Qualification of Drivers; Exemption Applications; Narcolepsy |
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Larry W. Minor
Federal Motor Carrier Safety Administration
August 17, 2015
[Federal Register Volume 80, Number 158 (Monday, August 17, 2015)]
[Notices]
[Pages 49301-49302]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20187]
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DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety Administration
[Docket No. FMCSA-2014-0373]
Qualification of Drivers; Exemption Applications; Narcolepsy
AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.
ACTION: Notice of denial of exemption applications.
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SUMMARY: FMCSA announces its decision to deny applications from three
individuals seeking exemptions from the prohibitions against operating
a commercial motor vehicle (CMV) in interstate commerce by persons
with: (1) Either a clinical diagnosis of epilepsy or any other
condition that is likely to cause a loss of consciousness or any loss
of ability to operate a CMV safely, or (2) a mental, nervous, organic,
or functional disease or psychiatric disorder likely to interfere with
his/her ability to drive a commercial motor vehicle safely. FMCSA has
statutory authority to exempt individuals from certain parts of the
Federal Motor Carrier Safety Regulations, if the exemptions granted
will not compromise safety. The Agency must conclude that granting
these exemptions provides a level of safety that will be equivalent to
or greater than the level of safety maintained without the exemptions
for these CMV drivers. Based on a review of the applications and
following an opportunity for public comment, FMCSA has concluded that
the individuals did not demonstrate that they could achieve a level of
safety that is equivalent to, or greater than, the level of safety that
would be obtained by complying with the regulation.
DATES: This decision is effective July 24, 2015.
FOR FURTHER INFORMATION CONTACT: Charles A. Horan III, Director, Office
of Carrier, Driver and Vehicle Safety Standards, (202) 366-4001, or via
email at fmcsamedical@dot.gov, or by letter FMCSA, Room W64-224,
Department of Transportation, 1200 New Jersey Avenue SE., 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
Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the Federal Motor Carrier Safety Regulations for a 2-year period
if it finds ``such exemption would likely achieve a level of safety
that is equivalent to or greater than the level that would be achieved
absent such exemption.'' FMCSA can renew exemptions at the end of each
2-year period. The three individuals listed in this notice have each
requested such an exemption from the physical qualification
requirements in 49 CFR 391.41(b)(8) and (b)(9), which applies to
drivers of CMVs in interstate commerce. Accordingly, the Agency
evaluates the qualifications of each applicant to determine whether
granting an exemption will achieve the required level of safety
mandated by statute.
Narcolepsy is a chronic neurological disorder caused by autoimmune
destruction of hypocretin-producing neurons inhibiting the brain's
ability to regulate sleep-wake cycles normally. Persons with narcolepsy
experience frequent excessive daytime sleepiness, comparable to how
non-narcoleptics feel after 24 to 48 hours of sleep deprivation, as
well as disturbed nocturnal sleep, which often is confused with
insomnia. See NIH Narcolepsy Fact Sheet at www.ninds.nih.gov/disorders/narcolepsy/detail_narcolepsy.htm.
The Agency considered the topic of narcolepsy and the potential
impact on commercial drivers in a 2009 Evidence Report. The Evidence
Report ``Narcolepsy (with and without cataplexy) and Commercial Motor
Vehicle Driver Safety'' addressed several key questions.\1\
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\1\ Evidence Report: Narcolepsy (with and without cataplexy) and
Commercial Motor Vehicle Driver Safety; October 6, 2009.
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Key Question 1: Are individuals with narcolepsy (with and without
cataplexy) at an increased risk for a motor vehicle crash when compared
to comparable individuals without the disorder?
Key Question 2: Do currently recommended treatments for narcolepsy
reduce the risk for a motor vehicle crash?
Key question 2 was further divided into several questions
concerning the impact of various medication therapies for narcolepsy on
driver safety. The complete report is included in the docket FMCSA
2014-0373.
The evidence report reviewed studies from the available literature
and evaluated outcomes on measures of Excessive Daytime Sleepiness
(EDS), cataplexy, event rate, measures of cognitive and psychomotor
function, and driving performance. For key question 1, the currently
available evidence (both direct and indirect) supports the contention
that drivers with narcolepsy are at an increased risk for a motor
vehicle crash when compared to otherwise similar individuals who do not
have the disorder. The strength of the evidence was rated as strong.
The direct evidence (from three crash studies) (study quality rating of
``Low'') conducted with non-CMV drivers showed that individuals with
narcolepsy are at an increased risk for a crash compared to individuals
who do not have narcolepsy. The indirect evidence (studies of driving
tests and driving simulation, quality rating ``moderate''), examined
factors associated with simulated driving outcomes, (driving
performance, tracking error, fewer correct responses and more instances
of going out of bounds compared to healthy controls). In summary, while
there are limitations in the quality of the studies that examined
direct crash risk in the evidence base, all study results showed a
strong effect size and statistical significance. Indirect evidence of
crash provides strong support for the direct crash study findings.
Based upon available information, there is strong evidence that non-
commercial drivers with narcolepsy are at an increased risk of crash.
Concerning key question 2 and its sub-questions, the American
Academy of Sleep Medicine (AASM) and the European Federation of
Neurological Societies recommend modafinil as the first-line of
treatment and
[[Page 49302]]
methylphenidate as the second-line of treatment. The AASM also
recommends amphetamine, methamphetamine, or dextroamphetamine as
alternative second-line treatments. No studies that directly examined
the impact of treatment with modafinil, armodafinil, sodium oxybate
(used with narcolepsy with cataplexy), or anti-depressants on crash
risk or driving performance were identified during the literature
searches. Evidence-based conclusions pertaining to treatment with these
medications on crash risk and driving performance could not be drawn.
Currently available evidence suggests that amphetamines and/or
methylphenidate are effective in improving symptoms of EDS in
individuals with narcolepsy (quality of studies range from ``moderate
to low''). However, these improvements do not result in levels of
daytime sleepiness that can be considered to be normal in the vast
majority of individuals. Evidence-based conclusions pertaining to the
impact of treatment with amphetamines, methylphenidate, or other
related stimulant drugs on cognitive and psychomotor function among
individuals with narcolepsy cannot be drawn at this time.
In January 2010, the FMCSA's Medical Review Board (MRB) recommended
that individuals with narcolepsy be ineligible for a commercial
driver's license, even with treatment.\2\
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\2\ Medical Review Board Meeting; January 6, 2010; http://www.mrb.fmcsa.dot.gov/documents/Final_Jan_6_2010_MRB_Meeting_Summary.pdf.
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Discussion of Public Comments
The FMCSA published the names of three individuals seeking
exemption in a Federal Register Notice, on April 17, 2015, and
requested public comment. The public comment period closed on May 18,
2015. A total of 17 commenters responded. The majority of commenters
were in favor of the applicants continuing to drive CMV's with
Narcolepsy. Fourteen commenters consisting mainly of private citizens
stated that the individual drivers listed in the notice were
responsible drivers, were stable and compliant with their medication
therapy, had safe driving histories, and believed that the individuals
would continue to be safe drivers while on medication The State of New
York's medical consultants reviewed the docket and suggested that
drivers with narcolepsy be allowed to operate commercially only if they
have been treated medically and have been event-free for at least one
year. Three commenters did not support exemption for drivers with
narcolepsy. One anonymous commenter encouraged the FMCSA not to grant
exemptions to these individuals due to concerns of the high risk of the
underlying medical condition in combination with operating a large CMV.
FMCSA Response
To evaluate the effects of these exemption requests on safety,
FMCSA reviewed and considered the content of each request individually
and all comments received.
FMCSA acknowledges comments received attesting that individual
applicants are responsible drivers currently on a stable therapeutic
regimen which includes medication therapy. The Agency considered
available medical and scientific data concerning medication therapy for
narcolepsy. As discussed in the background section of this notice,
evidence-based conclusions pertaining to treatment with medications on
crash risk and driving performance could not be drawn.
Concerning ATAs comments recommending granting fewer exemptions and
revising the current medical standards, FMCSA acknowledges ATA's
concerns. The FMCSA has statutory authority (49 U.S.C. 31136(e) and
31315), to consider granting exemptions from the Federal Motor Carrier
Safety Regulations for a 2-year period if it finds ``such exemption
would likely achieve a level of safety that is equivalent to or greater
than the level that would be achieved absent such exemption.'' The
FMCSA reviews its medical standards through the use of evidence
reports, various medical expert panels and the Agency's Medical Review
Board and proposes evidence-based revisions to the medical standards
through the rulemaking process which takes a considerable length of
time.
The exemption process is the Agency's most viable alternative in
the short term to consider whether drivers with disqualifying medical
conditions and who are found to meet an equivalent level of safety,
should be permitted to operate in interstate commerce.
Conclusion
FMCSA evaluated the three individual exemption requests on their
merits and available data from FMCSA's Evidence Reports, the Medical
Review Board recommendations and public comments received. The Agency
has determined that the available medical and scientific literature and
research provides insufficient data to enable the Agency to conclude
that granting the exemptions would achieve a level of safety equivalent
to or greater than the level of safety maintained without the
exemption. Each applicant has, prior to this notice, received a letter
of final disposition on his/her exemption request. Those decision
letters outlined fully the basis for the denial and constitute final
Agency action. The list published today summarizes the Agency's recent
denials as required under 49 U.S.C. 31315(b)(4).
The following three applicants are denied exemptions from the
physical qualification standards in [49 CFR 391.41(b)(8)] and [49 CFR
391.41(b)(9)]: Thomas Skagen, Charles Larry Peterson, and Stanley
Jandreau.
Issued on: August 3, 2015.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2015-20187 Filed 8-14-15; 8:45 am]
BILLING CODE 4910-EX-P