Evaluation of Safety Sensitive Personnel for Moderate-to-Severe Obstructive Sleep Apnea

Evaluation of Safety Sensitive Personnel for Moderate-to-Severe Obstructive Sleep Apnea

Evaluation of Safety Sensitive Personnel for Moderate-to-Severe Obstructive Sleep Apnea

Daphne Y. Jefferson
Federal Motor Carrier Safety Administration
Heath Hall
Federal Railroad Administration
8 August 2017

[Federal Register Volume 82, Number 151 (Tuesday, August 8, 2017)]
[Proposed Rules]
[Pages 37038-37039]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16451]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

49 CFR Part 391

Federal Railroad Administration

49 CFR Parts 240 and 242

[Docket Numbers FMCSA-2015-0419 and FRA-2015-0111]
RIN 2126-AB88 and 2130-AC52

Evaluation of Safety Sensitive Personnel for Moderate-to-Severe
Obstructive Sleep Apnea

ACTION: Advance notice of proposed rulemaking; withdrawal.

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SUMMARY: The Federal Motor Carrier Safety Administration (FMCSA) and
Federal Railroad Administration (FRA) (collectively, the Agencies)
withdraw the March 10, 2016, advance notice of proposed rulemaking
(ANPRM) concerning the prevalence of moderate-to-severe obstructive
sleep apnea (OSA) among individuals occupying safety sensitive
positions in highway and rail transportation, and its potential
consequences for the safety of highway and rail transportation. The
Agencies have determined not to issue a notice of proposed rulemaking
at this time.

DATES: As of August 8, 2017 the ANPRM published on March 10, 2016, at
81 FR 12642 is withdrawn.

FOR FURTHER INFORMATION CONTACT:
FMCSA: Ms. Christine Hydock, Chief of the Medical Programs
Division, FMCSA, 1200 New Jersey Ave. SE., Washington, DC 20590-0001,
by telephone at 202-366-4001, or by email at fmcsamedical@dot.gov.
FRA: Dr. Amanda Emo, Fatigue Program Manager, Risk Reduction
Program Division, Office of Safety Analysis, FRA, 1200 New Jersey
Avenue SE., Washington, DC 20590-0001, by telephone at 202-281-0695, or
by email at amanda.emo@dot.gov.
If you have questions about viewing or submitting material to the
docket, contact Docket Services, telephone 202-493-0402.

SUPPLEMENTARY INFORMATION:

Background

Based on the potential severity of OSA-related transportation
incidents and crashes/accidents, and the varied, non-regulatory, OSA-
related actions the Department's Operating Administrations have taken
to date, the Agencies issued a joint ANPRM to consider regulatory
action to ensure consistency in addressing the risk of OSA among
transportation workers with safety sensitive duties (81 FR 12642, March
10, 2016). The Agencies sought information from interested parties
regarding OSA to better inform their decision on whether to take
regulatory action and, if so, how to craft the most effective and
efficient regulations to address the potential safety risks associated
with untreated OSA.
The information requested in the ANPRM seemed to be necessary to
help the Agencies quantify the potential economic benefits and costs of
adopting standards to assess risks associated with motor carrier and
rail transportation workers in safety sensitive positions diagnosed
with OSA. To gather relevant data, the Agencies posed a series of
questions addressing the following matters:
Whether OSA is a problem among individuals occupying
safety sensitive positions in highway and rail transportation;
Cost and benefits of regulatory actions that address the
safety risks associated with motor carrier and rail transportation
workers in safety sensitive positions who have OSA;
Qualifications and restrictions for medical personnel; and
Treatment effectiveness.
The Agencies also sought information at three listening sessions in
May 2016, and extended the comment period by thirty days to review the
results from the American Transportation Research Institute (ATRI)
Commercial Driver Survey on Sleep Apnea Issues (http://atri-online.org/2016/04/14/atri-launches-commercial-driver-survey-on-sleep-apnea-issues/). The Agencies received more than 700 comments from
individuals, medical professionals, labor groups, and transportation
industry stakeholders. The Agencies also received comments from the
National Transportation Safety Board and three members of Congress, the
Honorable Anna Eshoo, the Honorable Sam Farr, and the Honorable Michael
M. Honda.

The Agencies' Decision

OSA remains an on-going concern for the Agencies and the motor
carrier and railroad industries because it 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. The
Agencies received valuable information in response to the ANPRM and a
series of public listening sessions in May 2016. The Agencies believe
that current safety

[[Page 37039]]

programs and FRA's rulemaking addressing fatigue risk management are
the appropriate avenues to address OSA.
FMCSA will consider an update to its January 2015 ``Bulletin to
Medical Examiners and Training Organizations Regarding Obstructive
Sleep Apnea'' regarding the physical qualifications standard and
related advisory criteria concerning respiratory dysfunction,
specifically how the standard applies to drivers who may have OSA. The
Agency would use the updated August 2016 Medical Review Board \1\
recommendations as a basis for updating the bulletin. On August 22-23,
2016, the MRB met in public meetings to deliberate on Medical Review
Board Task 16-1 regarding public comments from medical professionals
and associations on the FMCSA's and FRA's ANPRM on obstructive sleep
apnea. FMCSA tasked the MRB with reviewing and analyzing all ANPRM
comments from medical professionals and associations and to identify
factors the Agency should consider regarding making decisions about the
next step in the OSA rulemaking. FMCSA also requested that the MRB
review its previous February 2012 report on OSA from the MRB and Motor
Carrier Safety Advisory Committee (MCSAC). The MRB's February 2012
recommendations formed the basis of their August 2016 recommendations.
In scenarios where medical examiners may inappropriately screen and
refer drivers for diagnostic testing based on single criteria, the
MRB's 2016 recommendations provide objective criteria for identifying
drivers who may be at greater risk for OSA. And, as was the case with
the 2015 bulletin, the purpose of any action updating the bulletin is
to ensure that medical examiners fully understand their role in
screening drivers for OSA, identifying drivers at the greatest risk of
having OSA, and refer only those individuals to a sleep specialist for
testing. The Agency reminds medical examiners that there are no FMCSA
rules or other regulatory guidance beyond what is referenced in this
paragraph above with guidelines for screening, diagnosis, and treatment
of OSA in CMV drivers. Medical certification determinations for such
drivers are made by the examiners based on the examiner's medical
judgment rather than a Federal regulation or requirement.
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\1\ https://www.fmcsa.dot.gov/advisory-committees/mcsac/mrb-task-16-01-letter-report. A copy of the MRB recommendations is
included in this rulemaking docket.
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In addition, FMCSA will continue to recommend that drivers and
their employers use the North American Fatigue Management Program
(NAFMP) (http://www.nafmp.org/index.php?lang=en). The NAFMP is a
voluntary, fully interactive web-based educational and training program
developed to provide both truck and bus commercial vehicle drivers and
carriers and others in the supply chain with an awareness of the
factors contributing to fatigue and its impact on performance. Guidance
on health and wellness, time management, vehicle technologies and
scheduling best-practices provide effective mitigation strategies to
address fatigue while maintaining a healthy and productive work/life
balance. Module 8 of the program, Driver Sleep Disorders Management,
includes an extensive discussion of OSA. [The training materials may be
downloaded at http://www.nafmp.org/index.php?option=com_content&view=article&id=14:downloads&catid=26&lang=en&Itemid=115.]
On September 21, 2004, FRA issued Safety Advisory 2004-04 to alert
the railroad industry, and especially those employees with safety
sensitive duties, to the danger associated with degradation of
performance resulting from undiagnosed or unsuccessfully treated sleep
disorders (69 FR 58995, Oct. 1, 2004). That Safety Advisory set forth
recommended actions regarding OSA, which FRA reiterated in Safety
Advisory 2016-03 (81 FR 87649, Dec. 5, 2016). Additionally, FRA is
aware several railroads are implementing OSA identification and
treatment programs. FRA anticipates these programs will identify best
practices for OSA screening, diagnosis, treatment, and mitigation.
These programs will help identify the current and future needs of the
industry, potential costs, and help define FRA's role in addressing OSA
in the railroad industry. In addition, under the Rail Safety
Improvement Act of 2008 (RSIA), railroads must establish a fatigue
management plan as part of their Risk Reduction Program (RRP) or System
Safety Program (SSP) (49 U.S.C. 20156(f)). RSIA requires a railroad to
consider the need to include in its fatigue management plan
``opportunities for identification, diagnosis, and treatment of any
medical condition that may affect alertness or fatigue, including sleep
disorders.'' (Id. at section 20156(f)(3)(B).) While RSIA does not
address OSA by name, FRA believes railroads will consider OSA when
addressing medical conditions that affect alertness under a railroad's
fatigue risk management plan as part of an RRP or SSP. FRA will
continue to monitor railroads' voluntary OSA programs, as well as the
implementation of fatigue risk management plans, as part of an RRP or
SSP.
Based on the foregoing reasons, the Agencies withdraw the March
2016 ANPRM entitled ``Evaluation of Safety Sensitive Personnel for
Moderate-to-Severe Obstructive Sleep Apnea.'' If FRA or FMCSA
determines further action to be necessary, it will consider regulatory
action.

Issued under the authority of delegations in 49 CFR 1.87(f) and
(i) and 49 CFR 1.89(a), respectively: July 31, 2017.
Daphne Y. Jefferson,
Deputy Administrator, Federal Motor Carrier Safety Administration.
Heath Hall,
Acting Administrator, Federal Railroad Administration.
[FR Doc. 2017-16451 Filed 8-4-17; 8:45 am]
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