Denial of Exemption Applications; Epilepsy and Seizure Disorders |
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T.F. Scott Darling, III
Federal Motor Carrier Safety Administration
July 9, 2013
[Federal Register Volume 78, Number 131 (Tuesday, July 9, 2013)]
[Notices]
[Pages 41185-41187]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-16460]
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DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety Administration
[Docket No. FMCSA-2006-24278; FMCSA-2006-25854; FMCSA 2008-0355; FMCSA
2010-0203; FMCSA-2011-0089]
Denial of Exemption Applications; Epilepsy and Seizure Disorders
AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.
ACTION: Notice of denial for exemptions from the provisions of 49 CFR
391.41(b)(8).
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SUMMARY: FMCSA announces denial of applications from seven individuals
for an exemption from the prohibition against persons with a clinical
diagnosis of epilepsy or any other condition which is likely to cause a
loss of consciousness or any loss of ability to operate a commercial
motor vehicle (CMV), from operating CMVs in interstate commerce.
Reasons for denial are listed after each name entry.
[[Page 41186]]
FOR FURTHER INFORMATION CONTACT: Elaine M. Papp, Director, Medical
Programs Division, (202) 366-4001, fmcsamedical@dot.gov, 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. 31315 and 31136(e), FMCSA may grant an exemption
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 statutes also allow the
Agency to renew exemptions at the end of the 2-year period. The 7
individuals listed in this notice have recently requested an exemption
from the epilepsy and seizure disorder standard in 49 CFR 391.41(b)(8),
which applies to drivers who operate CMVs, as defined in 49 CFR 390.5,
in interstate commerce. Section 391.41(b)(8) states that a person is
physically qualified to drive a CMV if that person has no established
medical history or clinical diagnosis of epilepsy or any other
condition which is likely to cause the loss of consciousness or any
loss of ability to control a commercial motor vehicle.
In order to make an evidence-based decision, FMCSA conducted a
comprehensive review of scientific literature and convened a panel of
medical experts in the field of neurology to evaluate key questions
regarding seizure and anti-seizure medication related to the safe
operation of a commercial motor vehicle. In reaching the determination
to grant or deny exemption requests for individuals who have
experienced a seizure, the Agency considered both current medical
literature and information and the 2007 recommendations of the Agency's
Medical Expert Panel (MEP). The Agency previously gathered evidence for
decision-making concerning potential changes to the regulation, by
conducting a comprehensive review of scientific literature that was
compiled into a report entitled, ``Evidence Report on Seizure Disorders
and Commercial Vehicle Driving'' (Evidence Report) [CD-ROM HD TL230.3
.E95 2007]. The Agency then convened an MEP in the field of neurology
on May 14-15, 2007, to review: 49 CFR 391.41(b)(8) and the advisory
criteria regarding individuals who have experienced a seizure; and the
2007 Evidence Report. The Evidence Report and the MEP recommendations
are published on-line at http://www.fmcsa.dot.gov/rules-regulations/topics/mep/mep-reports.htm, under Seizure Disorders, and are in the
docket for this notice.
MEP Criteria for Evaluation
On October 15, 2007, the MEP issued the following recommended
criteria for evaluating whether an individual with epilepsy or a
seizure disorder should be allowed to operate a CMV.\1\ The MEP
recommendations are included in an appendix at the end of this notice
and in each of the previously published dockets.
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\1\ Engel, J., Fisher, R.S., Krauss, G.L., Krumholz, A., and
Quigg, M.S., ``Expert Panel Recommendations: Seizure Disorders and
Commercial Motor Vehicle Driver Safety,'' FMCSA, October 15, 2007.
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Epilepsy diagnosis. If there is an epilepsy diagnosis, the
applicant should be seizure-free for 8 years, on or off medication. If
the individual is taking anti-seizure medication(s), the plan for
medication should be stable for 2 years. Stable means no changes in
medication, dosage, or frequency of medication administration.
Recertification for drivers with an epilepsy diagnosis should be
performed every year.
Single unprovoked seizure. If there is a single unprovoked seizure
(i.e., there is no known trigger for the seizure), the individual
should be seizure-free for 4 years, on or off medication. If the
individual is taking anti-seizure medication(s), the plan for
medication should be stable for 2 years. Stable means no changes in
medication, dosage, or frequency of medication administration.
Recertification for drivers with a single unprovoked seizure should be
performed every 2 years.
Single provoked seizure. If there is a single provoked seizure
(i.e., there is a known reason for the seizure), the Agency should
consider specific criteria that fall into the following two categories:
Low-risk factors for recurrence and moderate-to-high risk factors for
recurrence.
Examples of low-risk factors for recurrence include
seizures that were caused by a medication; by non-penetrating head
injury with loss of consciousness less than or equal to 30 minutes; by
a brief loss of consciousness not likely to recur while driving; by
metabolic derangement not likely to recur; and by alcohol or illicit
drug withdrawal.
Examples of moderate-to-high-risk factors for recurrence
include seizures caused by non-penetrating head injury with loss of
consciousness or amnesia greater than 30 minutes, or penetrating head
injury; intracerebral hemorrhage associated with a stroke or trauma;
infections; intracranial hemorrhage; post-operative complications from
brain surgery with significant brain hemorrhage; brain tumor; or
stroke.
The MEP report indicates individuals with moderate to high-risk
conditions should not be certified. Drivers with a history of a single
provoked seizure with low risk factors for recurrence should be
recertified every year.
Medical Review Board Recommendations and Agency Decision
FMCSA presented the MEP's findings and the Evidence Report to the
Medical Review Board (MRB) for consideration. The MRB reviewed and
considered the 2007 ``Seizure Disorders and Commercial Driver Safety''
evidence report and the 2007 MEP recommendations. The MRB recommended
maintaining the current advisory criteria, which provide that ``drivers
with a history of epilepsy/seizures off anti-seizure medication and
seizure-free for 10 years may be qualified to drive a CMV in interstate
commerce. Interstate drivers with a history of a single unprovoked
seizure may be qualified to drive a CMV in interstate commerce if
seizure-free and off anti-seizure medication for a 5 year period or
more'' [Advisory criteria to 49 CFR 391.43(f)].
The Agency acknowledges the MRB's position on the issue but
believes relevant current medical evidence supports a less conservative
approach. The medical advisory criteria for epilepsy and other seizure
or loss of consciousness episodes was based on the 1988 ``Conference of
Neurological Disorders and Commercial Driving'' (NITS Accession No.
PB89-158950/AS). A copy of the report can be found in the docket
referenced in this notice.
The MRB's recommendation treats all drivers who have experienced a
seizure the same, regardless of individual medical conditions and
circumstances. In addition, the recommendation to continue prohibiting
drivers who are taking anti-seizure medication from operating a CMV in
interstate commerce does not consider a driver's actual seizure history
and time since the last seizure. The Agency has decided to use the 2007
MEP recommendations as the basis for evaluating applications for an
exemption from the seizure regulation on an individual, case-by-case
basis. The disposition of applications announced in this notice applies
the 2007 MEP recommendations.
[[Page 41187]]
Public Comments
Patty Cantagallo, MD, expressed her concern that applicant John
Morris had indications of alcohol abuse in his medical data. The Agency
did not include Mr. Morris in the final disposition. Dr. Cantagallo
also indicated uncertainty with applicant Anthony Besch having
unresolved ``nighttime seizures.'' Mr. Besch was excluded from final
disposition.
Denials and Reasons
The following drivers were listed previously in Federal
Register Notice FMCSA-2006-24278:
Anthony Besch--We are unable to contact Mr. Besch by phone or
through his former employer to ascertain his status.
Charles Gant--Mr. Gant's records indicated that he had suffered
transient ischemic attacks (stroke), not epilepsy.
John Morris--Mr. Morris' file indicated that his seizure was
induced by alcohol.
The following driver was previously listed in Federal
Register Notice FMCSA-2006-25854:
Daniel L. Pulse--Mr. Pulse may meet the criteria, but he has been
unresponsive in attempts to certify the date of his last seizure and/or
any anti-seizure medication he is taking.
The following driver was previously listed in Federal
Register FMCSA-2008-0355:
Travis Williams--Mr. Williams has a diagnosis of epilepsy, and his
last seizure was in 2008. He will have been seizure-free for 8 years,
as required by the MEP guidelines, in 2016. He may reapply at that
time.
The following driver was listed previously in Federal
Register FMCSA 2010-0203:
Leo Lombardio--Mr. Lombadrio had a loss of consciousness event
related to a diagnosis of complex partial seizures in 2009. He does not
meet the exemption criteria at this time.
The following driver was listed previously in Federal
Register FMCSA 2011-0089:
Richard Laqua--Mr. Laqua had a seizure in 2009 and does not
currently meet the exemption criteria.
Issued on: June 27, 2013.
T.F. Scott Darling, III,
Chief Counsel.
[FR Doc. 2013-16460 Filed 7-8-13; 8:45 am]
BILLING CODE 4910-EX-P