[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]


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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.

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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 http://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: http://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 http://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 http://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 http://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.
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    \1\ NVIC 04-08 is available for viewing on the Coast Guard's Web 
site at: http://www.uscg.mil/hq/cg5/nvic/2000s.asp#2008.
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    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\
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    \2\ Seizure Disorders and CMV Driver Safety: Recommendations of 
the MEP, October 15, 2007; available for viewing at http://www.fmcsa.dot.gov/rules-regulations/TOPICS/mep/report/Seizure-Disorders-MEP-Recommendations-v2-prot.pdf.
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    (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 http://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