Qualification of Drivers; Exemption Applications; Epilepsy and Seizure Disorders, 55167-55170 [2015-23036]

Agencies

• Federal Motor Carrier Safety Administration
• DEPARTMENT OF TRANSPORTATION

[Federal Register Volume 80, Number 177 (Monday, September 14, 2015)]
[Notices]
[Pages 55167-55170]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-23036]


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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2014-0379]


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 6 
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 6 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 September 14, 2015. The exemptions 
expire on September 14, 2017.

FOR FURTHER INFORMATION CONTACT: Charles A. Horan, III, Director, 
Office of Carrier, Driver and Vehicle Safety, (202) 366-4001, or via 
email at fmcsamedical@dot.gov, or by letter to 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., 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: https://www.regulations.gov.

[[Page 55168]]

    Docket: For access to the docket to read background documents or 
comments, go to 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., Monday through Friday, except Federal 
holidays.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits 
comments from the public to better inform its rulemaking process. DOT 
posts these comments, without edit, including any personal information 
the commenter provides, to www.regulations.gov, as described in the 
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at 
www.dot.gov/privacy.

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 6 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 https://www.fmcsa.dot.gov/regulations/medical/reports-how-medical-conditions-impact-driving, 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 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

[[Page 55169]]

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 6 individuals. Under current FMCSA regulations, all of the 6 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 6 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 6 drivers, some of 
whom currently drive a CMV in intrastate commerce. The CDLIS and MCMIS 
were searched for crash and violation data on the 6 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 was previously published.

D. Comments

Docket #FMCSA-2014-0379

    On November 24, 2014, FMCSA published a notice of receipt of 
exemption applications and requested public comment on 12 individuals 
(79 FR 69981; Docket number FMCSA-2014-27755). The comment period ended 
on December 24, 2014. Two commenters responded to this notice 
expressing support for the epilepsy standard and the duty to keep our 
roads safe. Of the 12 applicants, six were denied. The Agency has 
determined that the following six applicants should be granted an 
exemption.
Theodore C. Banet
    Mr. Banet is a 43 year-old driver in Pennsylvania. He has a history 
of epilepsy and has remained seizure free since 2004. He takes anti-
seizure medication with the dosage and frequency remaining the same 
since that time. If granted an exemption, he would like to drive a CMV. 
His physician states that he is supportive of Mr. Banet receiving an 
exemption.
David S. Campbell
    Mr. Campbell is a 70 year-old driver in Massachusetts. He has a 
history of seizures and has remained seizure free since 2005. He takes 
anti-seizure medication with the dosage and frequency remaining the 
same since that time. If granted an exemption, he would like to drive a 
CMV. His physician states that he is supportive of Mr. Campbell 
receiving an exemption.
Lewis R. Holbrook
    Mr. Holbrook is a 43 year-old driver in North Carolina. He has a 
history of a seizure disorder and has remained seizure free since 2004. 
He takes anti-seizure medication with the dosage and frequency 
remaining the same since 2005. If granted the exemption, he would like 
to drive a CMV. His physician states that he is supportive of Mr. 
Holbrook receiving an exemption.
Dominick Rezza
    Mr. Rezza is a 58 year-old class A CDL holder in Texas. He has a 
history of a seizure disorder and has remained seizure free since 1995. 
He takes anti-seizure medication with the dosage and frequency 
remaining the same since 1996. If granted the exemption, he would like 
to drive a CMV. His physician states that he is supportive of Mr. Rezza 
receiving an exemption.
Edgar A. Snapp
    Mr. Snapp is a 52 year-old class B CDL holder in Indiana. He has a 
history of a seizure disorder and has remained seizure free since 1988. 
He takes anti-seizure medication with the dosage and frequency 
remaining the same since that time. If granted the exemption, he would 
like to drive a CMV. His physician states that he is supportive of Mr. 
Snapp receiving an exemption.
Gregory W. Young
    Mr. Young is a 50 year-old class A CDL holder in South Carolina. He 
has a history of seizure and has remained seizure free since 1983. He 
takes anti-seizure medication with the dosage and frequency remaining 
the same since 2004. If granted the exemption, he would like to drive a 
CMV. His physician states that he is supportive of Mr. Young 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 6 individuals based on a thorough evaluation of 
each driver's safety experience, and medical condition. Safety analysis 
of information relating to these 6 applicants meets the burden of 
showing

[[Page 55170]]

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 6 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 6 drivers for a period of 2 years with 
annual medical certification required: Theodore Banet (PA); David 
Campbell (MA); Lewis Holbrook (NC); Dominick Rezza (TX); Edgar Snapp 
(IN); and Gregory Young (SC) 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: September 3, 2015.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2015-23036 Filed 9-11-15; 8:45 am]
BILLING CODE 4910-EX-P