[Federal Register Volume 77, Number 77 (Friday, April 20, 2012)]
[Rules and Regulations]
[Pages 24103-24135]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-9034]
[[Page 24103]]
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 (202) 366-4001. Email: FMCSAMedical@dot.gov.
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
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Acronym or abbreviation Term
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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
[[Page 24105]]
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.
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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
[[Page 24106]]
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
[[Page 24107]]
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
[[Page 24108]]
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
[[Page 24109]]
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.
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\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.
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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
[[Page 24110]]
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.
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\2\ Executive agreements have the same legal effect as treaties.
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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:
[[Page 24111]]
[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
[[Page 24112]]
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.
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\3\ http://nrcme.fmcsa.dot.gov/training.aspx, retrieved July 13,
2011.
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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
[[Page 24113]]
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
[[Page 24114]]
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.
[[Page 24115]]
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.
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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
[[Page 24116]]
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
[[Page 24117]]
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
[[Page 24118]]
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
[[Page 24119]]
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 contactnrcme@dot.gov; 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
[[Page 24120]]
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
Medical examiner certification testing. The Agency adds a new paragraph
(b) (and changes the designation of the subsequent paragraphs as
appropriate),
[[Page 24121]]
to require additional security and privacy procedures for those testing
organizations who intend to administer the test on-line as an
alternative or additional option to in-person testing. FMCSA also
eliminates the reference to Appendix A of this part. The NPRM had
proposed an Appendix A, but FMCSA did not adopt it in the final rule. A
provision is added to make it clear that the test to be administered is
the currently authorized test developed and furnished by FMCSA.
Section 390.109. FMCSA adopts Sec. 390.109 Issuance of the FMCSA
medical examiner certification credential, as proposed, except to
specify compliance with the requirements of Sec. 390.103(a) or (b)
rather than compliance with the requirements of Sec. Sec. 390.103-
390.107.
Section 390.111. Although proposed paragraph (a)(5)(ii) would have
required a certified ME to retake the initial training in alternating
6-year periods, this requirement was not adopted. Instead, the ME will
be required to complete periodic training as specified by FMCSA every 5
years. The ME will still be required to take the certification test
every 10 years in order to retain the certification.
Section 390.113. The final rule adds a general statement of the
grounds for removal of an ME, based on 49 U.S.C. 31149.
Section 390.115. In the NPRM, this section described procedures for
removal from the National Registry. Proposed paragraph (d) addressed
requests for administrative review after an ME has been removed from
the National Registry, but did not describe what would happen if the
administrative review found that the removal of the ME was not valid.
To correct this oversight, FMCSA adds text to paragraph (d)(2), which
requires FMCSA to reinstate the ME and reissue a certification
credential. The reinstated ME essentially must follow the requirements
of Sec. 390.111(a), which describes what the ME must do to continue to
be listed on the National Registry. Similarly, FMCSA adds the same text
to paragraph (f), which describes applying for reinstatement on the
National Registry after voluntary or involuntary removal. In addition
to requiring a person who was involuntarily removed to complete
corrective actions described in the notice of proposed removal, the
rule requires reinstated MEs to follow the requirements of Sec.
390.111(a).
Proposed paragraph (g) would have required that if a person is
removed from the National Registry under paragraph (c) or (e), or a
removal is affirmed under paragraph (d), then that person's listing is
removed and the certification credential is no longer valid. FMCSA
deletes the phrase ``or a removal is affirmed under paragraph (d),''
because a person who requests administrative review under paragraph (d)
has already been removed from the National Registry under paragraph (c)
or (e). That person's listing has been removed and his or her
certification credential is no longer valid.
Finally, Director of Medical Programs is updated to Director,
Office of Carrier, Driver and Vehicle Safety Standards throughout to
reflect a change in FMCSA's organizational structure.
Appendix A. FMCSA does not adopt proposed Appendix A to part 390,
Medical Examiner Application Data Elements. Instead of adopting
proposed Appendix A, FMCSA will make available on its Web site the
current minimum data elements that must be included in the application
for medical examiner certification.
Part 391
Section 391.23. Amendments to paragraphs (m)(1) and (m)(2)(i)(B) of
this section require the motor carrier to verify that a driver was
certified by an ME on the National Registry beginning 2 years after the
effective date of the rule.
Section 391.42. The NPRM contained a phase-in schedule for
implementation. In the final rule, beginning 2 years after the
effective date of the final rule, this section now requires that every
medical examination under subpart E of part 391 must be conducted by an
ME listed on the National Registry. For the reasons explained above in
Section IV.E.1, FMCSA does not believe a phase-in period is necessary.
Section 391.43. The NPRM contained several proposed amendments to
Sec. 391.43, including an addition to the information required on a
medical examiner's certificate. FMCSA adopts paragraph (a) as proposed
to specify that, in accordance with the compliance schedule established
in Sec. 391.42, the medical examination must be performed by an ME
listed on the National Registry under subpart D of part 390 of this
chapter.
Proposed paragraph (g) would have required the ME to complete a
medical examiner's certificate for drivers found to be physically
qualified to drive a CMV. In the final rule, the paragraph is modified
slightly to reflect the wording of the current paragraph, which was
revised on December 1, 2008 (73 FR 73096) to include providing a copy
of the medical examiner's certificate to the driver's employer. FMCSA
adopts the proposed new requirement in paragraph (g)(3) that, once
every calendar month, the ME must electronically transmit certain
information to the FMCSA Director, Office of Carrier, Driver and
Vehicle Safety Standards. (Director of Medical Programs is updated to
Director, Office of Carrier, Driver and Vehicle Safety Standards to
reflect a change in FMCSA's organizational structure.) The final rule
specifies that the information must be provided on Form MCSA-5850 and
transmitted via a secure FMCSA-designated Web site.
FMCSA adopts proposed paragraph (h) to revise the medical
examiner's certificate by adding a field for the ME to enter his or her
unique National Registry Number. Under the proposed paragraph, MEs
would have been allowed to use printed certificates they have on hand
until 4 years after the effective date of the final rule. Because the
MEs do not need to be listed on the National Registry until 2 years
after the effective date of the rule, FMCSA believes additional time
for using up old certificates is unnecessary and the final rule does
not provide for the use of obsolete printed certificates.
FMCSA adopts proposed paragraph (i) to specify that the ME must
retain the original (paper or electronic) completed Medical Examination
Report and a copy or electronic version of the medical examiner's
certificate, and make them available, along with related medical
documentation, to an authorized representative of FMCSA or an
authorized Federal, State, or local enforcement agency representative,
within 48 hours of the request. The proposed paragraph would have
required the records to be retained for 3 years, but the final rule
retains the Med. Cert./CDL language, which specifies ``at least 3 years
from the date of the examination.'' Nothing in our 3-year retention
requirement precludes longer retention which, in fact, may be required
by States. In the case of an ME whose practice has closed, State law
will govern the retention of medical records. Some States may require
the ME's successor to retain drivers' medical records, or in the case
of a deceased ME, the ME's estate may be responsible for retaining the
records. Additionally, FMSCA has modified the medical examiner's
certificate to include additional information.
Section 391.51. FMCSA amends this section to require the motor
carrier to place a note in the driver qualification file relating to
verification of ME listing on the National Registry beginning 2 years
after the effective date of the final rule.
[[Page 24122]]
VI. Regulatory Analyses and Notices
Executive Order 12866 (Regulatory Planning and Review) and DOT
Regulatory Policies and Procedures as Supplemented by Executive Order
13563
The FMCSA has determined that this rulemaking action is a
significant regulatory action under Executive Order 12866, Regulatory
Planning and Review, as supplemented by Executive Order 13563 (76 FR
3821, January 18, 2011), and that it is significant under DOT
regulatory policies and procedures.
This rule establishes a training, testing, and registration program
that would 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.
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
qualification 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 qualification 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.
Alternatives
The regulatory evaluation that accompanied the NPRM for this rule
considered three alternatives for implementing this Program. One
alternative, referred to as the Public-Private Partnership Model,
involved a partnership between the Agency and various private-sector
training and testing organizations that currently exist to provide
continuing professional education and credentialing to medical
professionals. This Public-Private Partnership Model was the Agency's
preferred alternative. The majority of public comments to the docket
during the notice and comment period for the NPRM supported the Public-
Private Partnership Model over the other alternatives considered. This
final rule implements the Public-Private Partnership Model. Under this
partnership, the Agency will develop and provide guidance for the core
curriculum specifications and the certification test and protocols. Any
interested organization that can meet FMCSA requirements will be
eligible to deliver training or testing. Training would therefore be
delivered by private-sector professional associations, health care
organizations, and other for-profit and non-profit training groups.
Testing will be delivered by private-sector professional testing
organizations. After completing one of these accredited training
programs, passing the certification test, and agreeing to comply with
FMCSA administrative requirements, MEs will be listed on the National
Registry, and authorized to conduct CMV driver physical examinations.
Once the National Registry is fully implemented, only physical
examinations conducted by MEs on the National Registry will be
recognized by FMCSA and enforcement personnel as proof of driver
physical qualification.
The second alternative considered by the Agency at the NPRM stage
was based on the Federal Aviation Administration's Aviation Medical
Examiner program, referred to here as the Government Model. This
alternative required the Agency to establish its own centralized
training and testing program. As described in the regulatory evaluation
accompanying the NPRM, this program would have required MEs to attend
this Agency-run program and pass a test administered by the Agency.
Upon completion of the test, an ME would be eligible for listing on the
National Registry. This program's components are essentially the same
as the Public-Private Partnership Model, but all training and testing
would have been conducted by the Agency rather than private-sector
training and testing programs. This alternative would also have
required all MEs to travel to the FMCSA facility or other regional
training sites to receive the FMCSA training. This would have involved
greater travel expenses for MEs when compared to the Public-Private
Partnership Model, which has training programs distributed throughout
the country as well as some vendors who would offer on-line training
modules. However, this option would have given FMCSA optimal control
over the training of MEs.
The third alternative, referred to as the MRO Model, was based on
the current MRO program requirements set forth in 49 CFR part 40,
subpart G. The DOT MRO training program grew out of the DOT drug and
alcohol program, which monitors use of controlled substances and
alcohol. MROs are trained and certified by accredited training programs
operated by professional associations in cooperation with DOT. Only
licensed MDs or DOs are eligible to be MROs. MROs review drug and
alcohol test results for other safety-sensitive occupations such as
airline mechanics, train operators, and ship's pilots.
The existing program specifies that MROs who oversee drug and
alcohol testing for commercial drivers must attend a training and
certification program that meets DOT standards. Each of these programs
maintains its own registry of graduates rather than contributing names
to a single Federal database. DOT does not administer the training
curriculum or testing protocols for these programs. Thus, the Agency
would exert less control over a program based on the MRO model than
under the other options discussed at the NPRM stage. In addition, MRO
programs charge more for testing than would likely be charged for
testing in the
[[Page 24123]]
National Registry program. Long distance travel for the initial
training and testing would also have been required under this
alternative.
As noted, the Agency has chosen to adopt the Public-Private
Partnership Model at the final rule stage. This alternative was
estimated to have the lowest cost of the three alternatives considered,
and would afford the greatest degree of flexibility, convenience, and
training opportunity to MEs. Moreover, it was supported by the majority
of comments that mentioned the various alternative models proposed in
the NPRM. We summarize the estimated costs and benefits of the three
models below. To a large extent, costs have not changed. However, the
Agency has decided to drop the phase-in described in the NPRM in which
drivers who work for carriers who employ 50 or more drivers would be
required to comply with the rule one year earlier than drivers who work
for smaller carriers or are owner-operators. The Agency concurs with
comments received 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 the phase-in would reflect the reality of the
industry's distribution of drivers. Under this final rule, all drivers,
regardless of the size carrier they work for, are required to obtain
medical certification from a National Registry-certified ME within 2
years of the full implementation of the Program. This change has
advanced the date at which all drivers must be certified by an ME on
the National Registry, and as a result, a portion of the impacts that
would be felt by drivers and the industry will be felt earlier than
would have been the case with the phase-in. Related cost adjustments
are described below in detail.
Summary of Costs and Benefits
The costs and benefits for all three alternatives are analyzed in
this regulatory evaluation. It is anticipated that approximately 40,000
MEs will be needed for the NRCME to accommodate the demand for an
estimated 2.6 million medical examinations per year, and to provide
adequate access, both in terms of geographic coverage and relatively
short appointment waiting times. All alternatives involve an initial
training phase in which the 40,000 MEs receive training. This phase is
expected to last 2 years. At the beginning of the third year the Agency
requires drivers to be examined by MEs listed on the NRCME once their
current medical certification expires. Under Alternative 1, the
alternative adopted by this Final Rule, MEs are required to attend a
training conducted by a private-sector organization. It is anticipated
that this will result in training and testing fees that would have to
be paid by MEs. Under Alternative 2, no training or testing fees would
have been incurred by MEs, but the Agency would have borne the costs of
providing the training and testing services. MEs would have borne the
cost of long distance travel to the FMCSA training center under
Alternative 2. Long distance travel to a designated training program
was also anticipated under Alternative 3. Under Alternative 1 it is
anticipated that training programs will be available throughout the
country, and that some programs will offer online training courses,
which will minimize the need for long distance travel.
It is also anticipated that by screening out physically unqualified
drivers, this rule may require some drivers, who cannot meet the
physical qualification standards, and would no longer be able to evade
detection, to leave the industry and seek an alternative occupation.
Carriers to would bear the cost of hiring replacement drivers.
Recruiting new drivers is an activity that consumes carrier resources,
and there is therefore a cost associated with that activity. We
therefore provide an estimate of the number of drivers who may be
forced to retire from the occupation, and estimate the costs associated
with recruiting an equal number of replacement drivers.
The 10-year total cost of the Public-Private Partnership Model is
estimated at $232 million, when discounted at a 7 percent discount
rate. Undiscounted annual costs vary between $14 million and $59
million, with ME certification costs (training and testing costs plus
lost time and travel costs) being the largest portion of the cost at
approximately $31.5 million in the highest-cost year. Alternative 2 has
a total discounted 10-year cost of $383 million, with undiscounted
annual costs ranging between $17 million and $88 million. Alternative 3
has a total 10-year discounted cost of $337 million, with undiscounted
annual costs ranging between $16 million and $92 million. In all
alternatives, the value of ME time spent in training is the largest
portion of cost. The costs of the training/testing, including lost time
and travel costs for MEs, is estimated to vary between $63 million and
$131 million during the initial training phase, depending on the
alternative, with Alternative 1 having the lowest cost. The lower cost
associated with Alternative 1 is due to its minimization of travel and
associated costs, both in expenses and lost time, to MEs.
Because all three alternatives are expected to improve the
performance of MEs by equivalent amounts, total benefits are expected
to be equivalent for all programs. These benefits are based on the
reduction in CMV crashes that is likely to result from improved medical
screening of drivers. It is estimated that physically impaired
interstate drivers are responsible for approximately 9,687 of the
roughly 440,000 commercial motor vehicle crashes that occur annually.
Although it is not anticipated that this program would completely
eliminate these crashes, it is expected to prevent a portion of them.
We estimate that this program may prevent up to one-fifth of these
crashes annually, which would result in approximately 1,219 fewer
crashes per year. The estimated annual benefit associated with avoiding
these crashes is $189 million per year, undiscounted. These full
benefits are not realized until the program is fully phased in, which
is several years after the establishment of the program. Nevertheless,
at a 7 percent discount rate, the 10-year net benefits of this rule are
estimated at approximately $633.2 million to $784.1 million over 10
years depending on the alternative. The Agency's chosen alternative has
the highest net benefits at $784.1 million.
Regulatory Flexibility Act
The Regulatory Flexibility Act of 1980 (5 U.S.C. 601-612) requires
Federal agencies to consider the effects of the regulatory action on
small business and other small entities and to minimize any significant
economic impact. The term ``small entities'' comprises small businesses
and not-for-profit organizations that are independently owned and
operated and are not dominant in their fields, and governmental
jurisdictions with populations of less than 50,000. Accordingly, DOT
policy requires an analysis of the impact of all regulations on small
entities, and mandates that agencies strive to lessen any adverse
effects on these businesses. The Agency conducted an initial Regulatory
Flexibility Analysis for the NPRM and found that the rule would not
have a significant economic impact on a substantial number of small
entities. No comments were received on that analysis from the public. I
certify that this rule would not have a significant economic impact on
a substantial number of small entities.
Unfunded Mandates Reform Act of 1995
This rulemaking will not impose an unfunded Federal mandate, as
defined by the Unfunded Mandates Reform Act
[[Page 24124]]
of 1995 (2 U.S.C. 1532, et seq.), that would result in the expenditure
by State, local, and tribal governments, in the aggregate, or by the
private sector, of $143.1 million or more in any 1 year. The $143.1
million figure was derived by inflation adjusting the $100 million cap
in the original Act from 1995 to 2010 dollars using the Consumer Price
Index.
Executive Order 12988 (Civil Justice Reform)
This action meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.
Executive Order 13045 (Protection of Children)
FMCSA analyzed this action under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. We
determined that this rulemaking does not concern an environmental risk
to health or safety that may disproportionately affect children.
Executive Order 12630 (Taking of Private Property)
This final rule does not effect a taking of private property or
otherwise have taking implications under Executive Order 12630,
Governmental Actions and Interference with Constitutionally Protected
Property Rights.
Executive Order 13132 (Federalism)
FMCSA analyzed this rule in accordance with the principles and
criteria contained in Executive Order 13132. FMCSA has determined that
this rulemaking will have no significant cost or other effect on or for
States. States will have policy-making discretion. Nothing in this
document will preempt any State law or regulation. Therefore, this rule
does not have sufficient federalism implications to warrant the
preparation of a federalism assessment.
Executive Order 12372 (Intergovernmental Review)
The regulations implementing Executive Order 12372 regarding
intergovernmental consultation on Federal programs and activities do
not apply to this program.
Privacy Impact Assessment
FMCSA conducted a privacy impact assessment of this rule as
required by section 522(a)(5) of division H of the Fiscal Year 2005
Omnibus Appropriations Act, Public Law 108-447, 118 Stat. 3268
(December 8, 2004) (set out as a note to 5 U.S.C. 552a). The assessment
considers any impacts of the rule on the privacy of information in an
identifiable form and related matters. FMCSA determined that this
initiative will create impacts on privacy of information associated
with implementation of this rule.
FMCSA only collects PII necessary for official purposes as stated
in the National Registry final rule. In addition, FMCSA only obtains
such PII by lawful and fair means and, to the greatest extent possible,
with the knowledge or consent of the individual. The FMCSA Office of
Information Technology adheres to the Fair Information Practice
Principles (FIPPs) to assist the Agency in protecting the
confidentiality and privacy of PII associated with the implementation
of the National Registry final rule. These best practices incorporate
standards and practices equivalent to those required under the Privacy
Act of 1974 (5 U.S.C. 552a) and other Federal laws that are consistent
with the FIPPs. These practices include management, operational, and
technical safeguards that are appropriate for the protection of PII.
The entire privacy impact assessment is available for review in the
docket.
Paperwork Reduction Act
This rule contains the following new information collection
requirements. As required by the Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3507(d)), FMCSA submitted the information requirements
associated with the proposal to the Office of Management and Budget for
its review.
Title: National Registry of Certified Medical Examiners (National
Registry).
Summary: Under SAFETEA-LU, the Secretary of Transportation is
required to establish and maintain a current national registry of
medical examiners who are qualified to perform examinations and issue
medical certificates that verify whether a CMV driver's health meets
FMCSA standards. In addition, section 4116(b) of SAFETEA-LU requires
that the medical examinations of CMV operators be performed by MEs who
have received training in physical and medical examination standards,
and, after the National Registry is established, are listed on the
National Registry. SAFETEA-LU also requires MEs to electronically
transmit the name of the applicant and FMCSA numerical identifier for
any completed Medical Examination Report required under Sec. 391.43 to
the Chief Medical Examiner on a monthly basis.
Once the National Registry Program is implemented, FMCSA will
accept medical examinations performed only by certified MEs listed on
the National Registry, as required by law. The National Registry
Program would require MEs to complete training developed from
standardized curriculum specifications and pass a national
certification test. The procedures used to develop and maintain the
quality of the Program are expected to be in accordance with national
accreditation standards for certification programs established by the
NCCA, the accreditation arm of the National Organization for Competency
Assurance.
Requirements imposed on intrastate drivers and employers for this
information collection are being considered since State laws are
generally in substantial conformity with the Federal regulations for
medical qualifications of commercial drivers. Consequently, the
estimate of the number of CMV drivers (respondents) covered by this
information collection reflects both interstate drivers subject to the
FMCSRs and intrastate drivers subject to compatible State regulations.
Although Federal regulations do not require States to comply with the
medical requirements in the FMCSRs, most States do mirror the Federal
requirements; therefore, we are including intrastate drivers, which is
consistent with other FMCSA information collections, to accurately
reflect the burden of this information collection.
Close tracking and monitoring of certification activities and
medical outcomes are crucial, and the rule addresses the information
collection aspects of National Registry implementation. To this end,
the rule requires MEs to submit four types of data:
(1) Medical Examiner Application and Test Results Data: To be
listed on the National Registry, MEs must first pass a certification
test to ensure they demonstrate an established level of competency.
FMCSA and private-sector testing organizations will collect data from
MEs as the medical professionals apply to take this certification test.
Data elements required of MEs at the time of application will include
professional contact and identifying information such as job title,
address, and training and State licenses obtained. These data will be
collected each time the ME applies to sit for the certification test
and information will be updated with FMCSA as needed. Test results data
will include total test score and responses for each test item.
Private-sector testing organizations will regularly transmit medical
examiner data and test results
[[Page 24125]]
electronically to FMCSA for inclusion in a centralized, confidential
database.
(2) CMV Driver Medical Examination Results Data: Once every
calendar month, each ME listed on the National Registry is required to
complete and transmit to FMCSA Form MCSA-5850, CMV Driver Medical
Examination Results, with the following information about each CMV
driver examined during the previous month: Name, date of birth,
driver's license number and State, date of examination, an indication
of the examination outcome (for example, medically qualified), whether
intrastate driver only, and date of driver medical certification
expiration. Data will be submitted electronically via a secure FMCSA-
designated Web site. In order to continue to be listed on and to
continue participation in the National Registry, MEs need to comply
with this requirement on a monthly basis. MEs who examine drivers who
operate only in intrastate commerce may report those driver examination
results on the form and check the checkbox for ``Intrastate Only''.
Data on intrastate only driver examinations will be used to provide
information to State and local enforcement officials on medical
examiner performance and driver physical qualifications.
(3) Medical Examination Reports and Medical Examiner's
Certificates: The National Registry Final Rule requires medical
examiners to provide copies of Medical Examination Reports and medical
examiner's certificates to authorized representatives, special agents,
or investigators of the FMCSA or authorized State or local enforcement
agency representatives. These documents contain the driver's social
security number, date of birth, driver license number, and health and
medical information.
It is necessary for medical examiners to provide Medical
Examination Reports and medical examiner's certificates to an
authorized representative, special agent, or investigator of FMCSA or
an authorized State or local enforcement agency representative in order
to determine ME compliance with FMCSA medical standards and guidelines
in performing CMV driver medical examinations. Failure to comply with
FMCSA medical standards and guidelines may result in removal from the
National Registry. Medical examiner's certificates provide additional
documentation to determine compliance with FMCSA medical standards and
guidelines by linking the ME to both the medical examination and the
driver medical certification decision. They also determine compliance
by ensuring the certification decision matches the information in the
medical examination and that the certificate is completed correctly.
(4) Verification of National Registry Number by Motor Carriers:
Motor carriers will be required to verify the National Registry Number
of the medical examiner for each driver required to be examined by a
medical examiner on the National Registry and place a note relating to
verification in the driver qualification file, as required by
provisions in 49 CFR 391.23 and 391.51. This data collection
requirement will also provide proof that the motor carrier has met its
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).
Respondents (Including the Number of): The likely respondents to
this proposed information requirement are 40,000 MEs from medical
professions who are believed to conduct the majority of current CMV
driver medical examinations (APNs, DCs, DOs, MDs, and PAs) and one or
more national private-sector testing organizations that deliver the
certification test. We are unable to estimate the number of private-
sector organizations that might wish to perform testing.
Frequency: FMCSA estimates each of the respondents would provide ME
test application data every 6 years and updated information as needed.
FMCSA further estimates that each respondent would provide CMV driver
examination data a maximum of 12 times per year. It is estimated that
an average of approximately 20,000 MEs will apply to take the
certification test annually for the first 2 years of National Registry
implementation. It is estimated that one or more testing organizations
will deliver the FMCSA medical examiner certification test to 20,000
MEs annually for the first 2 years following implementation of the
National Registry Program. It is projected that MEs would file
4,623,000 medical examiner's certificates per year and that authorized
representatives of FMCSA or authorized State or local enforcement
agency representatives would request MEs to provide copies of the
Medical Report Form and the medical examiner's certificate 2,100 times
a year.
Annual Burden Estimate: This proposal would result in an annual
recordkeeping and reporting burden as follows:
FMCSA estimates each of the respondents will provide medical
examiner certification test results and application data every 6 years
and updated information to FMCSA as needed. It is estimated that 20,000
medical examiner candidates will apply to take the certification test
annually for the first 2 years of National Registry implementation, or
an average of 13,333 applicants per year for the first 3 years of the
program. FMCSA estimates that the total annual burden hours for the
collection of the medical examiner application data is 1,111 hours
[13,333 applicants x 5 minutes/60 minutes per response = 1,111 hours].
This annual burden includes medical examiner candidate time for
submitting the application data to the private-sector testing
organizations.
It is estimated that it will take private-sector testing
organization personnel 5 minutes per ME to collect and upload to FMCSA
application data and test results. FMCSA estimates that the total
annual burden hours for private-sector testing organizations to collect
medical examiner application data and send ME application and test
results data to FMCSA is 1,111 hours (13,333 applicants x 5 minutes/60
minutes per medical examiner = 1,111 hours).
FMCSA estimates that respondents would provide CMV driver
examination data a maximum of 12 times per year and would file
4,623,000 medical examiner's certificates per year. It is projected
that 40,000 certified MEs will be needed to perform the 4,623,000 CMV
driver medical examinations required annually. The transmission of CMV
driver examination data will require approximately 46,525 hours of
medical examiner administrative personnel time on a yearly basis
[40,000 registered medical examiners x 1 minute/60 minutes to file a
report x 12 reports per year + 4,623,000 reports x 30 seconds/3600
seconds to enter each driver's examination data elements = 46,525
hours]. It is estimated that it will take medical examiner
administrative personnel 30 seconds to file the medical examiner's
certificate. This will require approximately 38,525 hours of
administrative personnel time on a yearly basis [4,623,000 examinations
x 30 seconds/3600 seconds per certificate = 38,525]. In addition, FMCSA
estimates that half of motor carriers will request a copy of the
medical examiner's certificate and that it will take administrative
personnel 1 minute to provide a copy of the medical examiner's
certificate to a motor carrier. The annual time burden to the
administrative personnel for providing motor carriers with a copy of
the medical examiner's certificate is approximately 38,525 hours
[4,623,000 examinations x .5 (50%) x 1 minute/60 minutes = 38,525
hours]. The annual time burden to medical examiner administrative
personnel for transmitting CMV driver examination
[[Page 24126]]
data to the FMCSA, filing medical examiner's certificates, and
providing copies of the medical examiner's certificates to motor
carriers is approximately 123,575 hours [46,525 hours to enter driver
examination data elements and 38,525 hours for filing the medical
examiner's certificate and 38,525 hours for providing medical
examiner's certificates to motor carriers = 123,575 hours].
FMCSA estimates that authorized representatives, special agents, or
investigators of FMCSA or authorized State or local enforcement agency
representatives will request MEs to provide copies of the Medical
Examination Report and the medical examiner's certificate 2,100 times a
year.
It is estimated that it will take ME administrative personnel 5
minutes to provide both the Medical Examination Report and the medical
examiner's certificate to FMCSA or an authorized State or local
enforcement agency representative upon request, so this will require
approximately 175 hours of administrative personnel time on a yearly
basis [2,100 requests x 5 minutes/60 minutes per response = 175 hours].
FMCSA estimates that motor carriers will verify the National
Registry Number for 4,623,000 drivers per year who are medically
certified. It is estimated that it will take motor carrier
administrative personnel 4 minutes to verify the National Registry
Number, write a note regarding the verification, and file the note in
the Driver Qualification file, so this will require approximately
308,200 hours of administrative personnel time on a yearly basis
[4,623,000 verifications x 4 minutes/60 minutes per verification =
308,200 hours].
The total estimated annual time burden to respondents for the
National Registry components is approximately 434,172 hours \7\ [2,222
hours for provision of medical examiner application and test results
data (1,111 hours for medical examiners and 1,111 hours for testing
organizations) + 123,575 hours for CMV driver examinations (46,525
hours to enter driver examination data elements + 38,525 hours for
filing the medical examiner's certificate + 38,525 hours for providing
medical examiner's certificates to motor carriers) + 175 hours for
provision of Medical Examination Reports and medical examiner's
certificates + 308,200 hours for verification of National Registry
Number].
---------------------------------------------------------------------------
\7\ The accompanying supporting statement also reflects the
correction of a minor mathematical error.
---------------------------------------------------------------------------
National Environmental Policy Act and Clean Air Act
The Agency analyzed this final rule for the purpose of the National
Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.) and
determined under our environmental procedures Order 5610.1, published
March 1, 2004, in the Federal Register (69 FR 9680), that this action
required an Environmental Assessment (EA) to determine if a more
extensive Environmental Impact Statement was required. FMCSA prepared
an EA and placed it in the docket for this rulemaking. The EA found
that there are no significant negative impacts expected from the
actions. Although congestion and air emission impacts are discussed in
the EA, the impacts are minimal and are not expected to alter the
Nation's highway congestion or air emissions from surface or air
transportation vehicles. In addition, while not quantified in this
analysis, minor benefits to the environment from reducing CMV crashes
are expected.
We have also analyzed this rule under the Clean Air Act, as amended
(CAA), section 176(c) (42 U.S.C. 7401 et seq.), and implementing
regulations promulgated by the Environmental Protection Agency.
Approval of this action is exempt from the CAA's general conformity
requirement since it involves rulemaking and policy development and
issuance.
Executive Order 13211 (Energy Effects)
We analyzed this action under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We determined that it is not a ``significant
energy action'' under that Executive Order because it will not be
likely to have a significant adverse effect on the supply,
distribution, or use of energy.
Executive Order 12898 (Environmental Justice)
FMCSA evaluated the environmental effects of this final rule in
accordance with Executive Order 12898 and determined that there are no
environmental justice issues associated with its provisions and no
collective environmental impact resulting from its promulgation.
Executive Order 13175 (Tribal Consultation)
FMCSA analyzed this action under Executive Order 13175, dated
November 6, 2000, and believes that it will not have substantial direct
effects on one or more Indian tribes; will not impose substantial
compliance costs on Indian tribal governments; and will not preempt
tribal law. Therefore, a tribal summary impact statement is not
required.
List of Subjects
49 CFR Part 350
Grant programs--transportation, Highway safety, Motor carriers,
Motor vehicle safety, Reporting and recordkeeping requirements.
49 CFR Part 383
Administrative practice and procedure, Alcohol abuse, Drug abuse,
Highway safety, Motor carriers
49 CFR Part 390
Highway safety, Intermodal transportation, Motor carriers, Motor
vehicle safety, Reporting and recordkeeping requirements.
49 CFR Part 391
Alcohol abuse, Drug abuse, Drug testing, Highway safety, Motor
carriers, Reporting and recordkeeping requirements, Safety,
Transportation.
In consideration of the foregoing, FMCSA amends title 49, Code of
Federal Regulations, parts 350, 383, 390, and 391, as follows:
PART 350--COMMERCIAL MOTOR CARRIER SAFETY ASSISTANCE PROVISION
0
1. The authority citation for part 350 continues to read as follows:
Authority: 49 U.S.C. 13902, 31101-31104, 31108, 31136, 31140-
31141, 31161, 31310-31311, 31502; and 49 CFR 1.73.
0
2. In Sec. 350.341, add paragraph (h)(3) to to read as follows:
Sec. 350.341 What specific variances from the FMCSRs are allowed for
State laws and regulations governing motor carriers, CMV drivers, and
CMVs engaged in intrastate commerce and not subject to Federal
jurisdiction?
* * * * *
(h) * * *
(3) The State may decide not to adopt laws and regulations that
implement a registry of medical examiners trained and qualified to
apply physical qualification standards or variances continued in effect
or adopted by the State under this paragraph that apply to drivers of
CMVs in intrastate commerce.
[[Page 24127]]
PART 383--COMMERCIAL DRIVER'S LICENSE STANDARDS; REQUIREMENTS AND
PENALTIES
0
3. The authority citation for part 383 continues to read as follows:
Authority: 49 U.S.C. 521, 31136, 31301 et seq., and 31502; secs.
214 and 215, Pub. L. 106-159, 113 Stat. 1748, 1766, 1767; sec. 4140,
Pub. L. 109-59, 119 Stat. 1144, 1746; and 49 CFR 1.73.
0
4. Amend Sec. 383.73 to by revising paragraph (o)(1)(iii)(E)to read as
follows:
Sec. 383.73 State procedures.
* * * * *
(o) * * *
(1) * * *
(iii) * * *
(E) Medical examiner's National Registry Number issued in
accordance with Sec. 390.109;
* * * * *
PART 390--FEDERAL MOTOR CARRIER SAFETY REGULATIONS; GENERAL
0
5. Revise the authority citation for part 390 to read as follows:
Authority: 49 U.S.C. 504, 508, 31132, 31133, 31136, 31144,
31151, and 31502; sec. 114, Pub. L. 103-311, 108 Stat. 1673, 1677-
1678; secs. 212 and 217, Pub. L. 106-159, 113 Stat. 1748, 1766,
1767; sec. 229, Pub. L. 106-159 (as transferred by sec. 4115 and
amended by secs. 4130-4132, Pub. L. 109-59, 119 Stat. 1144, 1726,
1743-1744); sec. 4136, Pub. L. 109-59, 119 Stat. 1144, 1745; and 49
CFR 1.73.
0
6. Amend Sec. 390.5 by revising the definition of ``medical examiner''
to read as follows:
Sec. 390.5 Definitions.
* * * * *
Medical examiner means the following:
(1) For medical examinations conducted before May 21, 2014, a
person who is licensed, certified, and/or registered, in accordance
with applicable State laws and regulations, to perform physical
examinations. The term includes but is not limited to, doctors of
medicine, doctors of osteopathy, physician assistants, advanced
practice nurses, and doctors of chiropractic.
(2) For medical examinations conducted on and after May 21, 2014,
an individual certified by FMCSA and listed on the National Registry of
Certified Medical Examiners in accordance with subpart D of this part.
* * * * *
0
7. Add subpart D, consisting of Sec. Sec. 390.101 through 390.115, to
read as follows:
Subpart D--National Registry of Certified Medical Examiners
Sec.
390.101 Scope.
390.103 Eligibility requirements for medical examiner certification.
390.105 Medical examiner training programs.
390.107 Medical examiner certification testing.
390.109 Issuance of the FMCSA medical examiner certification
credential.
390.111 Requirements for continued listing on the National Registry
of Certified Medical Examiners.
390.113 Reasons for removal from the National Registry of Certified
Medical Examiners.
390.115 Procedure for removal from the National Registry of
Certified Medical Examiners.
Subpart D--National Registry of Certified Medical Examiners
Sec. 390.101 Scope.
The rules in this subpart establish the minimum qualifications for
FMCSA certification of a medical examiner and for listing the examiner
on FMCSA's National Registry of Certified Medical Examiners. The
National Registry of Certified Medical Examiners Program is designed to
improve highway safety and operator health by requiring that medical
examiners be trained and certified to determine effectively whether an
operator meets FMCSA physical qualification standards under part 391 of
this chapter. One component of the National Registry Program is the
registry itself, which is a national database of names and contact
information for medical examiners who are certified by FMCSA to perform
medical examinations of operators.
Sec. 390.103 Eligibility requirements for medical examiner
certification.
(a) To receive medical examiner certification from FMCSA a person
must:
(1) Be licensed, certified, or registered in accordance with
applicable State laws and regulations to perform physical examinations.
The applicant must be an advanced practice nurse, doctor of
chiropractic, doctor of medicine, doctor of osteopathy, physician
assistant, or other medical professional authorized by applicable State
laws and regulations to perform physical examinations.
(2) Complete a training program that meets the requirements of
Sec. 390.105.
(3) Pass the medical examiner certification test provided by FMCSA
and administered by a testing organization that meets the requirements
of Sec. 390.107 and that has electronically forwarded to FMCSA the
applicant's completed test and application information no more than
three years after completion of the training program required by
paragraph (a)(2) of this section. An applicant must not take the test
more than once every 30 days.
(b) If a person has medical examiner certification from FMCSA, then
to renew such certification the medical examiner must remain qualified
under paragraph (a)(1) of this section and complete additional testing
and training as required by Sec. 390.111(a)(5).
Sec. 390.105 Medical examiner training programs.
An applicant for medical examiner certification must complete a
training program that:
(a) Is conducted by a training provider that:
(1) Is accredited by a nationally recognized medical profession
accrediting organization to provide continuing education units; and
(2) Meets the following administrative requirements:
(i) Provides training participants with proof of participation.
(ii) Provides FMCSA point of contact information to training
participants.
(b) Provides training to medical examiners on the following topics:
(1) Background, rationale, mission, and goals of the FMCSA medical
examiner's role in reducing crashes, injuries, and fatalities involving
commercial motor vehicles.
(2) Familiarization with the responsibilities and work environment
of commercial motor vehicle operation.
(3) Identification of the operator and obtaining, reviewing, and
documenting operator medical history, including prescription and over-
the-counter medications.
(4) Performing, reviewing, and documenting the operator's medical
examination.
(5) Performing, obtaining, and documenting additional diagnostic
tests or medical opinion from a medical specialist or treating
physician.
(6) Informing and educating the operator about medications and non-
disqualifying medical conditions that require remedial care.
(7) Determining operator certification outcome and period for which
certification should be valid.
(8) FMCSA reporting and documentation requirements.
Guidance on the core curriculum specifications for use by training
providers is available from FMCSA.
[[Page 24128]]
Sec. 390.107 Medical examiner certification testing.
An applicant for medical examiner certification or recertification
must apply, in, accordance with the minimum specifications for
application elements established by FMCSA, to a testing organization
that meets the following criteria:
(a) The testing organization has documented policies and procedures
that:
(1) Use secure protocols to access, process, store, and transmit
all test items, test forms, test data, and candidate information and
ensure access by authorized personnel only.
(2) Ensure testing environments are reasonably comfortable and have
minimal distractions.
(3) Prevent to the greatest extent practicable the opportunity for
a test taker to attain a passing score by fraudulent means.
(4) Ensure that test center staff who interact with and proctor
examinees or provide technical support have completed formal training,
demonstrate competency, and are monitored periodically for quality
assurance in testing procedures.
(5) Accommodate testing of individuals with disabilities or
impairments to minimize the effect of the disabilities or impairments
while maintaining the security of the test and data.
(b) Testing organizations that offer testing of examinees not at
locations that are operated and staffed by the organizations but by
means of remote, computer-based systems must, in addition to the
requirements of paragraph (a) of this section, ensure that such
systems:
(1) Provide a means to authenticate the identity of the person
taking the test.
(2) Provide a means for the testing organization to monitor the
activity of the person taking the test.
(3) Do not allow the person taking the test to reproduce or record
the contents of the test by any means.
(c) The testing organization has submitted its documented policies
and procedures as defined in paragraph (a) of this section and, if
applicable, paragraph (b) of this section to FMCSA and agreed to future
reviews by FMCSA to ensure compliance with the criteria listed in this
section.
(d) The testing organization administers only the currently
authorized version of the medical examiner certification test developed
and furnished by FMCSA.
Sec. 390.109 Issuance of the FMCSA medical examiner certification
credential.
Upon compliance with the requirements of Sec. 390.103(a) or (b),
FMCSA will issue to a medical examiner applicant an FMCSA medical
examiner certification credential with a unique National Registry
Number and will add the medical examiner's name to the National
Registry of Certified Medical Examiners. The certification credential
will expire 10 years after the date of its issuance.
Sec. 390.111 Requirements for continued listing on the National
Registry of Certified Medical Examiners.
(a) To continue to be listed on the National Registry of Certified
Medical Examiners, each medical examiner must:
(1) Continue to meet the requirements of this subpart and the
applicable requirements of part 391 of this chapter.
(2) Report to FMCSA any changes in the application information
submitted under Sec. 390.103(a)(3) within 30 days of the change.
(3) Continue to be licensed, certified, or registered, and
authorized to perform physical examinations, in accordance with the
applicable laws and regulations of each State in which the medical
examiner performs examinations.
(4) Maintain documentation of State licensure, registration, or
certification to perform physical examinations for each State in which
the examiner performs examinations and maintain documentation of and
completion of all training required by this section and Sec. 390.105.
The medical examiner must make this documentation available to an
authorized representative of FMCSA or an authorized representative of
Federal, State, or local government. The medical examiner must provide
this documentation within 48 hours of the request for investigations
and within 10 days of the request for regular audits of eligibility.
(5) Maintain medical examiner certification by completing training
and testing according to the following schedule:
(i) No sooner than 4 years and no later than 5 years after the date
of issuance of the medical examiner certification credential, complete
periodic training as specified by FMCSA.
(ii) No sooner than 9 years and no later than 10 years after the
date of issuance of the medical examiner certification credential:
(A) Complete periodic training as specified by FMCSA; and
(B) Pass the test required by Sec. 390.103(a)(3).
(b) FMCSA will issue a new medical examiner certification
credential valid for 10 years to a medical examiner who complies with
paragraphs (a)(1) through (4) of this section and who successfully
completes the training and testing as required by paragraphs (a)(5)(i)
and (ii) of this section.
Sec. 390.113 Reasons for removal from the National Registry of
Certified Medical Examiners.
FMCSA may remove a medical examiner from the National Registry of
Certified Medical Examiners when a medical examiner fails to meet or
maintain the qualifications established by this subpart, the
requirements of other regulations applicable to the medical examiner,
or otherwise does not meet the requirements of 49 U.S.C. 31149. The
reasons for removal may include, but are not limited to:
(a) The medical examiner fails to comply with the requirements for
continued listing on the National Registry of Certified Medical
Examiners, as described in Sec. 390.111.
(b) FMCSA finds that there are errors, omissions, or other
indications of improper certification by the medical examiner of an
operator in either the completed Medical Examination Reports or the
medical examiner's certificates.
(c) The FMCSA determines the medical examiner issued a medical
examiner's certificate to an operator of a commercial motor vehicle who
failed to meet the applicable standards at the time of the examination.
(d) The medical examiner fails to comply with the examination
requirements in Sec. 391.43 of this chapter.
(e) The medical examiner falsely claims to have completed training
in physical and medical examination standards as required by this
subpart.
Sec. 390.115 Procedure for removal from the National Registry of
Certified Medical Examiners.
(a) Voluntary removal. To be voluntarily removed from the National
Registry of Certified Medical Examiners, a medical examiner must submit
a request to the FMCSA Director, Office of Carrier, Driver and Vehicle
Safety Standards. Except as provided in paragraph (b) of this section,
the Director, Office of Carrier, Driver and Vehicle Safety Standards
will accept the request and the removal will become effective
immediately. On and after the date of issuance of a notice of proposed
removal from the National Registry of Certified Medical Examiners, as
described in paragraph (b) of this section, however, the Director,
Office of Carrier, Driver and Vehicle Safety Standards will not approve
the medical
[[Page 24129]]
examiner's request for voluntary removal from the National Registry of
Certified Medical Examiners.
(b) Notice of proposed removal. Except as provided by paragraphs
(a) and (e) of this section, FMCSA initiates the process for removal of
a medical examiner from the National Registry of Certified Medical
Examiners by issuing a written notice of proposed removal to the
medical examiner, stating the reasons that removal is proposed under
Sec. 390.113 and any corrective actions necessary for the medical
examiner to remain listed on the National Registry of Certified Medical
Examiners.
(c) Response to notice of proposed removal and corrective action. A
medical examiner who has received a notice of proposed removal from the
National Registry of Certified Medical Examiners must submit any
written response to the Director, Office of Carrier, Driver and Vehicle
Safety Standards no later than 30 days after the date of issuance of
the notice of proposed removal. The response must indicate either that
the medical examiner believes FMCSA has relied on erroneous reasons, in
whole or in part, in proposing removal from the National Registry of
Certified Medical Examiners, as described in paragraph (c)(1) of this
section, or that the medical examiner will comply and take any
corrective action specified in the notice of proposed removal, as
described in paragraph (c)(2) of this section.
(1) Opposing a notice of proposed removal. If the medical examiner
believes FMCSA has relied on an erroneous reason, in whole or in part,
in proposing removal from the National Registry of Certified Medical
Examiners, the medical examiner must explain the basis for his or her
belief that FMCSA relied on an erroneous reason in proposing the
removal. The Director, Office of Carrier, Driver and Vehicle Safety
Standards will review the explanation.
(i) If the Director, Office of Carrier, Driver and Vehicle Safety
Standards finds FMCSA has wholly relied on an erroneous reason for
proposing removal from the National Registry of Certified Medical
Examiners, the Director, Office of Carrier, Driver and Vehicle Safety
Standards will withdraw the notice of proposed removal and notify the
medical examiner in writing of the determination. If the Director,
Office of Carrier, Driver and Vehicle Safety Standards finds FMCSA has
partly relied on an erroneous reason for proposing removal from the
National Registry of Certified Medical Examiners, the Director, Office
of Carrier, Driver and Vehicle Safety Standards will modify the notice
of proposed removal and notify the medical examiner in writing of the
determination. No later than 60 days after the date the Director,
Office of Carrier, Driver and Vehicle Safety Standards modifies a
notice of proposed removal, the medical examiner must comply with this
subpart and correct any deficiencies identified in the modified notice
of proposed removal as described in paragraph (c)(2) of this section.
(ii) If the Director, Office of Carrier, Driver and Vehicle Safety
Standards finds FMCSA has not relied on an erroneous reason in
proposing removal, the Director, Office of Carrier, Driver and Vehicle
Safety Standards will affirm the notice of proposed removal and notify
the medical examiner in writing of the determination. No later than 60
days after the date the Director, Office of Carrier, Driver and Vehicle
Safety Standards affirms the notice of proposed removal, the medical
examiner must comply with this subpart and correct the deficiencies
identified in the notice of proposed removal as described in paragraph
(c)(2) of this section.
(iii) If the medical examiner does not submit a written response
within 30 days of the date of issuance of a notice of proposed removal,
the removal becomes effective and the medical examiner is immediately
removed from the National Registry of Certified Medical Examiners.
(2) Compliance and corrective action. (i) The medical examiner must
comply with this subpart and complete the corrective actions specified
in the notice of proposed removal no later than 60 days after either
the date of issuance of the notice of proposed removal or the date the
Director, Office of Carrier, Driver and Vehicle Safety Standards
affirms or modifies the notice of proposed removal, whichever is later.
The medical examiner must provide documentation of compliance and
completion of the corrective actions to the Director, Office of
Carrier, Driver and Vehicle Safety Standards. The Director, Office of
Carrier, Driver and Vehicle Safety Standards may conduct any
investigations and request any documentation necessary to verify that
the medical examiner has complied with this subpart and completed the
required corrective action(s). The Director, Office of Carrier, Driver
and Vehicle Safety Standards will notify the medical examiner in
writing whether he or she has met the requirements to continue to be
listed on the National Registry of Certified Medical Examiners.
(ii) If the medical examiner fails to complete the proposed
corrective action(s) within the 60-day period, the removal becomes
effective and the medical examiner is immediately removed from the
National Registry of Certified Medical Examiners. The Director, Office
of Carrier, Driver and Vehicle Safety Standards will notify the person
in writing that he or she has been removed from the National Registry
of Certified Medical Examiners.
(3) At any time before a notice of proposed removal from the
National Registry of Certified Medical Examiners becomes final, the
recipient of the notice of proposed removal and the Director, Office of
Carrier, Driver and Vehicle Safety Standards may resolve the matter by
mutual agreement.
(d) Request for administrative review. If a person has been removed
from the National Registry of Certified Medical Examiners under
paragraph (c)(1)(iii), (c)(2)(ii), or (e) of this section, that person
may request an administrative review no later than 30 days after the
date the removal becomes effective. The request must be submitted in
writing to the FMCSA Associate Administrator for Policy and Program
Development. The request must explain the error(s) committed in
removing the medical examiner from the National Registry of Certified
Medical Examiners, and include a list of all factual, legal, and
procedural issues in dispute, and any supporting information or
documents.
(1) Additional procedures for administrative review. The Associate
Administrator may ask the person to submit additional data or attend a
conference to discuss the removal. If the person does not provide the
information requested, or does not attend the scheduled conference, the
Associate Administrator may dismiss the request for administrative
review.
(2) Decision on administrative review. The Associate Administrator
will complete the administrative review and notify the person in
writing of the decision. The decision constitutes final Agency action.
If the Associate Administrator decides the removal was not valid, FMCSA
will reinstate the person and reissue a certification credential to
expire on the expiration date of the certificate that was invalidated
under paragraph (g) of this section. The reinstated medical examiner
must:
(i) Continue to meet the requirements of this subpart and the
applicable requirements of part 391 of this chapter.
(ii) Report to FMCSA any changes in the application information
submitted under Sec. 390.103(a)(3) within 30 days of the
reinstatement.
(iii) Be licensed, certified, or registered in accordance with
applicable
[[Page 24130]]
State laws and regulations to perform physical examinations.
(iv) Maintain documentation of State licensure, registration, or
certification to perform physical examinations for each State in which
the examiner performs examinations maintain documentation of completion
of all training required by Sec. 390.105 and Sec. 390.111. The
medical examiner must also make this documentation available to an
authorized representative of FMCSA or an authorized representative of
Federal, State, or local government. The medical examiner must provide
this documentation within 48 hours of the request for investigations
and within 10 days of the request for regular audits of eligibility.
(v) Complete periodic training as required by the Director, Office
of Carrier, Driver and Vehicle Safety Standards.
(e) Emergency removal. In cases of either willfulness or in which
public health, interest, or safety requires, the provisions of
paragraph (b) of this section are not applicable and the Director,
Office of Carrier, Driver and Vehicle Safety Standards may immediately
remove a medical examiner from the National Registry of Certified
Medical Examiners and invalidate the certification credential issued
under Sec. 390.109. A person who has been removed under the provisions
of this paragraph may request an administrative review of that decision
as described under paragraph (d) of this section.
(f) Reinstatement on the National Registry of Certified Medical
Examiners. No sooner than 30 days after the date of removal from the
National Registry of Certified Medical Examiners, a person who has been
voluntarily or involuntarily removed may apply to the Director, Office
of Carrier, Driver and Vehicle Safety Standards to be reinstated. The
person must:
(1) Continue to meet the requirements of this subpart and the
applicable requirements of part 391 of this chapter.
(2) Report to FMCSA any changes in the application information
submitted under Sec. 390.103(a)(3).
(3) Be licensed, certified, or registered in accordance with
applicable State laws and regulations to perform physical examinations.
(4) Maintain documentation of State licensure, registration, or
certification to perform physical examinations for each State in which
the person performs examinations and maintains documentation of
completion of all training required by Sec. Sec. 390.105 and 390.111.
The medical examiner must also make this documentation available to an
authorized representative of FMCSA or an authorized representative of
Federal, State, or local government. The person must provide this
documentation within 48 hours of the request for investigations and
within 10 days of the request for regular audits of eligibility.
(5) Complete training and testing as required by the Director,
Office of Carrier, Driver and Vehicle Safety Standards.
(6) In the case of a person who has been involuntarily removed,
provide documentation showing completion of any corrective actions
required in the notice of proposed removal.
(g) Effect of final decision by FMCSA. If a person is removed from
the National Registry of Certified Medical Examiners under paragraph
(c) or (e) of this section, the certification credential issued under
Sec. 390.109 is no longer valid. However, the removed person's
information remains publicly available for 3 years, with an indication
that the person is no longer listed on the National Registry of
Certified Medical Examiners as of the date of removal.
PART 391--QUALIFICATIONS OF DRIVERS AND LONGER COMBINATION VEHICLE
(LCV) DRIVER INSTRUCTORS
0
8. Revise the authority citation for part 391 to read as follows:
Authority: 49 U.S.C. 504, 508, 31133, 31136, and 31502; sec.
4007(b), Pub. L. 102-240, 105 Stat, 1914, 2152; sec. 114, Pub. L.
103-311, 108 Stat. 1673, 1677; sec. 215, Pub. L. 106-159, 113 Stat.
1748, 1767; and 49 CFR 1.73.
0
9. Amend Sec. 391.23 by:
0
a. Revising paragraph (m)(1);
0
b. Removing ``, and'' at the end of paragraph (m)(2)(i)(A) and adding
in its place a period;
0
c. Redesignating paragraph (m)(2)(i)(B) as (m)(2)(i)(C) and adding a
new paragraph (m)(2)(i)(B).
The revision and addition read as follows:
Sec. 391.23 Investigation and inquiries.
* * * * *
(m) * * *
(1) The motor carrier must obtain an original or copy of the
medical examiner's certificate issued in accordance with Sec. 391.43,
and any medical variance on which the certification is based, and,
beginning on or after May 21, 2014, verify the driver was certified by
a medical examiner listed on the National Registry of Certified Medical
Examiners as of the date of issuance of the medical examiner's
certificate, and place the records in the driver qualification file,
before allowing the driver to operate a CMV.
(2) * * *
(i) * * *
(B) Beginning on or after May 21, 2014, that the driver was
certified by a medical examiner listed on the National Registry of
Certified Medical Examiners as of the date of medical examiner's
certificate issuance.
* * * * *
0
10. Add Sec. 391.42 to read as follows:
Sec. 391.42 Schedule for use of medical examiners listed on the
National Registry of Certified Medical Examiners.
On and after May 21, 2014, each medical examination required under
this subpart must be conducted by a medical examiner who is listed on
the National Registry of Certified Medical Examiners.
0
11. Amend Sec. 391.43 by revising paragraphs (a), (g), and (h), and
adding paragraph (i) to read as follows:
Sec. 391.43 Medical examination; certificate of physical examination.
(a) Except as provided by paragraph (b) of this section and as
provided by Sec. 391.42, the medical examination must be performed by
a medical examiner listed on the National Registry of Certified Medical
Examiners under subpart D of part 390 of this chapter.
* * * * *
(g) Upon completion of the medical examination required by this
subpart:
(1) The medical examiner must date and sign the Medical Examination
Report and provide his or her full name, office address, and telephone
number on the Report.
(2) If the medical examiner finds that the person examined is
physically qualified to operate a commercial motor vehicle in
accordance with Sec. 391.41(b), he or she must complete a certificate
in the form prescribed in paragraph (h) of this section and furnish the
original to the person who was examined. The examiner must provide a
copy to a prospective or current employing motor carrier who requests
it.
(3) Once every calendar month, beginning May 21, 2014, the medical
examiner must electronically transmit to the Director, Office of
Carrier, Driver and Vehicle Safety Standards, via a secure FMCSA-
designated Web site, a completed Form MCSA-5850, Medical Examiner
Submission of CMV Driver Medical Examination Results. The Form must
include all information specified for each medical examination
conducted during the previous month for any driver who is required to
be
[[Page 24131]]
examined by a medical examiner listed on the National Registry of
Certified Medical Examiners.
(h) The medical examiner's certificate shall be substantially in
accordance with the following form.
BILLING CODE 4910-EX-P
[[Page 24132]]
[GRAPHIC] [TIFF OMITTED] TR20AP12.000
BILLING CODE 4910-EX-C
[[Page 24133]]
(i) Each original (paper or electronic) completed Medical
Examination Report and a copy or electronic version of each medical
examiner's certificate must be retained on file at the office of the
medical examiner for at least 3 years from the date of examination. The
medical examiner must make all records and information in these files
available to an authorized representative of FMCSA or an authorized
Federal, State, or local enforcement agency representative, within 48
hours after the request is made.
0
12. Amend Sec. 391.51 by:
0
a. Removing ``and'' at the end of paragraph (b)(7)(iii);
0
b. Removing the period at the end of paragraph (b)(8) and adding in its
place ``; and'';
0
c. Removing ``and'' at the end of paragraph (d)(4);
0
d. Removing the period at the end of paragraph (d)(5) and adding in its
place ``; and''; and
0
e. Adding paragraphs (b)(9) and (d)(6).
The additions read as follows:
Sec. 391.51 General requirements for driver qualification files.
* * * * *
(b) * * *
(9) A note relating to verification of medical examiner listing on
the National Registry of Certified Medical Examiners required by Sec.
391.23(m).
* * * * *
(d) * * *
(6) The note relating to verification of medical examiner listing
on the National Registry of Certified Medical Examiners required by
Sec. 391.23(m).
Issued on: April 10, 2012.
Anne S. Ferro,
Administrator.
Appendix A
Guidance for the Core Curriculum Specifications
The guidance for the core curriculum specifications is intended
to assist training organizations in developing programs that would
be used to fulfill the proposed requirements in the Federal Motor
Carrier Safety Administration's (FMCSA) final rule for the National
Registry of Certified Medical Examiners (National Registry). The
final rule states that a medical examiner must complete a training
program. FMCSA explained in the preamble to the final rule that
training providers and organizations must follow the core curriculum
specifications in developing training programs for medical examiners
who apply for listing on the Agency's National Registry. This
training prepares medical examiners to:
Apply knowledge of FMCSA's driver physical
qualifications standards and advisory criteria to findings gathered
during the driver's medical examination; and
Make sound determinations of the driver's medical and
physical qualifications for safely operating a commercial motor
vehicle (CMV) in interstate commerce.
The rule, 49 CFR 390.105(b), lists eight topics which must be
covered in the core curriculum specifications. The core curriculum
specifications are arranged below by numbered topic, followed by
guidance to assist training providers in developing programs based
on the core curriculum specifications.
Guidance for Each of the Core Curriculum Specifications
(1) Background, rationale, mission and goals of the FMCSA
medical examiner's role in reducing crashes, injuries and fatalities
involving commercial motor vehicles.
Mission and Goals of Federal Motor Carrier Safety Administration
(FMCSA)
Discuss the history of FMCSA and its position within
the Department of Transportation including its establishment by the
Motor Carrier Safety Improvement Act of 1999 and emphasize FMCSA's
Mission to reduce crashes, injuries and fatalities involving large
trucks and buses.
Role of the Medical Examiner
Explain the role of the medical examiner as described
in 49 CFR 391.43.
(2) Familiarization with the responsibilities and work
environment of commercial motor vehicle (CMV) operations.
The Job of CMV Driving
Describe the responsibilities, work schedules, physical
and emotional demands and lifestyle among CMV drivers and how these
vary by the type of driving.
Discuss factors and job tasks that may be involved in a
driver's performance, such as:
[cir] Loading and unloading trailers;
[cir] Inspecting the operating condition of the CMV; and
[cir] Work schedules:
[dec221] irregular work, rest, and eating patterns/dietary
choices.
(3) Identification of the driver and obtaining, reviewing, and
documenting driver medical history, including prescription and over-
the-counter medications.
Driver Identification and Medical History:
Discuss the importance of driver identification and review of
the following elements of the driver's medical history as related to
the tasks of driving a CMV in interstate commerce.
Inspect a State-issued identification document with the
driver's photo to verify the identity of the individual being
examined; identify the commercial driver's license or other types of
driver's license.
Identify, query and note issues in a driver's medical
record and/or health history as available, which may include:
[cir] specific information regarding any affirmative responses
in the history;
[cir] any illness, surgery, or injury in the last five years;
[cir] any other hospitalizations or surgeries;
[cir] any recent changes in health status;
[cir] whether he/she has any medical conditions or current
complaints;
[cir] any incidents of disability/physical limitations;
[cir] current medications and supplements, and potential side
effects, which may be potentially disqualifying;
[cir] his/her use of recreational/addictive substances (e.g.,
nicotine, alcohol, inhalants, narcotics or other habit-forming
drugs);
[cir] disorders of the eyes (e.g., retinopathy, cataracts,
aphakia, glaucoma, macular degeneration, monocular vision);
[cir] disorders of the ears (e.g., hearing loss, hearing aids,
vertigo, tinnitus, implants);
[cir] cardiac symptoms and disease (e.g., syncope, dyspnea,
chest pain, palpitations, hypertension, congestive heart failure,
myocardial infarction, coronary insufficiency, or thrombosis);
[cir] pulmonary symptoms and disease (e.g., dyspnea, orthopnea,
chronic cough, asthma, chronic lung disorders, tuberculosis,
previous pulmonary embolus, pneumothorax);
[cir] sleep disorders (e.g., obstructive sleep apnea, daytime
sleepiness, loud snoring, other);
[cir] gastrointestinal disorders (e.g., liver disease, digestive
problems, hernias);
[cir] genitourinary disorders (e.g., kidney stones and other
renal conditions, renal failure, hernias);
[cir] diabetes mellitus:
[dec221] current medications (type, potential side effects,
duration on current medication);
[dec221] complications from diabetes; and
[dec221] presence and frequency of hypoglycemic/hyperglycemic
episodes/reactions;
[cir] other endocrine disorders (e.g., thyroid disorders,
interventions/treatment);
[cir] musculoskeletal disorders (e.g., amputations, arthritis,
spinal surgery);
[cir] neurologic disorders (e.g., loss of consciousness,
seizures, stroke/transient ischemic attack, headaches/migraines,
numbness/weakness); or
[cir] psychiatric disorders (e.g., schizophrenia, severe
depression, anxiety, bipolar disorder, or other conditions) that
could impair a driver's ability to safely function.
(4) Performing, reviewing and documenting the driver's medical
examination.
Physical Examination (Qualification/Disqualification Standards (Sec.
391.41 and 391.43))
Explain the FMCSA physical examination requirements and
advisory criteria in relationship to conducting the driver's
physical examination of the following:
[cir] Eyes (Sec. 391.41(b)(10))
[dec221] equal reaction of both pupils to light;
[dec221] evidence of nystagmus and exophthalmos;
[dec221] evaluation of extra-ocular movements.
[cir] Ears (Sec. 391.41(b)(11))
[dec221] abnormalities of the ear canal and tympanic membrane;
[dec221] presence of a hearing aid.
[cir] Mouth and throat (Sec. 391.41(b)(5))
[dec221] conditions contributing to difficulty swallowing,
speaking or breathing;
[cir] Neck (Sec. 391.41(b)(7))
[dec221] range of motion;
[[Page 24134]]
[dec221] soft tissue palpation/examination (e.g., lymph nodes,
thyroid gland).
[cir] Heart (Sec. 391.41(b)(4) and (b)(6))
[dec221] chest inspection (e.g., surgical scars, pacemaker/
implantable automatic defibrillator);
[dec221] auscultation for thrills, murmurs, extra sounds, and
enlargement;
[dec221] blood pressure and pulse (rate and rhythm);
[dec221] additional signs of disease (e.g., edema, bruits,
diaphoresis, distended neck veins.
[cir] Lungs, chest, and thorax (Sec. 391.41(b)(5))
[dec221] respiratory rate and pattern;
[dec221] auscultation for abnormal breath sounds;
[dec221] abnormal chest wall configuration/palpation.
[cir] Abdomen (Sec. 391.41(a)(3)(i) and 391.43(f))
[dec221] surgical scars;
[dec221] palpation for enlarged liver or spleen, abnormal masses
or bruits/pulsation, abdominal tenderness, hernias (e.g., inguinal,
umbilical, ventral, femoral or other abnormalities).
[cir] Spine (Sec. 391.41(b)(7))
[dec221] surgical scars and deformities;
[dec221] tenderness and muscle spasm;
[dec221] loss in range of motion and painful motion;
[dec221] spinal deformities.
[cir] Extremities and trunk (Sec. 391.41(b)(1), (b)(4) and
(b)(7))
[dec221] gait, mobility, and posture while bearing his/her
weight; limping or signs of pain;
[dec221] loss, impairment, or use of orthosis;
[dec221] deformities, atrophy, weakness, paralysis, or surgical
scars;
[dec221] elbow and shoulder strength, function, and mobility;
[dec221] handgrip and prehension relative to requirements for
controlling a steering wheel and gear shift;
[dec221] varicosities, skin abnormalities, and cyanosis,
clubbing, or edema;
[dec221] leg length discrepancy; lower extremity strength,
motion, and function
[dec221] other abnormalities of the trunk.
[cir] Neurologic status (Sec. 391.41(b)(7), (b)(8) and(b)(9))
[dec221] impaired equilibrium, coordination or speech pattern
(e.g., ataxia);
[dec221] sensory or positional abnormalities;
[dec221] tremor;
[dec221] radicular signs;
[dec221] reflexes (e.g., asymmetric deep-tendon, normal/abnormal
patellar and Babinski).
[cir] Mental status (Sec. 391.41(b)(9))
[dec221] comprehension and interaction;
[dec221] cognitive impairment;
[dec221] signs of depression, paranoia, antagonism, or
aggressiveness that may require follow-up with a mental health
professional.
(5) Performing, obtaining and documenting diagnostic tests and
obtaining additional testing or medical opinion from a medical
specialist or treating physician.
Diagnostic Testing and Further Evaluation
Describe the FMCSA diagnostic testing requirements and
the medical examiner's ability to request further testing and
evaluation by a specialist.
[cir] Urine test for specific gravity, protein, blood and
glucose (Sec. 391.41(a)(3)(i));
[cir] Whisper or audiometric testing (Sec. 391.41(b)(11));
[cir] Vision testing for color vision, distant acuity,
horizontal field of vision and presence of monocular vision (Sec.
391.41(b)(10));
[cir] Other testing as indicated to determine the driver's
medical and physical qualifications for safely operating a CMV.
[cir] Refer to a specialist a driver who exhibits evidence of
any of the following disorders (Sec. 391.43(e) and (f)):
[dec221] vision (e.g., retinopathy, macular degeneration);
[dec221] cardiac (e.g., myocardial infarction, coronary
insufficiency, blood pressure control);
[dec221] pulmonary (e.g., emphysema, fibrosis);
[dec221] endocrine (e.g., diabetes);
[dec221] musculoskeletal (e.g., arthritis, neuromuscular
disease);
[dec221] neurologic (e.g., seizures);
[dec221] sleep (e.g., obstructive sleep apnea);
[dec221] mental/emotional health (e.g., depression,
schizophrenia); or
[dec221] other medical condition(s) that may interfere with
ability to safely operate a CMV.
(6) Informing and educating the driver about medications and
non-disqualifying medical conditions that require remedial care.
Health Counseling
Inform course participants of the importance of
counseling the driver about:
[cir] possible consequences of non-compliance with a care plan
for conditions that have been advised for periodic monitoring with
primary healthcare provider;
[cir] possible side effects and interactions of medications
(e.g., narcotics, anticoagulants, psychotropics) including products
acquired over-the-counter (e.g., antihistamines, cold and cough
medications or dietary supplements) that could negatively affect
his/her driving;
[cir] the effect of fatigue, lack of sleep, poor diet, emotional
conditions, stress, and other illnesses that can affect safe
driving;
[cir] if he/she is a contact lens user, the importance of
carrying a pair of glasses while driving;
[cir] if he/she uses a hearing aid, the importance of carrying a
spare power source for the device while driving;
[cir] if he/she has a history of deep vein thrombosis, the risk
associated with inactivity while driving and interventions that
could prevent another thrombotic event;
[cir] if he/she has a diabetes exemption, that he/she should:
[dec221] carry a rapidly absorbable form of glucose while
driving;
[dec221] self-monitor blood glucose one hour before driving and
at least once every four hours while driving;
[dec221] comply with each condition of his/her exemption;
[dec221] plan to submit glucose monitoring logs for each annual
recertification;
[cir] corrective or therapeutic steps needed for conditions
which may progress and adversely impact safe driving ability (e.g.,
seek follow-up from primary care physician);
[cir] steps needed for reconsideration of medical certification
if driver is certified with a limited interval, e.g., the return
date and documentation required for extending the certification time
period.
(7) Determining driver certification outcome and period for
which certification should be valid.
Assessing the Driver's Qualifications and Disposition
Explain how to assess the driver's medical and physical
qualification to operate a CMV safely in interstate commerce using
the medical examination findings weighed against the physical and
mental demands associated with operating a CMV by:
[cir] Considering a driver's ability to
[dec221] move his/her body through space while climbing ladders;
bend, stoop, and crouch; enter and exit the cab;
[dec221] manipulate steering wheel;
[dec221] perform precision prehension and power grasping;
[dec221] use arms, feet, and legs during CMV operation;
[dec221] inspect the operating condition of a tractor and/or
trailer;
[dec221] monitor and adjust to a complex driving situation; and
[dec221] consider the adverse health effects of fatigue
associated with extended work hours without breaks;
[cir] Considering identified disease or condition(s) progression
rate, stability, and likelihood of gradual or sudden incapacitation
for documented conditions (e.g., cardiovascular, neurologic,
respiratory, musculoskeletal and other).
Medical Certificate Qualification/Disqualification Decision and
Examination Intervals
Discuss the medical examiner's obligation to consider
potential risk to public safety and the driver's medical and
physical qualifications to drive safely when issuing a Medical
Examiner's Certificate, when to qualify/disqualify the driver and
how to determine the expiration date of the certificate by:
[cir] using the requirements stated in the FMCSRs, with
nondiscretionary certification standards to disqualify a driver
[dec221] with a history of epilepsy;
[dec221] with diabetes requiring insulin control (unless
accompanied by an exemption);
[dec221] when vision parameters (e.g., acuity, horizontal field
of vision, color) fall below minimum standards unless accompanied by
an exemption;
[dec221] when hearing measurements with or without a hearing aid
fall below minimum standards;
[dec221] currently taking methadone;
[dec221] with a current clinical diagnosis of alcoholism; or
[dec221] who uses a controlled substance including a narcotic,
an amphetamine, or another habit-forming drug without a prescription
from the treating physician;
[cir] using clinical expertise, disqualify a driver when
evidence shows a driver has a medical condition that in your opinion
will likely interfere with the safe operation of a CMV;
[cir] certifying a driver for an appropriate duration of
certification interval;
[[Page 24135]]
[cir] if he/she has a condition for which the medical examiner
is deferring the driver's medical certification or disqualifying the
driver, informing the driver of the reasons which may include:
[dec221] a vision deficiency (e.g., retinopathy, macular
degeneration);
[dec221] the immediate post-operative period;
[dec221] a cardiac event (e.g., myocardial infarction, coronary
insufficiency);
[dec221] a chronic pulmonary exacerbation (e.g., emphysema,
fibrosis);
[dec221] uncontrolled hypertension;
[dec221] endocrine dysfunctions (e.g., insulin-dependent
diabetes);
[dec221] musculoskeletal challenges (e.g., arthritis,
neuromuscular disease);
[dec221] a neurologic event (e.g., seizures, stroke, TIA);
[dec221] a sleep disorder (e.g., obstructive sleep apnea); or
[dec221] mental health dysfunctions (e.g., depression, bipolar
disorder).
(8) FMCSA reporting and documentation requirements.
Documentation of Medical Examination Findings
Demonstrate the required FMCSA medical examination report forms,
appropriate methods for recording the medical examination findings
and the rationale for certification decisions including:
Medical Examination Report Form
[cir] identification of the driver;
[cir] use of appropriate Medical Examination Report form;
[cir] assurance that driver completes and signs driver's portion
of the Medical Examination Report form;
[cir] specifics regarding any affirmative response on the
driver's medical history;
[cir] height/weight, blood pressure, pulse;
[cir] results of the medical examination, including details of
abnormal findings;
[cir] audiometric and vision testing results;
[cir] presence of a hearing aid and whether it is required to
meet the standard;
[cir] if obtained, funduscopic examination results;
[cir] the need for corrective lenses for driving;
[cir] presence or absence of monocular vision and need for a
vision exemption;
[cir] if driver has diabetes mellitus and is insulin dependent,
the need for a diabetes exemption;
[cir] other laboratory, pulmonary, cardiac testing performed;
and
[cir] the reason(s) for the disqualification and/or referral.
Other supporting documentation
[cir] if driver has current vision exemption, include the
ophthalmologist's or optometrist's report;
[cir] if a driver has a diabetes exemption, include the
endocrinologist's and ophthalmologist's/optometrist's report;
[cir] treating physician's work release;
[cir] if obtained, specialist's evaluation report;
[cir] if the driver has a current Skill Performance Evaluation
Certificate, include it; and
[cir] results of Substance Abuse Professional evaluations for
alcohol and drug use and/or abuse for a driver with
[dec221] alcoholism who completed counseling and treatment to
the point of full recovery.
Medical Examiner's Certificate
[cir] certification status, which may require:
[dec221] waiver/exemption;
[dec221] wearing corrective lenses;
[dec221] wearing a hearing aid; or
[dec221] a Skill Performance Evaluation Certificate;
[cir] complete and accurate documentation on medical
certification card including:
[dec221] the examiner's name, examination date, office address,
and telephone number and Medical Examiner signature; and
[dec221] the driver's signature.
[FR Doc. 2012-9034 Filed 4-19-12; 8:45 am]
BILLING CODE 4910-EX-P