80 FR 8586 - Medical Waivers for Merchant Mariner Credential Applicants With the Following Conditions: Cardiomyopathy; Diabetes Mellitus; Narcolepsy; and Obstructive Sleep Apnea

DEPARTMENT OF HOMELAND SECURITY
Coast Guard

Federal Register Volume 80, Issue 32 (February 18, 2015)

The Coast Guard is seeking public comment on the policy clarification proposed in this document regarding the specific medical documentation the Coast Guard will consider in determining whether a medical waiver is warranted for merchant mariners with cardiomyopathy, diabetes mellitus, or obstructive sleep apnea. Additionally, the proposed policy clarification specifies that narcolepsy, idiopathic hypersomnia, and other hypersomnias of central origin, are medically disqualifying and generally not waiverable due to significant risk of sudden and unpredictable incapacitation of individuals who have these conditions.

[Federal Register Volume 80, Number 32 (Wednesday, February 18, 2015)]
[Proposed Rules]
[Pages 8586-8588]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-03109]


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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

46 CFR Part 10

[Docket No. USCG-2015-0090]


Medical Waivers for Merchant Mariner Credential Applicants With 
the Following Conditions: Cardiomyopathy; Diabetes Mellitus; 
Narcolepsy; and Obstructive Sleep Apnea

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed policy clarification and request for 
comments.

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SUMMARY: The Coast Guard is seeking public comment on the policy 
clarification proposed in this document regarding the specific medical 
documentation the Coast Guard will consider in determining whether a 
medical waiver is warranted for merchant mariners with cardiomyopathy, 
diabetes mellitus, or obstructive sleep apnea. Additionally, the 
proposed policy clarification specifies that narcolepsy, idiopathic 
hypersomnia, and other hypersomnias of central origin, are medically 
disqualifying and generally not waiverable due to significant risk of 
sudden and unpredictable incapacitation of individuals who have these 
conditions.

DATES: Comments and related material must either be submitted to our 
online docket via http://www.regulations.gov on or before May 19, 2015 
or reach the Docket Management Facility by that date.

ADDRESSES: You may submit comments identified by docket number USCG-
2015-0090 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 and Request for Comments'' portion of 
the SUPPLEMENTARY INFORMATION section below for instructions on 
submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this 
document, call or email Lieutenant Ashley Holm, Mariner Credentialing 
Program Policy Division (CG-CVC-4), U.S. Coast Guard, telephone 202-
372-2357, email [email protected]. If you have questions on viewing 
material in the docket, call Docket Operations at 202-366-9826.

SUPPLEMENTARY INFORMATION:

I. Public Participation

    You may submit comments and related material regarding whether the 
policy clarification proposed in this document should be incorporated 
into final policy on the medical evaluation guidelines for mariners 
with cardiomyopathy, diabetes mellitus, narcolepsy or obstructive sleep 
apnea. 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 document (USCG-2015-0090) 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, 
type the docket number (USCG-2015-0090) in the ``SEARCH'' box and click 
``SEARCH.'' Click on ``Submit a Comment'' on the line associated with 
this document.
    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 them 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 comments and documents: To view comments, go to http://www.regulations.gov, type the docket number (USCG-2015-0090) in the 
``SEARCH'' box and click ``SEARCH.'' Click on ``Open Docket Folder'' on 
the line associated with this rulemaking. You may also visit 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

    46 CFR 10.302 contains 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 
10.302, waivers may be granted when the Coast Guard determines that 
extenuating circumstances warrant special consideration. See 46 CFR 
10.303. Current Coast Guard guidance in Enclosure (3) to Navigation and 
Vessel Inspection Circular 04-08, Medical and Physical Evaluation 
Guidelines for Merchant Mariner Credentials (NVIC 04-08), which is 
available at http://www.uscg.mil/hq/cg5/nvic/pdf/2008/NVIC%2004-08%20CH%201%20with%20Enclosures%2020130607.pdf.), states that the 
conditions of cardiomyopathy, diabetes mellitus, narcolepsy and 
obstructive sleep apnea \1\ require further

[[Page 8587]]

review. The same guidance publishes the ``recommended evaluation data'' 
that should be submitted for each condition; however it does not 
specify the medical criteria that the Coast Guard will consider in 
evaluating whether the risks associated with these conditions are low 
enough to warrant a medical waiver.
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    \1\ Enclosure (3) to Navigation and Vessel Inspection Circular 
04-08, Medical and Physical Evaluation Guidelines for Merchant 
Mariner Credentials, Item number 179, specifies that sleep apnea and 
other sleep disorders are subject to further review. Obstructive 
sleep apnea (OSA) is one specific type of sleep apnea and is, 
therefore, subject to further review under the same item number.
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    Since the issuance of NVIC 04-08 on September 15, 2008, there have 
been several instances where mariners sought waivers for these 
conditions. In some cases, mariners with these conditions were granted 
waivers; in other cases, the conditions were deemed an unacceptable 
risk and medical certification was denied. Published guidance on the 
criteria that will be used in determining whether an applicant's 
medical condition warrants a medical waiver will support Coast Guard 
efforts to consistently evaluate merchant mariners with these 
conditions and assess whether the risk associated with an applicant's 
medical condition is sufficiently mitigated to warrant a medical waiver 
under 46 CFR 10.303.
    Under the proposed policy, a medical waiver will be required for 
the conditions of cardiomyopathy, sleep apnea, and diabetes mellitus.
    In determining whether a mariner having one of the aforementioned 
conditions warrants a medical waiver under 46 CFR 10.303, the Coast 
Guard seeks public input on whether the Coast Guard should consider the 
following specific medical documentation and medical criteria:

    I. NVIC 04-08, Condition #77: Cardiac decompensation or 
cardiomyopathy. Individuals with these conditions may be denied 
medical certification unless they meet the criteria for a medical 
waiver.
    1. Submit a cardiology consultation, nuclear exercise stress 
test, echocardiogram and 24-hour Holter monitor.
    2. Criteria for consideration for a waiver include: a left 
ventricular ejection fraction of >=35%, no symptomatic or clinically 
significant heart failure in the past 2 years (must be New York 
Heart Association Class I), absence of significant ischemia on 
stress testing, exercise capacity of >=8 METs, no history of syncope 
or ventricular arrhythmia in the past three years; and the written 
opinion of the treating cardiologist or electrophysiologist supports 
low risk for sudden death, ventricular arrhythmia, adverse cardiac 
event and sudden incapacitation based upon objective testing and 
standard evaluation tools.
    3. Note: Individuals with cardiomyopathy who have had an 
implantable cardioverter defibrillator (ICD) placed, will be 
evaluated under the criteria for condition #81, Anti-tachycardia 
devices or implantable defibrillators.\2\ Individuals with 
cardiomyopathy who have been advised to undergo placement of an ICD 
by their cardiologist, but have failed to comply, do not meet the 
low risk criteria for consideration for a medical waiver. These 
individuals may be denied medical certification.
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    \2\ NVIC 04-08 Condition #81, Anti-tachycardia devices or 
implantable cardioverter defibrillators directs that conditions 
requiring use of these devices are ``generally not waiverable.'' 
Enclosure (7) to NVIC 04-08 contains the criteria for consideration 
for a medical waiver for conditions requiring use of these devices. 
The criteria are summarized as follows: (1) The applicant does not 
have a diagnosis of a cardiac channelopathy affecting the electrical 
conduction of the heart (to include Brugada syndrome, Long QT 
syndrome, etc.); (2) The applicant does not have a prior history of 
ventricular fibrillation or episodes of sustained ventricular 
tachycardia within the last three years; (3) The ICD or anti-
tachycardia device was implanted more than three years ago; (4) The 
ICD has not fired nor has the applicant required anti-tachycardia 
pacing therapy within the last three years; (5) There are no 
additional risk factors for inappropriate shock such as uncontrolled 
atrial fibrillation; (6) The applicant's left ventricular ejection 
fraction is greater than 35% with a steady or improving trend; (7) 
There is no history of any symptomatic or clinically significant 
heart failure in the past two years; (8) There is no evidence of 
significant reversible ischemia on myocardial perfusionimaging 
exercise stress testing; (9) The applicant's exercise capacity on 
formal stress testing (using standard Bruce Protocol) is greater 
than or equal to the 8 METs (metabolic equivalents); (10) The 
applicant's treating cardiologist or electrophysiologist provides a 
written assessment of the individual 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) The applicant does not have any 
other medical conditions which may alone, or incombination with an 
ICD or anti-tachycardia device, affect the mariner's fitness.
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    Justification: The Coast Guard recognizes that there is 
significant clinical variation within the population of individuals 
with cardiomyopathy, and that not all individuals with 
cardiomyopathy carry the same risks of sudden incapacitation or 
sudden death. These criteria seek to discern those individuals with 
cardiomyopathy who have factors that mitigate their risk, and who 
have prognostic indicators suggestive of a low risk of sudden 
incapacitation or adverse cardiac event.
    II. NVIC 04-08, Condition # 193: Diabetes mellitus treated with 
insulin or with history of diabetic ketoacidosis (DKA). Individuals 
with this condition may be denied medical certification unless they 
meet the criteria for a medical waiver:
    1. Submit an evaluation from the treating physician documenting 
interval history and two current glycated hemoglobin (HbA1c) levels 
separated by at least 90 days, the most recent of which is no more 
than 90 days old. An ophthalmology consultation may be required. 
Graded exercise testing may be required.
    2. If the evaluation of the treating physician supports good 
compliance with the treatment regimen, the absence of recent, severe 
hypoglycemic episodes,\3\ and the absence of impairing diabetic 
complications, then mariners with a consistent pattern of HbA1c 
levels of less than or equal to 10% may be considered for a waiver, 
with annual reporting requirements.
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    \3\ Recent, severe hypoglycemic episode is an episode of 
hypoglycemia within the prior 12 months resulting in seizure, loss 
of consciousness or altered consciousness, or requiring assistance 
from another person for treatment.
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    3. Mariners with HbA1c levels greater than 10% are generally not 
considered for a waiver unless extenuating circumstances confirm 
temporary irregularity due to acute illness, medication interaction, 
or other short-term occurrence that is not likely to recur.
    Justification: Although poorly controlled diabetes can lead to 
long term diabetic complications, the consequences of hypoglycemia 
pose an immediate threat of sudden incapacitation with a greater 
risk to public and maritime safety.
    III. NVIC 04-08, Condition #194: Diabetes requiring oral 
medication.
    1. Submit an evaluation from the treating physician documenting 
interval history and two current glycated hemoglobin (HbA1c) levels 
separated by at least 90 days, the most recent of which is no more 
than 90 days old. Ophthalmology consultation may be required. Graded 
exercise testing may be required.
    2. If the evaluation of the treating physician supports good 
compliance with the treatment regimen, the absence of recent, severe 
hypoglycemic (*) episodes, and the absence of impairing diabetic 
complications, then mariners with a consistent pattern of HbA1c 
levels of less than 8% may be considered for a waiver with biennial 
(every two years) reporting requirements; and mariners with HbA1c 
levels between 8%-10% inclusive may be considered for a waiver, with 
annual reporting requirements.
    3. Mariners with HbA1c levels of greater than 10% are generally 
not considered for waiver unless extenuating circumstances confirm 
temporary irregularity due to acute illness, medication interaction, 
or other short-term occurrence that is not likely to recur.
    Justification: Although poorly controlled diabetes can lead to 
long term diabetic complications, the consequences of hypoglycemia 
pose an immediate threat of sudden incapacitation with risk to 
public and maritime safety.
    IV. NVIC 04-08, Condition # 179: Obstructive Sleep Apnea, 
Central Sleep Apnea, Narcolepsy, Periodic Limb Movement, Restless 
Leg Syndrome or other sleep disorders.
    1. Submit all pertinent medical information, including sleep 
studies and a status report. If surgically treated, please submit a 
post-operative polysomnogram to document cure.
    2. Narcolepsy,idiopathic hypersomnia and other hypersomnias of 
central origin: Due to the significant risk of sudden and 
unpredictable incapacitation of individuals who have these 
conditions, narcolepsy, idiopathic hypersomnia and other 
hypersomnias of central origin are considered disqualifying. 
Additionally, the Coast Guard does not consider the conditions

[[Page 8588]]

of narcolepsy,idiopathic hypersomnia, or other hypersomnias of 
central origin, as low enough risk to warrant consideration for a 
medical waiver.
    3. Obstructive Sleep Apnea (OSA):
    A. Medical waivers for OSA require submission of an annual sleep 
specialist evaluation that documents treatment efficacy, the 
patient's treatment compliance and an assessment for symptoms of 
daytime sleepiness. If treated with CPAP/BiPAP, the evaluation 
should include a compliance information report from the positive 
airway pressure device that covers the preceding 12 months. For OSA 
treated by other means, submit a polysomnogram demonstrating the 
effectiveness of the alternative therapy.
    B. For purposes of receiving or maintaining a medical waiver, 
minimum compliance with positive airway pressure therapy is defined 
as:
    (i) Proper use of the CPAP/BiPAP device for at least four hours 
per night (or per major sleep period) during all major sleep periods 
while acting under the authority of the mariner credential, and
    (ii) Proper use of the CPAP/BiPAP device for at least four hours 
per night (or per major sleep period) on at least 70% of all nights 
(or major sleep periods).


    Authority:  This document is issued under the authority of 5 
U.S.C. 552(a) and 46 U.S.C. 7101 et seq.

    Dated: February 10, 2015.
J.C. Burton,
Captain, U.S. Coast Guard, Director of Inspections & Compliance.
[FR Doc. 2015-03109 Filed 2-17-15; 8:45 am]
BILLING CODE 9110-04-P