82 FR 37038 - Evaluation of Safety Sensitive Personnel for Moderate-to-Severe Obstructive Sleep Apnea

DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety Administration
Federal Railroad Administration

Federal Register Volume 82, Issue 151 (August 8, 2017)

Page Range		37038-37039
FR Document		2017-16451

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.

Federal Register, Volume 82 Issue 151 (Tuesday, August 8, 2017)

[Federal Register Volume 82, Number 151 (Tuesday, August 8, 2017)]
[Proposed Rules]
[Pages 37038-37039]
From the Federal Register Online  [www.thefederalregister.org]
[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81 FR 12642 is withdrawn.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 [email protected].
    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 [email protected].
    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.
---------------------------------------------------------------------------

    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

37038 Federal Register / Vol. 82, No. 151 / Tuesday, August 8, 2017 / Proposed Rules

you wish to make. EPA will generally DEPARTMENT OF TRANSPORTATION consistency in addressing the risk of
not consider comments or comment OSA among transportation workers with
contents located outside of the primary Federal Motor Carrier Safety safety sensitive duties (81 FR 12642,
submission (i.e., on the web, cloud, or Administration March 10, 2016). The Agencies sought
other file sharing system). For information from interested parties
additional submission methods, the full 49 CFR Part 391 regarding OSA to better inform their
EPA public comment policy, decision on whether to take regulatory
information about CBI or multimedia Federal Railroad Administration action and, if so, how to craft the most
submissions, and general guidance on effective and efficient regulations to
49 CFR Parts 240 and 242 address the potential safety risks
making effective comments, please visit
associated with untreated OSA.
http://www2.epa.gov/dockets/ [Docket Numbers FMCSA–2015–0419 and
The information requested in the
commenting-epa-dockets. FRA–2015–0111]
ANPRM seemed to be necessary to help
FOR FURTHER INFORMATION CONTACT: RIN 2126–AB88 and 2130–AC52 the Agencies quantify the potential
Andres Febres of the Air Regulatory economic benefits and costs of adopting
Evaluation of Safety Sensitive standards to assess risks associated with
Management Section, Air Planning and Personnel for Moderate-to-Severe
Implementation Branch, Air, Pesticides motor carrier and rail transportation
Obstructive Sleep Apnea workers in safety sensitive positions
and Toxics Management Division, U.S.
Environmental Protection Agency, ACTION:Advance notice of proposed diagnosed with OSA. To gather relevant
Region 4, 61 Forsyth Street SW., rulemaking; withdrawal. data, the Agencies posed a series of
Atlanta, Georgia 30303–8960. Mr. questions addressing the following
SUMMARY: The Federal Motor Carrier matters:
Febres can be reached via telephone at • Whether OSA is a problem among
(404) 562–8966 or via electronic mail at Safety Administration (FMCSA) and
Federal Railroad Administration (FRA) individuals occupying safety sensitive
febres-martinez.andres@epa.gov. positions in highway and rail
(collectively, the Agencies) withdraw
SUPPLEMENTARY INFORMATION: In the the March 10, 2016, advance notice of transportation;
Final Rules Section of this Federal proposed rulemaking (ANPRM) • Cost and benefits of regulatory
Register, EPA is approving Mississippi’s concerning the prevalence of moderate- actions that address the safety risks
June 7, 2016 SIP revision that modifies to-severe obstructive sleep apnea (OSA) associated with motor carrier and rail
the State’s PSD program by changing the among individuals occupying safety transportation workers in safety
IBR date for the Federal PSD regulations sensitive positions in highway and rail sensitive positions who have OSA;
transportation, and its potential • Qualifications and restrictions for
to February 17, 2016, as a direct final medical personnel; and
rule without prior proposal because the consequences for the safety of highway
• Treatment effectiveness.
Agency views this as a noncontroversial and rail transportation. The Agencies
The Agencies also sought information
submittal and anticipates no adverse have determined not to issue a notice of
at three listening sessions in May 2016,
comments. A detailed rationale for the proposed rulemaking at this time.
and extended the comment period by
approval is set forth in the direct final DATES: As of August 8, 2017 the ANPRM thirty days to review the results from
rule and incorporated herein by published on March 10, 2016, at 81 FR the American Transportation Research
reference. If no adverse comments are 12642 is withdrawn. Institute (ATRI) Commercial Driver
received in response to this rule, no FOR FURTHER INFORMATION CONTACT: Survey on Sleep Apnea Issues (http://
further activity is contemplated. If EPA FMCSA: Ms. Christine Hydock, Chief atri-online.org/2016/04/14/atri-launches
receives adverse comments, the direct of the Medical Programs Division, -commercial-driver-survey-on-sleep-
final rule will be withdrawn and all FMCSA, 1200 New Jersey Ave. SE., apnea-issues/). The Agencies received
adverse comments received will be Washington, DC 20590–0001, by more than 700 comments from
addressed in a subsequent final rule telephone at 202–366–4001, or by email individuals, medical professionals,
at fmcsamedical@dot.gov. labor groups, and transportation
based on this proposed rule. EPA will
FRA: Dr. Amanda Emo, Fatigue industry stakeholders. The Agencies
not institute a second comment period
Program Manager, Risk Reduction also received comments from the
on this document. Any parties Program Division, Office of Safety
interested in commenting on this National Transportation Safety Board
Analysis, FRA, 1200 New Jersey Avenue and three members of Congress, the
document should do so at this time. SE., Washington, DC 20590–0001, by Honorable Anna Eshoo, the Honorable
Dated: July 25, 2017. telephone at 202–281–0695, or by email Sam Farr, and the Honorable Michael
V. Anne Heard, at amanda.emo@dot.gov. M. Honda.
Acting Regional Administrator, Region 4.
If you have questions about viewing
or submitting material to the docket, The Agencies’ Decision
[FR Doc. 2017–16615 Filed 8–7–17; 8:45 am]
contact Docket Services, telephone 202– OSA remains an on-going concern for
BILLING CODE 6560–50–P 493–0402. the Agencies and the motor carrier and
SUPPLEMENTARY INFORMATION: railroad industries because it can cause
unintended sleep episodes and resulting
asabaliauskas on DSKBBXCHB2PROD with PROPOSALS

Background deficits in attention, concentration,
Based on the potential severity of situational awareness, and memory,
OSA-related transportation incidents thus reducing the capacity to safely
and crashes/accidents, and the varied, respond to hazards when performing
non-regulatory, OSA-related actions the safety sensitive duties. The Agencies
Department’s Operating received valuable information in
Administrations have taken to date, the response to the ANPRM and a series of
Agencies issued a joint ANPRM to public listening sessions in May 2016.
consider regulatory action to ensure The Agencies believe that current safety

VerDate Sep<11>2014 18:18 Aug 07, 2017 Jkt 241001 PO 00000 Frm 00008 Fmt 4702 Sfmt 4702 E:\FR\FM\08AUP1.SGM 08AUP1

Federal Register / Vol. 82, No. 151 / Tuesday, August 8, 2017 / Proposed Rules 37039

programs and FRA’s rulemaking having OSA, and refer only those several railroads are implementing OSA
addressing fatigue risk management are individuals to a sleep specialist for identification and treatment programs.
the appropriate avenues to address testing. The Agency reminds medical FRA anticipates these programs will
OSA. examiners that there are no FMCSA identify best practices for OSA
FMCSA will consider an update to its rules or other regulatory guidance screening, diagnosis, treatment, and
January 2015 ‘‘Bulletin to Medical beyond what is referenced in this mitigation. These programs will help
Examiners and Training Organizations paragraph above with guidelines for identify the current and future needs of
Regarding Obstructive Sleep Apnea’’ screening, diagnosis, and treatment of the industry, potential costs, and help
regarding the physical qualifications OSA in CMV drivers. Medical define FRA’s role in addressing OSA in
standard and related advisory criteria certification determinations for such the railroad industry. In addition, under
concerning respiratory dysfunction, drivers are made by the examiners based the Rail Safety Improvement Act of 2008
specifically how the standard applies to on the examiner’s medical judgment (RSIA), railroads must establish a
drivers who may have OSA. The Agency rather than a Federal regulation or fatigue management plan as part of their
would use the updated August 2016 requirement. Risk Reduction Program (RRP) or
Medical Review Board 1 In addition, FMCSA will continue to System Safety Program (SSP) (49 U.S.C.
recommendations as a basis for recommend that drivers and their 20156(f)). RSIA requires a railroad to
updating the bulletin. On August 22–23, employers use the North American consider the need to include in its
2016, the MRB met in public meetings Fatigue Management Program (NAFMP) fatigue management plan ‘‘opportunities
to deliberate on Medical Review Board (http://www.nafmp.org/ for identification, diagnosis, and
Task 16–1 regarding public comments index.php?lang=en). The NAFMP is a treatment of any medical condition that
from medical professionals and voluntary, fully interactive web-based may affect alertness or fatigue, including
associations on the FMCSA’s and FRA’s educational and training program sleep disorders.’’ (Id. at section
ANPRM on obstructive sleep apnea. developed to provide both truck and bus 20156(f)(3)(B).) While RSIA does not
FMCSA tasked the MRB with reviewing commercial vehicle drivers and carriers address OSA by name, FRA believes
and analyzing all ANPRM comments and others in the supply chain with an railroads will consider OSA when
from medical professionals and awareness of the factors contributing to addressing medical conditions that
associations and to identify factors the fatigue and its impact on performance. affect alertness under a railroad’s fatigue
Agency should consider regarding Guidance on health and wellness, time risk management plan as part of an RRP
making decisions about the next step in management, vehicle technologies and or SSP. FRA will continue to monitor
the OSA rulemaking. FMCSA also scheduling best-practices provide railroads’ voluntary OSA programs, as
requested that the MRB review its effective mitigation strategies to address well as the implementation of fatigue
previous February 2012 report on OSA fatigue while maintaining a healthy and risk management plans, as part of an
from the MRB and Motor Carrier Safety productive work/life balance. Module 8 RRP or SSP.
Advisory Committee (MCSAC). The of the program, Driver Sleep Disorders
Management, includes an extensive Based on the foregoing reasons, the
MRB’s February 2012 recommendations Agencies withdraw the March 2016
formed the basis of their August 2016 discussion of OSA. [The training
materials may be downloaded at http:// ANPRM entitled ‘‘Evaluation of Safety
recommendations. In scenarios where Sensitive Personnel for Moderate-to-
medical examiners may inappropriately www.nafmp.org/
index.php?option=com_content& Severe Obstructive Sleep Apnea.’’ If
screen and refer drivers for diagnostic FRA or FMCSA determines further
view=article&id=14:downloads&catid
testing based on single criteria, the action to be necessary, it will consider
=26&lang=en&Itemid=115.]
MRB’s 2016 recommendations provide On September 21, 2004, FRA issued regulatory action.
objective criteria for identifying drivers Safety Advisory 2004–04 to alert the
who may be at greater risk for OSA. Issued under the authority of delegations
railroad industry, and especially those in 49 CFR 1.87(f) and (i) and 49 CFR 1.89(a),
And, as was the case with the 2015 employees with safety sensitive duties,
bulletin, the purpose of any action respectively: July 31, 2017.
to the danger associated with Daphne Y. Jefferson,
updating the bulletin is to ensure that degradation of performance resulting
medical examiners fully understand from undiagnosed or unsuccessfully Deputy Administrator, Federal Motor Carrier
their role in screening drivers for OSA, Safety Administration.
treated sleep disorders (69 FR 58995,
identifying drivers at the greatest risk of Oct. 1, 2004). That Safety Advisory set Heath Hall,
forth recommended actions regarding Acting Administrator, Federal Railroad
1 https://www.fmcsa.dot.gov/advisory-committees
OSA, which FRA reiterated in Safety Administration.
/mcsac/mrb-task-16-01-letter-report. A copy of the
Advisory 2016–03 (81 FR 87649, Dec. 5, [FR Doc. 2017–16451 Filed 8–4–17; 8:45 am]
MRB recommendations is included in this
rulemaking docket. 2016). Additionally, FRA is aware BILLING CODE 4910–EX–P
asabaliauskas on DSKBBXCHB2PROD with PROPOSALS

VerDate Sep<11>2014 18:18 Aug 07, 2017 Jkt 241001 PO 00000 Frm 00009 Fmt 4702 Sfmt 9990 E:\FR\FM\08AUP1.SGM 08AUP1

Document Created: 2017-08-08 00:17:45
Document Modified: 2017-08-08 00:17:45

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Proposed Rules
Action		Advance notice of proposed rulemaking; withdrawal.
Dates		As of August 8, 2017 the ANPRM published on March 10, 2016, at 81 FR 12642 is withdrawn.
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 [email protected]
FR Citation		82 FR 37038
RIN Number		2126-AB88 and 2130-AC52
CFR Citation		49 CFR 240 49 CFR 242 49 CFR 391

82 FR 37038 - Evaluation of Safety Sensitive Personnel for Moderate-to-Severe Obstructive Sleep Apnea

DEPARTMENT OF TRANSPORTATIONFederal Motor Carrier Safety AdministrationFederal Railroad Administration

Federal Register Volume 82, Issue 151 (August 8, 2017)

DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety Administration
Federal Railroad Administration