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

T.F. Scott Darling III
Federal Motor Carrier Safety Administration
Sarah Feinberg
Federal Railroad Administration
10 March 2016

[Federal Register Volume 81, Number 47 (Thursday, March 10, 2016)]
[Proposed Rules]
[Pages 12642-12647]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05396]

[[Page 12642]]

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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; request for public
comments.

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SUMMARY: The Federal Motor Carrier Safety Administration (FMCSA) and
Federal Railroad Administration (FRA) request data and information
concerning the prevalence of moderate-to-severe obstructive sleep apnea
(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. FMCSA and FRA (collectively
``the Agencies'') also request 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. For instance, the agencies request
comment on the costs and benefits of requiring motor carrier and rail
transportation workers in safety sensitive positions who exhibit
multiple risk factors for OSA to undergo evaluation and treatment by a
healthcare professional with expertise in sleep disorders.

DATES: You must submit comments on or before June 8, 2016.

ADDRESSES: You may submit comments identified by either of the docket
numbers listed at the beginning of this notice using any one of the
following methods:
Federal Rulemaking Portal: www.regulations.gov.
Fax: 202-493-2251.
Mail: Docket Services (M-30), U.S. Department of Transportation,
West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE.,
Washington, DC 20590-0001.
Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is 202-366-9329.
To avoid duplication, please use only one of these four methods.
See the ``Public Participation and Request for Comments'' heading under
the SUPPLEMENTARY INFORMATION section below for instructions regarding
submitting comments.

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. 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.
If you have questions about viewing or submitting material to the
docket, call Ms. Cheryl Collins, Dockets Manager, Docket Services,
telephone 202-493-0402.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

The Department encourages the public to participate in this advance
notice of proposed rulemaking (ANPRM), by submitting comments and
related materials to the appropriate dockets. Where possible, the
Department would like the public to provide scientific peer-reviewed
data to support comments.

Submitting Comments

If you submit a comment, please include the docket number for this
ANPRM (FMCSA-2015-0419 and FRA-2015-0111), indicate the heading of 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, by fax, mail, or hand delivery, but
please use only one of these means. The Department recommends that you
include your name and a mailing address, an email address, or a phone
number in the body of your document so an Agency can contact you if it
has questions regarding your submission.
To submit your comment online, go to www.regulations.gov, type the
docket number, ``FMCSA-2015-0419'' or ``FRA-2015-0111 in the
``Keyword'' box, and click ``Search.'' When the new screen appears,
click the ``Comment Now!'' button and type your comment into the text
box in 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 electronic filing. The Agencies will consider all comments
and material received during the comment period and will use them to
inform any future rulemaking proposals.

Viewing Comments and Documents

To view comments and any document mentioned in this preamble, go to
www.regulations.gov, insert the docket number, ``FMCSA-2015-0419'' or
``FRA-2015-0111'' in the ``Keyword'' box, and click ``Search.'' Next,
click the ``Open Docket Folder'' button and choose the document listed
to review. If you do not have access to the Internet, you may view the
docket online by visiting the Docket Services 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. ET, 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 can be reviewed at
www.dot.gov/privacy.

Legal Basis for the Rulemaking

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

[[Page 12643]]

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.''
As discussed below, FMCSA, in conjunction with the Chief Medical
Examiner, asked the MRB to review and report specifically on OSA. The
MRB's recommendations are described in the MRB and Motor Carrier Safety
Advisory Committee (MCSAC) Recommendations section of this ANPRM.
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). The
railroad incidents discussed below illustrate the risks to railroad
safety posed by railroad employees that have moderate-to-severe OSA.
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, has statutory
authority to issue regulations to address the safety risks posed by
employees in safety sensitive positions with OSA.

Background

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).
Additionally, OSA is associated 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 awaken in the morning. 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. Thus, 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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The following paragraphs provide some examples of accidents where
the National Transportation Safety Board (NTSB) determined that OSA
played a role in causing an accident (or near-accident) involving motor
carriers and trains.
Work Zone Collision, Jackson, Tennessee
On July 26, 2000, the driver of a tractor-trailer traveling on
Interstate 40 near Jackson, Tennessee, collided with a Tennessee
Highway Patrol vehicle trailing construction vehicles, killing the
state trooper inside. The tractor-trailer then traveled across the
median and collided with a Chevrolet Blazer heading in the opposite
direction, seriously injuring the driver of the Blazer. The tractor-
trailer driver was 5 feet, 11 inches tall, weighed 358 pounds, and had
been diagnosed with and undergone surgery for OSA, but had not
indicated either the diagnosis or the surgery on examinations for
medical certification. The NTSB found that the driver's unreported OSA,
untreated hypothyroidism, or complications from either or both
conditions predisposed him to impairment or incapacitation, including
falling asleep at the wheel while driving. The NTSB determined the
probable cause of the accident was the driver's incapacitation, which
resulted from the failure of the medical certification process to
detect and remove a medically unfit driver from service.\2\
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\2\ Work Zone Collision Between a Tractor-Semitrailer and a
Tennessee Highway Patrol Vehicle, Jackson, Tennessee, July 26, 2000,
Highway Accident Report NTSB/HAR-02/01 (Washington, DC: National
Transportation Safety Board, 2002), available at http://www.ntsb.gov/investigations/AccidentReports/Reports/HAR0201.pdf.
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BNSF Railway Collision, Red Oak, Iowa
On April 17, 2011, at approximately 6:55 a.m. CDT, an eastbound
BNSF Railway (BNSF) coal train traveling near Red Oak, Iowa collided
with the rear end of a standing BNSF maintenance-of-way equipment
train. The collision resulted in the derailment of two locomotives and
12 cars, a diesel fuel fire, and the deaths of both crewmembers on the
striking train. In its investigative report, the NTSB noted that
neither of the fatally injured train crewmembers had undergone a sleep
study prior to the incident. However, in each case, medical records
indicated that both crewmembers had multiple risk factors for OSA.\3\
NTSB determined that the probable cause of the accident was ``the
failure of the crew of the striking train to comply with the signal
indication requiring them to operate in accordance with restricted
speed requirements and stop short of the standing train because they
had fallen asleep due to fatigue resulting from their irregular work
schedules and their medical conditions.'' \4\ NTSB recommended that FRA
``require railroads to medically screen employees

[[Page 12644]]

with safety sensitive duties for sleep apnea and other sleep
disorders.'' \5\
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\3\ NTSB, Railroad Accident Report, RAR-12/02, Collision of BNSF
Coal Train with the Rear End of Standing BNSF Maintenance-of-Way
Equipment Train, Red Oak, Iowa, April 17, 2011, pp. 43-44. http://www.ntsb.gov/investigations/AccidentReports/Reports/RAR1202.pdf.
\4\ Id. at 72.
\5\ Id. at 73.
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Metro-North Railroad Derailment, Bronx, NY
On December 1, 2013, at approximately 7:20 a.m. EST, southbound
Metro-North Railroad (Metro-North) passenger train 8808 derailed as it
approached the Spuyten Duyvil Station in New York City. All passenger
cars and the locomotive derailed, and, as a result, four passengers
died and at least 61 passengers were injured. The train was traveling
at 82 mph when it derailed in a section of curved track where the
maximum authorized speed was 30 mph. Following the accident, the
engineer reported that: (1) He felt dazed just before the derailment;
\6\ and (2) his wife had previously complained about his snoring. The
engineer then underwent a sleep evaluation, which identified excessive
daytime sleepiness, followed by a sleep study, which diagnosed severe
OSA. Based on its investigation of the derailment, the NTSB concluded
that the engineer had multiple OSA risk factors, such as obesity, male
gender, snoring, complaints of fatigue, and excessive daytime
sleepiness. Even though the engineer exhibited these OSA risk factors,
neither his personal health care provider nor his Metro-North
occupational health evaluations had screened the engineer for OSA.\7\
NTSB determined that the probable cause of the accident was the
``engineer's noncompliance with the 30-mph speed restriction because he
had fallen asleep due to undiagnosed severe obstructive sleep apnea
exacerbated by a recent circadian rhythm shift required by his work
schedule.'' \8\
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\6\ NTSB, Railroad Accident Brief, RAB-14/12, Metro-North
Railroad Derailment, October 24, 2014, p. 2. http://www.ntsb.gov/investigations/AccidentReports/Reports/RAB1412.pdf.
\7\ Id. at 3.
\8\ Id. at 5.
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Union Pacific Railroad and BNSF Railway Chaffee Collision
On May 25, 2013, at approximately 2:30 a.m., a Union Pacific
Railroad (UP) freight train collided with a BNSF freight train at an
interlocking near Chaffee, Missouri. The collision resulted in the
derailment of 13 cars from the BNSF train, two locomotives and 11 cars
from the UP train, and a diesel fuel fire. The two crew members from
the UP train were injured and transported to a local hospital. The
derailing train cars struck nearby highway bridge supports, resulting
in the collapse of portions of the bridge, two motor vehicle accidents,
and injury to five motor vehicle occupants. NTSB estimated the total
damages to be more than $11 million.\9\
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\9\ NTSB, Railroad Accident Report 14/02, Collision of Union
Pacific Railroad Freight Train with BNSF Railway Freight Train Near
Chaffee, Missouri, May 25, 2013, p. ii. http://www.ntsb.gov/investigations/accidentreports/reports/rar1402.pdf.
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NTSB determined the probable cause of the accident to be ``failure
of the Union Pacific Railroad train crewmembers to comply with wayside
signals leading into the Rockview Interlocking as a result of their
disengagement from their task, likely because of fatigue-induced
performance degradation.'' NTSB concluded that a contributing factor to
the engineer's fatigue was undiagnosed OSA.\10\
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\10\ Id. at 42.
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NTSB also concluded that absence of positive train control (PTC)
\11\ was a contributing factor in each of the above train
accidents.\12\ FRA agrees that PTC is an important technology that may
prevent certain types of accidents in which OSA is a contributing
factor. Nevertheless, PTC is not required on all track segments and any
potential OSA regulations could have substantial positive impact at
those locations. Potential OSA regulations could also have benefits
even where PTC is fully implemented. For instance, compliance with
potential OSA regulations could prevent incidents that PTC is not
designed to prevent. Even in a situation when an engineer with OSA
falls asleep and PTC functions as intended and stops a moving train
before certain incidents,\13\ there may be delay costs to passengers
and other trains from attending to the engineer that could be avoided
by potential OSA regulations. The three examples of train accidents
described above are illustrative of the consequences that could result
from accidents that occur due to OSA.
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\11\ The NTSB report for the Red Oak accident concluded that a
lack of a PTC system ``that identifies the rear of a train and stops
a following train if a safe braking profile is exceeded''
contributed to the accident. NTSB Railroad Accident Report, RAR-12/
02 at 72. NTSB further concluded that the type of PTC system that
was in development or being deployed at the time of the report
(2011) would not address this type of accident. Id. at 71.
\12\ See id. at 72; NTSB Railroad Accident Brief, RAB-14/12 at
5; and NTSB Railroad Accident Report 14/02 at 37-38, and 50.
\13\ See 49 CFR 236.1005(a).
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What actions have the Department's operating administrations taken?

The Department promotes the safety of America's transportation
system through information, Web sites, regulations, guidelines, and
policies. The Department's operating administrations regulate
transportation safety following authorizations from the Congress. The
authorities for determining and ensuring that transportation operators
engaged in interstate commerce are physically qualified differ among
the Department's operating administrations. Several administrations
have been working for many years, in some instances along with advisory
groups, to improve policies on medical fitness for duty of personnel in
safety-critical functions. The sections below summarize the initiatives
that several DOT operating administrations have taken to address OSA
under their current authority.
Federal Aviation Administration (FAA)
Although this ANPRM covers how FMCSA and FRA will potentially treat
OSA, FAA's history of its OSA screening of pilots is instructive. The
FAA was created to provide the safe and efficient use of the national
air space; that mission has evolved to providing the safest, most
efficient aerospace system in the world. While the United States has an
impressive safety record, the FAA continues to work with the aviation
and medical communities to maintain medical certification standards to
keep our skies safe. The FAA has always considered OSA a disqualifying
condition, but has used its special issuance process \14\ to
certificate airman if the hazard of OSA was satisfactorily treated or
mitigated.
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\14\ https://www.faa.gov/about/office_org/headquarters_offices/avs/offices/aam/ame/guide/app_process/general/si.
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In November 2013, FAA proposed guidance that would have required
pilots with a body mass index (BMI) of 40 or more to be evaluated for
OSA. Key aviation industry stakeholders, as well as members of
Congress, expressed concerns about this single-factor enhanced
screening as lacking a sufficient evidentiary basis, and thus being an
example of overregulation by the FAA.
In response, FAA worked with stakeholders, to revise the guidance
to address those concerns and issued new medical guidance to Aviation
Medical Examiners (AMEs) on March 2, 2015, which balanced industry and
Congressional concerns with the FAA and NTSB's safety concerns about
pilots flying with OSA. Under the new guidance, AMEs screen airman for
OSA using an integrated assessment of history, symptoms, and physical/
clinical findings. If screening identifies a need for further
evaluation, an OSA risk factor evaluation will be done by the AME at
the time of the physical

[[Page 12645]]

examination using the American Academy of Sleep Medicine (AASM)
guidance provided in the Guide for Aviation Medical Examiners.\15\
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\15\ https://www.faa.gov/about/office_org/headquarters_offices/avs/offices/aam/ame/guide/.
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A pilot identified as being at risk for OSA will be issued a
medical certificate, and shortly thereafter receive a letter from FAA's
Federal Air Surgeon requesting that an OSA evaluation be completed
within 90 days. The evaluation may be done by any physician (including
the AME), not just a sleep medicine specialist. If the evaluating
physician determines, using the AASM guidelines, that a laboratory
sleep study or home study is warranted, it should be ordered at that
time. The pilot will have 90 days (or longer under special
circumstances) to accomplish this, as outlined in the Federal Air
Surgeon's letter. The pilot may continue flying during the evaluation
period until they have been diagnosed with OSA. A pilot is not allowed
to fly once diagnosed with OSA, but upon submitting documentation of
effective treatment to FAA, the FAA will then consider the pilot for a
special issuance medical certificate, which allow the pilot to resume
flying. More information on FAA guidance can be found at: https://www.faa.gov/news/fact_sheets/news_story.cfm?newsId=18156.
Federal Motor Carrier Safety Administration
FMCSA's October 5, 2000, Advisory Criteria
In 2000, FMCSA issued advisory criteria providing interpretive
guidance to MEs concerning its physical qualifications standards. These
advisory criteria are recommendations from FMCSA to assist MEs in
applying the minimum physical qualification standards. The advisory
criteria were published with the Federal Motor Carrier Safety
Regulations as part of the medical examination report form in 49 CFR.
391.43 (Physical Qualification of Drivers; Medical Examination;
Certificate, 65 FR 59363 (October 5, 2000)).
The advisory criterion for section 391.41(b)(5), which has been
unchanged since 2000, provides the following guidance for MEs in making
the determination whether a driver satisfies the respiratory standard:

[Because] a driver must be alert at all times, any change in his
or her mental state is in direct conflict with highway safety. Even
the slightest impairment in respiratory function under emergency
conditions (when greater oxygen supply is necessary for performance)
may be detrimental to safe driving.
There are many conditions that interfere with oxygen exchange
and may result in incapacitation, including emphysema, chronic
asthma, carcinoma, tuberculosis, chronic bronchitis and sleep apnea.
If the MEs detect a respiratory dysfunction that in any way is
likely to interfere with the driver's ability to safely control and
drive a commercial motor vehicle, the driver must be referred to a
specialist for further evaluation and therapy. . . .

Based on the above advisory criterion, it is clear that FMCSA
considers OSA to be a respiratory dysfunction that interferes with
oxygen exchange. As such, if a ME believes a driver's respiratory
condition is, in any way, likely to interfere with the driver's ability
to safely control and drive a commercial motor vehicle, the examiner
may refer the driver to a specialist for further evaluation and
therapy. This advisory criterion is helpful to MEs when the examiner
has sufficient experience or information to recognize certain risk
factors for OSA and when a driver tells the examiner that he has been
diagnosed with OSA. Under these circumstances, MEs may consider
referring the driver to a specialist for evaluation before issuing a
ME's certificate, or request additional information from the driver and
his treating healthcare professional about the management of the
driver's OSA, respectively. However, the current guidance is not
helpful if the ME does not have sufficient experience or information to
suspect the driver may have OSA, or the driver does not share with the
examiner any previous diagnosis that he has the condition.
MRB and MCSAC Recommendations
In consideration of the limitations of the current advisory
criterion, FMCSA tasked its MRB and MCSAC in 2011 to provide
recommendations that FMCSA should consider to (1) develop new OSA
standards for motor carriers, commercial vehicle drivers, and MEs and
(2) determine whether drivers with this respiratory condition should
receive an unrestricted two-year medical certificate to operate CMVs in
interstate commerce. The MCSAC also recommended interim actions that
FMCSA could take to help MEs address the issue before completing a
rulemaking. A copy of the task statement, all presentations provided to
the MCSAC, MRB, and the Committees' December 13, 2011, letter report to
the FMCSA Administrator are included in the docket referenced at the
beginning of this notice and also at the MCSAC Web page at https://www.fmcsa.dot.gov/advisory-committees/mcsac/2012-past-meetings.
During the deliberations of the MCSAC and MRB, experts indicated
that studies \16\ show that a using a BMI of 33 as a screening
indicator for OSA is the value at which false positives and false
negatives are minimized. A false positive would require a driver who
does not have moderate-to-severe OSA to undergo a sleep study
unnecessarily, while a false negative would fail to require a driver
who actually has moderate-to-severe OSA to undergo a sleep study. The
medical experts participating in the meeting indicated that
approximately 75 percent of moderate-to-severe OSA cases would be
correctly identified by requiring a sleep study for drivers with a BMI
of 33 or greater; however, approximately 25 percent of drivers with
moderate-to-severe OSA would be missed with this cutoff. Because the
likelihood of OSA in patients with BMIs of 35 or greater rises to
nearly 80 percent, the MCSAC and MRB agreed to use a BMI of 35 (rather
than 33) in their interim advice to MEs screening drivers for referral
to a specialist. A copy of the MCSAC and MRB discussion notes is
included in the docket referenced at the beginning of this notice.
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\16\ Numerous studies were cited in presentations to the groups;
links to two relevant presentations are: (1) https://www.fmcsa.dot.gov/advisory-committees/mcsac/addressing-obstructive-sleep-apnea-cmv-drivers, and (2) https://www.fmcsa.dot.gov/advisory-committees/mcsac/screening-osa-commercial-vehicle-operators.
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The chairs of the MRB and MCSAC considered their December 13, 2011,
report as a first step towards recommendations for addressing OSA. The
two committees completed more detailed recommendations in February 2012
to support a future notice-and-comment rulemaking. A copy of those
recommendations is included in the docket referenced at the beginning
of this notice.
Before FMCSA issued a notice requesting public comment on proposed
regulatory guidance, several stakeholder groups expressed concerns
about the agency addressing OSA through regulatory guidance, even on an
interim basis. These groups requested that FMCSA pursue the matter
through a notice-and-comment rulemaking process.
In 2013, Congress enacted Public Law 113-45 (127 Stat. 557, October
13, 2013, in a note to 49 U.S.C. 31305) directing FMCSA to issue any
new or revised requirements concerning sleep disorders, including OSA,
by rulemaking. Such requirements would include those for sleep apnea
screening, testing, and treatment of CMV drivers.

[[Page 12646]]

On January 12, 2015, FMCSA issued a bulletin to healthcare
professionals on the National Registry of Certified Medical Examiners
regarding OSA. The bulletin reminded healthcare workers of the current
physical qualifications standards and advisory criteria concerning the
respiratory system, and specifically how those requirements apply to
drivers that may have OSA. It encouraged MEs to explain to drivers the
distinction between actions based on the current regulations and
advisory criteria versus actions based on the MEs' professional
judgment.
Federal Railroad Administration
The FRA has taken various regulatory and non-regulatory actions to
address the risk of accidents in which fatigue and/or OSA may be a
contributing factor.
FRA Hours of Service Laws and Regulations
FRA enforces laws and has issued regulations regarding hours of
service for certain railroad employees. See 49 U.S.C. chapter 211 and
49 CFR part 228. The hours of service (HOS) laws and regulations
establish maximum hours of work and minimum hours of rest for train
employees, signal employees, and dispatching service employees, as
defined at 49 U.S.C. 21101.
HOS laws and regulations are a necessary component of mitigating
risk associated with work schedules, including potential fatigue-
related risks. However, HOS laws and regulations do not adequately
mitigate risks associated with undiagnosed or inadequately treated OSA,
even if the work schedules comply with the HOS laws and regulations, as
they assume that the sleep that occurs during off-duty time is normal,
restful sleep.
Fatigue Management Plans
RSIA also requires certain railroads to establish a fatigue
management plan. See 49 U.S.C. 20156(f). FRA is currently working with
the Railroad Safety Advisory Committee (RSAC) to draft a regulation to
implement this mandate. The RSIA requires plans to be ``designed to
reduce the fatigue experienced by safety-related railroad employees and
to reduce the likelihood of accidents, incidents, injuries, and
fatalities caused by fatigue.'' Id. at section 20156(f)(1). Further,
the RSIA requires a railroad to consider the need to include in its
fatigue management plan, as applicable, ``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). However, RSIA does not specifically mandate
that the regulation require railroads to screen and evaluate safety-
related railroad employees for OSA or other sleep disorders.
FRA Safety Advisory 2004-04
On September 21, 2004, FRA issued Safety Advisory 2004-04 to alert
the railroad community, and especially those employees with safety
sensitive duties, to the danger associated with degradation of
performance resulting from sleep disorders that are undiagnosed or not
successfully treated. 69 FR 58995 (Oct. 1, 2004). FRA recommended that
the railroad community take the following actions:
1. Establish training and educational programs to inform employees
of the potential for performance impairment as a result of fatigue and
sleep related issues;
2. Develop standardized screening tools for diagnosis, referral,
and treatment of sleep disorders (especially sleep apnea);
3. Develop rules to encourage voluntary reporting of sleep
disorders by employees with safety sensitive duties;
4. Implement policies that would prohibit employees in safety
sensitive positions who have incapacitation or performance-impairing
medical conditions related to sleep from performing any safety
sensitive duties until the medical condition appropriately responds to
treatment; and
5. Implement policies to: (a) Promote self-reporting; (b) encourage
participation in evaluation and treatment; and (c) establish dispute
resolution to resolve any issues regarding fitness of those employees
who have reported sleep-related issues.
RSAC Medical Standards Working Group
In September 2006, the RSAC established the Medical Standards
Working Group to develop standards for identifying conditions that
could lead to sudden incapacitation or impairment of safety-critical
personnel. The Working Group established a Physicians Task Force that
developed draft medical standards and protocols. FRA put the Medical
Standards Working Group on hiatus due to the requirement to focus on
activities mandated in the Rail Safety Improvement Act of 2008.
Railroaders' Guide to Healthy Sleep Web Site
As part of its non-regulatory efforts to address fatigue, FRA
sponsors the Railroaders' Guide to Healthy Sleep Web site.\17\ This Web
site is set up to disseminate educational information to railroad
employees and their families about sleep disorders, the relevance of
healthy sleep to railroad safety, and information about improving the
quality of the railroaders' sleep. The Web site was developed in
conjunction with the Division of Sleep Medicine at Harvard Medical
School, WGBH Educational Foundation, and Volpe--The National
Transportation Systems Center.
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\17\ https://www.railroadersleep.org/.
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Why do the Agencies believe regulatory action may be necessary?

Based on the potential severity of OSA-related transportation
incidents and accidents, and the varied, non-regulatory, OSA-related
actions taken by the Department's Operating Administrations to date,
the Agencies are considering taking regulatory action to ensure
consistency in addressing the safety issue presented by transportation
workers with safety sensitive duties who are at risk for OSA.
The Agencies seek information from interested parties regarding
OSA, in order to better inform their decision on whether to take
regulatory action and, if so, how to craft the most effective and
efficient regulation to address the potential safety risks associated
with OSA.

Request for Comments

The Agencies 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

[[Page 12647]]

accidents caused by OSA? With respect to rail, how would any OSA
regulations and the current PTC 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?
Cost & 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 and 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 & Diagnostics
11. What medical guidelines other than the AASM FAA 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 a
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 & 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 other Agencies' 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?

Rulemaking Analyses and Notices

Executive Order (E.O.) 12866 (Regulatory Planning and Review) and DOT
Regulatory Policies and Procedures

Under E.O. 12866, ``Regulatory Planning and Review'' (issued
September 30, 1993, published October 4 at 58 FR 51735, and discussed
above in the ``Background'' section), as supplemented by E.O. 13563 and
DOT policies and procedures, if a regulatory action is determined to be
``significant,'' it is subject to Office of Management and Budget (OMB)
review. E.O. 12866 defines ``significant regulatory action'' as one
likely to result in a rule that may:
(1) Have an annual effect on the economy of $100 million or more or
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or Tribal government or communities.
(2) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another Agency.
(3) Materially alter the budgetary impact of entitlements, grants,
user fees, or loan programs or the rights and obligations of recipients
thereof.
(4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the E.O.
The Department has determined this ANPRM is a ``significant
regulatory action'' under E.O. 12866, and significant under DOT
regulatory policies and procedures due to significant public interest
in the legal and policy issues addressed. Therefore, this notice has
been reviewed by OMB.

Issued under the authority of delegations in 49 CFR 1.87(f) and
(i) and 49 CFR 1.89(a), respectively:
T.F. Scott Darling III,
Acting Administrator, Federal Motor Carrier Safety Administration.
Sarah Feinberg,
Administrator, Federal Railroad Administration.
[FR Doc. 2016-05396 Filed 3-9-16; 8:45 am]
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