Document ID: FMCSA-2015-0419-0276
Agency: fmcsa
Document Type: Proposed Rule
Title: Evaluation of Safety Sensitive Personnel for Moderate-to-Severe Obstructive Sleep Apnea; Public Listening Sessions
Posted Date: 2016-04-28T04:00Z

[Federal Register Volume 81, Number 82 (Thursday, April 28, 2016)]
[Proposed Rules]
[Pages 25366-25368]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09911]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

49 CFR Parts 240 and 242

Federal Motor Carrier Safety Administration

49 CFR Part 391

[Docket Numbers FMCSA-2015-0419 and FRA-2015-0111, Notice No. 2]

Evaluation of Safety Sensitive Personnel for Moderate-to-Severe 
Obstructive Sleep Apnea; Public Listening Sessions

AGENCIES: Federal Motor Carrier Safety Administration (FMCSA) and 
Federal Railroad Administration (FRA), Department of Transportation 
(DOT).

ACTION: Notice of public listening sessions.

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SUMMARY: FMCSA and FRA announce three public listening sessions on May 
12, 17, and 25, 2016, to solicit information on the prevalence of 
moderate-to-severe obstructive sleep apnea (OSA) among individuals 
occupying safety sensitive positions in highway and rail 
transportation, and of its potential consequences for the safety of 
rail and highway transportation. FMCSA and FRA (collectively ``the 
Agencies'') also request information on potential costs and benefits 
from possible regulatory actions that address the safety risks 
associated with motor carrier and rail transportation workers in safety 
sensitive positions who have OSA. The listening sessions will provide 
interested parties an opportunity to share their views and any data or 
analysis on this topic with representatives of both Agencies. The 
Agencies will transcribe all comments and place the transcripts in the 
dockets referenced above for the Agencies' consideration. The Agencies 
will webcast the entire proceedings of all three meetings.

DATES: The listening sessions will be held on:
     Thursday, May 12, 2016, in Washington, DC;
     Tuesday, May 17, in, Chicago, IL; and
     Wednesday, May 25, in Los Angeles, CA.
    All sessions will run from 10 a.m. to noon and 1:30 p.m. to 3:30 
p.m., local time. If all interested parties have the opportunity to 
comment, the sessions may conclude early.

ADDRESSES: The May 12, 2016, listening session will be held at the 
National Association of Home Builders, 1201 15th Street NW., 
Washington, DC 20005. The May 17, 2016, session will be held at the 
Marriott Courtyard Chicago Downtown/River North, 30 E. Hubbard Street, 
Chicago, IL 60611. The final session will be held on May 25, 2016, at 
the Westin Bonaventure Hotel and Suites, 404 S. Figueroa Street, Los 
Angeles, CA 90071. In addition to attending the sessions in person, the 
Agencies offer several ways to provide comments, as described below.
    Internet Address for Live Webcast. The Agencies will post specific 
information on how to participate via the Internet on the Agencies' Web 
sites at www.fmcsa.dot.gov/calendar and www.fra.dot.gov/ in advance of 
the listening session. This Notice provides more information on the 
listening sessions below in Section II., Meeting Participation and 
Information the Agencies Seek from the Public.
    Written comments. You may submit comments identified by Docket 
Numbers FMCSA-2015-0419 and FRA-2015-0111 using any of the following 
methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments;
     Mail: Docket Management Facility, U.S. Department of 
Transportation, Room W12-140, 1200 New Jersey Avenue SE., West 
Building, Ground Floor, Washington, DC 20590-0001;
     Hand Delivery or Courier: West Building, Ground Floor, 
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC, between 9 
a.m. and 5 p.m., Monday through Friday, except Federal holidays; and
     Fax: 202-493-2251.
    See the SUPPLEMENTARY INFORMATION section below for more details on 
how to submit written comments.

FOR FURTHER INFORMATION CONTACT: For information about the listening 
sessions: Ms. Shannon L. Watson, Senior Policy Advisor, FMCSA, 1200 New 
Jersey Avenue SE., Washington, DC 20590, by telephone at 202-366-2551, 
or by email at shannon.watson@dot.gov.
    If you need sign language interpretation or any other accessibility 
accommodation, please contact Ms. Watson at least one week in advance 
of each session to allow us to arrange for such services. The Agencies 
cannot guarantee that interpreter services requested on short notice 
will be provided.
    For other information on Obstructive Sleep Apnea:
    FMCSA: Ms. Angela Wongus, Medical Programs Division, FMCSA, 1200 
New Jersey Ave. SE., Washington, DC 20590, by telephone at 202-366-
3109, or by email at fmcsamedical@dot.gov.
    FRA: Dr. Bernard Arseneau, Medical Director, Assurance and 
Compliance, FRA, 1200 New Jersey Avenue SE., Washington, DC 20590, by 
telephone at 202-493-6232, or by email at bernard.arseneau@dot.gov.

SUPPLEMENTARY INFORMATION:

Submitting Comments

    If you submit a comment, please include the docket numbers for this 
notice (FMCSA-2015-0419 and FRA-2015-0111), indicate the specific 
section of this document to which each comment applies, and provide a 
reason for each suggestion or recommendation. You may submit your 
comments and material online or by fax, mail, or hand delivery, but 
please use only one of these means. The Agencies recommend that you 
include your name and a mailing address, an email address, or a phone 
number in the body of your document so the Agencies can contact you if 
there are questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov, 
enter the docket numbers, FMCSA-2015-0419 and FRA-2015-0111, in the 
keyword box, and click ``Search.'' When the new screen appears, click 
on the ``Comment Now!'' button and type your comment into the text box 
on the following screen. Choose whether you are submitting your comment 
as an individual or on behalf of a third party and then submit.
    If you submit your comments by mail or hand delivery, submit them 
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for 
copying and

[[Page 25367]]

electronic filing. If you submit comments by mail and would like to 
know that they reached the facility, please enclose a stamped, self-
addressed postcard or envelope.
    The Agencies published the ANPRM on March 10, 2016 (81 FR 12642). 
The Agencies will consider all comments and material received before 
the end of the comment period on June 8, 2016, and may draft a notice 
of proposed rulemaking based on your comments and other information and 
analysis.

Viewing Comments and Documents

    To view comments and any documents this preamble references as 
available in the docket, go to http://www.regulations.gov. Insert the 
docket number, FMCSA-2015-0419 and FRA-2015-0111, in the keyword box, 
and click ``Search.'' Next, click the ``Open Docket Folder'' button and 
choose the document to review. If you do not have access to the 
Internet, you may view the docket online by visiting the Docket 
Management Facility in Room W12-140 on the ground floor of the DOT West 
Building, 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

    Under 5 U.S.C. 553(c), DOT solicits comments from the public to 
better inform its potential rulemaking process. DOT posts these 
comments, without edit, including any personal information the 
commenter provides, to www.regulations.gov, as described in the system 
of records notice (DOT/ALL-14 FDMS), which you can review at 
www.transportation.gov/privacy.

I. Background

Advance Notice of Proposed Rulemaking

    On March 10, 2016, the Agencies published an advance notice of 
proposed rulemaking (ANPRM) requesting data and information regarding 
the prevalence of moderate-to-severe OSA among individuals occupying 
safety sensitive positions in highway and rail transportation, and on 
its potential consequences for the safety of rail and highway 
transportation. 81 FR 12642. The Agencies also requested information on 
potential costs and benefits from regulatory actions that address the 
safety risks associated with motor carrier and rail transportation 
workers in safety sensitive positions who have OSA. Id. The purpose of 
these listening sessions is to receive oral comments in response to the 
ANPRM.

Legal Basis

Federal Motor Carrier Safety Administration
    FMCSA has authority under 49 U.S.C. 31136(a) and 31502(b)--
delegated to the Agency by 49 CFR 1.87(f) and (i), respectively--to 
establish minimum qualifications, including medical and physical 
qualifications, for commercial motor vehicle (CMV) drivers operating in 
interstate commerce. Section 31136(a)(3) requires that FMCSA's safety 
regulations ensure that the physical conditions of CMV drivers enable 
them to operate their vehicles safely, and that medical examiners (MEs) 
trained in physical and medical examination standards perform the 
physical examinations required of such operators.
    In 2005, Congress authorized FMCSA to establish a Medical Review 
Board (MRB) composed of experts ``in a variety of medical specialties 
relevant to the driver fitness requirements'' to provide advice and 
recommendations on qualification standards. 49 U.S.C. 31149(a). The 
position of FMCSA Chief Medical Examiner was authorized at the same 
time. 49 U.S.C. 31149(b). Under section 31149(c)(1), FMCSA, with the 
advice of the MRB and Chief Medical Examiner, is directed to 
``establish, review and revise . . . medical standards for operators of 
commercial motor vehicles that will ensure that the physical condition 
of operators of commercial motor vehicles is adequate to enable them to 
operate the vehicles safely.'' FMCSA, in conjunction with the Chief 
Medical Examiner, asked the MRB to review and report specifically on 
OSA.
Federal Railroad Administration
    Under 49 U.S.C. 20103, the Secretary of Transportation (Secretary) 
has broad authority to issue regulations governing every area of 
railroad safety. The Secretary has delegated rulemaking responsibility 
under section 20103 to the Administrator of FRA. 49 CFR 1.89(a). 
Moreover, FRA has exercised this safety authority to require other 
medical testing. FRA regulations require locomotive engineers (49 CFR 
240.121) and conductors (49 CFR 242.117) to undergo vision and hearing 
testing as part of their qualification and certification at least every 
3 years. There are individual medical circumstances that may lead a 
railroad to require some engineers or conductors to undergo more 
frequent testing. In addition, Congress has authorized the Secretary to 
consider requiring certification of the following other crafts and 
classes of employees: (1) Car repair and maintenance employees; (2) 
onboard service workers; (3) rail welders; (4) dispatchers; (5) signal 
repair and maintenance employees; and (6) any other craft or class of 
employees that the Secretary determines appropriate. Therefore, the 
Secretary, and the FRA Administrator by delegation, have statutory 
authority to issue regulations to address the safety risks posed by 
employees in safety sensitive positions with OSA.

What is obstructive sleep apnea?

    OSA is a respiratory disorder characterized by a reduction or 
cessation of breathing during sleep. OSA is characterized by repeated 
episodes of upper airway collapse in the region of the upper throat 
(pharynx) that results in intermittent periods of partial airflow 
obstruction (hypopneas), complete airflow obstruction (apneas), and 
respiratory effort-related arousals from sleep (RERAs) in which 
affected individuals awaken partially and may experience gasping and 
choking as they struggle to breathe. Risk factors for developing OSA 
include: Obesity; male gender; advancing age; family history of OSA; 
large neck size; and an anatomically small oropharynx (throat). OSA is 
associated as well with increased risk for other adverse health 
conditions such as: Hypertension (high blood pressure); diabetes; 
obesity; cardiac dysrhythmias (irregular heartbeat); myocardial 
infarction (heart attack); stroke; and sudden cardiac death.
    Individuals who have undiagnosed OSA are often unaware they have 
experienced periods of sleep interrupted by breathing difficulties 
(apneas, hypopneas, or RERAs) when they wake. As a result, the 
condition is often unrecognized by affected individuals and 
underdiagnosed by medical professionals.

What are the safety risks in transportation?

    For individuals with OSA, eight hours of sleep can be less restful 
or refreshing than four hours of ordinary, uninterrupted sleep.\1\ 
Undiagnosed or inadequately treated moderate to severe OSA can cause 
unintended sleep episodes and resulting deficits in attention, 
concentration, situational awareness, and memory, thus reducing the 
capacity to safely respond to hazards when performing safety sensitive 
duties.

[[Page 25368]]

Therefore, OSA is a critical safety issue that can affect operations in 
all modes of travel in the transportation industry.
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    \1\ Gay, P., Weaver, T., Loube, D., Iber, C. (2006). Evaluation 
of positive airway pressure treatment for sleep related breathing 
disorders in adults. Positive Airway Pressure Task Force; Standards 
of Practice Committee; American Academy of Sleep Medicine. Sleep 
29:381-401.
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II. Meeting Participation and Information the Agencies Seek From the 
Public

    Each listening session is open to the public. Speakers should try 
to limit their remarks to 3-5 minutes. No preregistration is required. 
Attendees may submit material to the Agencies' staff at the session to 
include in the pubic dockets referenced in this notice.
    Those participating in the webcast will have the opportunity to 
submit comments online that will be read aloud at the sessions with 
comments made in the meeting rooms. The Agencies will docket the 
transcripts of the webcast, a separate transcription of each listening 
session prepared by an official court reporter, and all other materials 
submitted to the Agencies' personnel.
    The Agencies continue to request public comment on the questions 
below. In your response, please provide supporting materials and 
identify your interest in this rulemaking, whether in the 
transportation industry, medical profession, or other.

The Problem of OSA

    1. What is the prevalence of moderate-to-severe OSA among the 
general adult U.S. population? How does this prevalence vary by age?
    2. What is prevalence of moderate-to-severe OSA among individuals 
occupying safety sensitive transportation positions? If it differs from 
that among the general population, why does it appear to do so? If no 
existing estimates exist, what methods and information sources can the 
Agencies use to reliably estimate this prevalence?
    3. Is there information (studies, data, etc.) available for 
estimating the future consequences resulting from individuals with OSA 
occupying safety sensitive transportation positions in the absence of 
new restrictions? For example, does any organization track the number 
of historical motor carrier or train accidents caused by OSA? With 
respect to rail, how would any OSA regulations and the current positive 
train control system requirements interrelate?
    4. Which categories of transportation workers with safety sensitive 
duties should be required to undergo screening for OSA? On what basis 
did you identify those workers?

Costs and Benefits

    5. What alternative forms and degrees of restriction could FMCSA 
and FRA place on the performance of safety-sensitive duties by 
transportation workers with moderate-to-severe OSA, and how effective 
would these restrictions be in improving transportation safety? Should 
any regulations differentiate requirements for patients with moderate, 
as opposed to severe, OSA?
    6. What are the potential costs of alternative FMCSA/FRA regulatory 
actions that would restrict the safety sensitive activities of 
transportation workers diagnosed with moderate-to-severe OSA? Who would 
incur those costs? What are the benefits of such actions and who would 
realize them?
    7. What are the potential improved health outcomes for individuals 
occupying safety sensitive transportation positions who would receive 
OSA treatment due to regulations?
    8. What models or empirical evidence is available to use to 
estimate potential costs and benefits of alternative restrictions?
    9. What costs would be imposed on transportation workers with 
safety sensitive duties by requiring screening, evaluation, and 
treatment of OSA?
    10. Are there any private or governmental sources of financial 
assistance? Would health insurance cover costs for screening and/or 
treatment of OSA?

Screening Procedures and Diagnostics

    11. What medical guidelines, other than those the American Academy 
of Sleep Medicine guidance the Federal Aviation Administration 
currently uses, are suitable for screening transportation workers with 
safety sensitive duties that are regulated by FMCSA/FRA for OSA? What 
level of effectiveness are you seeing with these guidelines?
    12. What were the safety performance histories of transportation 
workers with safety sensitive duties who were diagnosed with moderate-
to-severe OSA, who are now successfully compliant with treatment before 
and after their diagnosis?
    13. When and how frequently should transportation workers with 
safety sensitive duties be screened for OSA? What methods (laboratory, 
at-home, split, etc.) of diagnosing OSA are appropriate and why?
    14. What, if any, restrictions or prohibitions should there be on 
transportation workers' safety sensitive duties while they are being 
evaluated for moderate-to-severe OSA?
    15. What methods are currently employed for providing training or 
other informational materials about OSA to transportation workers with 
safety sensitive duties? How effective are these methods at identifying 
workers with OSA?

Medical Personnel Qualifications and Restrictions

    16. What qualifications or credentials are necessary for a medical 
practitioner who performs OSA screening? What qualifications or 
credentials are necessary for a medical practitioner who performs the 
diagnosis and treatment of OSA?
    17. With respect to FRA, should it use Railroad MEs to perform OSA 
screening, diagnosis, and treatment?
    18. Should MEs or Agencies' other designated medical practitioners 
impose restrictions on a transportation worker with safety sensitive 
duties who self-reports experiencing excessive sleepiness while 
performing safety sensitive duties?

Treatment Effectiveness

    19. What should be the acceptable criteria for evaluating the 
effectiveness of prescribed treatments for moderate-to-severe OSA?
    20. What measures should be used to evaluate whether transportation 
employees with safety sensitive duties are receiving effective OSA 
treatment?

    Issued on: April 22, 2016.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2016-09911 Filed 4-27-16; 8:45 am]
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