[Federal Register Volume 77, Number 77 (Friday, April 20, 2012)]
[Rules and Regulations]
[Pages 24104-24135]
[FR Doc No: 2012-9034]

Vol. 77

Friday,

No. 77

April 20, 2012

Part IV

 Department of Transportation

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 Federal Motor Carrier Safety Administration

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49 CFR Parts 350, 383, 390, et al.

National Registry of Certified Medical Examiners; Final Rule

Federal Register / Vol. 77 , No. 77 / Friday, April 20, 2012 / Rules
and Regulations

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

49 CFR Parts 350, 383, 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: Final rule.

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SUMMARY: FMCSA establishes a National Registry of Certified Medical
Examiners (National Registry) with requirements that all medical
examiners who conduct physical examinations for interstate commercial
motor vehicle (CMV) drivers meet the following criteria: Complete
certain training concerning FMCSA's physical qualification standards,
pass a test to verify an understanding of those standards, and maintain
and demonstrate competence through periodic training and testing.
Following establishment of the National Registry and a transition
period, FMCSA will require that motor carriers and drivers use only
those medical examiners on the Agency's National Registry and will only
accept as valid medical examiner's certificates issued by medical
examiners listed on the National Registry. FMCSA is developing the
National Registry program to improve highway safety and driver health
by requiring that medical examiners be trained and certified so they
can determine effectively whether a CMV driver's medical fitness for
duty meets FMCSA's standards.

DATES: Effective on May 21, 2012. Compliance required beginning on May
21, 2014.

FOR FURTHER INFORMATION CONTACT: Elaine Papp, Office of Carrier, Driver
and Vehicle Safety Standards (MC-PSP), Federal Motor Carrier Safety
Administration, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
Telephone<PHONE_NUMBER>. Email<EMAIL_ADDRESS>
ADDRESSES: Availability of Rulemaking Documents: For access to docket
FMCSA-2008-0363 to read background documents and comments received, go
to http://www.regulations.gov at any time, or to U.S. Department of
Transportation, Room W12-140, 1200 New Jersey Avenue SE., Washington,
DC 20590, between 9 a.m. and 5 p.m. e.t., Monday through Friday, except
Federal holidays.
    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, published in the Federal Register on
April 11, 2000 (65 FR 19476), or you may visit http://DocketInfo.dot.gov.

SUPPLEMENTARY INFORMATION: This document is organized as follows:

I. Table of Acronyms and Abbreviations
II. Legal Basis for the Rulemaking
III. Background
IV. Discussion of Comments Received on the Proposed Rule
V. Section-by-Section Explanation of Changes from the NPRM
VI. Regulatory Analyses and Notices

                                       Table of Acronyms and Abbreviations
----------------------------------------------------------------------------------------------------------------
                      Acronym or  abbreviation                                           Term
----------------------------------------------------------------------------------------------------------------
AANP...............................................................  American Academy of Nurse Practitioners
AAOHN..............................................................  American Association of Occupational Health
                                                                      Nurses
AAPA...............................................................  American Academy of Physician Assistants
ABA................................................................  American Bus Association
ACOEM..............................................................  American College of Occupational and
                                                                      Environmental Medicine
ADA................................................................  American Diabetes Association
Advocates..........................................................  Advocates for Highway and Auto Safety
AME................................................................  Aviation Medical Examiner
APN................................................................  Advanced Practice Nurse
ATA................................................................  American Trucking Associations, Inc.
BISC...............................................................  Bus Industry Safety Council
CAA................................................................  Clean Air Act
CDL................................................................  Commercial Driver's License
CDLIS..............................................................  Commercial Driver's License Information
                                                                      System
CME................................................................  Continuing Medical Education
CMV................................................................  Commercial Motor Vehicle
DC.................................................................  Doctor of Chiropractic
DEP................................................................  Diabetes Expert Panel
DO.................................................................  Doctor of Osteopathy
DOT................................................................  U.S. Department of Transportation
EA.................................................................  Environmental Assessment
FHWA...............................................................  Federal Highway Administration
FMCSA..............................................................  Federal Motor Carrier Safety Administration
FMCSRs.............................................................  Federal Motor Carrier Safety Regulations
HIPAA..............................................................  Health Insurance Portability and
                                                                      Accountability Act
ISAREC.............................................................  Indiana Statewide Association of Rural
                                                                      Electric Cooperatives
LTCCS..............................................................  Large Truck Crash Causation Study
LFC................................................................  Licencia Federal de Conductor
MCMIS..............................................................  Motor Carrier Management Information System
MCSAP..............................................................  Motor Carrier Safety Assistance Program
MD.................................................................  Doctor of Medicine
ME.................................................................  Medical Examiner
MEP................................................................  Medical Expert Panel
Med. Cert./CDL.....................................................  Medical Certification Requirements as Part
                                                                      of the CDL
MOU................................................................  Memorandum of Understanding
MRB................................................................  (FMCSA's) Medical Review Board
MRO................................................................  Medical Review Officer

NADME..............................................................  National Academy of DOT Medical Examiners
NAFTA..............................................................  North American Free Trade Agreement
NCCA...............................................................  National Commission of Certifying Agencies
NPRM...............................................................  Notice of Proposed Rulemaking
National Registry..................................................  National Registry of Certified Medical
                                                                      Examiners
NSTA...............................................................  National School Transportation Association
NTSB...............................................................  National Transportation Safety Board
OOIDA..............................................................  Owner-Operator Independent Drivers
                                                                      Association
PA.................................................................  Physician Assistant
PHI................................................................  Protected Health Information
PIA................................................................  Privacy Impact Assessment
PII................................................................  Personally Identifiable Information
PRA................................................................  Paperwork Reduction Act
RDS................................................................  Role Delineation Study
RIA................................................................  Regulatory Impact Analysis
SAFETEA-LU.........................................................  Safe, Accountable, Flexible, Efficient
                                                                      Transportation Equity Act: A Legacy for
                                                                      Users
SBA................................................................  Small Business Administration
SDLAs..............................................................  State Driver Licensing Agencies
Wynne..............................................................  Wynne Transport Services, Inc.
----------------------------------------------------------------------------------------------------------------

I. Summary of the Final Rule

    This rule establishes a training, testing, and registration program
to certify medical professionals as qualified to conduct medical
certification examinations of commercial drivers. Current regulations
require all interstate commercial drivers (with certain limited
exceptions) to be medically examined by a licensed health care provider
to determine whether these drivers meet the FMCSA physical
qualification requirements. All drivers must carry a medical examiner's
certificate as proof that they have passed this physical qualification
examination. The MEs who conduct said physical examinations must retain
copies of the Medical Examination Reports of all drivers they examine
and certify. The Medical Examination Report lists the specific results
of the various medical tests used to determine whether a driver meets
the physical qualification standards set forth in subpart E of part 391
of the FMCSRs.
    Before the adoption of this rule, there was no required training
program for the medical professionals who conduct driver physical
examinations, although the FMCSRs required MEs to be knowledgeable
about the regulations (49 CFR 391.43(c)(1)). The former rules required
that any medical professional licensed by his or her State to conduct
physical examinations could conduct driver medical certification exams.
No specific knowledge of the Agency's physical qualification standards
was required or verified by testing. As a result, some of the medical
professionals who conduct these examinations may be unfamiliar with
FMCSA physical qualification standards and how to apply them. These
professionals may also be unaware of the mental and physical rigors
that accompany the occupation of CMV driver, and how various medical
conditions (and the therapies used to treat them) can affect the
ability of drivers to safely operate CMVs.
    This rule establishes the National Registry to ensure that all MEs
who conduct driver medical certifications have been trained in FMCSA
physical qualifications standards and guidelines. In order to be listed
on the National Registry, MEs are required to attend an accredited
training program and pass a certification test to assess their
knowledge of the Agency's physical qualifications standards and
guidelines and how to apply them to drivers. Upon passing this
certification test, and meeting the other administrative requirements
associated with the Program, MEs will be listed on the National
Registry. Once this rule is fully implemented, only medical
certificates issued to drivers by MEs on the National Registry will be
considered valid by the Agency as proof of medical certification.

II. Legal Basis for the Rulemaking

    The primary legal basis for the National Registry of Certified
Medical Examiners program comes from 49 U.S.C. 31149, enacted by
section 4116(a) of Safe, Accountable, Flexible, Efficient
Transportation Equity Act: A Legacy for Users, Public Law 109-59, 119
Stat. 1726 (Aug. 10, 2005) (SAFETEA-LU). Subsection (d) of section
31149 provides that:
    The Secretary, acting through the Federal Motor Carrier Safety
Administration--
     Shall establish and maintain a current national registry
of medical examiners who are qualified to perform examinations and
issue medical certificates;
     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;
     Shall accept as valid only medical certificates issued by
persons on the national registry of medical examiners; and
     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 implements through this rulemaking
certain other provisions from section 31149 related to a national
registry. First, subsection (c) requires FMCSA, with the advice of the
Agency's 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 will
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 (c)(1)(D)). Second, FMCSA also implements requirements for medical
examiners to

transmit electronically, on a monthly basis, certain information about
completed Medical Examination Reports of CMV drivers (section
31149(c)(1)(E)). Third, the rule requires medical examiners to provide
copies of Medical Examination Reports and medical examiner's
certificates to FMCSA within 48 hours of a request from enforcement
personnel. This level of responsiveness is required 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 rule
establishes 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 requires 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 the general rulemaking authority in 49 U.S.C.
31136(a), the Secretary of Transportation 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
National Registry program has been delegated to the Administrator of
FMCSA (49 CFR 1.73(g)).

III. Background

    On December 1, 2008, FMCSA published a notice of proposed
rulemaking (NPRM) to establish the National Registry (73 FR 73129). The
public comment period for the NPRM closed on January 30, 2009. The
FMCSA also proposed to require that all medical examiners who conduct
physical examinations for interstate CMV drivers complete certain
training concerning FMCSA physical qualification standards, pass a test
to verify an understanding of those standards, and maintain and
demonstrate competence through periodic training and testing. Following
establishment of the National Registry and a transition period, only
medical examiner's certificates issued by medical examiners listed on
the National Registry would be accepted as valid.

IV. Discussion of Comments Received on the Proposed Rule

A. Overview of Comments

    In response to the December 2008 NPRM, FMCSA received approximately
80 comments. Most of the commenters were individuals, many of whom
identified themselves as health care professionals. Among other
commenters were the following: nine health care provider professional
associations, among them the American College of Occupational and
Environmental Medicine (ACOEM) and the American Chiropractic
Association; the American Diabetes Association; five trucking and other
trade associations, including the American Trucking Associations, Inc.
(ATA), Owner-Operator Independent Drivers Association (OOIDA), and
jointly from American Bus Association (ABA) and Bus Industry Safety
Council (BISC); six motor carriers; six other private businesses,
including driver training and testing organizations; nine State
agencies (from Arizona, California, Delaware, Florida, Illinois,
Indiana, Iowa, Missouri, and Virginia); Advocates for Highway and Auto
Safety (Advocates); and the National Transportation Safety Board
(NTSB). Comments were also received from FMCSA's Medical Review Board
(MRB), an advisory group of physicians appointed by FMCSA to make
evidence-based recommendations for the development of physical
qualification standards for drivers, driver examination requirements,
and materials for training Medical Examiners (MEs). The MRB is convened
by FMCSA to provide information, advice, and recommendations to the
Secretary of Transportation and the FMCSA Administrator on the
development and implementation of science-based physical qualification
standards applicable to interstate CMV drivers. The MRB does not hold
regulatory development responsibilities, manage programs, or make
decisions affecting such programs.
    Fourteen commenters expressed support for the proposed rule.
However, nearly all of those supporting the proposed rule added
recommendations or voiced concern about various parts of the proposed
requirements, including increased costs and training requirements for
MEs, the implementation period, and the lack of a developed training
curriculum. Seven commenters explicitly opposed the proposed rule.
Other commenters expressed serious concerns over specific requirements
that they believed would cause the proposed rule to fail, including
increased costs, lack of access to MEs, and driver privacy rights if
State Driver Licensing Agencies (SDLAs) are permitted to obtain the
commercial driver's Medical Examination Reports. The following sections
provide details regarding specific issues raised by the commenters.

B. Scope of National Registry Program

1. Eligibility To Be a Medical Examiner
    Who should be eligible? Under 49 CFR 390.103, FMCSA proposed a
requirement, based on the existing regulation at 49 CFR 390.5, that
medical examiners must be licensed, certified, or registered in
accordance with applicable State laws and regulations to perform
physical examinations. The list of major health care professionals who
may apply for ME certification included: Advanced Practice Nurses
(APNs), Doctors of Chiropractic (DCs), Doctors of Medicine (MDs),
Doctors of Osteopathy (DOs), Physician Assistants (PAs), or other
health care professionals authorized by their States to perform
physical examinations. Commenters asserted that only physicians (MDs
and DOs), or only physicians, APNs, and PAs, or only health care
providers who are permitted by their States to prescribe medications,
should be eligible to be certified and be on the National Registry.
Others argued that other health care professionals who are licensed by
their States to perform physical examinations are qualified to perform
the driver examinations and should be eligible.
    Several commenters thought that the proposed requirements would
lead to a decrease in the quality of MEs. Arizona stated that with
fewer doctors serving as MEs due to the time needed for training and
testing, there would be an increase in the number of allied health and
non-physician medical professionals completing examinations. On the
other hand, Schneider National suggested that the National Registry
requirements will deter only those medical professionals who today may
be performing commercial driver medical examinations with little or no
knowledge of the driver physical requirements of FMCSA.
    FMCSA Response: The final rule makes no change in the regulatory
text. In a 1992 rule, the Federal Highway Administration (FHWA) (which
was responsible for administering Federal motor carrier safety
requirements until 1999) amended the FMCSRs to expand the definition of
``medical examiner'' to allow other health care professionals

such as PAs, APNs, and DCs, in addition to MDs and DOs authorized
previously, to perform examinations of CMV drivers (57 FR 33276; July
28, 1992). 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. The 1992 rule acknowledged that should an ME discover a medical
condition outside his or her scope of practice, best practice would be
to refer the driver to an MD, DO, or specialist. The FHWA indicated
this was consistent with what other medical practitioners do in ``this
age of specialization.'' States determine who is legally qualified to
perform physical examinations within their jurisdictions by setting
scope of practice requirements, and FMCSA will continue to rely on
State determinations.
    Qualification by Other Criteria. FMCSA proposed that medical
examiner candidates be required to complete training that meets the
core curriculum specifications established by FMCSA for medical
examiner training and pass an FMCSA-provided certification test. Both
the core curriculum specifications and the FMCSA-provided certification
test will be based on FMCSA regulations and guidelines.
    Several commenters proposed the substitution of other types of
training for the training requirements proposed in the NPRM. Two MDs,
and the States of Arizona and Delaware, suggested that Federal Aviation
Administration (FAA) aviation medical examiners (AMEs) could be
certified, without further training or testing as FMCSA MEs. One
physician recommended that we accept MD and DO board certification. The
American Association of Occupational Health Nurses (AAOHN) suggested
similarly that we should reduce required training for APNs and
physicians who are experienced and professionally trained in
occupational health.
    National Registry Training Systems, an independent entity not
affiliated with FMCSA, and a clinician suggested that we should certify
health care professionals who participated as subject matter experts in
the development of the National Registry program training and testing
components. Similarly, a MD suggested that we permit health care
professionals to by-pass training if they have a working knowledge of
the DOT requirements and guidance.
    FMCSA Response: The FMCSA acknowledges the specialized knowledge
and expertise that some health care professionals bring to the driver
qualification process. Physicians can and do serve as both MEs for CMV
drivers and designated AMEs for pilots. However, the National Registry
program has been developed with strategic differences from the FAA AME
designee program, as detailed in the regulatory evaluation for this
rulemaking, to be suitable for the oversight of large numbers of MEs
performing examinations for large numbers of drivers, using medical
standards and guidelines developed specifically for CMV drivers. The
final rule will require all ME candidates to undergo the initial
training and the certification testing that objectively measures
candidate qualification and ensures that all MEs have the same level of
working knowledge of the FMCSA regulations and guidelines. Due to the
specialized nature of CMV driving, FMCSA retains the requirement that
MEs must take training and pass its certification test to give driver
exams. Only the specified training will provide pertinent knowledge of
the FMCSA regulations and guidelines.
    Limitations on Performance of Driver Examinations. FMCSA did not
propose any change in the regulations and guidelines for performance of
the driver qualification physicals.
    The MRB's members submitted comments that reiterated the Board's
recommendation that only physicians should perform examinations on
drivers who have more severe or multiple medical conditions. ADA
commented specifically on drivers with diabetes. Claiming that not all
MEs would have the requisite clinical knowledge to complete the
examination, ADA urged FMCSA to include physicians who treat
individuals with diabetes, including endocrinologists, in the process
of certifying drivers with diabetes. The commenter said that a
physician or endocrinologist should examine drivers with that condition
before such drivers are rejected. ADA also referenced the
recommendations of FMCSA's Medical Expert Panel (MEP) on Diabetes,
Expert Panel Commentary and Recommendations, Diabetes and Commercial
Motor Vehicle Driver Safety, September 8, 2006, available at http://www.fmcsa.dot.gov/rules-regulations/topics/mep/mep-reports.htm and
recommended that no denial of certification could be made for any
reason related to diabetes without the review and approval of an
endocrinologist.
    OOIDA, the American Academy of Nurse Practitioners (AANP), and the
American Academy of Physician Assistants (AAPA) claimed that we should
reject the recommendation to only allow physicians as MEs for drivers
who have multiple active medical problems, claiming that this
requirement would require most drivers to be examined by MEs who are
physicians and would contribute to a shortage of qualified MEs. Both
OOIDA and AAPA stated that this requirement would negatively affect a
significant portion of the CMV driver population. OOIDA said that a
large percentage of drivers would have to travel greater distances for
medical exams. AAPA noted the results of a survey of 1,167 drivers
across the United States, which found 32 percent of drivers with
hypertension and 14 percent with diabetes. AAPA said that the proposed
requirement could mean a driver who discovers an additional condition
during an exam with an ME, who is not a physician, would have to stop
that examination and reschedule with a physician.
    AANP and AAPA argued that practitioners in their respective
professions are well-qualified to perform examinations on drivers with
multiple active medical problems. AANP noted that its members have been
performing driver examinations since 1992 without incident. AAPA
similarly claimed that PAs have regularly been performing examinations
on this class of drivers for 17 years and have specifically received
authorization to do so in the FMCSRs. This commenter also noted that
State laws and regulations do not preclude PAs from treating patients
with diabetes or multiple medical conditions.
    AAPA stated that SAFETEA-LU and the Agency charge the MRB with
making science and evidence-based recommendations, but the commenter
claimed that no evidence, studies, or data were presented in support of
restricting PAs from performing examinations on drivers with multiple
active medical problems. AAPA argued that it would be unfair to
eliminate PAs from performing these types of examinations since the
commenter and many individual PAs aided FMCSA's development of the
National Registry program by participating as subject matter experts in
the development of several components of the program.
    Finally, because of the potential for a conflict of interest in
completing an objective examination, comments from the MRB and
Schneider National recommended against allowing primary care or
personal health care

professionals to perform the examinations. The MRB advised FMCSA to
allow for an exception to this prohibition if no other medical provider
was located within a 200-mile radius from the driver's residence or
location of employment. In its comments, OOIDA recommended that the
final rule expressly prohibit motor carriers from restricting the
driver's rights to be examined by the ME of his or her choice, noting
that once the final rule is implemented, all MEs listed on the National
Registry will be equally qualified to perform a driver examination.
Therefore, there should be no ME quality concern on the part of the
motor carrier.
    FMCSA Response: We do not believe we should impose an additional
burden on drivers by requiring them to be examined by MEs who do not
provide primary care to them. FMCSA anticipates that requirements for
medical examiners to be trained and tested in FMCSA standards and
guidelines will result in more consistency in certification decisions
among MEs. FMCSA anticipates that MEs will be deterred from making
driver qualification decisions that violate FMCSA standards by the
provisions in the rule that would allow FMCSA to remove an ME from the
National Registry.
    In addition, we believe that employers should continue to have the
option to require their drivers to be examined by a ME selected and/or
compensated by the employer, because they have an obligation to require
drivers to comply with the regulations that apply to the driver (49
U.S.C. 31135(a) and 49 CFR 390.11). This option is permitted by 49 CFR
390.3(d), which states that nothing in the FMCSRs ``shall be construed
to prohibit an employer from requiring and enforcing more stringent
requirements relating to safety of operation and employee safety and
health.''
    Comments that recommended restricting some MEs from performing
examinations for certain drivers or to include specialists in the
driver certification decision relate to medical standards and
guidelines for determining the physical qualifications of drivers and
are therefore beyond the scope of this rulemaking. Moreover, the MRB
does not have authority to undertake regulatory development
responsibilities, manage programs, or make decisions affecting such
programs.
2. Employer and Carrier Responsibilities
    FMCSA proposed that all driver examinations would be performed by a
medical examiner on the National Registry three years after the final
rule implementation date, and all examinations for drivers who worked
for an employer who employed 50 or more drivers would be required to be
performed by a medical examiner on the National Registry two years
after the final rule implementation date. FMCSA also proposed that
medical examiners on the National Registry would be required 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.
    Daecher Consulting Group and Comcar Industries expressed concern
that motor carriers would be responsible for determining whether a
driver's physical qualification information was accurate. Asserting
that the proposed rule was an attempt to make carriers responsible for
ensuring that physical examination data are correct, Comcar Industries
said that a carrier could not provide such assurances because it is not
present for the physical examination and has no access to medical
information from any previous employer.
    Dart Transit Company suggested that the ME should be required to
notify the motor carrier if a driver fails the medical examination. ATA
recommended that motor carriers should have access to an electronic
database to obtain their drivers' Medical Examination Reports. OOIDA
opposed disclosure of sensitive medical information to motor carriers
because misconceptions or prejudices about the driver's medical
condition could lead to termination of an employee from a job, even
though the condition would not prevent the driver from doing his or her
job in a safe and professional manner.
    Daecher Consulting Group stated that there was no method proposed
in the NPRM for notifying a carrier that it employs a driver certified
by an examiner who was removed from the National Registry. The
commenter said that unless a notification system is devised and
implemented (which would require registering Commercial Driver's
License (CDL)-licensed drivers in a database, matching them with
current carriers employing them, and having a method to track any
change in carriers), significant liability may rest with carriers that
use a driver certified by a once-certified ME who has since been
involuntarily removed from the National Registry.
    FMCSA Response: Although the rule provides for FMCSA and State and
local law enforcement personnel to obtain copies of driver examination
records, the purpose of this requirement is to monitor ME performance,
not driver qualification. FMCSA is not requiring employers to monitor
ME performance. In order to clarify this matter in light of these
comments, FMCSA is making one change in employer responsibility under
this rule. FMCSA is adding a requirement that the employer verify that
the driver was issued a medical certificate by an ME on the National
Registry and place a note to that effect in the driver qualification
file required by 49 CFR 391.51. This will also be consistent and
enhance compliance with 49 U.S.C. 31149(d)(3). Beyond that, FMCSA
recognizes that employers are not required by the current FMCSA
regulations to obtain copies of Medical Examination Reports for their
drivers, and does not hold employers responsible for knowing what
medical conditions may be recorded therein.
    FMCSA has the discretion to void any medical certificate issued to
a driver by a medical examiner who has been removed from the National
Registry (49 U.S.C. 31149(c)(2)). The NPRM did not need to propose and
does not include any provisions to implement that authority, which can
be exercised by FMCSA on a case-by-case basis when the facts and
circumstances indicate that it would be appropriate.
    Notification of employers of failed examinations is desirable, and
in the future, FMCSA may use driver physical examination results data
to notify employers. However, FMCSA modifies the final rule to require
employers, upon hiring or upon expiration of a medical examiner's
certificate on or after 24 months after the effective date of this
final rule to verify the driver presenting a medical certificate was
examined by a ME on the National Registry. The rule does not require
employers to recheck the National Registry Web site to determine if the
medical examiner has been involuntarily removed subsequent to
conducting an examination and completing the certificate.
3. State Responsibilities
    FMCSA proposed revising medical examiner's certificate to include
the National Registry number issued by FMCSA to identify the ME.
California and Virginia expressed uncertainty about the State's role in
determining whether the medical examination was completed by an ME on
the National Registry and expressed concern about the cost of re-
programming the Commercial Driver's License Information System (CDLIS)
to query the ME database, when processing driver medical
certifications. Indiana asked whether MEs would be expected to include
the National Registry number

on any old medical examiner's certificate forms or would States have to
look up the number.
    Indiana questioned how involuntary removal of an ME from the
National Registry will affect that ME's previously issued certificates.
Similarly, Indiana also requested that we clarify how we will notify
SDLAs that an ME has been removed from the National Registry.
    FMCSA Response: States will not be required to cross-check National
Registry numbers with the National Registry database when processing
driver medical certifications. Indiana's concern about entering
National Registry numbers on old certificates is moot, because the
final rule will not allow the use of any old forms. This final rule
does not require changes to State driver's license databases or CDLIS
beyond those required by the already-published final rule in Medical
Certification Requirements as Part of the CDL (73 FR 73096, December 1,
2008) (Med. Cert./CDL). However, FMCSA anticipates initiating a future
rulemaking to expand medical certification information exchange with
the States.
    Certificates previously issued by a medical examiner who has been
involuntarily removed are not automatically voided. FMCSA has the
discretion to void any medical certificate issued to a driver by an ME
who is removed from the National Registry (49 U.S.C. 31149(c)(2)). The
NPRM did not need to propose and does not include any provisions to
implement that authority, which can be exercised by FMCSA on a case-by-
case basis when the facts and circumstances indicate that it would be
appropriate.
    State Investigation of Driver Certification. Advocates criticized
the lack of any systematic procedure in the proposed rule that requires
State law enforcement agencies to compare each Medical Examination
Report with the related medical examiner certificate. The commenter
noted that in the preamble to the proposal we do not explain why and
how State enforcement agencies would have reason to investigate
specific Medical Examination Reports and medical certificates. On the
other hand, OOIDA argued that Federal preemption would prohibit State
and local agencies from requesting an ME to give a driver's Medical
Examination Report to them as we proposed. The commenter said that once
we prescribe safety standards requiring MEs on the National Registry to
examine and issue certificates to show a CMV driver's physical
condition is adequate for safe vehicle operations, those regulations
would have a preemptive effect under section 31136.
    OOIDA cited Freightliner Corp. v. Myrick, 514 U.S. 280, 287 (1995),
and Gade v. National Solid Wastes Management Ass'n, 505 U.S. 88, 98
(1992), in support of implied preemption ``when a `state law is in
actual conflict with federal law * * * or where state law stands as an
obstacle to the accomplishment and execution of the full purposes and
objectives of Congress'.'' OOIDA argued that allowing State and local
authorities to access a driver's personal medical information might
dissuade drivers from openly discussing their health issues with an ME.
OOIDA said unqualified State government personnel might apply their own
standards to driver medical information and inconsistently judge them
medically unfit for reasons that are erroneous or unjustifiably exceed
the Federal medical standards being applied. OOIDA concluded that, at a
minimum, we should require States to limit any Medical Examination
Report (commonly called the ``long-form'') request to circumstances
where the State has clearly articulated legitimate reasons for
believing that the medical certificate was falsified or otherwise
improperly issued.
    FMCSA Response: OOIDA's comment does not recognize that State and
local enforcement personnel have a role in enforcing the FMCSRs. The
final rule retains the requirement for MEs to give State and local
enforcement personnel access to Medical Examination Reports and ME
certificates within 48 hours of a request for purposes of monitoring ME
performance. States that receive Motor Carrier Safety Assistance
Program (MCSAP) grant funds are required as a condition of receiving
the grants to adopt regulations that are compatible with these final
regulations (49 U.S.C. 31102(a) and 49 CFR 350.201(a)). States
receiving MCSAP grants, therefore, will generally have to adopt
regulations compatible with requirements that all drivers be examined
by an ME on a registry of trained and certified MEs applicable to both
interstate and intrastate transportation as soon as practicable, but
not later than 3 years from effective date of this rule (49 CFR
350.331(d)).\1\ State government personnel operating under MCSAP will
have the same authority and responsibility to request that an ME
produce a driver's Medical Examination Report that FMCSA personnel will
have in accordance with this final rule. The States receiving MCSAP
grants will be expected to adopt and implement compatible provisions
and apply them consistently. There will be no inconsistency between
State and Federal law that would require either express or implied
preemption.
---------------------------------------------------------------------------

    \1\ As explained later, States that have in effect variances for
physical qualification requirements for drivers operating CMVs in
intrastate commerce will have the option of not establishing a
separate registry of medical examiners trained and qualified to
apply those standards.
---------------------------------------------------------------------------

    FMCSA believes that the establishment of the National Registry,
with its training and testing requirements will improve the performance
of the MEs. Verification of the certification and listing of the MEs on
the National Registry will be enhanced. In addition, the availability
of the examiner's records to enforcement personnel, when necessary to
conduct an investigation into the validity of the medical certificate,
is sufficient to deter improper medical certification of CMV drivers.
4. Intrastate-Only CMV Drivers
    FMCSA proposed that MEs would include information on the monthly
reports of driver examinations whether each driver operated only in
intrastate commerce. OccuMedix and Missouri raised the issue that MEs
would not be able to distinguish between interstate drivers and
intrastate-only drivers required by their States to obtain a medical
certification from an ME on the National Registry. The commenters
suggested that the final rule should require all drivers--interstate
and intrastate--to obtain medical examinations from examiners listed on
the National Registry.
    Missouri said we should consider that many States require CMV
drivers operating in intrastate commerce to follow the FMCSRs and that
there would be confusion if we require MEs to examine only CDL drivers
operating in interstate commerce. Missouri argued that we can promote
public safety further if all nonexempt CDL drivers are required to
obtain medical examinations from examiners listed on the National
Registry, even when the drivers operate CMVs exclusively in intrastate
commerce.
    FMCSA Response: States will continue to set requirements for
intrastate drivers. States that receive MCSAP grant funds are required,
as a condition of receiving the grants, to adopt regulations compatible
with these final regulations (49 U.S.C. 31102(a) and 49 CFR
350.201(a)); however, the Agency is including in this final rule a
revision to 49 CFR 350.341 to make it clear that States that have in
effect variances for physical qualification requirements for drivers
operating CMVs in intrastate commerce will have

the option of not establishing a separate registry of medical examiners
trained and qualified to apply those intrastate standards, although
they have the discretion to do so if they wish. A State with variances
in effect under 350.341(h)(1) and (2) that chooses to set up a separate
registry of examiners qualified to apply those variances to intrastate
drivers will not be allowed to use MCSAP funds for that purpose. Such
use of MCSAP grant funds would not be consistent with the overall
purpose of establishing a uniform standard for all CMV drivers
nationwide. Intrastate-only CMV drivers in States that do not have such
variances can utilize MEs on the National Registry because they will be
trained and qualified in applying physical qualification standards that
are identical for both interstate and intrastate drivers. All MCSAP
States, either with or without variances, thus will have the option to
establish their own registries, but FMCSA is not requiring them to do
so as a condition of receiving MCSAP funds.
    The rule does not restrict MEs who are certified to perform
physical examinations for interstate drivers from performing physical
examinations for intrastate only drivers. MEs should ask drivers
whether they intend to operate in intrastate commerce only. FMCSA Form
MCSA-5850, CMV Driver Medical Examination Results Form, requires MEs to
identify ``Intrastate Only'' drivers on the CMV Driver Examination
Results so that FMCSA can distinguish data about intrastate-only driver
examinations.
5. Canadian and Mexican Drivers
    The NPRM noted that existing reciprocity agreements with Canada and
Mexico will govern Canada-domiciled and Mexico-domiciled drivers,
respectively, operating in the United States (73 FR 73131, n.3). As a
result, Canadian and Mexican drivers do not need to be examined by an
ME on the National Registry before operating a CMV in the United
States. OOIDA said this language constituted an exemption from Federal
regulations, and that we had no authority to grant such an exemption.
    FMCSA Response: OOIDA's contention that 49 U.S.C. 31149 does not
allow FMCSA to ``exempt'' Canadian and Mexican drivers operating in the
United States from being examined by an ME is incorrect because two
separate executive agreements \2\ with Canada and Mexico remain in
effect. A brief history of these two agreements is provided for
clarification.
---------------------------------------------------------------------------

    \2\ Executive agreements have the same legal effect as treaties.
---------------------------------------------------------------------------

    Prior to the amendments made by section 4116(b) of SAFETEA-LU, the
provisions of 49 U.S.C. 31136(a)(3) stated:
    The Secretary of Transportation shall prescribe regulations on
commercial motor vehicle safety. The regulations shall prescribe
minimum safety standards for commercial motor vehicles. At a minimum,
the regulations shall ensure that--
     The physical condition of operators of commercial motor
vehicles is adequate to enable them to operate the vehicles safely. * *
*

For this purpose, a ``commercial motor vehicle'' is defined in 49
U.S.C. 31132(1).
    FMCSA regulations generally required all operators of CMVs in the
United States to be examined by an ME (as defined in 49 CFR 390.5) and
to obtain from the examiner a certificate that the operator is
physically qualified. 49 CFR 391.11(b)(4) and 49 CFR part 391, subpart
E. These requirements will continue to apply after establishment of the
National Registry Program.
    In 1991, the Secretary and his counterpart in Mexico entered into
an agreement on the matter of driver license reciprocity. The agreement
is contained in a memorandum of understanding (MOU) that was reproduced
as Appendix A to a final rule issued in 1992 by FMCSA's predecessor
agency, the FHWA. Commercial Driver's License Reciprocity with Mexico,
57 FR 31454 (July 16, 1992), affirmed, Int'l Brotherhood of Teamsters
v. Pe[ntilde]a 17 F.3rd 1478 (DC Cir. 1994). The primary purpose of the
MOU was to establish reciprocal recognition of the CDL issued by the
States to U.S. operators and the Licencia Federal de Conductor (LF)
issued by the government of the United Mexican States (i.e., by the
national government of Mexico, not by the individual Mexican states).
In light of the agreement, the FHWA determined that an LF meets the
standards contained in 49 CFR part 383 for a CDL. 49 CFR 383.23(b)(1)
and note 1. The FHWA's final rule preamble also states, at 57 FR 31455:

    It should be noted that Mexican drivers must be medically
examined every 2 years to receive and retain the Licencia Federal de
Conductor; no separate medical card [certificate] is required as in
the United States for drivers in interstate commerce. As the
Licencia Federal de Conductor cannot be issued to or kept by any
driver who does not pass stringent physical exams, the Licencia
Federal de Conductor itself is evidence that the driver has met
medical standards as required by the United States. Therefore,
Mexican drivers with a Licencia Federal de Conductor do not need to
possess a medical card while driving a CMV in the United States.

    Implicit in the determination that Mexican drivers with an LF do
not need to possess a separate medical certificate is an underlying
determination that the medical examination necessary to obtain the LF
meets the standards for an examination by an ME in accordance with
FMCSA regulations, and would therefore meet the requirements of 49
U.S.C. 31136(a)(3).
    The MOU does not specifically address medical qualifications for
Mexican drivers operating a CMV in the United States that does not
require a CDL. In order to enter the United States at the border
crossing points (all of which are accessed only by federal highways in
Mexico) a Mexican driver must have a Licencia Federal. FMCSA
enforcement policy accepts a Licencia Federal as proof of physical
qualification for a driver to operate a CMV that does not require a CDL
in the United States.
    In 1998, a similar agreement was reached with Canada under the
auspices of the Land Transportation Standards Subcommittee established
by the North American Free Trade Agreement (NAFTA). This agreement
supplements a 1988 agreement with Canada accepting the CDLs issued by
Canadian provinces in accordance with the Canadian National Safety Code
as valid for operation of a CMV in the United States. 49 CFR 383.23(b),
note 1. The 1998 agreement, which became effective on March 30, 1999,
provides, with some exceptions, that Canadian drivers holding such a
CDL issued in Canada are physically qualified to operate a CMV in the
United States and are not required to possess a medical certificate
issued by a ME. In Canada, drivers are required to have CDLs in order
to operate a CMV that would not require a CDL to operate in the United
States. Under the 1998 agreement, a Canadian CDL issued in conformity
with the National Safety Code is accepted by FMCSA as proof of a
driver's physical qualification to operate a CMV in the United States.
    The substance of these two agreements is also reflected in a note
in 49 CFR 391.41(a)(1), as recently amended. Medical Certification
Requirements as Part of the CDL, 73 FR 73096, 73127 (December 1, 2008).
    In 2005, 49 U.S.C. 31136(a)(3) was amended by SAFETEA-LU section
4116(b), which added the following at the end:

    [T]he periodic physical examinations required of such operators
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 under
section 31149(d) is established, are listed on such registry.

    As explained above, section 4116(a) of SAFETEA-LU added a new 49
U.S.C. 31149, which among other things, includes a provision that FMCSA
``shall accept as valid only medical certificates issued by persons on
the national registry of medical examiners.'' Section 31149(d)(3).
    OOIDA contends that this statute supersedes the two agreements with
Canada and Mexico and that drivers from these two countries operating
CMVs will have to be examined and certified by MEs on the National
Registry. According to the cases that are cited in OOIDA's comments
subsequently enacted statutes may abrogate an executive agreement or
treaty. The case law states, however, that ``neither a treaty nor an
executive agreement will be considered abrogated or modified by a later
statute unless such purpose on the part of Congress has been clearly
expressed.'' Roeder v. Islamic Republic of Iran, 333 F.3d 228, 237
(D.C. Cir. 2003), cert. denied, 542 U.S. 915 (2004) (internal
quotations and citations omitted). There is no such clear expression of
purpose in the relevant statutes. Neither the amended statutes nor
their legislative histories contain any provision addressing these two
executive agreements. The reciprocity agreements with Canada and
Mexico, and the implementing provisions in the note in 49 CFR
391.41(a)(1), will continue to be in effect after issuance of this
final rule. Accordingly, Canadian and Mexican drivers operating CMVs in
the United States who hold the proper licenses will not be required to
obtain a medical certificate from an ME on the National Registry.
    In any case, FMCSA has reviewed the Canadian and Mexican physical
qualification processes. Driver medical examinations in Canada are
performed only by MDs. National standards direct the medical examiners
when to obtain the opinion of a medical specialist. In addition, in
most jurisdictions, doctors, including family doctors, have a legal
obligation to report any medical condition that may affect driving
functions.
    The medical examinations in Mexico are conducted by Federal
government doctors or Federal government-approved doctors. In addition,
the medical certification for an LF is part of Mexico's licensing
process for commercial drivers. This means the license is not issued or
renewed unless there is proof the driver has satisfied the Mexican
physical qualifications standards. FMCSA has compared each of its
physical qualifications standards with the corresponding requirements
in Mexico and continues to believe acceptance of the Mexico
government's medical certificate is appropriate.

C. Components of the National Registry Program

1. Training of Medical Examiners
    Length of Training. In the NPRM, FMCSA projected it would take one
day to cover the FMCSA core curriculum specifications. Two commenters
claimed that the length of training was inadequate and we should
consider increasing it. A chiropractor stated that training should last
perhaps two long days followed with reading and study materials. NRCME
Training Systems claimed that it would be very difficult in a lecture-
based setting, with all of the class questions and discussions
generated in a presentation of this nature, to complete quality
training in one day. The commenter concluded that, at minimum for a 17-
module National Registry training program to thoroughly provide quality
training for examiner candidates, five to six, six-hour days of
didactic lecture in an attended seminar format would be required.
    FMCSA Response: The rule does not prescribe how long training must
be. The core curriculum specifications are limited to FMCSA regulations
and guidelines, and the mental and physical demands of CMV driving. One
advantage of the Public-Private Partnership, is that training can be
expanded to meet the needs of health care professionals from diverse
educational and professional backgrounds.
    Training Intervals. The NPRM proposed that the ME would be required
to complete periodic retraining at least every three years and repeat
the complete initial training program once every 12 years in lieu of
periodic training. Some commenters asserted that repeating the initial
training was not necessary, or suggested other frequencies for
training. AAPA and ACOEM recommended that FMCSA eliminate the proposed
requirement to retake the initial training course every 12 years. AAPA
stated that the requirement offers no benefit to MEs who are already
required to participate in periodic training and recertification
examinations. ACOEM supported requiring MEs to obtain 12 hours of
advanced training every three years instead. Iowa recommended requiring
MEs to attend a one-day course in person after the sixth year to renew
certification.
    FMCSA Response: FMCSA agrees with the commenters that the proposed
requirement for MEs to repeat the initial training is not necessary for
those MEs who do not allow their certifications to lapse and has
modified the final rule to require only periodic training at five-year
intervals for recertification. MEs will be required to pass the test
for recertification every 10 years.
    Training Program Accreditation. FMCSA proposed that medical
examiner candidates be required to complete a training program
accredited by a nationally-recognized medical profession accrediting
organization. NRCME Training Systems endorsed having post-graduate
institutions review and approve National Registry training for MEs,
reasoning that these institutions are already certified by a national
accrediting agency and that FMCSA would retain control over the
training programs through third-party post-graduate programs.
    FMCSA Response: Only training programs that have been accredited by
a nationally recognized medical profession accrediting organization to
provide continuing education units will be eligible to provide the
required training to MEs. As long as the training program is
accredited, and is based on FMCSA's core curriculum specifications and
guidelines, the Agency does not seek to restrict the number or location
of programs that provide ME training. Post-graduate divisions of
colleges and universities would be eligible to provide training to MEs,
as would other accredited training organizations such as professional
association continuing medical education (CME) programs and provider
network training organizations.
    Core Curriculum Specifications. Several commenters expressed
concern that we did not provide the content of the core curriculum in
the proposed rule and questioned how it would be established and
implemented.
    One physician commenter was concerned that since the core
curriculum specifications have not been developed or approved, it will
likely be several years before there are a significant number of
trained MEs to accommodate the proposed requirements. A certified
Medical Review Officer (MRO) urged us to incorporate good scientific
rationale into the development of the curriculum and commented that all
sections of the

driver examination need to be addressed.
    ABA and BISC requested that we engage the private bus industry in
developing ME curricula that are related to bus operations and driver
wellness. ADA requested that the FMCSA-appointed Diabetes Expert Panel
(DEP) be consulted with regard to curriculum elements pertaining to
diabetes and suggested that these core curriculum elements be submitted
to the DEP for final approval. The commenter also suggested that the
DEP's 2006 suggested training module be incorporated in the curriculum.
    FMCSA Response: The core curriculum specifications are being issued
as guidance for organizations delivering training for MEs who apply for
listing on the National Registry when it is implemented. FMCSA
published a notice of availability of draft guidance and request for
comments on the core curriculum specifications in the Federal Register
on May 17, 2011 (76 FR 28403). Additionally, FMCSA has posted these
specifications on the National Registry Web site (http://nrcme.fmcsa.dot.gov) and in the docket for this rulemaking. The
guidance for the core curriculum specifications is Appendix A to this
Federal Register document.
    The guidance for the core curriculum specifications are based on
current FMCSA regulations on physical qualifications published in 49
CFR part 391, as well as guidance that is published in 49 CFR 391.43.
The guidance for the core curriculum specifications are also based on
the task list developed in the Role Delineation Study (RDS) completed
in April 2007, as described in the NPRM. The RDS is a rigorous
methodology regularly employed in the certification and medical fields
when developing a valid, reliable, and fair certification test. An
executive summary of the RDS Final Report and the full text of the
Final Report are available through the National Registry Web site \3\
and the docket for this rulemaking.
---------------------------------------------------------------------------

    \3\ http://nrcme.fmcsa.dot.gov/training.aspx, retrieved July 13,
2011.
---------------------------------------------------------------------------

    The Agency does not envision separate medical criteria for bus
drivers at this time. Any changes in the basic requirements for
training specified in 49 CFR 390.105(b) will be subject to notice and
comment proceedings. On the other hand, future changes in the guidance
for the core curriculum specifications do not require a notice and
comment rulemaking proceeding because they will reflect only
regulations and guidelines for performing the driver physical
examination. FMCSA has provided and continues to provide for
stakeholder input into revising the standards and guidelines through
MRB meetings, and public notice of MRB meetings, including specific
instructions on where to send comments. FMCSA will revise the guidance
for the core curriculum specifications only after we have established
new or revised existing, regulations and guidelines. The training
provider could expand its course content to tailor training to the
needs of its target audience but the course content must cover the
FMCSA core curriculum specifications.
    FMCSA considered the recommendations of the DEP for ME training in
the development of the guidance for the core curriculum specifications.
At this time, FMCSA is not adopting the ADA's request to implement the
recommendation of the DEP on drivers with diabetes. In general, such
MEPs are convened on an ad hoc basis to act in an advisory capacity to
FMCSA in its work of reviewing and revising physical qualification
standards and guidelines. In any event, FMCSA will consider
recommendations from the MEP on standards and specifications for
drivers with diabetes in future proceedings.
    Comments on the Notice of Availability of the Core Curriculum
Specifications.
    FMCSA published a notice of availability and request for comments
on the draft guidance for the core curriculum specifications in the
Federal Register on May 17, 2011 (76 FR 28403). Additionally, FMCSA has
posted this guidance on the National Registry Web site (http://nrcme.fmcsa.dot.gov) and in the docket for this rulemaking. FMCSA
received five comments from interested parties during the public
comment period. The Agency considered the public comments on the draft
guidance and now publishes the guidance as Appendix A to this Federal
Register document.
    In response to the notice of availability, ATA suggested that FMCSA
needs to educate MEs about the mental and physical demands of driving a
CMV. Several commenters suggested that the curriculum convey to MEs an
understanding of the distinction between guidance and recommendations
submitted by various FMCSA advisory committees and boards. NRCME
Training Systems thought that FMCSA expected training programs to give
continuing education credits. There was also a comment requesting
notice and comment rulemaking for future changes in the core
curriculum. There were several comments addressing other aspects of the
rulemaking other than the core curriculum specifications, which are
beyond the scope of the notice of availability.
    FMCSA Response: In response to ATA's comment, MEs are, and will
still be, required to be knowledgeable of the specific physical and
mental demands associated with operating a CMV. 49 CFR 391.43(c)(1).
Section 2 of the core curriculum specifications addresses the job of
CMV driving, including physical and emotional demands. Section 7
includes consideration of driver ability to perform physical tasks
associated with operating a CMV.
    The guidance for the core curriculum specifications expands the
description of the topics to be covered in training, and do not provide
the details that should be included in the actual training. FMCSA
commercial driver medical certification regulations, advisory criteria,
MRB and MEP functions, and other resources on the Web site are outside
the scope of this notice. Nonetheless, FMCSA continuously reviews and
updates information on its Web sites for content and clarity, and will
make sure the difference between regulations, guidance, and advisory
recommendations are made clear.
    FMCSA wants to clarify that it is not requiring that the training
given to MEs qualify for continuing education credits, although the
training organizations must be accredited to give continuing education
credits.
    The Agency is making no changes to the draft guidance for the core
curriculum specifications, and issues them as an appendix A to this
Federal Register document. Only future changes in medical certification
standards will be subject to notice and comment rulemaking. FMCSA will
then update the guidance for the core curriculum specifications as
appropriate. Because the core curriculum specifications are guidance,
consideration and issuance of updated specifications does not require
notice and comment in a rulemaking proceeding.
2. Testing of Medical Examiners
    Certification Testing Intervals. Some commenters suggested
different intervals for such testing. FMCSA proposed a requirement that
MEs pass the ME certification test every 6 years in order to remain
listed on the National Registry.
    FMCSA Response: FMCSA modifies the requirement for MEs already on
the registry to pass the certification test again before 10 years
instead of before 6 years to demonstrate knowledge of

changes and retention of previous knowledge and application. This
period was chosen as there are varying lengths of times utilized by
medical and healthcare boards to issue board certifications. FMCSA
chose 10 years because it is not as burdensome on the medical examiner,
but, in FMCSA's judgment, it is a short-enough period to verify MEs are
knowledgeable about any changes to our physical qualifications
standards and guidance. MEs will also be kept knowledgeable by
completing refresher training every 5 years, and receiving updates from
FMCSA by email and Web site postings.
3. Accreditation of National Registry Program
    FMCSA asked for comment on its consideration of obtaining
accreditation of the components of the National Registry Program that
test and certify MEs for listing on the National Registry, in order to
demonstrate the robustness of its Program. This accreditation was not
the same as the accreditation that was proposed to be required for
training.
    Several commenters commented regarding the process of obtaining
National Commission of Certifying Agencies (NCCA) accreditation of the
certification component of the National Registry Program. ATA expressed
concern that the accreditation process might cause delay or increase
program costs. Calling accreditation time-consuming, burdensome, and
costly, ATA said it would oppose accreditation of the ME certification
program if the process delayed implementation of the National Registry.
Instead, ATA recommended that we either certify the program through a
periodic program evaluation and audits conducted by a designated
oversight authority, or certify the program using a third-party
certifying body.
    FMCSA Response: The Agency agrees that accreditation of the
National Registry certification component could be expensive and delay
implementation of the program. As stated in the NPRM, FMCSA proposed
accrediting the testing and certification components of the National
Registry Program using the accreditation standards of the NCCA, and is
considering the costs and benefits of applying for accreditation for
these components (which are administered by the Agency). A new
certification program (one that has not previously received
accreditation by the NCCA), 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. FMCSA will conduct program evaluations which are subject
to internal and external audits, as well as Congressional oversight.
4. Public Participation in Development of Components
    Advocates said FMCSA failed to provide the key features of the
preferred Public-Private Partnership approach for evaluation through
notice and comment. Advocates contended that the Agency should publish
a supplementary notice of proposed rulemaking (SNPRM) with details of
the major features to allow for public review and comment. The features
Advocates believes are not covered are the core curriculum provided for
training companies to use, the criteria to qualify private
organizations to conduct training and testing, and the reason for
choosing the NCCA as the accreditation organization for the program.
Advocates asserts further that another feature of the proposal that
``must be exposed to public comment'' is the specific content of the
test that would be administered to MEs.
    FMCSA Response: FMCSA has determined that it is unnecessary to
accept Advocate's view that an SNPRM is either required or appropriate.
However, the Agency has taken steps to make certain components of the
National Registry program available for public comment before their
implementation.
    FMCSA has determined that the guidance for the core curriculum
specifications and other similar documents implementing the National
Registry program, such as information for testing providers, does not
have to be a subject to a notice and comment rulemaking. The guidance
for the core curriculum specifications will meet the minimum
requirements of 49 CFR 390.105(b), but will not establish a ``binding
norm'' for MEs for compliance with that provision. American Hospital
Ass'n v. Bowen, 834 F.2d 1037, 1046 (D.C. Cir., 1987). Organizations
that will provide the training must have the flexibility to develop a
particular training curriculum suitable for the type of medical
professionals who intend to be listed on the National Registry. This is
especially important because, as explained above in Section IV.B.1,
FMCSA's regulations will continue to allow several different types of
medical professionals, with a wide range of different backgrounds,
knowledge, and skills, to act as MEs. This approach is entirely
consistent with the authority granted to FMCSA to ``develop, as
appropriate, specific courses and materials for medical examiners'' 49
U.S.C. 31149(c)(1)(D) (emphasis added). In view of the nature of the
training that needs to be provided to applicants for certification and
listing on the National Registry, and the broad discretionary authority
delegated to the Agency to implement the training component, FMCSA has
determined that it is appropriate to issue guidance providing the core
curriculum specifications for development of training by the various
training providers.
    Moreover, there are criteria for determining which organizations
would be deemed acceptable for conducting the training. The
requirements of 49 CFR 390.105 that the Agency proposed in the NPRM set
out the criteria that candidates for certification and listing on the
National Registry must use in selecting an organization to provide
their training. Those criteria were thus available for public comment.
FMCSA has responded to those comments (including substantive comments
by Advocates) in Section IV.C.1 above.
    Finally, MEs seeking to be listed on the National Registry will
need to successfully complete a test administered in accordance with 49
CFR 390.103 and 390.107. Like the core curriculum specifications, the
specific content of the test will be based on current FMCSA regulations
and guidelines on the Medical Examination Report applicable at the time
the test is administered. As those underlying regulations and
guidelines are updated, both the core curriculum specifications and the
certification test will be modified accordingly.
    The Agency has added a requirement to the final rule (49 CFR
390.107(d)) to make it clear that any testing organization
administering the test must use only the test obtained from FMCSA. This
requirement was stated in the preamble to the NPRM (73 FR at 73133).
5. Records and Recordkeeping
    Retention of Driver Examination Records. The NPRM proposed
implementation of the SAFETEA-LU requirement that MEs 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 49 CFR 391.43 (49 U.S.C.
31149(c)(1)(E)). Additionally, the proposed rule would require MEs to
retain for 3 years the Medical Examination Report for each examination
performed and the medical examiner's certificate, if the ME certified
the driver as physically qualified. It would also require MEs to
provide copies of specified 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)).
    ACOEM, AAOHN, and an occupational medicine consulting firm,
OccuMedix, Inc., claimed that MEs should be required to retain driver
examination records for longer than 3 years to allow MEs to check their
own records or the records of other MEs so that medical conditions
would not be overlooked. The commenters noted that some drivers may use
different MEs from year to year or may enter or leave the driver pool,
so records should be maintained for 6 or 7 years and reviewed if
questions arise.
    FMCSA Response: FMCSA proposed a minimum time of 3 years for
retention of driver examination records because a driver is certified
for a period of 2 years or less, and an additional year will allow
FMCSA time to request driver examination records from MEs to assess ME
performance by determining whether the ME completed the medical
examination report accurately and did not certify a driver in error.
Also, MEs are still subject to any State laws requiring medical records
to be retained for longer than 3 years. Therefore, FMCSA will retain
the requirement for MEs to keep the Medical Examination Report and the
medical examiner's certificate for 3 years and retains the words ``at
least'' from the Med. Cert./CDL rule to clarify that this is a minimum.
    Privacy of Information. Transportation Safety Services, a
consulting firm, stated that Federal government databases established
to monitor medical information cannot be adequately protected from
unauthorized access. AAOHN, however, suggested that a standardized
electronic database with appropriate safeguards is imperative for the
confidentiality of personal health information and compliance with
Health Insurance Portability and Accountability Act (HIPAA)
regulations. Dart Transit Company encouraged us to address the question
of possible conflicts with HIPAA that would be encountered in the
industry's attempt to comply with the rule.
    FMCSA Response: Pursuant to 49 CFR 391.43(g), as revised by this
final rule, each month MEs will be required to transmit on Form MCS-
5850 the results of every physical examination performed on a CMV
driver and the information from each medical examination certificate
issued to a CMV driver. This form indicates whether or not the driver
examined was issued a medical certificate. This information is
necessary to satisfy the requirements of 49 U.S.C. 31149(c)(1)(E). The
form does not contain any personal health information about the driver.
It does include information identifying each driver examined such as
driver's name and driver's license information.
    If the Agency should find it appropriate in conducting any review
of the performance of MEs on the National Registry, as provided by 49
U.S.C. 31149(c)(1)(C) and (F), to obtain copies of the Medical
Examination Reports and any supporting medical records for CMV drivers
examined, it will follow the applicable policies and procedures to
ensure the security and privacy of the personal health information
about the drivers contained therein. FMCSA will also follow similar
procedures in conducting any investigation into whether or not a CMV
driver is or should be physically qualified to operate a CMV.
Therefore, we are requiring submission of medical records through a
secure Web application for which each certified ME will have a
password-protected account. FMCSA will implement policies and
procedures to reasonably limit the uses and disclosures of Protected
Health Information (PHI). The Privacy Impact Assessment (PIA)
supporting the final rule gives a full and complete explanation of
FMCSA practices for protecting Personally Identifiable Information
(PII) in general and specifically in relation to this rule. The PIA is
available for review in the docket.
    On the other hand, HIPAA privacy regulations do not apply to the
transmission of PHI to FMCSA because the Agency does not provide
services on behalf of the ME, and therefore does not qualify as a
business associate. The definition of a business associate requires
more than receipt of PHI. As stated in 45 CFR 160.103, to qualify as a
business associate the entity or person must perform a function or
activity involving the use or disclosure of individually identifiable
health information on behalf of such covered entity or of an organized
health care arrangement. FMCSA is not providing services on behalf of a
covered entity or in association with an organized health care
arrangement. In this case, FMCSA is not performing services for the ME,
but for the public by ensuring the safe performance of commercial
vehicle drivers. FMCSA will monitor the performance of MEs in order to
ensure they effectively determine whether CMV drivers are safe to drive
in interstate commerce.
    FMCSA disagrees that there are possible conflicts with HIPAA that
would be encountered by employers (or the MEs for that matter) in
complying with the final rule. The Agency did not propose and is not
making any changes in the existing regulations governing the physical
qualifications of drivers and the responsibilities of employers to
ensure compliance with those requirements, with the exception of the
requirement for employers to verify that the ME is listed on the
National Registry. The employer may validate the National Registry
Number from the medical examiner's certificate or State driver record,
without the need to access any of the driver's personal health
information.
    Public Web site. We indicated in the preamble to the proposed rule
that information about the National Registry Program would be available
through a public Web site, so that drivers and employers could find the
names and addresses of nearby MEs listed on the National Registry.
Several commenters described other information pertaining to the ME
that should be provided as well. A chiropractor and Dart Transit
Company suggested that the Web site should also include information
about parking, hours, and directions. Schneider National, Inc.
mentioned that the ME's State license number, National Registry Number,
and certification expiration date should be posted. Schneider National,
ACOEM, and OccuMedix expressed that the Web site and email
notifications to MEs could be used for informational purposes.
    Wynne Transport Service, Inc. (Wynne), California, and AAOHN noted
that the National Registry itself must be updated frequently so drivers
and motor carriers always have access to the most current ME
information. Wynne asked whether the ME's unique identifier will be
recognizable as valid. OOIDA noted that although we envision a resource
center with a toll-free telephone number, it is not clear what
information will be available by telephone and whether the Resource
Center would be staffed by knowledgeable people who can answer a
variety of physical examination-related questions. California urged us
to ensure that the toll-free telephone number is staffed during regular
business hours in the Pacific Time Zone.
    OOIDA also argued that reliance on the Internet posed an obstacle
because long-haul drivers often spend extended periods of time away
from home and not all own laptop computers that could be used to
identify conveniently located MEs over the Internet.

    FMCSA Response: FMCSA is considering these ideas in the design and
implementation of the National Registry Web site. FMCSA anticipates the
National Registry will include the unique National Registry Number and
the certification date for each ME. Information for MEs who have been
removed from the National Registry will be shown with the date of
removal. We anticipate using the public Web site and email
notifications to MEs for informational updates. Callers to the Resource
Center will be able to receive assistance in locating an ME on the
National Registry and will be given access to knowledgeable personnel
who can answer questions about the commercial driver physical
examination.
    Access to Driver Examination Records. ATA, Road Ready, Inc., and
Florida argued for a Web-based electronic data entry and document-
storage system for Medical Examination Reports. Road Ready, a company
that electronically collects and stores drivers' DOT medical
examination information for motor carriers, argued that developing and
maintaining such a system would enhance our ability to effectively
manage and audit driver files and obtain required medical information.
Florida said an FMCSA repository of Medical Examination Reports would
eliminate the need to require and enforce monthly entry of separate
data.
    AAOHN, Dart Transit Company, ATA, and an individual MD suggested
that the ME should have access to previous driver physical examination
records in order to more easily detect disqualifying illnesses not
reported by the driver.
    FMCSA Response: The Agency acknowledges the potential benefits of a
comprehensive, searchable Web-based database of Medical Examination
Reports. This type of system could incorporate automated checks that
would prevent the erroneous certification of drivers who do not meet
certification standards and would facilitate the collection of driver
examination records for monitoring ME performance. However, this rule
will not require MEs to enter all data into a prescribed on-line
Medical Examination Report form, because of the administrative burden
this would place on MEs.
    Medical Examiner's Certificates. The NPRM proposed a change in the
medical examiner's certificate form to require the ME to record his or
her unique National Registry Number. The proposed rule would have
allowed the ME to use existing medical examiner's certificate forms
(without a box for the National Registry Number) for up to 4 years.
Iowa opposed the use of obsolete forms.
    FMCSA Response: FMCSA agrees there is no need to delay
implementation of the updated medical examiner's certificate and has
made changes to the final rule to require MEs to use the medical
examiner's certificate with the National Registry Number for all
examinations on or after a date 24 months after the effective date of
this final rule. FMCSA has posted the current medical examiner's
certificate on its public Web site since 2003, so MEs have not had to
order supplies of paper copies. Therefore the two-year implementation
date will not impose hardship or waste with regard to availability of
the current certificate.

D. Costs and Benefits of the National Registry Program

1. Benefits
    FMCSA requested comments on the costs and benefits of the proposed
rule. The Indiana Statewide Association of Rural Electric Cooperatives
(ISAREC) questioned the need for and the benefit of the National
Registry, arguing that it might not be a good, targeted use of Agency
resources. A private citizen questioned whether any study shows MEs
make highways safer. Southern Company, a public utility company,
opposed establishment of a National Registry and suggested instead that
physicians should be given easy access to on-line directions and
guidance to use any time.
    In contrast, a chiropractor reported that in the past year, he had
disqualified drivers who previously had been improperly qualified to
drive by other MEs or required exemptions for blindness in one eye,
insulin use, psychological conditions, limb/appendage loss, implanted
defibrillators, seizure disorders, and cardiovascular disorders.
California noted a 2005 study that found that 10 percent of Medical
Examination Reports (long forms) submitted and marked as qualified were
actually from unqualified drivers, which, to the commenter, indicates
that MEs misinterpreted the Agency standards.
    The American Chiropractic Association and a comment signed by 147
chiropractors stated that the National Registry will both improve
highway safety and reduce the number of erroneous driver
disqualifications. They agreed that the ME certification program will
raise the quality and conformity of the CMV driver physical
examination. California and Iowa expressed similar opinions in stating
that the training protocol will ensure that MEs are knowledgeable and
capable of performing these examinations.
    FMCSA Response: FMCSA is required by statute to establish the
National Registry. As described in the regulatory evaluation, the Large
Truck Crash Causation Study (LTCCS) data show that approximately 2.2
percent of crashes involve a crash where the truck driver was assigned
the critical reason for the crash and the main contributing factor was
the health or physical condition of the truck driver.\4\ The LTCCS is
the most comprehensive examination of truck-crash causation conducted
in the United States. It is clear that driver health is a factor
contributing to a significant number of crashes. Clearly, there are
benefits from a program that would improve the screening of drivers,
keep medically unqualified drivers off the road, and that would,
therefore, in FMCSA's estimation, prevent 1,219 crashes per year.
---------------------------------------------------------------------------

    \4\ Internal analysis of the LTCCS conducted by Agency data
analysts. A description of the LTCCS, it's methodology, and the data
is available at http://ai.fmcsa.dot.gov/ltccs/default.asp.
---------------------------------------------------------------------------

    It will not be possible to evaluate the effectiveness of training
programs for MEs to be listed in the National Registry until after the
training programs have been initiated. It is impossible to predict the
degree to which the training program will improve ME screening of
drivers. However, comments received from MEs who currently conduct
driver physical evaluations, and evidence from the field from MEs and
enforcement personnel indicate that many drivers who do not meet the
Agency's physical qualification standards are being erroneously
medically certified. The Agency expects the National Registry Program
to reduce the number of errors committed by MEs. It will depend upon
the effectiveness of training and the knowledge that MEs gain about
Agency standards and guidelines.
    CME programs have received extensive evaluations and have been
shown to improve medical practitioner knowledge and skills, as well as
patient outcomes.\5\ A comprehensive review of the effectiveness of CME
programs sponsored by the U.S. Department of Health and Human Services

demonstrated that these programs are effective in increasing
participant knowledge, skills, and clinical practices, among other
improvements.\6\ The National Registry Program is more rigorous than
many CME programs because it includes a post-training knowledge
assessment. Given that other CME programs have been shown to be
effective, it is reasonable to expect, therefore, that the National
Registry Program would attain some level of effectiveness.
---------------------------------------------------------------------------

    \5\ Bordage G, Carlin B, Mazmanian PE. ``Continuing medical
education effect on physician knowledge: Effectiveness of continuing
medical education: American College of Chest Physicians Evidence-
Based Educational Guidelines.'' Chest. 2009 and Neff JA, Weiner RV,
Gaskill SP, Smith JA, Weiner M, Brown HP, Prihoda TJ, Newton E.
``Preliminary Evaluation of Continuing Medical Education-Based
Versus Clinic-Based Sexually Transmitted Disease Education
Interventions for Primary Care Practitioners'' Teaching and Learning
in Medicine. 10(2) 74-82. 1998.
    \6\ Marinopoulos, S, Dorman T, Ratanawongsa N, Wilson LM, Ashar
BH, Magaziner JL, Miller RG, Thomas PA, Prokopowicz GP, Qayyum R,
Bass EB. Effectiveness of Continuing Medical Education. Evidence
Report/Technology Assessment Number 149, Agency for Healthcare
Research and Quality--U.S. Department of Health and Human Services,
2007. Available online at: http://www.ahrq.gov/downloads/pub/evidence/pdf/cme/cme.pdf.
---------------------------------------------------------------------------

2. Costs
    We proposed developing the core curriculum specifications and
administrative requirements for ME training-- referred to as the
Public-Private Partnership Model. We asked for comment on alternative
training delivery methods and the ability of accredited training
programs to adapt their continuing education programs to ensure quality
and consistency of training.
    We received many comments about the cost of ME training, testing,
and certification. In 49 CFR 390.105, we require that all ME applicants
complete training conducted by a private-sector training provider
(administered by a nationally accredited medical professional
organization that provides continuing education units). In 49 CFR
390.103(a)(3), we require that after completing mandatory training, an
ME applicant must pass our ME certification test. In 49 CFR 390.111, we
list requirements for continued listing on the National Registry,
including periodic retraining every 5 years and recertification every
10 years. We anticipate that FMCSA will provide Web-based, periodic
retraining at no cost to MEs. We estimate the annual costs of training
and testing--including lost time to MEs--as varying between $14 million
and $59 million (undiscounted) during the initial training phase.
    Costs to Medical Examiners. Commenters presented various arguments
concerning whether we had properly assessed the cost of the rule and
which stakeholders would pay the cost of ME training and certification.
Comcar Industries said we had ``significantly understated'' the cost
impact of this rule on the trucking industry. A private citizen
questioned whether we had properly evaluated what costs will increase
after the National Registry is established. ISAREC, OOIDA, Virginia,
and Wynne said that MEs would pass on cost increases to drivers or
motor carriers and other employers of drivers. A chiropractor, ATA, the
National School Transportation Association (NSTA), OOIDA, and Wynne
agreed that to recover their training investments, MEs in remote areas
would impose higher physical examination fees over a smaller base of
drivers. NSTA recommended that to prevent disparate examination fees
across the country, FMCSA should limit the amount by which MEs can
increase their physical examination fees to recover the cost of having
to comply with the National Registry rule.
    FMCSA Response: There will likely be a minimal increase in the cost
charged by MEs to reflect the cost of becoming certified. In the
regulatory evaluation, we estimated that becoming certified would cost
approximately $550 per examiner in out of pocket costs--$440 for
training and $110 to take the certification test. Fees for driver
examinations vary, but generally fall in the range of $70-$100,
assuming no specialized tests are required. As noted by one commenter,
MEs in lower volume areas may already charge higher fees--up to $170
per examination. At $170 per examination, an ME would only have to
conduct 3-4 examinations in order to recoup the out-of-pocket costs of
certification. At the lower-end price of $70 per examination, an ME
would need to conduct a minimum of approximately 8 driver examinations
to recoup the out-of-pocket costs of certification. In addition, many
occupational health consortia and other organizations offer training on
the CMV driver physical, and other ME training, free of charge, to
physicians and other providers in their networks. It is unclear how
many MEs would have access to these free courses, but at least some
would bear little or no out-of-pocket costs for obtaining the required
training.
    The opportunity cost of time for an ME to attend certification
training and testing was estimated at $83 per hour, and the time
commitment for certification was estimated at 11.5 hours, for a total
cost of approximately $954. If an ME took on these costs, approximately
148 examinations at most would be needed to pay back the investment of
time required to become certified. The NPRM proposed requiring MEs to
repeat initial training every 12 years. This final rule eliminates this
requirement for repeating the initial training but substitutes
refresher training every 5 years, thereby reducing the cost to MEs for
maintaining certification.
    At a maximum, an ME would need to conduct approximately 26
examinations to compensate for the total cost of certification
including both out-of-pocket costs and indirect costs of the time
involved. The financial payoff for being able to continue conducting
these examinations seems sufficient to induce most MEs who currently
conduct 10 or more driver certifications per year to become certified.
Based on the revenue generated by the examination, this volume would be
sufficient to pay back both the value of time spent by an ME in
training and out-of-pocket expenses in a little over 2 years.
    The initial training required by this certification program is a
fixed cost--a one-time expense. This is not a marginal cost that is
incurred with each examination. In competitive markets, the cost of a
service approaches its marginal cost, as fixed costs are averaged over
multiple units of production. Given that there are MEs who evaluate
hundreds of CMV drivers per year, the amount that initial certification
costs would contribute to the per-unit cost of providing examinations
would approach zero. We expect these higher volume MEs to set the
market price for driver examinations. Those MEs who conduct fewer
examinations would have pressure to match the prevailing price, or most
drivers would go to an ME who charges a lower fee. We therefore expect
a minimal increase in the fees charged for these examinations. In
addition, we expect that the MEs who choose to obtain training and be
listed on the National Registry will see an increase in the volume of
commercial driver examinations, because there may be fewer
professionals eligible to conduct the driver examinations. Greater
volume should help control cost increases because the cost of training
will be spread across a greater number of examinations. As a result, a
smaller price per examination increase would be necessary for MEs to
recover their costs.
    If training costs are incorporated into higher medical examination
fees, this would not result in an increase in the total cost of the
program, although it would result in a pass-through of these costs to
the industry. If MEs pass some or all of the costs of the training on
to the industry, the costs passed on would be borne by drivers and
carriers rather than MEs, but whether these costs are passed on or
absorbed by MEs would not change the total cost of the program.
Therefore, the Agency feels it has fully

accounted for the potential effects of the rule, although we cannot
predict with a great deal of certainty how much of the associated costs
would be absorbed by MEs rather than passed on to the industry.
    Finally, the Agency disagrees that we should put a ceiling on the
fees MEs are allowed to charge for physical examinations. Commenters
are concerned both that there will be a shortage of MEs and that fees
will increase. However, the ability to charge a higher fee for driver
examinations increases the incentive that MEs have to obtain
certification. Capping the fee too low would exacerbate any shortage in
MEs, because it would reduce the financial incentive to become
certified. In the interest of ensuring the broadest geographic coverage
possible for the National Registry, we do not agree that capping driver
examination fees would be advisable.
    It must be kept in mind that once this program reaches full
implementation, all MEs who choose not to participate in this
certification program will lose all revenue associated with conducting
driver physical examinations. MEs face the choice of becoming certified
to retain the current revenue stream they receive from driver
examinations, or not becoming certified and losing this revenue to
other professionals who are certified. The Agency believes that, for
most MEs, preserving this revenue stream will outweigh any costs
associated with becoming certified.
    Scarcity of Medical Examiners. FMCSA requested comments on whether
the proposed requirements may deter otherwise qualified MEs from
performing these types of examinations and on ways to ensure that MEs
are accessible to drivers in rural areas and areas where the demand for
driver certification may be low. The Agency also asked for comments on
additional costs drivers may incur to locate and travel to an ME for
periodic examinations.
    AAPA, AAOHN, Advocates, California, Virginia, and two individuals
said that the cost of training and testing would diminish the number of
physicians and others willing to become MEs. However, a physician with
the Delaware Department of Health suggested that most physicians would
find the costs of training and travel, certification, and
recertification acceptable.
    OOIDA also expressed concern that the burdensome and costly
administrative obligations for listed MEs will discourage health care
professionals from providing driver physical examinations.
Administrative burdens would include the need for a computer system
that can interface with the Agency and personnel available to provide
the Medical Examination Reports when requested. California requested
that MEs be given sufficient notice prior to an onsite inspection and
sufficient time to comply with a request for information.
    Several commenters discussed the scarcity of MEs in rural areas and
the resulting costs to CMV drivers. ATA, Arizona, Comcar Industries,
ISAREC, National Academy of DOT Medical Examiners (NADME), OOIDA,
Southern Company, Virginia, and Wynne said that a scarcity of MEs would
burden truck drivers with having to travel long distances for physical
examinations. ATA commented further that such travel likely would
result in a loss of wages for the driver and loss of revenue to the
motor carrier.
    Commenters also argued that scarcity would result in difficulties
in scheduling physical examinations. Commenters said many drivers will
experience longer wait times and no walk-in opportunities for physical
examinations. According to NSTA, difficulties in scheduling physical
examinations could impede school bus service because newly hired
drivers may be unable to receive physical examinations before the start
of school.
    Several commenters suggested actions we might take to avoid a
scarcity of MEs. These suggestions included offering financial
incentives to secure a local ME, permitting physical examinations by
CMV drivers' family doctors, though not certified, having motor
carriers take responsibility for finding physicians in their areas who
are willing to become MEs, and extending the rule's implementation date
if there are not sufficient numbers of MEs.
    FMCSA Response: There are 3,140 counties or county-equivalent
administrative units in the United States, according to the U.S. Census
Bureau. Assuming the Agency reaches its goal of certifying 40,000 MEs,
there would certainly be a sufficient number of certified MEs to
provide broad geographic coverage. Even half that number of certified
MEs would be sufficient to provide comprehensive national coverage. It
is unlikely that MEs would be evenly distributed throughout the Nation,
but coverage should be sufficient to ensure reasonably convenient
access in all but the most remote areas of the Nation. Lack of access
to a certified ME would be likely to affect only a small number of
drivers, especially considering that many of these drivers from rural
areas would be delivering loads on a regular basis to larger towns and
cities and, thus, have access to the broader ME populations in such
areas. Given the mobile nature of the CMV driver occupation and the
number of MEs we anticipate to join the National Registry, we do not
believe that access to certified MEs will be an issue once the Registry
is fully populated. In addition, we anticipate that the searchable
National Registry may make it easier for drivers to find health care
professionals who are qualified to conduct the driver physical
certification examination. It is possible that in some areas where MEs
are in short supply, such as rural areas, driver examination costs
might increase, but the increase is not a certainty and is not likely
to be large. Also, travel costs to drivers might increase due to
drivers traveling further to find MEs.
    Mode of Training and Testing. We proposed developing the core
curriculum specifications and administrative requirements for ME
training, which we would provide to private-sector training
organizations for developing course content. We mentioned that training
delivery could vary among providers and include self-paced, on-line
training; the traditional classroom model; or a blended format. We also
envisioned private-sector organizations administering a proctored and
secure certification test, with the ME applicant traveling to the test
center. We asked for comment on alternative training and testing
delivery methods and how FMCSA could offer training directly to MEs in
a cost-effective manner.
    ATA, Comcar Industries, ISAREC, MRB, NADME, NRCME Training Systems,
OOIDA, and Schneider National endorsed on-line training as efficient
and cost-effective. Schneider National also endorsed other cost-
efficient technologies like video-conferencing, along with traditional
classroom training.
    A chiropractor said that live Web conferencing had the benefit of
reducing costs and allowing conversation between a trainer and course
attendees.
    Delaware noted that some physicians favored an initial on-line Web-
based product designed to educate new examiners, followed by on-site
lectures and then initial testing, leading to qualification. However,
OccuMedix stated that in-person, classroom training was optimal for
initial certification since discussing case studies and in-person
interacting with other ME candidates and faculty would be extremely
beneficial.
    Several of the commenters, including ATA, supported on-line
testing. ATA

said that on-line testing should be the preferred method of
administration of the test to reduce costs. One commenter, a
chiropractor, said that FMCSA should offer the test on its Web site.
    FMCSA Response: The Agency agrees with comments that on-line
training would reduce the cost associated with training. This rule does
not preclude on-line training as a viable training, or the other
suggested training formats, delivery methods. Allowing flexibility in
alternative training delivery methods is one of the primary benefits of
the Public-Private Partnership Model. While some organizations may
charge for this training, others (larger hospital systems, occupational
health consortiums, professional associations, etc.) may offer training
that is free of charge to group members. The Agency is aware of several
ME training programs that are offered free to members of particular
organizations. It is therefore likely that under the Public-Private
Partnership Model a percentage of MEs would be able to obtain on-line
training with no out-of-pocket costs or travel costs. At present, the
Agency cannot estimate with any degree of certainty the number of MEs
who might take advantage of on-line training, so we leave the travel
costs estimates at the NPRM stage unchanged for the Public-Private
Partnership Model. It is expected, however, that on-line training will
reduce travel costs associated with this model.
    The Agency agrees with commenters that allowing on-line testing
will increase accessibility and decrease costs. This rule allows for
secure online testing to be offered by testing organizations as an
alternative or additional option to in-person testing. It requires
online testing to be subject to specific security and privacy
requirements due to the nature of the test and the need for
authentication and security of the test. The Agency expects that, just
as with on-line training, allowing for the increased flexibility
provided by secure on-line testing in the final rule will reduce costs
for MEs without adversely impacting the ability of the Agency to verify
the qualifications of the MEs on the National Registry or compromising
safety.
    Estimates of Frequency of Driver Examinations. The NPRM estimated
the number of MEs who would need to be certified by estimating that 3
million driver examinations are performed on interstate CMV drivers per
year. All CMV drivers must be certified at least every 2 years, and
some drivers are certified more frequently. We specifically requested
comments on how frequently drivers are examined more often than every 2
years. A chiropractor said that in 2008, his practice issued 41 percent
of CMV medical certificates for less than 2 years. Schneider National
said that of the approximately 650 medical examinations it performed
each month, it issued about 50 percent of the medical certifications
for less than 2 years. Comcar Industries reported that 39 percent of
its drivers receive medical certificates for less than 2 years.
    NSTA said FMCSA underestimated the number of drivers by not
including intrastate drivers, because all States but two adopt the
FMCSRs for intrastate drivers. NSTA also said that most States require
school bus drivers to have a physical examination annually.
    FMCSA Response: The Agency agrees that, given the estimates of the
number of drivers who require certification more than once every two
years, it is likely that more than 3 million drivers would be certified
in a given year. However, we do not believe that this increase in the
estimated number of drivers needing medical examinations per year is
great enough to require more registered MEs than the 40,000 we used as
the baseline for calculating the costs of the program. The increase in
medical certifications does not, therefore, impact our estimate of the
direct costs of the rule, which are based on the cost of training,
certifying, and registering a given number of MEs. This rule does not
change the regulations and guidelines that MEs use to determine how
long drivers are certified.
    In regard to counting intrastate-only driver examinations, FMCSA
acknowledges the potential impact of certifying intrastate drivers and
exempted school bus drivers on the number of driver examinations MEs on
the National Registry will perform. However, for the purposes of
estimating the costs of the program, as required by 49 U.S.C.
31136(c)(2)(A) and Executive Order 12866 (see Section VI below), we
considered the direct impact of the rule, which is limited to
interstate drivers.

E. Implementation of National Registry Program

1. Phased-In Implementation
    The NPRM proposed phasing in the requirement for using MEs listed
on the National Registry, with phase one requiring compliance for motor
carriers with more than 50 drivers (so-called large carriers), and
phase two requiring compliance for drivers not covered in phase one.
Phase one would have begun 2 years after the rule's effective date;
phase two would have begun 3 years after that date.
    The majority of commenters to this section opposed the
implementation schedule, while some offered alternatives to the
proposed approach. ATA claimed that it is unfair to require drivers of
large motor carriers to bear the costs of compliance for one year
longer than drivers of smaller motor carriers. A joint comment from ABA
and BISC voiced concern that the phased-in implementation schedule
could result in only a limited number of MEs obtaining certification,
which would make it difficult for drivers to locate an ME. The
commenter recommended a single two-year implementation period, which it
believed would provide adequate time for MEs to obtain certification.
Comcar Industries added that the proposed implementation schedule
demonstrates a lack of understanding of the transportation industry and
is not realistic or reasonable. The commenter stated that we did not
provide any valid reasons for proposing the approach and are
unjustified in forcing the motor carriers to be responsible for
implementation by requiring them to search for an ME when one may not
be available in certain areas. Both ATA and Comcar Industries urged us
to ensure that the National Registry is sufficiently populated
throughout the country before implementing the proposed requirements.
NSTA said that the proposed phase-in schedule would cause hardships for
rural school bus operations, because many school bus companies are not
located in areas where there is easy access to MEs. NSTA suggested that
we phase in the National Registry Program by either population density
or by facility size from which buses are dispatched rather than by
company size.
    OOIDA claimed that the schedule was developed on flawed Agency
assumptions. First, it stated that drivers employed by large carriers,
just as their smaller independent counterparts, have the same
likelihood of living in rural areas where MEs will not be concentrated.
The commenter then suggested that there will always be a shortage of
MEs in rural areas or other areas where the demand for examinations is
low.
    Dart Transit Company opposed the implementation schedule,
suggesting that to actually improve highway safety, all motor carriers
should be required to comply at the same time. California also
recommended that the proposed requirements should be applicable to all
participants on the effective date of the final rule. It noted that a
driver could avoid compliance by claiming employment by a ``small''
carrier; a

claim that the State SDLAs would be unable to verify.
    Schneider National and a chiropractor suggested a ``geographical''
or ``regional'' approach to implementation. Schneider National claimed
that ensuring there are a sufficient number of MEs in a particular
region will reduce the traveling burden on a driver to obtain his or
her examination. However, the chiropractor noted a potential drawback
to implementing this geographic or regional approach, suggesting that
MEs and drivers may not receive adequate notice that they are in a
regional area where they must follow the new requirements.
    Finally, Delaware suggested that FMCSA create a matrix that would
allow a State to determine by date when they must only accept medical
certificates issued by certified examiners.
    FMCSA Response: The Agency concurs with comments that the phase-in
schedule would pose some issues, such as limiting the number of MEs in
the first year. Additionally, FMCSA does not believe this would reflect
the reality of the industry's distribution of drivers. In response, the
Agency has eliminated the phase-in schedule from the final rule. The
final rule will require that all drivers requiring certification under
49 CFR part 391, subpart E must be certified by an ME on the National
Registry beginning 2 years after the effective date of this rule,
regardless of the size of the employing carrier. The cost estimates
based on the original phase-in period have been adjusted to account for
this change in the accompanying regulatory evaluation.
2. Reviews of Performance of Medical Examiners
    The NPRM proposed implementation of the SAFETEA-LU requirement that
MEs 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 49 CFR 391.43
(49 U.S.C. 31149(c)(1)(E)). OccuMedix, Dart Transit Company, and
Advocates supported implementing a quality assurance program with a
detailed removal process for non-compliant MEs. Advocates asserted we
must ensure MEs fulfill the requirement to provide information about
completed medical examinations on a regular basis. The commenter
described our proposed oversight as vestigial and hit-or-miss,
expressing concern that we did not detail the approach to ensure that
MEs actually are properly administering the physical examination.
    Transportation Safety Services recommended that we address the
problem area of many physician errors resulting from the physician's
support staff incorrectly completing the paperwork. California
requested that we provide a mechanism and authorize SDLAs to
immediately report to FMCSA any health care professionals not on the
National Registry who are performing driver examinations, and any MEs
engaged in fraudulent or illegal activity.
    Finally, a certified MRO recommended that we incorporate the
Federal Transit Administration's approach for ``Best Practices'' awards
for MEs that set model examples.
    FMCSA Response: FMCSA intends to ensure that MEs comply with the
requirement in this rule to electronically submit a completed MCSA-
5850, CMV Driver Medical Examination Results, form monthly to FMCSA.
The details of FMCSA's compliance and monitoring program will relate to
FMCSA's future implementation of the provision of SAFETEA-LU (49 U.S.C.
31149(c)(2)), and therefore will not be part of this rulemaking.
    FMCSA acknowledges that expanding the National Registry to include
training and certification of auxiliary staff, whether health care
professionals or administrative personnel, might be beneficial.
However, in order to minimize the cost burden to the public, the Agency
will not include these requirements in the final rule. MEs are reminded
that they are responsible for reviewing and correcting any errors in
the driver examination documentation.
    States, other stakeholders, or the public may direct complaints
about the performance of MEs as follows: If health care professionals
not listed in the National Registry are known to be performing required
driver examinations on or after 24 months from the effective date, or
if MEs are believed to be engaged in fraudulent or illegal activity,
FMCSA should be notified by: (1) Writing the Office of Carrier, Driver
and Vehicle Safety Standards, FMCSA, 1200 New Jersey Avenue SE.,
Washington, DC 20590; (2) sending an email to<EMAIL_ADDRESS>or
(3) calling an FMCSA-designated toll-free telephone number listed on
the National Registry Web site.
    Finally, FMCSA does not anticipate creating a ``best practice
award'' for MEs as part of the initial implementation of the National
Registry Program. FMCSA may revisit this issue after the program has
been fully implemented.

F. Issues Outside of the Scope of the Rulemaking

    A number of respondents submitted comments on topics that were
either outside the scope of what was proposed in the NPRM or were based
on a misunderstanding of what the Agency proposed in this rulemaking.
Many of these issues concern how FMCSA could prevent driver fraud in
the medical certification process, track commercial driver
examinations, require SDLAs to review Medical Examination Reports as
part of the CDL, or establish specific medical examination
requirements.
    FMCSA Response: FMCSA acknowledges the policy concerns of the
commenters. However, as stated in the NPRM, the legal and policy
direction of this rulemaking is limited to requiring drivers to be
examined by MEs that have been trained and certified to effectively
determine whether they meet FMCSA physical qualification standards
under 49 CFR part 391. FMCSA continues to believe this rulemaking
represents a major step in improving oversight capabilities by
establishing the National Registry, ensuring that MEs are trained and
qualified to perform driver examinations, removing MEs who do not meet
program requirements from the National Registry, and requiring carriers
and drivers to use only MEs on the National Registry.
    The driver certification issues addressed by this rule complement
the driver licensing issues that were addressed by the rule titled
``Medical Certification Requirements as Part of the CDL'' (December 1,
2008, 73 FR 73096), which established a system for interstate CDL
drivers to provide medical certification status information to the
SDLAs by providing the ME's certificates. It also required the SDLA to
post that medical certification status information into the CDLIS
driver record for licensing, enforcement, and employment decisions. The
2008 rule represented a significant first step in improving the
oversight capabilities of medical certification status information for
non-excepted, interstate CDL drivers.
    Neither this final rule nor the 2008 rule are intended to address
fraud perpetrated by drivers regarding their medical certification or
to update SDLAs on disqualified drivers. While we acknowledge that
these are important issues, these comments are outside the scope of
this rule. However, as previously stated, FMCSA anticipates initiating
a future rulemaking to expand medical certification information
exchange with the States.
    A third step toward improving oversight of the driver qualification

process is the review and revision, as necessary, of the driver
physical qualification standards. The Agency, with the advice of its
Medical Review Board and its newly appointed Chief Medical Examiner,
has begun the process, which will take several years to complete.
Changes to the standards and guidelines for driver qualification are
beyond the scope of this rulemaking.

G. Comments on the Modified Information Collection

    FMCSA published a request for public comments concerning a
modification of the proposed information collection request under
consideration on March 16, 2011 (76 FR 14366). FMCSA proposed a new
information collection burden related to a requirement for employers of
CMV drivers to verify the National Registry Number of the ME for each
driver required to be examined by an ME on the National Registry, and
to place a note relating to verification in the driver qualification
file.
    Comment on the information collection burden. One commenter, OOIDA,
noted that the information collection burden would affect a large
number of motor carriers and add to the already existing burden of
recordkeeping obligations for both small motor carriers and owner-
operators.
    FMCSA Response: The Agency's regulations already require small
carriers and owner-operators to comply with all of the regulations
applicable to both carriers and drivers (see 49 CFR 390.11). The
additional information collection burden from this verification
requirement on an individual employer is minimal, amounting to a few
minutes per driver. The Agency adopts the requirement for employers to
verify the ME's National Registry Number for each of its drivers, as
proposed.
    Comments beyond the scope of the information collection notice.
Multiple commenters, including several State organizations, stated that
requiring employers to verify the National Registry Number would be
redundant and unnecessary, because they believed the SDLAs would or
should verify the qualifications of the MEs as part of the process for
posting medical status information on CDLIS. FMCSA is not requiring
SDLAs to verify the National Registry Number. CDLIS only contains this
information for CDL holders, and, as employers will be required to
verify the ME numbers for both CDL holders and non-CDL holders, this
would not be sufficient.
    Several commenters, including AHAS, ATA, and OOIDA, noted that the
Agency's proposal would not substantially deter driver fraud, and
suggested alternate ways of addressing fraud. Several of these
suggestions would, if adopted, increase the burden of this rulemaking
on the employer or require additional public notice and comment
rulemaking.
    FMCSA Response: This rulemaking is one of several incremental steps
towards a comprehensive medical certification oversight process that
includes the ME, driver, and motor carrier. FMCSA believes that
employer verification of an ME National Registry Number is one of
several steps toward improving the driver medical certification
process. Eliminating opportunities for fraud from the process is one of
the goals for the medical certification oversight process. Though the
Agency is unable to implement these various suggestions for fraud
reduction in this final rule, they have been noted, and may be
considered in a future rulemaking.

V. Section-by-Section Explanation of Changes From the NPRM

Part 350 Commercial Motor Carrier Safety Assistance Program

    Section 350.341. FMCSA is revising this section so that States that
receive MCSAP grants and that have in effect variances for physical
qualification requirements for drivers operating CMVs in intrastate
commerce will have the option of not establishing a separate registry
of medical examiners trained and qualified to apply those standards.
Without this option, in order to comply with the general requirement of
compatibility established by 49 U.S.C. 31102 and 49 CFR 350.201(a),
such States would have the burden of establishing and administering a
separate registry for such examiners applying different standards to
intrastate-only CMV drivers. FMCSA does not believe it is necessary to
place that burden on the States that may have such variances in effect.
A State with variances in effect under 350.341(h)(1) and (2) that
chooses to set up a separate registry of examiners qualified to apply
those variances to intrastate drivers will not be allowed to use MCSAP
funds for that purpose. Such use of MCSAP grant funds would not be
consistent with the overall purpose of establishing a uniform standard
for all CMV drivers nationwide.

Part 383 Medical Recordkeeping

    Section 383.73(o)(1)(iii)(E). FMCSA revises the list of items that
the State must post to the CDLIS driver record by deleting the phrase
``(if the National Registry of Medical Examiners, mandated by 49 U.S.C.
31149(d), requires one)'' after ``Medical examiner's National Registry
identification number,'' because the National Registry Program
implementation will indeed require such a number for certified MEs.

Part 390 Definitions

    Section 390.5. The NPRM contained a phase-in schedule for
implementation. In the final rule, however, the proposed phase-in has
been eliminated and the revised definition applies beginning 2 years
after the effective date of the final rule. Thereafter, every medical
examination under subpart E of part 391 must be conducted by an ME
listed on the National Registry. FMCSA revises the proposed definition
of medical examiner to reflect that there is no phase-in schedule.

Subpart D of Part 390--National Registry of Certified Medical Examiners

    Section 390.103. FMCSA adds an introductory phrase to paragraph (b)
to clarify that it applies to a person who has ME certification. FMCSA
adopts paragraph (a)(1) as proposed. We require the applicant for
medical certification to have a legally permitted scope of practice
(i.e., license, certification, or registration) that allows him or her
to perform independently the requirements of Sec.  391.43. FMCSA
eliminates the reference to Appendix A from paragraph (a)(3) because
Appendix A was not adopted in the final rule. As originally proposed in
the NPRM, Appendix A specified contact information and required
statements ME candidates would have to submit to testing organizations
before the testing organizations would permit them to take the ME test.
In paragraph (a)(3), FMCSA also prohibits an applicant who does not
pass the certification test from retaking the test within 30 days, and
requires an applicant to take the certification test no more than three
years after completing the training.
    Section 390.105. FMCSA deletes the provision on compliance with
section 508 of the Rehabilitation Act for two reasons. First, this
section only applies to Federal departments and agencies that provide
electronic and information technology to their employees, or who use
such technology to provide information and services to members of the
public. Second, it is unnecessary in light of the provisions of section
504 of the Rehabilitation Act and Department regulations in 49 CFR part
28.
    Section 390.107. FMCSA makes changes to proposed Sec.  390.107