Medical Waivers for Merchant Mariner Credential Applicants With a History of Seizure Disorders, 17917-17919 [2013-06704]
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Federal Register / Vol. 78, No. 57 / Monday, March 25, 2013 / Proposed Rules
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Dated: March 19, 2013.
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[FR Doc. 2013–06649 Filed 3–22–13; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
46 CFR Part 10
[Docket No. USCG–2013–0009]
Medical Waivers for Merchant Mariner
Credential Applicants With a History of
Seizure Disorders
Coast Guard, DHS.
ACTION: Notice of proposed policy
change and request for comments.
AGENCY:
The Coast Guard is seeking
public comment regarding criteria for
granting medical waivers to merchant
mariners with a history of seizure
disorders. Coast Guard regulations
provide that convulsive disorders (also
known as seizure disorders) are
conditions that may lead to
disqualification for a merchant mariner
credential (MMC). Because a significant
number of merchant mariner applicants
have suffered from seizure disorders, it
is important for the Coast Guard to
develop and publish clear guidance
regarding how such MMC applicants are
srobinson on DSK4SPTVN1PROD with PROPOSALS
SUMMARY:
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17:07 Mar 22, 2013
Jkt 229001
evaluated. Prior to issuing a policy
change on when waivers should be
granted for seizure disorders, the Coast
Guard will accept comments from the
public on whether the proposed criteria
adequately address safety concerns.
DATES: Comments and related material
must either be submitted to our online
docket via https://www.regulations.gov
on or before April 24, 2013 or reach the
Docket Management Facility by that
date.
ADDRESSES: You may submit comments
identified by docket number USCG–
2013–0009 using any one of the
following methods:
(1) Federal eRulemaking Portal:
https://www.regulations.gov.
(2) Fax: 202–493–2251.
(3) Mail: Docket Management Facility
(M–30), U.S. Department of
Transportation, West Building Ground
Floor, Room W12–140, 1200 New Jersey
Avenue SE., Washington, DC 20590–
0001.
(4) Hand delivery: Same as mail
address above, between 9 a.m. and 5
p.m., Monday through Friday, except
Federal holidays. The telephone number
is 202–366–9329.
To avoid duplication, please use only
one of these four methods. See the
‘‘Public Participation’’ portion of the
SUPPLEMENTARY INFORMATION section
below for instructions on submitting
comments.
FOR FURTHER INFORMATION CONTACT: If
you have questions about this notice,
call or email Lieutenant Ashley Holm,
Mariner Credentialing Program Policy
Division (CG–CVC–4), U.S. Coast Guard,
telephone 202–372–1128, email
MMCPolicy@uscg.mil. If you have
questions on viewing material in the
docket, call Docket Operations at 202–
366–9826.
SUPPLEMENTARY INFORMATION:
Public Participation
You may submit comments and
related material regarding this proposed
policy change. All comments received
will be posted, without change, to
https://www.regulations.gov and will
include any personal information you
have provided.
Submitting comments: If you submit a
comment, please include the docket
number for this notice (USCG–2013–
0009) and provide a reason for each
suggestion or recommendation. You
may submit your comments and
material online or by fax, mail or hand
delivery, but please use only one of
these means. We recommend that you
include your name and a mailing
address, an email address, or a
telephone number in the body of your
PO 00000
Frm 00030
Fmt 4702
Sfmt 4702
17917
document so that we can contact you if
we have questions regarding your
submission.
To submit your comment online, go to
https://www.regulations.gov and use
‘‘USCG–2013–0009’’ as your search
term. Locate this notice in the results
and click the corresponding ‘‘Comment
Now’’ box to submit your comment. If
you submit your comments by mail or
hand delivery, submit them in an
unbound format, no larger than 81⁄2 by
11 inches, suitable for copying and
electronic filing. If you submit
comments by mail and would like to
know that they reached the Facility,
please enclose a stamped, self-addressed
postcard or envelope.
We will consider all comments and
material received during the comment
period.
Viewing the comments: To view
comments, as well as documents
mentioned in this notice as being
available in the docket, go to https://
www.regulations.gov and use ‘‘USCG–
2013–0009’’ as your search term. Use
the filters on the left side of the page to
highlight ‘‘Public Submissions’’ or other
document types. If you do not have
access to the Internet, you may view the
docket online by visiting the Docket
Management Facility in Room W12–140
on the ground floor of the Department
of Transportation West Building, 1200
New Jersey Avenue SE., Washington,
DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal
holidays. We have an agreement with
the Department of Transportation to use
the Docket Management Facility.
Privacy Act: Anyone can search the
electronic form of comments received
into any of our dockets by the name of
the individual submitting the comment
(or signing the comment, if submitted
on behalf of an association, business,
labor union, etc.). You may review a
Privacy Act system of records notice
regarding our public dockets in the
January 17, 2008 issue of the Federal
Register (73 FR 3316).
Background and Purpose
Coast Guard regulations in 46 CFR
10.215 contain the medical standards
that merchant mariner applicants must
meet prior to being issued an MMC. In
cases where the MMC applicant does
not meet the medical standards in 46
CFR 10.215, the Coast Guard may issue
a waiver when extenuating
circumstances exist that warrant special
consideration (46 CFR 10.215(g)).
On September 15, 2008, the Coast
Guard issued Navigation and Vessel
Inspection Circular (NVIC) 04–08,
‘‘Medical and Physical Evaluation
Guidelines for Merchant Mariner
E:\FR\FM\25MRP1.SGM
25MRP1
srobinson on DSK4SPTVN1PROD with PROPOSALS
17918
Federal Register / Vol. 78, No. 57 / Monday, March 25, 2013 / Proposed Rules
Credentials.’’ 1 NVIC 04–08 provides
that MMC applicants with a history of
seizure disorders should contact the
National Maritime Center (NMC) for
guidance. Since the issuance of NVIC
04–08, a number of MMC applicants
have sought and received waivers for
seizure disorders in accordance with 46
CFR 10.215(g). However, because NVIC
04–08 does not identify waiver criteria
associated with seizure disorders, it has
been difficult for Coast Guard personnel
to consistently evaluate MMC
applicants with a history of seizures and
assess whether an individual applicant’s
medical condition warrants granting a
medical waiver under 46 CFR 10.215(g).
Accordingly, the Coast Guard is
considering whether to change its policy
regarding waivers for seizure disorders,
and under what criteria an MMC
applicant may be eligible for waiver
consideration.
The Coast Guard intends to consider
public input as well as the
recommendations of the Merchant
Mariner Medical Advisory Committee
(MMMAC), established under the
authority of 46 U.S.C. 7115, prior to
establishing a final policy regarding
which circumstances warrant granting
waivers for seizure disorders. Due to the
complexity of the medical and policy
issues involved, the Coast Guard
intends to thoroughly analyze the issues
prior to issuing the final policy.
Because there is no medical literature
that specifically addresses the safety
implications that seizure disorders in
mariners might have on both mariners
and the public, the Coast Guard
reviewed the guidelines and
recommendations of the Federal Motor
Carrier Safety Administration (FMCSA)
Medical Review Board (January 28,
2008) and FMCSA’s Medical Expert
Panel (MEP) (October 15, 2007) with
regard to commercial motor vehicle
drivers with seizure disorders. Although
the FMCSA provides guidelines and
medical regulations specific to drivers
of commercial motor vehicles, the
FMCSA’s mission of promoting public
safety by evaluating the medical fitness
of drivers is similar to the Coast Guard’s
mission of promoting public and
maritime safety by evaluating the
medical fitness of merchant mariners.
While the FMCSA standards are not
binding on the Coast Guard, they
provide a sound basis for the Coast
Guard to use in formulating policy with
respect to evaluating merchant mariner
applicants with seizure disorders and
assessing whether an MMC applicant’s
1 NVIC 04–08 is available for viewing on the
Coast Guard’s Web site at: https://www.uscg.mil/hq/
cg5/nvic/2000s.asp#2008.
VerDate Mar<15>2010
17:07 Mar 22, 2013
Jkt 229001
condition warrants granting a medical
waiver. We used the FMCSA standards
as a starting point in formulating our
proposed policy detailed below.
In October 2007, the MEP conducted
a review of the medical literature and
revised its recommendations for
medical certification of commercial
motor vehicle drivers with seizure
disorders. The MEP presented the
following recommendations and
findings to the FMCSA Medical Review
Board on January 28, 2008: 2
(1) On the basis of the medical
literature review, the MEP concluded
that the longer an individual remains
seizure-free, the less likely the
individual is to have a recurrent seizure.
Specifically, the MEP found that
individuals who have been seizure-free
for at least 8 years have less than a 2
percent risk of seizure recurrence per
year, while those who have been
seizure-free for 10 years have less than
a 1 percent chance of seizure recurrence
per year.
(2) The MEP asserted that a seizure
recurrence risk of less than two percent
was sufficiently low so as to permit an
individual to be certified to drive a
commercial motor vehicle. The MEP
recommended that an individual with a
history of epilepsy (a type of seizure
disorder) may be granted conditional
certification to drive, provided that the
individual meets certain criteria.
Although the MEP recommended an 8year seizure-free period, the FMCSA
Medical Review Board opted to retain
stricter guidelines, recommending a
minimum 10-year seizure-free period, to
reduce the risk of seizure recurrence to
less than 1 percent.
Proposed Policy
The Coast Guard is considering
granting waivers to MMC applicants
with seizure disorders under the
conditions delineated below. The Coast
Guard has been using an interim policy
of an eight-year seizure-free period for
determining whether or not a waiver is
warranted. The Coast Guard recognizes
that in some situations, a shorter period
may be justified. The Coast Guard
requests public comment on whether
the criteria listed below are appropriate
and sufficient for determining whether
an MMC applicant should be eligible for
consideration for a medical waiver
under 46 CFR 10.215(g).
2 Seizure Disorders and CMV Driver Safety:
Recommendations of the MEP, October 15, 2007;
available for viewing at https://www.fmcsa.dot.gov/
rules-regulations/TOPICS/mep/report/SeizureDisorders-MEP-Recommendations-v2-prot.pdf.
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Fmt 4702
Sfmt 4702
Unprovoked Seizures
Unprovoked seizures are those
seizures not precipitated by an
identifiable trigger. Mariners with a
history of unprovoked seizure(s) may be
considered for a waiver.
(1) Mariners with a history of epilepsy
or seizure disorder may be considered
for a waiver if the mariner has been
seizure-free for a minimum of eight
years (on or off anti-epileptic drugs
(AEDs)); and
(a) If AEDs have been stopped, the
mariner must have been seizure-free for
a minimum of eight years since
cessation of medication; or
(b) If still using AEDs, the mariner
must have been on a stable medication
regimen 3 for a minimum of two years.
(2) Mariners with a single unprovoked
seizure may be considered for a waiver
if the mariner has been seizure-free for
a minimum of four years (on or off
AEDs); and
(a) If all AEDs have been stopped, the
mariner must have been seizure-free for
a minimum of four years since cessation
of medication; or
(b) If still using AEDs, the mariner
must have been on a stable medication
regimen for a minimum of two years.
Provoked Seizures
Provoked seizures are those seizures
precipitated by an identifiable trigger.
Mariners with a history of provoked
seizure(s) may be considered for a
waiver. Mariners in this group can be
divided into those with low risk of
recurrence and those with a higher risk
of recurrence (e.g., with a structural
brain lesion).
(1) If a mariner is determined to be
low-risk for seizure recurrence, does not
require AEDs, and the precipitating
factor is unlikely to recur, a waiver may
be considered when the mariner has
been seizure-free and off AEDs for a
minimum of one year.
(2) Generally, mariners with one of
the following precipitating factors will
be considered low-risk for recurrence:
(a) Lidocaine-induced seizure during
a dental appointment;
(b) Concussive seizure, loss of
consciousness ≤30 minutes with no
penetrating injury;
(c) Seizure due to syncope not likely
to recur;
(d) Seizure from an acute metabolic
derangement not likely to recur;
3 As used in this document, a stable medication
regimen is considered to be a dosage within the
therapeutic range that is consistent given changes
in the mariner’s weight or other factors such as drug
interactions. Significant dosage reductions or
tapering of the medication dosage would not be
considered stable. Additionally, changes in the type
or classification of anti-epileptic medication
utilized would not be considered stable.
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Federal Register / Vol. 78, No. 57 / Monday, March 25, 2013 / Proposed Rules
(1) Is there evidence that the chronic
use of AEDs for the treatment of
epilepsy impairs judgment or reaction
time?
(2) Is there evidence that individuals
who have been seizure-free and off
AEDs for a period of time have a lower
likelihood of seizure recurrence than
individuals who have been apparently
seizure-free and on stable AED dosing?
(3) What is the risk of seizure
recurrence as a function of time since
last seizure among individuals on AEDs
who are apparently seizure-free?
(4) What is the likelihood of seizure
recurrence as a function of time in
individuals who are seizure-free
following removal of a benign brain
tumor?
(5) Are there instances in which the
Coast Guard should issue credentials to
mariners with seizure disorders,
provided that the credentials contain
operational limitations that would allow
such mariners a limited role in industry
without causing an undue safety risk?
(6) Should mariners who are granted
a waiver be restricted from solowatchkeeping in ports, harbors, and
other waters subject to congested vessel
traffic or other hazardous
circumstances?
(7) Are there individuals with seizure
disorders due to a structural brain lesion
that are at low-risk for seizure
recurrence?
In addition to submitting public
comments in response to this notice, the
public may also wish to participate in
the MMMAC public meetings. MMMAC
meetings are advertised separately in
the Federal Register and on the NMC’s
Web site at https://www.uscg.mil/nmc.
Additional Specific Questions
The Coast Guard also specifically
requests public comment on the
following questions:
srobinson on DSK4SPTVN1PROD with PROPOSALS
(e) Severe dehydration;
(f) Hyperthermia; or
(g) Drug reaction or withdrawal.
(2) If a mariner is determined to be at
higher risk for seizure recurrence, a
waiver may be considered if the mariner
has been seizure-free for a minimum of
eight years (on or off AEDs); and
(a) If all AEDs have been stopped, the
mariner must have been seizure-free for
a minimum of eight years since
cessation of medication; or
(b) If still using AEDs, the mariner
must have been on a stable medication
regimen for a minimum of two years.
(3) Generally, mariners with a history
of provoked seizures caused by a
structural brain lesion (e.g., tumor,
trauma, or infection) characterized by
one of the following precipitating
factors will be considered at higher risk
for recurrence:
(a) Head injury with loss of
consciousness or amnesia ≥30 minutes
or penetrating head injury;
(b) Intracerebral hemorrhage of any
etiology, including stroke and trauma;
(c) Brain infection, such as
encephalitis, meningitis, abscess, or
cysticercosis;
(d) Stroke;
(e) Intracranial hemorrhage;
(f) Post-operative brain surgery with
significant brain hemorrhage; or
(g) Brain tumor.
(4) Under exceptional circumstances
in which a mariner has had provoked
seizures with structural brain lesions,
individuals may be considered for a
waiver once they have been seizure-free
for a minimum of four years, provided
that objective evidence supports
extremely low risk of seizure
recurrence.
Authority
This notice is issued under the
authority of 5 U.S.C. 552(a), 46 U.S.C.
7101 et seq., 46 CFR 10.215, and
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17:07 Mar 22, 2013
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17919
Department of Homeland Security
Delegation No. 0710.1.
Dated: March 14, 2013.
P.F. Thomas,
Captain, U.S. Coast Guard, Director of
Inspections and Compliance.
[FR Doc. 2013–06704 Filed 3–22–13; 8:45 am]
BILLING CODE 9110–04–P
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 300
[Docket No. 130104011–3011–01]
RIN 0648–BC87
International Fisheries; Western and
Central Pacific Fisheries for Highly
Migratory Species; Fishing
Restrictions and Observer
Requirements in Purse Seine Fisheries
for 2013–2014
Correction
In proposed rule document 2013–
05330, appearing on pages 14755–14762
in the issue of Thursday, March 7, 2013,
make the following correction:
On page 14755, in the third column,
under the sub-heading ‘‘Electronic
Submission’’, beginning in the fourth
line, ‘‘www.regulations.gov/
#!docketDetail;D=;NOAA-NMFS-20130043’’ is corrected to read
‘‘www.regulations.gov/
#!docketDetail;D=NOAA-NMFS-20130043’’.
[FR Doc. C1–2013–05330 Filed 3–22–13; 8:45 am]
BILLING CODE 1505–01–D
E:\FR\FM\25MRP1.SGM
25MRP1
Agencies
[Federal Register Volume 78, Number 57 (Monday, March 25, 2013)]
[Proposed Rules]
[Pages 17917-17919]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06704]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HOMELAND SECURITY
Coast Guard
46 CFR Part 10
[Docket No. USCG-2013-0009]
Medical Waivers for Merchant Mariner Credential Applicants With a
History of Seizure Disorders
AGENCY: Coast Guard, DHS.
ACTION: Notice of proposed policy change and request for comments.
-----------------------------------------------------------------------
SUMMARY: The Coast Guard is seeking public comment regarding criteria
for granting medical waivers to merchant mariners with a history of
seizure disorders. Coast Guard regulations provide that convulsive
disorders (also known as seizure disorders) are conditions that may
lead to disqualification for a merchant mariner credential (MMC).
Because a significant number of merchant mariner applicants have
suffered from seizure disorders, it is important for the Coast Guard to
develop and publish clear guidance regarding how such MMC applicants
are evaluated. Prior to issuing a policy change on when waivers should
be granted for seizure disorders, the Coast Guard will accept comments
from the public on whether the proposed criteria adequately address
safety concerns.
DATES: Comments and related material must either be submitted to our
online docket via https://www.regulations.gov on or before April 24,
2013 or reach the Docket Management Facility by that date.
ADDRESSES: You may submit comments identified by docket number USCG-
2013-0009 using any one of the following methods:
(1) Federal eRulemaking Portal: https://www.regulations.gov.
(2) Fax: 202-493-2251.
(3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590-0001.
(4) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is 202-366-9329.
To avoid duplication, please use only one of these four methods.
See the ``Public Participation'' portion of the SUPPLEMENTARY
INFORMATION section below for instructions on submitting comments.
FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice, call or email Lieutenant Ashley Holm, Mariner Credentialing
Program Policy Division (CG-CVC-4), U.S. Coast Guard, telephone 202-
372-1128, email MMCPolicy@uscg.mil. If you have questions on viewing
material in the docket, call Docket Operations at 202-366-9826.
SUPPLEMENTARY INFORMATION:
Public Participation
You may submit comments and related material regarding this
proposed policy change. All comments received will be posted, without
change, to https://www.regulations.gov and will include any personal
information you have provided.
Submitting comments: If you submit a comment, please include the
docket number for this notice (USCG-2013-0009) and provide a reason for
each suggestion or recommendation. You may submit your comments and
material online or by fax, mail or hand delivery, but please use only
one of these means. We recommend that you include your name and a
mailing address, an email address, or a telephone number in the body of
your document so that we can contact you if we have questions regarding
your submission.
To submit your comment online, go to https://www.regulations.gov and
use ``USCG-2013-0009'' as your search term. Locate this notice in the
results and click the corresponding ``Comment Now'' box to submit your
comment. If you submit your comments by mail or hand delivery, submit
them in an unbound format, no larger than 8\1/2\ by 11 inches, suitable
for copying and electronic filing. If you submit comments by mail and
would like to know that they reached the Facility, please enclose a
stamped, self-addressed postcard or envelope.
We will consider all comments and material received during the
comment period.
Viewing the comments: To view comments, as well as documents
mentioned in this notice as being available in the docket, go to https://www.regulations.gov and use ``USCG-2013-0009'' as your search term.
Use the filters on the left side of the page to highlight ``Public
Submissions'' or other document types. If you do not have access to the
Internet, you may view the docket online by visiting the Docket
Management Facility in Room W12-140 on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. We have an agreement with the Department of
Transportation to use the Docket Management Facility.
Privacy Act: Anyone can search the electronic form of comments
received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review a
Privacy Act system of records notice regarding our public dockets in
the January 17, 2008 issue of the Federal Register (73 FR 3316).
Background and Purpose
Coast Guard regulations in 46 CFR 10.215 contain the medical
standards that merchant mariner applicants must meet prior to being
issued an MMC. In cases where the MMC applicant does not meet the
medical standards in 46 CFR 10.215, the Coast Guard may issue a waiver
when extenuating circumstances exist that warrant special consideration
(46 CFR 10.215(g)).
On September 15, 2008, the Coast Guard issued Navigation and Vessel
Inspection Circular (NVIC) 04-08, ``Medical and Physical Evaluation
Guidelines for Merchant Mariner
[[Page 17918]]
Credentials.'' \1\ NVIC 04-08 provides that MMC applicants with a
history of seizure disorders should contact the National Maritime
Center (NMC) for guidance. Since the issuance of NVIC 04-08, a number
of MMC applicants have sought and received waivers for seizure
disorders in accordance with 46 CFR 10.215(g). However, because NVIC
04-08 does not identify waiver criteria associated with seizure
disorders, it has been difficult for Coast Guard personnel to
consistently evaluate MMC applicants with a history of seizures and
assess whether an individual applicant's medical condition warrants
granting a medical waiver under 46 CFR 10.215(g). Accordingly, the
Coast Guard is considering whether to change its policy regarding
waivers for seizure disorders, and under what criteria an MMC applicant
may be eligible for waiver consideration.
---------------------------------------------------------------------------
\1\ NVIC 04-08 is available for viewing on the Coast Guard's Web
site at: https://www.uscg.mil/hq/cg5/nvic/2000s.asp#2008.
---------------------------------------------------------------------------
The Coast Guard intends to consider public input as well as the
recommendations of the Merchant Mariner Medical Advisory Committee
(MMMAC), established under the authority of 46 U.S.C. 7115, prior to
establishing a final policy regarding which circumstances warrant
granting waivers for seizure disorders. Due to the complexity of the
medical and policy issues involved, the Coast Guard intends to
thoroughly analyze the issues prior to issuing the final policy.
Because there is no medical literature that specifically addresses
the safety implications that seizure disorders in mariners might have
on both mariners and the public, the Coast Guard reviewed the
guidelines and recommendations of the Federal Motor Carrier Safety
Administration (FMCSA) Medical Review Board (January 28, 2008) and
FMCSA's Medical Expert Panel (MEP) (October 15, 2007) with regard to
commercial motor vehicle drivers with seizure disorders. Although the
FMCSA provides guidelines and medical regulations specific to drivers
of commercial motor vehicles, the FMCSA's mission of promoting public
safety by evaluating the medical fitness of drivers is similar to the
Coast Guard's mission of promoting public and maritime safety by
evaluating the medical fitness of merchant mariners. While the FMCSA
standards are not binding on the Coast Guard, they provide a sound
basis for the Coast Guard to use in formulating policy with respect to
evaluating merchant mariner applicants with seizure disorders and
assessing whether an MMC applicant's condition warrants granting a
medical waiver. We used the FMCSA standards as a starting point in
formulating our proposed policy detailed below.
In October 2007, the MEP conducted a review of the medical
literature and revised its recommendations for medical certification of
commercial motor vehicle drivers with seizure disorders. The MEP
presented the following recommendations and findings to the FMCSA
Medical Review Board on January 28, 2008: \2\
---------------------------------------------------------------------------
\2\ Seizure Disorders and CMV Driver Safety: Recommendations of
the MEP, October 15, 2007; available for viewing at https://www.fmcsa.dot.gov/rules-regulations/TOPICS/mep/report/Seizure-Disorders-MEP-Recommendations-v2-prot.pdf.
---------------------------------------------------------------------------
(1) On the basis of the medical literature review, the MEP
concluded that the longer an individual remains seizure-free, the less
likely the individual is to have a recurrent seizure. Specifically, the
MEP found that individuals who have been seizure-free for at least 8
years have less than a 2 percent risk of seizure recurrence per year,
while those who have been seizure-free for 10 years have less than a 1
percent chance of seizure recurrence per year.
(2) The MEP asserted that a seizure recurrence risk of less than
two percent was sufficiently low so as to permit an individual to be
certified to drive a commercial motor vehicle. The MEP recommended that
an individual with a history of epilepsy (a type of seizure disorder)
may be granted conditional certification to drive, provided that the
individual meets certain criteria. Although the MEP recommended an 8-
year seizure-free period, the FMCSA Medical Review Board opted to
retain stricter guidelines, recommending a minimum 10-year seizure-free
period, to reduce the risk of seizure recurrence to less than 1
percent.
Proposed Policy
The Coast Guard is considering granting waivers to MMC applicants
with seizure disorders under the conditions delineated below. The Coast
Guard has been using an interim policy of an eight-year seizure-free
period for determining whether or not a waiver is warranted. The Coast
Guard recognizes that in some situations, a shorter period may be
justified. The Coast Guard requests public comment on whether the
criteria listed below are appropriate and sufficient for determining
whether an MMC applicant should be eligible for consideration for a
medical waiver under 46 CFR 10.215(g).
Unprovoked Seizures
Unprovoked seizures are those seizures not precipitated by an
identifiable trigger. Mariners with a history of unprovoked seizure(s)
may be considered for a waiver.
(1) Mariners with a history of epilepsy or seizure disorder may be
considered for a waiver if the mariner has been seizure-free for a
minimum of eight years (on or off anti-epileptic drugs (AEDs)); and
(a) If AEDs have been stopped, the mariner must have been seizure-
free for a minimum of eight years since cessation of medication; or
(b) If still using AEDs, the mariner must have been on a stable
medication regimen \3\ for a minimum of two years.
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\3\ As used in this document, a stable medication regimen is
considered to be a dosage within the therapeutic range that is
consistent given changes in the mariner's weight or other factors
such as drug interactions. Significant dosage reductions or tapering
of the medication dosage would not be considered stable.
Additionally, changes in the type or classification of anti-
epileptic medication utilized would not be considered stable.
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(2) Mariners with a single unprovoked seizure may be considered for
a waiver if the mariner has been seizure-free for a minimum of four
years (on or off AEDs); and
(a) If all AEDs have been stopped, the mariner must have been
seizure-free for a minimum of four years since cessation of medication;
or
(b) If still using AEDs, the mariner must have been on a stable
medication regimen for a minimum of two years.
Provoked Seizures
Provoked seizures are those seizures precipitated by an
identifiable trigger. Mariners with a history of provoked seizure(s)
may be considered for a waiver. Mariners in this group can be divided
into those with low risk of recurrence and those with a higher risk of
recurrence (e.g., with a structural brain lesion).
(1) If a mariner is determined to be low-risk for seizure
recurrence, does not require AEDs, and the precipitating factor is
unlikely to recur, a waiver may be considered when the mariner has been
seizure-free and off AEDs for a minimum of one year.
(2) Generally, mariners with one of the following precipitating
factors will be considered low-risk for recurrence:
(a) Lidocaine-induced seizure during a dental appointment;
(b) Concussive seizure, loss of consciousness <=30 minutes with no
penetrating injury;
(c) Seizure due to syncope not likely to recur;
(d) Seizure from an acute metabolic derangement not likely to
recur;
[[Page 17919]]
(e) Severe dehydration;
(f) Hyperthermia; or
(g) Drug reaction or withdrawal.
(2) If a mariner is determined to be at higher risk for seizure
recurrence, a waiver may be considered if the mariner has been seizure-
free for a minimum of eight years (on or off AEDs); and
(a) If all AEDs have been stopped, the mariner must have been
seizure-free for a minimum of eight years since cessation of
medication; or
(b) If still using AEDs, the mariner must have been on a stable
medication regimen for a minimum of two years.
(3) Generally, mariners with a history of provoked seizures caused
by a structural brain lesion (e.g., tumor, trauma, or infection)
characterized by one of the following precipitating factors will be
considered at higher risk for recurrence:
(a) Head injury with loss of consciousness or amnesia >=30 minutes
or penetrating head injury;
(b) Intracerebral hemorrhage of any etiology, including stroke and
trauma;
(c) Brain infection, such as encephalitis, meningitis, abscess, or
cysticercosis;
(d) Stroke;
(e) Intracranial hemorrhage;
(f) Post-operative brain surgery with significant brain hemorrhage;
or
(g) Brain tumor.
(4) Under exceptional circumstances in which a mariner has had
provoked seizures with structural brain lesions, individuals may be
considered for a waiver once they have been seizure-free for a minimum
of four years, provided that objective evidence supports extremely low
risk of seizure recurrence.
Additional Specific Questions
The Coast Guard also specifically requests public comment on the
following questions:
(1) Is there evidence that the chronic use of AEDs for the
treatment of epilepsy impairs judgment or reaction time?
(2) Is there evidence that individuals who have been seizure-free
and off AEDs for a period of time have a lower likelihood of seizure
recurrence than individuals who have been apparently seizure-free and
on stable AED dosing?
(3) What is the risk of seizure recurrence as a function of time
since last seizure among individuals on AEDs who are apparently
seizure-free?
(4) What is the likelihood of seizure recurrence as a function of
time in individuals who are seizure-free following removal of a benign
brain tumor?
(5) Are there instances in which the Coast Guard should issue
credentials to mariners with seizure disorders, provided that the
credentials contain operational limitations that would allow such
mariners a limited role in industry without causing an undue safety
risk?
(6) Should mariners who are granted a waiver be restricted from
solo-watchkeeping in ports, harbors, and other waters subject to
congested vessel traffic or other hazardous circumstances?
(7) Are there individuals with seizure disorders due to a
structural brain lesion that are at low-risk for seizure recurrence?
In addition to submitting public comments in response to this
notice, the public may also wish to participate in the MMMAC public
meetings. MMMAC meetings are advertised separately in the Federal
Register and on the NMC's Web site at https://www.uscg.mil/nmc.
Authority
This notice is issued under the authority of 5 U.S.C. 552(a), 46
U.S.C. 7101 et seq., 46 CFR 10.215, and Department of Homeland Security
Delegation No. 0710.1.
Dated: March 14, 2013.
P.F. Thomas,
Captain, U.S. Coast Guard, Director of Inspections and Compliance.
[FR Doc. 2013-06704 Filed 3-22-13; 8:45 am]
BILLING CODE 9110-04-P