[Federal Register Volume 77, Number 77 (Friday, April 20, 2012)]
[Notices]
[Pages 23794-23797]
From the Federal Register Online via the Government Publishing 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 http://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 http://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 http://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
http://edocket.access.gpo.gov/2008/pdf/E8-785.pdf.
FOR FURTHER INFORMATION CONTACT: Angela Ward, Nurse Consultant Medical
Programs, (202) 366-4001, [email protected], 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