Document ID: USCG-2012-0734-0001
Agency: uscg
Document Type: Proposed Rule
Title: Medical Waivers for Merchant Mariner Credential Applicants with Anti-Tachycardia Devices or Implantable Cardioverter Defibrillators (Federal Register Publication)  (Notice of proposed policy change and request for comments.)
Posted Date: 2012-09-07T04:00Z

[Federal Register Volume 77, Number 174 (Friday, September 7, 2012)]
[Proposed Rules]
[Pages 55174-55175]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-22006]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

46 CFR Part 10

[Docket No. USCG-2012-0734]

Medical Waivers for Merchant Mariner Credential Applicants With 
Anti-Tachycardia Devices or Implantable Cardioverter Defibrillators

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 mariners who have anti-tachycardia 
devices or implantable cardioverter defibrillators (ICDs). Current 
Coast Guard guidance found in Navigation and Vessel Inspection Circular 
04-08, Medical and Physical Evaluation Guidelines for Merchant Mariner 
Credentials (NVIC 04-08), states that anti-tachycardia devices or ICDs 
are generally not waiverable. The Coast Guard is considering changing 
that policy. Prior to issuing a policy change on whether to grant 
waivers for anti-tachycardia devices or ICDs and the criteria for such 
waivers, the Coast Guard will accept comments from the public on 
whether the proposed criteria would adequately address safety concerns 
regarding merchant mariners with ICDs.

DATES: Comments and related material must either be submitted to our 
online docket via http://www.regulations.gov on or before October 9, 
2012 or reach the Docket Management Facility by that date.

ADDRESSES: You may submit comments identified by docket number USCG-
2011-0734 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 Renee V. Wright, Program Manager, Docket 
Operations, telephone 202-366-9826.

SUPPLEMENTARY INFORMATION:

Public Participation

    You may submit comments and related material regarding whether this 
proposed policy change should be incorporated into a final policy on 
issuing medical waivers to mariners with ICDs. 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-2012-0734) 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 
insert ``USCG-2012-0734'' in the ``Search'' box. Click ``Search,'' find 
this notice in the list of Results, and then click on the corresponding 
``Comment Now'' box. 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 insert ``USCG-2012-0734'' in the ``Search'' 
box. Click ``Search'' and 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 mariners must meet prior to being issued a 
merchant mariner credential (MMC). In cases where the mariner 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. See 46 CFR 10.215(g).
    In NVIC 04-08, the Coast Guard states that anti-tachycardia devices 
and ICDs are generally not waiverable. Since the issuance of NVIC 04-08 
on September 15, 2008, a number of mariners have sought and received 
waivers for anti-tachycardia devices or ICDs in accordance with 46 CFR 
10.215(g). However, because NVIC 04-08 does not identify waiver 
criteria associated with anti-tachycardia devices or ICDs, it has been 
difficult for Coast Guard personnel to consistently evaluate merchant 
mariners with anti-tachycardia devices or ICDs and assess whether an 
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 anti-tachycardia devices or 
ICDs, and under what criteria a mariner 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, 
established under the authority of 46

[[Page 55175]]

U.S.C. 7115, prior to establishing a final policy on whether waivers 
should be granted for anti-tachycardia devices or ICDs, and if so, 
under what circumstances. Because of the complexity of the issues 
involved, the Coast Guard intends to thoroughly analyze the issues 
prior to issuing the final policy.
    The Coast Guard specifically requests public comment on the 
likelihood of an ICD inappropriately firing and whether that shock 
could potentially incapacitate a merchant mariner. Additionally, the 
Coast Guard seeks public comment on whether the criteria listed below 
are appropriate and sufficient to evaluate whether a mariner should be 
eligible for consideration for a medical waiver under 46 CFR 10.215(g).
    Below is a series of 12 questions we are considering as the 
criteria for granting a medical waiver. A review of the mariner's 
record should lead the Coast Guard to answer ``no'' for each question 
in order for the mariner to be eligible for waiver consideration. We 
request public comment regarding whether the 12 questions below 
represent an appropriate and sufficient list of the criteria a mariner 
should be required to meet in order to be eligible for waiver 
consideration, or whether we should eliminate or modify any of the 
questions, or add other questions to the list.
    (1) Does the mariner have a diagnosis of a cardiac channelopathy 
affecting the electrical conduction of the heart (including Brugada 
syndrome, Long QT syndrome, etc.)?
    (2) Does the mariner have a prior history of ventricular 
fibrillation or episodes of sustained ventricular tachycardia and, if 
so, did the arrhythmia episode occur greater than three years ago?
    (3) Was the ICD or anti-tachycardia device implanted more than 
three years ago?
    (4) Has the ICD fired or has the mariner required anti-tachycardia 
pacing within the last three years?
    (5) Does the mariner's condition present any confounding risk 
factors for inappropriate shock such as uncontrolled atrial 
fibrillation?
    (6) Is the mariner's ejection fraction greater than 40% with a 
steady or improving trend?
    (7) Does the mariner have a history of any symptomatic or 
clinically significant heart failure in the past two years?
    (8) Does the mariner's record contain any evidence of significant 
reversible ischemia on myocardial perfusion imaging exercise stress 
testing?
    (9) Has the mariner's exercise capacity been assessed to be greater 
than or equal to 10 metabolic equivalents (METs)?
    (10) Did the mariner provide a written opinion of the treating 
cardiologist or electrophysiologist that supports a determination that 
the mariner is at low risk for future arrhythmia, adverse cardiac event 
or sudden incapacitation based upon objective testing and standard 
evaluation tools?
    (11) Does the mariner have any other medical conditions which may 
alone, or in combination with an ICD or anti-tachycardia device, affect 
the mariner's fitness?
    (12) Is the mariner applying for an original credential, raise-in-
grade, or renewal of an existing credential?

    Authority: We issue this request for public comments under the 
authority of 5 U.S.C. 552(a).

    Dated: August 13, 2012.
P.F. Thomas,
Captain, U.S. Coast Guard, Director of Inspections and Compliance.
[FR Doc. 2012-22006 Filed 9-6-12; 8:45 am]
BILLING CODE 9110-04-P