[Federal Register Volume 84, Number 174 (Monday, September 9, 2019)]
[Rules and Regulations]
[Pages 47141-47146]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19370]
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DEPARTMENT OF HOMELAND SECURITY
Coast Guard
46 CFR Part 10
[Docket No. USCG-2018-0041]
COMDTINST M16721.48 Merchant Mariner Medical Manual
AGENCY: Coast Guard, DHS.
ACTION: Notification of availability.
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SUMMARY: The Coast Guard announces the availability of the Merchant
Mariner Medical Manual, Commandant Instruction Manual (COMDTINST
M16721.48). The guidance in this Manual should assist medical
practitioners, the maritime industry, individual mariners, and Coast
Guard personnel in evaluating a mariner applicant's physical and
medical status to meet the requirements of the merchant mariner medical
certificate. This Manual incorporates and consolidates prior guidance
on the medical evaluation of merchant mariners contained in several
Coast Guard documents. The Manual includes guidance on the medical
certificate and related processes, including procedures for
application, issuance, and cancellation of the medical certificate.
DATES: The Merchant Mariner Medical Manual, COMDTINST M16721.4, is
effective on September 9, 2019.
FOR FURTHER INFORMATION CONTACT: For information about this document or
to suggest changes, call or email Adrienne Buggs, M.D., United States
Coast Guard, Office of Merchant Mariner
[[Page 47142]]
Credentialing; telephone: 202-372-2357, email: [email protected].
SUPPLEMENTARY INFORMATION:
Viewing Documents
The Merchant Mariner Medical Manual, COMDTINST M16721.4, is
available on the internet at: https://www.dcms.uscg.mil/Our-Organization/Assistant-Commandant-for-C4IT-CG-6/The-Office-of-Information-Management-CG-61/About-CG-Directives-System/ and on
CGPortal at: https://cgportal2.uscg.mil/library/directives/SitePages/Home.aspx. A link to the document will also be located on the National
Maritime Center (NMC) site: https://www.dco.uscg.mil/Our-Organization/Assistant-Commandant-for-Prevention-Policy-CG-5P/National-Maritime-Center/.
Background and Discussion of the Merchant Mariner Medical Manual
Coast Guard regulations contained in 46 CFR part 10, subpart C,
provide the medical and physical standards that merchant mariner
applicants must meet prior to being issued a merchant mariner medical
certificate. The Merchant Mariner Medical Manual provides guidance to
the regulated community on how to comply with the regulations
pertaining to medical and physical qualifications for merchant
mariners.
Previously, the Coast Guard provided guidance on the medical and
physical requirements for merchant mariners in the Medical and Physical
Evaluation Guidelines for Merchant Mariner Credentials, Navigation and
Inspection Circular (NVIC) 04-08, Commandant Publication (COMDTPUB)
16700.4; in the Guidance on the Issuance of Medical Certificates (NVIC
01-14); and in Part A of the Marine Safety Manual, Volume III, Marine
Industry Personnel, COMDTINST M16000.8 (Series) [MSM]. The Merchant
Mariner Medical Manual revises, updates and combines the medical
evaluation guidance previously published in NVIC 04-08, Part A of the
MSM, Volume III, and NVIC 01-14. The Coast Guard developed the draft
Manual in consultation with experienced maritime community medical
practitioners and industry stakeholders serving on the Merchant Mariner
Medical Advisory Committee (MEDMAC) and the Merchant Marine Personnel
Advisory Committee (MERPAC). The Manual reflects a synthesis of their
recommendations and the medical requirements of title 46 Code of
Federal Regulations (CFR) part 10, subpart C.
Members of the public participated in the development of medical
policy by providing comment and serving on working groups at the public
meetings of MEDMAC and MERPAC. Additionally, the public had the
opportunity to comment on drafts of policies contained in this Manual,
and its predecessor, NVIC 04-08. See requests for comment on proposed
policies regarding: Diabetes, cardiomyopathy, and sleep disorders (80
FR 8586, Feb. 18, 2015); Medications (80 FR 4582, Jan. 28, 2015);
Seizures (78 FR 17917, Mar. 25, 2013); and Implantable cardioverter
defibrillators (77 FR 55174, Sep. 7, 2012). The Coast Guard considered
these public comments when developing this Manual.
Public Comments on the Draft Merchant Mariner Medical Manual:
The Coast Guard published a draft of the Merchant Mariner Medical
Manual in the Federal Register and sought input from the public on the
draft (83 FR 56272, Nov. 13, 2018). The current version of the Manual
includes revisions made to address comments received in response to the
Federal Register notification. While the Coast Guard is not required to
seek or respond to public comments prior to publication of a policy
document, we chose to do so in this case because of the perceived
complexity of the Merchant Mariner Medical Manual, and because doing so
provides us the opportunity to (1) create a guidance document that is
more viable and responsive to the needs of the impacted community; and
(2) to identify and clarify remaining areas of confusion and concern
amongst the regulated community.
The Coast Guard's notification sought general comments on the draft
Medical Manual, with emphasis on suggestions to improve readability,
clarity, and ease of use; and comments on whether the draft Manual's
proposed medical certificate cancellation policy adequately addresses
safety concerns in situations where the Coast Guard receives
information indicating that a medical certificate holder has developed
a medical condition that poses a significant risk of sudden
incapacitation, or is taking a medication that poses a significant risk
of impairment. The Coast Guard received 37 comment letters in response.
General Comments
Ten comment letters provided a general opinion of the draft Manual,
with the majority expressing an overall positive opinion. These
commenters found the guidance in the Manual to be thorough,
straightforward and easy to use, and they found that it answered many
questions that had arisen with previous medical policy documents. The
favorable commenters appreciated that the document provides medical
evaluators, mariners and medical providers with needed and relevant
information that will reduce the need for ``back and forth'' between
the mariner and the National Maritime Center. They also found it
helpful that the Manual outlines the Coast Guard's general concerns
with particular medical conditions and discusses the general factors
that the Coast Guard will use to evaluate the medical condition and
make a fitness determination. Comments provided by the National
Transportation Safety Board (NTSB) found that the draft Medical Manual
aptly streamlines the medical certification guidance and provides a
level of detail that should assist medical personnel during the mariner
medical certification exams. The NTSB comment letter also provided the
following observations:
The combination of the Coast Guard's increased oversight of
medical certification and development of medical guidance appears to
be highly effective at addressing safety concerns regarding medical
conditions that pose a significant risk of sudden incapacitation.
Since 2009, the NTSB has not found any medical conditions to have
contributed to the probable cause of a marine accident. However, the
NTSB continues to find effects from impairing substances (alcohol
and over-the-counter, prescription, or illicit drugs) to have
contributed to the probable cause across all modes of
transportation.
One comment letter expressed a generally negative opinion of the
draft Medical Manual. This commenter expressed concerns that the
guidance in the Medical Manual would sacrifice maritime safety unless
the Coast Guard provided further clarification and a plan for
implementation. Additionally, the commenter opined that the guidance
does not adequately ensure that medical conditions are sufficiently
controlled for those mariners at higher risk, because the Medical
Manual does not establish clear standards for specific medical
conditions. The Coast Guard does strive to increase clarity with
publication of the Medical Manual, however, the Coast Guard disagrees
that improved clarity requires publication of an implementation plan.
Discussion of the Coast Guard's internal implementation plans are
beyond the scope of the Medical Manual. Moreover, the majority of the
policy contained in the mariner medical manual is not new guidance. It
is the same guidance, explained in greater detail, that was already
implemented in the years following the
[[Page 47143]]
publication of NVIC 04-08. The Coast Guard also disagrees with the
assertion that the Medical Manual should establish condition-specific
medical standards. The medical and physical standards for merchant
mariner medical certification have already been established in 46 CFR
part 10, subpart C. Establishing new medical standards is beyond the
scope of a policy document.
Ease of Use and Clarity
A letter from another commenter requested that the Coast Guard add
an appendix that puts common conditions in a table format for quick
reference, similar to that used in the International Maritime
Organization's (IMO) Guidelines on the Medical Examination of
Seafarers. The Coast Guard disagrees on the basis that a quick
reference table would not adequately capture the discussion,
explanation and rationale that mariners, treating providers and medical
examiners need to understand in order to provide quality examinations
to the Coast Guard.
Requirements for Medical Certification
Three comment letters recommended that the Medical Manual provide
additional medical requirements for medical certification. One letter
commented that the Medical Manual should require all mariners to meet
the same medical standard, and should provide ``specific acceptable
parameters'' for many conditions to include BMI, pulmonary function,
glucose levels, blood pressure, and cardiac function. Another comment
letter suggested that the Coast Guard should implement a random medical
testing program, similar to that used for drug testing. The third
comment letter stated that the physical ability requirements should
also include criteria for the speed and facility with which a mariner
performs required tasks. The Coast Guard disagrees with these comments.
While some of the recommendations pertaining to medical standards may
warrant future discussion, changes or additions to the medical and
physical requirements for medical certification are beyond the scope of
this document. As discussed earlier, the medical and physical standards
for medical certification are provided in 46 CFR part 10, subpart C,
and changes to those requirements would require a rulemaking.
Guidance on the Conduct of the General Medical Examination
One comment letter addressed the guidance pertaining to the general
medical examination and recommended that the mariner medical
examination include an evaluation of the mariner's oral/dental health
condition to ensure that there are no untreated infections or other
dental problems that could cause significant impairment while at sea.
The Coast Guard agrees that such guidance may prove helpful and will
work with MEDMAC to consider whether and what type of guidance would be
appropriate for inclusion in a future version of the Medical Manual.
Frequency of Required Medical Examinations
Four comments letters addressed the frequency of required medical
examinations. Three commenters opined that it is excessive to require
mariners to undergo a medical examination every two years. They
recommended that the medical examination for all mariners, including
those sailing under the authority of their Standards of Training,
Certification, and Watchkeeping (STCW) endorsement, should remain valid
for a period of 5 years, unless the mariner's medical condition
warrants issuance of a shorter-duration medical certificate. A
different commenter requested clarity on how often a mariner is
required to obtain a medical exam, noting that in some instances
maritime employers require an annual medical examination, even when the
Coast Guard does not.
The Merchant Mariner Medical Manual provides detailed discussion of
medical examination and medical certification requirements for specific
endorsements, and cites the corresponding regulatory references. It is
important to note that the medical certificate validity period and the
frequency of required medical examinations may differ between
endorsements because of the differing legal requirements. Since these
requirements are established in regulation, changing them would require
a rulemaking and is beyond the scope of this policy document. The
medical examination requirements of individual employers are also
outside the scope of this policy document.
Medical Exam Forms
One comment letter requested that the Medical Manual provide a list
of medical examination forms that would be acceptable in place of the
Form CG-719K or KE. The Coast Guard disagrees and did not provide a
list of alternative forms because 46 CFR 10.302(a) requires the
following: ``to qualify for a medical certificate, a mariner must
provide evidence of meeting the medical and physical standards . . . on
a CG-719-K or CG-719-K/E, as appropriate.''
Medical Examiners
Ten comment letters provided comments on the topic of medical
examiners. Three commenters requested additional information on the
Designated Medical Examiner (DME) program, with one requesting that the
Coast Guard publish its timeline and intent to create the DME program.
The Coast Guard understands that there is significant interest in the
DME program and will publish additional information, as and when
appropriate.
Five commenters recommended changes to the regulations regarding
individuals who may perform examinations for purposes of the mariner
medical certification examination. The Coast Guard considered each of
these recommendations, but noted that changes to the regulations are
beyond the scope of this policy document.
Internal National Maritime Center Processes
Two comment letters requested that the Manual provide more detail
on internal National Maritime Center (NMC) processes. One of these
comments expressed concern that the Manual's instructions would allow
non-medical personnel to make medical determinations for U.S.
mariners.'' This commenter recommended that the Coast Guard add
language to specify that all medical certification decisions will be
supervised by a licensed medical officer. The second comment noted that
the Manual does not contain ``any reassurance or check and balance of
examiners, examination quality, or the NMC medical certification
process.'' This commenter requested that the Coast Guard add language
to address these concerns. The Coast Guard considered both of the
comments, but does not concur with them. The staffing and internal
quality assurance practices of the NMC are beyond the scope of this
document. Nonetheless, the Coast Guard affirms that the activities of
the NMC Medical Evaluations Division, particularly those related to
medical certification, are supervised by a licensed medical officer. On
the issue of providing quality assurance for medical examiners, it is
important to recognize that medical examiners are not regulated by the
Coast Guard. Therefore, providing reassurance or checks and balances of
examiners and their exam quality, is inappropriate and is beyond the
scope of this document.
Positive Drug Tests
Two comment letters complained that the Manual does not provide
guidance
[[Page 47144]]
for the evaluation of mariners who test positive for illegal drug use.
One also requested that the Coast Guard add language to the Medical
Manual requiring medical treatment for any mariner who fails a USCG
required drug test. The Coast Guard does not concur with these
commenters. The Medical Manual does not address requirements related to
positive drug tests because the regulations and guidance on the
management and disposition of individuals who have a positive drug test
are contained in 46 CFR parts 5, 10, and 16. Changes to the DOT and
Coast Guard drug testing regulation and policy are beyond the scope of
this policy document. The Medical Manual contains guidance on how the
Coast Guard will conduct the medical certification evaluation for
individuals who have been diagnosed with a substance abuse disorder.
The Medical Manual does not, however, direct treatment nor provide
diagnostic instruction, because such areas are beyond the scope this
policy document.
Reporting Material Changes in Medical Condition for Mariners
One commenter asked whether a mariner who holds a medical waiver is
required to report a material change in their medical condition. The
Coast Guard notes that the answer to this question will depend on the
provisions outlined in the mariner's medical waiver letter. Some waiver
letters require that the mariner report changes in medical condition to
the Coast Guard within a specified period of time. If no such provision
is provided in the mariner's waiver letter, then the mariner is not
required to disclose the change in medical condition until the time of
the next medical certificate application.
Three commenters asked whether employers have an obligation to
report to the Coast Guard information regarding a change in condition.
One of these same commenters also asked how employees could protect
themselves from inaccurate reports. The Coast Guard considered each of
these comments and advises that this manual does not impose any new
reporting requirements on anyone. In response to the concerns about how
mariners will be able to protect themselves from inaccurate reports,
the Coast Guard offers that the Merchant Mariner Medical Manual only
proposes to take action on medical information that the Coast Guard has
determined as credible. The information that the Coast Guard would deem
credible differs depending upon the circumstances, but generally will
include medical provider documentation, formal incident reports,
emergency medical services reports, and investigative reports. The
Coast Guard also asserts that mariners will be able to protect
themselves from inaccurate reports because this manual provides a
standard process for evaluating these reports and further provides
mariners with notice of, and the opportunity to respond to, information
that indicates that they are no longer fit for medical certification.
Medications
Two comment letters noticed discrepancies in the language in
Chapter 7 related to required disclosures of over-the-counter (OTC)
medications. One of the commenters also observed that the guidance in
the Manual highlighted an error on the most recent version of the
Application for Medical Certificate (Form CG-719K, Rev 04/17, Exp. Date
03/31/2021) which incorrectly states that applicants must disclose all
OTC medications taken within 30 days prior to the date the applicant
signs the CG-719K. Both commenters noted that prior versions of the CG-
719K and the Medical Manual only instructed mariners to disclose OTC
medications if the medications were used for a period of 30 days or
more within the 90 days prior to the date the applicant signs the
application to the Coast Guard. They requested that the Coast Guard
provide additional language in the Medical Manual to clarify that
applicants need only disclose OTC medications, when such medications
were used for a period of 30 days or more within the 90 days prior to
the date the applicant signs the application to the Coast Guard. The
Coast Guard agrees that the language change regarding OTC medication
disclosures on the most recent version of the CG-719K was an
inadvertent change, and language was added to Chapter 7 of the Medical
Manual to clarify the reporting requirements for OTC medications. The
Coast Guard will be pursuing a change to CG-719K in the future to
correct this change.
Attendant with the language change regarding OTC medications, the
Coast Guard also considered the NTSB's comments about impairing
medication effects that have contributed to the probable cause of
accidents across all modes of transportation. In light of these
concerns, the Coast Guard determined that it would be prudent to add
additional guidance regarding OTC medications to the Important Safety
Warnings paragraph of Chapter 7. Specifically, the additional guidance
warns that some OTC medications and preparations may contain
intoxicants or other dangerous drugs prohibited by Department of
Transportation regulations.
NMC Medical Evaluation Procedures for Mariners With Existing Waivers
One commenter expressed confusion over the discussion of the term
clear error in Paragraph I.3. of Chapter 3 of the Medical Manual.
Paragraph I discusses NMC medical evaluation procedures for mariners
with existing waivers, and Paragraph I.3. states that the Coast Guard
is not bound to honor a medical waiver that was issued in clear error,
contrary to duly promulgated policy in effect at time of issuance. The
commenter mistakenly interpreted the clear error discussion to mean
that the Coast Guard would not take responsibility for any erroneous
certification decisions that might lead to mishaps or untoward medical
situations at sea. In order to clear up this area of confusion, the
Coast Guard added language to Paragraph I.3. of Chapter 3, to clarify
that the discussion of clear error pertains to medical waivers that
were issued in error.
Alternative Testing Methodologies for Color Vision
One comment letter asserted that the discussion of alternative
testing methodologies for demonstrating satisfactory color vision
contained Paragraph A.1.d.(2)(c) contains an error because it indicates
that the Farnsworth D-15 may be used as a potential alternative color
vision test for Deck personnel. The Coast Guard disagrees. Title 46 CFR
10.305(a) provides that mariners must demonstrate satisfactory color
sense through one of the tests listed in the regulation, or through an
alternative test acceptable to the Coast Guard. Paragraph A.1.d.(2) of
the Medical Manual provides guidance for mariner applicants seeking to
demonstrate satisfactory color vision sense through use of an
alternative test, and describes the type of information that the Coast
Guard will consider in determining whether an alternative test is
sufficient for issuance of the medical certificate. The guidance does
not guarantee that any singular test will be accepted as an alternative
methodology for any particular mariner applicant, but rather states
that the Coast Guard retains final authority for determining whether
the testing is acceptable, and recommends that any alternative test be
accompanied by a formal color vision evaluation from an ophthalmologist
or optometrist.
[[Page 47145]]
Coast Guard Mission and Motives With Respect to Medical Credentialing
One commenter asserted that the Coast Guard should ``consider its
mission and motives with respect to medical credentialing,'' and
expressed displeasure that the Medical Manual focuses on ``medical
credentialing without making any decisions on mariner fitness for
duty.'' The Coast Guard considered this commenter's concerns and noted
that the Medical Manual's purpose, as stated in Paragraph 1 of the
Letter of Promulgation for the Merchant Mariner Medical Manual, is to
``provide guidance for evaluating the physical and medical condition of
applicants for merchant mariner medical certificates.'' The Coast Guard
also notes that making a determination of fitness for certification is
distinctly different from making a determination of fitness for duty,
and refers the reader to the discussion that follows.
Fitness-for-certification. The medical and physical standards for
merchant mariner medical certification are contained in 46 CFR part 10,
subpart C. The Coast Guard mariner medical evaluation and certification
process seeks to determine whether an applicant meets the medical and
physical standards for merchant mariners based upon the information
available to the Coast Guard at the time of the certification decision.
In accordance with 46 CFR 10.301, the Coast Guard will issue a medical
certificate to a mariner meeting the medical and physical standards for
merchant mariners. This decision is necessarily a snapshot of the
mariner's medical and physical condition at a single point in time.
Fitness-for-duty. In general, fitness for duty refers to an
employee's ability to perform his/her essential job functions, as
specified by the employer, without impairment from medical conditions
or medications. There are some important considerations with respect to
fitness for duty. First, an individual's fitness-for-duty status is not
static, thus it should be considered whenever an individual reports for
duty. Fitness-for-duty status can change suddenly due to an acute
illness, injury or incident. As an example, an individual with no
medical problems who has been issued a medical certificate and who
normally performs their essential job functions without impairment,
could become ``not-fit-for duty'' because of an impairing illness such
as the flu, and/or due to impairing medications used to treat an acute
illness. The second important consideration is that a ``fitness-for
duty'' determination refers to an evaluation ordered by an employer to
assess an employee's ability to perform the essential functions of
their assigned job (as specified by the employer). Such an evaluation
might be requested when the employer has a reasonable belief that an
employee will not be able to perform essential job functions because of
their medical condition. A variety of state and Federal laws govern
fitness for duty determinations depending upon the specific
circumstances. Generally, a fitness for duty physical must be job-
related and consistent with business necessity. One other important
consideration is that the merchant mariner medical qualification
standards in part 10, subpart C, are the minimum acceptable standards.
Some maritime employers may choose to establish medical and/or physical
ability requirements for their employees that are more stringent than
the Coast Guard medical certification standards based on factors such
as specific duty requirements, austere work environments, and
operational tempo. In these cases, the employer's fitness-for-duty
determinations may differ from the medical certification determination
because they are based upon different standards. The Merchant Mariner
Medical Manual does not preclude marine employers from establishing
more rigorous medical or physical ability guidelines; however, there
are additional laws and regulations that apply.
Line-by-Line List of Changes
Two commenters requested a detailed, line-by-line list of proposed
changes that compares the current language in NVIC 04-08 with each
change, addition and deletion made in the Medical Manual. The Coast
Guard considered this comment, but determined that a line-by-line list
of changes would not be helpful because of the extensive changes in
wording, format and organization between the two documents. Instead,
the Coast Guard has already provided a fairly comprehensive discussion
of the major changes in Paragraph 6 of the Letter of Promulgation for
the Medical Manual.
Medical Certificate Cancellation
Commenters were both supportive of, and objected to, the proposed
medical certificate cancellation policy. After considering the
comments, we decided to proceed with the proposed policy. One commenter
who opposed the policy nevertheless provided a number of suggested
edits to the text which were adopted. Those opposed to the cancellation
policy suggested the Suspension and Revocation (S&R) process (46 CFR
part 5) as an alternative. The Suspension and Revocation (S&R) process
has limited jurisdiction over mariner medical issues. On this subject,
S&R is authorized in circumstances where a credentialed mariner has
committed an act of incompetence relating to the operation of a vessel
(see 46 U.S.C. 7703(4)). A mariner having a disqualifying medical
condition is not something addressed through S&R unless and until it
has impacted vessel operation. Accordingly, the medical certificate
cancellation and waiver processes set forth in the manual effectively
address mariner medical qualification and fitness for duty concerns in
ways that the S&R system cannot. There are also situations such as
mariners using dangerous drugs or operating vessels under the influence
of alcohol or other intoxicants that present both medical qualification
and S&R concerns, so it may be appropriate for the Coast Guard to
utilize both the procedures set forth in this manual and the S&R
process to address and resolve these issues in the interest of safety.
Waivers, Limitations, Restrictions
One commenter requested more detail on limitations and
restrictions. The commenter noted that waivers seem not to have been
consistently applied to conditions. The Coast Guard agrees in part and
over the last few years has provided further guidance on waivers for
the most frequently occurring conditions. Those changes to NVIC 04-08
have been carried forward into this manual.
Process for Removing Waivers, Limitations and Restrictions
One commenter complained that the process for removing restrictions
and waivers ``seems uncomfortably weighted toward taking away one's
ability to sail, without considering that many conditions--even very
serious ones--are temporary in nature.'' The Coast Guard disagrees and
notes that the Medical Manual provides specific guidance on medical
evaluation procedures for mariners with short-term conditions (see
paragraph J. of Chapter 3 of the Medical Manual). These provisions were
included to reduce the burden of imposing and then removing waivers and
restrictions for conditions that are expected to resolve in the short-
term.
This document is issued under the authority of 5 U.S.C. 552(a), 46
U.S.C. 7101, and 46 U.S.C. 7302.
[[Page 47146]]
Dated: September 3, 2019.
J. G. Lantz,
Director, Commercial Regulations and Standards, U.S. Coast Guard.
[FR Doc. 2019-19370 Filed 9-6-19; 8:45 am]
BILLING CODE 9110-04-P