National Registry of Certified Medical Examiners, 24104-24135 [2012-9034]
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Federal Register / Vol. 77, No. 77 / Friday, April 20, 2012 / Rules and Regulations
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
Federal Motor Carrier Safety
Administration (FMCSA), DOT.
ACTION: Final rule.
AGENCY:
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
SUMMARY:
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.
Effective on May 21, 2012.
Compliance required beginning on May
21, 2014.
DATES:
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 https://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 https://
DocketInfo.dot.gov.
This
document is organized as follows:
SUPPLEMENTARY INFORMATION:
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
AANP ...........................................................................
AAOHN ........................................................................
AAPA ...........................................................................
ABA ..............................................................................
ACOEM ........................................................................
ADA ..............................................................................
Advocates ....................................................................
AME .............................................................................
APN ..............................................................................
ATA ..............................................................................
BISC .............................................................................
CAA ..............................................................................
CDL ..............................................................................
CDLIS ..........................................................................
CME .............................................................................
CMV .............................................................................
DC ................................................................................
DEP ..............................................................................
DO ................................................................................
DOT .............................................................................
EA ................................................................................
FHWA ..........................................................................
FMCSA ........................................................................
FMCSRs ......................................................................
HIPAA ..........................................................................
ISAREC ........................................................................
LTCCS .........................................................................
LFC ..............................................................................
MCMIS .........................................................................
MCSAP ........................................................................
MD ...............................................................................
ME ................................................................................
MEP .............................................................................
Med. Cert./CDL ............................................................
MOU .............................................................................
MRB .............................................................................
MRO .............................................................................
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American Academy of Nurse Practitioners
American Association of Occupational Health Nurses
American Academy of Physician Assistants
American Bus Association
American College of Occupational and Environmental Medicine
American Diabetes Association
Advocates for Highway and Auto Safety
Aviation Medical Examiner
Advanced Practice Nurse
American Trucking Associations, Inc.
Bus Industry Safety Council
Clean Air Act
Commercial Driver’s License
Commercial Driver’s License Information System
Continuing Medical Education
Commercial Motor Vehicle
Doctor of Chiropractic
Diabetes Expert Panel
Doctor of Osteopathy
U.S. Department of Transportation
Environmental Assessment
Federal Highway Administration
Federal Motor Carrier Safety Administration
Federal Motor Carrier Safety Regulations
Health Insurance Portability and Accountability Act
Indiana Statewide Association of Rural Electric Cooperatives
Large Truck Crash Causation Study
Licencia Federal de Conductor
Motor Carrier Management Information System
Motor Carrier Safety Assistance Program
Doctor of Medicine
Medical Examiner
Medical Expert Panel
Medical Certification Requirements as Part of the CDL
Memorandum of Understanding
(FMCSA’s) Medical Review Board
Medical Review Officer
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TABLE OF ACRONYMS AND ABBREVIATIONS—Continued
Acronym or
abbreviation
Term
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NADME ........................................................................
NAFTA .........................................................................
NCCA ...........................................................................
NPRM ..........................................................................
National Registry .........................................................
NSTA ...........................................................................
NTSB ...........................................................................
OOIDA .........................................................................
PA ................................................................................
PHI ...............................................................................
PIA ...............................................................................
PII .................................................................................
PRA ..............................................................................
RDS .............................................................................
RIA ...............................................................................
SAFETEA–LU ..............................................................
SBA ..............................................................................
SDLAs ..........................................................................
Wynne ..........................................................................
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
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National Academy of DOT Medical Examiners
North American Free Trade Agreement
National Commission of Certifying Agencies
Notice of Proposed Rulemaking
National Registry of Certified Medical Examiners
National School Transportation Association
National Transportation Safety Board
Owner-Operator Independent Drivers Association
Physician Assistant
Protected Health Information
Privacy Impact Assessment
Personally Identifiable Information
Paperwork Reduction Act
Role Delineation Study
Regulatory Impact Analysis
Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users
Small Business Administration
State Driver Licensing Agencies
Wynne Transport Services, Inc.
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—
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• 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
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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
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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 evidencebased 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
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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 nonphysician 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
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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.
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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
https://www.fmcsa.dot.gov/rulesregulations/topics/mep/mepreports.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.
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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
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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
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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
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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
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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 alreadypublished 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,
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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
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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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.
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
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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
2 Executive agreements have the same legal effect
as treaties.
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effect. A brief history of these two
agreements is provided for clarification.
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. Pena 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
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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:
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[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 governmentapproved doctors. In addition, the
medical certification for an LF is part of
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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, sixhour 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
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24111
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 fiveyear 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
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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 FMCSAappointed 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 (https://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.
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
3 https://nrcme.fmcsa.dot.gov/training.aspx,
retrieved July 13, 2011.
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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 (https://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
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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
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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 timeconsuming, 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.
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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
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24113
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
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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
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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.
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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.
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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 documentstorage 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
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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
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24115
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.
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
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
https://ai.fmcsa.dot.gov/ltccs/default.asp.
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.
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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.
2. Costs
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We proposed developing the core
curriculum specifications and
administrative requirements for ME
training— referred to as the PublicPrivate 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
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: https://www.ahrq.gov/
downloads/pub/evidence/pdf/cme/cme.pdf.
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19:29 Apr 19, 2012
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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
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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-ofpocket 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
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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
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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
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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 selfpaced, 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 costefficient technologies like videoconferencing, 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 inperson interacting with other ME
candidates and faculty would be
extremely beneficial.
Several of the commenters, including
ATA, supported on-line testing. ATA
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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 online 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 online training, so we leave the travel costs
estimates at the NPRM stage unchanged
for the Public-Private Partnership
Model. It is expected, however, that online 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
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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.
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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
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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 phasein 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.
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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.
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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
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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
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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
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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 § 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 § 390.107 Medical
examiner certification testing. The
Agency adds a new paragraph (b) (and
changes the designation of the
subsequent paragraphs as appropriate),
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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
§ 390.109 Issuance of the FMCSA
medical examiner certification
credential, as proposed, except to
specify compliance with the
requirements of § 390.103(a) or (b)
rather than compliance with the
requirements of §§ 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 § 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 § 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
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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
§ 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 § 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
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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 3year 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.
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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
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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 PublicPrivate 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 privatesector 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.
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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
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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 owneroperators. 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,
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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 PublicPrivate 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 10year 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.
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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
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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)
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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)
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(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
§ 391.43 to the Chief Medical Examiner
on a monthly basis.
Once the National Registry Program is
implemented, FMCSA will accept
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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
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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
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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
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24125
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 × 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 privatesector 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 × 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 × 1
minute/60 minutes to file a report × 12
reports per year + 4,623,000 reports × 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 ×
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 × .5 (50%) × 1 minute/60
minutes = 38,525 hours]. The annual
time burden to medical examiner
administrative personnel for
transmitting CMV driver examination
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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 × 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 × 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
7 The accompanying supporting statement also
reflects the correction of a minor mathematical
error.
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Jkt 226001
for verification of National Registry
Number].
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
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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
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.
2. In § 350.341, add paragraph (h)(3)
to to read as follows:
■
§ 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.
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PART 383—COMMERCIAL DRIVER’S
LICENSE STANDARDS;
REQUIREMENTS AND PENALTIES
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.
4. Amend § 383.73 to by revising
paragraph (o)(1)(iii)(E)to read as follows:
■
§ 383.73
State procedures.
*
*
*
*
*
(o) * * *
(1) * * *
(iii) * * *
(E) Medical examiner’s National
Registry Number issued in accordance
with § 390.109;
*
*
*
*
*
PART 390—FEDERAL MOTOR
CARRIER SAFETY REGULATIONS;
GENERAL
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.
6. Amend § 390.5 by revising the
definition of ‘‘medical examiner’’ to
read as follows:
■
§ 390.5
Definitions.
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*
*
*
*
*
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.
*
*
*
*
*
■ 7. Add subpart D, consisting of
§§ 390.101 through 390.115, to read as
follows:
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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
§ 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.
§ 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 § 390.105.
(3) Pass the medical examiner
certification test provided by FMCSA
and administered by a testing
organization that meets the
requirements of § 390.107 and that has
electronically forwarded to FMCSA the
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24127
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 § 390.111(a)(5).
§ 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 nondisqualifying 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.
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§ 390.107
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Medical examiner certification
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.
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§ 390.109 Issuance of the FMCSA medical
examiner certification credential.
Upon compliance with the
requirements of § 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.
§ 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 § 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
§ 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
§ 390.103(a)(3).
(b) FMCSA will issue a new medical
examiner certification credential valid
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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.
§ 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 § 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 § 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.
§ 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
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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
§ 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
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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
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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 § 390.103(a)(3) within 30 days of
the reinstatement.
(iii) Be licensed, certified, or
registered in accordance with applicable
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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
§ 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 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 § 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 § 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 §§ 390.105 and
390.111. The medical examiner must
also make this documentation available
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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 § 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
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.
9. Amend § 391.23 by:
a. Revising paragraph (m)(1);
b. Removing ‘‘, and’’ at the end of
paragraph (m)(2)(i)(A) and adding in its
place a period;
■ 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:
■
■
■
§ 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 § 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
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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.
*
*
*
*
*
■ 10. Add § 391.42 to read as follows:
§ 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.
11. Amend § 391.43 by revising
paragraphs (a), (g), and (h), and adding
paragraph (i) to read as follows:
■
§ 391.43 Medical examination; certificate
of physical examination.
(a) Except as provided by paragraph
(b) of this section and as provided by
§ 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 § 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
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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.
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(i) Each original (paper or electronic)
completed Medical Examination Report
and a copy or electronic version of each
medical examiner’s certificate must be
retained on file at the office of the
medical examiner for 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.
12. Amend § 391.51 by:
a. Removing ‘‘and’’ at the end of
paragraph (b)(7)(iii);
■ b. Removing the period at the end of
paragraph (b)(8) and adding in its place
‘‘; and’’;
■ c. Removing ‘‘and’’ at the end of
paragraph (d)(4);
■ d. Removing the period at the end of
paragraph (d)(5) and adding in its place
‘‘; and’’; and
■ e. Adding paragraphs (b)(9) and (d)(6).
The additions read as follows:
■
■
§ 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 § 391.23(m).
*
*
*
*
*
(d) * * *
(6) The note relating to verification of
medical examiner listing on the
National Registry of Certified Medical
Examiners required by § 391.23(m).
Issued on: April 10, 2012.
Anne S. Ferro,
Administrator.
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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
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• 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:
Æ Loading and unloading trailers;
Æ Inspecting the operating condition of the
CMV; and
Æ Work schedules:
› 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:
Æ specific information regarding any
affirmative responses in the history;
Æ any illness, surgery, or injury in the last
five years;
Æ any other hospitalizations or surgeries;
Æ any recent changes in health status;
Æ whether he/she has any medical
conditions or current complaints;
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Æ any incidents of disability/physical
limitations;
Æ current medications and supplements,
and potential side effects, which may be
potentially disqualifying;
Æ his/her use of recreational/addictive
substances (e.g., nicotine, alcohol, inhalants,
narcotics or other habit-forming drugs);
Æ disorders of the eyes (e.g., retinopathy,
cataracts, aphakia, glaucoma, macular
degeneration, monocular vision);
Æ disorders of the ears (e.g., hearing loss,
hearing aids, vertigo, tinnitus, implants);
Æ cardiac symptoms and disease (e.g.,
syncope, dyspnea, chest pain, palpitations,
hypertension, congestive heart failure,
myocardial infarction, coronary
insufficiency, or thrombosis);
Æ pulmonary symptoms and disease (e.g.,
dyspnea, orthopnea, chronic cough, asthma,
chronic lung disorders, tuberculosis,
previous pulmonary embolus,
pneumothorax);
Æ sleep disorders (e.g., obstructive sleep
apnea, daytime sleepiness, loud snoring,
other);
Æ gastrointestinal disorders (e.g., liver
disease, digestive problems, hernias);
Æ genitourinary disorders (e.g., kidney
stones and other renal conditions, renal
failure, hernias);
Æ diabetes mellitus:
› current medications (type, potential
side effects, duration on current medication);
› complications from diabetes; and
› presence and frequency of
hypoglycemic/hyperglycemic episodes/
reactions;
Æ other endocrine disorders (e.g., thyroid
disorders, interventions/treatment);
Æ musculoskeletal disorders (e.g.,
amputations, arthritis, spinal surgery);
Æ neurologic disorders (e.g., loss of
consciousness, seizures, stroke/transient
ischemic attack, headaches/migraines,
numbness/weakness); or
Æ 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 (§ 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:
Æ Eyes (§ 391.41(b)(10))
› equal reaction of both pupils to light;
› evidence of nystagmus and
exophthalmos;
› evaluation of extra-ocular movements.
Æ Ears (§ 391.41(b)(11))
› abnormalities of the ear canal and
tympanic membrane;
› presence of a hearing aid.
Æ Mouth and throat (§ 391.41(b)(5))
› conditions contributing to difficulty
swallowing, speaking or breathing;
Æ Neck (§ 391.41(b)(7))
› range of motion;
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› soft tissue palpation/examination (e.g.,
lymph nodes, thyroid gland).
Æ Heart (§ 391.41(b)(4) and (b)(6))
› chest inspection (e.g., surgical scars,
pacemaker/implantable automatic
defibrillator);
› auscultation for thrills, murmurs, extra
sounds, and enlargement;
› blood pressure and pulse (rate and
rhythm);
› additional signs of disease (e.g., edema,
bruits, diaphoresis, distended neck veins.
Æ Lungs, chest, and thorax (§ 391.41(b)(5))
› respiratory rate and pattern;
› auscultation for abnormal breath
sounds;
› abnormal chest wall configuration/
palpation.
Æ Abdomen (§ 391.41(a)(3)(i) and
391.43(f))
› surgical scars;
› palpation for enlarged liver or spleen,
abnormal masses or bruits/pulsation,
abdominal tenderness, hernias (e.g., inguinal,
umbilical, ventral, femoral or other
abnormalities).
Æ Spine (§ 391.41(b)(7))
› surgical scars and deformities;
› tenderness and muscle spasm;
› loss in range of motion and painful
motion;
› spinal deformities.
Æ Extremities and trunk (§ 391.41(b)(1),
(b)(4) and (b)(7))
› gait, mobility, and posture while
bearing his/her weight; limping or signs of
pain;
› loss, impairment, or use of orthosis;
› deformities, atrophy, weakness,
paralysis, or surgical scars;
› elbow and shoulder strength, function,
and mobility;
› handgrip and prehension relative to
requirements for controlling a steering wheel
and gear shift;
› varicosities, skin abnormalities, and
cyanosis, clubbing, or edema;
› leg length discrepancy; lower extremity
strength, motion, and function
› other abnormalities of the trunk.
Æ Neurologic status (§ 391.41(b)(7), (b)(8)
and(b)(9))
› impaired equilibrium, coordination or
speech pattern (e.g., ataxia);
› sensory or positional abnormalities;
› tremor;
› radicular signs;
› reflexes (e.g., asymmetric deep-tendon,
normal/abnormal patellar and Babinski).
Æ Mental status (§ 391.41(b)(9))
› comprehension and interaction;
› cognitive impairment;
› 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.
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Æ Urine test for specific gravity, protein,
blood and glucose (§ 391.41(a)(3)(i));
Æ Whisper or audiometric testing
(§ 391.41(b)(11));
Æ Vision testing for color vision, distant
acuity, horizontal field of vision and
presence of monocular vision
(§ 391.41(b)(10));
Æ Other testing as indicated to determine
the driver’s medical and physical
qualifications for safely operating a CMV.
Æ Refer to a specialist a driver who
exhibits evidence of any of the following
disorders (§ 391.43(e) and (f)):
› vision (e.g., retinopathy, macular
degeneration);
› cardiac (e.g., myocardial infarction,
coronary insufficiency, blood pressure
control);
› pulmonary (e.g., emphysema, fibrosis);
› endocrine (e.g., diabetes);
› musculoskeletal (e.g., arthritis,
neuromuscular disease);
› neurologic (e.g., seizures);
› sleep (e.g., obstructive sleep apnea);
› mental/emotional health (e.g.,
depression, schizophrenia); or
› 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:
Æ possible consequences of noncompliance with a care plan for conditions
that have been advised for periodic
monitoring with primary healthcare provider;
Æ 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;
Æ the effect of fatigue, lack of sleep, poor
diet, emotional conditions, stress, and other
illnesses that can affect safe driving;
Æ if he/she is a contact lens user, the
importance of carrying a pair of glasses while
driving;
Æ if he/she uses a hearing aid, the
importance of carrying a spare power source
for the device while driving;
Æ 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;
Æ if he/she has a diabetes exemption, that
he/she should:
› carry a rapidly absorbable form of
glucose while driving;
› self-monitor blood glucose one hour
before driving and at least once every four
hours while driving;
› comply with each condition of his/her
exemption;
› plan to submit glucose monitoring logs
for each annual recertification;
Æ 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);
PO 00000
Frm 00032
Fmt 4701
Sfmt 4700
Æ 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:
Æ Considering a driver’s ability to
› move his/her body through space while
climbing ladders; bend, stoop, and crouch;
enter and exit the cab;
› manipulate steering wheel;
› perform precision prehension and
power grasping;
› use arms, feet, and legs during CMV
operation;
› inspect the operating condition of a
tractor and/or trailer;
› monitor and adjust to a complex driving
situation; and
› consider the adverse health effects of
fatigue associated with extended work hours
without breaks;
Æ 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:
Æ using the requirements stated in the
FMCSRs, with nondiscretionary certification
standards to disqualify a driver
› with a history of epilepsy;
› with diabetes requiring insulin control
(unless accompanied by an exemption);
› when vision parameters (e.g., acuity,
horizontal field of vision, color) fall below
minimum standards unless accompanied by
an exemption;
› when hearing measurements with or
without a hearing aid fall below minimum
standards;
› currently taking methadone;
› with a current clinical diagnosis of
alcoholism; or
› who uses a controlled substance
including a narcotic, an amphetamine, or
another habit-forming drug without a
prescription from the treating physician;
Æ 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;
Æ certifying a driver for an appropriate
duration of certification interval;
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Æ 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:
› a vision deficiency (e.g., retinopathy,
macular degeneration);
› the immediate post-operative period;
› a cardiac event (e.g., myocardial
infarction, coronary insufficiency);
› a chronic pulmonary exacerbation (e.g.,
emphysema, fibrosis);
› uncontrolled hypertension;
› endocrine dysfunctions (e.g., insulindependent diabetes);
› musculoskeletal challenges (e.g.,
arthritis, neuromuscular disease);
› a neurologic event (e.g., seizures, stroke,
TIA);
› a sleep disorder (e.g., obstructive sleep
apnea); or
› 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:
VerDate Mar<15>2010
19:29 Apr 19, 2012
Jkt 226001
• Medical Examination Report Form
Æ identification of the driver;
Æ use of appropriate Medical Examination
Report form;
Æ assurance that driver completes and
signs driver’s portion of the Medical
Examination Report form;
Æ specifics regarding any affirmative
response on the driver’s medical history;
Æ height/weight, blood pressure, pulse;
Æ results of the medical examination,
including details of abnormal findings;
Æ audiometric and vision testing results;
Æ presence of a hearing aid and whether it
is required to meet the standard;
Æ if obtained, funduscopic examination
results;
Æ the need for corrective lenses for driving;
Æ presence or absence of monocular vision
and need for a vision exemption;
Æ if driver has diabetes mellitus and is
insulin dependent, the need for a diabetes
exemption;
Æ other laboratory, pulmonary, cardiac
testing performed; and
Æ the reason(s) for the disqualification
and/or referral.
• Other supporting documentation
Æ if driver has current vision exemption,
include the ophthalmologist’s or
optometrist’s report;
PO 00000
Frm 00033
Fmt 4701
Sfmt 9990
24135
Æ if a driver has a diabetes exemption,
include the endocrinologist’s and
ophthalmologist’s/optometrist’s report;
Æ treating physician’s work release;
Æ if obtained, specialist’s evaluation
report;
Æ if the driver has a current Skill
Performance Evaluation Certificate, include
it; and
Æ results of Substance Abuse Professional
evaluations for alcohol and drug use and/or
abuse for a driver with
› alcoholism who completed counseling
and treatment to the point of full recovery.
• Medical Examiner’s Certificate
Æ certification status, which may require:
› waiver/exemption;
› wearing corrective lenses;
› wearing a hearing aid; or
› a Skill Performance Evaluation
Certificate;
Æ complete and accurate documentation
on medical certification card including:
› the examiner’s name, examination date,
office address, and telephone number and
Medical Examiner signature; and
› the driver’s signature.
[FR Doc. 2012–9034 Filed 4–19–12; 8:45 am]
BILLING CODE 4910–EX–P
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Agencies
[Federal Register Volume 77, Number 77 (Friday, April 20, 2012)]
[Rules and Regulations]
[Pages 24104-24135]
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
[[Page 24104]]
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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.
-----------------------------------------------------------------------
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 https://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 https://DocketInfo.dot.gov.
SUPPLEMENTARY INFORMATION: This document is organized as follows:
I. Table of Acronyms and Abbreviations
II. Legal Basis for the Rulemaking
III. Background
IV. Discussion of Comments Received on the Proposed Rule
V. Section-by-Section Explanation of Changes from the NPRM
VI. Regulatory Analyses and Notices
Table of Acronyms and Abbreviations
----------------------------------------------------------------------------------------------------------------
Acronym or abbreviation Term
----------------------------------------------------------------------------------------------------------------
AANP............................................................... American Academy of Nurse Practitioners
AAOHN.............................................................. American Association of Occupational Health
Nurses
AAPA............................................................... American Academy of Physician Assistants
ABA................................................................ American Bus Association
ACOEM.............................................................. American College of Occupational and
Environmental Medicine
ADA................................................................ American Diabetes Association
Advocates.......................................................... Advocates for Highway and Auto Safety
AME................................................................ Aviation Medical Examiner
APN................................................................ Advanced Practice Nurse
ATA................................................................ American Trucking Associations, Inc.
BISC............................................................... Bus Industry Safety Council
CAA................................................................ Clean Air Act
CDL................................................................ Commercial Driver's License
CDLIS.............................................................. Commercial Driver's License Information
System
CME................................................................ Continuing Medical Education
CMV................................................................ Commercial Motor Vehicle
DC................................................................. Doctor of Chiropractic
DEP................................................................ Diabetes Expert Panel
DO................................................................. Doctor of Osteopathy
DOT................................................................ U.S. Department of Transportation
EA................................................................. Environmental Assessment
FHWA............................................................... Federal Highway Administration
FMCSA.............................................................. Federal Motor Carrier Safety Administration
FMCSRs............................................................. Federal Motor Carrier Safety Regulations
HIPAA.............................................................. Health Insurance Portability and
Accountability Act
ISAREC............................................................. Indiana Statewide Association of Rural
Electric Cooperatives
LTCCS.............................................................. Large Truck Crash Causation Study
LFC................................................................ Licencia Federal de Conductor
MCMIS.............................................................. Motor Carrier Management Information System
MCSAP.............................................................. Motor Carrier Safety Assistance Program
MD................................................................. Doctor of Medicine
ME................................................................. Medical Examiner
MEP................................................................ Medical Expert Panel
Med. Cert./CDL..................................................... Medical Certification Requirements as Part
of the CDL
MOU................................................................ Memorandum of Understanding
MRB................................................................ (FMCSA's) Medical Review Board
MRO................................................................ Medical Review Officer
[[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.
----------------------------------------------------------------------------------------------------------------
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 https://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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
\2\ Executive agreements have the same legal effect as treaties.
---------------------------------------------------------------------------
Prior to the amendments made by section 4116(b) of SAFETEA-LU, the
provisions of 49 U.S.C. 31136(a)(3) stated:
The Secretary of Transportation shall prescribe regulations on
commercial motor vehicle safety. The regulations shall prescribe
minimum safety standards for commercial motor vehicles. At a minimum,
the regulations shall ensure that--
The physical condition of operators of commercial motor
vehicles is adequate to enable them to operate the vehicles safely. * *
*
For this purpose, a ``commercial motor vehicle'' is defined in 49
U.S.C. 31132(1).
FMCSA regulations generally required all operators of CMVs in the
United States to be examined by an ME (as defined in 49 CFR 390.5) and
to obtain from the examiner a certificate that the operator is
physically qualified. 49 CFR 391.11(b)(4) and 49 CFR part 391, subpart
E. These requirements will continue to apply after establishment of the
National Registry Program.
In 1991, the Secretary and his counterpart in Mexico entered into
an agreement on the matter of driver license reciprocity. The agreement
is contained in a memorandum of understanding (MOU) that was reproduced
as Appendix A to a final rule issued in 1992 by FMCSA's predecessor
agency, the FHWA. Commercial Driver's License Reciprocity with Mexico,
57 FR 31454 (July 16, 1992), affirmed, Int'l Brotherhood of Teamsters
v. Pe[ntilde]a 17 F.3rd 1478 (DC Cir. 1994). The primary purpose of the
MOU was to establish reciprocal recognition of the CDL issued by the
States to U.S. operators and the Licencia Federal de Conductor (LF)
issued by the government of the United Mexican States (i.e., by the
national government of Mexico, not by the individual Mexican states).
In light of the agreement, the FHWA determined that an LF meets the
standards contained in 49 CFR part 383 for a CDL. 49 CFR 383.23(b)(1)
and note 1. The FHWA's final rule preamble also states, at 57 FR 31455:
It should be noted that Mexican drivers must be medically
examined every 2 years to receive and retain the Licencia Federal de
Conductor; no separate medical card [certificate] is required as in
the United States for drivers in interstate commerce. As the
Licencia Federal de Conductor cannot be issued to or kept by any
driver who does not pass stringent physical exams, the Licencia
Federal de Conductor itself is evidence that the driver has met
medical standards as required by the United States. Therefore,
Mexican drivers with a Licencia Federal de Conductor do not need to
possess a medical card while driving a CMV in the United States.
Implicit in the determination that Mexican drivers with an LF do
not need to possess a separate medical certificate is an underlying
determination that the medical examination necessary to obtain the LF
meets the standards for an examination by an ME in accordance with
FMCSA regulations, and would therefore meet the requirements of 49
U.S.C. 31136(a)(3).
The MOU does not specifically address medical qualifications for
Mexican drivers operating a CMV in the United States that does not
require a CDL. In order to enter the United States at the border
crossing points (all of which are accessed only by federal highways in
Mexico) a Mexican driver must have a Licencia Federal. FMCSA
enforcement policy accepts a Licencia Federal as proof of physical
qualification for a driver to operate a CMV that does not require a CDL
in the United States.
In 1998, a similar agreement was reached with Canada under the
auspices of the Land Transportation Standards Subcommittee established
by the North American Free Trade Agreement (NAFTA). This agreement
supplements a 1988 agreement with Canada accepting the CDLs issued by
Canadian provinces in accordance with the Canadian National Safety Code
as valid for operation of a CMV in the United States. 49 CFR 383.23(b),
note 1. The 1998 agreement, which became effective on March 30, 1999,
provides, with some exceptions, that Canadian drivers holding such a
CDL issued in Canada are physically qualified to operate a CMV in the
United States and are not required to possess a medical certificate
issued by a ME. In Canada, drivers are required to have CDLs in order
to operate a CMV that would not require a CDL to operate in the United
States. Under the 1998 agreement, a Canadian CDL issued in conformity
with the National Safety Code is accepted by FMCSA as proof of a
driver's physical qualification to operate a CMV in the United States.
The substance of these two agreements is also reflected in a note
in 49 CFR 391.41(a)(1), as recently amended. Medical Certification
Requirements as Part of the CDL, 73 FR 73096, 73127 (December 1, 2008).
In 2005, 49 U.S.C. 31136(a)(3) was amended by SAFETEA-LU section
4116(b), which added the following at the end:
[[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 (https://nrcme.fmcsa.dot.gov) and in the docket for this rulemaking. The
guidance for the core curriculum specifications is Appendix A to this
Federal Register document.
The guidance for the core curriculum specifications are based on
current FMCSA regulations on physical qualifications published in 49
CFR part 391, as well as guidance that is published in 49 CFR 391.43.
The guidance for the core curriculum specifications are also based on
the task list developed in the Role Delineation Study (RDS) completed
in April 2007, as described in the NPRM. The RDS is a rigorous
methodology regularly employed in the certification and medical fields
when developing a valid, reliable, and fair certification test. An
executive summary of the RDS Final Report and the full text of the
Final Report are available through the National Registry Web site \3\
and the docket for this rulemaking.
---------------------------------------------------------------------------
\3\ https://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 (https://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 https://ai.fmcsa.dot.gov/ltccs/default.asp.
---------------------------------------------------------------------------
It will not be possible to evaluate the effectiveness of training
programs for MEs to be listed in the National Registry until after the
training programs have been initiated. It is impossible to predict the
degree to which the training program will improve ME screening of
drivers. However, comments received from MEs who currently conduct
driver physical evaluations, and evidence from the field from MEs and
enforcement personnel indicate that many drivers who do not meet the
Agency's physical qualification standards are being erroneously
medically certified. The Agency expects the National Registry Program
to reduce the number of errors committed by MEs. It will depend upon
the effectiveness of training and the knowledge that MEs gain about
Agency standards and guidelines.
CME programs have received extensive evaluations and have been
shown to improve medical practitioner knowledge and skills, as well as
patient outcomes.\5\ A comprehensive review of the effectiveness of CME
programs sponsored by the U.S. Department of Health and Human Services
[[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: https://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