Change-1 to Navigation and Inspection Circular 04-08, 58328-58332 [2013-23114]

Download as PDF 58328 Federal Register / Vol. 78, No. 184 / Monday, September 23, 2013 / Notices in OMB’s receipt and processing of mail sent through the U.S. Postal Service, commenters are encouraged to submit their comments to OMB via email to: OIRA_Submission@omb.eop.gov. Although commenters are encouraged to send their comments via email, commenters may also fax their comments to: 202–395–7285. Commenters may also mail them to: Office of Management and Budget, Office of Information and Regulatory Affairs, New Executive Office Building, Room 10102, Washington, DC 20503. of Commercial Vessel Compliance (CG– CVC), 202–372–1128, email MMCPolicy@uscg.mil. 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 DEPARTMENT OF HOMELAND SECURITY 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)). Coast Guard Anti-Tachycardia Devices and Implantable Cardioverter Defibrillators Summer King, Statistician. [FR Doc. 2013–22958 Filed 9–20–13; 8:45 am] BILLING CODE 4162–20–P [Docket No. USCG–2013–0499] Change-1 to Navigation and Inspection Circular 04–08 Coast Guard, DHS. Notice of availability. AGENCY: ACTION: 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 emcdonald on DSK67QTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 20:16 Sep 20, 2013 Jkt 229001 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 antitachycardia 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 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 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; (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 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%. E:\FR\FM\23SEN1.SGM 23SEN1 Federal Register / Vol. 78, No. 184 / Monday, September 23, 2013 / Notices Bruce Protocol) 2 is greater than or equal to 8 metabolic equivalents (METs); 3 (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. emcdonald on DSK67QTVN1PROD with NOTICES 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 antitachycardia 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 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. VerDate Mar<15>2010 20:16 Sep 20, 2013 Jkt 229001 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 antitachycardia 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-bycase 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 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 58329 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, antitachycardia 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 E:\FR\FM\23SEN1.SGM 23SEN1 emcdonald on DSK67QTVN1PROD with NOTICES 58330 Federal Register / Vol. 78, No. 184 / Monday, September 23, 2013 / Notices 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 VerDate Mar<15>2010 20:16 Sep 20, 2013 Jkt 229001 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 Change1 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 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 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 seizurefree 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 E:\FR\FM\23SEN1.SGM 23SEN1 emcdonald on DSK67QTVN1PROD with NOTICES Federal Register / Vol. 78, No. 184 / Monday, September 23, 2013 / Notices 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 VerDate Mar<15>2010 20:16 Sep 20, 2013 Jkt 229001 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 seizurefree 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 10year 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 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 58331 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 E:\FR\FM\23SEN1.SGM 23SEN1 emcdonald on DSK67QTVN1PROD with NOTICES 58332 Federal Register / Vol. 78, No. 184 / Monday, September 23, 2013 / Notices 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 seizurefree, 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 seizurefree 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 VerDate Mar<15>2010 20:16 Sep 20, 2013 Jkt 229001 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 caseby-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 DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Docket ID FEMA–2013–0002] Changes in Flood Hazard Determinations Federal Emergency Management Agency, DHS. ACTION: Final notice. AGENCY: New or modified Base (1% annual-chance) Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, and/or the regulatory floodway (hereinafter referred to as flood hazard determinations) as shown on the indicated Letter of Map Revision (LOMR) for each of the communities listed in the table below are finalized. Each LOMR revises the Flood Insurance Rate Maps (FIRMs), and in some cases the Flood Insurance Study (FIS) reports, currently in effect for the listed SUMMARY: PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 communities. The flood hazard determinations modified by each LOMR will be used to calculate flood insurance premium rates for new buildings and their contents. DATES: The effective date for each LOMR is indicated in the table below. ADDRESSES: Each LOMR is available for inspection at both the respective Community Map Repository address listed in the table below and online through the FEMA Map Service Center at www.msc.fema.gov. FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC 20472, (202) 646–4064, or (email) Luis.Rodriguez3@fema.dhs.gov; or visit the FEMA Map Information eXchange (FMIX) online at www.floodmaps.fema.gov/fhm/fmx_ main.html. SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency (FEMA) makes the final flood hazard determinations as shown in the LOMRs for each community listed in the table below. Notice of these modified flood hazard determinations has been published in newspapers of local circulation and ninety (90) days have elapsed since that publication. The Deputy Associate Administrator for Mitigation has resolved any appeals resulting from this notification. The modified flood hazard determinations are made pursuant to section 206 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq., and with 44 CFR part 65. For rating purposes, the currently effective community number is shown and must be used for all new policies and renewals. The new or modified flood hazard determinations are the basis for the floodplain management measures that the community is required either to adopt or to show evidence of being already in effect in order to remain qualified for participation in the National Flood Insurance Program (NFIP). These new or modified flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or E:\FR\FM\23SEN1.SGM 23SEN1

Agencies

[Federal Register Volume 78, Number 184 (Monday, September 23, 2013)]
[Notices]
[Pages 58328-58332]
From the Federal Register Online via the Government Printing 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 MMCPolicy@uscg.mil. 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;
---------------------------------------------------------------------------

    \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%.
---------------------------------------------------------------------------

    (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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    (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