Qualification of Drivers; Exemption Applications; Epilepsy and Seizure Disorders |
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Larry W. Minor
Federal Motor Carrier Safety Administration
November 28, 2014
[Federal Register Volume 79, Number 229 (Friday, November 28, 2014)]
[Notices]
[Pages 70917-70920]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28071]
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DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety Administration
[Docket No. FMCSA-2006-25854; FMCSA-2011-0389; FMCSA-2012-0294; FMCSA-
2013-0109]
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 five
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 five 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 November 28, 2014. The exemptions
expire on November 28, 2016.
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 five 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\
[[Page 70918]]
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.
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 five individuals. Under current FMCSA regulations, all of the five
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 five 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
[[Page 70919]]
for the five drivers, some of whom currently drive a CMV in intrastate
commerce. The CDLIS and MCMIS were searched for crash and violation
data on the five 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 comment on nine individuals (72 FR
44916; Docket number FMCSA-2006-25854). The comment period ended on
September 10, 2007. Five comments were received. A discussion of the
comments were presented in a previous notice. Of the nine applicants,
five were previously granted exemptions, one withdrew his request, and
two were denied. The Agency has determined that the following applicant
should be granted an exemption.
Jay Whitehead
Mr. Whitehead is a 51 year-old class B CDL holder in New York. He
has a history of seizures and has remained seizure free since 1983. He
takes anti-seizure medication with the dosage and frequency remaining
the same for over 2 years. If granted the exemption, he would like to
continue to drive a CMV. His physician states he is supportive of Mr.
Whitehead receiving an exemption.
Docket # FMCSA-2011-0389
On January 5, 2012, FMCSA published a notice of receipt of
exemption applications and requested public comment on 15 individuals
(77 FR 33781; Docket number FMCSA-2011-0389). The comment period ended
on February 5, 2012. Seven comments were received. A discussion of the
comments were presented in a previous notice. Of the 15 applicants,
three were previously granted exemptions. FMCSA has determined that the
following applicant should be granted an exemption. The Agency will
issue a decision on the other drivers at a later date.
Lonnie Rieker
Mr. Rieker is a 55 year-old class A CDL holder in Illinois. He has
a history of a single seizure and has remained seizure free for 4
years. He takes anti-seizure medication with the dosage and frequency
remaining the same for over 2 years. If granted the exemption, he would
like to continue to drive a CMV. His physician states he is supportive
of Mr. Rieker receiving an exemption.
Docket # FMCSA-2012-0294
On January 15, 2013, FMCSA published a notice of receipt of
exemption applications and requested public comment on nine individuals
(78 FR 00712; Docket number FMCSA-2012-0294). The comment period ended
on February 15, 2013. Eight comments were received, including three
duplicate comments. A discussion of the comments were presented in a
previous notice. Of the nine applicants, eight were previously granted
exemptions. FMCSA has determined that the following applicant should be
granted an exemption.
Michael Ranalli
Mr. Ranalli is a 29 year-old driver in Pennsylvania. He has a
history of juvenile epilepsy and has remained seizure free for 8 years.
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 he is supportive of Mr.
Ranalli receiving an exemption.
Docket # FMCSA-2013-0109
On November 13, 2013, FMCSA published a notice of receipt of
exemption applications and requested public comment on 11 individuals
(78 FR 68144). The comment period ended on December 13, 2013. No
commenters responded to this Federal Register notice. Of the 11
applicants, four were previously granted exemptions. FMCSA has
determined that the following two applicants should be granted an
exemption. The Agency will issue a decision on the other drivers at a
later date.
Jeffrey Ballweg
Mr. Ballweg is 51 year-old driver in Wisconsin. He has a history of
epilepsy and has remained seizure free for 8 years. He takes anti-
seizure medication with the dosage and frequency remaining the same for
over 2 years. If granted the exemption, he would like to drive a CMV.
His physician states he is supportive of Mr. Ballweg receiving an
exemption.
Bryan Couture
Mr. Couture is a 48 year-old class B CDL holder in Rhode Island. He
has a history of seizure and has remained seizure free for 10 years. He
takes anti-seizure medication with the dosage and frequency remaining
the same for over 2 years. If granted the exemption, he would like to
continue to drive a CMV. His physician states he is supportive of Mr.
Couture 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 five individuals based on a thorough evaluation of
each driver's qualifications, safety experience, and medical condition.
Safety analysis of information relating to these five 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 five 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)
[[Page 70920]]
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 five drivers for a period of 2 years
with annual medical certification required: Jeffrey Ballweg (WI); Bryan
Couture (RI); Michael Ranalli (PA); Lonnie Rieker (IL); and Jay
Whitehead (NY) 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: November 21, 2014.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2014-28071 Filed 11-26-14; 8:45 am]
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