Qualification of Drivers; Exemption Applications; Epilepsy and Seizure Disorders |
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Anne S. Ferro
Federal Motor Carrier Safety Administration
July 12, 2013
[Federal Register Volume 78, Number 134 (Friday, July 12, 2013)]
[Notices]
[Pages 41979-41985]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-16686]
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DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety Administration
[Docket No. FMCSA-2008-0355; FMCSA-2011-0389, FMCSA-2012-0050, FMCSA-
2012-0094, FMCSA 2012-0294]
Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders
AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.
ACTION: Notice of final disposition.
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SUMMARY: FMCSA announces its decision to grant requests from 24
individuals for exemptions from the regulatory requirement that
interstate commercial motor vehicle (CMV) drivers have ``no established
medical history or clinical diagnosis of epilepsy or any other
condition which is likely to cause loss of consciousness or any loss of
ability to control a CMV.'' The regulation and the associated advisory
criteria published in the Code of Federal Regulations as the
``Instructions for Performing and Recording Physical Examinations''
have resulted in numerous drivers being prohibited from operating CMVs
in interstate commerce based on the fact that they have had one or more
seizures and are taking anti-seizure medication, rather than an
individual analysis of their circumstances by a qualified medical
examiner. The Agency concluded that granting exemptions for these CMV
drivers will provide a level of safety that is equivalent to or greater
than the level of safety maintained without the exemptions. FMCSA
grants exemptions that will allow these 24 individuals to operate CMVs
in interstate commerce for a 2-year period. The exemptions preempt
State laws and regulations and may be renewed.
DATES: The exemptions are effective July 12, 2013. The exemptions
expire on July 13, 2015.
FOR FURTHER INFORMATION CONTACT: Elaine M. Papp, Division Chief,
Physical Qualifications, Office of 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 8:30 a.m. to 5 p.m., e.t., Monday through Friday, except
Federal holidays.
SUPPLEMENTARY INFORMATION:
A. Electronic Access
You may see all the comments online through the Federal Document
Management System (FDMS) at: http://www.regulations.gov.
Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/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., e.t., Monday through Friday,
except Federal holidays.
Privacy Act: Anyone may search the electronic form of all comments
received into any of DOT's 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, or other
entity). You may review DOT's complete Privacy Act Statement in the
Federal Register (73 FR 3316, January 17, 2008). This statement is also
available at http://Docketinfo.dot.gov.
B. Background
Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the 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 statute also allows the Agency to renew exemptions at
the end of the 2-year period.
FMCSA grants 24 individuals an exemption from the regulatory
requirement in Sec. 391.41(b)(8) allowing individuals who take anti-
seizure medication to operate CMVs in interstate commerce for a 2-year
period. The Agency's decision on these exemption applications is based
on an individualized assessment of each applicant's medical
information, including the root cause of the respective seizure(s); the
length of time elapsed since the individual's last seizure; and each
individual's treatment regimen. In addition, the Agency reviewed the
applicant's driving record found in the CDLIS,\1\ for CDL holders, and
interstate and intrastate inspections recorded in MCMIS.\2\ The Agency
acknowledges the potential consequences of a driver experiencing a
seizure while operating a CMV. However, the Agency believes the drivers
covered by the exemptions have demonstrated that they are unlikely to
have a seizure and their medical condition does not pose a risk to
public safety.
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\1\ Commercial Driver License Information System (CDLIS) is an
information system that allows the exchange of commercial driver
licensing information among all the States. CDLIS includes the
databases of fifty-one licensing jurisdictions and the CDLIS Central
Site, all connected by a telecommunications network.
\2\ Motor Carrier Management Information System (MCMIS) is an
information system that captures data from field offices through
SAFETYNET, CAPRI, and other sources. It is a source for FMCSA
inspection, crash, compliance review, safety audit, and registration
data.
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In reaching the decision to grant these exemption requests, 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 potential changes to the
regulation by conducting a comprehensive review of scientific
literature that was compiled into the ``Evidence Report on Seizure
Disorders and Commercial Vehicle Driving'' (Evidence Report) [CD-ROM HD
TL230.3 .E95 2007]. The Agency then convened a panel of medical experts
in the field of neurology (MEP) 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.\3\ 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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\3\ 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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[[Page 41980]]
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 on
Neurological Disorders and Commercial Drivers'' (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.
C. Exemptions
Following individualized assessments of the exemption applications,
including a review of detailed follow-up information requested from
each applicant, FMCSA is granting exemptions from 49 CFR 391.41(b)(8)
to 24 individuals. Under current FMCSA regulations, all of the 24
drivers receiving exemptions from 49 CFR 391.41(b)(8) would have been
considered physically qualified to drive a CMV in interstate commerce
except that they presently take or have recently stopped taking anti-
seizure medication. All but one of the 24 drivers receiving an
exemption currently take anti-seizure medication. For these 24 drivers,
the primary obstacle to medical qualification was the FMCSA Advisory
Criteria for Medical Examiners, based on the 1988 ``Conference on
Neurological Disorders and Commercial Drivers,'' stating that a driver
should be off anti-seizure medication in order to drive in interstate
commerce. In fact, the Advisory Criterion has little if anything to do
with the actual risk of a seizure and more to do with assumptions about
individuals who are taking anti-seizure medication.
In addition to evaluating the medical status of each applicant,
FMCSA evaluated the crash and violation data for the 24 drivers, some
of whom currently drive a CMV in intrastate commerce. The Commercial
Driver's License Information System (CDLIS) and the FMCSA Motor Carrier
Management Information System (MCMIS) were searched for crash and
violation data on the 24 applicants. The crash and violation history on
each individual driver is listed in his or her biographical profile.
These exemptions are contingent on the driver maintaining a stable
treatment regimen and remaining seizure-free during the 2-year
exemption period. The exempted drivers must submit annual reports from
their treating physicians attesting to the stability of treatment and
that the driver has remained seizure-free. The driver must undergo an
annual medical examination by a medical examiner, as defined by 49 CFR
390.5, following the FCMSA's regulations for the physical
qualifications for CMV drivers.
FMCSA published a notice of receipt of application and requested
public comment during a 30 day public comment period in a Federal
Register notice for each of the applicants. A short summary of the
applicants' qualifications follows. A discussion of the comments
received follows in section D. Comments. For those applicants who were
denied an exemption, a notice will be published at a later date.
Docket FMCSA-2008-0355
On December 10, 2008, FMCSA published a notice of receipt of
exemption applications and requested public comment on 15 individuals
(Docket number FMCSA-2008-0355). The comment period ended on January
10, 2009. Seven commenters responded to the Federal Register notice. A
discussion of the comments is presented later in this document. FMCSA
has determined that one of these applicants should be granted an
exemption. The Agency will issue a decision on the other drivers at a
later date.
Prince Austin Jr. Mr. Austin is a 55- year-old intrastate driver in
Ohio. Mr. Austin should be granted an exemption because he meets the
MEP criteria of being seizure-free 8 years in May 2013. He was
diagnosed with epilepsy in 1974. He has remained on anti-seizure
medication with the dose and frequency
[[Page 41981]]
remaining the same for the last eight years. His personal physician
states that he and Mr. Austin's treating neurologist are supportive of
the exemption. Mr. Austin has no recent entries in CDLIS or MCMIS.
Docket FMCSA-2011-0389
On April 5, 2011, FMCSA published a notice of receipt of exemption
applications and requested public comment on 8 individuals (Docket
number FMCSA-2011-0094). The comment period ended on May 5, 2011. Seven
commenters responded to the Federal Register notice. A discussion of
the comments is presented later in this document. FMCSA has determined
that one of these applicants should be granted an exemption. The Agency
will issue a decision on the other drivers at a later date.
Frank Cekovic. Mr. Cekovic is 45-year-old intrastate CMV driver in
the state of Pennsylvania. Mr. Cekovic should be granted an exemption
because he meets the MEP criteria of having no diagnosis of epilepsy
and being seizure-free four years as of April 2013. He was diagnosed
with a seizure disorder in January 2009 and placed on the anti-seizure
medication Keppra at that time. His treating physician states that he
is compliant with his medication regimen and that his risk of a
recurrent seizure is very low. The CMV that he operates is a ``bucket
truck'' for a power and light company, and Mr. Cekovic states that the
maximum distance he drives between job sites is no more than 20 miles
per day. He has 2 minor speeding entries on CDLIS, one each in 2009 and
2010, and no entries in MCMIS.
Docket FMCSA-2011-0389
On January 5, 2012, FMCSA published a notice of receipt of
exemption applications and requested public comment on 15 individuals
(Docket number FMCSA-2011-0389). The comment period ended on February
5, 2012. Seven commenters responded to the Federal Register notice. A
discussion of the comments is presented later in this document. FMCSA
has determined that four of the applicants should be granted an
exemption. The Agency will issue a decision on the other drivers at a
later date.
Joseph D'Angelo. Mr. D'Angelo is a 56-year-old CMV driver in New
York. Mr. D'Angelo should be granted an exemption because he meets the
MEP criteria by having no seizures for the last 43 years, and being on
a stable medication regimen for over 10 years. He experienced a single
seizure at age 14 in 1970. Mr. D'Angelo believes that he would achieve
a level of safety that is equivalent to the level of safety obtained by
complying with the regulation because he has remained seizure-free for
43 years. He has no entries in CDLIS or MCMIS.
Ricki Gutermann. Mr. Gutermann is a 46-year-old intrastate CMV
driver in Wisconsin. Mr. Gutermann should be granted an exemption
because he meets the MEP criteria by having no seizures for the last 15
years, and being on a stable medication regimen for 15 years. He
previously held a CDL and drove a truck for Mobil Oil. He was involved
in a non-job related motor vehicle accident and sustained a traumatic
head injury. He was prescribed anti-seizure medication and had two
seizures in 1998 while physicians were adjusting his medication. His
last seizure was July 1998. His physician states he is taking the same
medication, with dose and frequency remaining the same for 15 years and
states he beleves it is appropriate to allow Mr. Gutermann to be
recertified to drive commercial vehicles. Mr. Gutermann has no entries
in CDLIS or MCMIS.
David Kietzman. Mr. Kietzman is a 50-year-old intrastate CMV driver
in Wisconsin. Mr. Kietzman should be granted an exemption because he
meets the MEP criteria by having no diagnosis of epilepsy, having been
seizure-free for over four years and on a stable medication regimen for
over four years. In December 2007 he underwent surgery for a right
parietal vascular formation. His physician states this brain
abnormality was the cause of his seizures. He has remained on the same
anti-seizure medication since December 2007, with the dose and
frequency remaining the same since October 2008. His last seizure was
October 2008. His physician states he is neurologically normal. His
current employer states he has been an intrastate semi-tractor trailer
driver for them since 1991 and has proven to be a safe, competent and
conscientious driver. Mr. Kietzman has no entries in CDLIS or MCMIS.
Joseph Kogut. Mr. Kogut is a 54-year-old intrastate CMV driver in
North Carolina. Mr. Kogut should be granted an exemption because he
meets the MEP criteria by having no seizures for the last 30 years and
being on a stable medication regimen for 30 years. In 1982 he was
involved in a motor vehicle accident and sustained a head injury.
Following the accident, he had a single seizure. He has been seizure-
free for over 30 years. He takes the same anti-seizure medication with
the dose and frequency remaining the same for 30 years. His physician
states he believes Mr. Kogut should be allowed to drive CMV's. Mr.
Kogut has one entry from CDLIS for failure to obey a traffic signal in
1999.
Docket FMCSA-2012-0050.
On February 29, 2012, FMCSA published a notice of receipt of
exemption applications and requested public comments on five
individuals (Docket number FMCSA-2012-0050). The comment period ended
on March 30, 2012. No comments were received. Of the five applicants,
FMCSA determined that the following three individuals should be granted
an exemption. The Agency will issue a decision on the other drivers at
a later date.
Todd Brock. Mr. Brock is a 54-year-old driver in Colorado. Mr.
Brock should be granted an exemption because he meets the MEP criteria
by having no seizures for the last 10 years, and being on a stable
medication regimen, with dose and frequency remaining the same for 4
years. He previously drove delivery trucks. He was diagnosed with a
seizure disorder in 2003. He takes the same anti-seizure medication
with dose and frequency remaining the same for 4 years. He will return
to driving package trucks in interstate commerce. Mr. Brock has no
entries in CDLIS or MCMIS.
Diana Mugford. Ms. Mugford is a 44-year-old intrastate CMV driver
in Vermont. Ms. Mugford should be granted an exemption because she
meets the MEP criteria by having no diagnosis of epilepsy, no seizures
for the last 8 years, and being on a stable medication regimen for
longer than 2 years. She was diagnosed with complex partial seizures
and takes anti-seizure medication. She has remained seizure-free for 9
years, having her last seizure in 2004. She takes the same anti-seizure
medication with the dose and frequency remaining the same for 9 years.
Her physician endorses her receiving the exemption. She has two CDLIS
entries, one for a CMV accident with property damage in 2011 and a
speeding violation in 2004. Ms. Mugford has no entries in MCMIS.
James Wiggins. Mr. Wiggins is a 57-year-old intrastate CMV driver
in Florida. Mr. Wiggins should be granted an exemption because he meets
the MEP criteria by having no diagnosis of epilepsy, no seizures for
the last 4 years, and being on a stable medication regimen for longer
than 2 years. He had a single seizure in March 2008 and was diagnosed
with a brain tumor. He had the brain tumor removed in April 2008 and
has remained seizure-free for over 4 years. He takes anti-seizure
medication with the dose and frequency remaining the same for 4 years.
Mr.
[[Page 41982]]
Wiggins has no entries in CDLIS or MCMIS.
Docket FMCSA-2012-0094
On January 15, 2013, FMCSA published a notice of receipt of
exemption applications and requested public comment on 14 individuals
(Docket number FMCSA-2012-0094). The comment period ended on February
15, 2013. FMCSA received 16 comments. A discussion of the comments is
presented later in this document. Of the 14 applicants, FMCSA
determined that the following seven individuals should be granted an
exemption. The Agency will issue a decision on the other drivers at a
later date.
Salvatore Gerard Adamita. Mr. Adamita is a 46-year-old intrastate
CMV driver in Florida. Mr. Adamita should be granted an exemption
because he meets the MEP criteria by having a diagnosis of epilepsy, no
seizures for the last 8 years, and being on a stable medication regimen
for longer than 2 years. He has a history of epilepsy and has had two
seizures in his lifetime; the last seizure was in 1992. He has remained
seizure free for 20 years. He takes anti-seizure medication with the
dosage and frequency remaining the same for 20 years. He would like to
drive straight trucks or single tractor trailer trucks. His physician
states he is supportive of Mr. Adamita receiving an exemption and Mr.
Adamita states he feels he would operate a vehicle at the same safety
level as someone who did not require an exemption. Mr. Adamita has no
entries in CDLIS or MCMIS.
John W. Boerth. Mr. Boerth is a 61-year-old intrastate CMV driver
in Wisconsin. Mr. Boerth should be granted an exemption because he
meets the MEP criteria by having no diagnosis of epilepsy, no seizures
for the last 4 years, and being on a stable medication regimen for
longer than 2 years. He had brain surgery in 2002 and has since had 2
seizures, one in 2002 and the last seizure was June 2003. He takes
anti-seizure medication with the dosage and frequency remaining the
same for over 10 years. He would like to drive vehicles from one-half
ton vans to 18,000 pound straight trucks in interstate commerce. Mr.
Boerth has no entries in CDLIS or MCMIS.
Michael C. Breitbach. Mr. Breitbach is a 57-year-old intrastate CMV
driver in Iowa. Mr. Breitbach should be granted an exemption because he
meets the MEP criteria by having no diagnosis of epilepsy, no seizures
for the last 4 years, and being on a stable medication regimen for
longer than 2 years. He has a history of two nocturnal seizures in his
lifetime; the last seizure was in 2002. He has remained seizure free
for 11 years. He takes anti-seizure medication with the dosage and
frequency remaining the same for 5 years. He would like to drive
tractor trailer trucks. His physician states he is supportive of Mr.
Breitbach receiving an exemption. Mr. Breitbach has one CDLIS entry
with a non-injury crash in 2011 and no entries in MCMIS.
Timothy Grant Edwards. Mr. Edwards is a 25-year-old intrastate CMV
driver in Tennessee. Mr. Edwards should be granted an exemption because
he meets the MEP criteria by having no diagnosis of epilepsy, no
seizures for the last 4 years, and being on a stable medication regimen
for longer than 2 years. He has a diagnosis of complex partial
seizures. His last seizure was in 1992. He has remained seizure free
for 20 years. He takes anti-seizure medication with the dosage and
frequency remaining the same for 10 years. He would like to drive a
service truck for his employer that weighs more than 10,000 pounds, but
less than 26,000 pounds, in interstate commerce. Mr. Edwards has no
entries in CDLIS or MCMIS.
James Gorniak. Mr. Gorniak is a 49-year-old intrastate CMV driver
in Wisconsin. Mr. Gorniak should be granted an exemption because he
meets the MEP criteria by having no diagnosis of epilepsy, no seizures
for the last 4 years, and has been off of anti-seizure medication for
over 5 years. Mr. Gorniak had a single seizure in January 2007. It was
discovered he had a brain tumor which was then removed. He was given
anti-seizure medication for a short time after the surgery, but has
been off the medication for 6 years and has remained seizure free since
2007. His physician states he is supportive of him receiving the
exemption. He would like to return to driving tractor trailers in
interstate commerce. Mr. Gorniak has no entries in CDLIS or MCMIS.
Brian Hanson. Mr. Hanson is a 54-year-old intrastate driver in
Oregon. Mr. Hanson should be granted an exemption because he meets the
MEP criteria by having a diagnosis of epilepsy, no seizures for the
last 8 years, and being on a stable medication regimen for longer than
2 years. Mr. Hanson has a diagnosis of epilepsy and his last seizure
was in April 2004. He has been off of anti-seizure medication for 7
years. He has remained seizure free for 9 years. He would like to
attend truck driving school and drive tractor trailers with his wife,
as she is a long-haul driver. His physician found him fit has no
concerns regarding his driving a CMV. Mr. Hanson has no entries in
CDLIS or MCMIS.
Robert J. Mooney. Mr. Mooney is a 51-year-old intrastate CMV driver
in Ohio. Mr. Mooney should be granted an exemption because he meets the
MEP criteria by having no diagnosis of epilepsy, no seizures for the
last 4 years, and being on a stable medication regimen for longer than
2 years. He has a diagnosis of seizure disorder and his last seizure
was in 1981. He has remained seizure free for over 30 years. He takes
anti-seizure medication with the dosage and frequency remaining the
same for over 20 years. He would like to drive 18-passenger buses in
interstate commerce. He has entries in CDLIS for 2009 and 2010 for non-
injury (property damage) motor vehicle crashes and a 2009 improper turn
violation. Mr. Mooney has no entries in MCMIS.
Docket FMCSA-2012-0294
On January 15, 2013, FMCSA published a notice of receipt of
exemption applications and requested comments from the public on nine
individuals (Docket number FMCSA-2012-0294). The comment period ended
on February 15, 2013. FMCSA received eight comments, including three
duplicate comments. A discussion of the comments is presented later in
this document. Of the nine applicants, FMCSA determined that the
following seven individuals should be granted an exemption. The Agency
will issue a decision on the other drivers at a later date.
Patrick Andreasen. Mr. Andreasen is a 55-year-old Class C driver in
Pennsylvania. Mr. Andreasen should be granted an exemption because he
meets the MEP criteria by having a diagnosis of epilepsy, no seizures
for the last 8 years, and being on a stable medication regimen for
longer than 2 years. He has a diagnosis of epilepsy and his last
seizure was in 1982. He has remained seizure free for 30 years. He
takes anti-seizure medication with the dosage and frequency remaining
the same for 20 years. He would like to drive a 15-passenger bus. His
physician states he is strongly supportive of Mr. Andreasen receiving
an exemption and Mr. Andreasen states he feels he would operate a
vehicle at the same safety level as someone who did not require an
exemption. Mr. Andreasen has no entries in CDLIS or MCMIS.
Samuel D. Beverly Jr. Mr. Beverly is a 47-year-old driver in
Virginia. Mr. Beverly should be granted an exemption because he meets
the MEP criteria by having no diagnosis of epilepsy, no seizures for
the last 4 years, and being on a stable medication regimen for longer
than 2 years. He has a history of seizures and his last seizure was in
[[Page 41983]]
1995. He takes anti-seizure medication with the dosage and frequency
remaining the same for over 17 years. He would like to drive a dump
truck. Mr. Beverly's physician states he is highly supportive of Mr.
Beverly receiving an exemption. Mr. Beverly has one entry in CDLIS for
speeding in 2010 and no entries in MCMIS.
Craig Bugella. Mr. Bugella is a 46-year-old intrastate CMV driver
in Wisconsin. Mr. Bugella should be granted an exemption because he
meets the MEP criteria by having no diagnosis of epilepsy, no seizures
for the last 4 years, and being on a stable medication regimen for
longer than 2 years. He has a history of complex partial and
generalized seizures. He has remained seizure free for 11 years. He
takes anti-seizure medication with the dosage and frequency remaining
the same for 11 years. He would like to drive bucket trucks and Derrick
diggers. His physician states he is extremely confident Mr. Bugella can
operate CMVs in interstate commerce. Mr. Bugella has no entries in
CDLIS or MCMIS.
Eric Hilmer. Mr. Hilmer is a 37-year-old driver in Wisconsin. Mr.
Hilmer should be granted an exemption because he meets the MEP criteria
by having no diagnosis of epilepsy, no seizures for the last 4 years,
and being on a stable medication regimen for longer than 2 years. He
has a history of generalized seizure disorder as a child. His last
seizure in October 2007, following a closed head injury and at that
time, he was not taking anti-seizure medication prior to that event,
his last seizure had been at age 17. He takes anti-seizure medication
with the dosage and frequency remaining the same for 6 years. He would
like to drive CMVs. His physician is supportive of Mr. Hilmer being
granted an exemption. Mr. Hilmer has no entries in CDLIS or MCMIS.
Tye Dale Moore. Mr. Moore is a 47-year-old driver in Indiana. Mr.
Moore should be granted an exemption because he meets the MEP criteria
by having no diagnosis of epilepsy, no seizures for the last 4 years,
and being on a stable medication regimen for longer than 2 years. He
has a diagnosis of seizure disorder and has remained seizure free for
more than 28 years; his last seizure was May 1984. He takes anti-
seizure medication with the dosage and frequency remaining the same for
18 years. He would like to drive tractor trailers in interstate
commerce. His physician states he is supportive of Mr. Moore receiving
an exemption. Mr. Moore has no entries in CDLIS or MCMIS.
Robert Spencer. Mr. Spencer is a 30-year-old driver in Florida. Mr.
Spencer should be granted an exemption because he meets the MEP
criteria by having no diagnosis of epilepsy and being on a stable
medication regimen for longer than 2 years. He will be seizure-free for
4 years in April 2013. He has a diagnosis of seizure disorder and his
last seizure was in April 2009. He takes anti-seizure medication with
the dosage and frequency remaining the same for 4 years. He would like
to drive a delivery van under 26,000 pounds. His physician is
supportive of Mr. Spencer being granted an exemption. Mr. Spencer has
no entries in CDLIS or MCMIS.
Brian J. Wiggins. Mr. Wiggins is a 52-year-old driver in Idaho. Mr.
Wiggins should be granted an exemption because he meets the MEP
criteria by not having a diagnosis of epilepsy, no seizures for the
last 4 years, and being on a stable medication regimen for longer than
2 years. He has a diagnosis of seizure disorder and his last seizure
was in 1996. This seizure was the result of his physician taking him
off of his anti-seizure medication. He has remained seizure free for 16
years. He takes anti-seizure medication with the dosage and frequency
remaining the same for 16 years. He is a diesel mechanic and will be
driving Class 6, 7, and 8 trucks for diagnosis and repair purposes. His
physician is supportive of Mr. Wiggins being granted an exemption. Mr.
Wiggins has no entries in CDLIS or MCMIS.
Timothy M. Zahratka. Mr. Zahratka is a 38-year-old driver in
Minnesota. He suffered a penetrating head injury in 1993 and developed
a seizure disorder following the injury. He was taking anti-seizure
medications with good control until his treating physician changed his
medication to a generic in 2008. His last seizure was in August 2008
and his medication was changed. He has remained seizure-free for over 4
years. He takes anti-seizure medication with the dosage and frequency
remaining the same for over 4 years. He would like to drive a single
axle dump truck. His physician states he is supportive of Mr. Zarhatka
being granted an exemption. Mr. Zahratka has no entries in CDLIS or
MCMIS.
D. Comments
In response to the five notices, FMCSA received 35 comments,
including several duplicate comments. Comments that relate specifically
to applicants other than the ones covered in this notice will be
addressed in a subsequent notice of denial of application.
Medical Expert Panel's Criteria is Too Liberal
Natalie Hartenbaum, MD, states that she believes the MEP's criteria
for granting exemptions from the epilepsy standard is too liberal and
that not all of the applicants in the notice would meet those criteria.
She further states that the MEP's criteria is based on faulty
assumptions and an inadequate understanding of the commercial driver
medical certification process. She notes that the MEP addressing the
seizure topic lacked an Occupational Physician. It is her expressed
belief that the Panel's assessment did not take into consideration the
commercial drivers who have long periods of time behind the wheel and
that some anti-seizure medications have a high risk of cognitive
impairment with prolonged use. Dr. Hartenbaum notes that the treating
physician is most often not the provider conducting the medical
certification exam and is not legally obligated in more than 7 states
to report a driver they feel would be a safety risk. She urges FMCSA to
again review current literature and ensure it is reassessed, addressing
the Medical Review Board's comments.
FMCSA Response: FMCSA acknowledges Dr. Hartenbaum's concerns. Dr.
Hartenbaum is correct in stating that not all of the applicants in the
notice will meet the criteria. FMCSA is required to publish all
applicants in the Federal Register for 30-day public comment,
regardless of whether they meet the criteria. Each applicant is
considered on a case-by-case basis. The Agency believes that evaluating
each individual's medical history on a case-by-case basis and
investigating the past driving/violation record ensures an acceptable
level of safety for a driver who has not experienced a seizure for an
extended period of time. FMCSA will only consider granting an exemption
to those applicants who meet the criteria indicated above in this
notice on a case-by-case basis.
The Agency conducted a comprehensive literature review and convened
a panel of medical experts in epilepsy and neurology to address key
questions and make recommendations concerning new guidelines for CMV
drivers. FMCSA is conducting individualized case assessments of persons
seeking an exemption from Sec. 391.41(b)(8). The Agency seeks to
assess safety risks, medical history, and compliance to determine
whether there is likelihood the individual will experience a seizure
while operating a CMV in interstate commerce on or off medication. The
goal is to ensure a
[[Page 41984]]
minimal safety risk to the driver and the traveling public.
Concerns From the Previous Medical Review Board Members
The comments are authored by five previous MRB members who
constituted the MRB at the time the subject of seizures was addressed
by FMCSA. The group notes several concerns. They state that the Seizure
Evidence Report did not include a summary of the basic incidence and
prevalence rates of seizures and epilepsy and failed to include what
they felt were relevant studies. They also state that the report used
graphs that omitted available data points to extrapolate risks over
time. These former MRB members note that while they felt most of the
evidence reports they examined during their tenure were excellent, the
report on seizures had notable weaknesses.
In further comment, the group notes that they had previously
requested that FMCSA include an occupational physician and/or
physicians with occupational medicine expertise. They note that the
seizure MEP did not have an expert in occupational medicine, relied
almost exclusively on the Evidence Report and included two members they
felt held bias in favor of loosening the limitations on those with
seizures. They alleged several errors in the Evidence Report.
The former MRB members recommend, after reviewing the Evidence
Report and hearing the MEP's recommendations, maintaining the previous
criteria. The group states that FMCSA has represented that the MRB
recommended treating all drivers the same, and they strongly state that
this is not what the MRB concluded. They conclude their comments with
recognizing the work of the MEP, but note the extrapolation of risk
after a seizure to zero was scientifically unsound. The MRB calculated
that the 2% risk, recommended by the MEP, translated to a 40-fold
increased risk of crash, which was not tolerable.
FMCSA Response: The Agency acknowledges the five former MRB
members' comments. The MRB members advocated the continued use of the
Agency's advisory criteria recommending the 10-year seizure-free/off
medication period for driving a CMV which were established by a panel
of neurologists in 1988. In 2007, the MEP updated the information
regarding treatment of seizure disorders and the likelihood of seizure
recurrence for a variety of seizure disorders and situations. FMCSA
believes that this current research and information supersede the
information presented by the panel of neurologists in the 1988
``Conference on Neurological Disorders and Commercial Drivers.''
Also, the drivers covered by the exemptions have been free of
seizures for a period of 4 to more than 20 years. The Agency believes
that a driver who has not experienced a seizure for such extended
periods should not be precluded from driving a CMV in interstate
commerce solely because he remains on anti-seizure medication.
Generally, the Agency does not preclude drivers with medical conditions
other than seizure disorders from operating a CMV in interstate
commerce solely because they are taking medication. In addition, all
drivers must be stable on the medication for 2 years, which is a long
enough period of time for the driver and his treating physician to note
any adverse reactions to the medication such as excessive drowsiness.
As mentioned in the background section, only those drivers meeting the
MEP criteria are being granted an exemption.
In response to the former MRB members' comment regarding medical
evidence, FMCSA reviews each individual applicant, assesses the driving
record and the individual's medical condition, and determines on a
case-by-case basis the driver's risk to public safety. FMCSA is not
granting drivers with recent seizure events an exemption based on the
MEP recommendations. The Agency has made the decision to use the more
current 2007 MEP recommendations to grant exemptions on a case-by-case
basis rather than to judge all drivers by the criteria established in
the 1988 ``Conference on Neurological Disorders and Commercial
Drivers'' report. The Agency evaluated each individual's medical
condition, comparing it to the 2007 MEP. In addition, to ensure the
safest roads possible, the Agency researched each individual's driving
record. Further, we believe that each driver has shown evidence of
compliance with his or her treatment regimen. Thus, we believe that the
individuals listed above have a level of safety equivalent to those
drivers who do not suffer from a seizure disorder. FMCSA's MRB is a
Federal Advisory Committee, whose role is to provide scientific and
medical advice to FMCSA on ongoing medical issues, including the
identification of appropriate physical qualifications of CMV drivers,
medical standards, and educational curriculum for training medical
examiners who certify that drivers meet the physical qualification
standards and functional tests for drivers with disabilities. The MRB
reviews all current FMCSA medical standards and makes recommendations
to FMCSA for new science-based standards and guidelines to ensure that
drivers operating CMVs in interstate commerce, as defined in 49 CFR
390.5, are physically capable. Thus, the MRB makes recommendations, but
the Agency is the deciding body, determining what advice and which of
the MRB's recommendations to adopt. 49 U.S.C. 31149(a)(1) and (c)(1).
The Agency does not believe it was the Congress's intent that the MRB
serve as a medical certification review board for each individual
seeking an exemption.
No Exemptions for Seizures
The American College for Occupational and Environmental Medicine
(ACOEM) commented that it has special interest sections of physicians
working in the transportation industry and familiar with the job
requirements of commercial drivers. These comments are from its
perspective. ACOEM expresses concern that if a driver were to have a
seizure while operating a CMV, fatalities and injuries would likely
result. ACOEM states further that the anti-seizure medications can have
worrisome side effects and that other departments of transportation
continue to disqualify drivers with a history of seizures.
The ACOEM physicians state that, in their opinion, the MEP
recommendations are too liberal, that the recommendations were made
without considering fully all the available literature, and that the
MEP failed to incorporate the risk of medications. They note that
seizures may occur after years of seizure-free periods and there are no
tests to guarantee that an individual will not have a seizure in the
future. They oppose granting any exemption for seizures or epilepsy.
FMCSA Response: FMCSA acknowledges the concerns of the ACOEM. FMCSA
believes, however, that the current research and information supersede
the information presented by the panel of neurologists in the 1988
``Conference on Neurological Disorders and Commercial Drivers.'' The
Agency believes that a driver who has not experienced a seizure in
years should not be precluded from driving a CMV in interstate commerce
solely because he remains on anti-seizure medication. FMCSA does not
preclude drivers with medical conditions other than seizure disorders
from operating a CMV in interstate commerce solely because they are
taking medication. The findings of the 2007 comprehensive literature
review and the
[[Page 41985]]
MEP recommendations provide current information that the Agency
considered in making the determination that an exemption would likely
achieve a level of safety that is equivalent to or greater than the
level achieved without the exemption.
Public Support for Applicants and the Exemptions
Duane Napper comments (FMCSA-2011-0389) that he has known David
Kietzman for more than 20 years, that Mr. Kietzman takes his job very
seriously and that he is careful at all times. He also states he
believes Mr. Kietzman should be allowed to drive trucks. Ms. Tana
Shallenbanger (FMCSA-2011-0389) comments that Mr. Kietzman is
motivated, hauls for their company and that his ``safety practices are
stellar.'' Bart James Gardner and Duane Jon Hegland (FMCSA-2012-0094)
both commented that they have worked with James Gorniak for over 15
years and see no reason he should not be able to drive a CMV. David J.
Sander (FMCSA-2012-0094) also commented that he has worked with James
Gorniak for over 20 years and he was an excellent driver and worker.
Anonymous (FMCSA-2012-0094) stated that he is a close friend of James
Gorniak and gives an account of Mr. Gorniak's hospital visit. He states
he is supportive of Mr. Gorniak receiving the exemption. Dr. Stephen
Tenniswood, DC (FMCSA-2012-0094) states that Mr. Gorniak has been his
patient for 15 years and he can accurately attest to his functionality.
He states he sees no reason not to allow him to drive a CMV again.
Shannon Hilmer (FMCSA-2012-0294) comments that she believes that
``as long as their seizures are under control, they should be able to
live out their dream.'' Sharon Bugella (FMCSA-2012-0294) says of her
husband Craig Bugella, that he has been a lineman for 20 years. She
states that he has not had a seizure in over 11 years and that by
receiving the exemption he will be able to receive full lineman wages
and benefits.
E. Basis for Exemption
Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the epilepsy/seizure standard in 49 CFR 391.41(b)(8) if the
exemption is likely to achieve an equivalent or greater level of safety
than would be achieved without the exemption. Without the exemption,
applicants will continue to be restricted to intrastate driving. With
the exemption, applicants can drive in interstate commerce. Thus, the
Agency's analysis focuses on whether an equal or greater level of
safety is likely to be achieved by permitting each of these drivers to
drive in interstate commerce as opposed to restricting him or her to
driving in intrastate commerce.
Conclusion
The Agency is granting exemptions from the epilepsy standard, 49
CFR 391.41(b)(8), to 24 individuals based on a thorough evaluation of
each driver's qualifications, safety experience, and medical condition.
Safety analysis of information relating to these 24 applicants meets
the burden of showing that granting the exemptions would achieve a
level of safety that is equivalent to or greater than the level that
would be achieved without the exemption. By granting the exemptions,
the interstate CMV industry will gain 24 highly trained and experienced
drivers. In accordance with 49 U.S.C. 31315, each exemption will be
valid for 2 years with annual recertification required unless revoked
earlier by FMCSA. The exemption will be revoked if the following
occurs: (1) The person fails to comply with the terms and conditions of
the exemption; (2) the exemption has resulted in a lower level of
safety than was maintained prior to being granted; or (3) continuation
of the exemption would not be consistent with the goals and objectives
of 49 U.S.C. 31136 and 31315.
FMCSA exempts the following 24 drivers for a period of 2 years with
annual medical certification required: Prince Austin Jr. (OH); Frank
Cekovic (PA); Joseph D'Angelo (NY); Ricki Gutermann (WI); David R.
Kietzman (WI); Joseph Kogut (NC); Todd Brock (CO); Diana Mugford (VT);
James Wiggins (FL); Salvatore Gerard Adamita (FL); John Boerth (WI);
Michael Breitbach (IA); Timothy Grant Edwards (TN); James Gorniak (WI);
Brian Hanson (OR); Robert J. Mooney (OH); Patrick Andreasen (PA);
Samuel D. Beverly (VA); Craig Bugella (WI); Eric Hilmer (WI); Tye Dale
Moore (IN); Robert Spencer (FL); Brian J. Wiggins, (IN), and Timothy M.
Zahratka (MN) from the prohibition of CMV operations by persons with a
clinical diagnosis of epilepsy or seizures. If the exemption is still
in effect at the end of the 2-year period, the person may apply to
FMCSA for a renewal under procedures in effect at that time.
Issued on: July 2, 2013.
Anne S. Ferro,
Administrator.
[FR Doc. 2013-16686 Filed 7-11-13; 8:45 am]
BILLING CODE 4910-EX-P