[Federal Register Volume 78, Number 184 (Monday, September 23, 2013)]
[Notices]
[Pages 58328-58332]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-23114]
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DEPARTMENT OF HOMELAND SECURITY
Coast Guard
[Docket No. USCG-2013-0499]
Change-1 to Navigation and Inspection Circular 04-08
AGENCY: Coast Guard, DHS.
ACTION: Notice of availability.
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SUMMARY: The Coast Guard announces the availability of Change-1 to
Navigation and Vessel Inspection Circular 04-08, ``Medical and Physical
Evaluation Guidelines for Merchant Mariner Credentials'' (NVIC 04-08).
Change-1 to NVIC 04-08 contains a summary and clarification of Coast
Guard policies regarding the criteria for granting medical waivers to
merchant mariner credential applicants who have had either anti-
tachycardia devices or implantable cardioverter defibrillators
implanted, and to applicants who have had a seizure. This notice also
addresses comments we received in response to Coast Guard notices
published in the Federal Register on September 7, 2012, and March 25,
2013 soliciting public comments on these issues.
DATES: Change-1 to NVIC 04-08 is effective on September 23, 2013.
ADDRESSES: NVIC 04-08 is available in the docket and can be viewed by
going to http://www.regulations.gov and using ``USCG-2013-0499'' as
your search term. Locate this notice in the search results. NVIC 04-08
is available by clicking the ``Supporting Documents'' link. NVIC 04-08
is also available on the Coast Guard's Web site at: www.uscg.mil/nmc.
FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or email Lieutenant Ashley Holm, Office of Commercial Vessel
Compliance (CG-CVC), 202-372-1128, email [email protected]. If you
have questions on viewing or submitting material to the docket, call
Barbara Hairston, Program Manager, Docket Operations, telephone 202-
366-9826.
SUPPLEMENTARY INFORMATION:
I. Background and Purpose
General Waiver Criteria
Coast Guard regulations in 46 CFR 10.215 contain the medical
standards that merchant mariner applicants must meet prior to being
issued a merchant mariner credential (MMC). In cases where the
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 (see 46 CFR 10.215(g)).
Anti-Tachycardia Devices and Implantable Cardioverter Defibrillators
Coast Guard guidance in NVIC 04-08 provides that anti-tachycardia
devices and implantable cardioverter defibrillators (ICDs) are
generally not waiverable. Prior to issuing Change-1 to NVIC 04-08,
Coast Guard guidance did not identify waiver criteria associated with
anti-tachycardia devices or ICDs, rendering it difficult for Coast
Guard personnel to consistently evaluate merchant mariner applicants
with anti-tachycardia devices or ICDs, and assess whether an
applicant's medical condition warranted granting a medical waiver under
46 CFR 10.215(g). Enclosure (7) to NVIC 04-08 now provides guidelines
to use when assessing an applicant's eligibility for a waiver.
On September 7, 2012 we published a notice in the Federal Register
requesting public comments on this issue (77 FR 55174). On December 17,
2012, we re-opened and extended the public comment period for an
additional 30 days to provide additional opportunity to comment (77 FR
74630). We summarize the policy in Enclosure (7) to NVIC 04-08 and
address the public comments below.
Seizures
Coast Guard regulations in 46 CFR 10.215(d) state that a convulsive
disorder (i.e., seizure disorder) could lead to an applicant's
disqualification from receiving a credential. Prior to issuing Change-1
to NVIC 04-08, Coast Guard guidance did not identify waiver criteria
associated with applicants that had a history of seizures rendering it
difficult for Coast Guard personnel to consistently evaluate merchant
mariner applicants with seizures and assess whether an applicant's
medical condition warranted granting a medical waiver under 46 CFR
10.215(g). Enclosure (8) to NVIC 04-08 now provides guidelines to use
when assessing an applicant's eligibility for a waiver.
On March 25, 2013 we published a notice in the Federal Register
requesting public comments on this issue (78 FR 17917). We summarize
the policies in Enclosure (8) to NVIC 04-08 and address the public
comments below.
II. Discussion
ICD Policy
Prior to Change-1, NVIC 04-08 referred applicants to the Coast
Guard's National Maritime Center (NMC) for guidance on the treatment of
ICDs. ICDs were generally not waiverable. Enclosure (7) provides a list
of criteria to be considered when evaluating an application from a
mariner with an ICD. While the policy remains that ICDs are generally
not waiverable, the criteria in Enclosure (7) will identify those
limited situations where a waiver will be considered. The criteria that
must be met to be considered for a waiver are:
(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 (EF) \1\ is
greater than 35% with a steady or improving trend;
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\1\ The left ventricular ejection fraction measures the
percentage of blood that the left ventricle of the heart is able to
pump with each beat. A normal ejection fraction is greater than 50%.
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(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 perfusion imaging exercise stress testing;
(9) The applicant's exercise capacity on formal stress testing
(using standard
[[Page 58329]]
Bruce Protocol) \2\ is greater than or equal to 8 metabolic equivalents
(METs); \3\
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\2\ The Bruce protocol is a diagnostic test used in the
evaluation of cardiac function, developed by Robert A. Bruce. It is
a treadmill exercise test with set stages to ensure standardized
results. Each stage has a pre-set incline and speed. A stage is 3
minutes long.
\3\ METs are a measure of physical work or exercise capacity.
While there is no direct correlation, generally the physical ability
guidelines in Enclosure (2) to NVIC 04-08 are similar to 6 METs. 8
METs are called for in the NVIC because the higher threshold results
in better diagnostic and prognostic information. A mariner facing an
emergency situation could likely be expected to have to function at
least at 8 METs.
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(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; and
(11) The applicant does not have any other medical conditions which
may alone, or in combination with an ICD or anti-tachycardia device,
pose an unacceptable risk for sudden incapacitation.
Discussion of Public Comments on ICD Policy
On September 7, 2012 we published a notice in the Federal Register
requesting public comments on proposed ICD policy (77 FR 55174). We
received approximately 37 comments on whether to grant waivers for
anti-tachycardia devices or ICDs and the proposed criteria for such
waivers. The majority of the comments were supportive of the proposed
policy.
Many commenters referenced specific individuals that they argued
were well qualified to hold a merchant mariner credential, despite
having an ICD. Although this notice was not designed to render fitness
determinations for specific individuals, the Coast Guard acknowledges
that there may be some mariners with ICDs who warrant consideration for
a medical waiver. The new policy clarification seeks to identify those
limited situations where a waiver will be considered.
Several commenters felt that a requirement for applicants to reach
10 metabolic equivalents (METs) on a stress test using the standard
Bruce Protocol was excessive. Instead, these commenters favored a
standard of 8 METs, similar to the standard for other cardiac
conditions addressed in NVIC 04-08. The Coast Guard proposed use of the
10 METs standard because it provides additional prognostic information
over the 8 MET standard. Following review of the public comments,
however, the Coast Guard considered that, when combined with the
stringency of all of the criteria required by the policy, the 8 METs
standard provides sufficient prognostic information for evaluation. The
Coast Guard, therefore, agrees with these commenters, and Change-1
incorporates 8 METs as the relevant standard.
Many commenters agreed with establishing waiver criteria, but they
suggested that some of the proposed criteria were too restrictive (3
year exclusionary period, 10 METs, EF >40%, etc.). Several commenters
expressed concern that the proposed checklist format was somewhat
rigid, and that it over-simplified the process to a ``go/no-go''
decision that would not allow all factors to be considered. In response
to these comments, we have determined that a relatively stringent set
of criteria with respect to anti-tachycardia devices and ICDs is
necessary because an underlying medical condition that warrants
treatment with an ICD generally poses an unacceptable risk for sudden
incapacitation. We developed the guidelines in Enclosure (7) to NVIC
04-08 for evaluating whether the underlying condition has improved
significantly, and to help determine whether it no longer poses an
inordinate risk. This allows for a margin of safety for individuals
with ICDs who are seeking to work in a safety-sensitive position. The
policy allows for an individual assessment, and, under exceptional
circumstances, applicants who do not meet all of the criteria may be
eligible for a waiver if they can demonstrate to the satisfaction of
the Coast Guard that there is not an inordinate risk. We will continue
to assess whether this policy strikes the proper balance between public
safety and an individual's interest in holding a merchant mariner
credential.
Many commenters favored a case-by-case or individualized assessment
of the applicant's condition; as opposed to a blanket denial for all
applicants with ICDs. We note that even prior to Change-1, NVIC 04-08
has included a case-by-case evaluation of the applicant's condition. We
developed the criteria in Enclosure (7) to NVIC 04-08 in order to
provide a framework for those evaluations.
Some commenters favored offering credential limitations, instead of
denial, if the condition still posed some risk. We note that applicants
who do not meet all of the outlined criteria in Enclosure (7) to NVIC
04-08 may be considered for a waiver if the Coast Guard is satisfied
that the risk can be reduced to an acceptable level. This may require
limiting the scope of the applicant's credential to enforce certain
working conditions that may reduce the risk of sudden incapacitation.
When circumstances warrant, the Coast Guard will work with individual
applicants to tailor restrictions and limitations appropriate to
individual situations.
Many commenters felt that a cardiologist's assessment should be
sufficient for determining whether the applicant's medical condition is
safe enough to warrant granting a waiver. The Coast Guard disagrees.
The Coast Guard wishes to emphasize that mariner credentials often
enable individuals to work in safety-sensitive positions aboard
vessels, which amplifies the risks and potential consequences of a
condition requiring use of an ICD or anti-tachycardia device.
Accordingly, the Coast Guard has determined that a mariner's self-
evaluation, or even the evaluation of a physician, is not sufficient
evidence that the ICD, anti-tachycardia device, or underlying condition
pose no inordinate risk. While the Coast Guard gives the treating
physician's evaluation great weight, it is not the sole factor to
consider. Because the mariner's safety and public safety are at stake,
the Coast Guard has determined it must also consider the objective
criteria outlined in Enclosure 7 to NVIC 04-08 in making the final
decision of whether to grant a mariner's credential.
Many commenters pointed out the risks to maritime safety posed by
prohibiting service as a mariner solely on the basis of the mode of
treatment (e.g., ICDs). These commenters felt that such a prohibition
would lead mariners to choose to forego medical treatment out of fear
of losing their jobs. This would pose a significant risk to both the
mariner and the public. Several commenters stated that a mariner with a
known, closely-managed medical condition and an ICD, is far safer for
the public and maritime industry than a mariner not seeking care, with
undiagnosed medical conditions. The Coast Guard shares these concerns,
and we crafted Enclosure (7) to NVIC 04-08 to focus more on the
underlying condition rather than the mere presence of an ICD.
We received 6 comments from people who identified themselves as
physicians or representatives of a physician group. Two of these
commenters opposed allowing waivers for mariners with ICDs, arguing
that the ICD itself presents an inordinate risk, and that the
underlying condition would pose an inordinate risk. The Coast Guard
disagrees. While acknowledging that there may be some cases where the
ICD
[[Page 58330]]
and the underlying condition pose an inordinate risk of sudden
incapacitation, the Coast Guard has not found this to be true for all
individuals. For these reasons, the Coast Guard disagrees with imposing
a blanket exclusion of waivers for all individuals with ICDs. This
policy allows for an individualized assessment of the mariner. The
criteria outlined in Enclosure (7) to NVIC 04-08 are designed to
distinguish those individuals whose underlying conditions have
substantially improved and no longer pose an unacceptable risk of
sudden incapacitation. Individuals with ICDs who meet the stringent
criteria outlined in this policy, are at low enough risk to warrant
consideration for a medical waiver, and a blanket exclusion would
unnecessarily put mariners out of work.
One of these commenters expressed the concern that an inappropriate
ICD discharge might result in sudden incapacitation. The Coast Guard
recognizes this concern, but found other comments to be more
persuasive. Specifically, cardiology experts commented on the low risk
of inappropriate ICD discharge in this carefully selected population,
and the ability to further mitigate such risk with selective device
programming. Furthermore, these experts pointed out that with modern
ICDs, the likelihood of an inappropriate ICD shock causing a sudden
incapacitation is extremely small, and the benefits of having an ICD
would outweigh any risk posed by the ICD in this setting.
Three of the other four physicians/physician groups agreed with
establishing waiver criteria, but felt the proposed criteria were too
restrictive (3 year exclusionary period, EF of 40%, 10 METs). The Coast
Guard agrees in part. As noted above, we recognize that these criteria
are strict, but necessary to demonstrate that individuals are at low
enough risk to warrant consideration for a medical waiver. As discussed
above, mariner credentials often enable individuals to work in safety-
sensitive positions aboard vessels, which amplifies the risks and
potential consequences of a condition requiring use of an ICD or anti-
tachycardia device. Accordingly, the policy only grants waivers in
those instances where the mariner's underlying condition has improved
significantly such that it no longer poses an unacceptable risk of
sudden incapacitation. Because the mariner's safety and public safety
are at stake, the Coast Guard has chosen to maintain fairly stringent,
objective criteria (to include requiring three years of clinical
stability, recovery of the left ventricular ejection fraction and
normal exercise capacity) in making the final decision on whether to
grant a mariner's credential. As noted above, though, the Coast Guard
concedes that the ability to attain 8 METs of exercise capacity, and an
EF of 35%, along with meeting all of the other criteria outlined in the
policy, is sufficient to demonstrate low enough risk to warrant
consideration for a medical waiver. Additionally, under exceptional
circumstances, the policy allows for applicants who do not meet all of
the criteria to be considered for a waiver if the risk of sudden
incapacitation may be reduced.
Seizure Policy
Generally, the final policy in Change-1 to NVIC 04-08 distinguishes
between provoked and unprovoked seizures. A summary of the waiver
criteria for both types of seizures is provided below.
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 as follows:
(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 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.
(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, off AEDs; and
(a) If all medication has been stopped, the mariner must have been
seizure-free for a minimum of four years since cessation of medication;
or
(b) If still requiring treatment with AEDs, the mariner's condition
will be considered under the criteria for epilepsy listed above in (1)
(i.e., the mariner may be considered for a waiver after they have been
seizure-free for a minimum of 8 years, and on a stable medication
regimen for a minimum of two years).
Provoked seizures are those seizures precipitated by an
identifiable trigger. (This does not include epileptic seizures or
seizures brought on by lack of sleep, stress, or photo-stimulation.
Seizures of this nature will be evaluated under the criteria for
unprovoked seizures listed above). Mariners with provoked seizures 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 medication 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;
(e) Severe dehydration;
(f) Hyperthermia; or
(g) Drug reaction or withdrawal.
(3) 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 medication has 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.
(4) 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.
(5) Under exceptional circumstances in which a mariner has had
provoked seizures due to a benign brain lesion that has subsequently
been removed, such 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.
Public Comments on Seizure Policy
On March 25, 2013 we published a notice in the Federal Register
[[Page 58331]]
requesting public comments on proposed policy regarding waivers for
mariners with seizure disorders (78 FR 17917). We received 7 comments
on the proposed policy for granting waivers for mariners with seizure
disorders. The majority of commenters supported the proposed policy.
One commenter agreed with the proposed policy, noting that the
criteria are strict, but appropriate when considered in light of the
risks associated with a mariner having a seizure while in a safety-
sensitive position aboard a ship.
Another commenter questioned whether it was appropriate for the
Coast Guard to consider the guidelines and recommendations of the
Federal Motor Carrier Safety Administration (FMCSA) Medical Review
Board (MRB) and FMCSA's Medical Expert Panel regarding seizure
disorders in automobile drivers when developing similar Coast Guard
policy for mariners (see 78 FR 17918). The commenter suggested that
mariners may need to undergo stricter evaluations than automobile
drivers, such as evaluation by immersion in sea simulation and video
electronystagmography to study their vestibular systems. The Coast
Guard agrees that there may be special situations where certain
mariners may require more extensive evaluation. NVIC 04-08 reflects
that approach by giving the Coast Guard discretion to apply stricter
standards on a case-by-case basis as needed. The Coast Guard disagrees
that sea simulation and electronystagmography testing should be a
blanket requirement for all mariners with seizure disorders. Neither
the commenter nor the relevant medical literature provided acompelling
rationale to justify such comprehensive vestibular testing for every
mariner with a seizure disorder. Accordingly, the Coast Guard will
determine whether an individual mariner requires extensive vestibular
evaluation on a case-by-case basis, in consultation with the mariner's
treating neurologist.
One commenter generally disagreed with the proposed policy, arguing
that it was too strict. This commenter felt that it should be
sufficient for mariners to demonstrate that their condition is under
control and they are under the care of a doctor. The Coast Guard
disagrees. As discussed above, mariner credentials often enable
individuals to work in safety-sensitive positions aboard vessels, which
amplifies the risks and potential consequences of a seizure disorder.
Accordingly, the Coast Guard has determined that a mariner's self-
evaluation, or even the evaluation of a physician, is not sufficient
evidence that a seizure disorder poses no inordinate risk. While the
Coast Guard gives the treating physician's evaluation great weight, it
is not the sole factor to consider. Because the mariner's safety and
public safety are at stake, the Coast Guard has determined it must also
consider the objective criteria described above in making the final
decision of whether to grant a mariner's credential.
Notably, the Epilepsy Foundation provided comments in support of
the proposed policy. The Epilepsy Foundation identifies itself as the
leading voluntary health agency working on behalf of people with
epilepsy. The Epilepsy Foundation applauded the Coast Guard's efforts
to develop a policy that recognizes the potential for mariners with
seizure disorders to work, while allowing for a case-by-case evaluation
of the applicant's fitness. The Epilepsy Foundation also noted that
epilepsy is a highly variable disorder, with varying levels of seizure
control in different individuals. The Epilepsy Foundation pointed out
that this variability makes it difficult to generalize about safety
concerns and makes it inappropriate to enact blanket exclusionary rules
and qualification standards that bar individuals with epilepsy. The
Coast Guard agrees. Our policy has always included an individualized
evaluation of the mariner's condition to determine fitness. We
developed the criteria outlined in this policy to provide a framework
within which to make these evaluations and to provide a margin of
safety for individuals with seizure disorders who are seeking to work
in a safety-sensitive position.
We also received 3 comments from individuals who self-identified as
physicians or representatives of physician groups. All agreed with the
decision to grant waivers for individuals with seizure disorders. One
physician argued that the criteria are too restrictive because the
required seizure-free time intervals are too long. The Coast Guard
agrees that the criteria are stringent, but believes they are necessary
to ensure the mariner's safety and public safety.
One of the physicians contended that the criteria are not strict
enough. This physician expressed support for a 10-year seizure free
time period for seizures, similar to that recommended for commercial
drivers by the FMCSA's MRB. The Coast Guard disagrees. The aim of this
policy is to distinguish those individuals who are no longer at
inordinate risk of seizure recurrence. As part of the background
research for determining a reasonable seizure-free time interval, the
Coast Guard considered the recommendations of the FMCSA's MRB, which
uses a 10-year seizure-free requirement, as well as the recommendations
of the FMCSA's 2007 Neurology Medical Expert Panel (MEP). The 2007
Neurology MEP asserted that individuals with certain types of seizures
would be at low risk of seizure recurrence after 8 years or 4 years
seizure-free. The Coast Guard found the recommendations of the 2007
MEP, which were based upon contemporary medical literature and
research, to be more persuasive than the suggestion advocated by this
commenter or the position of the FMCSA MRB. The 4-year and 8-year
seizure-free time intervals allow sufficient time for individuals to
demonstrate clinical stability and to distinguish those who are at
lowest risk of seizure recurrence. Additionally, the Coast Guard notes
that the FMCSA has recently announced its decision to utilize the
recommendations of its 2007 MEP as the basis for evaluating commercial
drivers with epilepsy. Those recommendations are similar to the
criteria outlined in the Coast Guard's policy.
The third physician group, the American Epilepsy Society (AES),
agreed with the policy as proposed. The AES acknowledged that the
criteria strict, but agreed that such criteria are necessary to address
public safety concerns. The Coast Guard agrees and will continue to
assess whether this policy strikes the proper balance between public
safety and an individual's interest in holding a merchant mariner
credential.
The AES, the Epilepsy Foundation, and one self-identified physician
also provided responses to the seven questions that the Coast Guard
posed in the March 25, 2013 Federal Register notice as follows:
(1) On the question of whether or not there is evidence that
chronic use of anti-epileptic drugs (AEDs) impairs judgment and
reaction time, both AES and the Epilepsy Foundation stated that AEDs
used in appropriate dosages do not affect these functions or result in
cumulative impairment. The other commenter noted that all AEDs have the
potential to impair judgment, mood and motor skills, but recommended
that this be considered on an individual basis, instead of drawing a
blanket conclusion. The Coast Guard agrees. The policy does not impose
a blanket disqualification for use of AEDs; instead it allows the Coast
Guard to consider the treating neurologist's assessment of medication
impairment when making a final determination.
(2) All three of these commenters stated that there is no evidence
that
[[Page 58332]]
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. The Coast
Guard agrees. The policy allows for those individuals with seizure
disorders who require treatment with AEDS to be considered for waivers,
similar to those who do not require treatment with AEDs.
(3) On the question of risk of seizure recurrence as a function of
time since the last seizure among individuals on AEDs who are
apparently seizure-free, AES and the Epilepsy Foundation advised that
the risk of recurrent seizures decreases with time seizure-free, on or
off AED medications. The other commenter opined that the risk of
seizure recurrence in this setting was uncertain and dependent upon too
many variables. The Coast Guard agrees with both answers. Because the
risk of seizure recurrence decreases with time seizure-free, the policy
requires a minimum seizure-free time interval before an affected
individual can be considered for a waiver. Additionally, in
acknowledgement of the many variables that might affect likelihood of
seizure recurrence in a particular individual, the policy allows for an
individualized assessment and considers the risk evaluation of the
treating neurologist.
(4) On the question of the likelihood of seizure recurrence as a
function of time in individuals who are seizure-free following removal
of a benign brain tumor, none of the commenters gave a specific answer.
AES and the Epilepsy Foundation advised, however, that such a situation
was already accounted for in the policy. The other commenter asserted
that the answer was too variable to generalize. The Coast Guard agrees.
The policy specifies a minimum seizure-free time interval for such
individuals, but also allows for an individualized assessment.
(5)-(6) Questions five and six asked about the need and
appropriateness of applying operational limitations and/or restrictions
for mariners with seizure disorders. Both AES and the Epilepsy
Foundation pointed out that the seizure-free time requirements outlined
in the policy are conservative enough that if exceeded, there should be
no need to differentiate between roles. However, they did recommend
that less restrictive criteria be applied to individuals who do not
operate dangerous machinery, work over 10 feet above ground, pilot a
vessel, or stand watch alone. For these individuals, they recommended
consideration for specific jobs if they have been seizure free for one
year and on stable medications for one year. The other commenter
advised that use of operational restrictions and limitations may be
reasonable depending on the individual's job function and
circumstances. The Coast Guard agrees and will consider applying
operational limitations and/or restrictions on a case-by-case basis,
when appropriate.
(7) Question seven asked if there are individuals with seizure
disorders due to a structural brain lesion that are at low-risk for
seizure recurrence. Both AES and the Epilepsy foundation noted that
individuals with structural brain lesions are at higher risk, as
reflected in the longer restriction times outlined in the policy. The
other commenter noted that the answer would depend on the definition of
structural brain lesion. The Coast Guard agrees. The policy outlines a
minimum seizure-free time interval for such cases, while allowing for
an individualized assessment and consideration of exceptional
circumstances.
III. 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: August 28, 2013.
J.C. Burton,
Captain, U.S. Coast Guard, Director of Inspections & Compliance.
[FR Doc. 2013-23114 Filed 9-20-13; 8:45 am]
BILLING CODE 9110-04-P