner must
comply with this subpart and complete the corrective actions specified
in the notice of proposed removal no later than 60 days after either
the date of issuance of the notice of proposed removal or the date the
Director of Medical Programs affirms or modifies the notice of proposed
removal, whichever is later. The medical examiner must provide
documentation of compliance and completion of the corrective actions to
the Director. The Director may conduct any investigations and request
any documentation necessary to verify that the medical examiner has
complied with this subpart and completed the required corrective
action(s). The Director will notify the medical examiner in writing
whether he or she has met the requirements to continue to be listed on
the National Registry.
(ii) If the medical examiner fails to complete the proposed
corrective action(s) within the 60-day period, the removal becomes
effective and the medical examiner is immediately removed from the
National Registry. The Director will notify the medical examiner in
writing that he or she has been removed from the National Registry.
(3) At any time before a notice of proposed removal from the
National Registry becomes final, the recipient of the notice of
proposed removal and the Director may resolve the matter by mutual
agreement.
(d) Request for administrative review. If a person has been removed
from the National Registry of Certified Medical Examiners under
paragraph (c)(1)(iii), (c)(2)(ii), or (e) of this section, that person
may request an administrative review no later than 30 days after the
date the removal becomes effective. The request must be submitted in
writing to the FMCSA Associate Administrator for Policy and Program
Development. The
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request must explain the error(s) committed in removing the medical
examiner from the National Registry of Certified Medical Examiners, and
include a list of all factual, legal, and procedural issues in dispute,
and any supporting information or documents.
(1) Additional procedures for administrative review. The Associate
Administrator may ask the person to submit additional data or attend a
conference to discuss the removal. If the person does not provide the
information requested, or does not attend the scheduled conference, the
Associate Administrator may dismiss the request for administrative
review.
(2) Decision on administrative review. The Associate Administrator
will complete the administrative review and notify the person in
writing of the decision. The decision constitutes final Agency action.
(e) Emergency removal. In cases of either willfulness or in which
public health, interest, or safety requires, the provisions of
paragraph (b) of this section are not applicable and the Director of
Medical Programs may immediately remove a medical examiner from the
National Registry and invalidate the certification credential issued
under Sec. 390.109. A person who has been removed under the provisions
of this paragraph may request an administrative review of that decision
as described under paragraph (d) of this section.
(f) Reinstatement on the National Registry of Certified Medical
Examiners. No sooner than 30 days after the date of removal from the
National Registry of Certified Medical Examiners, a person who has been
removed may apply to the Director of Medical Programs to be reinstated.
The person must provide documentation showing compliance with all the
requirements of Sec. 390.103(a) and completion of any additional
corrective actions required in the notice of proposed removal. A person
who has been voluntarily removed may be reinstated by the Director of
Medical Programs after providing documentation showing proof of
compliance with the requirements of Sec. 390.111.
(g) Effect of final decision by FMCSA. If a person is removed from
the National Registry of Certified Medical Examiners under paragraph
(c) or (e), or a removal is affirmed under paragraph (d), of this
section, the person's listing is removed and the certification
credential issued under Sec. 390.109 is no longer valid. However, the
removed person's information remains publicly available for 3 years,
with an indication that the person is no longer listed on the National
Registry of Certified Medical Examiners as of the date of removal.
4. Add appendix A, Medical Examiner Application Data Elements, to
part 390 to read as follows:
Appendix A of Part 390--Medical Examiner Application Data Elements
The following minimum data elements must be included in the
application for medical examiner certification as specified by Sec.
390.107:
1. Date of application.
2. Full Name.
3. Medical profession (Advanced Practice Nurse (APN), Doctor of
Chiropractic (DC), Doctor of Osteopathy (DO), Medical Doctor (MD),
Physician Assistant (PA), etc.).
4. Job title, if applicable (e.g., Director of * * *, etc.).
5. Current employer.
6. Employer mailing address.
7. Employer phone number.
8. Employer fax number.
9. Employer e-mail.
10. Business address (street, city, state, and zip code, if
different from employer mailing address; P.O. Box is not
sufficient).
11. Business phone number(s).
12. Business fax number(s).
13. Business e-mail.
14. Medical license, certificate, or registration number(s) and
State(s) where issued.
15. Expiration date of State license(s), registration(s), or
certification(s).
16. Statement self-certifying completion of training required by
Sec. 390.103(a) or (b).
17. Date training completed.
18. Training provider and address.
19. Group that accredited the training.
20. Type of certification: Initial--Recertification--
Reinstatement.
21. Statement of capability and willingness to comply with FMCSA
requirement to electronically transmit to FMCSA once every calendar
month the following information about each person examined under
part 391, subpart E, of this chapter:
Name.
FMCSA numerical identifier.
Date of examination.
An indication of whether the person was found to be
medically qualified, medically unqualified, or temporarily
disqualified.
Date of expiration of medical examiner's certificate,
if applicable.
22. Statement agreeing to provide copies of certification of
completion of training, and State license(s), certificate(s), or
registration(s) to perform physical examinations to an authorized
representative of FMCSA or to an authorized State or local
enforcement agency representative upon request.
23. Statement affirming all information provided is true.
PART 391--QUALIFICATIONS OF DRIVERS AND LONGER COMBINATION VEHICLE
(LCV) DRIVER INSTRUCTORS
5. Revise the authority citation for part 391 to read as follows:
Authority: 49 U.S.C. 322, 504, 508, 31133, 31136, 31149, and
31502; Sec. 4007(b) of Pub. L. 102-240 (105 Stat. 2152); Sec. 114,
Pub. L. 103-311 (108 Stat. 1673, 1677); and 49 CFR 1.73.
6. Add Sec. 391.42 to read as follows:
Sec. 391.42 Schedule for use of medical examiners listed on the
National Registry of Certified Medical Examiners.
(a) On and after [Date 2 years after the effective date of the
final rule] each medical examination required under this subpart for
persons who are employed by motor carriers that employ 50 or more
drivers of CMVs, as defined in Sec. 390.5 of this chapter, must be
conducted by a medical examiner who is listed on the National Registry
of Certified Medical Examiners.
(b) On and after [Date 3 years after the effective date of the
final rule] each medical examination required under this subpart must
be conducted by a medical examiner who is listed on the National
Registry of Certified Medical Examiners.
7. Amend Sec. 391.43 by revising paragraph (a), paragraph (g), and
the introductory text and the form in paragraph (h), and adding
paragraph (i) to read as follows:
Sec. 391.43 Medical examination; certificate of physical examination.
(a) Except as provided by paragraph (b) of this section and by
Sec. 391.42, the medical examination must be performed by a medical
examiner listed on the National Registry of Certified Medical Examiners
under subpart D of part 390 of this chapter.
* * * * *
(g) Upon completion of the medical examination required by this
subpart:
(1) The medical examiner must date and sign the Medical Examination
Report and provide his or her full name, office address, and telephone
number on the Report.
(2) If the medical examiner finds that the person is physically
qualified to drive a commercial motor vehicle in accordance with Sec.
391.41(b), he or she must complete a certificate in the form prescribed
in paragraph (h) of this section and furnish one copy to the person who
was examined and one copy to the motor carrier that employs the person
examined.
(3) Once every calendar month, the medical examiner must
electronically transmit to the FMCSA Medical Program the following
information for each Medical Examination Report completed during the
previous month, for any driver who is required to be examined by a
medical examiner listed on the National Registry of Certified Medical
Examiners:
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(i) Driver's name.
(ii) Driver's FMCSA numerical identifier.
(iii) Date of the examination.
(iv) Whether the person was found to be medically qualified,
medically unqualified, or temporarily disqualified.
(v) Date of expiration of medical examiner's certificate, if
applicable.
(h) The medical examiner's certificate shall be substantially in
accordance with the following form. Existing forms may be used until
current printed supplies are depleted or until [Date 4 years after the
effective date of the final rule], whichever occurs first.
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(i) Each original (paper or electronic) completed Medical
Examination Report and a copy or electronic version of each medical
examiner's certificate must be retained on file at the office of the
medical examiner for 3 years from the date of examination. The medical
examiner must make all records and information in these files available
to an authorized representative of the FMCSA or an authorized State or
local enforcement agency representative, within 48 hours after the
request is made.
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Issued on: November 20, 2008.
John H. Hill,
Administrator.
[FR Doc. E8-28172 Filed 11-28-08; 8:45 am]
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