Document ID: FRA-2015-0111-0001
Agency: fra
Document Type: Proposed Rule
Title: Evaluation of Safety Sensitive Personnel for Moderate-to-Severe Obstructive Sleep Apnea
Posted Date: 2016-03-10T05:00Z

[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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