
[Federal Register Volume 78, Number 247 (Tuesday, December 24, 2013)]
[Notices]
[Pages 77774-77776]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-30662]


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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2006-25854; FMCSA-2013-0107; FMCSA-2013-0108]


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 seven 
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 seven 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 December 24, 2013. The exemptions 
expire on December 24, 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(b), 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 seven individuals an exemption from the regulatory 
requirement in Sec.  391.41(b)(8), to allow these 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 each 
applicant's driving record found in the Commercial Driver's License 
Information System (CDLIS) \1\ for commercial driver's license (CDL) 
holders, and interstate and intrastate inspections recorded in Motor 
Carrier Management Information System (MCMIS).\2\ For non-CDL holders, 
the Agency reviewed the driving records from the State licensing 
agency. 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 granted here 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 at 49 CFR 391.41(b)(8) 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 (the 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.

[[Page 77775]]

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 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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    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 seven individuals. Under current FMCSA regulations, all of the seven 
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. For these seven 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 Criteria have 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 seven drivers, 
some of whom currently drive a CMV in intrastate commerce. The CDLIS 
and MCMIS were searched for crash and violation data on the seven 
applicants. For non-CDL holders, the Agency reviewed the driving 
records from the State licensing agency.
    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 and a discussion of the comments received 
follows this section. For applicants who were denied an exemption, a 
notice will be published at a later date.

D. Comments

Docket  FMCSA-2006-25854

    On August 9, 2007, FMCSA published a notice of receipt of exemption 
applications and requested public comments on nine individuals (72 FR 
44916). The comment period ended on September 10, 2007. Five commenters 
responded to the Federal Register Notice. A discussion of these 
comments and a decision was made on four applicants in (72 FR 3069). 
FMCSA has determined that one of these applicants

[[Page 77776]]

should be granted an exemption. The Agency will issue a decision on the 
other drivers at a later date.

Docket  FMCSA-2013-0107

    On July 12, 2013, FMCSA published a notice of receipt of exemption 
applications and requested public comment on nine individuals (78 FR 
41988). The comment period ended on August 12, 2013. Seven commenters 
responded to the Federal Register notice. All commenters support the 
idea of granting an exemption. 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.

Docket  FMCSA-2013-0108

    On September 16, 2013, FMCSA published a notice of receipt of 
exemption applications and requested public comment on six individuals 
(78 FR 56984). The comment period ended on October 16, 2013. One 
commenter responded to the Federal Register notice. This commenter 
expressed his safety concerns about permitting drivers with a history 
of seizure to drive commercially, and stated it does not make sense to 
allow these drivers to drive 80,000 lb. trucks up and down our 
highways.
    FMCSA Response: 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. Drivers, who have been seizure-free, on or off medication for 
at least four years, pose a minimal risk to public safety. The Agency 
considered the 2007 Evidence Report and the 2007 MEP recommendations to 
determine the driver's level of risk for recurrence of seizure. The 
Agency believes this data and information addresses this commenter's 
concerns.
    FMCSA has determined that five of these applicants should be 
granted an exemption. The Agency will issue a decision on the other 
driver at a later date.
Stephen Amell, Sr.
    Mr. Amell is a 55 year-old driver in Vermont. He has a history of a 
single seizure in 2004 and has remained seizure free since that time. 
He takes anti-seizure medication with the dosage and frequency 
remaining the same for six years. If granted the exemption, he would 
like to drive a CMV. His physician states that he is supportive of Mr. 
Amell receiving an exemption.
Erik Fleiner
    Mr. Fleiner is a 25 year-old class A commercial driver's license 
holder in Nevada. He has a history of seizures and has remained seizure 
free for at least 10 years. He takes anti-seizure medication with the 
dosage and frequency remaining the same for 10 years. If granted the 
exemption, he would like to continue to drive a CMV. His physician 
states that he is supportive of Mr. Fleiner receiving an exemption.
Gary Freeman
    Mr. Freeman is a 48 year-old class A commercial driver's license 
holder in Wisconsin. He has a history of seizures and has remained 
seizure free for at least 10 years. He takes anti-seizure medication 
with the dosage and frequency remaining the same for over seven years. 
His physician states that he is supportive of Mr. Freeman receiving an 
exemption.
Aaron Gillette
    Mr. Gillette is a 42 year-old driver in South Dakota. He has a 
history of epilepsy and has remained seizure free for over eight years. 
He takes anti-seizure medication with the dosage and frequency 
remaining the same for seven years. His physician states that he is 
supportive of Mr. Gillette receiving an exemption.
David Kestner
    Mr. Kestner is a 28 year-old driver in Virginia. He has a history 
of epilepsy and has remained seizure free for nine years. He takes 
anti-seizure medication with the dosage and frequency remaining the 
same for five years. His physician states that he is supportive of Mr. 
Kestner receiving an exemption.
Michael Kramer
    Mr. Kramer is a 46 year-old driver in Kansas. He had a seizure due 
to a brain tumor which was removed in 2009. He has remained seizure-
free since that time. He does not require anti-seizure medication. His 
physician is supportive of Mr. Kramer receiving an exemption.
Chad Smith
    Mr. Smith is a 36 year-old driver in Massachusetts. He has a 
history of seizures and has remained seizure free for at least 15 
years. He takes anti-seizure medication with the dosage and frequency 
remaining the same for six years. His physician states that he is 
supportive of Mr. Smith receiving an exemption.

E. Basis For Exemption

    Under 49 U.S.C. 31136(e) and 31315(b), 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 the driver to 
driving in intrastate commerce.

Conclusion

    The Agency is granting exemptions from the epilepsy standard, 49 
CFR 391.41(b)(8), to seven individuals based on a thorough evaluation 
of each driver's qualifications, safety experience, and medical 
condition. Safety analysis of information relating to these seven 
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 seven highly trained 
and experienced drivers. In accordance with 49 U.S.C. 31315(b)(1), 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 seven drivers from the prohibition of 
CMV operations by persons with a clinical diagnosis of epilepsy or 
seizures for a period of 2 years with annual medical certification 
required: Stephen Amell, Sr. (VT); Erik Fleiner (NV); Gary Freeman 
(WI); Aaron Gillette (SD); David Kestner (VA); Michael Kramer (KS); and 
Chad Smith (MA). 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: December 16, 2013.
Anne S. Ferro,
Administrator.
[FR Doc. 2013-30662 Filed 12-23-13; 8:45 am]
BILLING CODE 4910-EX-P


