Proposed Recommendations on Obstructive Sleep Apnea, 23794-23797 [2012-9555]

Agencies

• Federal Motor Carrier Safety Administration
• DEPARTMENT OF TRANSPORTATION

[Federal Register Volume 77, Number 77 (Friday, April 20, 2012)]
[Notices]
[Pages 23794-23797]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-9555]


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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA-2012-0102]


Proposed Recommendations on Obstructive Sleep Apnea

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice; request for public comments.

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SUMMARY: FMCSA announces proposed recommendations from the Motor 
Carrier Safety Advisory Committee (MCSAC) and the Medical Review Board 
(MRB) on Obstructive Sleep Apnea (OSA) and the medical certification of 
commercial motor vehicle (CMV) drivers. The MCSAC and the MRB are FMCSA 
advisory committees and operate in accordance with the Federal Advisory 
Committee Act (FACA). At the Agency's request, the committees 
deliberated and provided their finalized recommendations to FMCSA on 
February 6, 2012. The Agency proposes to adopt the recommendations as 
regulatory guidance after reviewing and evaluating comments received 
from the public.

DATES: Comments must be received on or before May 21, 2012.

ADDRESSES: You may submit comments bearing the Federal Docket 
Management System (FDMS) Docket No. FMCSA 2012-0102 using any of the 
following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the on-line instructions for submitting 
comments.
     Mail: Docket Management Facility; U.S. Department of 
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor, 
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140, 
1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., 
Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the 
docket numbers for this notice. Note that all comments received will be 
posted without change to https://www.regulations.gov, including any 
personal information provided. Please see the Privacy Act heading below 
for further information.
    Docket: For access to the docket to read background documents or

[[Page 23795]]

comments, go to https://www.regulations.gov at any time or Room W12-140 
on the ground level of the West Building, 1200 New Jersey Avenue SE., 
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, 
except Federal holidays. The FDMS is available 24 hours each day, 365 
days each year. If you want acknowledgment that we received your 
comments, please include a self-addressed, stamped envelope or postcard 
or print the acknowledgment page that appears after submitting comments 
on-line.
    Privacy Act: Anyone may search the electronic form of all comments 
received into any of our dockets by the name of the individual 
submitting the comment (or of the person signing the comment, if 
submitted on behalf of an association, business, labor union, etc.). 
You may review DOT's Privacy Act Statement for the FDMS published in 
the Federal Register on January 17, 2008 (73 FR 3316), or you may visit 
https://edocket.access.gpo.gov/2008/pdf/E8-785.pdf.

FOR FURTHER INFORMATION CONTACT: Angela Ward, Nurse Consultant Medical 
Programs, (202) 366-4001, fmcsamedical@dot.gov, FMCSA, Department of 
Transportation, 1200 New Jersey Avenue SE., Room W64-224, Washington, 
DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m., Monday 
through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION: 

Background

    49 CFR 391.41(b)(5) provides that a person is qualified physically 
to drive a CMV if that person has no established medical history or 
clinical diagnosis of a respiratory dysfunction likely to interfere 
with the ability to control and drive a CMV safely.
    The Instructions to The Medical Examiner on the Medical Examination 
Report, (49 CFR 391.43), identifies OSA as one of several respiratory 
dysfunctions that may be detrimental to safe driving as this condition 
may interfere with driver alertness and may cause gradual or sudden 
incapacitation.
    FMCSA directed its two advisory committees, the MCSAC and the MRB, 
meet jointly and publically to deliberate on the topic of OSA and 
whether CMV drivers with OSA should be medically certified.
    FMCSA tasked the MCSAC and the MRB with jointly providing 
information, concepts, and ideas the Agency should consider in 
developing regulatory guidance for motor carriers, CMV drivers, and 
medical examiners on OSA and whether drivers with this condition should 
be medically certified to operate CMVs in interstate commerce. FMCSA 
instructed the MCSAC and MRB to provide information about how to 
address drivers with OSA in the short-term until the Agency can 
consider stategies for a long-term regulatory action.
    As part of the committees' process for developing recommendations 
to be considered for regulatory guidance on OSA, the November 2007 
Evidence Report was updated in November 2011 and presented at the 
December 2011 joint meeting of the MCSAC and the MRB.
    After the December 2011 joint MCSAC-MRB meeting, a MCSAC-MRB 
subcommittee was formed in accordance with FACA requirements. The 
subcommittee's task was to bring recommendations back to the full joint 
committee for deliberation. The subcommittee met publicly on January 4-
5, 2012, to discuss this task and prepared recommendations for the full 
MCSAC's and MRB's consideration and deliberation at the February 2012 
joint MCSAC-MRB meeting. In February 2012 the joint committee 
deliberated and finalized its recommendations on OSA and medical 
certification of CMV drivers.

Basis for Proposed Guidance on OSA

    The existing advisory criteria for the Respiratory Dysfunction 
requirement [391.41(b)(5)] states that ``There are many conditions that 
interfere with oxygen exchange and may result in incapacitation, 
including [among others] sleep apnea. If the medical examiner detects 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.''
    Currently, FMCSA relies on medical examiners to apply professional 
judgment in applying FMCSA's advisory criteria on OSA to determine 
whether a driver has a respiratory dysfunction such as OSA that may 
affect his or her ability to operate a CMV safely. The motor carrier 
community and medical examiners have requested that FMCSA improve the 
existing advisory criteria and provide more uniform regulatory guidance 
on OSA to the motor carrier industry and medical examiners.

The Proposed Recommendations

Introduction

    The MCSAC and MRB developed and discussed several key questions in 
considering Task 11-05 to provide information, concepts, and ideas 
FMCSA should consider in developing regulatory guidance for motor 
carriers, CMV drivers, and medical examiners on OSA and whether drivers 
with this condition should be medically certified to operate CMVs in 
interstate commerce. These questions are listed below.
     Are individuals with OSA at an increased risk for a motor 
vehicle crash when compared to comparable individuals who do not have 
OSA?
     What disease-related factors are associated with an 
increased motor vehicle crash risk among individuals with OSA?
     Are individuals with OSA unaware of the presence of the 
factors that appear to be associated with an increased motor vehicle 
crash risk?
     Are there screening/diagnostic tests available that will 
enable examiners to identify those individuals with OSA who are at an 
increased risk for a motor vehicle crash?
     Which treatments have been shown to effectively reduce 
crash risk among individuals with OSA?
     What is the length of time required following initiation 
of an effective treatment for individuals with OSA to reach a degree of 
improvement that would permit safe driving?
     How soon following cessation of treatment will individuals 
with OSA demonstrate reduced driver safety (i.e., as a consequence of 
non-compliance)?
    Discussion of the above questions formed the basis of the joint 
MCSAC-MRB recommendations for consideration by FMCSA when developing 
regulatory guidance regarding OSA. The joint MCSAC-MRB recommendations 
are summarized below.

I. General Recommendations Regarding OSA

    A. OSA diagnosis precludes unconditional certification.
    B. A driver with an OSA diagnosis may be certified if the following 
conditions are met:
    1. The driver has untreated OSA with an apnea-hypopnea index (AHI) 
of less than or equal to 20 (i.e., mild-to-moderate OSA), and
    2. The driver does not admit to experiencing excess sleepiness 
during the major wake period, or
    3. The driver's OSA is being effectively treated.
    C. Notes on AHI threshold:
    1. The AHI threshold is used to prioritize drivers with OSA who 
need immediate treatment.
    2. The AHI threshold is set at 20 because crash risk in the 
moderate-to-

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severe OSA range is statistically higher than for drivers with mild 
OSA.
    3. Although an AHI of 15 is likely a safer threshold, there is no 
data to support this and such a threshold may be less practical in 
terms of enrolling patients for treatment.
    4. Drivers with mild OSA (AHI levels as low as 5) may benefit from 
OSA treatment, and should be encouraged to explore treatment options.
    5. Drivers with an AHI between 5 and 20 should be encouraged to 
seek treatment if they have a history involving a fatigue-related crash 
or a DOT-defined single vehicle crash,\1\ or if they report sleepiness 
while operating a motor vehicle.
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    \1\ Per 49 CFR 390.5, ``accident'' means (1) an occurrence 
involving a commercial motor vehicle operating on a highway in 
interstate or intrastate commerce which results in: (i) A fatality; 
(ii) Bodily injury to a person who, as a result of the injury, 
immediately receives medical treatment away from the scene of the 
accident; or (iii) One or more motor vehicles incurring disabling 
damage as a result of the accident, requiring the motor vehicle(s) 
to be transported away from the scene by a tow truck or other motor 
vehicle.
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    D. A driver with an OSA diagnosis may be recertified annually, 
based on demonstrating compliance with treatment.
    1. Minimally acceptable compliance with Positive Airway Pressure 
(PAP) treatment consists of at least 4 hours per day of use on 70 
percent of days.
    2. Drivers should be made aware that more hours of PAP use is 
preferable and that optimal treatment efficacy occurs with 7 or more 
hours of daily use during sleep.

II. Immediate Disqualification or Certification Denial

    A. Drivers should be disqualified immediately or denied 
certification if any of the following conditions are met:
    1. The driver admits to experiencing excessive sleepiness during 
the major wake period while driving; or
    2. The driver experienced a crash associated with falling asleep; 
or
    3. The driver has been found non-compliant with treatment per 
Recommendation I.D.

III. Conditional Certification

    A. Drivers may be granted conditional certification if any of the 
following conditions are met:
    1. The driver has an AHI of greater than 20 until compliant with 
PAP; or
    2. The driver has undergone surgery and is pending post-op findings 
per Recommendations VI-VIII; or
    3. The driver has a Body Mass Index (BMI) of greater than or equal 
to 35 kg/m\2\ pending a sleep study.
    B. Notes on BMI threshold:
    1. The MRB is in agreement that a BMI threshold of 33 is supported 
by studies.
    2. MCSAC member Robert Petrancosta (Con-Way Freight) asserted that 
a BMI threshold should be objectively related to crash risk.
    C. Conditional certification should include the following elements:
    1. A driver with a BMI of greater than or equal to 35 kg/m\2\ may 
be certified for 60 days pending sleep study and treatment (if the 
driver is diagnosed with OSA).
    2. Within 60 days, if a driver being treated with OSA is compliant 
with treatment (per Recommendations I.D. and V-IX), the driver may 
receive an additional 90-day conditional certification.
    3. After 90 days, if the driver is still compliant with treatment, 
the driver may be certified for no more than 1 year. Future 
certification should be dependent on continued compliance.
    D. OSA Screening (i.e., identifying individuals with undiagnosed 
OSA)
    1. In addition to a BMI of 35 or above, the following information 
may help a clinician diagnose OSA:
    a. Symptoms of OSA may include loud snoring, witnessed apneas, or 
sleepiness during the major wake period;
    b. Risk factors of OSA may include the following factors. However, 
a single risk factor alone may not infer risk, and a combination of 
multiple factors should be examined.
    i. Factors associated with high risk:

--Small or recessed jaw
--Small airway (Mallampati Scale score of Class 3 or 4)
--Neck size (=) 17 inches (male), 15.5 inches (female)
--Hypertension (treated or untreated)
--Type 2 diabetes (treated or untreated)
--Hypothyroidism (untreated)

    ii. Other factors:

--BMI greater than or equal to 28 kg/m\2\
--Age 42 and above
--Family history
--Male or post-menopausal female
--Experienced a single-vehicle crash

IV. Method of Diagnosis and Severity

    A. Methods of diagnosis include in-laboratory polysomnography, at-
home polysomnography, or an FDA-approved limited channel ambulatory 
testing device which ensures chain of custody.
    1. In-laboratory polysomnography, which is more comprehensive, 
should be considered when the clinician suspects another sleep disorder 
in addition to sleep apnea.
    2. New OSA screening technologies will likely emerge.
    B. The driver should be tested while on usual chronic medications.
    C. The MCSAC and MRB did not consider AHI levels from unattended 
(i.e., in-home) studies, only in-laboratory sleep studies that detect 
the arousal component of hypopneas, as well as saturation.
    1. An in-home sleep study may underestimate AHI when compared to an 
in-laboratory sleep study because the in-home study likely does not 
consider total sleep time.
    2. The medical examiner should use clinical judgment when 
interpreting the results of an unattended sleep study.
    a. If the clinician believes the level of apnea is greater than the 
level reported by the in-home study, the clinician should consider 
recommending an in-laboratory sleep study.

V. Treatment: Positive Airway Pressure (PAP)

    A. All individuals with OSA should be referred to a clinician with 
relevant expertise.
    B. PAP is the preferred OSA therapy.
    C. Adequate PAP pressure should be established through one of the 
following methods:
    1. Titration study with polysomnography
    D. Auto-titration system
    A driver who has been disqualified may be conditionally certified 
(per Recommendation III) if the following conditions are met:
    1. The driver is successfully treated for one week; and
    2. The driver can demonstrate at least minimal compliance (i.e., 4 
hours per use on 70 percent of nights); and
    3. The driver does not report excessive sleepiness during the major 
wake period.

VI. Treatment: Bariatric Surgery

    A. After bariatric surgery, a driver may be certified if the 
following conditions are met:
    1. Six months have passed since the surgery (for weight loss); and
    2. The driver has been compliant with PAP for six months; and
    3. The driver has been cleared by the treating physician; and
    4. The driver does not report excessive sleepiness during the major 
wake period.
    B. After six months have passed since surgery, if the apnea appears 
to have resolved, a repeat sleep study should be considered to test for 
the presence of ongoing sleep apnea.
    C. Annual recertification:
    1. If clinically indicated, repeat the sleep study.

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VII. Treatment: Oropharyngeal Surgery, Facial Bone Surgery

    A. After oropharyngeal or facial bone surgery, a driver may be 
certified if the following conditions are met:
    1. One month has passed since surgery; and
    2. The driver has been cleared by the treating physician; and
    3. The driver does not report excessive sleepiness during the major 
wake period.
    B. After one month has passed since surgery, if the apnea appears 
to have resolved a repeat sleep study should be considered to test for 
the presence of ongoing sleep apnea.
    C. Annual recertification:
    1. If clinically indicated, repeat the sleep study.

VIII. Treatment: Tracheostomy

    A. After a tracheostomy, a driver may be certified if the following 
conditions are met:
    1. One month has passed since surgery; and
    2. The driver has been cleared by the treating physician; and
    3. The driver does not report excessive sleepiness during the major 
wake period.
    B. After one month has passed since surgery, if the apnea appears 
to have resolved a repeat sleep study should be considered to test for 
the presence of ongoing sleep apnea.
    C. Annual recertification:
    1. If clinically indicated, repeat the sleep study.

IX. Treatment Alternatives

    A. There is limited data regarding compliance and long-term 
efficacy of dental appliances and these technologies are not approved 
alternatives at this time.\2\
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    \2\ Based on public comments received at the February MCSAC 
meeting, one member (Danny Schnautz, Clark Freight Lines, Inc., 
Pasadena, TX) suggested that the efficacy of dental appliances may 
need to be reviewed.
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    B. Surgical treatment is acceptable (See Recommendations VI-VIII).

Request for Comments

    FMCSA requests comments on the above joint recommendations provided 
to the Agency by its Motor Carrier Safety Advisory Committee and 
Medical Review Board on Obstructive Sleep Apnea. Commenters are 
requested to provide supporting data wherever appropriate.
    The Agency will consider all comments received before the close of 
business May 21, 2012. Comments will be available for examination in 
the docket at the location listed under the ADDRESSES section of this 
notice. The Agency will file comments received after the comment 
closing date in the public docket, and will consider them to the extent 
practicable. In addition to late comments, FMCSA will also continue to 
file, in the public docket, relevant information that becomes available 
after the comment closing date. Interested persons should monitor the 
public docket for new material.

    Issued on: April 16, 2012.
 Larry W. Minor,
 Associate Administrator of Policy.
[FR Doc. 2012-9555 Filed 4-19-12; 8:45 am]
BILLING CODE 4910-EX-P