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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, [email protected]. 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]
BILLING CODE 4910-EX-P
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