COMDTINST M16721.48 Merchant Mariner Medical Manual, 47141-47146 [2019-19370]

Download as PDF 47141 Federal Register / Vol. 84, No. 174 / Monday, September 9, 2019 / Rules and Regulations under FFDCA section 408(d), such as the exemptions in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply. This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled ‘‘Federalism’’ (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled ‘‘Consultation and Coordination with Indian Tribal Governments’’ (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note). VIII. Congressional Review Act Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: August 21, 2019. Donna Davis, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.910, add alphabetically the inert ingredient ‘‘Alcohols, C2–33, manuf. of, by-products from, overheads (CAS Reg. No. 876065–86–0)’’ to the table to read as follows: ■ § 180.910 Inert ingredients used pre- and post-harvest; exemptions from the requirement of a tolerance. * * * * Inert ingredients Limits * * * * * Alcohols, C2–33, manuf. of, by-products from, overheads (CAS Reg. No. 876065–86–0) .......... * ..................................... * * * 3. In § 180.930, add alphabetically the inert ingredient ‘‘Alcohols, C2–33, manuf. of, by-products from, overheads (CAS ■ * * Reg. No. 876065–86–0)’’ to the table to read as follows: * § 180.930 Inert ingredients applied to animals; exemptions from the requirement of a tolerance. * * * * * * * * * Alcohols, C2–33, manuf. of, by-products from, overheads (CAS Reg. No. 876065–86–0) .......... * ..................................... * [FR Doc. 2019–19398 Filed 9–6–19; 8:45 am] * ACTION: * Notification of availability. BILLING CODE 6560–50–P The Coast Guard announces the availability of the Merchant Mariner Medical Manual, Commandant Instruction Manual (COMDTINST M16721.48). The guidance in this Manual should assist medical practitioners, the maritime industry, individual mariners, and Coast Guard personnel in evaluating a mariner applicant’s physical and medical status to meet the requirements of the merchant mariner medical certificate. This Manual incorporates and consolidates prior guidance on the SUMMARY: DEPARTMENT OF HOMELAND SECURITY Coast Guard 46 CFR Part 10 [Docket No. USCG–2018–0041] COMDTINST M16721.48 Merchant Mariner Medical Manual AGENCY: Coast Guard, DHS. VerDate Sep<11>2014 15:58 Sep 06, 2019 Jkt 247001 PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 * Solvent. * Limits * * Uses Inert ingredients * jbell on DSK3GLQ082PROD with RULES List of Subjects in 40 CFR Part 180 * Uses * * Solvent. * medical evaluation of merchant mariners contained in several Coast Guard documents. The Manual includes guidance on the medical certificate and related processes, including procedures for application, issuance, and cancellation of the medical certificate. The Merchant Mariner Medical Manual, COMDTINST M16721.4, is effective on September 9, 2019. DATES: For information about this document or to suggest changes, call or email Adrienne Buggs, M.D., United States Coast Guard, Office of Merchant Mariner FOR FURTHER INFORMATION CONTACT: E:\FR\FM\09SER1.SGM 09SER1 47142 Federal Register / Vol. 84, No. 174 / Monday, September 9, 2019 / Rules and Regulations Credentialing; telephone: 202–372– 2357, email: MMCPolicy@uscg.mil. SUPPLEMENTARY INFORMATION: jbell on DSK3GLQ082PROD with RULES Viewing Documents The Merchant Mariner Medical Manual, COMDTINST M16721.4, is available on the internet at: https:// www.dcms.uscg.mil/Our-Organization/ Assistant-Commandant-for-C4IT-CG-6/ The-Office-of-Information-ManagementCG-61/About-CG-Directives-System/ and on CGPortal at: https:// cgportal2.uscg.mil/library/directives/ SitePages/Home.aspx. A link to the document will also be located on the National Maritime Center (NMC) site: https://www.dco.uscg.mil/OurOrganization/Assistant-Commandantfor-Prevention-Policy-CG-5P/NationalMaritime-Center/. Background and Discussion of the Merchant Mariner Medical Manual Coast Guard regulations contained in 46 CFR part 10, subpart C, provide the medical and physical standards that merchant mariner applicants must meet prior to being issued a merchant mariner medical certificate. The Merchant Mariner Medical Manual provides guidance to the regulated community on how to comply with the regulations pertaining to medical and physical qualifications for merchant mariners. Previously, the Coast Guard provided guidance on the medical and physical requirements for merchant mariners in the Medical and Physical Evaluation Guidelines for Merchant Mariner Credentials, Navigation and Inspection Circular (NVIC) 04–08, Commandant Publication (COMDTPUB) 16700.4; in the Guidance on the Issuance of Medical Certificates (NVIC 01–14); and in Part A of the Marine Safety Manual, Volume III, Marine Industry Personnel, COMDTINST M16000.8 (Series) [MSM]. The Merchant Mariner Medical Manual revises, updates and combines the medical evaluation guidance previously published in NVIC 04–08, Part A of the MSM, Volume III, and NVIC 01–14. The Coast Guard developed the draft Manual in consultation with experienced maritime community medical practitioners and industry stakeholders serving on the Merchant Mariner Medical Advisory Committee (MEDMAC) and the Merchant Marine Personnel Advisory Committee (MERPAC). The Manual reflects a synthesis of their recommendations and the medical requirements of title 46 Code of Federal Regulations (CFR) part 10, subpart C. Members of the public participated in the development of medical policy by VerDate Sep<11>2014 15:58 Sep 06, 2019 Jkt 247001 providing comment and serving on working groups at the public meetings of MEDMAC and MERPAC. Additionally, the public had the opportunity to comment on drafts of policies contained in this Manual, and its predecessor, NVIC 04–08. See requests for comment on proposed policies regarding: Diabetes, cardiomyopathy, and sleep disorders (80 FR 8586, Feb. 18, 2015); Medications (80 FR 4582, Jan. 28, 2015); Seizures (78 FR 17917, Mar. 25, 2013); and Implantable cardioverter defibrillators (77 FR 55174, Sep. 7, 2012). The Coast Guard considered these public comments when developing this Manual. Public Comments on the Draft Merchant Mariner Medical Manual: The Coast Guard published a draft of the Merchant Mariner Medical Manual in the Federal Register and sought input from the public on the draft (83 FR 56272, Nov. 13, 2018). The current version of the Manual includes revisions made to address comments received in response to the Federal Register notification. While the Coast Guard is not required to seek or respond to public comments prior to publication of a policy document, we chose to do so in this case because of the perceived complexity of the Merchant Mariner Medical Manual, and because doing so provides us the opportunity to (1) create a guidance document that is more viable and responsive to the needs of the impacted community; and (2) to identify and clarify remaining areas of confusion and concern amongst the regulated community. The Coast Guard’s notification sought general comments on the draft Medical Manual, with emphasis on suggestions to improve readability, clarity, and ease of use; and comments on whether the draft Manual’s proposed medical certificate cancellation policy adequately addresses safety concerns in situations where the Coast Guard receives information indicating that a medical certificate holder has developed a medical condition that poses a significant risk of sudden incapacitation, or is taking a medication that poses a significant risk of impairment. The Coast Guard received 37 comment letters in response. General Comments Ten comment letters provided a general opinion of the draft Manual, with the majority expressing an overall positive opinion. These commenters found the guidance in the Manual to be thorough, straightforward and easy to use, and they found that it answered PO 00000 Frm 00028 Fmt 4700 Sfmt 4700 many questions that had arisen with previous medical policy documents. The favorable commenters appreciated that the document provides medical evaluators, mariners and medical providers with needed and relevant information that will reduce the need for ‘‘back and forth’’ between the mariner and the National Maritime Center. They also found it helpful that the Manual outlines the Coast Guard’s general concerns with particular medical conditions and discusses the general factors that the Coast Guard will use to evaluate the medical condition and make a fitness determination. Comments provided by the National Transportation Safety Board (NTSB) found that the draft Medical Manual aptly streamlines the medical certification guidance and provides a level of detail that should assist medical personnel during the mariner medical certification exams. The NTSB comment letter also provided the following observations: The combination of the Coast Guard’s increased oversight of medical certification and development of medical guidance appears to be highly effective at addressing safety concerns regarding medical conditions that pose a significant risk of sudden incapacitation. Since 2009, the NTSB has not found any medical conditions to have contributed to the probable cause of a marine accident. However, the NTSB continues to find effects from impairing substances (alcohol and over-the-counter, prescription, or illicit drugs) to have contributed to the probable cause across all modes of transportation. One comment letter expressed a generally negative opinion of the draft Medical Manual. This commenter expressed concerns that the guidance in the Medical Manual would sacrifice maritime safety unless the Coast Guard provided further clarification and a plan for implementation. Additionally, the commenter opined that the guidance does not adequately ensure that medical conditions are sufficiently controlled for those mariners at higher risk, because the Medical Manual does not establish clear standards for specific medical conditions. The Coast Guard does strive to increase clarity with publication of the Medical Manual, however, the Coast Guard disagrees that improved clarity requires publication of an implementation plan. Discussion of the Coast Guard’s internal implementation plans are beyond the scope of the Medical Manual. Moreover, the majority of the policy contained in the mariner medical manual is not new guidance. It is the same guidance, explained in greater detail, that was already implemented in the years following the E:\FR\FM\09SER1.SGM 09SER1 Federal Register / Vol. 84, No. 174 / Monday, September 9, 2019 / Rules and Regulations publication of NVIC 04–08. The Coast Guard also disagrees with the assertion that the Medical Manual should establish condition-specific medical standards. The medical and physical standards for merchant mariner medical certification have already been established in 46 CFR part 10, subpart C. Establishing new medical standards is beyond the scope of a policy document. jbell on DSK3GLQ082PROD with RULES Ease of Use and Clarity A letter from another commenter requested that the Coast Guard add an appendix that puts common conditions in a table format for quick reference, similar to that used in the International Maritime Organization’s (IMO) Guidelines on the Medical Examination of Seafarers. The Coast Guard disagrees on the basis that a quick reference table would not adequately capture the discussion, explanation and rationale that mariners, treating providers and medical examiners need to understand in order to provide quality examinations to the Coast Guard. Requirements for Medical Certification Three comment letters recommended that the Medical Manual provide additional medical requirements for medical certification. One letter commented that the Medical Manual should require all mariners to meet the same medical standard, and should provide ‘‘specific acceptable parameters’’ for many conditions to include BMI, pulmonary function, glucose levels, blood pressure, and cardiac function. Another comment letter suggested that the Coast Guard should implement a random medical testing program, similar to that used for drug testing. The third comment letter stated that the physical ability requirements should also include criteria for the speed and facility with which a mariner performs required tasks. The Coast Guard disagrees with these comments. While some of the recommendations pertaining to medical standards may warrant future discussion, changes or additions to the medical and physical requirements for medical certification are beyond the scope of this document. As discussed earlier, the medical and physical standards for medical certification are provided in 46 CFR part 10, subpart C, and changes to those requirements would require a rulemaking. Guidance on the Conduct of the General Medical Examination One comment letter addressed the guidance pertaining to the general medical examination and recommended VerDate Sep<11>2014 15:58 Sep 06, 2019 Jkt 247001 that the mariner medical examination include an evaluation of the mariner’s oral/dental health condition to ensure that there are no untreated infections or other dental problems that could cause significant impairment while at sea. The Coast Guard agrees that such guidance may prove helpful and will work with MEDMAC to consider whether and what type of guidance would be appropriate for inclusion in a future version of the Medical Manual. Frequency of Required Medical Examinations Four comments letters addressed the frequency of required medical examinations. Three commenters opined that it is excessive to require mariners to undergo a medical examination every two years. They recommended that the medical examination for all mariners, including those sailing under the authority of their Standards of Training, Certification, and Watchkeeping (STCW) endorsement, should remain valid for a period of 5 years, unless the mariner’s medical condition warrants issuance of a shorter-duration medical certificate. A different commenter requested clarity on how often a mariner is required to obtain a medical exam, noting that in some instances maritime employers require an annual medical examination, even when the Coast Guard does not. The Merchant Mariner Medical Manual provides detailed discussion of medical examination and medical certification requirements for specific endorsements, and cites the corresponding regulatory references. It is important to note that the medical certificate validity period and the frequency of required medical examinations may differ between endorsements because of the differing legal requirements. Since these requirements are established in regulation, changing them would require a rulemaking and is beyond the scope of this policy document. The medical examination requirements of individual employers are also outside the scope of this policy document. Medical Exam Forms One comment letter requested that the Medical Manual provide a list of medical examination forms that would be acceptable in place of the Form CG– 719K or KE. The Coast Guard disagrees and did not provide a list of alternative forms because 46 CFR 10.302(a) requires the following: ‘‘to qualify for a medical certificate, a mariner must provide evidence of meeting the medical and physical standards . . . on a CG–719–K or CG–719–K/E, as appropriate.’’ PO 00000 Frm 00029 Fmt 4700 Sfmt 4700 47143 Medical Examiners Ten comment letters provided comments on the topic of medical examiners. Three commenters requested additional information on the Designated Medical Examiner (DME) program, with one requesting that the Coast Guard publish its timeline and intent to create the DME program. The Coast Guard understands that there is significant interest in the DME program and will publish additional information, as and when appropriate. Five commenters recommended changes to the regulations regarding individuals who may perform examinations for purposes of the mariner medical certification examination. The Coast Guard considered each of these recommendations, but noted that changes to the regulations are beyond the scope of this policy document. Internal National Maritime Center Processes Two comment letters requested that the Manual provide more detail on internal National Maritime Center (NMC) processes. One of these comments expressed concern that the Manual’s instructions would allow nonmedical personnel to make medical determinations for U.S. mariners.’’ This commenter recommended that the Coast Guard add language to specify that all medical certification decisions will be supervised by a licensed medical officer. The second comment noted that the Manual does not contain ‘‘any reassurance or check and balance of examiners, examination quality, or the NMC medical certification process.’’ This commenter requested that the Coast Guard add language to address these concerns. The Coast Guard considered both of the comments, but does not concur with them. The staffing and internal quality assurance practices of the NMC are beyond the scope of this document. Nonetheless, the Coast Guard affirms that the activities of the NMC Medical Evaluations Division, particularly those related to medical certification, are supervised by a licensed medical officer. On the issue of providing quality assurance for medical examiners, it is important to recognize that medical examiners are not regulated by the Coast Guard. Therefore, providing reassurance or checks and balances of examiners and their exam quality, is inappropriate and is beyond the scope of this document. Positive Drug Tests Two comment letters complained that the Manual does not provide guidance E:\FR\FM\09SER1.SGM 09SER1 47144 Federal Register / Vol. 84, No. 174 / Monday, September 9, 2019 / Rules and Regulations jbell on DSK3GLQ082PROD with RULES for the evaluation of mariners who test positive for illegal drug use. One also requested that the Coast Guard add language to the Medical Manual requiring medical treatment for any mariner who fails a USCG required drug test. The Coast Guard does not concur with these commenters. The Medical Manual does not address requirements related to positive drug tests because the regulations and guidance on the management and disposition of individuals who have a positive drug test are contained in 46 CFR parts 5, 10, and 16. Changes to the DOT and Coast Guard drug testing regulation and policy are beyond the scope of this policy document. The Medical Manual contains guidance on how the Coast Guard will conduct the medical certification evaluation for individuals who have been diagnosed with a substance abuse disorder. The Medical Manual does not, however, direct treatment nor provide diagnostic instruction, because such areas are beyond the scope this policy document. Reporting Material Changes in Medical Condition for Mariners One commenter asked whether a mariner who holds a medical waiver is required to report a material change in their medical condition. The Coast Guard notes that the answer to this question will depend on the provisions outlined in the mariner’s medical waiver letter. Some waiver letters require that the mariner report changes in medical condition to the Coast Guard within a specified period of time. If no such provision is provided in the mariner’s waiver letter, then the mariner is not required to disclose the change in medical condition until the time of the next medical certificate application. Three commenters asked whether employers have an obligation to report to the Coast Guard information regarding a change in condition. One of these same commenters also asked how employees could protect themselves from inaccurate reports. The Coast Guard considered each of these comments and advises that this manual does not impose any new reporting requirements on anyone. In response to the concerns about how mariners will be able to protect themselves from inaccurate reports, the Coast Guard offers that the Merchant Mariner Medical Manual only proposes to take action on medical information that the Coast Guard has determined as credible. The information that the Coast Guard would deem credible differs depending upon the circumstances, but generally will include medical provider documentation, formal incident reports, VerDate Sep<11>2014 15:58 Sep 06, 2019 Jkt 247001 emergency medical services reports, and investigative reports. The Coast Guard also asserts that mariners will be able to protect themselves from inaccurate reports because this manual provides a standard process for evaluating these reports and further provides mariners with notice of, and the opportunity to respond to, information that indicates that they are no longer fit for medical certification. Medications Two comment letters noticed discrepancies in the language in Chapter 7 related to required disclosures of overthe-counter (OTC) medications. One of the commenters also observed that the guidance in the Manual highlighted an error on the most recent version of the Application for Medical Certificate (Form CG–719K, Rev 04/17, Exp. Date 03/31/2021) which incorrectly states that applicants must disclose all OTC medications taken within 30 days prior to the date the applicant signs the CG– 719K. Both commenters noted that prior versions of the CG–719K and the Medical Manual only instructed mariners to disclose OTC medications if the medications were used for a period of 30 days or more within the 90 days prior to the date the applicant signs the application to the Coast Guard. They requested that the Coast Guard provide additional language in the Medical Manual to clarify that applicants need only disclose OTC medications, when such medications were used for a period of 30 days or more within the 90 days prior to the date the applicant signs the application to the Coast Guard. The Coast Guard agrees that the language change regarding OTC medication disclosures on the most recent version of the CG–719K was an inadvertent change, and language was added to Chapter 7 of the Medical Manual to clarify the reporting requirements for OTC medications. The Coast Guard will be pursuing a change to CG–719K in the future to correct this change. Attendant with the language change regarding OTC medications, the Coast Guard also considered the NTSB’s comments about impairing medication effects that have contributed to the probable cause of accidents across all modes of transportation. In light of these concerns, the Coast Guard determined that it would be prudent to add additional guidance regarding OTC medications to the Important Safety Warnings paragraph of Chapter 7. Specifically, the additional guidance warns that some OTC medications and preparations may contain intoxicants or other dangerous drugs prohibited by PO 00000 Frm 00030 Fmt 4700 Sfmt 4700 Department of Transportation regulations. NMC Medical Evaluation Procedures for Mariners With Existing Waivers One commenter expressed confusion over the discussion of the term clear error in Paragraph I.3. of Chapter 3 of the Medical Manual. Paragraph I discusses NMC medical evaluation procedures for mariners with existing waivers, and Paragraph I.3. states that the Coast Guard is not bound to honor a medical waiver that was issued in clear error, contrary to duly promulgated policy in effect at time of issuance. The commenter mistakenly interpreted the clear error discussion to mean that the Coast Guard would not take responsibility for any erroneous certification decisions that might lead to mishaps or untoward medical situations at sea. In order to clear up this area of confusion, the Coast Guard added language to Paragraph I.3. of Chapter 3, to clarify that the discussion of clear error pertains to medical waivers that were issued in error. Alternative Testing Methodologies for Color Vision One comment letter asserted that the discussion of alternative testing methodologies for demonstrating satisfactory color vision contained Paragraph A.1.d.(2)(c) contains an error because it indicates that the Farnsworth D–15 may be used as a potential alternative color vision test for Deck personnel. The Coast Guard disagrees. Title 46 CFR 10.305(a) provides that mariners must demonstrate satisfactory color sense through one of the tests listed in the regulation, or through an alternative test acceptable to the Coast Guard. Paragraph A.1.d.(2) of the Medical Manual provides guidance for mariner applicants seeking to demonstrate satisfactory color vision sense through use of an alternative test, and describes the type of information that the Coast Guard will consider in determining whether an alternative test is sufficient for issuance of the medical certificate. The guidance does not guarantee that any singular test will be accepted as an alternative methodology for any particular mariner applicant, but rather states that the Coast Guard retains final authority for determining whether the testing is acceptable, and recommends that any alternative test be accompanied by a formal color vision evaluation from an ophthalmologist or optometrist. E:\FR\FM\09SER1.SGM 09SER1 jbell on DSK3GLQ082PROD with RULES Federal Register / Vol. 84, No. 174 / Monday, September 9, 2019 / Rules and Regulations Coast Guard Mission and Motives With Respect to Medical Credentialing One commenter asserted that the Coast Guard should ‘‘consider its mission and motives with respect to medical credentialing,’’ and expressed displeasure that the Medical Manual focuses on ‘‘medical credentialing without making any decisions on mariner fitness for duty.’’ The Coast Guard considered this commenter’s concerns and noted that the Medical Manual’s purpose, as stated in Paragraph 1 of the Letter of Promulgation for the Merchant Mariner Medical Manual, is to ‘‘provide guidance for evaluating the physical and medical condition of applicants for merchant mariner medical certificates.’’ The Coast Guard also notes that making a determination of fitness for certification is distinctly different from making a determination of fitness for duty, and refers the reader to the discussion that follows. Fitness-for-certification. The medical and physical standards for merchant mariner medical certification are contained in 46 CFR part 10, subpart C. The Coast Guard mariner medical evaluation and certification process seeks to determine whether an applicant meets the medical and physical standards for merchant mariners based upon the information available to the Coast Guard at the time of the certification decision. In accordance with 46 CFR 10.301, the Coast Guard will issue a medical certificate to a mariner meeting the medical and physical standards for merchant mariners. This decision is necessarily a snapshot of the mariner’s medical and physical condition at a single point in time. Fitness-for-duty. In general, fitness for duty refers to an employee’s ability to perform his/her essential job functions, as specified by the employer, without impairment from medical conditions or medications. There are some important considerations with respect to fitness for duty. First, an individual’s fitness-forduty status is not static, thus it should be considered whenever an individual reports for duty. Fitness-for-duty status can change suddenly due to an acute illness, injury or incident. As an example, an individual with no medical problems who has been issued a medical certificate and who normally performs their essential job functions without impairment, could become ‘‘not-fit-for duty’’ because of an impairing illness such as the flu, and/ or due to impairing medications used to treat an acute illness. The second important consideration is that a VerDate Sep<11>2014 15:58 Sep 06, 2019 Jkt 247001 ‘‘fitness-for duty’’ determination refers to an evaluation ordered by an employer to assess an employee’s ability to perform the essential functions of their assigned job (as specified by the employer). Such an evaluation might be requested when the employer has a reasonable belief that an employee will not be able to perform essential job functions because of their medical condition. A variety of state and Federal laws govern fitness for duty determinations depending upon the specific circumstances. Generally, a fitness for duty physical must be jobrelated and consistent with business necessity. One other important consideration is that the merchant mariner medical qualification standards in part 10, subpart C, are the minimum acceptable standards. Some maritime employers may choose to establish medical and/or physical ability requirements for their employees that are more stringent than the Coast Guard medical certification standards based on factors such as specific duty requirements, austere work environments, and operational tempo. In these cases, the employer’s fitnessfor-duty determinations may differ from the medical certification determination because they are based upon different standards. The Merchant Mariner Medical Manual does not preclude marine employers from establishing more rigorous medical or physical ability guidelines; however, there are additional laws and regulations that apply. Line-by-Line List of Changes Two commenters requested a detailed, line-by-line list of proposed changes that compares the current language in NVIC 04–08 with each change, addition and deletion made in the Medical Manual. The Coast Guard considered this comment, but determined that a line-by-line list of changes would not be helpful because of the extensive changes in wording, format and organization between the two documents. Instead, the Coast Guard has already provided a fairly comprehensive discussion of the major changes in Paragraph 6 of the Letter of Promulgation for the Medical Manual. Medical Certificate Cancellation Commenters were both supportive of, and objected to, the proposed medical certificate cancellation policy. After considering the comments, we decided to proceed with the proposed policy. One commenter who opposed the policy nevertheless provided a number of suggested edits to the text which were adopted. Those opposed to the PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 47145 cancellation policy suggested the Suspension and Revocation (S&R) process (46 CFR part 5) as an alternative. The Suspension and Revocation (S&R) process has limited jurisdiction over mariner medical issues. On this subject, S&R is authorized in circumstances where a credentialed mariner has committed an act of incompetence relating to the operation of a vessel (see 46 U.S.C. 7703(4)). A mariner having a disqualifying medical condition is not something addressed through S&R unless and until it has impacted vessel operation. Accordingly, the medical certificate cancellation and waiver processes set forth in the manual effectively address mariner medical qualification and fitness for duty concerns in ways that the S&R system cannot. There are also situations such as mariners using dangerous drugs or operating vessels under the influence of alcohol or other intoxicants that present both medical qualification and S&R concerns, so it may be appropriate for the Coast Guard to utilize both the procedures set forth in this manual and the S&R process to address and resolve these issues in the interest of safety. Waivers, Limitations, Restrictions One commenter requested more detail on limitations and restrictions. The commenter noted that waivers seem not to have been consistently applied to conditions. The Coast Guard agrees in part and over the last few years has provided further guidance on waivers for the most frequently occurring conditions. Those changes to NVIC 04– 08 have been carried forward into this manual. Process for Removing Waivers, Limitations and Restrictions One commenter complained that the process for removing restrictions and waivers ‘‘seems uncomfortably weighted toward taking away one’s ability to sail, without considering that many conditions—even very serious ones—are temporary in nature.’’ The Coast Guard disagrees and notes that the Medical Manual provides specific guidance on medical evaluation procedures for mariners with short-term conditions (see paragraph J. of Chapter 3 of the Medical Manual). These provisions were included to reduce the burden of imposing and then removing waivers and restrictions for conditions that are expected to resolve in the short-term. This document is issued under the authority of 5 U.S.C. 552(a), 46 U.S.C. 7101, and 46 U.S.C. 7302. E:\FR\FM\09SER1.SGM 09SER1 47146 Federal Register / Vol. 84, No. 174 / Monday, September 9, 2019 / Rules and Regulations Dated: September 3, 2019. J. G. Lantz, Director, Commercial Regulations and Standards, U.S. Coast Guard. [FR Doc. 2019–19370 Filed 9–6–19; 8:45 am] BILLING CODE 9110–04–P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 25 [GN Docket No. 14–177, FCC 19–30] Use of Spectrum Bands Above 24 GHz for Mobile Radio Services Federal Communications Commission. ACTION: Final rule; announcement of compliance date. AGENCY: In this document, the Commission announces that the Office of Management and Budget (OMB) has approved the information collection associated with a rule for specific millimeter wave bands above 24 GHz in the Commission’s Fifth Report and Order, FCC 19–30, and that compliance with the modified rule is now required. It removes paragraphs advising that compliance was not required until OMB approval was obtained. This document is consistent with the Fifth Report and Order FCC 19–30, which states the Commission will publish a document in the Federal Register announcing a compliance date for the modified rule section and revise the rule accordingly. DATES: Effective date: This rule is effective September 9, 2019. Compliance date: Compliance with 47 CFR 25.136(e), (f), and (g), published 84 FR 20810 on May 13, 2019, is required as of September 9, 2019. FOR FURTHER INFORMATION CONTACT: John Schauble of the Wireless Telecommunications Bureau, Broadband Division at (202) 418–0797 or John.Schauble@fcc.gov, Michael Ha of the Office of Engineering and Technology, Policy and Rules Division, at 202–418–2099 or Michael.Ha@ fcc.gov, or Jose Albuquerque of the International Bureau, Satellite Division, at 202–418–2288 or Jose.Albuquerque@ fcc.gov. SUPPLEMENTARY INFORMATION: This document announces that OMB approved the information collection requirement in § 25.136(e), (f), and (g) on August 27, 2019. The rule was modified in the Fifth Report and Order, FCC 19–30, published 84 FR 20810, May 13, 2019. The Commission publishes this document as an announcement of the compliance date jbell on DSK3GLQ082PROD with RULES SUMMARY: VerDate Sep<11>2014 15:58 Sep 06, 2019 Jkt 247001 of the rules. The other rule amendments adopted in the Fifth Report and Order, which did not require OMB approval, became effective on June 12, 2019. If you have any comments on the burden estimates listed below, or how the Commission can improve the collections and reduce any burdens caused thereby, please contact Cathy Williams, Federal Communications Commission, Room 1–C823, 445 12th Street SW, Washington, DC 20554, regarding OMB Control Number 3060– 1215. Please include the applicable OMB Control Number in your correspondence. The Commission will also accept your comments via email at PRA@fcc.gov. To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to fcc504@ fcc.gov or call the Consumer and Governmental Affairs Bureau at (202) 418–0530 (voice), (202) 418–0432 (TTY). This document also removes § 25.136(h) of the Commission’s rules, which advised that compliance was not required until OMB approval was obtained. Synopsis As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the FCC is notifying the public that it received final OMB approval on August 27, 2019, for the information collection requirement contained in the modification to § 25.136(e), (f), and (g). Under 5 CFR part 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a current, valid OMB Control Number. The OMB Control Number for the information collection requirement in § 25.136(e), (f), and (g) is 3060–1215. The foregoing notice is required by the Paperwork Reduction Act of 1995, Public Law 104–13, October 1, 1995, and 44 U.S.C. 3507. The total annual reporting burdens and costs for the respondents are as follows: OMB Control Number: 3060–1215. OMB Approval Date: August 27, 2019. OMB Expiration Date: August 31, 2022. Title: Use of Spectrum Bands Above 24 GHz for Mobile Radio Services. Form Number: N/A. Respondents: Business or other forprofit, not-for-profit institutions, and state, local and tribal government. PO 00000 Frm 00032 Fmt 4700 Sfmt 4700 Number of Respondents and Responses: 1,230 respondents; 1,230 responses. Estimated Time per Response: .5–10 hours. Frequency of Response: On occasion reporting requirement; third party disclosure requirement; recordkeeping; upon commencement of service, or within 3 years of effective date of rules; and at end of license term, or 2024 for incumbent licensees. Obligation to Respond: Statutory authority for this collection are contained in sections 1, 2, 3, 4, 5, 7, 10, 201, 225, 227, 301, 302, 302a, 303, 304, 307, 309, 310, 316, 319, 332, and 336 of the Communications Act of 1934, 47 U.S.C. 151, 152, 153, 154, 155, 157, 160, 201, 225, 227, 301, 302, 302a, 303, 304, 307, 309, 310, 316, 319, 332, 336, Section 706 of the Telecommunications Act of 1996, as amended, 47 U.S.C. 1302. Total Annual Burden: 735 hours. Total Annual Cost: $540,000. Privacy Act Impact Assessment: No impact(s). Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information. Needs and Uses: In this collection, the Commission amended in the Fifth Report and Order’s § 25.136 by revising the section heading and revising paragraphs (e), (f), and (g) and adding paragraphs (e)(1), (2), (3), and (e)(4)(i), (ii), (iii), and (iv). The Fifth Report and Order was adopted on April 12, 2019 and released on April 15, 2019. The Commission added the 50 GHz band (50.4–51.4 GHz) to the bands that are subject to the framework for sharing between the Upper Microwave Flexible Use Service (UMFUS) and the FixedSatellite Service (FSS) established in that rule. In turn, since the rules now apply in additional bands, the number of respondents, the annual number of responses, annual burden hours and annual costs will increase for this collection. In addition, the Commission re-orders the paragraphs in § 25.136. List of Subjects in 47 CFR Part 25 Satellite communication. Federal Communications Commission. Marlene Dortch, Secretary. Final Rules For the reason discussed in the preamble, the Federal Communications Commission amends 47 CFR part 25 as follows: E:\FR\FM\09SER1.SGM 09SER1

Agencies

[Federal Register Volume 84, Number 174 (Monday, September 9, 2019)]
[Rules and Regulations]
[Pages 47141-47146]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19370]


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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

46 CFR Part 10

[Docket No. USCG-2018-0041]


COMDTINST M16721.48 Merchant Mariner Medical Manual

AGENCY: Coast Guard, DHS.

ACTION: Notification of availability.

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SUMMARY: The Coast Guard announces the availability of the Merchant 
Mariner Medical Manual, Commandant Instruction Manual (COMDTINST 
M16721.48). The guidance in this Manual should assist medical 
practitioners, the maritime industry, individual mariners, and Coast 
Guard personnel in evaluating a mariner applicant's physical and 
medical status to meet the requirements of the merchant mariner medical 
certificate. This Manual incorporates and consolidates prior guidance 
on the medical evaluation of merchant mariners contained in several 
Coast Guard documents. The Manual includes guidance on the medical 
certificate and related processes, including procedures for 
application, issuance, and cancellation of the medical certificate.

DATES: The Merchant Mariner Medical Manual, COMDTINST M16721.4, is 
effective on September 9, 2019.

FOR FURTHER INFORMATION CONTACT: For information about this document or 
to suggest changes, call or email Adrienne Buggs, M.D., United States 
Coast Guard, Office of Merchant Mariner

[[Page 47142]]

Credentialing; telephone: 202-372-2357, email: [email protected].

SUPPLEMENTARY INFORMATION: 

Viewing Documents

    The Merchant Mariner Medical Manual, COMDTINST M16721.4, is 
available on the internet at: https://www.dcms.uscg.mil/Our-Organization/Assistant-Commandant-for-C4IT-CG-6/The-Office-of-Information-Management-CG-61/About-CG-Directives-System/ and on 
CGPortal at: https://cgportal2.uscg.mil/library/directives/SitePages/Home.aspx. A link to the document will also be located on the National 
Maritime Center (NMC) site: https://www.dco.uscg.mil/Our-Organization/Assistant-Commandant-for-Prevention-Policy-CG-5P/National-Maritime-Center/.

Background and Discussion of the Merchant Mariner Medical Manual

    Coast Guard regulations contained in 46 CFR part 10, subpart C, 
provide the medical and physical standards that merchant mariner 
applicants must meet prior to being issued a merchant mariner medical 
certificate. The Merchant Mariner Medical Manual provides guidance to 
the regulated community on how to comply with the regulations 
pertaining to medical and physical qualifications for merchant 
mariners.
    Previously, the Coast Guard provided guidance on the medical and 
physical requirements for merchant mariners in the Medical and Physical 
Evaluation Guidelines for Merchant Mariner Credentials, Navigation and 
Inspection Circular (NVIC) 04-08, Commandant Publication (COMDTPUB) 
16700.4; in the Guidance on the Issuance of Medical Certificates (NVIC 
01-14); and in Part A of the Marine Safety Manual, Volume III, Marine 
Industry Personnel, COMDTINST M16000.8 (Series) [MSM]. The Merchant 
Mariner Medical Manual revises, updates and combines the medical 
evaluation guidance previously published in NVIC 04-08, Part A of the 
MSM, Volume III, and NVIC 01-14. The Coast Guard developed the draft 
Manual in consultation with experienced maritime community medical 
practitioners and industry stakeholders serving on the Merchant Mariner 
Medical Advisory Committee (MEDMAC) and the Merchant Marine Personnel 
Advisory Committee (MERPAC). The Manual reflects a synthesis of their 
recommendations and the medical requirements of title 46 Code of 
Federal Regulations (CFR) part 10, subpart C.
    Members of the public participated in the development of medical 
policy by providing comment and serving on working groups at the public 
meetings of MEDMAC and MERPAC. Additionally, the public had the 
opportunity to comment on drafts of policies contained in this Manual, 
and its predecessor, NVIC 04-08. See requests for comment on proposed 
policies regarding: Diabetes, cardiomyopathy, and sleep disorders (80 
FR 8586, Feb. 18, 2015); Medications (80 FR 4582, Jan. 28, 2015); 
Seizures (78 FR 17917, Mar. 25, 2013); and Implantable cardioverter 
defibrillators (77 FR 55174, Sep. 7, 2012). The Coast Guard considered 
these public comments when developing this Manual.

Public Comments on the Draft Merchant Mariner Medical Manual:

    The Coast Guard published a draft of the Merchant Mariner Medical 
Manual in the Federal Register and sought input from the public on the 
draft (83 FR 56272, Nov. 13, 2018). The current version of the Manual 
includes revisions made to address comments received in response to the 
Federal Register notification. While the Coast Guard is not required to 
seek or respond to public comments prior to publication of a policy 
document, we chose to do so in this case because of the perceived 
complexity of the Merchant Mariner Medical Manual, and because doing so 
provides us the opportunity to (1) create a guidance document that is 
more viable and responsive to the needs of the impacted community; and 
(2) to identify and clarify remaining areas of confusion and concern 
amongst the regulated community.
    The Coast Guard's notification sought general comments on the draft 
Medical Manual, with emphasis on suggestions to improve readability, 
clarity, and ease of use; and comments on whether the draft Manual's 
proposed medical certificate cancellation policy adequately addresses 
safety concerns in situations where the Coast Guard receives 
information indicating that a medical certificate holder has developed 
a medical condition that poses a significant risk of sudden 
incapacitation, or is taking a medication that poses a significant risk 
of impairment. The Coast Guard received 37 comment letters in response.

General Comments

    Ten comment letters provided a general opinion of the draft Manual, 
with the majority expressing an overall positive opinion. These 
commenters found the guidance in the Manual to be thorough, 
straightforward and easy to use, and they found that it answered many 
questions that had arisen with previous medical policy documents. The 
favorable commenters appreciated that the document provides medical 
evaluators, mariners and medical providers with needed and relevant 
information that will reduce the need for ``back and forth'' between 
the mariner and the National Maritime Center. They also found it 
helpful that the Manual outlines the Coast Guard's general concerns 
with particular medical conditions and discusses the general factors 
that the Coast Guard will use to evaluate the medical condition and 
make a fitness determination. Comments provided by the National 
Transportation Safety Board (NTSB) found that the draft Medical Manual 
aptly streamlines the medical certification guidance and provides a 
level of detail that should assist medical personnel during the mariner 
medical certification exams. The NTSB comment letter also provided the 
following observations:

    The combination of the Coast Guard's increased oversight of 
medical certification and development of medical guidance appears to 
be highly effective at addressing safety concerns regarding medical 
conditions that pose a significant risk of sudden incapacitation. 
Since 2009, the NTSB has not found any medical conditions to have 
contributed to the probable cause of a marine accident. However, the 
NTSB continues to find effects from impairing substances (alcohol 
and over-the-counter, prescription, or illicit drugs) to have 
contributed to the probable cause across all modes of 
transportation.

    One comment letter expressed a generally negative opinion of the 
draft Medical Manual. This commenter expressed concerns that the 
guidance in the Medical Manual would sacrifice maritime safety unless 
the Coast Guard provided further clarification and a plan for 
implementation. Additionally, the commenter opined that the guidance 
does not adequately ensure that medical conditions are sufficiently 
controlled for those mariners at higher risk, because the Medical 
Manual does not establish clear standards for specific medical 
conditions. The Coast Guard does strive to increase clarity with 
publication of the Medical Manual, however, the Coast Guard disagrees 
that improved clarity requires publication of an implementation plan. 
Discussion of the Coast Guard's internal implementation plans are 
beyond the scope of the Medical Manual. Moreover, the majority of the 
policy contained in the mariner medical manual is not new guidance. It 
is the same guidance, explained in greater detail, that was already 
implemented in the years following the

[[Page 47143]]

publication of NVIC 04-08. The Coast Guard also disagrees with the 
assertion that the Medical Manual should establish condition-specific 
medical standards. The medical and physical standards for merchant 
mariner medical certification have already been established in 46 CFR 
part 10, subpart C. Establishing new medical standards is beyond the 
scope of a policy document.

Ease of Use and Clarity

    A letter from another commenter requested that the Coast Guard add 
an appendix that puts common conditions in a table format for quick 
reference, similar to that used in the International Maritime 
Organization's (IMO) Guidelines on the Medical Examination of 
Seafarers. The Coast Guard disagrees on the basis that a quick 
reference table would not adequately capture the discussion, 
explanation and rationale that mariners, treating providers and medical 
examiners need to understand in order to provide quality examinations 
to the Coast Guard.

Requirements for Medical Certification

    Three comment letters recommended that the Medical Manual provide 
additional medical requirements for medical certification. One letter 
commented that the Medical Manual should require all mariners to meet 
the same medical standard, and should provide ``specific acceptable 
parameters'' for many conditions to include BMI, pulmonary function, 
glucose levels, blood pressure, and cardiac function. Another comment 
letter suggested that the Coast Guard should implement a random medical 
testing program, similar to that used for drug testing. The third 
comment letter stated that the physical ability requirements should 
also include criteria for the speed and facility with which a mariner 
performs required tasks. The Coast Guard disagrees with these comments. 
While some of the recommendations pertaining to medical standards may 
warrant future discussion, changes or additions to the medical and 
physical requirements for medical certification are beyond the scope of 
this document. As discussed earlier, the medical and physical standards 
for medical certification are provided in 46 CFR part 10, subpart C, 
and changes to those requirements would require a rulemaking.

Guidance on the Conduct of the General Medical Examination

    One comment letter addressed the guidance pertaining to the general 
medical examination and recommended that the mariner medical 
examination include an evaluation of the mariner's oral/dental health 
condition to ensure that there are no untreated infections or other 
dental problems that could cause significant impairment while at sea. 
The Coast Guard agrees that such guidance may prove helpful and will 
work with MEDMAC to consider whether and what type of guidance would be 
appropriate for inclusion in a future version of the Medical Manual.

Frequency of Required Medical Examinations

    Four comments letters addressed the frequency of required medical 
examinations. Three commenters opined that it is excessive to require 
mariners to undergo a medical examination every two years. They 
recommended that the medical examination for all mariners, including 
those sailing under the authority of their Standards of Training, 
Certification, and Watchkeeping (STCW) endorsement, should remain valid 
for a period of 5 years, unless the mariner's medical condition 
warrants issuance of a shorter-duration medical certificate. A 
different commenter requested clarity on how often a mariner is 
required to obtain a medical exam, noting that in some instances 
maritime employers require an annual medical examination, even when the 
Coast Guard does not.
    The Merchant Mariner Medical Manual provides detailed discussion of 
medical examination and medical certification requirements for specific 
endorsements, and cites the corresponding regulatory references. It is 
important to note that the medical certificate validity period and the 
frequency of required medical examinations may differ between 
endorsements because of the differing legal requirements. Since these 
requirements are established in regulation, changing them would require 
a rulemaking and is beyond the scope of this policy document. The 
medical examination requirements of individual employers are also 
outside the scope of this policy document.

Medical Exam Forms

    One comment letter requested that the Medical Manual provide a list 
of medical examination forms that would be acceptable in place of the 
Form CG-719K or KE. The Coast Guard disagrees and did not provide a 
list of alternative forms because 46 CFR 10.302(a) requires the 
following: ``to qualify for a medical certificate, a mariner must 
provide evidence of meeting the medical and physical standards . . . on 
a CG-719-K or CG-719-K/E, as appropriate.''

Medical Examiners

    Ten comment letters provided comments on the topic of medical 
examiners. Three commenters requested additional information on the 
Designated Medical Examiner (DME) program, with one requesting that the 
Coast Guard publish its timeline and intent to create the DME program. 
The Coast Guard understands that there is significant interest in the 
DME program and will publish additional information, as and when 
appropriate.
    Five commenters recommended changes to the regulations regarding 
individuals who may perform examinations for purposes of the mariner 
medical certification examination. The Coast Guard considered each of 
these recommendations, but noted that changes to the regulations are 
beyond the scope of this policy document.

Internal National Maritime Center Processes

    Two comment letters requested that the Manual provide more detail 
on internal National Maritime Center (NMC) processes. One of these 
comments expressed concern that the Manual's instructions would allow 
non-medical personnel to make medical determinations for U.S. 
mariners.'' This commenter recommended that the Coast Guard add 
language to specify that all medical certification decisions will be 
supervised by a licensed medical officer. The second comment noted that 
the Manual does not contain ``any reassurance or check and balance of 
examiners, examination quality, or the NMC medical certification 
process.'' This commenter requested that the Coast Guard add language 
to address these concerns. The Coast Guard considered both of the 
comments, but does not concur with them. The staffing and internal 
quality assurance practices of the NMC are beyond the scope of this 
document. Nonetheless, the Coast Guard affirms that the activities of 
the NMC Medical Evaluations Division, particularly those related to 
medical certification, are supervised by a licensed medical officer. On 
the issue of providing quality assurance for medical examiners, it is 
important to recognize that medical examiners are not regulated by the 
Coast Guard. Therefore, providing reassurance or checks and balances of 
examiners and their exam quality, is inappropriate and is beyond the 
scope of this document.

Positive Drug Tests

    Two comment letters complained that the Manual does not provide 
guidance

[[Page 47144]]

for the evaluation of mariners who test positive for illegal drug use. 
One also requested that the Coast Guard add language to the Medical 
Manual requiring medical treatment for any mariner who fails a USCG 
required drug test. The Coast Guard does not concur with these 
commenters. The Medical Manual does not address requirements related to 
positive drug tests because the regulations and guidance on the 
management and disposition of individuals who have a positive drug test 
are contained in 46 CFR parts 5, 10, and 16. Changes to the DOT and 
Coast Guard drug testing regulation and policy are beyond the scope of 
this policy document. The Medical Manual contains guidance on how the 
Coast Guard will conduct the medical certification evaluation for 
individuals who have been diagnosed with a substance abuse disorder. 
The Medical Manual does not, however, direct treatment nor provide 
diagnostic instruction, because such areas are beyond the scope this 
policy document.

Reporting Material Changes in Medical Condition for Mariners

    One commenter asked whether a mariner who holds a medical waiver is 
required to report a material change in their medical condition. The 
Coast Guard notes that the answer to this question will depend on the 
provisions outlined in the mariner's medical waiver letter. Some waiver 
letters require that the mariner report changes in medical condition to 
the Coast Guard within a specified period of time. If no such provision 
is provided in the mariner's waiver letter, then the mariner is not 
required to disclose the change in medical condition until the time of 
the next medical certificate application.
    Three commenters asked whether employers have an obligation to 
report to the Coast Guard information regarding a change in condition. 
One of these same commenters also asked how employees could protect 
themselves from inaccurate reports. The Coast Guard considered each of 
these comments and advises that this manual does not impose any new 
reporting requirements on anyone. In response to the concerns about how 
mariners will be able to protect themselves from inaccurate reports, 
the Coast Guard offers that the Merchant Mariner Medical Manual only 
proposes to take action on medical information that the Coast Guard has 
determined as credible. The information that the Coast Guard would deem 
credible differs depending upon the circumstances, but generally will 
include medical provider documentation, formal incident reports, 
emergency medical services reports, and investigative reports. The 
Coast Guard also asserts that mariners will be able to protect 
themselves from inaccurate reports because this manual provides a 
standard process for evaluating these reports and further provides 
mariners with notice of, and the opportunity to respond to, information 
that indicates that they are no longer fit for medical certification.

Medications

    Two comment letters noticed discrepancies in the language in 
Chapter 7 related to required disclosures of over-the-counter (OTC) 
medications. One of the commenters also observed that the guidance in 
the Manual highlighted an error on the most recent version of the 
Application for Medical Certificate (Form CG-719K, Rev 04/17, Exp. Date 
03/31/2021) which incorrectly states that applicants must disclose all 
OTC medications taken within 30 days prior to the date the applicant 
signs the CG-719K. Both commenters noted that prior versions of the CG-
719K and the Medical Manual only instructed mariners to disclose OTC 
medications if the medications were used for a period of 30 days or 
more within the 90 days prior to the date the applicant signs the 
application to the Coast Guard. They requested that the Coast Guard 
provide additional language in the Medical Manual to clarify that 
applicants need only disclose OTC medications, when such medications 
were used for a period of 30 days or more within the 90 days prior to 
the date the applicant signs the application to the Coast Guard. The 
Coast Guard agrees that the language change regarding OTC medication 
disclosures on the most recent version of the CG-719K was an 
inadvertent change, and language was added to Chapter 7 of the Medical 
Manual to clarify the reporting requirements for OTC medications. The 
Coast Guard will be pursuing a change to CG-719K in the future to 
correct this change.
    Attendant with the language change regarding OTC medications, the 
Coast Guard also considered the NTSB's comments about impairing 
medication effects that have contributed to the probable cause of 
accidents across all modes of transportation. In light of these 
concerns, the Coast Guard determined that it would be prudent to add 
additional guidance regarding OTC medications to the Important Safety 
Warnings paragraph of Chapter 7. Specifically, the additional guidance 
warns that some OTC medications and preparations may contain 
intoxicants or other dangerous drugs prohibited by Department of 
Transportation regulations.

NMC Medical Evaluation Procedures for Mariners With Existing Waivers

    One commenter expressed confusion over the discussion of the term 
clear error in Paragraph I.3. of Chapter 3 of the Medical Manual. 
Paragraph I discusses NMC medical evaluation procedures for mariners 
with existing waivers, and Paragraph I.3. states that the Coast Guard 
is not bound to honor a medical waiver that was issued in clear error, 
contrary to duly promulgated policy in effect at time of issuance. The 
commenter mistakenly interpreted the clear error discussion to mean 
that the Coast Guard would not take responsibility for any erroneous 
certification decisions that might lead to mishaps or untoward medical 
situations at sea. In order to clear up this area of confusion, the 
Coast Guard added language to Paragraph I.3. of Chapter 3, to clarify 
that the discussion of clear error pertains to medical waivers that 
were issued in error.

Alternative Testing Methodologies for Color Vision

    One comment letter asserted that the discussion of alternative 
testing methodologies for demonstrating satisfactory color vision 
contained Paragraph A.1.d.(2)(c) contains an error because it indicates 
that the Farnsworth D-15 may be used as a potential alternative color 
vision test for Deck personnel. The Coast Guard disagrees. Title 46 CFR 
10.305(a) provides that mariners must demonstrate satisfactory color 
sense through one of the tests listed in the regulation, or through an 
alternative test acceptable to the Coast Guard. Paragraph A.1.d.(2) of 
the Medical Manual provides guidance for mariner applicants seeking to 
demonstrate satisfactory color vision sense through use of an 
alternative test, and describes the type of information that the Coast 
Guard will consider in determining whether an alternative test is 
sufficient for issuance of the medical certificate. The guidance does 
not guarantee that any singular test will be accepted as an alternative 
methodology for any particular mariner applicant, but rather states 
that the Coast Guard retains final authority for determining whether 
the testing is acceptable, and recommends that any alternative test be 
accompanied by a formal color vision evaluation from an ophthalmologist 
or optometrist.

[[Page 47145]]

Coast Guard Mission and Motives With Respect to Medical Credentialing

    One commenter asserted that the Coast Guard should ``consider its 
mission and motives with respect to medical credentialing,'' and 
expressed displeasure that the Medical Manual focuses on ``medical 
credentialing without making any decisions on mariner fitness for 
duty.'' The Coast Guard considered this commenter's concerns and noted 
that the Medical Manual's purpose, as stated in Paragraph 1 of the 
Letter of Promulgation for the Merchant Mariner Medical Manual, is to 
``provide guidance for evaluating the physical and medical condition of 
applicants for merchant mariner medical certificates.'' The Coast Guard 
also notes that making a determination of fitness for certification is 
distinctly different from making a determination of fitness for duty, 
and refers the reader to the discussion that follows.
    Fitness-for-certification. The medical and physical standards for 
merchant mariner medical certification are contained in 46 CFR part 10, 
subpart C. The Coast Guard mariner medical evaluation and certification 
process seeks to determine whether an applicant meets the medical and 
physical standards for merchant mariners based upon the information 
available to the Coast Guard at the time of the certification decision. 
In accordance with 46 CFR 10.301, the Coast Guard will issue a medical 
certificate to a mariner meeting the medical and physical standards for 
merchant mariners. This decision is necessarily a snapshot of the 
mariner's medical and physical condition at a single point in time.
    Fitness-for-duty. In general, fitness for duty refers to an 
employee's ability to perform his/her essential job functions, as 
specified by the employer, without impairment from medical conditions 
or medications. There are some important considerations with respect to 
fitness for duty. First, an individual's fitness-for-duty status is not 
static, thus it should be considered whenever an individual reports for 
duty. Fitness-for-duty status can change suddenly due to an acute 
illness, injury or incident. As an example, an individual with no 
medical problems who has been issued a medical certificate and who 
normally performs their essential job functions without impairment, 
could become ``not-fit-for duty'' because of an impairing illness such 
as the flu, and/or due to impairing medications used to treat an acute 
illness. The second important consideration is that a ``fitness-for 
duty'' determination refers to an evaluation ordered by an employer to 
assess an employee's ability to perform the essential functions of 
their assigned job (as specified by the employer). Such an evaluation 
might be requested when the employer has a reasonable belief that an 
employee will not be able to perform essential job functions because of 
their medical condition. A variety of state and Federal laws govern 
fitness for duty determinations depending upon the specific 
circumstances. Generally, a fitness for duty physical must be job-
related and consistent with business necessity. One other important 
consideration is that the merchant mariner medical qualification 
standards in part 10, subpart C, are the minimum acceptable standards. 
Some maritime employers may choose to establish medical and/or physical 
ability requirements for their employees that are more stringent than 
the Coast Guard medical certification standards based on factors such 
as specific duty requirements, austere work environments, and 
operational tempo. In these cases, the employer's fitness-for-duty 
determinations may differ from the medical certification determination 
because they are based upon different standards. The Merchant Mariner 
Medical Manual does not preclude marine employers from establishing 
more rigorous medical or physical ability guidelines; however, there 
are additional laws and regulations that apply.

Line-by-Line List of Changes

    Two commenters requested a detailed, line-by-line list of proposed 
changes that compares the current language in NVIC 04-08 with each 
change, addition and deletion made in the Medical Manual. The Coast 
Guard considered this comment, but determined that a line-by-line list 
of changes would not be helpful because of the extensive changes in 
wording, format and organization between the two documents. Instead, 
the Coast Guard has already provided a fairly comprehensive discussion 
of the major changes in Paragraph 6 of the Letter of Promulgation for 
the Medical Manual.

Medical Certificate Cancellation

    Commenters were both supportive of, and objected to, the proposed 
medical certificate cancellation policy. After considering the 
comments, we decided to proceed with the proposed policy. One commenter 
who opposed the policy nevertheless provided a number of suggested 
edits to the text which were adopted. Those opposed to the cancellation 
policy suggested the Suspension and Revocation (S&R) process (46 CFR 
part 5) as an alternative. The Suspension and Revocation (S&R) process 
has limited jurisdiction over mariner medical issues. On this subject, 
S&R is authorized in circumstances where a credentialed mariner has 
committed an act of incompetence relating to the operation of a vessel 
(see 46 U.S.C. 7703(4)). A mariner having a disqualifying medical 
condition is not something addressed through S&R unless and until it 
has impacted vessel operation. Accordingly, the medical certificate 
cancellation and waiver processes set forth in the manual effectively 
address mariner medical qualification and fitness for duty concerns in 
ways that the S&R system cannot. There are also situations such as 
mariners using dangerous drugs or operating vessels under the influence 
of alcohol or other intoxicants that present both medical qualification 
and S&R concerns, so it may be appropriate for the Coast Guard to 
utilize both the procedures set forth in this manual and the S&R 
process to address and resolve these issues in the interest of safety.

Waivers, Limitations, Restrictions

    One commenter requested more detail on limitations and 
restrictions. The commenter noted that waivers seem not to have been 
consistently applied to conditions. The Coast Guard agrees in part and 
over the last few years has provided further guidance on waivers for 
the most frequently occurring conditions. Those changes to NVIC 04-08 
have been carried forward into this manual.

Process for Removing Waivers, Limitations and Restrictions

    One commenter complained that the process for removing restrictions 
and waivers ``seems uncomfortably weighted toward taking away one's 
ability to sail, without considering that many conditions--even very 
serious ones--are temporary in nature.'' The Coast Guard disagrees and 
notes that the Medical Manual provides specific guidance on medical 
evaluation procedures for mariners with short-term conditions (see 
paragraph J. of Chapter 3 of the Medical Manual). These provisions were 
included to reduce the burden of imposing and then removing waivers and 
restrictions for conditions that are expected to resolve in the short-
term.
    This document is issued under the authority of 5 U.S.C. 552(a), 46 
U.S.C. 7101, and 46 U.S.C. 7302.


[[Page 47146]]


    Dated: September 3, 2019.
J. G. Lantz,
Director, Commercial Regulations and Standards, U.S. Coast Guard.
[FR Doc. 2019-19370 Filed 9-6-19; 8:45 am]
 BILLING CODE 9110-04-P