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


American Government

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81 FR 12642 is withdrawn.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]
 BILLING CODE 4910-EX-P




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