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Qualifications of Drivers: Medical Examiner's Handbook Regulatory Guidance Publication: Federal Register Agency: Federal Motor Carrier Safety Administration Byline: Robin Hutcheson Date: 22 January 2024 Subjects: American Government  , Safety
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[Federal Register Volume 89, Number 14 (Monday, January 22, 2024)]
[Rules and Regulations]
[Pages 3892-3895]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01056]
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DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety Administration
49 CFR Part 391
[Docket No. FMCSA-2022-0111]
Qualifications of Drivers: Medical Examiner's Handbook Regulatory
Guidance
AGENCY: Federal Motor Carrier Safety Administration (FMCSA), Department
of Transportation (DOT).
ACTION: Notification of regulatory guidance.
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SUMMARY: FMCSA announces the availability of the Medical Examiner's
Handbook (MEH), which includes updates to the Medical Advisory Criteria
published in the Code of Federal Regulations (CFR). The MEH provides
information about regulatory requirements and guidance to medical
examiners (ME) listed on FMCSA's National Registry of Certified Medical
Examiners (National Registry) who perform physical qualification
examinations of interstate commercial motor vehicle (CMV) drivers. The
January 2024 edition of the MEH replaces all previous handbook
editions.
DATES: This guidance is applicable on January 22, 2024.
FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division, FMCSA, 1200 New Jersey Avenue SE,
Washington, DC 20590, (202) 366-4001, FMCSAMedical@dot.gov. If you have
questions on viewing material in the docket, call Dockets Operations at
(202) 366-9826.
SUPPLEMENTARY INFORMATION:
I. Availability of Documents
To view comments or any documents mentioned as being available in
the docket, go to https://www.regulations.gov/docket/FMCSA-2022-0111/document and choose the document to review. To view comments, click
``Browse All Comments.'' If you do not have access to the internet, you
may view the docket online by visiting Dockets Operations on the ground
floor of the DOT West Building, 1200 New Jersey Avenue SE, Washington,
DC 20590-0001, between 9 a.m. and 5 p.m., Monday through Friday, except
Federal holidays. To be sure someone is there to help you, please call
(202) 366-9317 or (202) 366-9826 before visiting Dockets Operations.
II. Legal Basis
FMCSA has statutory authority under 49 U.S.C. 31136(a)(3) and
31149(c)(1)(A)(i)--delegated to the Agency by 49 CFR 1.87(f)--to
establish regulations to ensure the physical condition of CMV operators
is adequate to enable them to operate the vehicles safely. The guidance
in the MEH and Medical Advisory Criteria is related to the physical
qualification regulations required by those sections.
The notice and comment rulemaking procedures of the Administrative
Procedure Act (APA) do not apply to interpretative rules and general
statements of policy (commonly called ``guidance'') (5 U.S.C.
553(b)(A)). The MEH is a guidance document that does not amend any
Agency regulation or establish any requirements for MEs or drivers not
found in existing regulations. Accordingly, FMCSA was not required
under the APA to solicit public comment on the MEH. Nevertheless, to
ensure that the MEH provides clear, useful, and relevant information
for stakeholders and as encouraged by DOT policy,\1\ FMCSA opted to
make a draft of the MEH available for public review and comment (87 FR
50282 (Aug. 16, 2022)). Although FMCSA voluntarily provided an
opportunity for public comment on the MEH, its decision to do so does
not make applicable any of the other procedural requirements in the APA
or most of the other statutes or Executive orders that would apply if
the opportunity for prior notice and public comment were required.
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\1\ Section 14(f) of DOT 2100.6A (Rulemaking and Guidance
Procedures) states that it is DOT policy to encourage providing an
opportunity for public comment on guidance documents, as public
input can be very helpful in formulating and improving the guidance
that DOT offers.
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III. Background
FMCSA's mission is to reduce crashes, injuries, and fatalities
involving large trucks and buses. A critical element of FMCSA's safety
program is ensuring CMV drivers are in adequate physical condition to
operate the vehicles safely. MEs on the National Registry make the
determination regarding a driver's physical qualification.
The Federal Motor Carrier Safety Regulations (FMCSRs), in 49 CFR
391.41 through 391.49, provide the basic driver physical qualification
standards for interstate CMV operators. MEs make physical qualification
determinations on a case-by-case basis and may consider guidance to
assist with making those determinations.
FMCSA first posted the MEH to its website in 2008 to provide
guidance to MEs on the physical qualification standards in the FMCSRs
and the conducting of the physical qualification examination. FMCSA has
also issued guidance for MEs in the form of Medical Advisory Criteria,
now published at 49 CFR part 391, Appendix A. However, FMCSA withdrew
the MEH in 2015 because some of the information was obsolete or was
prescriptive in nature, and informed MEs and training organizations
that the MEH was no longer in use and should not be considered as
Agency guidance.
FMCSA's Medical Review Board (MRB) was established to provide FMCSA
with medical advice and recommendations on medical standards and
guidelines for the physical qualifications of CMV operators, ME
education, and medical research (49 U.S.C. 31149(a)(1)). The MRB, in
view of its statutory creation and advisory function, is chartered by
DOT as an advisory committee under the Federal Advisory Committee Act
(5 U.S.C. Ch. 10). See also Announcement of Establishment of the
Federal Motor Carrier Safety Administration Medical Review Board (70 FR
57642 (Oct. 3, 2005)). The Secretary appoints MRB's members to reflect
expertise in a variety of medical specialties relevant to the driver
fitness requirements of FMCSA (49 U.S.C. 31149(a)(2)).
To assist in the development of the MEH, FMCSA, in collaboration
with its
[[Page 3893]]
Chief Medical Officer, requested advice from the MRB for the Agency to
consider via MRB Task Statement 17-1. Specifically, FMCSA asked the MRB
to review and provide recommendations for streamlining the MEH. This
included removing non-regulatory directive language and updating and
removing obsolete information. At public meetings, the MRB discussed
the development of the new MEH and Medical Advisory Criteria and
reviewed drafts of the MEH. Details of the meetings, including MRB Task
Statement 17-1, are posted on the Agency's public website at https://www.fmcsa.dot.gov/medical-review-board-mrb-meeting-topics.
After consideration of the public comments and further internal
review, FMCSA is now issuing a revised MEH, which includes updated
Medical Advisory Criteria, with the goal of providing information about
regulatory requirements and guidance for MEs to consider when making
physical qualification determinations in conjunction with established
best medical practices. In addition to being included in the MEH, the
revised Medical Advisory Criteria are being published in Appendix A to
49 CFR part 391 concurrent with this notification. The final version of
the criteria is identical in both publications.
The Agency notes that the updated MEH reflects the fact that
medical certification under 49 CFR 391.64 for certain drivers who
participated in FMCSA's Vision Waiver Study Program is no longer
available. On January 21, 2022, FMCSA published a new alternative
vision standard and eliminated physical qualification under Sec.
391.64 (87 FR 3390). As of March 22, 2023, all Medical Examiner's
Certificates, Form MCSA-5876, issued under Sec. 391.64 became void.
FMCSA is aware that references to medical certification under Sec.
391.64 exist in FMCSA's current regulations and forms. The Agency plans
to remove obsolete provisions in an upcoming technical amendment rule.
IV. Comments Received
FMCSA received 67 comments in response to the draft MEH from a wide
range of commenters, including individuals; medical providers (such as
MEs listed on the National Registry and Concentra); drivers; motor
carriers (including owner-operators and Schneider National, Inc.); a
patient advocacy group (the Alliance of Sleep Apnea Partners (ASAP));
safety advocacy groups (a joint comment was filed by the Truck Safety
Coalition (TSC), Citizens for Reliable and Safe Highways (CRASH), and
Parents Against Tired Truckers (PATT)); the National Transportation
Safety Board (NTSB); five members of Congress who filed a joint
comment; and additional associations. Specifically, the medical
associations were the American Academy of Sleep Medicine (AASM), the
American College of Occupational and Environmental Medicine (ACOEM),
and the American Physical Therapy Association. The trade associations
were the American Trucking Associations (ATA), the National Association
of Small Trucking Companies, the National Beer Wholesalers Association,
the Owner-Operator Independent Drivers Association (OOIDA), and the
Truckload Carriers Association.
The comments covered a variety of topics. Although the APA notice
and comment requirements do not apply to guidance documents, FMCSA
provides its responses to some of the comments in the interest of
transparency.
General Comments
Some commenters wanted FMCSA to provide more specificity regarding
certain types of evaluations and stated the draft MEH is less useful
than the previous MEH due to its lack of specificity. Most of the
physical qualification standards are broadly stated, and establishing
specific testing requirements, such as methodology and acceptable
laboratory values, would have to occur through rulemaking. Thus, FMCSA
believes the level of specificity in the current version of the MEH is
appropriate for a regulatory guidance document.
However, FMCSA made numerous changes to improve the overall
clarity, quality, and substance of the MEH based on suggestions from
commenters. For example, based on comments from ACOEM and an
individual, FMCSA edited several sections to emphasize privacy
protections for the individuals being examined, particularly that the
right to receive a copy of the Medical Examination Report Form, MCSA-
5875, is personal to the individual and does not depend on who paid for
or requested the physical qualification examination. In response to a
comment from OOIDA, FMCSA also clarified when the individual's consent
is required for the ME and the employer to request and receive
protected health information about the individual being examined.
FMCSA incorporated a suggestion from OOIDA to add that individuals
may request a second opinion and physical qualification examination
from another ME if they choose but are expected to provide the same
medical information to both MEs. In response to comments from an
individual and ACOEM, FMCSA also stated that MEs should visualize the
body while examining an individual and conduct an inguinal hernia
examination for all males.
ACOEM also asked FMCSA to clarify issues regarding incomplete
examinations, and the MEH now states that once an ME begins an
examination, the results must be reported to the National Registry even
if the examination is not completed. At the request of ACOEM and two
MEs, FMCSA clarified issues relating to the use of the determination
pending status, including that it does not extend the expiration date
of an individual's current Medical Examiner's Certificate, Form MCSA-
5876. One commenter, who is both an ME and a commercial driver's
license holder, noted that some MEs do not use the most current
versions of forms, so FMCSA clarified that using the current form is
mandatory.
FMCSA made several other revisions to the MEH in response to
comments and suggestions from ACOEM. For example, FMCSA clarified that
the alternative vision standard is applicable only if the worse eye
cannot be corrected to meet the distant visual acuity standard with
corrective lenses. FMCSA added that if the individual meets the vision
standard while wearing corrective lenses, it is not necessary to
document the distant visual acuity without corrective lenses. FMCSA
also added that when it is indicated that a medical exemption is
required, the Medical Examiner's Certificate, Form MCSA-5876, is not
valid unless the individual applies for and is issued the medical
exemption from FMCSA. It was emphasized that MEs may certify an
individual for less than the maximum period whenever they determine
they need to monitor the individual more frequently. FMCSA moved the
discussion of renal dialysis from the section on cardiovascular
diseases to the section on diabetes because diabetes leads to a greater
incidence of kidney disease than cardiovascular disease does.
In addition, ACOEM requested that FMCSA establish a regular cadence
for updating the MEH. FMCSA intends to update the MEH periodically.
Concentra and ACOEM questioned why certain medical expert panel
reports and other guidance were included in the draft MEH, while others
were not. After reviewing the comments, FMCSA agrees that including
some reports but not others has the potential to create confusion.
[[Page 3894]]
The more recent evidence reports and medical expert panel reports are
readily available on FMCSA's website at https://www.fmcsa.dot.gov/regulations/medical/reports-how-medical-conditions-impact-driving.
Thus, FMCSA decided to remove references to these additional sources of
information from the MEH. FMCSA notes that evidence reports and medical
expert panel reports are disseminated by FMCSA in the interest of
information exchange and are not official Agency guidance.
FMCSA revised the sections on narcolepsy and idiopathic hypersomnia
based on comments by AASM and an individual. FMCSA deleted the
references to obstructive sleep apnea (OSA) and added that the
conditions should be diagnosed with an overnight lab-based sleep study
followed by a Multiple Sleep Latency Test the next morning.
FMCSA made several changes in the section relating to the scheduled
drug and alcohol standards in light of comments by SAPList.com. For
example, FMCSA clarified that DOT-regulated drug and alcohol testing is
not part of the physical qualification examination but may be conducted
concurrently with the examination for pre-employment or other
authorized purposes. FMCSA also clarified that substance abuse
professionals are not certified and not part of non-DOT drug testing.
FMCSA also provided a more in-depth discussion of the intent of
Questions 31 and 32 on the Medical Examination Report Form, MCSA-5875.
Obstructive Sleep Apnea (OSA)
Of the 67 comments received, 36 referenced OSA. Of these, 27
commented only on OSA.
Several commenters, including ATA and OOIDA, indicated that the
guidance in the MEH relating to OSA runs afoul of Public Law 113-45
(127 Stat. 557 (Oct. 15, 2013), 49 U.S.C. 31305 note), which provides
FMCSA may implement or enforce a requirement providing for the
screening, testing, or treatment of CMV operators for sleep disorders
only if the requirement is adopted pursuant to a rulemaking proceeding.
When drafting the MEH, FMCSA was mindful of Public Law 113-45. However,
Public Law 113-45 is not applicable here because the MEH offers only
guidance and FMCSA has not adopted requirements regarding OSA
screening, testing, or treatment. Because this is not a rulemaking
proceeding, FMCSA cannot accommodate the requests by commenters that
FMCSA require MEs to use specific, objective criteria for OSA
screening, treatment, and treatment evaluation.
FMCSA has gone to great efforts throughout the MEH to distinguish
between regulatory requirements and non-binding guidance. The MEH
states that MEs are free to choose whether to utilize guidance and
recommendations as a basis for decision-making and that when the terms
``recommend,'' ``consider,'' ``may,'' ``should,'' or ``could'' are used
in the MEH, they are used in a recommendatory or permissive sense and
relate to guidance. In particular, the MEH states that the FMCSRs do
not include requirements for MEs to screen individuals for OSA or to
recommend that an individual be referred for OSA testing and do not
include preferred diagnostic testing methods, treatment methods, or
requirements by which to assess compliance with treatment. Instead, the
MEH presents various considerations for ME when making a physical
qualification determination.
Several commenters, including ASAP, ATA, CRASH, PATT, and TSC,
indicated FMCSA should initiate a rulemaking to develop specific OSA
screening, testing, and treatment requirements for CMV drivers rather
than to issue more guidance. The notice issued in 2017 withdrawing an
advance notice of proposed rulemaking explains FMCSA's reasons for not
proceeding with a rulemaking on OSA (see Evaluation of Safety Sensitive
Personnel for Moderate-to-Severe Obstructive Sleep Apnea, 82 FR 37038
(Aug. 8, 2017)).
Several comments were received regarding the link in the MEH to the
November 21, 2016, joint MRB and Motor Carrier Safety Advisory
Committee recommendations regarding OSA. FMCSA continues to include the
link in the final MEH for ease of access. As suggested by NTSB, FMCSA
added text to state that the joint recommendations includes information
on screening and diagnosing individuals with moderate-to-severe OSA,
and not just certifying such individuals.
AASM, ASAP, OOIDA, and an individual questioned why the draft MEH
included a window of 3 to 5 years for retesting individuals diagnosed
with moderate-to-severe OSA treated with continuous positive airway
pressure. FMCSA removed the recommendation of a time frame for
retesting. FMCSA added that ``untreated moderate-to-severe OSA is
associated with cardiovascular and cerebrovascular morbidity, metabolic
disease, and mortality'' in response to a comment from AASM.
AASM recommended that FMCSA remove ``moderate-to-severe'' from the
statement that untreated moderate-to-severe OSA may contribute to
certain adverse conditions because they may be experienced at any level
of OSA severity. FMCSA determined that the focus of the guidance is
appropriately on moderate-to-severe OSA because it is likely to
interfere with the ability to control and drive a CMV safely as
required by the applicable standard.
Several commenters stated that MEs should not consider a single
factor as being determinative with respect to whether an individual
needs to be screened for OSA. FMCSA agrees and reiterates that the MEH
provides guidance stating that the use of multiple risk factors is a
reasonable approach to identify individuals at risk for moderate-to-
severe OSA, rather than relying only on a single factor. The MEH
guidance leaves it to the ME to determine whether an individual needs
to be screened based on the individual circumstances.
AASM and ASAP recommended adding that moderate-to-severe OSA is to
be ``adequately treated'' or ``treated effectively.'' As indicated in
the MEH, determining whether treatment is adequate or effective should
be left to the ME to determine based on the individual circumstances.
High Blood Pressure
Several commenters, including ACOEM and Concentra, stated that the
hypertension table from the 2013 expert panel recommendations titled
``Medical Examiner Physical Qualification Standards and Clinical
Guidelines for Cardiovascular Disease and Commercial Motor Vehicle
Driver Safety'' was vague, confusing, and difficult to understand.
FMCSA agrees that the table has the potential to create confusion.
FMCSA therefore decided to remove the hypertension table from the MEH
and to continue the current guidance in the Medical Advisory Criteria.
FMCSA is currently conducting research on this topic and will update
the MEH based on the final report if warranted.
Non-Insulin-Treated Diabetes Mellitus
The NTSB and ACOEM stated that the information provided for non-
insulin-treated diabetes is inadequate and that there should be some
guidance on the complications and co-morbidities of non-insulin-treated
diabetes mellitus. FMCSA does not have a medical standard specific to
non-insulin-treated diabetes mellitus, and therefore cannot provide the
level of specificity sought by these commenters.
[[Page 3895]]
However, FMCSA provided some additional information, including
considerations for MEs when making a physical qualification
determination for an individual with non-insulin-treated diabetes
mellitus. In addition, FMCSA is in the process of seeking approval from
the Office of Management and Budget for a new Non-Insulin-Treated
Diabetes Mellitus Assessment Form. If approved, FMCSA will post the
form on its website for MEs to use as a voluntary, optional tool to
request additional information, with the individual's consent, when
making a physical qualification determination for an individual with
non-insulin-treated diabetes mellitus. It will also update the MEH with
this information if approved.
Out of Scope Comments
Some commenters requested changes to the MEH that are beyond the
scope of this guidance, including some that would require rulemaking
and changes to existing law.
V. Publication of the Regulatory Guidance
Each guidance document issued by FMCSA must be published on a
publicly accessible DOT internet website on the date of issuance (49
U.S.C. 113 note).\2\ Accordingly, in addition to being available in
this docket, the MEH will be available in FMCSA's Guidance Portal
(https://www.fmcsa.dot.gov/guidance) and on FMCSA's website at https://www.fmcsa.dot.gov/regulations/medical/medical-regulations-and-guidance-resource-links and on the National Registry website at https://nationalregistry.fmcsa.dot.gov/resource-center.
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\2\ See section 5203(a)(2)(A) and (a)(3) of the Fixing America's
Surface Transportation Act, Public Law 114-94, 129 Stat. 1312, 1535
(Dec. 4, 2015).
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FMCSA expects to review the guidance no later than 5 years after it
is published and will consider at that time whether the guidance should
be withdrawn, reissued, or incorporated into FMCSA's regulations.
Robin Hutcheson,
Administrator.
[FR Doc. 2024-01056 Filed 1-19-24; 8:45 am]
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