Evaluation of Safety Sensitive Personnel for Moderate-to-Severe Obstructive Sleep Apnea; Public Listening Sessions |
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Larry W. Minor
Federal Motor Carrier Safety Administration
Federal Railroad Administration
28 April 2016
[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.
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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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