Lifejacket Approval Harmonization, 97356-97402 [2024-28264]

Download as PDF 97356 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 181 46 CFR Parts 25, 28, 108, 117, 133, 141, 160, 169, 180 and 199 [Docket No. USCG–2022–0120] RIN 1625–AC62 I. Abbreviations Lifejacket Approval Harmonization Coast Guard, DHS. ACTION: Final rule. AGENCY: The Coast Guard amends the approval requirements and follow-up program requirements for lifejackets by incorporating new standards to replace existing legacy standards. The Coast Guard further amends lifejacket and personal flotation device (PFD) carriage requirements to allow for the use of equipment approved to the new standards and removes obsolete equipment approval requirements. The amendments streamline the process for the approval of PFDs and allow manufacturers the opportunity to produce innovative equipment that complies with standards in both Canada and the United States. Manufacturing firms also stand to benefit through a reduced production-inspections burden. DATES: Effective dates: This final rule is effective January 6, 2025. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of January 6, 2025. Compliance date: The Coast Guard will begin enforcing this rule on June 4, 2025. ADDRESSES: To view documents mentioned in this preamble as being available in the docket, go to www.regulations.gov, type USCG–2022– 0120 in the search box and click ‘‘Search.’’ Next, in the Document Type column, select ‘‘Supporting & Related Material.’’ SUMMARY: For information about this document call or email Jacqueline Yurkovich, Coast Guard; telephone 571–607–4931, email Jacqueline.M.Yurkovich@uscg.mil. SUPPLEMENTARY INFORMATION: lotter on DSK11XQN23PROD with RULES3 FOR FURTHER INFORMATION CONTACT: Table of Contents for Preamble I. Abbreviations II. Background, Basis, and Purpose III. Discussion of Comments IV. Discussion of the Rule V. Incorporation by Reference VI. Regulatory Analyses VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 A. Regulatory Planning and Review B. Small Entities C. Assistance for Small Entities D. Collection of Information E. Federalism F. Unfunded Mandates G. Taking of Private Property H. Civil Justice Reform I. Protection of Children J. Indian Tribal Governments K. Energy Effects L. Technical Standards M. Environment ANSI American National Standards Institute CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register FRFA Final Regulatory Flexibility Analysis IBR Incorporation by reference ISO International Organization for Standardization NAICS North American Industry Classification System NBSAC National Boating Safety Advisory Committee NIH National Institutes of Health NPRM Notice of proposed rulemaking OMB Office of Management and Budget PFD Personal flotation device QMS Quality management system RA Regulatory analysis RFA Regulatory Flexibility Act § Section SBA Small Business Administration SME Subject matter expert SOLAS International Convention for the Safety of Life at Sea U.S.C. United States Code II. Background, Basis, and Purpose The Coast Guard has statutory authority under Title 46 of the United States Code (U.S.C.), Sections 3306(a) and (b), 4102(b), 4302(a) and (c), and 4502(a) and (c)(2)(B), to prescribe regulations for the design, construction, performance, testing, carriage, use, and inspection of lifesaving equipment on commercial and recreational vessels. Under Department of Homeland Security (DHS) Delegation 00170.1, Revision No. 01.4, paragraph (II)(92)(b), the Secretary delegated authority under these statutes to the Commandant of the Coast Guard. With this rulemaking, we are incorporating the American National Standards Institute (ANSI) standards ANSI/CAN/UL 12402–5 for Level 50 and Level 70 personal flotation devices (PFDs), ANSI/CAN/UL 12402–4 for Level 100 PFDs, and ANSI/CAN/UL 9595 for quality assurance. In addition, we are incorporating the ANSI/UL 1123 and ANSI/UL 1175 standards for marine buoyant devices and inherently buoyant and inflatable throwable PFDs, respectively. The Coast Guard currently approves some inherently buoyant and inflatable throwable PFDs that meet PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 these standards because we have determined that a throwable PFD meeting the requirements in ANSI/UL 1123 or ANSI/UL 1175 provides an equivalent level of safety as a throwable PFD currently described in 46 CFR 160.064. Therefore, incorporating these standards in the Code of Federal Regulations (CFR) will not result in any changes in practice but will improve transparency. We are also removing portions of title 46 in part 160 of the CFR, where the new incorporated standards supersede the previous standards or requirements. Additionally, we are adding amendments to lifesaving equipment carriage requirements that permit the use of Level 50, Level 70, and Level 100 PFDs approved to the new standards. The Coast Guard actively participates in the development of ANSI-accredited industry consensus standards for lifesaving equipment. In that capacity, the Coast Guard worked with Transport Canada and United States and Canadian stakeholders in the development of the suite of harmonized ANSI/CAN/UL standards to streamline the process for approval of PFDs. Additionally, the harmonization allows manufacturers the opportunity to produce more innovative equipment that meets approval requirements in both Canada and the United States. On September 22, 2014, the Coast Guard published a final rule in the Federal Register titled Personal Flotation Devices Labeling and Standards (79 FR 56491).1 That rule removed references to type codes in its regulations on the carriage and labeling of Coast Guard approved PFDs to facilitate the future incorporation by reference (IBR) of new industry consensus standards. In April 2017, the Coast Guard and Transport Canada signed a Memorandum of Understanding outlining an intended cooperation for the approval of personal lifesaving appliances that comply with mutually acceptable standards, are tested by mutually accepted conformity assessment bodies or independent test laboratories, and are covered by a mutually acceptable follow-up program.2 On April 3, 2012, the Coast Guard published a final rule titled Inflatable Personal Flotation Devices (77 FR 19937), incorporating by reference updated revisions of industry consensus 1 https://www.federalregister.gov/documents/ 2014/09/22/2014-22373/personal-flotation-deviceslabeling-and-standards (last accessed November 15, 2024). 2 https://downloads.regulations.gov/USCG-20180565-0002/content.pdf (last accessed November 15, 2024). E:\FR\FM\06DER3.SGM 06DER3 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations standards for PFDs including UL 1180, ‘‘UL Standard for Safety for Fully Inflatable Recreational Personal Flotation Devices,’’ Second Edition (including revisions through December 3, 2010).3 The discussion and response to comments in that rulemaking included a discussion on inflatable PFDs for users less than 16 years of age. UL 1180 limits the approval of inflatable PFDs to persons of at least 16 years of age, and thus the 2012 final rule retained that age limit for approved users of inflatable PFDs. No age limit was included in the regulatory text to allow for a possible future rulemaking to incorporate by reference a standard that sufficiently addresses the needs of younger wearers. On August 17, 2018, the Coast Guard published a notice in the Federal Register (83 FR 41095) regarding a policy letter and deregulatory savings analysis on accepting the standard ANSI/CAN/UL 12402–5 for Level 70 PFDs, not including inflatable PFDs for use by persons less than 16 years old.4 On November 15, 2019, the Coast Guard published a notice (84 FR 62546) that finalized this policy.5 lotter on DSK11XQN23PROD with RULES3 III. Discussion of Comments On April 7, 2023, the Coast Guard published a notice of proposed rulemaking (NPRM) titled Lifejacket Approval Harmonization (88 FR 21016) requesting comments on the proposed changes implemented by this final rule.6 In response to the NPRM, we received 390 written submissions, nearly all of which were supportive of this rulemaking. Several commenters observed that performance-based standards such as those incorporated by this final rule allow manufacturers to design more innovative, comfortable, and stylish personal flotation devices and give manufacturers more flexibility when selecting materials, design, and construction. Others commented that aligning standards with Canada would promote consistency and enhance boating safety through improved lifejacket usage. We appreciate these supportive comments. We received 370 comments as part of a write-in campaign. Of these comments, 368 were identical or nearly 3 https://www.federalregister.gov/documents/ 2012/04/03/2012-7791/inflatable-personalflotation-devices (last accessed November 15, 2024). 4 https://www.federalregister.gov/documents/ 2018/08/17/2018-17799/lifejacket-approvalharmonization. (last accessed November 7, 2024). 5 https://www.federalregister.gov/documents/ 2019/11/15/2019-24836/lifejacket-approvalharmonization. (last accessed November 7, 2024). 6 https://www.federalregister.gov/documents/ 2023/04/07/2023-06504/lifejacket-approvalharmonization. (last accessed November 7, 2024). VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 identical in content and supported the harmonization of lifejacket standards between the United States and Canada. The commenters noted several benefits of harmonization, including streamlined processes, reduced costs, and enhanced cooperation between the United States and Canada. Two commenters submitted comments that were nearly identical to the content of the write-in comments but offered opposition or an additional comment. One commenter used the supportive content of the write-in letter but indicated he was writing against the proposed changes. This commenter did not offer any reasoning for opposing the changes and cited the same benefits of harmonization as the other write-in commenters. The other commenter wrote ‘‘not in support’’ of the rule, but also used the full text of the write-in letter, including the referenced benefits of harmonization. However, this commenter added a comment that urged the Coast Guard to actively develop our own standard. The standards were not developed solely by Canada, but also by the Coast Guard, Transport Canada, and industry organizations from both countries working in coordination. The Coast Guard actively participates in the development of lifejacket standards, including the standards being incorporated here. One commenter suggested that if the new Level 50 devices do result in increased lifejacket usage and thus more lives saved, then the Coast Guard should consider mandating lifejacket wear in other circumstances. We may consider this suggestion for a future rulemaking. One commenter questioned why 33 CFR subchapters N and NN were omitted from this rulemaking. These subchapters are out of scope for this rulemaking. Lifejackets approved under approval series 160.255 will not satisfy the requirements of 33 CFR 142.45 or 149.316 at this time. However, we thank the commenter and may consider updates to subchapters N and NN in a future rulemaking. One commenter questioned what this rule means for current PFD devices, and specifically wondered if PFDs currently in use will need to be replaced. As explained in this preamble, PFDs that satisfied carriage requirements prior to publication of this final rule will continue to do so. It is not necessary for owners and operators to purchase new equipment if their current equipment is in good and serviceable condition. One commenter stated that PFDs should not be mandated by any government. The Coast Guard considers PO 00000 Frm 00003 Fmt 4701 Sfmt 4700 97357 PFDs critical lifesaving equipment, for each person on each vessel. With this rulemaking, the Coast Guard amends current carriage requirements to include new approval series to allow owners, operators, and users the option of using PFDs approved to newly incorporated standards. We have not modified the requirement to carry PFDs; doing so would be outside the scope of this rulemaking. One commenter noted that several subsections of the proposed rule reference 46 CFR 159.010, which in turn includes references to the older International Organization for Standardization (ISO) standard ISO/IEC 17025:2005 (covering accreditation of third party independent laboratories), with ISO/IEC 17025:2017 being the most current standard. The Coast Guard thanks the commenter for their thorough review, but criteria for acceptance, recognition, and accreditation of third party independent laboratories are outside the scope of this rulemaking project. Therefore, we did not make changes in response to this comment. One commenter fully supported the rulemaking but suggested some minor corrections. The commenter noted that § 160.077 is referenced in §§ 199.620 and 169.539, but those sections do not include an additional effective date requirement. We did not make changes in response to this comment. The Coast Guard does not believe it is necessary to include an effective date requirement in either of those sections, since an effective date is only needed in sections mentioning a commercial hybrid PFD. The commenter also noted that the definition of inspector in 46 CFR 160.060–3 references § 160.255–15, but instead should reference § 160.060–15. That was an error in the NPRM which is corrected in this final rule. In addition to the reference in § 160.060– 3 identified by the commenter, we discovered similar errors in §§ 160.055– 3 and 160.064–3 and corrected the reference in those sections. One commenter stated that the changes proposed in the NPRM were ‘‘great’’ but sought clarification on the replacement of the two-word term ‘‘life jacket’’ with the one-word term ‘‘lifejacket’’ and asked us to use the twoword term rather than the proposed oneword term. The commenter asserted that the two-word term has always been used in the United States and suggested this clarification avoids the appearance that this document is proposing that the United States needs to change the way the term ‘‘life jacket’’ is spelled in so many other places. We did not make changes based on this suggestion. The two-word term has not always been E:\FR\FM\06DER3.SGM 06DER3 lotter on DSK11XQN23PROD with RULES3 97358 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations used in the United States. The Coast Guard, industry, stakeholders, and user groups use the terms ‘‘lifejacket’’ and ‘‘life jacket’’ interchangeably. In the NPRM, the Coast Guard proposed to standardize the term to the one-word variation and we are finalizing that proposal here. We specifically selected the one-word term for use in our regulations to align with the use of the one-word term in the ANSI/CAN/UL 12402 standard, which is one of the standards incorporated by reference. However, industry, stakeholders, and user groups can continue to use the term ‘‘life jacket’’ if that is their preference. One commenter fully supported the rule, specifically noting that PFDs would become stylish, comfortable, and appealing to the boating public, ultimately saving lives because they will wear them. The commenter suggested that the Coast Guard should permit anyone over 13 years old to wear an inflatable PFD to fulfill the mandated PFD carriage requirements. We agree with the commenter. The proposed rule did not include an age restriction for inflatable PFDs, which is finalized in this final rule. One commenter noted that there seemed to be inconsistencies in the proposed requirements for back-up chambers, specifically that back-up chambers are required for lifejackets in 46 CFR 117.71 and 180.71 but not elsewhere. Another commenter requested clarification on why back-up chambers are required for lifejackets in 46 CFR 117.71, 180.71, and 199.620, but not 46 CFR 141.340.7 These differences are intentional. Because the incorporated standard ANSI/CAN/UL 12402–4 does not require back up chambers for inflatable Level 100 lifejackets, the proposed rule included the additional requirement that inflatable Level 100 lifejackets must have a back-up chamber to meet carriage requirements for passenger vessels, and this final rule retains that requirement. One commenter supported the amendments to Requirements for Instruction Pamphlets for PFDs and suggested that the Coast Guard engage the Technical Committee 1123 to develop a ‘‘label standard’’ to address outstanding issues, such as the prospect that the placard would not effectively replace the pamphlet for products with legacy labels. The Coast Guard is fully engaged in UL Technical Committee 1123—Personal Flotation Devices and 7 The commenter actually specified 46 CFR 141.349, a section which does not exist. From context, we assume this was a typographical error and the commenter actually meant 46 CFR 141.340. VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 would be open to the development of a label standard in the future. The Coast Guard notes the suggestion from another commenter to include an icon on the lifejacket itself indicating Coast Guard approval. While there is no Coast Guard icon required to be printed directly on the device, the device must be marked with the words ‘‘USCG Approved’’ followed by the unique approval number and must also be marked with the laboratory’s certification mark. Additionally, the information placard at the point of sale clearly indicates with a check mark if the device is Coast Guard approved. IV. Discussion of the Rule A. General Discussion By means of this final rule, the Coast Guard makes seven main amendments to our regulations: (1) Adding new subpart 160.255, which incorporates by reference ANSI/ CAN/UL 12402–4 for approval of Level 100 PFDs, and removing sections of subpart 160.055 related to materials and construction, marking, and procedure for approval because no new approvals will be granted under approval series 160.055; (2) Adding new subparts 160.264 (Wearable Recreational PFDs) and 160.276 (Wearable Recreational Inflatable PFDs), both of which incorporate by reference ANSI/CAN/UL 12402–5 for approval of Level 50 and Level 70 PFDs without additional buoyancy or age restrictions; removing the sections of subparts 160.060, 160.064, and 160.076 pertaining to the approval of new wearable PFDs; relocating the sections pertaining to throwable PFDs from subpart 160.064 to new subpart 160.045 and incorporating by reference ANSI/UL 1123 and ANSI/ UL 1175; and removing subpart 160.077 (Hybrid Inflatable PFDs) in its entirety; (3) Incorporating by reference ANSI/ CAN/UL 9595 for quality assurance requirements in subparts 160.045, 160.055, 160.060, 160.064, 160.076, 160.255, 160.264, and 160.276; (4) Removing subparts 160.001, 160.002, 160.005, 160.006, 160.047, 160.048, and 160.052, as these subparts are mostly or entirely obsolete, and moving the remaining relevant material from subpart 160.001 to subpart 160.055; (5) Amending lifesaving equipment carriage requirements to include the new approval categories, where appropriate, and removing any remaining references to type codes; (6) Amending the requirements for instruction pamphlets for PFDs to also include the placard specified in part 181 PO 00000 Frm 00004 Fmt 4701 Sfmt 4700 subpart G in subparts 160.055, 160.060, 160.076, 160.255, 160.264, and 160.276, while retaining the option of instruction pamphlets for lifejackets approved under subparts 160.055, 160.060, 160.064, and 160.076; and (7) Amending the existing regulatory text to make editorial corrections and increase clarity. We provide additional details and discussion on each of these seven main categories of amendments below. Under 46 U.S.C. 4302(b), the effective (implementation) date of provisions in this final rule applying to recreational vessels must be at least 180 days after publication. For simplicity, the implementation date of the entire rule will be 180 days after the date of publication. While we have specified an effective date 30 days after publication of this final rule, we have also specified that we will not enforce these regulations until 180 days after publication in the DATES section above. We consulted the National Boating Safety Advisory Committee (NBSAC) regarding the updated standards in this rule, as shown by NBSAC Resolutions 2009–83–01 8 and 2011–87–01,9 and the revalidation of those resolutions found in Resolution 2022–03–01.10 1. Add New Subpart, 46 CFR 160.255, Incorporate by Reference ANSI/CAN/UL 12402–4, and Remove Sections of Subpart 160.055 We are adding a new subpart, 160.255, to 46 CFR. PFDs approved under this new subpart meet the carriage requirements for wearable PFDs for three groups: (1) inspected vessels; (2) uninspected commercial vessels over 40 feet (12m) in length; and (3) uninspected passenger vessels. New subpart 160.255 contains structural and performance requirements for approval of Level 100 PFDs, as well as requirements for production inspections and quality control, markings, information pamphlets, and associated manuals. ANSI/CAN/UL 12402–4 is incorporated by reference. PFDs approved under this subpart rely upon inherently buoyant material, inflation, or a combination of 8 Available at https://homeport.uscg.mil/Lists/ Content/Attachments/449/NBSAC%20Resolution %202009-83-01%20Changes%20to% 20Approval%20Process%20for%20PFD_s.pdf (last accessed November 12, 2024). 9 Available at https://homeport.uscg.mil/Lists/ Content/Attachments/459/NBSAC%202011-8701%20-%20Signed_2.pdf (last accessed November 12, 2024). 10 Available at https://homeport.uscg.mil/Lists/ Content/Attachments/75876/Recommendation2022-03-01--Signed.pdf (last accessed November 12, 2024). E:\FR\FM\06DER3.SGM 06DER3 lotter on DSK11XQN23PROD with RULES3 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations the two to achieve the minimum buoyancy. A Level 100 PFD has the same basic requirements as a PFD meeting current 46 CFR 160.055 (life preservers). The minimum amount of buoyancy, basic mechanical properties, and in-water performance requirements are the same. However, ANSI/CAN/UL 12402–4 is less prescriptive regarding the design requirements of a Level 100 PFD, so manufacturing firms can develop more innovative designs. The marking requirements in ANSI/CAN/UL 12402– 4 specify pictorial graphics to communicate the performance of the PFD and warnings for use. The Coast Guard conducted research and focus groups to identify issues with the Type code labels and to evaluate multiple new pictorial labeling options. Our research indicated that people consistently preferred pictorial markings.11 Therefore, we expect this marking format to be more easily understandable to both Englishspeaking and non-English-speaking populations. ANSI/CAN/UL 12402–4 does not require fully or partially inflatable Level 100 PFDs to provide redundant back-up inflation chambers. Current regulations require inflatable lifejackets under approval series 160.176 to have at least two inflation chambers 12 and to reach minimum in-water performance with any one chamber deflated.13 These inflatable lifejackets meet the International Maritime Organization Life-Saving Appliance Code and are intended for use on vessels subject to SOLAS. Back-up chambers were originally required for inflatable lifejackets intended for use on inspected vessels as an additional safety measure in case the primary inflation chamber failed to inflate (see 54 FR 50316, 50322, Dec. 5, 1989). In the 1989 interim final rule ‘‘Approval of Inflatable Lifejackets’’ preamble, the Coast Guard noted that we would continue discussions with industry, standards organizations, and state boating law administrators regarding the reliability of inflatable PFDs (54 FR 50317). We also indicated that when new developments or innovations reduced the risk of inflation failure to an acceptable level, we could address this issue with a subsequent rulemaking. Since the publication of that rule in 1989, the Coast Guard has no evidence that a well-maintained PFD 11 ‘‘Revision of Labeling and Classification for Personal Flotation Devices (PFDs),’’ Applied Safety & Ergonomics, Inc., December 28, 2004, Young et al. 12 46 CFR 160.176–9(a)(1). 13 46 CFR 160.176–13(j)(3). VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 with a single inflation chamber is less reliable in the event of an emergency than an inherently buoyant PFD. Additionally, the Coast Guard has approved inflatable PFDs without backup chambers under approval series 160.076. Such devices have been in use in the United States on uninspected commercial vessels less than 12 meters in length, and by recreational vessels and in Canada on small vessels, for over a decade. Therefore, the Coast Guard believes that the material testing of the PFD components coupled with the required annual servicing of inflatable Level 100 PFDs is sufficient, and that redundant back-up inflation chambers are not necessary to provide an equivalent level of safety to PFDs meeting current 46 CFR 160.055. Because new subpart 160.255 supersedes the requirements for life preservers in subpart 160.055, we are removing structural and performance requirements for approval of life preservers in subpart 160.055, but maintaining the requirements for production inspections, tests, and quality assurance. Manufacturers can continue to produce life preservers currently approved under subpart 160.055, while all new lifejackets will require Coast Guard approval under new subpart 160.255. At the same time, we are restructuring subpart 160.055 to include a statement of the subpart’s scope and to mirror the structure of other PFD-related subparts. We are adding sections for scope in § 160.055–1 and definitions in § 160.055–3, and standards incorporated by reference are moved from § 160.055– 1 to § 160.055–5. Because no new approvals are granted under § 160.055, we are removing existing requirements for materials and construction, marking, and procedure for approval, including current 46 CFR 160.055–3, 160.055–4, 160.055–5, 160.055–6, 160.055–8, and 160.055–9. We are adding independent laboratory requirements in new § 160.055–11. We move sampling, tests, and inspections from § 160.055–7 to newly created § 160.055–15 and include pamphlet requirements in new § 160.055–19. We include procedures for the approval of design or material changes in new § 160.055–23 and information on suspension or termination of approval in new § 160.055–25. PO 00000 97359 2. Add New Subparts 46 CFR 160.045, 160.264, and 160.276, Incorporate by Reference ANSI/CAN/UL 12402–5, ANSI/UL 1123, and ANSI/UL 1175, Remove Sections of Subparts 160.060, 160.064, and 160.076, and Remove Subpart 160.077 in Its Entirety We are adding three new subparts in 46 CFR: 160.045, 160.264, and 160.276. PFDs approved under these subparts meet the carriage requirements for recreational boats, in accordance with 33 CFR part 175. Wearable PFDs approved under subparts 160.264 and 160.276 also meet the carriage requirements for uninspected commercial vessels less than 40 feet (12m) in length and not carrying passengers for hire in accordance with 46 CFR subpart 25.25. New subpart 160.264 contains structural and performance requirements for approval of Level 50 and Level 70 inherently buoyant PFDs, as well as requirements for production inspections and quality control, markings, information placards, and associated manuals. New subpart 160.276 contains structural and performance requirements for approval of Level 50 and Level 70 fully and partially inflatable recreational PFDs, as well as requirements for production inspections and quality control, associated manuals, information placards, and markings. ANSI/CAN/UL 12402–5 is incorporated by reference in both subparts. ANSI/CAN/UL 12402–5 prescribes minimum performance requirements instead of prescribing design requirements. This performance-based standard allows manufacturing firms to design more innovative, comfortable, and stylish PFDs. New PFD designs could lead to more individuals choosing to wear their PFDs, resulting in fewer drownings.14 Drowning is the leading cause of death in recreational boating accidents, accounting for 79 percent of all recreational boating casualties where the cause of death is known.15 Of those 14 Readers should reference the National Center for Biotechnology Information, which is part of the National Library of Medicine at the National Institutes of Health (NIH), and perform a literature search for articles on the topic of PFDs and their usage. Readers can access this website at https:// pubmed.ncbi.nlm.nih.gov. More specifically, readers should reference the following articles for further information: ‘‘Personal, social, and environmental factors associated with lifejacket wear in adults and children: A systematic literature review’’ (https://www.ncbi.nlm.nih.gov/pmc/ articles/PMC5931488) and ‘‘Barriers to life jacket use among adult recreational boaters.’’ (https:// www.ncbi.nlm.nih.gov/pmc/articles/PMC4310692) (last accessed April 23, 2024). 15 United States Coast Guard, ‘‘2019 Recreational Boating Statistics.’’ https://safe.menlosecurity.com/ Continued Frm 00005 Fmt 4701 Sfmt 4700 E:\FR\FM\06DER3.SGM 06DER3 97360 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations lotter on DSK11XQN23PROD with RULES3 who drowned, 86 percent were not wearing lifejackets. Wearing a lifejacket is one of the best means available of preventing accidental drowning in recreational boating. Unfortunately, recreational boaters only wear lifejackets about 24 percent of the time.16 Discomfort, whether real or perceived, is negatively associated with PFD wear.17 ANSI/CAN/UL 12402–5 allows manufacturers more flexibility when selecting materials, design, and construction of new PFDs. Because manufacturers will be less limited in the materials, design, and construction, we expect that new PFDs might be slimmer, lighter in weight, or more comfortable to wear than PFDs approved under the current requirements. In our 2018 policy letter, CG–ENG Policy 02–18, titled Adoption of ANSI/ CAN/UL 12402–5 and 9,18 the Coast Guard determined that Level 70 inherently buoyant devices, Level 70 inflatable devices, and Level 70 multichamber devices that meet the requirements of ANSI/CAN/UL 12402–5 provide equivalent performance to wearable PFDs meeting the requirements in current 46 CFR 160.064 or 160.076.19 The Coast Guard has now determined that a Level 50 PFD, when worn and used in accordance with the label, provides an equivalent level of safety as a wearable PFD that meets current subpart 160.064 or 160.076 requirements. A Level 50 PFD has a lower minimum amount of buoyancy than the current minimum requirement for Coast Guard approved PFDs. However, ANSI/CAN/UL 12402–5 requires that a Level 50 PFD keep the user’s airway above the water, as demonstrated by in-water performance testing. A Level 50 PFD is intended for use by those who can swim and who have help or rescue nearby. As required doc/docview/viewer/docN0C8787B5BC27 b941976de80db865a89b27e43db4732447826e405 d5b93b8a0a1dd64625cf817 (last accessed April 23, 2024). 16 United States Coast Guard, ‘‘2019 Life Jacket Wear Rate Observation Study.’’ https:// uscgboating.org/library/national-live-jacket-wearstudy/2019-Life-Jacket-Wear-Rate-Report.pdf (last accessed April 23, 2024). 17 Amy Peden, Daniel Demant, Martin Hagger, and Kyra Hamilton, ‘‘Personal, social, and environmental factors associated with lifejacket wear in adults and children: A systematic literature review.’’ https://www.ncbi.nlm.nih.gov/pmc/ articles/PMC5931488/ (last accessed April 23, 2024). 18 https://www.dco.uscg.mil/Portals/9/ DCO%20Documents/5p/5ps/Design%20and%20 Engineering%20Standards/Life%20Saving%20 and%20Fire%20Safety/Docs/L%20A%20HARM% 20POLICY%2020180801-Signed.pdf?ver=2018-0801-131843-173 (last accessed April 23, 2024). 19 83 FR 41095 VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 in ANSI/CAN/UL 12402–5, Level 50 PFDs must be marked: ‘‘Not recommended for weak or nonswimmers.’’ Every PFD offered for sale must have a placard providing users with information on how to select the appropriate PFD and reminding users to try the PFD on in the water to ensure proper fit and performance. To satisfy requirements of ANSI/CAN/UL 12402– 5, Level 50 PFDs must be worn and must be marked: ‘‘Approval conditions state that this device must be worn to be counted as equipment required by vessels meeting Transport Canada or USCG regulations.’’ A Level 50 PFD, when worn by a person who can swim and used in accordance with ANSI/ CAN/UL 12402–5, provides an equivalent level of safety as a PFD meeting the current requirements in 46 CFR 160.064 or 160.076. By approving Level 50 PFDs, the Coast Guard provides a critical level of oversight to the currently unregulated Level 50 competition watersports PFDs, resulting in safer products for the public. In this final rule, we are not adding requirements that limit users of inflatable PFDs based on age. There are already requirements in ANSI/CAN/UL 12402–5 addressing inflatable PFDs for users less than 16 years of age. To be certified as meeting ANSI/CAN/UL 12402–5, an inflatable PFD intended for wearers less than 16 years of age must automatically inflate, must not require secondary donning, must be worn, and must include a warning statement about adult supervision. The Coast Guard believes these requirements are adequate to ensure safety for wearers less than 16 years of age, so we are fully incorporating ANSI/CAN/UL 12402–5 without any additional age restrictions beyond those included in the standard. New subparts 160.264 and 160.276 supersede the requirements for foam buoyant vests in subpart 160.060, marine buoyancy devices in subpart 160.064, inflatable recreational personal flotation devices in subpart 160.076, and hybrid inflatable personal flotation devices in subpart 160.077. We are removing the structural and performance requirements for the approval of foam buoyant vests, marine buoyant devices, and inflatable recreational flotation devices in subparts 160.060, 160.064, and 160.076, respectively, but retaining the requirements for production inspections, tests, and quality control of wearable PFDs. We are deleting subpart 160.077 entirely and modifying the scope of subpart 160.076 to include PFDs previously approved under subpart 160.077. By retaining the requirements for production PO 00000 Frm 00006 Fmt 4701 Sfmt 4700 inspections, tests, and quality control, we ensure that manufacturing firms producing PFDs currently approved under approval series 160.060, 160.064, 160.076, or 160.077 can continue to manufacture and sell these PFDs, but the Coast Guard will not approve new products under these approval series. At the same time, we are reformatting the remaining text of subparts 160.060, 160.064, and 160.076, without amending the language, to align with the other subparts related to PFDs and increase the ease of understanding for the reader. To eliminate confusion over approval categories, we are relocating the requirements for throwable PFDs from subpart 160.064 to new subpart 160.045. The new subpart 160.045 is dedicated to throwable PFDs intended for carriage on recreational boats. We permit the use of inflatable compartments to meet the minimum required buoyancy in § 160.045–7. This new subpart incorporates by reference the ANSI/UL 1175 standard for inherently buoyant and inflatable throwable PFDs and the ANSI/UL 1123 standard for marine buoyant devices. The Coast Guard already approves throwable PFDs to these standards; we are formally incorporating them by reference in this rulemaking to increase clarity and transparency of the approval requirements. 3. Incorporate by Reference ANSI/CAN/ UL 9595 We are incorporating by reference new industry consensus standard ANSI/ CAN/UL 9595, ‘‘Standard for factory follow-up of Personal Flotation Devices (PFDs)’’ (First Edition, June 4, 2020), into subparts 160.045, 160.055, 160.060, 160.064, 160.076, 160.255, 160.264, and 160.276. This standard covers the basic elements of a production inspection program for various types of PFDs. The Coast Guard currently requires a satisfactory follow-up (production testing and inspection) program administered by an independent laboratory recognized by the Coast Guard for each approved PFD. A task group of experts and stakeholders convened over the past decade to develop ANSI/CAN/UL 9595 to improve the consistency of follow-up programs among different recognized independent laboratories and to provide a binational harmonized standard for production testing acceptable to the Coast Guard and Transport Canada. ANSI/CAN/UL 9595 establishes a set of Process Ratings (A, B, and C) based on the quality management system (QMS) at each facility. Process Rating A is reserved for facilities that have E:\FR\FM\06DER3.SGM 06DER3 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations lotter on DSK11XQN23PROD with RULES3 demonstrated a superior QMS meeting ISO standard ISO 9001. Process Rating B is assigned to facilities with a good QMS including a Quality Manual that incorporates the requirements in ANSI/ CAN/UL 9595 but is not approved by a third party. Process Rating C provides a minimum requirement for production inspections that is equivalent to current industry practice for follow-up programs and meets the minimum requirements currently accepted by the Commandant. At Process Ratings A and B, ANSI/ CAN/UL 9595 provides the option for the manufacturer to implement a QMS to reduce the number of inspections required. ANSI/CAN/UL 9595 lists roles and responsibilities; required tests, sample sizes, and acceptability criteria; and specific requirements for inspection frequency, traceability of components, critical dimensions verification, visual inspection of completed PFDs, and review of records. Annex A provides test methods and Annex B provides information on the elements of a QMS. We include ANSI/CAN/UL 9595 in the new subparts 160.045, 160.255, 160.264, and 160.276 and in existing subparts 160.055, 160.060, 160.064, and 160.076, to allow manufacturers that implement a QMS to be evaluated as Process Rating A or B, resulting in fewer required inspections. A QMS can result in greater production consistency, a reduction in defects and errors, increased efficiency, and continuous improvement. 4. Remove Obsolete Material and Relocate Pertinent Material We are removing subparts 160.002, 160.005, 160.006, 160.047, 160.048, and 160.052, while also removing or relocating the entirety of subpart 160.001. Subpart 160.001 provides general requirements for all life preservers. Most of this information is either obsolete or found elsewhere in the CFR. We are removing subpart 160.001, while preserving the stillpertinent information on production oversight by relocating it to § 160.055– 15. Subpart 160.006 provides two paragraphs related to the repairing of life preservers. Subpart 160.006 is no longer relevant and is not referenced in any approval or carriage requirement; therefore, we are removing it. Subparts 160.002, 160.005, 160.047, and 160.048 provide specifications and requirements for kapok and fibrous glass life preservers. Subpart 160.052 provides specifications and requirements for a unicellular plastic foam buoyant vest. Manufacturers no longer produce any of these types of life VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 preservers due to the unavailability of material, the advancement of foam technology, and improvements to the fit and function of PFDs industry-wide. With no current approvals for equipment under any of these subparts, these approval categories have become obsolete. Therefore, we are removing subparts 160.002, 160.005, 160.047, 160.048, and 160.052. All new PFD approvals will have to meet the requirements in subparts 160.255, 160.264, and 160.276, which incorporate current industry standards. 5. Amend Lifesaving Equipment Carriage Requirements Where existing carriage requirements specify approval series for PFDs, we are adding the new approval series, as applicable. The affected subchapters are subchapter C (Uninspected Commercial Vessels), subchapters K and T (Small Passenger Vessels), subchapter L (Offshore Supply Vessels), subchapter M (Towing Vessels), and subchapter W (Lifesaving Appliances for Certain Inspected Vessels). If we identify other affected subchapters in the future, we could address them in a future rulemaking or guidance document. For example, according to the existing requirements under subchapter C, an uninspected vessel carrying passengers for hire must have at least one PFD approved under approval series 160.055, 160.155, or 160.176 for each person on board (46 CFR 25.25–5). We are adding approval series 160.255 to the list of approval series to permit the use of PFDs approved under this new approval series. We are not removing any of the currently accepted approval series from the carriage requirements. Therefore, it will not be necessary for owners and operators to purchase new equipment if their current equipment is in good and serviceable condition. We are also removing references to PFDs approved under approval series 160.177 because there have never been any approvals granted under that series. All new commercial PFDs, including commercial hybrid PFDs, will be approved under approval series 160.255. 6. Amend the Requirements for Instruction Pamphlets for PFDs We are amending the requirements for instruction pamphlets for PFDs in 33 CFR 181 to allow both pamphlets and placards to meet the requirements for information furnished with each PFD sold or offered for sale for use on recreational boats. As previously described, we are incorporating both ANSI/CAN/UL 12402–4 and ANSI/ CAN/UL 12402–5 with respect to the PO 00000 Frm 00007 Fmt 4701 Sfmt 4700 97361 approval of PFDs. Both standards require that a PFD include an informational placard in a pictographic format containing specific information on PFD performance, selection, approval, and maintenance, as well as general water safety information. To permit the placard to be used in place of the currently required pamphlet, the Coast Guard is adding the term ‘‘placard’’ to 33 CFR 181.702. We are also removing 33 CFR 181.703, which requires that placards conform with UL 1123, and adding text to 33 CFR 181.702 specifying that a pamphlet or placard must meet the requirements in the applicable subpart of 46 CFR part 160 or be accepted by the Commandant. All currently approved PFDs have pamphlets or placards that have been accepted by the Commandant. Removing 33 CFR 181.703 eliminates all references to UL 1123 in this subpart, so we are removing 33 CFR 181.4, which incorporates that standard, as well. Finally, we are removing the separate requirements for hybrid and inflatable PFDs in 33 CFR 181.704 and 181.705, respectively, and including requirements for all PFDs in 33 CFR 181.702. 7. Amend the Existing Regulatory Text To Make Editorial Corrections and Increase Clarity We are updating the introductory IBR text, in accordance with current practice, in 46 CFR 160.055, 160.060, 160.064, and 160.076. We are amending Table 28.110 to replace ‘‘Do’’ (meaning ‘‘ditto’’) with the actual text to clarify the requirements in plain language, and to remove references to type codes from the table without modifying the intent or application of the requirements. We are also removing reference to approval series 160.177 in 46 CFR 108, 133 and 199 because this approval series has never been used, and removing outdated provisions allowing cork and balsa wood lifejackets until March 11, 1999, from 46 CFR 117 and 180. Finally, we are consistently using the term ‘‘lifejacket’’ by amending instances of ‘‘life jacket’’ from two words to one. B. Standards Incorporated by Reference To Be Updated or Added Following this paragraph, we include an alphabetical list of the standards we are adding, each with a listing of the sections in which they appear in 46 CFR. For each standard listed, we describe the topics covered by the standard, the edition adopted, and a list of subparts or sections that reference the standard. • ANSI/CAN/UL 9595, Standard for Safety Factory Follow-Up on Personal E:\FR\FM\06DER3.SGM 06DER3 lotter on DSK11XQN23PROD with RULES3 97362 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations Flotation Devices (PFDs), First Edition, June 4, 2020 (including revisions through September 9, 2021). This standard is incorporated by reference in §§ 160.045–15, 160.055–15, 160.060–15, 160.064–15, 160.076–29, 160.255–15, 160.264–15, and 160.276–15. This binational standard covers the basic elements of a production inspection program for various types of PFDs, and formalizes and modifies current industry standards. • ANSI/CAN/UL 12402–4, Standard for Safety Personal Flotation Devices— Part 4: Lifejackets, Performance Level 100—Safety Requirements, First Edition, July 9, 2020. This standard is incorporated by reference in §§ 160.255–7, 160.255–13, 160.255–17, 160.255–19, and 160.255–21. This binational standard specifies the safety requirements for lifejackets that provide face-up flotation for use in sheltered or calm water, where users may have to wait for rescue. A lifejacket meeting the requirements of ANSI/CAN/UL 12402–4 provides an equivalent level of safety to a lifejacket currently approved under current 46 CFR subpart 160.055. • ANSI/CAN/UL 12402–5, Standard for Safety Personal Flotation Devices— Part 5: Buoyancy Aids (Level 50)— Safety Requirements, First Edition, December 31, 2015 (including revisions through January 27, 2022). This standard is incorporated by reference in §§ 160.264–7, 160.264–13, 160.264–17, 160.264–19, 160.264–21, 160.276–7, 160.276–13, 160.276–17, 160.276–19, and 160.276–21. This binational standard specifies the safety requirements for buoyancy aids used in sheltered waters with help and rescue nearby. A PFD meeting the requirements of ANSI/CAN/UL 12402–5 provides an equivalent level of safety as a PFD currently approved under 46 CFR 160.064 or 160.076. • ANSI/UL 1123, Standard for Safety Marine Buoyant Devices, Seventh Edition, October 1, 2008 (including revisions through November 23, 2020). This standard is incorporated by reference in §§ 160.045–7 and 160.045– 13. ANSI/UL 1123 provides requirements for Type II, Type III, and Type IV marine buoyant devices, including vests, jackets, horseshoe buoys and ring buoys, with or without lifelines, intended for recreational use, and throwable cushions. • ANSI/UL 1175, Standard for Safety Buoyant Cushions, Fourth Edition, April 20, 2007 (including revisions through January 10, 2020). This standard is incorporated by reference in §§ 160.045–7 and 160.045–13. This standard provides requirements for throwable PFDs using inherent or VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 inflatable buoyancy that are intended to be used in accordance with applicable Coast Guard regulations. C. Standards Incorporated by Reference To Be Removed Following this paragraph, we include an alphabetical list of the standards we are removing as a result of this final rule. These standards are being removed because the regulatory text applying to these standards has been removed, and the newly incorporated standards supersede and replace these standards. • ASTM B117–97, Standard Practice for Operating Salt Spray (Fog) Apparatus. • ASTM D413–82, Standard Test Methods for Rubber Property— Adhesion to Flexible Substrate. • ASTM D570–95, Standard Test Method for Water Absorption of Plastics. • ASTM D751–95, Standard Test Method for Coated Fabrics. • ASTM D882–97, Standard Test Method for Tensile Properties of Thin Plastic Sheeting. • ASTM D1004–94a, Standard Test Method for Initial Tear Resistance of Plastic Film and Sheeting. • ASTM D1434–82 (Reapproved 2009), Standard Test Method for Determining Gas Permeability Characteristics of Plastic Film and Sheeting. • CCC–C–426D, Cloth, Cotton Drill. • CCC–C–700G, Cloth, Coated, Vinal, Coated (Artificial Leather). • Color Names Dictionary, ‘‘The Universal Color Language’’ and ‘‘The Color Names Dictionary’’ in Color: Universal Language and Dictionary of Names, National Institute of Standards Special Publication 440. • Federal Standard No. 595A, Color. • Federal Standards No. 751 and 751A, Stitches, Seams, and Stitchings. • Federal Test Method Standard No. 191, Textile Test Methods, including: Æ Method 5100, Strength and Elongation, Breaking of Woven Cloth; Grab Method; Æ Method 5132, Strength of Cloth, Tearing; Falling-Pendulum Method; Æ Method 5134, Strength of Cloth, Tearing; Tongue Method; Æ Method 5804.1, Weathering Resistance of Cloth; Accelerated Weathering Method; and Æ Method 5762, Mildew Resistance of Textile Materials; Soil Burial Method. • L–P–375 and L–P–375C, Plastic Film, Flexible, Vinyl Chloride. • MIL–C–43006D, Cloth and Strip Laminated, Vinyl-Nylon High Strength, Flexible. • MIL–L–24611(SH), Life Preserver Support Package for Life Preserver, MK 4. PO 00000 Frm 00008 Fmt 4701 Sfmt 4700 • MIL–B–2766 and MIL–R–2766B, Batt, Fibrous Glass, Lifesaving Equipment. • MIL–T–3530E, Thread and Twine; Mildew Resistant or Water Repellant Treated. • MIL–W–530 and MIL–W–530F, Webbing, Textiles, Cotton, General Purpose, Natural and in Colors. • MIL–W–17337D, Webbing, Woven, Nylon. • UL 1123, UL Standard for Safety for Marine Buoyant Devices. • UL 1180, UL Standard for Safety for Fully Inflatable Recreational Personal Flotation Devices. • UL 1191, Components for Personal Flotation Devices. • UL 1517, Standard for Hybrid Personal Flotation Devices. D. Changes to the Regulatory Text From the NPRM As discussed in Section III of this preamble, Discussion of Comments, we corrected three errors in cross-references that were the result of typographical errors in the NPRM. We updated the definition for inspector in 46 CFR 160.055–3 to now cross-reference § 160.055–15 rather than § 160.255–15; in § 160.060–3 to now cross-reference § 160.060–15 rather than § 160.255–15; and in § 160.064–3 to now crossreference § 160.064–15 rather than § 160.264–15. We also corrected the definition for inspector in 46 CFR 160.276–15 to cross-reference § 160.276–15 rather than ‘‘part 15 of this guideline.’’ In § 160.076–1 (‘‘Scope’’), we added a paragraph, (c), to help explain and clarify the applicability of subpart 160.076. We also added additional amendatory instructions that were inadvertently missed in the NPRM. These include removing § 160.076–3 and redesignating § 160.076–3 as § 160.076–5, redesignating § 160.076–11 as § 160.076–5, and revising the newly redesignated § 160.076–5. There are no other changes to the regulatory text from the NPRM. V. Incorporation by Reference Material for incorporation by reference appears in 46 CFR 160.045–5, 160.055–5, 160.060–5, 160.064–5, 160.076–5, 160.255–5, 160.264–5, and 160.276–5 and is summarized in section IV.B of this preamble, Standards Incorporated by Reference to be Updated or Added. Copies of the material are available either at the publisher’s web address listed in the incorporation by reference sections in 46 CFR 160.045–5, 160.055–5, 160.060– 5, 160.064–5, 160.076–5, 160.255–5, 160.264–5, and 160.276–5, or by E:\FR\FM\06DER3.SGM 06DER3 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations contacting the publisher listed for those standards. We reviewed and updated all the publisher’s web addresses listed in the parts to ensure they are current. You may also contact the person in the FOR FURTHER INFORMATION CONTACT section for additional direction on how to obtain access to electronic copies of the materials. We believe industry already has access to and uses these new standards. The affected industry, in particular recognized independent laboratories, typically obtains the most recent editions of standards in the course of their business to address advancements in technology. The Director of the Federal Register approved the material in 46 CFR 160.045–5, 160.055–5, 160.060–5, 160.064–5, 160.076–5, 160.255–5, 160.264–5, and 160.276–5 for incorporation by reference under 5 U.S.C. 552 and 1 CFR part 51. VI. Regulatory Analyses We developed this rule after considering numerous statutes and Executive orders related to rulemaking. We have prepared a full regulatory analysis (RA) based on these statutes and Executive orders and have placed it in the docket where indicated under the ADDRESSES portion of the preamble. A summary of our analysis follows. Where we mention the analysis in the RA, we are referring the reader to the RA in the docket. A. Regulatory Planning and Review Executive Order 12866 (Regulatory Planning and Review), as amended by Executive Order 14094 (Modernizing Regulatory Review), and Executive Order 13563 (Improving Regulation and Regulatory Review) direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of 97363 quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Two additional Executive orders promote the goals of Executive Order 13563: Executive Order 13609 (Promoting International Regulatory Cooperation) and Executive Order 13610 (Identifying and Reducing Regulatory Burdens). Executive Order 13609 targets international regulatory cooperation to reduce, eliminate, or prevent unnecessary differences in regulatory requirements. Executive Order 13610 aims to modernize the regulatory systems and to reduce unjustified regulatory burdens and costs on the public. The Office of Management and Budget (OMB) has not designated this rule a significant regulatory action under section 3(f) of Executive Order 12866, as amended by Executive Order 14094 (Modernizing Regulatory Review). A summary of the RA follows; see the docket for our full analysis. TABLE 1—SUMMARY OF IMPACTS OF THE FINAL RULE Category Summary Applicability ............................................................................................................. IBR of ANSI/CAN/UL 9595, ANSI/CAN/UL 12402–5, and ANSI/CAN/UL 12402–4. Affected Population ................................................................................................. 2 recognized independent laboratories (1 U.S. and 1 foreign), 61 PFD manufacturing firms (39 U.S. and 22 foreign), the Coast Guard, recreational vessel operators, and commercial vessel operators. Costs to American Firms ($2023, 2% discount rate) ............................................. 10-year ................................................... Annualized ............................................. 10-year ................................................... Annualized ............................................. 10-year ................................................... Annualized ............................................. 10-year ................................................... Annualized ............................................. 10-year ................................................... Annualized ............................................. 10-year ................................................... Annualized ............................................. 10-year ................................................... Annualized ............................................. 10-year ................................................... Annualized ............................................. 10-year ................................................... Annualized ............................................. 10-year ................................................... Annualized ............................................. 10-year ................................................... Annualized ............................................. Costs to Foreign Firms ($2023, 2% discount rate) ................................................ Total Costs ($2023, 2% discount rate) ................................................................... Benefits to American Firms ($2023, 2% discount rate) ......................................... Benefits to Foreign Firms ($2023, 2% discount rate) ............................................ Benefits to the United States Government ($2023, 2% discount rate) .................. Total Benefits to All Entities ($2023, 2% discount rate) ......................................... Net Benefits to American Firms ($2023, 2% discount rate) ................................... Net Benefits to Foreign Firms ($2023, 2% discount rate) ...................................... Net Benefits to the United States Government ($2023, 2% discount rate) ........... Net Benefits to All Entities ($2023, 2% discount rate) ........................................... lotter on DSK11XQN23PROD with RULES3 Unquantified Benefits .............................................................................................. VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 PO 00000 Frm 00009 Fmt 4701 Sfmt 4700 $1,865,564 207,687 455,782 50,741 2,321,343 258,427 8,871,985 987,687 2,222,303 247,401 38,895 4,330 11,133,183 1,239,419 7,006,423 780,001 1,766,522 196,661 38,895 4,330 8,811,839 980,991 The newer performance-based standards will allow for the development of more innovative PFD designs that might better meet boaters’ needs. New PFD designs that may be more form fitting, in addition to the requirement that Level 50 devices be worn to count for carriage, could lead to higher PFD wear rates and additional lives saved from drowning. Placards are cheaper to produce than pamphlets and provide pictorial instructions, understandable by non-English reading populations. E:\FR\FM\06DER3.SGM 06DER3 97364 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations lotter on DSK11XQN23PROD with RULES3 By means of this final rule, the Coast Guard harmonizes its approval process for PFDs with that of Canada, resulting in cost savings from eliminating a second set of approval requirements for PFD manufacturers wishing to sell in both Canada and the United States and reducing the required amount of product inspections depending on the quality management system in place at a given manufacturing facility. This rule removes barriers to entry for future innovative personal flotation devices and will save manufacturers money from reducing regulatory burdens without sacrificing quality. On net, the Coast Guard projects that manufacturers and the Coast Guard will save over $1,000,000 annually on reduced production inspections. Additionally, the Coast Guard expects that the introduction of Level 50 devices, coupled with the requirement to wear them if they are to count for the purposes of PFD carriage requirements, will lead to an unquantifiable increase in PFD wear rates among recreational boaters, and thereby potentially decrease the rate of drowning in the event of an accident. Only Coast Guard approved devices are eligible to count for PFD carriage requirements, and, for Level 50 devices to count, they must be worn. The Coast Guard therefore expects that recreational boaters purchasing Level 50 PFDs for the purposes of carriage are more likely to wear them. Drowning is the leading cause of death in recreational boating accident and a study of drowning incidents found that, 86 percent of the time, individuals who drowned were not wearing a PFD.20 Absent these regulations, Level 50 devices cannot be sold as Coast Guard approved devices, and the expected increase in PFD wear rates among recreational boaters will not materialize. The final rule introduces harmonized performance standards instead of design standards for PFDs. It amends PFD approval and follow-up program requirements by incorporating three new binational standards into regulations, amending PFD carriage requirements to allow for the use of equipment approved to the new standards, and removing obsolete equipment approval requirements. The performance-based standards are more 20 United States Coast Guard. ‘‘2019 Recreational Boating Statistics.’’ https://uscgboating.org/library/ accident-statistics/Recreational-Boating-Statistics2019.pdf (last accessed April 22, 2024). VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 current and intended to replace the legacy design standards. The amendments allow manufacturers to produce more innovative equipment that meets the approval requirements of Canada and the United States and reduce the burden for manufacturers in the approval process and follow-up program. Specifically, the Coast Guard incorporates by reference the following binational industry consensus standards: (1) ANSI/CAN/UL 12402–4. This binational standard specifies the safety requirements for lifejackets that provide face-up flotation for use in sheltered or calm water, where users may have to wait for rescue. A lifejacket meeting the requirements of ANSI/CAN/UL 12402–4 provides an equivalent level of safety to a lifejacket currently approved under 46 CFR subpart 160.055. (2) ANSI/CAN/UL 12402–5. This binational standard specifies the safety requirements for buoyancy aids used in sheltered waters with help and rescue nearby. A PFD meeting the requirements of ANSI/CAN/UL 12402–5 provides an equivalent level of safety as a PFD currently approved under 46 CFR 160.064 or 160.076. (3) ANSI/CAN/UL 9595. This binational standard covers the basic elements of a production inspection program for various types of PFDs and formalizes and modifies current industry standards. Additionally, the Coast Guard incorporates two national standards (ANSI/UL 1123 and ANSI/UL 1175) and amends numerous CFR parts to remove obsolete PFD design standards and update carriage requirements to include PFDs approved to the new subparts. As mentioned earlier, ANSI/UL 1123 and ANSI/UL 1175 are both currently in use as a matter of policy and are being incorporated by reference for the sake of clarity. We do not estimate any costs or benefits from their incorporation by reference into the CFR. Similarly, we do not anticipate any quantifiable costs or benefits from the removal of obsolete design standards, as these design standards are not currently in use. In moving from the NPRM to this final rule, we made the following changes to the RA and small entities section: (1) Updated wage figures to use the most recently available data. (2) Updated deflators and costs to 2023. PO 00000 Frm 00010 Fmt 4701 Sfmt 4700 (3) Added a Final Regulatory Flexibility Act Analysis (FRFA). (4) Updated the affected population numbers based on more recent data. (5) Included descriptions of public comments that supported assumptions we made in the NPRM. As noted above, public comments overwhelmingly supported this rule. Some of those comments supported assumptions we made in the NPRM. We did not receive any comments that disagreed with our assumptions or offered new information that would require changes to the analysis. Affected Population To determine the affected population of the rule, it is first necessary to describe the economic impacts from this final rule. The economic impacts stem from the following four provisions: (1) The IBR of ANSI/CAN/UL 12402– 4 in 46 CFR 160.255 to replace the design requirements in 46 CFR 160.055; (2) The IBR of ANSI/CAN/UL 12402– 5 in 46 CFR 160.264 and 160.276 to replace the design standards in 46 CFR 160.064, 160.076, and 160.077; (3) The IBR of ANSI/CAN/UL 9595 for follow-up service into the PFD approval requirements of existing subparts 46 CFR 160.055, 160.060, 160.064, 160.076 and new subparts of 46 CFR 160.045, 160.255, 160.264, and 160.276; and (4) The edits to 33 CFR 181 subpart G, which permit manufacturers of all PFDs to provide placards instead of information pamphlets. These four provisions affect PFD manufacturers, the two recognized independent laboratories, and the Coast Guard. Before we present the affected population for each of these provisions, we present the overall PFD manufacturing firm population. As of 2023, there are over 800 models of PFDs approved by the Coast Guard, manufactured by 61 separate manufacturing firms worldwide.21 Based on a review of publicly available information across the 61 manufacturing firms, the Coast Guard estimates that 39 are U.S. firms and 22 are foreign firms. Market share and production volumes are not equal across the firms.22 21 The Coast Guard lists all approved products on the Coast Guard Maritime Information Exchange website, https://cgmix.uscg.mil/. Last accessed April 25, 2024. 22 We used the headquarters location of a firm’s parent company, as indicated on the company website, to determine whether a firm was U.S. or foreign. E:\FR\FM\06DER3.SGM 06DER3 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations 97365 TABLE 2—DISTRIBUTION OF MARKET SHARE OF PFD MANUFACTURERS Total market share (%) Manufacturing firms U.S. firm market share (%) Foreign firm market share (%) Top 5 Manufacturing Firms ......................................................................................................... Manufacturing Firms 6–13 ........................................................................................................... All Other Manufacturing Firms ..................................................................................................... 75 20 5 65.00 12.50 3.125 10.00 7.50 1.875 Total ...................................................................................................................................... 100 80.625 19.375 The first provision, the IBR of ANSI/ CAN/UL 12402–4, affects three populations: (1) PFD manufacturers that seek approval to manufacture devices meeting the requirements of ANSI/CAN/ UL 12402–4; (2) The two recognized independent laboratories that review and certify these devices; and (3) The Coast Guard, which corresponds with the recognized independent laboratories and manufacturers on device approval. In table 3, we list the number of PFD manufacturing firms that are affected by ANSI/CAN/UL 12402–4. We estimate that each of the top 13 firms that produce ANSI/CAN/UL 12402–4 devices or components of those devices at 2 facilities each and firms outside of the top 13 firms that produce ANSI/ CAN/UL 12402–4 devices at 1 facility each.23 TABLE 3—MANUFACTURING FIRMS AND FACILITIES IMPACTED BY ANSI/CAN/UL 12402–4 Firm ownership U.S. firms Foreign firms U.S. associated facilities Foreign facilities Total facilities Firms in top 13 ..................................................................... All other firms ....................................................................... 5 4 3 2 10 4 6 2 16 6 Total facilities ................................................................ 9 5 14 8 22 In the second provision, by incorporating by reference ANSI/CAN/ UL 12402–5, the Coast Guard introduces new categories for youth inflatables and Level 50 PFDs for approval. Permitting youth inflatables and Level 50 devices affects three populations: (1) PFD manufacturers that seek Coast Guard approval to produce youth inflatables or Level 50 devices; (2) The two recognized independent laboratories that review and certify youth inflatables and Level 50 devices; and (3) The boating public that purchases youth inflatables or Level 50 devices instead of Level 70 or Type III devices, because youth inflatables and Level 50 devices are likely to be more form-fitting than Level 70 or Type III devices. In the third provision, the Coast Guard intends to incorporate by reference ANSI/CAN/UL 9595, covering production inspections and inspection frequency, into multiple new and existing subparts in 46 CFR, as listed in table 4. TABLE 4—PFDS IMPACTED BY ANSI/CAN/UL 9595 Subpart lotter on DSK11XQN23PROD with RULES3 160.045 160.255 160.264 160.276 160.055 160.060 160.064 160.076 New or existing subpart PFD type ...................................................... ...................................................... ...................................................... ...................................................... ...................................................... ...................................................... ...................................................... ...................................................... Throwable PFDs ........................................................................................................... Level 100 PFDs ............................................................................................................ Inherently Buoyant Level 50 and Level 70 PFDs ......................................................... Inflatable Level 50 and Level 70 PFDs ........................................................................ Life Preservers .............................................................................................................. Buoyant Vests ............................................................................................................... Marine Buoyant Devices ............................................................................................... Inflatable PFDs .............................................................................................................. New. New. New. New. Existing. Existing. Existing. Existing. ANSI/CAN/UL 9595 establishes a set of Process Ratings (A, B, and C) based on the QMS at each facility. Process Rating A is reserved for facilities that have demonstrated a superior QMS. Process Rating B is assigned to facilities with a good QMS. Process Rating C is assigned to facilities with a minimally compliant QMS. The requirements for Process Rating C are equivalent to the current minimum requirements. Because Process Rating C is equivalent to current industry practice, the affected population for the IBR of ANSI/CAN/UL 9595 are any PFD manufacturer 23 The PFD manufacturing firm does not necessarily own the facilities where its products are produced. Instead, the facility may be producing PFDs on contract for the PFD manufacturing firm. Additionally, much production for U.S. firms occurs at overseas facilities. We call these ‘‘U.S. Associated Facilities’’ not because they are in the United States but because they have a longstanding relationship with U.S. firms, while ‘‘Foreign Facilities’’ have longstanding relationships with foreign firms. VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 PO 00000 Frm 00011 Fmt 4701 Sfmt 4700 E:\FR\FM\06DER3.SGM 06DER3 97366 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations producing a device approved under one of the subparts listed in table 4 and eligible to gain a Process Rating of A or B. In table 5, we estimate the market share likely to be at Process Rating A, B, or C and whether they are foreign or domestic firms.24 Because a QMS system is expensive to set up, industry stakeholders informed the Coast Guard that firms are not expected to develop a QMS solely to secure the cost savings of ANSI/CAN/UL 9595. However, a number of firms have already established QMS systems at their facilities because of other benefits, such as production consistency and quality control. The firms that have already established a QMS system will experience net cost savings from the IBR of ANSI/CAN/UL 9595. As a result, we estimated the process rating distribution recorded in table 5. TABLE 5—MARKET SHARE OF PRODUCTION LIKELY TO BE AT EACH PROCESS RATING Firm category Process rating U.S. Firms .................................................................................................................................................... Foreign Firms ............................................................................................................................................... U.S. Firms .................................................................................................................................................... Foreign Firms ............................................................................................................................................... U.S. and Foreign Firms ............................................................................................................................... Total ...................................................................................................................................................... The fourth provision, permitting the option for placards to replace instruction pamphlets, affects all firms manufacturing PFDs approved to any of the categories in table 6 that list A A B B C Market share (%) ................................ ................................ ................................ ................................ ................................ 26.5 15.0 51.0 2.5 5.0 .................................... 100.0 placards as permitted under the final rule. TABLE 6—DEVICE CATEGORY AND PERMITTED INSTRUCTION TYPES Device category Types of instructions allowed by the final rule New Level 50 Devices (ANSI/CAN/UL 12402–5) ................................... Placard ........................................... New Level 70 Devices (ANSI/CAN/UL 12402–5) ................................... New Level 100 Devices (ANSI/CAN/UL 12402–4) ................................. Placard ........................................... Placard ........................................... Existing Existing Existing Existing Placard or Information Pamphlet ... Placard or Information Pamphlet ... Placard or Information Pamphlet ... Information Pamphlet .................... Type Type Type Type I Commercial Devices ...................................................... II Recreational Devices .................................................... III Recreational Devices ................................................... IV Throwable Devices ...................................................... N/A because these devices are not yet produced. Placard. N/A because these devices are not yet produced. Information Pamphlet. Information Pamphlet. Information Pamphlet. Information Pamphlet. There are two sources of costs from this provision: (1) independent laboratories will need to train their staff to these new standards and (2) manufacturing firms that intend to sell in only one market (the United States or Canada) will experience additional costs due to an increase in the cost of testing according to ANSI/CAN/UL 12402–4 when compared to the cost of testing to the legacy standards.25 We provide our estimate for the total costs of the IBR of ANSI/CAN/UL 12402–4 to U.S. firms in table 7. These costs include $29,500 paid by independent laboratories in the first year to develop the instructions and manuals on how to conduct the new ANSI/CAN/UL 12402–4 testing and the estimated $1,659 per year manufacturers will spend on the more expensive ANSI/CAN/UL 12402–4 certification as opposed to the legacy certification.26 24 The process rating applies to a facility owned by a PFD manufacturing firm. The lowest process rating is C; if manufacturers seek a higher process rating of A or B, then an independent laboratory must certify that each facility owned by a manufacturing firm meets the standard of the higher rating, which is determined through an audit of a facility. A PFD manufacturing firm incurs the cost of a higher process rating at each facility. A PFD manufacturing firm who currently has a QMS (at least partially in place) will be able to seek a higher process rating, A or B, for each facility it owns (process rating C is the current baseline or default rating and represents the current inspection volume at facilities). A separate QMS inspection or audit is necessary for this to occur. A higher process rating will result in a reduction in the inspection volume at facilities, which will save PFD manufacturing firms money. 25 We estimate the increase in the cost of testing based upon data provided by representatives of independent laboratories. 26 We estimate the cost of Level 100 testing and approval to be about $52,250 and we estimate the cost for the new Type I approval to be about $47,200. The Coast Guard estimates 0.45 new approvals annually for products intended for sale exclusively in the United States. Therefore, the total additional cost to manufacturers for the more expensive Level 100 certification will be about $2,273. There are currently 51 products approved as Type I devices under 46 CFR part 160.055, of which 37 (73 percent) are produced by U.S. PFD firms and 14 (27 percent) are produced by foreign PFD firms. Therefore, we estimate the cost to U.S. PFD firms for the new UL 12402–4 approval will be about $1,659 annually. We estimate the cost to foreign PFD firms will be about $614 annually. Costs and Cost Savings of the Four Provisions of This Rule 1. ANSI/CAN/UL 12402–4 Costs lotter on DSK11XQN23PROD with RULES3 Types of instructions currently in use VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 PO 00000 Frm 00012 Fmt 4701 Sfmt 4700 E:\FR\FM\06DER3.SGM 06DER3 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations 97367 TABLE 7—ESTIMATED COSTS TO U.S. FIRMS FOR LEVEL 100 DEVICES UNDER STANDARD ANSI/CAN/UL 12402–4 [2023 Dollars, 10-year period of analysis] Total undiscounted costs Year Discounted costs 2% 1 ............................................................................................................................................................................... 2 ............................................................................................................................................................................... 3 ............................................................................................................................................................................... 4 ............................................................................................................................................................................... 5 ............................................................................................................................................................................... 6 ............................................................................................................................................................................... 7 ............................................................................................................................................................................... 8 ............................................................................................................................................................................... 9 ............................................................................................................................................................................... 10 ............................................................................................................................................................................. $31,159 1,659 1,659 1,659 1,659 1,659 1,659 1,659 1,659 1,659 $30,548 1,595 1,563 1,533 1,503 1,473 1,444 1,416 1,388 1,361 Total .................................................................................................................................................................. 46,090 43,824 Annualized ........................................................................................................................................................ ........................ 4,879 We present the 10-year total costs to foreign firms from the IBR of ANSI/ CAN/UL 12402–4 in table 8. Foreign firms will experience additional approval costs of $614 per year. TABLE 8—ESTIMATED COSTS TO FOREIGN FIRMS FOR LEVEL 100 DEVICES UNDER STANDARD ANSI/CAN/UL 12402–4 [2023 Dollars, 10-year period of analysis] Total undiscounted costs Year Discounted costs 2% 1 ............................................................................................................................................................................... 2 ............................................................................................................................................................................... 3 ............................................................................................................................................................................... 4 ............................................................................................................................................................................... 5 ............................................................................................................................................................................... 6 ............................................................................................................................................................................... 7 ............................................................................................................................................................................... 8 ............................................................................................................................................................................... 9 ............................................................................................................................................................................... 10 ............................................................................................................................................................................. $614 614 614 614 614 614 614 614 614 614 $602 590 579 567 556 545 535 524 514 504 Total .................................................................................................................................................................. 6,140 5,515 Annualized ........................................................................................................................................................ ........................ 614 We present the 10-year total costs to U.S. and foreign firms from the IBR of ANSI/CAN/UL 12402–4 in table 9. TABLE 9—ESTIMATED TOTAL COST TO ALL FIRMS FOR LEVEL 100 DEVICES UNDER STANDARD ANSI/CAN/UL 12402–4 [2023 Dollars, 10-year period of analysis] Total undiscounted costs lotter on DSK11XQN23PROD with RULES3 Year 1 2 3 4 5 6 7 8 9 ............................................................................................................................................................................... ............................................................................................................................................................................... ............................................................................................................................................................................... ............................................................................................................................................................................... ............................................................................................................................................................................... ............................................................................................................................................................................... ............................................................................................................................................................................... ............................................................................................................................................................................... ............................................................................................................................................................................... VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 PO 00000 Frm 00013 Fmt 4701 Sfmt 4700 E:\FR\FM\06DER3.SGM 06DER3 $31,773 2,273 2,273 2,273 2,273 2,273 2,273 2,273 2,273 Discounted costs 2% $31,150 2,185 2,142 2,100 2,059 2,018 1,979 1,940 1,902 97368 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations TABLE 9—ESTIMATED TOTAL COST TO ALL FIRMS FOR LEVEL 100 DEVICES UNDER STANDARD ANSI/CAN/UL 12402– 4—Continued [2023 Dollars, 10-year period of analysis] Total undiscounted costs Year Discounted costs 2% 10 ............................................................................................................................................................................. 2,273 1,865 Total .................................................................................................................................................................. 52,230 49,339 Annualized ........................................................................................................................................................ ........................ 5,493 Cost Savings By adopting ANSI/CAN/UL 12402–4, the Coast Guard can harmonize commercial PFD requirements of the United States with those of Transport Canada. Harmonization of commercial PFD standards will lead to cost savings for PFD manufacturing firms through less expensive approval requirements and less frequent ongoing facility inspections. Additionally, as a performance-based standard, ANSI/CAN/UL 12402–4 allows for more innovative designs than the current standards and regulations, which might better meet boater needs. Seven commenters noted that permission to create more innovative designs is a benefit. The adoption of a performance-based standard spares the Coast Guard from making the equivalency determinations frequently necessary when using the current prescriptive requirements. Consequently, the Coast Guard will experience time savings from reducing the review time of new device applications during the approval process. In total, we estimate three sources of quantified cost savings associated with the IBR of ANSI/CAN/UL 12402–4: (1) The Coast Guard will spend less time reviewing approval applications and making equivalency determinations for the approval of innovative PFDs because ANSI/CAN/UL 12402–4 is a performance-based rather than prescriptive standard and allows more innovative designs to meet the standard; (2) All firms that apply for approval in both United States and Canadian markets will save the difference between one certification to ANSI/CAN/ UL 12402–4 and separate United States and Canadian certifications to legacy standards; and (3) Manufacturing facilities producing devices meeting the requirements of ANSI/CAN/UL 12402–4 for the United States and Canadian markets will be able to be inspected just once for approval, instead of the current requirement to be inspected twice; once for United States approval and once for Canadian approval. We summarize the total quantified benefits for the cost savings of the IBR of ANSI/CAN/UL 12402–4 by reporting the annual undiscounted cost savings in table 10. TABLE 10—ESTIMATED ANNUAL COST SAVINGS OF ANSI/CAN/UL 12402–4 TO THE INDUSTRY AND THE U.S. GOVERNMENT [2023 Dollars] Cost savings to U.S. entities Annual cost savings item Cost savings to foreign entities Value of Coast Guard time saved ........................................................................................................................... Canadian and United States approval savings ....................................................................................................... Billed facility inspection savings .............................................................................................................................. Quality manager’s time saved ................................................................................................................................. $4,330 27,779 15,372 3,359 $0 10,274 8,784 1,334 Total .................................................................................................................................................................. 50,840 20,392 In table 11 and table 12, we record the 10-year cost savings from the adoption of ANSI/CAN/UL 12402–4 to U.S. and foreign firms, respectively. In table 13, we record the total 10-year cost savings from this provision to the U.S. Government. TABLE 11—ESTIMATED COST SAVINGS TO U.S. FIRMS FROM ANSI/CAN/UL 12402–4 [2023 Dollars, 10-year period of analysis] Total undiscounted cost savings lotter on DSK11XQN23PROD with RULES3 Year 1 2 3 4 5 ............................................................................................................................................................................... ............................................................................................................................................................................... ............................................................................................................................................................................... ............................................................................................................................................................................... ............................................................................................................................................................................... VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 PO 00000 Frm 00014 Fmt 4701 Sfmt 4700 E:\FR\FM\06DER3.SGM 06DER3 $46,510 46,510 46,510 46,510 46,510 Discounted cost savings 2% $45,598 44,704 43,827 42,968 42,126 97369 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations TABLE 11—ESTIMATED COST SAVINGS TO U.S. FIRMS FROM ANSI/CAN/UL 12402–4—Continued [2023 Dollars, 10-year period of analysis] Total undiscounted cost savings Year Discounted cost savings 2% 6 ............................................................................................................................................................................... 7 ............................................................................................................................................................................... 8 ............................................................................................................................................................................... 9 ............................................................................................................................................................................... 10 ............................................................................................................................................................................. 46,510 46,510 46,510 46,510 46,510 41,300 40,490 39,696 38,917 38,154 Total .................................................................................................................................................................. 465,100 417,780 Annualized ........................................................................................................................................................ ........................ 46,510 TABLE 12—ESTIMATED COST SAVINGS TO FOREIGN FIRMS FROM ADOPTING ANSI/CAN/UL 12402–4 [2023 Dollars, 10-year period of analysis] Total undiscounted cost savings Year Discounted cost savings 2% 1 ............................................................................................................................................................................... 2 ............................................................................................................................................................................... 3 ............................................................................................................................................................................... 4 ............................................................................................................................................................................... 5 ............................................................................................................................................................................... 6 ............................................................................................................................................................................... 7 ............................................................................................................................................................................... 8 ............................................................................................................................................................................... 9 ............................................................................................................................................................................... 10 ............................................................................................................................................................................. $20,392 20,392 20,392 20,392 20,392 20,392 20,392 20,392 20,392 20,392 $19,992 19,600 19,216 18,839 18,470 18,108 17,752 17,404 17,063 16,729 Total .................................................................................................................................................................. 203,920 183,173 Annualized ........................................................................................................................................................ ........................ 20,392 TABLE 13—ESTIMATED COST SAVINGS TO THE U.S. GOVERNMENT OF ANSI/CAN/UL 12402–4 [2023 Dollars, 10-year period of analysis] Total undiscounted cost savings lotter on DSK11XQN23PROD with RULES3 Year Discounted cost savings 2% 1 ............................................................................................................................................................................... 2 ............................................................................................................................................................................... 3 ............................................................................................................................................................................... 4 ............................................................................................................................................................................... 5 ............................................................................................................................................................................... 6 ............................................................................................................................................................................... 7 ............................................................................................................................................................................... 8 ............................................................................................................................................................................... 9 ............................................................................................................................................................................... 10 ............................................................................................................................................................................. $4,330 4,330 4,330 4,330 4,330 4,330 4,330 4,330 4,330 4,330 $4,245 4,162 4,080 4,000 3,922 3,845 3,770 3,696 3,623 3,552 Total .................................................................................................................................................................. 43,300 38,895 Annualized ........................................................................................................................................................ ........................ 4,330 In table 14, we record the total discounted 10-year cost savings to the U.S. and foreign PFD industry for the ANSI/CAN/UL 12402–4 portion of this VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 final rule. We estimate that this provision saves the U.S. and foreign PFD industry about $66,902 annually and produces cost savings for the PO 00000 Frm 00015 Fmt 4701 Sfmt 4700 industry of about $600,953 over a 10year period of analysis using a 2-percent discount rate. E:\FR\FM\06DER3.SGM 06DER3 97370 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations TABLE 14—TOTAL ESTIMATED COST SAVINGS TO INDUSTRY OF THE FINAL RULE FOR ANSI/CAN/UL 12402–4 [2023 Dollars, 10-year period of analysis] Total undiscounted cost savings Year Discounted cost savings 2% 1 ............................................................................................................................................................................... 2 ............................................................................................................................................................................... 3 ............................................................................................................................................................................... 4 ............................................................................................................................................................................... 5 ............................................................................................................................................................................... 6 ............................................................................................................................................................................... 7 ............................................................................................................................................................................... 8 ............................................................................................................................................................................... 9 ............................................................................................................................................................................... 10 ............................................................................................................................................................................. $66,902 66,902 66,902 66,902 66,902 66,902 66,902 66,902 66,902 66,902 $65,590 64,304 63,043 61,807 60,595 59,407 58,242 57,100 55,981 54,883 Total .................................................................................................................................................................. 669,020 600,953 Annualized ........................................................................................................................................................ ........................ 66,902 2. ANSI/CAN/UL 12402–5 Costs The PFD industry also incurs an increase in costs from this final rule because, based on consultation with industry experts, we estimate that this rule will increase the PFD market by 5 percent, meaning manufacturing firms would seek new device approvals and produce more devices.27 (In the NPRM, we requested public comment on the possibility that this rule would increase the PFD market by 5 percent, and no commenter disagreed with this estimate.) We estimate the costs of this provision as the costs of the additional device approvals and the costs of the additional production inspections for the greater volume of production that we expect this rule to generate.28 In table 15, table 16, and table 17, we present the discounted costs of introducing Level 50 devices over the 10-year period of analysis to U.S. firms, foreign firms, and all firms, respectively. The tables include the estimated costs of Level 50 devices approved and inspected under the current inspections regime. In Year 1, the undiscounted costs are only the costs of Level 50 approval for manufacturers, or $610,299 for U.S. manufacturers and $146,661 for foreign manufacturers. For Year 2, the undiscounted costs are the costs of Level 50 approvals to manufacturers ($610,299 for U.S. firms and $146,661 for foreign firms) plus the cost of inspections ($33,900 for U.S. firms and $7,587 for foreign firms), for a total of about $644,199 ($610,299 + $33,900) for U.S. firms and $154,248 ($146,661 + $7,587) for foreign firms. The estimated 10-year cost, discounted at 2 percent, is $1,694,898, or $188,687 annualized, for U.S. firms, and $398,884, or $44,406 annualized, for foreign firms. TABLE 15—ESTIMATED COSTS TO U.S. FIRMS FROM INTRODUCING LEVEL 50 DEVICES [2023 Dollars, 10-year period of analysis] Total undiscounted cost lotter on DSK11XQN23PROD with RULES3 Year Discounted cost 2% 1 ............................................................................................................................................................................... 2 ............................................................................................................................................................................... 3 ............................................................................................................................................................................... 4 ............................................................................................................................................................................... 5 ............................................................................................................................................................................... 6 ............................................................................................................................................................................... 7 ............................................................................................................................................................................... 8 ............................................................................................................................................................................... 9 ............................................................................................................................................................................... 10 ............................................................................................................................................................................. $610,299 644,199 67,800 67,800 67,800 67,800 67,800 67,800 67,800 67,800 $598,332 619,184 63,889 62,637 61,409 60,204 59,024 57,867 56,732 55,620 Total .................................................................................................................................................................. 1,796,898 1,694,898 Annualized ........................................................................................................................................................ ........................ 188,687 27 As part of our discussion with PFD manufacturing firms, we asked their representatives whether the introduction of Level 50 devices would lead to a net growth in the PFD market (inclusive of substitution out of existing types of products). Manufacturing firm representatives stated that they VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 would expect the PFD market would grow by about 5 percent from this provision. We interpret the 5percent growth as a one-time growth in the level of manufacturing spread over a 2-year period. 28 We estimate the additional production inspections based on the current production PO 00000 Frm 00016 Fmt 4701 Sfmt 4700 inspection requirements, and we estimate the reduction in these inspections through the incorporation by reference of ANSI/CAN/UL 9595 in its associated section. E:\FR\FM\06DER3.SGM 06DER3 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations 97371 TABLE 16—ESTIMATED COSTS TO FOREIGN FIRMS FROM THE INTRODUCTION OF LEVEL 50 DEVICES [2023 Dollars, 10-year period of analysis] Total undiscounted cost Year Discounted cost 2% 1 ............................................................................................................................................................................... 2 ............................................................................................................................................................................... 3 ............................................................................................................................................................................... 4 ............................................................................................................................................................................... 5 ............................................................................................................................................................................... 6 ............................................................................................................................................................................... 7 ............................................................................................................................................................................... 8 ............................................................................................................................................................................... 9 ............................................................................................................................................................................... 10 ............................................................................................................................................................................. $146,661 154,248 15,174 15,174 15,174 15,174 15,174 15,174 15,174 15,174 $143,785 148,258 14,299 14,018 13,744 13,474 13,210 12,951 12,697 12,448 Total .................................................................................................................................................................. 422,301 398,884 Annualized ........................................................................................................................................................ ........................ 44,406 TABLE 17—TOTAL ESTIMATED COSTS TO PFD MANUFACTURERS FROM THE INTRODUCTION OF LEVEL 50 DEVICES [2023 Dollars, 10-year period of analysis] Total undiscounted cost lotter on DSK11XQN23PROD with RULES3 Year Discounted cost 2% 1 ............................................................................................................................................................................... 2 ............................................................................................................................................................................... 3 ............................................................................................................................................................................... 4 ............................................................................................................................................................................... 5 ............................................................................................................................................................................... 6 ............................................................................................................................................................................... 7 ............................................................................................................................................................................... 8 ............................................................................................................................................................................... 9 ............................................................................................................................................................................... 10 ............................................................................................................................................................................. $756,960 798,447 82,974 82,974 82,974 82,974 82,974 82,974 82,974 82,974 $742,118 767,442 78,188 76,655 75,152 73,679 72,234 70,818 69,429 68,068 Total .................................................................................................................................................................. 2,219,199 2,093,782 Annualized ........................................................................................................................................................ ........................ 233,093 Qualitative Benefits The Coast Guard believes that the introduction of Level 50 devices, coupled with the requirement to wear them if they are to count for the purposes of PFD carriage requirements, may lead to an unquantifiable increase in PFD wear rates among recreational boaters and thereby potentially decrease the rate of drowning. Drowning is the leading cause of death in recreational boating accidents, accounting for 79 percent of all recreational boating casualties where we know the cause of death.29 Of those who drowned, 86 percent were not wearing a lifejacket. Wearing a lifejacket is one of the best means available of preventing accidental drowning in recreational boating. Unfortunately, recreational 29 United States Coast Guard, ‘‘2019 Recreational Boating Statistics.’’ https://uscgboating.org/library/ accident-statistics/Recreational-Boating-Statistics2019.pdf (last accessed April 25th, 2024). VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 boaters only wear lifejackets about 24 percent of the time.30 Level 50 devices are likely to be slimmer, lighter in weight, and more comfortable to wear than current Type III and Level 70 devices. Additionally, the Coast Guard will require recreational boaters to wear Level 50 devices for such devices to count towards PFD carriage requirements. Individuals who purchase Level 50 devices are more likely to wear PFDs than similar individuals who purchase bulkier Type III or Level 70 devices without a requirement that they be worn for the purposes of carriage. The NIH conducted a literature review, and, among other factors, found discomfort to be negatively associated with lifejacket wear [NIH, 2018].31 It is the Coast Guard’s view that PFDs worn are more effective than PFDs carried on board if a person overboard situation occurs. As a result, it is possible that the public is safer due to recreational boaters wearing a greater number of PFDs while boating. Since the Level 50 devices provide a lower level of buoyancy than Level 70 devices, a direct comparison is not possible. However, the view of the subject matter experts (SMEs) in the Coast Guard’s Office of Boating Safety is that the wearing of Level 50 PFDs by recreational boaters and the general boating public improves safety on the water. Recreational boaters fail to wear lifejackets 76 percent of the time, 30 United States Coast Guard, ‘‘2019 Life Jacket Wear Rate Observation Study.’’ https:// uscgboating.org/library/national-live-jacket-wearstudy/2019-Life-Jacket-Wear-Rate-Report.pdf (last accessed April 25, 2024). 31 We cited this review from the NIH earlier in the preamble in footnote number 8. Readers should reference that footnote for a link to this article and other articles by the NIH for more information on PFD usage. PO 00000 Frm 00017 Fmt 4701 Sfmt 4700 E:\FR\FM\06DER3.SGM 06DER3 97372 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations leaving themselves vulnerable to drowning. The Coast Guard believes that, by offering recreational boaters an additional choice of a Level 50 PFD, which is required to be worn, more recreational boaters will choose to wear their lifejacket while engaged in boating activities. A lifejacket that is worn by the user is more effective than a lifejacket stowed on the boat. 3. ANSI/CAN/UL 9595 The third provision incorporates by reference the consensus standard ANSI/ CAN/UL 9595 to cover follow-up inspections and inspection frequency for Coast Guard approved PFDs. Currently, when a manufacturing firm produces a Coast Guard approved PFD, there is a required follow-up inspection regime to ensure that the devices continue to meet the specifications under which the Coast Guard approved them. Although the Coast Guard has not previously published a substantive minimum requirement for what constitutes a follow-up inspections regime, we set out general requirements in 46 CFR 159, 160.064–4, and 160.076– 29. The Coast Guard reviews each recognized independent laboratory’s follow-up services program to ensure compliance with these regulations. Incorporating by reference ANSI/ CAN/UL 9595 provides a few key benefits to the regulated public and the testing laboratories. First, ANSI/CAN/ UL 9595 is one standard, ensuring consistency across all accepted and recognized independent laboratories. Second, ANSI/CAN/UL 9595 is a standard that is widely available to the industry and transparently clarifies guidance on what constitutes a followup inspection regime. Third, and most importantly, ANSI/CAN/UL 9595 establishes a rating system for each facility, which results in cost savings for the firms manufacturing at facilities with a good or superior QMS rating. Costs There are three cost items associated with the adoption of ANSI/CAN/UL 9595. These costs are based on input from PFD industry SMEs on how ANSI/ CAN/UL 9595 is likely to be implemented. (1) The two recognized independent laboratories will need to train their staff to implement ANSI/CAN/UL 9595. (2) Manufacturing firms could request a special inspection in the first year to certify their QMS at a given facility meets the requirements for Process Rating of A or B. We expect the top 13 firms to request this certification across all 27 facilities at which they manufacture. This special inspection is expected to be in addition to the regular production inspections required for Process Rating C. (3) After the first year, where the QMS inspection is supplemental to standard inspections, the QMS inspection could replace one of the mandatory inspections, but could cost more than a standard inspection, at the top 13 firms with 27 facilities. We estimate the 10-year discounted cost for inspections under this provision that are associated with U.S. firms is approximately $126,840, or $14,121 annualized using a 2-percent discount rate. We estimate the total 10-year discounted cost for inspections that are associated with foreign firms is approximately $51,382, or $5,720 annualized using a 2-percent discount rate. In total, we estimate the 10-year discounted costs from ANSI/CAN/UL 9595 are $178,223 or $19,841 annualized using a 2-percent discount rate. We present these costs to U.S., foreign, and both U.S. and foreign firms in table 18, table 19, and table 20, respectively. TABLE 18—ESTIMATED QMS INSPECTION COSTS TO U.S. FIRMS FROM ANSI/CAN/UL 9595 [2023 Dollars, 10-year period of analysis] Total undiscounted cost Year Discounted cost 2% 1 ............................................................................................................................................................................... 2 ............................................................................................................................................................................... 3 ............................................................................................................................................................................... 4 ............................................................................................................................................................................... 5 ............................................................................................................................................................................... 6 ............................................................................................................................................................................... 7 ............................................................................................................................................................................... 8 ............................................................................................................................................................................... 9 ............................................................................................................................................................................... 10 ............................................................................................................................................................................. $61,296 8,341 8,341 8,341 8,341 8,341 8,341 8,341 8,341 8,341 $60,094 8,017 7,860 7,706 7,555 7,407 7,261 7,119 6,979 6,843 Total .................................................................................................................................................................. 136,365 126,841 Annualized ........................................................................................................................................................ ........................ 14,121 TABLE 19—ESTIMATED QMS INSPECTION COSTS TO FOREIGN FIRMS FROM ANSI/CAN/UL 9595 [2023 Dollars, 10-year period of analysis] Total undiscounted cost lotter on DSK11XQN23PROD with RULES3 Year 1 2 3 4 5 6 7 ............................................................................................................................................................................... ............................................................................................................................................................................... ............................................................................................................................................................................... ............................................................................................................................................................................... ............................................................................................................................................................................... ............................................................................................................................................................................... ............................................................................................................................................................................... VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 PO 00000 Frm 00018 Fmt 4701 Sfmt 4700 E:\FR\FM\06DER3.SGM 06DER3 $23,744 3,512 3,512 3,512 3,512 3,512 3,512 Discounted cost 2% $23,278 3,376 3,309 3,245 3,181 3,119 3,057 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations 97373 TABLE 19—ESTIMATED QMS INSPECTION COSTS TO FOREIGN FIRMS FROM ANSI/CAN/UL 9595—Continued [2023 Dollars, 10-year period of analysis] Total undiscounted cost Year Discounted cost 2% 8 ............................................................................................................................................................................... 9 ............................................................................................................................................................................... 10 ............................................................................................................................................................................. 3,512 3,512 3,512 2,997 2,939 2,881 Total .................................................................................................................................................................. 55,352 51,382 Annualized ........................................................................................................................................................ ........................ 5,720 TABLE 20—TOTAL ESTIMATED QMS INSPECTION COSTS FOR ANSI/CAN/UL 9595 [2023 Dollars, 10-year period of analysis] Total undiscounted cost Year Discounted cost 2% 1 ............................................................................................................................................................................... 2 ............................................................................................................................................................................... 3 ............................................................................................................................................................................... 4 ............................................................................................................................................................................... 5 ............................................................................................................................................................................... 6 ............................................................................................................................................................................... 7 ............................................................................................................................................................................... 8 ............................................................................................................................................................................... 9 ............................................................................................................................................................................... 10 ............................................................................................................................................................................. $85,040 11,853 11,853 11,853 11,853 11,853 11,853 11,853 11,853 11,853 $83,373 11,393 11,169 10,950 10,736 10,525 10,319 10,116 9,918 9,724 Total .................................................................................................................................................................. 191,717 178,223 Annualized ........................................................................................................................................................ ........................ 19,841 Cost Savings The IBR of ANSI/CAN/UL 9595 generates benefits in the form of cost savings for PFD manufacturing firms who have a QMS in place. Manufacturers with an audited QMS can secure a higher Process Rating, which, in turn, reduces the frequency of production inspections for PFDs based upon their higher Process Rating. We estimate this provision to generate cost savings for U.S. firms of $8,454,204, or $941,177, annualized, over a 10-year period of analysis using a 2-percent discount rate. We similarly estimate cost savings of $2,039,131, or $227,009, annualized, to foreign firms over a 10year period of analysis, discounted at 2 percent. In total, we estimate $10,493,335, or $1,168,187 annualized, in cost savings to all firms under this provision using a 10-year period of analysis and a 2-percent discount rate. We present these 10-year cost savings to U.S., foreign, and both U.S. and foreign firms in table 21, table 22, and table 23, respectively. TABLE 21—ESTIMATED COST SAVINGS TO U.S. FIRMS FROM ANSI/CAN/UL 9595 [2023 Dollars, 10-year period of analysis] Total undiscounted cost savings lotter on DSK11XQN23PROD with RULES3 Year Discounted cost savings 2% 1 ............................................................................................................................................................................... 2 ............................................................................................................................................................................... 3 ............................................................................................................................................................................... 4 ............................................................................................................................................................................... 5 ............................................................................................................................................................................... 6 ............................................................................................................................................................................... 7 ............................................................................................................................................................................... 8 ............................................................................................................................................................................... 9 ............................................................................................................................................................................... 10 ............................................................................................................................................................................. $0 1,037,396 1,059,092 1,059,092 1,059,092 1,059,092 1,059,092 1,059,092 1,059,092 1,059,092 $0 997,113 998,006 978,437 959,252 940,443 922,003 903,925 886,201 868,824 Total .................................................................................................................................................................. 9,510,132 8,454,204 Annualized ........................................................................................................................................................ ........................ 941,177 VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 PO 00000 Frm 00019 Fmt 4701 Sfmt 4700 E:\FR\FM\06DER3.SGM 06DER3 97374 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations TABLE 22—ESTIMATED COST SAVINGS TO FOREIGN FIRMS FROM ANSI/CAN/UL 9595 [2023 Dollars, 10-year period of analysis] Total undiscounted cost savings Year Discounted cost savings 2% 1 ............................................................................................................................................................................... 2 ............................................................................................................................................................................... 3 ............................................................................................................................................................................... 4 ............................................................................................................................................................................... 5 ............................................................................................................................................................................... 6 ............................................................................................................................................................................... 7 ............................................................................................................................................................................... 8 ............................................................................................................................................................................... 9 ............................................................................................................................................................................... 10 ............................................................................................................................................................................. $0 250,371 255,429 255,429 255,429 255,429 255,429 255,429 255,429 255,429 $0 240,649 240,696 235,977 231,350 226,814 222,366 218,006 213,732 209,541 Total .................................................................................................................................................................. 2,293,803 2,039,131 Annualized ........................................................................................................................................................ ........................ 227,009 TABLE 23—ESTIMATED COST SAVINGS TO ALL FIRMS FROM ANSI/CAN/UL 9595 [2023 Dollars, 10-year period of analysis] Total undiscounted cost savings Year Discounted cost savings 2% 1 ............................................................................................................................................................................... 2 ............................................................................................................................................................................... 3 ............................................................................................................................................................................... 4 ............................................................................................................................................................................... 5 ............................................................................................................................................................................... 6 ............................................................................................................................................................................... 7 ............................................................................................................................................................................... 8 ............................................................................................................................................................................... 9 ............................................................................................................................................................................... 10 ............................................................................................................................................................................. $0 1,287,767 1,314,521 1,314,521 1,314,521 1,314,521 1,314,521 1,314,521 1,314,521 1,314,521 $0 1,237,761 1,238,702 1,214,414 1,190,602 1,167,257 1,144,370 1,121,931 1,099,932 1,078,365 Total .................................................................................................................................................................. 11,803,935 10,493,334 Annualized ........................................................................................................................................................ ........................ 1,168,186 4. Placards in Lieu of Information Pamphlets The fourth provision in the rule comes from details contained within ANSI/CAN/UL 12402–4 and ANSI/ CAN/UL 12402–5. These standards specify requirements for a placard to be attached to all devices certified to those standards. The placard provides information on PFD performance, selection, and approval, warnings, maintenance, and general water safety information in a pictographic format. This rule amends 33 CFR 181 to permit manufacturing firms to use a placard in lieu of the informational pamphlet. Costs Affected Population section of this preamble to list the various types of PFDs impacted by this rule, and whether they are required to use placards to convey safety instructions or whether they could use either placards or information pamphlets.32 For the convenience of the reader, table 24 reproduces table 6 from the lotter on DSK11XQN23PROD with RULES3 TABLE 24—DEVICE CATEGORY AND PERMITTED INSTRUCTION TYPES Device category Types of instructions allowed by the final rule New Level 50 Devices (ANSI/CAN/UL 12402–5) ................................... Placard ........................................... New Level 70 Devices (ANSI/CAN/UL 12402–5) ................................... New Level 100 Devices (ANSI/CAN/UL 12402–4) ................................. Placard ........................................... Placard ........................................... 32 Current marking requirements require a pamphlet, while the new marking requirement will be for a placard or pamphlet. Because these placards and pamphlets are both produced in VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 factories, the Coast Guard estimates that it will take the same amount of time to produce and include either a pamphlet or a placard with a newly manufactured PFD for sale. As a result, we do not PO 00000 Frm 00020 Fmt 4701 Sfmt 4700 Types of instructions currently in use N/A because these devices are not yet produced. Placard. N/A because these devices are not yet produced. estimate there will be any changes in the Paperwork Reduction Act burden brought on by the switch from pamphlets to placards. E:\FR\FM\06DER3.SGM 06DER3 97375 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations TABLE 24—DEVICE CATEGORY AND PERMITTED INSTRUCTION TYPES—Continued Types of instructions allowed by the final rule Device category Existing Existing Existing Existing Type Type Type Type I Commercial Devices ...................................................... II Recreational Devices .................................................... III Recreational Devices ................................................... IV Throwable Devices ...................................................... As shown in table 24, the changes in instruction information either applies to PFD categories not yet produced or permits an additional compliance option. No devices would have fewer options for instruction materials than under current regulations. As a result, we estimate no additional costs from replacing safety information pamphlets with placards because firms could either continue their current activities or produce placards instead. Unquantified Benefits There are two sources of unquantified benefits from the requirement for the use of placards on new device categories and the permitting of placard use on existing device categories. The first source of unquantified benefits occurs because a placard may be less expensive to produce than an information pamphlet. A representative from the PFD manufacturing industry stated that Placard or Information Pamphlet ... Placard or Information Pamphlet ... Placard or Information Pamphlet ... Information Pamphlet .................... the placard could be around $0.05 cheaper to produce than the information pamphlet, because the placard contains fewer materials than the information pamphlet. However, we did not find (nor did we receive) any data on the costs to produce information pamphlets and the costs to produce placards, so we cannot determine the relative size of this cost savings. We believe, based on the full discussion in the RA, that the $0.05 estimate expresses the fact that placards are slightly less expensive than information pamphlets but, ultimately, about the same price. Additionally, we have no way of estimating how large a share of current production will switch from producing information pamphlets to placards, as placards will not be required. Due to these factors, we did not produce a quantitative estimate of the cost savings due to placards. The second unquantified benefit comes from the fact that placards use Types of instructions currently in use Information Information Information Information Pamphlet. Pamphlet. Pamphlet. Pamphlet. pictorial images to communicate safety information, while information pamphlets use English-language text. Pictorial information is superior to text at communicating information to nonEnglish-reading audiences. We do not have a way of quantifying this benefit but would like to note that approximately 21 percent of the U.S. population has a ‘‘low’’ level of English literacy. For those populations, pictorial information may be better than textbased information.33 Total Costs We display the total costs from this final rule to U.S. entities, foreign entities, and both U.S. and foreign entities, using a 10-year period of analysis, discounted at 2 percent, in table 25, table 26, and table 27, respectively. TABLE 25—ESTIMATED COSTS FOR U.S. FIRMS [2023 Dollars, 10-year period of analysis] Total undiscounted costs Year Discounted costs 2% 1 ............................................................................................................................................................................... 2 ............................................................................................................................................................................... 3 ............................................................................................................................................................................... 4 ............................................................................................................................................................................... 5 ............................................................................................................................................................................... 6 ............................................................................................................................................................................... 7 ............................................................................................................................................................................... 8 ............................................................................................................................................................................... 9 ............................................................................................................................................................................... 10 ............................................................................................................................................................................. $702,754 654,199 77,800 77,800 77,800 77,800 77,800 77,800 77,800 77,800 $688,975 628,796 73,313 71,875 70,466 69,084 67,730 66,402 65,100 63,823 Total .................................................................................................................................................................. 1,979,353 1,865,564 Annualized ........................................................................................................................................................ ........................ 207,687 TABLE 26—ESTIMATED COSTS FOR FOREIGN FIRMS [2023 Dollars, 10-year period of analysis] Total undiscounted costs lotter on DSK11XQN23PROD with RULES3 Year 1 ............................................................................................................................................................................... 2 ............................................................................................................................................................................... 33 U.S. Department of Education, ‘‘Data Point: Adult Literacy in the United States’’ (July 2019). VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 https://nces.ed.gov/pubs2019/2019179.pdf (last accessed April 25, 2024). PO 00000 Frm 00021 Fmt 4701 Sfmt 4700 E:\FR\FM\06DER3.SGM 06DER3 $171,019 158,374 Discounted costs 2% $167,666 152,224 97376 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations TABLE 26—ESTIMATED COSTS FOR FOREIGN FIRMS—Continued [2023 Dollars, 10-year period of analysis] Total undiscounted costs Year Discounted costs 2% 3 ............................................................................................................................................................................... 4 ............................................................................................................................................................................... 5 ............................................................................................................................................................................... 6 ............................................................................................................................................................................... 7 ............................................................................................................................................................................... 8 ............................................................................................................................................................................... 9 ............................................................................................................................................................................... 10 ............................................................................................................................................................................. 19,300 19,300 19,300 19,300 19,300 19,300 19,300 19,300 18,187 17,830 17,481 17,138 16,802 16,472 16,149 15,833 Total .................................................................................................................................................................. 483,793 455,782 Annualized ........................................................................................................................................................ ........................ 50,741 TABLE 27—TOTAL ESTIMATED COSTS FOR U.S. AND FOREIGN FIRMS [2023 Dollars, 10-year period of analysis] Total undiscounted costs Year Discounted costs 2% 1 ............................................................................................................................................................................... 2 ............................................................................................................................................................................... 3 ............................................................................................................................................................................... 4 ............................................................................................................................................................................... 5 ............................................................................................................................................................................... 6 ............................................................................................................................................................................... 7 ............................................................................................................................................................................... 8 ............................................................................................................................................................................... 9 ............................................................................................................................................................................... 10 ............................................................................................................................................................................. $873,773 812,573 97,100 97,100 97,100 97,100 97,100 97,100 97,100 97,100 $856,640 781,020 91,499 89,705 87,946 86,222 84,531 82,874 81,249 79,656 Total .................................................................................................................................................................. 2,463,146 2,321,343 Annualized ........................................................................................................................................................ ........................ 258,427 Total Cost Savings We display the total cost savings from this final rule to U.S. firms, the U.S. government, foreign firms, and all entities using a 10-year period of analysis discounted at 2 percent in table 28, table 29, table 30, and table 31, respectively. TABLE 28—TOTAL ESTIMATED COST SAVINGS TO U.S. FIRMS [2023 Dollars, 10-year period of analysis] Total undiscounted cost savings lotter on DSK11XQN23PROD with RULES3 Year Discounted cost savings 2% 1 ............................................................................................................................................................................... 2 ............................................................................................................................................................................... 3 ............................................................................................................................................................................... 4 ............................................................................................................................................................................... 5 ............................................................................................................................................................................... 6 ............................................................................................................................................................................... 7 ............................................................................................................................................................................... 8 ............................................................................................................................................................................... 9 ............................................................................................................................................................................... 10 ............................................................................................................................................................................. $46,510 1,083,906 1,105,602 1,105,602 1,105,602 1,105,602 1,105,602 1,105,602 1,105,602 1,105,602 $45,598 1,041,817 1,041,833 1,021,405 1,001,378 981,743 962,493 943,621 925,118 906,979 Total .................................................................................................................................................................. 9,975,232 8,871,985 Annualized ........................................................................................................................................................ ........................ 987,687 VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 PO 00000 Frm 00022 Fmt 4701 Sfmt 4700 E:\FR\FM\06DER3.SGM 06DER3 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations 97377 TABLE 29—TOTAL ESTIMATED COST SAVINGS TO FOREIGN FIRMS [2023 Dollars, 10-year period of analysis] Total undiscounted cost savings Year Discounted cost savings 2% 1 ............................................................................................................................................................................... 2 ............................................................................................................................................................................... 3 ............................................................................................................................................................................... 4 ............................................................................................................................................................................... 5 ............................................................................................................................................................................... 6 ............................................................................................................................................................................... 7 ............................................................................................................................................................................... 8 ............................................................................................................................................................................... 9 ............................................................................................................................................................................... 10 ............................................................................................................................................................................. $20,392 270,763 275,821 275,821 275,821 275,821 275,821 275,821 275,821 275,821 $19,992 260,249 259,912 254,816 249,820 244,921 240,119 235,411 230,795 226,269 Total .................................................................................................................................................................. 2,497,723 2,222,303 Annualized ........................................................................................................................................................ ........................ 247,401 TABLE 30—TOTAL ESTIMATED COST SAVINGS TO THE U.S. GOVERNMENT [2023 Dollars, 10-year period of analysis] Total undiscounted cost savings Year Discounted cost savings 2% 1 ............................................................................................................................................................................... 2 ............................................................................................................................................................................... 3 ............................................................................................................................................................................... 4 ............................................................................................................................................................................... 5 ............................................................................................................................................................................... 6 ............................................................................................................................................................................... 7 ............................................................................................................................................................................... 8 ............................................................................................................................................................................... 9 ............................................................................................................................................................................... 10 ............................................................................................................................................................................. $4,330 4,330 4,330 4,330 4,330 4,330 4,330 4,330 4,330 4,330 $4,245 4,162 4,080 4,000 3,922 3,845 3,770 3,696 3,623 3,552 Total .................................................................................................................................................................. 43,300 38,895 Annualized ........................................................................................................................................................ ........................ 4,330 TABLE 31—TOTAL ESTIMATED COST SAVINGS TO U.S. AND FOREIGN MANUFACTURING FIRMS AND THE U.S. GOVERNMENT [2023 Dollars, 10-year period of analysis] Total undiscounted cost savings lotter on DSK11XQN23PROD with RULES3 Year Discounted cost savings 2% 1 ............................................................................................................................................................................... 2 ............................................................................................................................................................................... 3 ............................................................................................................................................................................... 4 ............................................................................................................................................................................... 5 ............................................................................................................................................................................... 6 ............................................................................................................................................................................... 7 ............................................................................................................................................................................... 8 ............................................................................................................................................................................... 9 ............................................................................................................................................................................... 10 ............................................................................................................................................................................. $71,232 1,358,999 1,385,753 1,385,753 1,385,753 1,385,753 1,385,753 1,385,753 1,385,753 1,385,753 $69,835 1,306,227 1,305,826 1,280,222 1,255,119 1,230,509 1,206,381 1,182,727 1,159,536 1,136,800 Total .................................................................................................................................................................. 12,516,255 11,133,183 Annualized ........................................................................................................................................................ ........................ 1,239,419 VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 PO 00000 Frm 00023 Fmt 4701 Sfmt 4700 E:\FR\FM\06DER3.SGM 06DER3 97378 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations Net Cost Savings We display the total net cost savings from this final rule to U.S. firms, the U.S. government, foreign firms, and all entities using a 10-year period of analysis discounted at 2 percent in table 32, table 33, table 34, and table 35, respectively. TABLE 32—TOTAL ESTIMATED NET COST SAVINGS TO U.S. FIRMS [2023 Dollars, 10-year period of analysis] Net undiscounted cost savings Year Net discounted cost savings 2% 1 ............................................................................................................................................................................... 2 ............................................................................................................................................................................... 3 ............................................................................................................................................................................... 4 ............................................................................................................................................................................... 5 ............................................................................................................................................................................... 6 ............................................................................................................................................................................... 7 ............................................................................................................................................................................... 8 ............................................................................................................................................................................... 9 ............................................................................................................................................................................... 10 ............................................................................................................................................................................. ¥$656,244 429,707 1,027,802 1,027,802 1,027,802 1,027,802 1,027,802 1,027,802 1,027,802 1,027,802 ¥$643,376 413,021 968,521 949,530 930,912 912,659 894,763 877,219 860,019 843,156 Total .................................................................................................................................................................. 7,995,879 7,006,423 Annualized ........................................................................................................................................................ ........................ 780,001 TABLE 33—TOTAL ESTIMATED NET COST SAVINGS TO FOREIGN FIRMS [2023 Dollars, 10-year period of analysis] Net undiscounted cost savings Year Net discounted cost savings 2% 1 ............................................................................................................................................................................... 2 ............................................................................................................................................................................... 3 ............................................................................................................................................................................... 4 ............................................................................................................................................................................... 5 ............................................................................................................................................................................... 6 ............................................................................................................................................................................... 7 ............................................................................................................................................................................... 8 ............................................................................................................................................................................... 9 ............................................................................................................................................................................... 10 ............................................................................................................................................................................. ¥$150,627 112,389 256,521 256,521 256,521 256,521 256,521 256,521 256,521 256,521 ¥$147,674 108,025 241,725 236,986 232,339 227,783 223,317 218,938 214,645 210,437 Total .................................................................................................................................................................. 2,013,930 1,766,522 Annualized ........................................................................................................................................................ ........................ 196,661 TABLE 34—TOTAL ESTIMATED COST SAVINGS TO THE U.S. GOVERNMENT [2023 Dollars, 10-year period of analysis] Net undiscounted cost savings Year Net discounted cost savings lotter on DSK11XQN23PROD with RULES3 2% 1 ............................................................................................................................................................................... 2 ............................................................................................................................................................................... 3 ............................................................................................................................................................................... 4 ............................................................................................................................................................................... 5 ............................................................................................................................................................................... 6 ............................................................................................................................................................................... 7 ............................................................................................................................................................................... 8 ............................................................................................................................................................................... 9 ............................................................................................................................................................................... 10 ............................................................................................................................................................................. $4,330 4,330 4,330 4,330 4,330 4,330 4,330 4,330 4,330 4,330 $4,245 4,162 4,080 4,000 3,922 3,845 3,770 3,696 3,623 3,552 Total .................................................................................................................................................................. 43,300 38,895 VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 PO 00000 Frm 00024 Fmt 4701 Sfmt 4700 E:\FR\FM\06DER3.SGM 06DER3 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations 97379 TABLE 34—TOTAL ESTIMATED COST SAVINGS TO THE U.S. GOVERNMENT—Continued [2023 Dollars, 10-year period of analysis] Net undiscounted cost savings Year Net discounted cost savings 2% Annualized ........................................................................................................................................................ ........................ 4,330 TABLE 35—TOTAL ESTIMATED NET COST SAVINGS TO ALL ENTITIES [2023 Dollars, 10-year period of analysis] Net undiscounted cost savings Year Net discounted cost savings 2% 1 ............................................................................................................................................................................... 2 ............................................................................................................................................................................... 3 ............................................................................................................................................................................... 4 ............................................................................................................................................................................... 5 ............................................................................................................................................................................... 6 ............................................................................................................................................................................... 7 ............................................................................................................................................................................... 8 ............................................................................................................................................................................... 9 ............................................................................................................................................................................... 10 ............................................................................................................................................................................. ¥$802,541 546,426 1,288,653 1,288,653 1,288,653 1,288,653 1,288,653 1,288,653 1,288,653 1,288,653 ¥$786,805 525,208 1,214,327 1,190,516 1,167,173 1,144,287 1,121,850 1,099,853 1,078,287 1,057,144 Total .................................................................................................................................................................. 10,053,109 8,811,839 Annualized ........................................................................................................................................................ ........................ 980,991 Alternatives We identified three alternatives to this final rule: (1) Incorporate ANSI/CAN/UL 12402– 5 for the approval of Level 70 PFDs only, prohibiting the approval of Level 50 PFDs; (2) Require placards for existing Type I, II, and III PFDs instead of providing the option to continue the use of informational pamphlets; and (3) Adopt ANSI/CAN/UL 12402–4 and ANSI/CAN/UL 12402–5 by policy. lotter on DSK11XQN23PROD with RULES3 Alternative 1: Incorporate ANSI/CAN/ UL 12402–5 for Level 70 PFDs Only We considered an alternative that would incorporate ANSI/CAN/UL 12402–5, but limit approval to Level 70 PFDs only. Level 50 PFDs would not be eligible for Coast Guard approval and would not meet carriage requirements on any vessel. If the Coast Guard were to choose this alternative, the market for Level 50 devices would not be viable because Level 50 devices would no longer meet carriage requirements. Without a viable market, the costs of compliance estimated in the section of ANSI/CAN/UL 12402–5 would not exist. However, the benefits from a new market and increased wear-rates would be lost were these devices to not be sold. We would also be restricting VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 recreational boaters to one category of PFD when Level 50 PFDs could better suit their purposes. As a result, we rejected this alternative because we expect that wear rates, and therefore benefits, would be lower without the option of a Level 50 PFD. Alternative 2: Require placards Instead of the Option of Placards or Pamphlets Under this final rule, we require that only new Level 50, 70, and 100 devices use placards. We considered the alternative of requiring that PFD manufacturers use placards instead of information pamphlets for all existing PFDs and not just new devices. While we observe that the cost of producing a placard is generally less than the cost of producing an information pamphlet, we also observe that some manufacturers may have already printed pamphlets or may not choose to use placards. As a result, we rejected this alternative. Alternative 3: Adopt ANSI/CAN/UL 12402–4 and ANSI/CAN/UL 12402–5 by Policy Another alternative we considered would be to adopt ANSI/CAN/UL 12402–4 and ANSI/CAN/UL 12402–5 by policy instead of incorporating them by reference into the CFR. Under 46 CFR 159.005–7(c), the Coast Guard has the authority to approve an item of PO 00000 Frm 00025 Fmt 4701 Sfmt 4700 equipment that does not meet all the requirements of 46 CFR 160.055 if it has equivalent performance characteristics. The Coast Guard has already used this authority to partially adopt ANSI/CAN/ UL 12402–4 and ANSI/CAN/UL 12402– 5 by policy. Because this authority is limited to the approval of equipment with equivalent performance characteristics, we cannot adopt the portion of standards not already equivalent to existing types of equipment. In particular, Level 50 PFDs, youth inflatable PFDs, and inflatable Level 100 PFDs could not be approved by policy because they are not equivalent to any current Coast Guard standards. For that reason, we rejected this alternative. B. Small Entities Under the Regulatory Flexibility Act, (RFA) 5 U.S.C. 601–612, we have considered whether this rule has a significant economic impact on a substantial number of small entities. The RFA (Public Law 96–354) establishes ‘‘as a principle of regulatory issuance that agencies shall endeavor, consistent with the objectives of the rule and of applicable statutes, to fit regulatory and informational requirements to the scale of the businesses, organizations, and governmental jurisdictions subject to E:\FR\FM\06DER3.SGM 06DER3 lotter on DSK11XQN23PROD with RULES3 97380 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations regulation. To achieve this principle, agencies are required to solicit and consider flexible regulatory proposals and to explain the rationale for their actions to assure that such proposals are given serious consideration.’’ When an agency promulgates a final rule under section 553 of the RFA, after being required by that section or any other law to publish a general notice of proposed rulemaking, or promulgates a final interpretative rule involving the internal revenue laws of the United States as described in section 603(a), the agency must prepare a final Regulatory Flexibility Analysis (FRFA) or have the head of the agency certify pursuant to RFA section 605(b) that the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities. The RFA prescribes the content of the FRFA in section 604(a), which we discuss as follows. In accordance with the RFA (5 U.S.C. 601–612), the Coast Guard prepared this FRFA that examines the impacts of the final rule on small entities (5 U.S.C. 601, et seq.). A small entity may be: • A small independent business, defined as any independently owned and operated business not dominant in its field that qualifies as a small business per the Small Business Act (5 U.S.C. 632); • A small not-for-profit organization; and • A small governmental jurisdiction (locality with fewer than 50,000 people). This FRFA addresses the following: (1) A statement of the need for, and objectives of, the rule; (2) A statement of the significant issues raised by the public comments in response to the initial regulatory flexibility analysis, a statement of the assessment of the agency of such issues, and a statement of any changes made in the proposed rule as a result of such comments; (3) The response of the agency to any comments filed by the Chief Counsel for Advocacy of the Small Business Administration (SBA) in response to the proposed rule, and a detailed statement of any change made to the proposed rule in the final rule as a result of the comments; (4) A description of and an estimate of the number of small entities to which the rule will apply or an explanation of why no such estimate is available; (5) A description of the projected reporting, recordkeeping and other VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 compliance requirements of the rule, including an estimate of the classes of small entities which will be subject to the requirement and the type of professional skills necessary for preparation of the report or record; and (6) A description of the steps the agency has taken to minimize the significant economic impact on small entities consistent with the stated objectives of applicable statutes, including a statement of the factual, policy, and legal reasons for selecting the alternative adopted in the final rule and why each one of the other significant alternatives to the rule considered by the agency which affect the impact on small entities was rejected. Below is a discussion of FRFA analysis by each of these six elements: (1) A statement of the need for, and objectives of, the rule. The Coast Guard amends the lifejacket approval requirements and follow-up program requirements by incorporating three new binational standards. At the same time, the Coast Guard amends lifejacket and PFD carriage requirements to allow for the use of equipment approved to the new standards, and to remove obsolete equipment approval requirements. The new standards are state-of-the-art and are intended to replace the legacy standards. The amendments will streamline the process for approval of PFDs and allow manufacturers to produce more innovative equipment that meets the approval requirements of both the United States and Canada; and will reduce the burden for manufacturers in both the approval process and follow-up program. Absent this regulation, the United States and Canada would continue to have two different PFD standards, resulting in additional costs for manufacturers. (2) A statement of the significant issues raised by the public comments in response to the initial regulatory flexibility analysis, a statement of the assessment of the agency of such issues, and a statement of any changes made in the proposed rule as a result of such comments. The Coast Guard received no public comments in response to the initial Regulatory Flexibility Analysis. (3) The response of the agency to any comments filed by the Chief Counsel for Advocacy of the SBA in response to the proposed rule, and a detailed statement PO 00000 Frm 00026 Fmt 4701 Sfmt 4700 of any change made to the proposed rule in the final rule as a result of the comments. The Coast Guard received no comments filed by the Chief Counsel for Advocacy of the SBA in response to the proposed rule. (4) A description of and an estimate of the number of small entities to which the rule will apply or an explanation of why no such estimate is available. This rule has four major provisions: (1) The incorporation by reference of ANSI/CAN/UL 12402–4 replacing Type I device approval with Level 100 device approval; (2) The incorporation by reference of ANSI/CAN/UL 12402–5 introducing new Level 50 device approvals; (3) The incorporation by reference of ANSI/CAN/UL 9595 for new follow-on production inspection standards; and (4) The option to use placards in lieu of information pamphlets on currently approved devices and the requirement to use placards for new Level 50, Level 70, and Level 100 devices. Across these four provisions, we estimate that this rule affects two Coast Guard recognized laboratories and 61 PFD manufacturers. We researched these two Coast Guard recognized independent laboratories and 61 PFD manufacturers to determine if they are U.S. companies or foreign companies based on the location of their parent company’s headquarters. We found one Coast Guard recognized laboratory to be a U.S. company and one to be a foreign company. We found 39 of the 61 PFD manufacturers to be U.S. companies and 22 to be foreign companies. We then researched each of these 40 U.S. companies (1 testing laboratory and 39 PFD manufacturers) to determine its North American Industry Classification System (NAICS) code and its size standard using the SBA’s size standard table. Next, we reviewed each U.S. parent company’s revenue or employee information to determine whether the company is small or not small, according to SBA size standards. We present the results of our research in table 36. The Coast Guard recognized independent laboratory is not a small entity. Of 39 U.S. manufacturers, 32 are small entities according to SBA size standards. We did not find any U.S. small entities to be small governmental jurisdictions or not-for-profit organizations. E:\FR\FM\06DER3.SGM 06DER3 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations 97381 TABLE 36—NUMBER OF SMALL ENTITIES AFFECTED BY THE RULE NAICS code NAICS code and industry type Size standard type 314910 ........... 314999 ........... Textile Bag and Canvas Mills ......................................... All Other Miscellaneous Store Retailers (except Tobacco Stores). Other Cut and Sew Apparel Manufacturing .................... Apparel Accessories and Other Apparel Manufacturing All Other Plastics Product Manufacturing ....................... All Other Rubber Product Manufacturing ........................ Clay Building Material and Refractories Manufacturing Boat Building ................................................................... Sporting and Athletic Goods Manufacturing ................... All Other Miscellaneous Manufacturing .......................... Sporting and Recreational Goods and Supplies Merchant Wholesalers. Boat Dealers ................................................................... Family Clothing Stores .................................................... Clothing Accessories Stores ........................................... Sporting Goods Stores .................................................... All Other General Merchandise Stores ........................... Manufactured (Mobile) Home Dealers ............................ Testing Laboratories ....................................................... Advertising Material Distribution Services ...................... All Other Support Services ............................................. Marinas ............................................................................ Unknown ......................................................................... Employees ..... Revenue ........ 315280 315990 326199 326299 327120 336612 339920 339999 423910 ........... ........... ........... ........... ........... ........... ........... ........... ........... 441222 ........... 448140 ........... 448150 ........... 451110 ........... 452319 ........... 453930 ........... 541380 ........... 541870 ........... 561990 ........... 713930 ........... Unknown ........ Number of U.S. companies Number of small entities 500 $8.0 1 2 1 2 ..... ..... ..... ..... ..... ..... ..... ..... ..... 750 500 750 500 750 1,000 750 500 100 1 1 2 1 1 2 4 1 1 1 1 0 1 1 2 3 1 1 ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ $35.0 $41.5 $16.5 $16.5 $35.0 $16.5 $16.5 $16.5 $12.0 $8.0 Unknown 5 1 2 2 1 1 1 1 1 1 7 4 0 1 2 1 0 0 1 1 1 7 Employees Employees Employees Employees Employees Employees Employees Employees Employees Revenue Revenue Revenue Revenue Revenue Revenue Revenue Revenue Revenue Revenue Unknown Size standard used * 40 32 * Some size standards are based on the number of employees and others on the firm’s total revenue. Each of the four provisions in this final rule affects a different subset of the 32 small entities and has a different distribution of costs and cost savings across those small entities. We discuss each provision separately in the following sections, and then summarize each provision’s impacts. lotter on DSK11XQN23PROD with RULES3 Provision 1: Incorporation by Reference of ANSI/CAN/UL 12402–4 The first provision, ANSI/CAN/UL 12402–4, affects seven small entities, six of which have known revenues. The first provision results in costs to small entities that intend to sell Level 100 devices in only one market (United States or Canada). Firms wishing to sell Level 100 devices in both United States and Canadian markets will reduce costs by no longer conducting duplicative approvals and facility inspections. Whether small entities will or will not experience cost savings depends on whether each small entity prefers to sell their device in only the United States or Canada or in both markets. The Coast Guard does not know which small entities will prefer a cheaper set of product approval tests with only the ability to sell in one market and which will prefer a more expensive set of product approval tests with the ability to sell in both markets. Therefore, we compare both the costs and cost savings estimates to each small entity. VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 In the RA, we estimate the Level 100 approval to be $5,050 more expensive than the current Type I approval. We estimate that testing laboratories receive an application for approval to Level 100 standards 0.45 times per year. Each small entity will apply for an approval once they develop a new device and will experience this cost only when they submit a new application. The Coast Guard cannot predict when each small entity might submit a new application; instead, we use the cost of $5,050 as an estimate of a one-time (initial-year cost) per-small-entity-cost of ANSI/CAN/UL 12402–4. We estimate the cost savings for small entities that wish to sell in two markets as $42,150 per new Level 100 approval, $5,594 per modification of an existing approval with testing, and $1,373 per revision of an existing approval without testing. As with the costs of ANSI/CAN/ UL 12402–4, each small entity will experience the cost savings only when it submits each application. The Coast Guard does not know when small entities might seek new approvals or revisions in the future, so we estimate these as one-time cost savings to small entities from ANSI/CAN/UL 12402–4. Specifically, we estimate that each small entity will experience a one-time total cost savings of $41,638 for each approval, which is the sum of the Level 100 approvals and revisions to PO 00000 Frm 00027 Fmt 4701 Sfmt 4700 approvals with or without testing ($42,150 + $7,605 + $1,373). These seven small entities will also experience an ongoing (annual) cost savings of $1,338.00 from reduced facility inspection frequency.34 Provision 2: Incorporation by Reference of ANSI/CAN/UL 12402–5 Incorporating by reference ANSI/ CAN/UL 12402–5 permits small entities to seek Coast Guard approval to produce and sell Level 50 devices. The Coast Guard has not previously approved these devices. We estimate that this provision affects all 32 small entities, 24 of which have known revenues. In the RA, we estimate that the introduction of Level 50 devices will cause the North American PFD market to grow by 5 percent. We interpret the 5-percent growth in terms of the number of approved devices (a growth of 38 device approvals). The initial approvals represent a one-time (initial year) cost to small entities. Small entities will also experience an annual cost of additional production inspections based on the volume of Level 50 PFDs produced. 34 Facility inspections last 4 hours and include the billed cost of an inspector’s time, or $274.50, and the opportunity cost of a Quality Manager’s time, or $60 per hour as a loaded weighted average. The cost savings is therefore 4 × $274.50 + 4 × $60 or $1,338. Readers should refer to section 7 of the RA discussing the ANSI/CAN/UL 12402–4 standard for more detail. E:\FR\FM\06DER3.SGM 06DER3 97382 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations We estimate a new Level 50 device approval costs a small entity about $39,840. We do not know which small entities will seek Coast Guard approval for a Level 50 device or how many devices each small entity might seek approval for. As a result, we treat each small entity as seeking approval for one Level 50 device costing $39,840. This will be a one-time (initial year) cost to small entities. Production is not distributed equally across the small entities that produce PFDs for the North American market. Instead, some small entities produce vastly more PFDs than others. In the RA, we estimate the market share of the 13 largest firms to be collectively about 95 percent. We estimate the remaining 44 firms’ market share collectively to be about 5 percent. We do not know the relative market share of the 44 firms, so we divide the 5 percent equally across the 44 firms. Therefore, we treat each of the 44 firms as accounting for about 0.11 percent of the PFD market.35 For the 32 small entities that would use the ANSI/CAN/UL 12402–5 standard, 24 are in the set of 44 firms collectively having 5 percent market share, and therefore we assume each has a market share of 0.11 percent. Based on conversations with PFD manufacturing executives, we estimate 5 of the 32 firms have a market share of 2.5 percent each, 1 has a market share of 7.5 percent, 1 has a market share of 15 percent, and 1 has a market share of 25 percent. We could not find revenue data for eight small entities. We display this information in table 37 below. TABLE 37—MARKET SIZE OF SMALL ENTITIES AFFECTED BY THE RULE Number of small entities Market share of each entity (%) 24 .......................................... 5 ............................................ 1 ............................................ 1 ............................................ 1 ............................................ 0.11 2.5 7.5 15 25 In the RA, we estimate the annual cost of production inspections across the whole industry to be $82,974. Because we do not know which small entities will seek Level 50 approval, we estimate the additional costs from production inspections from Level 50 device sales for each small entity by multiplying each small entity’s market share by the total costs. For example, if we use a small entity that has a market share of 0.11 percent, then we estimate the small entity’s additional production inspection costs to be about $91.27 ($82,974 × 0.0011, rounded) annually. Provision 3: Incorporation by Reference of ANSI/CAN/UL 9595 Incorporating ANSI/CAN/UL 9595 by reference establishes production testing standards for the PFD manufacturing industry. ANSI/CAN/UL 9595 will lead to reductions in testing frequency for PFD manufacturing entities with a QMS in place. We estimate that eight small entities would be affected by this provision, seven of which have known revenue. Small entities will experience onetime costs of an initial QMS inspection, and ongoing costs because a QMS inspection is more expensive than the facility inspection it replaces in subsequent years. We estimate that each small entity has two facilities, with the largest small entity having three facilities, and QMS inspection costs occur per facility. In the RA, we estimate that the total costs to U.S. firms for the ANSI/CAN/UL 9595 standard will be about $61,296 for 19 facilities. We estimate that 7 of the firms in the top 13 are small entities, including the top firm. Because we do not know where each small entity’s facilities are located, to estimate each small entity’s one-time costs, we multiply $61,296 by each small entity’s share of the 19 facilities, yielding $6,452 ((2 ÷ 19) × $61,296) for all but the largest small entity and $9,678 ((3 ÷ 19) × $61,296) for the largest small entity. We estimate annual costs to be about $439 per facility, which is the difference between 8 hours of billed QMS inspector time and 8 hours of a regular inspector’s time.36 The largest small entity has three facilities, so will experience $1,316 ($439 × 3) in additional costs. All the other small entities have two facilities, and they will experience $878 ($439 × 2) in annual costs. We reflect this information in table 38. TABLE 38—COSTS PER SMALL ENTITY FROM UL 9595 Number of facilities Entity type lotter on DSK11XQN23PROD with RULES3 The Largest .................................................................................................................................. All Others ..................................................................................................................................... Total one-time costs 3 2 $9,678 6,452 Annual costs $1,317 878 Small entities that achieve a higher process rating according to the ANSI/ CAN/UL 9595 standard will also experience annual cost savings based on each small entity’s market share and the rigor of the QMS system in place. As mentioned previously, we estimate that only the top 13 firms will experience savings from ANSI/CAN/UL 9595, and we estimate that 7 of those firms are small entities. Cost savings will be different for each of the seven small entities. To estimate the cost savings per small entity, we need to estimate the number of reductions in inspections per small entity and then multiply by $2,712 ($2,196 of billed inspector time and $516 of weighted average quality manager loaded wages). To calculate the reductions in inspections for each small entity, we take the share of current inspections for each small entity and then estimate the number of inspections that would take place under Process Rating A or B for each small entity. Next, we subtract the reduced inspection frequency per small entity from the current inspection frequency, yielding a reduction in inspection frequency for current production. In the RA, we also estimate that U.S. firms will experience 16 fewer inspections on Level 50 devices that they do not yet produce, resulting in cost savings from reduced inspection frequency. We then multiply the 16 inspections by each small entity’s share of reduction in current inspections. For example, assume that a small entity had a 10-percent market share, half of which would be at Process Rating A and half of which would be at Process Rating B. We first take the total number of current inspections on U.S. firms (587) and multiply by the small entity’s market share relative to the total affected U.S. market share, or 10 percent 35 We divided 5 percent or 0.05 by 44 companies to obtain 0.11 percent of the market for each one. 36 Independent laboratories bill QMS inspections at $329.40 per hour, while they bill normal inspections at $274.50 per hour. Thus, the additional cost is $54.90 per hour ($329.40¥$274.50), or $439 in an 8-hour workday ($54.90 × 8). See section 9.1.2 in the RA. VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 PO 00000 Frm 00028 Fmt 4701 Sfmt 4700 E:\FR\FM\06DER3.SGM 06DER3 97383 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations ÷ 77.5 percent × 587, yielding 76 rounded. Then we derive the reduced number of inspections at B and the reduced number of inspections at A by multiplying the reduced inspection frequency at B (194) by the share of the small entity’s Process Rating at B relative to all other U.S. firms at B, or 5 percent ÷ 51 percent, yielding 19 rounded. To estimate the reduced inspection frequency at A, we take the number of facilities at A (one) and multiply by two, accounting for the number of inspections that occur once the facility is at Process Rating A. Next, total estimated reduction in U.S. firm inspections from Table 42 in the RA (54 ÷ 376) and multiply by the 16 total reduction in inspections, yielding 2 rounded. We add the reduction in Level 50 inspections (2) and the reduction in current inspections (54) together and multiply by the cost of each inspection ($2,712), yielding $151,872 ((2+54) × $2,712), or the small entity’s annual cost savings from reduced inspection frequency. We perform this process for each of the eight small entities. We record these calculations in table 39; the results are rounded. we add to it the multiplication of the number of commercial PFD production inspections at A (7) and the small entity’s relative share of production at A, or 5 percent ÷ 26.5 percent, yielding 3 rounded (2 × 1) + (7 × 5 percent ÷ 26.5 percent). Taken together, the small entity’s reduced inspection frequency is 22 (19 + 3), meaning the small entity experiences 54 fewer production inspections annually (76¥22). To calculate the number of reduced Level 50 inspections for each small entity, we take the small entity’s share of U.S. firm inspection reduction divided by the TABLE 39—ANNUAL COST SAVINGS FOR A REPRESENTATIVE SMALL ENTITY IN 2023 DOLLARS Total market share Market share at B Market share at A Current inspection frequency Inspection frequency at B Inspection frequency at A Total inspection reduction Reduced level 50 inspections Total annual cost savings A B=A÷2 C=A÷2 D = 587 × A ÷ 77.5% E = 194 × B ÷ 51% F = (2 × 1) + (7 × C ÷ 26.5%) G = D¥E¥F H = G ÷ 376 × 16 (G + H) × $2,712 2 $151,872 10% ............. 5% 5% 76 Provision 4: Replacement of Information Pamphlets With Booklets We did not estimate any costs or cost savings from this provision, so we do 19 3 not estimate that there will be any impact on small entities. We summarize the number of small entities affected, cost impacts, cost 54 savings impacts, and transfers per provision in table 40. TABLE 40—NUMBER OF AFFECTED SMALL ENTITIES, COSTS, AND COST SAVINGS PER PROVISION Provision PFD manufacturing population affected Costs Cost savings ANSI/CAN/UL 12402–4 37 ..... 7 small entities of the 30; 6 small entities with known revenues. One-time testing to Level 100 will cost $5,050 more than testing to Legacy Type I standards for entities wishing to sell in only Canada or the United States. ANSI/CAN/UL 12402–5 38 ..... 32 small entities, 24 small entities with known revenues. ANSI/CAN/UL 9595 39 ........... 8 small entities, 7 small entities with known revenues. Information Pamphlets .......... 32 small entities, 24 small entities with known revenues. One-time (initial year) testing to Level 50 standards will cost about $39,840. Additional ongoing costs from inspections will be between $91.27 and $20,743.50 based on each small entity’s market share (small entities with larger market shares will experience greater costs). One-time (initial year) cost from an additional QMS inspection of about $9,678.32 for the largest small entity based on three facilities and $6,452.21 for all other small entities with two facilities. Ongoing (annual) costs will result from a QMS inspection and will be more than a regular inspection. We estimate ongoing costs to be about $439 per facility or $1,317 for the largest small entity with three facilities and $878 for each other small entity with two facilities. No estimated costs ................................................. One-time testing to Level 100 will be $42,150 less than testing to Type I standards for entities wishing to sell in both the United States and Canada. Small entities will also save costs from cheaper revisions with and without testing, $5,594 and $1,373 respectively. Together, small entities will save $49,117. Small entities will also experience $1,338 in annual cost savings from reduced facility inspections. No estimated cost savings for these small entities. lotter on DSK11XQN23PROD with RULES3 We provide a list of the range of costs, cost savings, and net cost savings per 37 See Section 7 of the RA for more detail about the costs and cost savings of ANSI/CAN/UL 12402– 4. Numbers in this table may not match precisely numbers in the RA as this FRFA adjust costs to be on a per entity basis accounting for market share. 38 See Section 8 of the RA for more detail about the costs and cost savings of ANSI/CAN/UL 12402– VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 entity in table 41. Because each entity 5. Numbers in this table may not match precisely numbers in the RA as this FRFA adjust costs to be on a per entity basis accounting for market share. 39 See Section 9 of the RA for more detail about the costs and cost savings of ANSI/CAN/UL 9595. Numbers in this table may not match precisely numbers in the RA as this FRFA adjust costs to be on a per entity basis accounting for market share. PO 00000 Frm 00029 Fmt 4701 Sfmt 4700 Small entities will save through reduced inspection frequencies based on each small entity’s market share and each small entity’s QMS in place. We estimate these 8 small entities will experience between $24,408 and $265,776 in savings per year based upon their market share and QMS ratings. No estimated cost savings. is subject to a different subset of provisions, this table should be interpreted as the minimum and maximum, cost, cost savings, and net cost savings per entity. Specifically, the cost, cost savings, and net cost savings rows are the minimum or maximum observed across the range of entities. E:\FR\FM\06DER3.SGM 06DER3 97384 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations Net cost savings is therefore not a function of the cost and cost savings in Table 41. For example, the lowest net cost savings in Table 40, ¥$46,292.21, demonstrates a cost greater than the lowest cost that will be experienced by an entity, or $39,840, which is why it is not the lowest cost per entity. Similarly, lowest and highest ongoing impacts do not necessarily match to the lowest and highest one-time impacts. We are simply reporting the lowest and highest impacts per entity across costs, cost savings, and net cost savings. TABLE 41—RANGE OF IMPACTS PER ENTITY One-time impacts Lowest per entity Cost .................................................................................................................. Cost Savings .................................................................................................... Net Cost Savings ............................................................................................. In table 42, we report the estimated overall net cost savings revenue impact $39,840.00 ........................ (46,292.21) Ongoing impacts Highest per entity $54,568.32 49,117.00 4,227.00 Lowest per entity Highest per entity $91.27 ........................ (47,870.27) $71,177.50 267,114.00 195,936.50 per small entity of this final rule across all provisions. TABLE 42—PERCENTAGE OF ESTIMATED REVENUE IMPACT ON SMALL ENTITIES FROM OVERALL IMPACT (NET COST SAVINGS) OF THIS FINAL RULE One-time net impacts % Revenue impact Small entities with known revenue lotter on DSK11XQN23PROD with RULES3 <1 ..................................................................................... 1–3% ................................................................................ >3 ..................................................................................... (5) A description of the projected reporting, recordkeeping and other compliance requirements of the rule, including an estimate of the classes of small entities which will be subject to the requirement and the type of professional skills necessary for preparation of the report or record. This rule calls for no new collection of information under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501– 3520. (6) A description of the steps the agency has taken to minimize the significant economic impact on small entities consistent with the stated objectives of applicable statutes, including a statement of the factual, policy, and legal reasons for selecting the alternative adopted in the final rule and why each one of the other significant alternatives to the rule considered by the agency which affect the impact on small entities was rejected. The Coast Guard identified three alternatives: (1) Incorporate ANSI/CAN/UL 12402– 5 for the approval of Level 70 PFDs only, prohibiting the approval of Level 50 PFDs; (2) Require placards instead of pamphlets; and (3) Adopt ANSI/CAN/UL 12402–4 and ANSI/CAN/UL 12402–5 by policy. VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 Portion of small entities with known revenue (%) 17 2 5 Under the first alternative, we could have chosen to incorporate ANSI/CAN/ UL 12402–5 but limit approval to Level 70 PFDs only. Level 50 PFDs would not be eligible for Coast Guard approval and would not meet carriage requirements on any vessel, severely restricting their use. If the Coast Guard chose this alternative, the market for Level 50 devices would not be viable because Level 50 devices would no longer partially substitute for Level 70 or Type III devices. Small entities would be unable to sell these new devices and would not experience a positive revenue impact from this alternative. As a result, we rejected this alternative because it does not maximize small entities’ revenue. Alternative 2: Require Placards Instead of Pamphlets We considered the alternative of requiring that PFD manufacturers use placards instead of information pamphlets for the mandatory PFD instructional materials. While the Coast Guard observes that the cost of producing placards is generally less than the costs of producing information pamphlets, the Coast Guard observes Frm 00030 Fmt 4701 Sfmt 4700 Small entities with known revenue 71 8 21 Alternative 1: Incorporate by Reference ANSI/CAN/UL 12402–5 for Level 70 PFDs Only PO 00000 Ongoing net impacts 20 2 2 Portion of small entities with known revenue (%) 83 8 8 that some manufacturers may not have switched to producing placards yet. As such, if we required that manufacturers use placards, we could place undue burden on small entities in the PFD industry by requiring that they acquire new equipment to produce placards. We do not know how large these costs could be, but small entities would experience greater compliance costs. As a result, we ultimately rejected this alternative. Alternative 3: Adopt ANSI/CAN/UL 12402–4 and ANSI/CAN/UL 12402–5 by Policy The third alternative we considered was to adopt ANSI/CAN/UL 12402–4 and ANSI/CAN/UL 12402–5 by policy instead of incorporating them by reference in the regulations. Under 46 CFR 159.005–7(c), the Coast Guard has the authority to approve an item of equipment that does not meet all the requirements of 46 CFR 160.055 if it has equivalent performance characteristics. The Coast Guard has utilized this authority to partially adopt ANSI/CAN/ UL 12402–4 and ANSI/CAN/UL 12402– 5 by policy. However, because this authority is limited to the approval of equipment with equivalent performance characteristics, we cannot adopt the portion of standards not already equivalent to existing types of equipment. In particular, Level 50 PFDs, E:\FR\FM\06DER3.SGM 06DER3 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations youth inflatable PFDs, and inflatable Level 100 PFDs cannot be approved by policy because they are not equivalent to any current Coast Guard standards. As a result, small entities would not receive the additional revenue from the sale of Level 50 devices or the cost savings on Level 100 inflatable device approvals as compared to Type I device approvals. For these reasons, we rejected this alternative. C. Assistance for Small Entities Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996, Public Law 104– 121, we offer to assist small entities in understanding this rule so that they can better evaluate its effects on them and participate in the rulemaking. The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard. Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency’s responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1– 888–REG–FAIR (1–888–734–3247). lotter on DSK11XQN23PROD with RULES3 D. Collection of Information This rule calls for no new or revised collection of information under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501–3520. E. Federalism A rule has implications for federalism under Executive Order 13132 (Federalism) if it has a substantial direct effect on States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this final rule under Executive Order 13132 and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132. Our analysis follows. It is well settled that States may not regulate in categories reserved for regulation by the Coast Guard. It is also well settled that all the categories covered in 46 U.S.C. 3306, 3703, 7101, and 8101 (design, construction, alteration, repair, maintenance, operation, equipping, personnel qualification, and manning of vessels), VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 as well as the reporting of casualties and any other category in which Congress intended the Coast Guard to be the sole source of a vessel’s obligations, are within the field foreclosed from regulation by the States. The statutory authorities upon which this rulemaking is based—46 U.S.C. 3306(a), 4102(a), 4302(a), and 4502(a) and (c)(2)(B)—are areas in which Congress intended the Coast Guard to be the sole source of a vessel’s obligations and, as such, are within the field foreclosed from regulation by the States. See, e.g., United States v. Locke, 529 U.S. 89 (2000) (finding that the states are foreclosed from regulating tanker vessels), see also Ray v. Atlantic Richfield Co., 435 U.S. 151, 157 (1978) (state regulation is preempted where ‘‘the scheme of federal regulation may be so pervasive as to make reasonable the inference that Congress left no room for the States to supplement it [or where] the Act of Congress may touch a field in which the federal interest is so dominant that the federal system will be assumed to preclude enforcement of state laws on the same subject.’’ (citations omitted)). Therefore, because the States may not regulate within these categories, this rule is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132. F. Unfunded Mandates The Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1531–1538, requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Although this rule does not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble. G. Taking of Private Property This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630 (Governmental Actions and Interference with Constitutionally Protected Property Rights). H. Civil Justice Reform This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988 (Civil Justice Reform) to minimize litigation, eliminate ambiguity, and reduce burden. I. Protection of Children We have analyzed this rule under Executive Order 13045 (Protection of PO 00000 Frm 00031 Fmt 4701 Sfmt 4700 97385 Children from Environmental Health Risks and Safety Risks). This rule is not an economically significant rule and will not create an environmental risk to health or risk to safety that might disproportionately affect children. J. Indian Tribal Governments This rule does not have tribal implications under Executive Order 13175 (Consultation and Coordination with Indian Tribal Governments), because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. K. Energy Effects We have analyzed this rule under Executive Order 13211 (Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use). We have determined that it is not a ‘‘significant energy action’’ under that order because it is not a ‘‘significant regulatory action’’ under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. L. Technical Standards The National Technology Transfer and Advancement Act, codified as a note to 15 U.S.C. 272, directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through OMB, with an explanation of why using these standards are inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies. This rule uses the following voluntary consensus standards: • ANSI/CAN/UL 9595, Standard for Safety Factory Follow-Up on Personal Flotation Devices (PFDs), First Edition, June 4, 2020 (including revisions through September 9, 2021). • ANSI/CAN/UL 12402–4, Standard for Safety Personal Flotation Devices— Part 4: Lifejackets, Performance Level 100—Safety Requirements, First Edition, July 9, 2020. • ANSI/CAN/UL 12402–5, Standard for Safety Personal Flotation Devices— Part 5: Buoyancy Aids (Level 50)— Safety Requirements, First Edition, E:\FR\FM\06DER3.SGM 06DER3 97386 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations lotter on DSK11XQN23PROD with RULES3 December 31, 2015 (including revisions through January 27, 2022). • ANSI/UL 1123, Standard for Safety Marine Buoyant Devices, Seventh Edition, October 1, 2008 (including revisions through November 23, 2020). • ANSI/UL 1175, Standard for Safety Buoyant Cushions, Fourth Edition, April 20, 2007 (including revisions through January 10, 2020). The sections that reference these standards and the locations where these standards are available are listed in 46 CFR 160.045–5, 160.055–5, 160.060–5, 160.064–5, 160.076–5, 160.255–5, 160.264–5, and 160.276–5. The Director of the Federal Register has approved the material in 46 CFR 160.045–5, 160.055–5, 160.060–5, 160.064–5, 160.076–5, 160.255–5, 160.264–5, and 160.276–5 for incorporation by reference under 5 U.S.C. 552 and 1 CFR part 51. Copies of the material are available from the sources listed in 46 CFR 160.045–5, 160.055–5, 160.060–5, 160.064–5, 160.076–5, 160.255–5, 160.264–5, and 160.276–5. Consistent with 1 CFR part 51 incorporation by reference provisions, this material is reasonably available. Interested persons have access to it through their normal course of business, may purchase it from the organization identified in 46 CFR 160.045–5, 160.055–5, 160.060–5, 160.064–5, 160.076–5, 160.255–5, 160.264–5, and 160.276–5, or may view a copy by means we have identified in that section. M. Environment We have analyzed this rule under Department of Homeland Security Management Directive 023–01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321–4370f), and have made a determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the ADDRESSES section of this preamble. This final rule is categorically excluded under paragraph L52 and L58 of Appendix A, Table 1 of DHS Instruction Manual 023–01–001–01, Rev. 1. Paragraph L52 pertains to regulations concerning vessel operation safety standards. Paragraph L58 pertains to regulations concerning equipment VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 approval and carriage requirements. This final rule involves approval requirements and follow-up program requirements for lifejackets by incorporating new standards to replace existing legacy standards. The rule further amends lifejacket and PFD carriage requirements to allow for the use of equipment approved to the new standards and remove obsolete equipment approval requirements. The amendments streamline the process for the approval of PFDs and allow manufacturers the opportunity to produce more innovative equipment that meet approval requirements in both the United States and Canada while also reducing the burden of the approval process and the production inspections on manufacturing firms. List of Subjects 46 CFR Part 199 Cargo vessels, Marine safety, Oil and gas exploration, Passenger vessels, Reporting and recordkeeping requirements. For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 181 and 46 CFR parts 25, 28, 108, 117, 133, 141, 160, 169, 180, and 199 as follows: Title 33—Navigation and Navigable Waters PART 181—MANUFACTURER REQUIREMENTS 1. The authority citation for part 181 is revised to read as follows: ■ Authority: 46 U.S.C. 4302; DHS Delegation 00170.1, Revision No. 01.4. § 181.4 33 CFR Part 181 Labeling, Marine safety, Reporting and recordkeeping requirements. 46 CFR Part 25 ■ Subpart G—Information Pamphlet or Placard for Personal Flotation Devices 3. Revise the heading of Subpart G to read as set forth above. Fire prevention, Marine safety, Reporting and recordkeeping requirements. ■ 46 CFR Part 28 ■ Alaska, Fire prevention, Fishing vessels, Marine safety, Occupational safety and health, Reporting and recordkeeping requirements, Seamen. 46 CFR Part 108 [Removed and Reserved] 2. Remove and reserve § 181.4. § 181.701 [Amended] 4. Amend § 181.701 by adding the words ‘‘Coast Guard approved’’ after the word ‘‘all’’. ■ 5. Revise § 181.702 to read as follows: § 181.702 Information pamphlet or placard: requirement to furnish. Marine safety, Occupational health and safety, Reporting and recordkeeping requirements, Towing vessels. (a) Each manufacturer of a Coast Guard approved personal flotation device (PFD) must furnish, with each PFD that is sold or offered for sale for use on a recreational boat, an information pamphlet or placard accepted by the Commandant (CG– ENG–4) or meeting the requirements in the applicable subpart of 46 CFR part 160. (b) No person may sell or offer for sale for use on a recreational boat a Coast Guard approved PFD unless an information pamphlet or placard required by this section is attached in such a way that it can be read prior to purchase. 46 CFR Part 160 §§ 181.703 through 181.705 Incorporation by reference, Marine safety, Reporting and recordkeeping requirements. ■ Fire prevention, Marine safety, Occupational safety and health, Oil and gas exploration, Vessels. 46 CFR Part 117 Marine safety, Passenger vessels. 46 CFR Part 133 Cargo vessels, Marine safety, Reporting and recordkeeping requirements. 46 CFR Part 141 46 CFR Part 169 Fire prevention, Marine safety, Reporting and recordkeeping requirements, Schools, Vessels. 46 CFR Part 180 Marine safety, Passenger vessels. PO 00000 Frm 00032 Fmt 4701 Sfmt 4700 [Removed] 6. Remove §§ 181.703 through 181.705. Title 46—Shipping PART 25—REQUIREMENTS 7. The authority citation for part 25 is revised to read as follows: ■ Authority: 33 U.S.C. 1903(b); 46 U.S.C. 2103, 3306, 4102, 4302; DHS Delegation 00170.1, Revision No. 01.4. E:\FR\FM\06DER3.SGM 06DER3 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations it is in good and serviceable condition and— * * * * * 8. Amend § 25.25–5 by: a. Removing in paragraph (b)(2), the text ‘‘or 160.176’’ and adding, in its place, the text ‘‘160.176, or 160.255’’; and ■ b. Revising the introductory text to paragraph (c)(2). The revision reads as follows: ■ ■ PART 28—REQUIREMENTS FOR COMMERCIAL FISHING INDUSTRY VESSELS 9. The authority citation for part 28 is revised to read as follows: ■ § 25.25–5 Life preservers and other lifesaving equipment required. * * * * * (c) * * * (2) On each vessel, regardless of length and regardless of whether carrying passengers for hire, a commercial hybrid PFD approved under former approval series 160.077 prior to January 6, 2025, may be substituted for a PFD approved under approval series 160.055, 160.155, 160.176, or 160.255 if Authority: 46 U.S.C. 3316, 4502, 4505, 4506, 6104, 8103, 10603; DHS Delegation 00170.1, Revision No. 01.4. ■ 10. Revise § 28.110 to read as follows: § 28.110 Life preservers or other personal flotation devices. (a) Except as provided by § 28.305 of this chapter, each vessel must be equipped with at least one immersion suit, exposure suit, or wearable personal 97387 flotation device of the proper size for each individual on board as specified in table 1 to § 28.110 and part 25, subpart 25.25 of this chapter. Notwithstanding the provisions of paragraphs (c) and (d) of § 25.25–1 of this chapter, each commercial fishing industry vessel propelled by sail, and each manned barge employed in commercial fishing activities, must meet the requirements of this paragraph. (b) Each wearable personal flotation device must be stowed so that it is readily accessible to the individual for whom it is intended, from both the individual’s normal work station and berthing area. If there is no location accessible to both the work station and the berthing area, an appropriate device must be stowed in both locations. TABLE 1 TO § 28.110—PERSONAL FLOTATION DEVICES AND IMMERSION SUITS Applicable waters Vessel type Devices required Seaward of the Boundary Line and North of 32° N or South of 32° S; and Lake Superior. Coastal Waters on the West Coast of the United States north of Point Reyes, CA; Beyond Coastal Waters, cold water; and Lake Superior. All other waters (Includes all Great Lakes except Lake Superior). Documented Vessel ............... All vessels .............................. 40 feet (12.2 meters) or more in length. Less than 40 feet (12.2 meters) in length. Other regulations Immersion suit or exposure suit. Immersion suit or exposure suit. 28.135; 25.25–9(a); 25.25–13; 25.25–15. 28.135; 25.25–9(a); 25.25–13; 25.25–15. Wearable PFD approved under approval series 160.055, 160.155, or 160.176, or 160.255 immersion suit, or exposure suit.1 Wearable PFD approved under subchapter Q of this chapter, immersion suit, or exposure suit.1 28.135; 25.25–5; 25.25–9(a); 25.25–13; 25.25–15. 28.135; 25.25–5; 25.25–9(a); 25.25–13; 25.25–15. 1 A commercial hybrid approved under former approval series 160.077 prior to [EFFECTIVE DATE OF FINAL RULE] may be substituted for a PFD approved under approval series 160.055, 160.155, 160.176, or 160.255 if it is in good and serviceable condition, used in accordance with the conditions marked on the PFD and in the owner’s manual, and labeled for use on commercial vessels. PART 108—DESIGN AND EQUIPMENT 11. The authority citation for part 108 continues to read as follows: ■ Authority: 43 U.S.C. 1333; 46 U.S.C. 3102, 3306; DHS Delegation 00170.1, Revision No. 01.4. 12. Amend § 108.580 by revising paragraph (b) introductory text to read as follows: ■ § 108.580 Personal lifesaving appliances. lotter on DSK11XQN23PROD with RULES3 * * * * * (b) Lifejackets. Each unit must carry lifejackets approved under approval series 160.155 or 160.176. If the unit carries inflatable lifejackets, they must be of the same or similar design and have the same method of operation. * * * * * VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 PART 117—LIFESAVING EQUIPMENT AND ARRANGEMENTS 13. The authority citation for part 117 is revised to read as follows: ■ Authority: 46 U.S.C. 2103, 3306; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; DHS Delegation 00170.1, Revision No. 01.4. 14. Amend § 117.71 by: a. Revising the section heading and paragraph (c); ■ b. Removing paragraph (d); and ■ c. Redesignating paragraph (e) as paragraph (d). The revisions read as follows: ■ ■ § 117.71 Lifejackets. * * * * * (c) Each lifejacket must be approved under approval series 160.002, 160.005, 160.055, 160.155, 160.176, or 160.255 in subchapter Q of this chapter, or other standard specified by the Commandant. An inflatable lifejacket approved under PO 00000 Frm 00033 Fmt 4701 Sfmt 4700 approval series 160.255 must include a full back-up inflation chamber. * * * * * 15. Amend § 117.72 by revising the section heading and paragraphs (b) and (d) to read as follows: ■ § 117.72 Personal flotation devices carried in addition to lifejackets. * * * * * (b) Wearable PFDs approved in accordance with §§ 160.064, 160.076, 160.264, or 160.276 in subchapter Q of this chapter, or other standard specified by the Commandant, may be carried as additional equipment. * * * * * (d) A commercial hybrid PFD approved under former approval series 160.077 prior to January 6, 2025 may be carried as additional equipment for use by persons working near or over the water if it is in good and serviceable condition, used in accordance with the E:\FR\FM\06DER3.SGM 06DER3 97388 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations conditions marked on the PFD and in the owner’s manual, of the same or similar design, and has the same method of operation as each other hybrid PFD carried on board. Subpart 160.005 [Removed and Reserved] 23. Remove and reserve subpart 160.005, consisting of §§ 160.005–1 through 160.005–7. ■ PART 133—LIFESAVING SYSTEMS 16. The authority citation for part 133 is revised to read as follows: ■ Authority: 46 U.S.C. 3306, 3307; DHS Delegation 00170.1, Revision No. 01.4. § 133.70 [Amended] 17. Amend § 133.70(b) introductory text by removing the text ‘‘160.177’’ and adding, in its place, the text ‘‘160.255’’. ■ PART 141—LIFESAVING 18. The authority citation for part 141 is revised to read as follows: ■ Authority: 46 U.S.C. 3103, 3301, 3306, 3308, 3316, 8104, 8904; 33 CFR 1.05; DHS Delegation 00170.1, Revision No. 01.4. § 141.340 [Amended] 19. Amend § 141.340 by: ■ a. Removing in paragraph (a) the text ‘‘or 160.176,’’ and adding, in its place, the text ‘‘160.176, or 160.255’’; and ■ b. Adding paragraph (i). The addition reads as follows: ■ § 141.340 * * * * * (i) Wearable PFDs approved in accordance with §§ 160.064, 160.076, 160.264, or 160.276 in subchapter Q of this chapter, or other standard specified by the Commandant, may be carried as additional equipment. Additional equipment is not acceptable in lieu of any portion of the required lifejackets. PART 160—LIFESAVING EQUIPMENT 20. The authority citation for part 160 continues to read as follows: ■ Authority: 46 U.S.C. 2103, 3306, 3703 and 4302; E.O. 12234; 45 FR 58801; 3 CFR, 1980 Comp., p. 277; and DHS Delegation 00170.1, Revision No. 01.4. Subpart 160.001 [Removed and Reserved] 21. Remove and reserve subpart 160.001, consisting of §§ 160.001–1 through 160.001–5. lotter on DSK11XQN23PROD with RULES3 ■ Subpart 160.002 [Removed and Reserved] 22. Remove and reserve subpart 160.002, consisting of §§ 160.002–1 through 160.002–7. ■ 19:44 Dec 05, 2024 24. Remove and reserve subpart 160.006, consisting of § 160.006–2. ■ 25. Add subpart 160.045, consisting of §§ 160.045–1 through 160.045–25, to read as follows: ■ Subpart 160.045—Recreational Throwable PFDs Sec. 160.045–1 Scope. 160.045–3 Definitions. 160.045–5 Incorporation by reference. 160.045–7 Design, construction, and performance of throwable PFDs. 160.045–9 Approval procedures for throwable PFDs. 160.045–11 Recognized laboratory. 160.045–13 Approval inspections and tests. 160.045–15 Production inspections, tests, and quality control of throwable PFDs. 160.045–17 Marking and Labeling. 160.045–21 PFD manuals. 160.045–23 Procedure for approval of design or material change. 160.045–25 Suspension or termination of approval. Subpart 160.045—Recreational Throwable PFDs Lifejackets. VerDate Sep<11>2014 Subpart 160.006 [Removed and Reserved] Jkt 265001 § 160.045–1 Scope. (a) This subpart contains structural and performance standards for approval of throwable PFDs for use on recreational vessels, as well as requirements for production follow-up inspections, associated manuals, information pamphlets or placards, and markings. (b) Throwable PFDs approved under this subpart may rely entirely on inherently buoyant material, or rely entirely or partially upon inflation to achieve the minimum buoyancy. (c) Throwable PFDs approved under this subpart are intended to meet the carriage requirements for uninspected commercial vessels under 40 ft (12 m) not carrying passengers for hire and recreational boats, in accordance with 33 CFR part 175. § 160.045–3 Definitions. The following definitions apply to this subpart: Commandant means the Chief of the Lifesaving and Fire Safety Standards Division. Address: Commandant (CG– ENG–4), Attn: Lifesaving and Fire Safety Division, U.S. Coast Guard Stop 7509, 2703 Martin Luther King Jr. Avenue SE, PO 00000 Frm 00034 Fmt 4701 Sfmt 4700 Washington, DC 20593–7509; email TypeApproval@uscg.mil. First quality workmanship means construction that is free from any defect materially affecting appearance or serviceability. Recognized laboratory means an independent laboratory accepted by the Commandant in accordance with subpart 159.010 of this subchapter, with a valid memorandum of understanding in accordance with § 159.010–7 of this subchapter. § 160.045–5 Incorporation by reference. Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by reference (IBR) material is available for inspection at the Coast Guard Headquarters and at the National Archives and Records Administration (NARA). Contact Commandant (CG–ENG–4), Attn: Lifesaving and Fire Safety Division, U.S. Coast Guard Stop 7509, 2703 Martin Luther King Jr. Avenue SE, Washington, DC 20593–7509. For information on the availability of this material at NARA, visit www.archives.gov/federal-register/ cfr/ibr-locations or email: fr.inspection@ nara.gov. The material may be obtained from UL, 333 Pfingsten Road, Northbrook, IL 60062–2002; phone 847– 272–8800; website: www.ul.com. (a) ANSI/CAN/UL 9595:2021, Standard for Safety Factory Follow-Up on Personal Flotation Devices (PFDs), First Edition, June 4, 2020 (including revisions through September 9, 2021) (‘‘ANSI/CAN/UL 9595’’); IBR approved for § 160.045–15(e). (b) ANSI/UL 1123, Standard for Safety Marine Buoyant Devices, Seventh Edition, October 1, 2008 (including revisions through November 23, 2020); IBR approved for §§ 160.045–7(e); 160.045–13(d). (c) ANSI/UL 1175, Standard for Safety Buoyant Cushions, Fourth Edition, April 20, 2007 (including revisions through January 10, 2020); IBR approved for §§ 160.045–7(e); 160.045– 13(d). § 160.045–7 Design, construction, and performance of throwable PFDs. (a) General. Every throwable PFD must conform to the requirements as accepted by the Commandant for listing and labeling by a recognized laboratory, and must be of such design, materials, and construction as to meet the requirements specified in this section. (b) Designs and constructions. Throwable PFDs must not provide means for adjustment or close fitting to E:\FR\FM\06DER3.SGM 06DER3 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations the body. Methods of construction must provide strengths, with reinforcements where necessary, to be adequate for the intended use and purpose of the device. (c) Materials. All materials used in any device covered by this subpart must meet the applicable requirements of subpart 164.019 of this chapter, must be all new materials, must be suitable for the purpose intended, and must be at least equivalent to corresponding materials specified for standard buoyant cushions. Hardware or fastenings must be of sufficient strength for the purpose of the device and must be of inherently corrosion-resistant material, such as stainless steel, brass, bronze, certain plastics, etc. Decorative platings of any thickness are permissible. Fabrics, coated fabrics, tapes, and webbing must be either mildew-resistant or treated for mildew resistance. Buoyancy provided by inherently buoyant material must not be dependent upon loose, granulated material. (d) Standard construction. A standard foam cushion that is designed to be thrown must be 2 inches or more in thickness and must have 225 or more square inches of top surface area. (e) Nonstandard construction. A nonstandard throwable PFD must meet the requirements in ANSI/UL 1123 or ANSI/UL 1175 (both incorporated by reference, see § 160.045–5) and any additional requirements that the Commandant may prescribe to approve unique or novel designs. (f) Buoyancy. (1) Ring life buoys must have 161⁄2 pounds or more of buoyancy. (2) Foam cushions must have 18 pounds or more of buoyancy. (3) A device other than those standard devices specified in paragraph (f)(1) or (2) of this section must have 20 pounds or more of buoyancy. (g) Workmanship. Throwable PFDs must be of first quality workmanship and must be free from any defects materially affecting their appearance or serviceability. lotter on DSK11XQN23PROD with RULES3 § 160.045–9 Approval procedures for throwable PFDs. (a) Each application for approval of a throwable PFD must be submitted directly to a Coast Guard recognized laboratory. (b) The recognized laboratory must determine if a throwable PFD with novel design features requires a preliminary review by the Coast Guard prior to testing. Submissions requiring preliminary review must be sent to TypeApproval@uscg.mil, and must include a full description and drawings. Pictures, samples, and preliminary test results may also be submitted. VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 § 160.045–11 Recognized laboratory. (a) The approval inspections and tests required by § 160.045–13, and production inspections, tests, and quality control required by § 160.045– 15, must be conducted by an independent laboratory recognized by the Coast Guard under 46 CFR subpart 159.010 to perform such functions. A list of recognized independent laboratories is available from the Commandant and online at: https:// cgmix.uscg.mil. (b) The same laboratory that performs the approval tests must also perform production oversight unless the employees of the laboratory performing production oversight receive training and support equal to that of the laboratory that performed the approval testing, as determined by the Commandant. § 160.045–13 tests. Approval inspections and (a) Each throwable PFD must be certified by a recognized laboratory as meeting the requirements of this subpart. Approval tests must be conducted or supervised by a recognized laboratory using PFDs constructed in accordance with the plans and specifications submitted with the application for approval. (b) Each throwable PFD design must be visually examined for compliance with the construction and performance requirements of this subpart. (c) Standard PFDs must be submerged in fresh water for 24 or more continuous hours. The measured buoyancy after the 24 hours of submersion must be the buoyancy specified in § 160.045–7(f). (d) Non-standard throwable PFDs must be subjected to approval tests specified in ANSI/UL 1123 or ANSI/UL 1175 (both incorporated by reference, see § 160.045–5) or another test program accepted by the Commandant. Approval tests must be conducted or supervised by a recognized laboratory using throwable PFDs constructed in accordance with the plans and specifications submitted with the application for approval. (e) The Commandant may prescribe additional tests for approval of novel or unique designs. § 160.045–15 Production inspections, tests, and quality control of throwable PFDs. (a) Manufacturer’s inspection and tests. Manufacturers of approved throwable PFDs must maintain quality control of the materials used, manufacturing methods and the finished product to meet the applicable requirements, and make sufficient PO 00000 Frm 00035 Fmt 4701 Sfmt 4700 97389 inspections and tests of representative samples and components produced to maintain the quality of the finished product. Records of tests conducted by the manufacturer and records of materials, including affidavits by suppliers that applicable requirements are met, must be made available to the recognized laboratory inspector or to the Coast Guard marine inspector, or both, for review upon request. (b) Laboratory inspections and tests. The laboratory inspector will conduct examinations, inspections, and tests for listed and labeled devices, as required by the recognized laboratory, at the place of manufacture or other location at the option of the laboratory. (c) Test facilities. The laboratory inspector, or the Coast Guard marine inspector assigned by the Commander of the District in which the factory is located, or both, must be admitted to any place in the factory where work is being done on listed and labeled products. Either or both inspectors may take samples of parts or materials entering construction or final assemblies, for further examinations, inspections, or tests. The manufacturer must provide a suitable place and the apparatus necessary for the performance of the tests done at the place of manufacture. (d) Additional tests, etc. Unannounced examinations, tests, and inspections of samples obtained either directly from the manufacturer or through commercial channels may be made to determine the suitability of a product for listing and labeling, or to determine conformance of a labeled product to the applicable requirements. These may be conducted by the recognized laboratory or by the United States Coast Guard. (e) Follow-up program. A follow-up program in accordance with ANSI/CAN/ UL 9595 (incorporated by reference, see § 160.045–5) meets the requirements of this section. § 160.045–17 Marking and Labeling. (a) Each throwable PFD must be marked in accordance with the recognized laboratory’s listing and labeling requirements in accordance with § 160.045–3(a). At a minimum, all labels must include— (1) Size information, as appropriate; (2) The Coast Guard approval number; (3) Manufacturer’s contact information; (4) Model name/number; (5) Lot number, manufacturer date; and (6) Any limitations or restrictions on approval or special instructions for use. E:\FR\FM\06DER3.SGM 06DER3 97390 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations (b) Marking must be of a type that will be durable and legible for the expected life of the device. (c) The Commandant may prescribe additional marking requirements for special purpose devices or unique or novel designs. § 160.045–21 PFD manuals. (a) An owner’s manual must be provided with each fully or partially inflatable throwable PFD sold or offered for sale. The text of each manual is reviewed with the application for approval. (b) The Commandant may prescribe additional information in the manual for special purpose devices or unique or novel designs. (c) Additional information, instructions, or illustrations may be included in the owner’s manual if there is no contradiction to the required information. § 160.045–23 Procedure for approval of design or material change. (a) The manufacturer must submit any proposed changes in design, material, or construction to the recognized laboratory for approval before changing throwable PFD production methods. (b) Determinations of equivalence of design, construction, and materials may be made only by the Commandant or a designated representative. § 160.045–25 approval. Suspension or termination of As provided in 46 CFR 159.005–15, the Commandant may suspend or terminate the approval of a throwable PFD if the manufacturer fails to comply with this subpart or the recognized laboratory’s accepted procedures or requirements. Subpart 160.047 [Removed and Reserved] 26. Remove and reserve subpart 160.047, consisting of §§ 160.047–1 through 160.047–7. ■ Subpart 160.048 [Removed and Reserved] 27. Remove and reserve subpart 160.048, consisting of §§ 160.048–1 through 160.048–8. lotter on DSK11XQN23PROD with RULES3 ■ Subpart 160.052 [Removed and Reserved] 28. Remove and reserve subpart 160.052, consisting of §§ 160.052–1 through 160.052–9. ■ VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 Subpart 160.055—Life Preservers, Unicellular Plastic Foam, Adult and Child, for Merchant Vessels 29. Revise § 160.055–1 to read as follows: ■ § 160.055–1 Scope. (a) This subpart contains requirements for production follow-up inspections for life preservers approved under this subpart prior to January 6, 2025. (b) Life preservers approved under this subpart rely upon inherently buoyant material to achieve the minimum buoyancy. (c) Life preservers approved under this subpart are intended to meet the carriage requirements for wearable PFDs for uninspected passenger vessels, uninspected commercial vessels over 40 ft (12m), and for inspected vessels. (d) Each life preserver specified in this subpart is a: (1) Standard, bib type, vinyl dip coated: (i) Model 62, adult (for persons weighing over 90 pounds); or (ii) Model 66, child (for persons weighing less than 90 pounds); or (2) Standard, bib type, cloth covered; (i) Model 63, adult (for persons weighing over 90 pounds); or (ii) Model 67, child (for persons weighing less than 90 pounds); or (3) Nonstandard, shaped type: (i) Model,1 adult (for persons weighing over 90 pounds); or (ii) Model,1 child (for persons weighing less than 90 pounds). 1 A model designation for each nonstandard life preserver is to be assigned by the manufacturer. That designation must be different from any standard lifesaving device designation. § 160.055–2 [Removed and Reserved] 30. Remove and reserve § 160.055–2. ■ 31. Revise § 160.055–3 to read as follows: ■ § 160.055–3 Frm 00036 Fmt 4701 Sfmt 4700 § 160.055–4 [Removed and Reserved] 32. Remove and reserve § 160.055–4. 33. Revise § 160.055–5, including the section heading, to read as follows: ■ ■ § 160.055–5 Incorporation by reference. Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by reference (IBR) material is available for inspection at the Coast Guard Headquarters and at the National Archives and Records Administration (NARA). Contact Commandant (CG–ENG–4), Attn: Lifesaving and Fire Safety Division, U.S. Coast Guard Stop 7509, 2703 Martin Luther King Jr. Avenue SE, Washington, DC 20593–7509. For information on the availability of this material at NARA, visit www.archives.gov/federal-register/ cfr/ibr-locations or email fr.inspection@ nara.gov. The material may be obtained from UL, 333 Pfingsten Road, Northbrook, IL 60062–2002 phone (847) 272–8800; website: www.ul.com. (a) ANSI/CAN/UL 9595:2021, Standard for Safety Factory Follow-Up on Personal Flotation Devices (PFDs), First Edition, June 4, 2020 (including revisions through September 9, 2021) (‘‘ANSI/CAN/UL 9595’’); IBR approved for § 160.055–15(a). (b) [Reserved] §§ 160.055–6 through 160.055–9 and Reserved] [Removed 34. Remove and reserve §§ 160.055–6 through 160.055–9. ■ 35. Add § 160.055–11 to read as follows: ■ Definitions. The following definitions apply to this subpart: Commandant means the Chief of the Lifesaving and Fire Safety Standards Division. Address: Commandant (CG– ENG–4), Attn: Lifesaving and Fire Safety Division, U.S. Coast Guard Stop 7509, 2703 Martin Luther King Jr. Avenue SE, Washington, DC 20593–7509; email TypeApproval@uscg.mil. First quality workmanship means construction that is free from any defect materially affecting appearance or serviceability. Inspector means a recognized laboratory representative assigned to PO 00000 perform, supervise, or oversee the duties described in § 160.055–15 or any Coast Guard representative performing duties related to the approval. Recognized laboratory means an independent laboratory accepted by the Commandant in accordance with 46 CFR 159.010, with a valid memorandum of understanding in accordance with 46 CFR 159.010–7. § 160.055–11 Independent laboratory. The production inspections, tests, and quality control required by this subpart must be conducted by an independent laboratory accepted by the Coast Guard under 46 CFR subpart 159.010 to perform such functions. A list of accepted independent laboratories is available from the Commandant and online at https://cgmix.uscg.mil. ■ 36. Add § 160.055–15 to read as follows: E:\FR\FM\06DER3.SGM 06DER3 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations lotter on DSK11XQN23PROD with RULES3 § 160.055–15 Production inspections, tests, and quality control of life preservers. (a) General. Production tests and inspections must be conducted in accordance with this section, subpart 159.007 of this chapter, and the independent laboratory’s procedures for production inspections and tests as accepted by the Commandant. The Commandant may prescribe additional production tests and inspections necessary to maintain quality control and to monitor compliance with the requirements of this subchapter. A follow-up program in accordance with ANSI/CAN/UL 9595 (incorporated by reference, see § 160.055–5), meets the requirements of this subpart. (b) Oversight. In addition to responsibilities set out in part 159 of this chapter and the accepted laboratory procedures for production inspections and tests, each manufacturer of a life preserver and each laboratory inspector must comply with the following, as applicable: (1) Manufacturer. Each manufacturer must— (i) Perform all tests and examinations necessary to show compliance with this subpart on each lot before any inspector’s tests and inspection of the lot; (ii) Follow established procedures for maintaining quality control of the materials used, manufacturing operations, and the finished product; and (iii) Allow an inspector to take samples of completed units or of component materials for tests required by this subpart and for tests relating to the safety of the design. (2) Laboratory. An inspector from the accepted laboratory must oversee production in accordance with the laboratory’s procedures for production inspections and tests accepted by the Commandant. During production oversight, the inspector must not perform or supervise any production test or inspection unless— (i) The manufacturer has a valid approval certificate; and (ii) The inspector has first observed the manufacturer’s production methods and any revisions to those methods. (3) At least quarterly, the inspector must check the manufacturer’s compliance with the company’s quality control procedures, examine the manufacturer’s required records, and observe the manufacturer perform each of the required production tests. (c) Test facilities. The manufacturer must provide a suitable place and apparatus for conducting the tests and inspections necessary to determine compliance of life preservers with this VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 subpart. The manufacturer must provide means to secure any test that is not continuously observed, such as the 48hour buoyancy test. The manufacturer must have the calibration of all test equipment checked in accordance with the test equipment manufacturer’s recommendation and interval but not less than at least once every year. (d) Lots. A lot must not consist of more than 1000 life preservers. A lot number must be assigned to each group of life preservers produced. Lots must be numbered serially. A new lot must be started whenever any change in materials or a revision to a production method is made, and whenever any substantial discontinuity in the production process occurs. The lot number assigned, along with the approval number, must enable the PFD manufacturer to determine the supplier’s identifying information for the component lot. (e) Samples. (1) From each lot of life preservers, manufacturers must randomly select a number of samples from completed units at least equal to the applicable number required by table 1 to § 160.055–15(e)(1) for buoyancy testing. Additional samples must be selected for any tests, examinations, and inspections required by the laboratory’s production inspections and tests procedures. TABLE 1 TO § 160.055–15(e)(1)— SAMPLING FOR BUOYANCY TESTS Number of life preservers in sample Lot size 100 101 201 301 501 751 and under ...................... to 200 ............................ to 300 ............................ to 500 ............................ to 750 ............................ to 1,000 ......................... 1 2 3 4 6 8 (2) For a lot succeeding one from which any sample life preserver failed the buoyancy test, the sample must consist of not less than ten specimen life preservers to be tested for buoyancy in accordance with paragraph (f) of this section. (f) Buoyancy test. The buoyancy of the life preservers must be determined by measuring the upward force exerted by the individual submerged unit. The buoyancy measurement must be made at the end of the 48 hours of submersion, during which period the pad inserts must not be disturbed. (g) Buoyancy required. The buoyant pad inserts from Model 3 adult life preservers must provide not less than 25 pounds buoyancy in fresh water, and the pads from Model 5 child life PO 00000 Frm 00037 Fmt 4701 Sfmt 4700 97391 preservers must provide not less than 16.5 pounds buoyancy. (h) Lot inspection. On each lot, the laboratory inspector must perform a final lot inspection to be satisfied that the life preservers meet this subpart. Each lot must demonstrate— (1) First quality workmanship; (2) That the general arrangement and attachment of all components, such as body straps, closures, tie tapes, and drawstrings, are as specified in the approved plans and specifications; (3) Compliance with the marking requirements; and (4) The information pamphlet or placard specified in 33 CFR part 181 subpart G, if required, is securely attached to the device, with the PFD selection information visible and accessible prior to purchase. (i) Lot acceptance. When the independent laboratory has determined that the life preservers in the lot are of a type officially approved in the name of the company, and that such life preservers meet the requirements of this subpart, they must be plainly marked in waterproof ink with the independent laboratory’s name or identifying mark. (j) Lot rejection. Each nonconforming unit must be rejected. If three or more nonconforming units are rejected for the same kind of defect, lot inspection must be discontinued and the lot rejected. The inspector must discontinue lot inspection and reject the lot if examination of individual units or the records for the lot shows noncompliance with either this subchapter or the laboratory’s or the manufacturer’s quality control procedures. A rejected unit or lot may be resubmitted for testing and inspection if the manufacturer first removes and destroys each defective unit or, if authorized by the laboratory, reworks the unit or lot to correct the defect. A rejected lot or rejected unit must not be sold or offered for sale under the representation that it meets this subpart or that it is Coast Guard approved. 37. Add § 160.055–19 to read as follows: ■ § 160.055–19 Pamphlet or Placard. Each life preserver sold or offered for sale for use on recreational boats must be provided with a pamphlet or placard that a prospective purchaser can read prior to purchase, as specified in 33 CFR part 181 subpart G. 38. Add § 160.055–23 to read as follows: ■ E:\FR\FM\06DER3.SGM 06DER3 97392 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations § 160.060–2 § 160.055–23 Procedure for approval of design or material change. (a) The manufacturer must submit any proposed changes in design, material, or construction to typeapproval@uscg.mil for approval before changing life preserver production methods. (b) Only the Commandant or a designated representative may make determinations of equivalence of design, construction, and materials. ■ 39. Add § 160.055–25 to read as follows: § 160.055–25 approval. Suspension or termination of As provided in 46 CFR 159.005–15, the Commandant may suspend or terminate the approval if the manufacturer fails to comply with this subpart or the recognized laboratory’s accepted procedures or requirements. Subpart 160.060—Specification for a Buoyant Vest, Unicellular Polyethylene Foam, Adult and Child 40. Revise § 160.060–1 to read as follows: ■ lotter on DSK11XQN23PROD with RULES3 § 160.060–1 Scope. (a) This subpart contains requirements for production follow-up inspections for buoyant vests approved under this subpart prior to January 6, 2025. (b) Buoyant vests approved under this subpart rely upon inherently buoyant material to achieve the minimum buoyancy. (c) Buoyant vests approved under this subpart are intended to meet the carriage requirements for wearable PFDs for uninspected passenger vessels, uninspected commercial vessels over 40 ft (12m), and for inspected vessels. (d) Each buoyant vest specified in this subpart is a standard model: (1) Standard: (i) Model AY, adult (for persons weighing over 90 pounds); or (ii) Model CYM, child, medium (for children weighing from 50 to 90 pounds); or (iii) Model CYS, child, small (for children weighing less than 50 pounds). (2) Nonstandard: (i) Model,1 adult (for persons weighing over 90 pounds); or (ii) Model,1 child, medium (for persons weighing from 50 to 90 pounds); or (iii) Model,1 child, small (for persons weighing less than 50 pounds). 1 A model designation for a nonstandard vest is to be assigned by the individual manufactured and must be different from any standard vest. VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 [Removed and Reserved] 41. Remove and reserve § 160.060–2. ■ 42. Revise § 160.060–3 to read as follows: ■ § 160.060–3 Definitions. The following definitions apply to this subpart: Commandant means the Chief of the Lifesaving and Fire Safety Standards Division. Address: Commandant (CG– ENG–4), Attn: Lifesaving and Fire Safety Division, U.S. Coast Guard Stop 7509, 2703 Martin Luther King Jr. Avenue SE, Washington, DC 20593–7509; email TypeApproval@uscg.mil. First quality workmanship means construction that is free from any defect materially affecting appearance or serviceability. Inspector means a recognized laboratory representative assigned to perform, supervise, or oversee the duties described in § 160.060–15 or any Coast Guard representative performing duties related to the approval. Recognized laboratory means an independent laboratory accepted by the Commandant in accordance with 46 CFR subpart 159.010, with a valid memorandum of understanding in accordance with 46 CFR 159.010–7. § 160.060–3a ■ [Removed and Reserved] 43. Remove and reserve § 160.060–3a. § 160.060–4 [Removed and Reserved] 44. Remove and reserve § 160.060–4. 45. Revise § 160.060–5 to read as follows: ■ ■ § 160.060–5 Incorporation by reference. Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by reference (IBR) material is available for inspection at the Coast Guard Headquarters and at the National Archives and Records Administration (NARA). Contact Commandant (CG–ENG–4), Attn: Lifesaving and Fire Safety Division, U.S. Coast Guard Stop 7509, 2703 Martin Luther King Jr. Avenue SE, Washington, DC 20593–7509. For information on the availability of this material at NARA, visit www.archives.gov/federal-register/ cfr/ibr-locations or email fr.inspection@ nara.gov. The material may be obtained from UL, 333 Pfingsten Road, Northbrook, IL 60062–2002; phone (847) 272–8800; website: www.ul.com. (a) ANSI/CAN/UL 9595:2021, Standard for Safety Factory Follow-Up on Personal Flotation Devices (PFDs), First Edition, June 4, 2020 (including revisions through September 9, 2021) PO 00000 Frm 00038 Fmt 4701 Sfmt 4700 (‘‘ANSI/CAN/UL 9595’’); IBR approved for § 160.060–15(h). (b) [Reserved] §§ 160.060–6 through 160.060–9 and Reserved] [Removed 46. Remove and reserve §§ 160.060–6 through 160.060–9. ■ 47. Add § 160.060–11 to read as follows: ■ § 160.060–11 Independent laboratory. (a) The production inspections, tests, and quality control required by this subpart must be conducted by an independent laboratory recognized by the Coast Guard under § 159.010 of this subchapter to perform such functions. A list of recognized independent laboratories is available from the Commandant and online at https:// cgmix.uscg.mil. (b) The same laboratory that performs the approval tests must also perform production oversight unless the employees of the laboratory performing production oversight receive training and support equal to that of the laboratory that performed the approval testing, as determined by the Commandant. ■ 48. Add § 160.060–15 to read as follows: § 160.060–15 Production inspections, tests, and quality control. (a) General. Manufacturers of listed and labeled buoyant vests must— (1) Maintain quality control of the materials used, the manufacturing methods, and the finished product to meet the applicable requirements of this subpart by conducting sufficient inspections and tests of representative samples and components produced; (2) Make available to the recognized laboratory inspector or the Coast Guard inspector, upon request, records of tests conducted by the manufacturer and records of materials used during production of the device, including affidavits by suppliers; and (3) Permit any examination, inspection, or test required by the recognized laboratory or the Coast Guard for a produced listed and labeled device, either at the place of manufacture or some other location. (b) Lot size and sampling. (1) A lot must consist of 500 buoyant vests or fewer; (2) A new lot begins after any change or modification in materials used or manufacturing methods employed; (3) The manufacturer of the buoyant vests must notify the recognized laboratory when a lot is ready for inspection; (4) The manufacturer must select samples in accordance with the E:\FR\FM\06DER3.SGM 06DER3 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations test removed from the tank or otherwise exposed to air. (iii) After the 24-hour submergence period, unlock or unseal the tank and weigh the wire basket with the inserts TABLE 1 TO § 160.060–15(b)(4)— inside while both are still under water. (iv) The buoyancy is computed as SAMPLE FOR BUOYANCY TESTS paragraph (e)(1)(i) of this section minus Number of paragraph (e)(1)(iii) of this section. Lot size vests in (2) Buoyancy required. The buoyant sample inserts from adult size buoyant vests 1 100 and under ...................... 1 must provide not less than 15 ⁄2 pounds of buoyancy in fresh water; the inserts 101 to 200 ............................ 2 201 to 300 ............................ 3 from the child medium size buoyant 301 to 500 ............................ 4 vests must provide not less than 11 pounds buoyancy; and the inserts from (5) If a sample vest fails the buoyancy the child small size buoyant vests must test, the sample from the next provide not less than 7 pounds succeeding lot must consist of 10 buoyancy. specimen vests or more to be tested for (f) Body strap test. The complete body buoyancy in accordance with paragraph strap assembly, including hardware (e) of this section. must be tested for strength by attaching (c) Additional compliance tests. An the D-ring to a suitable support such inspector may conduct an examination, that the assembly hangs vertically its test, and inspection of a buoyant device full length. A weight of 150 pounds for obtained from the manufacturer or an adult size and 115 pounds for a child through commercial channels to size must be attached to the other end determine the suitability of the device on the snap hook for 10 minutes. The for listing and labeling, or to determine specified weight must not break or its conformance to applicable excessively distort the body strap requirements. assembly. (d) Test facilities. The manufacturer (g) Additional approval tests for must admit the inspector to any part of nonstandard vests. Tests in addition to the premises at the place of manufacture those required by this section may be of a listed and labeled device to— conducted by the inspector for a (1) Examine, inspect, or test a sample nonstandard vest to determine of a part or a material that is included performance equivalence to a standard in the construction of the device; and vest. Such additional tests may include (2) Conduct any examination, determining performance in water, inspection, or test in a suitable place suitability of materials, donning time, and with appropriate apparatus ease of adjustment, and similar provided by the manufacturer. equivalency tests. Costs for any (e) Buoyancy—(1) Buoyancy test additional tests must be assumed by the method. Remove the buoyant inserts manufacturer. from the vests. Securely attach the (h) Follow-up program. A follow-up spring scale in a position directly over program in accordance with ANSI/CAN/ the test tank. Suspend the weighted UL 9595 (incorporated by reference, see wire basket from the scale in such a § 160.060–5) meets the requirements of manner that the basket can be weighed this section. while it is completely under water. In ■ 49. Add § 160.060–19 to read as order to measure the actual buoyancy follows: provided by the inserts, the underwater weight of the empty basket must exceed § 160.060–19 Pamphlet or placard. the buoyancy of the inserts. To obtain Each buoyant vest sold or offered for the buoyancy of the inserts, proceed as sale for use on recreational boats must follows: be provided with a pamphlet or placard (i) Weigh the empty wire basket under that a prospective purchaser can read water. prior to purchase, as specified in 33 CFR (ii) Place the inserts inside the basket part 181 subpart G. and submerge it so that the top of the ■ 50. Add § 160.060–23 to read as basket is at least 2 inches below the follows: surface of the water. Allow the inserts § 160.060–23 Procedure for approval of to remain submerged for 24 hours. The design or material change. tank must be locked or sealed during this 24-hour submergence period. It is (a) The manufacturer must submit any important that after the inserts have proposed changes in design, material, or once been submerged they remain construction to typeapproval@uscg.mil submerged for the duration of the test, for approval before changing PFD and at no time during the course of the production methods. lotter on DSK11XQN23PROD with RULES3 requirements in Table 1 to § 160.060– 15(b)(4) from each lot of buoyant vests to be tested for buoyancy in accordance with paragraph (e) of this section; and VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 PO 00000 Frm 00039 Fmt 4701 Sfmt 4700 97393 (b) Only the Commandant or a designated representative may make determinations of equivalence of design, construction, and materials. ■ 51. Add § 160.060–25 to read as follows: § 160.060–25 approval. Suspension or termination of As provided in 46 CFR 159.005–15, the Commandant may suspend or terminate the approval if the manufacturer fails to comply with this subpart or the recognized laboratory’s accepted procedures or requirements. Subpart 160.064—Marine Buoyant Devices 52. Revise § 160.064–1 to read as follows: ■ § 160.064–1 Scope. (a) This subpart contains requirements for production follow-up inspections for wearable PFDs and throwable PFDs approved under this subpart prior to January 6, 2025. (b) PFDs approved under this subpart are intended to meet the carriage requirements for PFDs for uninspected commercial vessels under 40 ft (12m) not carrying passengers for hire and recreational boats, in accordance with 33 CFR 175 and 46 CFR 25.25. (c) PFDs covered by this subpart are of two general types: those intended to be worn on the body and those intended to be thrown. § 160.064–2 [Removed and Reserved] 53. Remove and reserve § 160.064–2. 54. Revise § 160.064–3 to read as follows: ■ ■ § 160.064–3 Definitions. The following definitions apply to this subpart: Commandant means the Chief of the Lifesaving and Fire Safety Standards Division. Address: Commandant (CG– ENG–4), Attn: Lifesaving and Fire Safety Division, U.S. Coast Guard Stop 7509, 2703 Martin Luther King Jr. Avenue SE, Washington, DC 20593–7509; email TypeApproval@uscg.mil. First class workmanship means construction that is free from any defect materially affecting appearance or serviceability. Inspector means a recognized laboratory representative assigned to perform, supervise, or oversee the duties described in § 160.064–15 or any Coast Guard representative performing duties related to the approval. Recognized laboratory means an independent laboratory accepted by the Commandant in accordance with 46 CFR subpart 159.010, with a valid E:\FR\FM\06DER3.SGM 06DER3 97394 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations § 160.064–15 Production inspections, tests, and quality control of PFDs. memorandum of understanding in accordance with 46 CFR 159.010–7. § 160.064–4 [Removed and Reserved] 55. Remove and reserve § 160.064–4. 56. Add § 160.064–5 to read as follows: ■ ■ § 160.064–5 Incorporation by reference. Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by reference (IBR) material is available for inspection at the Coast Guard Headquarters and at the National Archives and Records Administration (NARA). Contact Commandant (CG–ENG–4), Attn: Lifesaving and Fire Safety Division, U.S. Coast Guard Stop 7509, 2703 Martin Luther King Jr. Avenue SE, Washington, DC 20593–7509. For information on the availability of this material at NARA, visit www.archives.gov/federal-register/ cfr/ibr-locations or email fr.inspection@ nara.gov. The material may be obtained from UL, 333 Pfingsten Road, Northbrook, IL 60062–2002; phone (847) 272–8800; website: www.ul.com. (a) ANSI/CAN/UL 9595:2021, Standard for Safety Factory Follow-Up on Personal Flotation Devices (PFDs), First Edition, June 4, 2020 (including revisions through September 9, 2021) (‘‘ANSI/CAN/UL 9595’’); IBR approved for § 160.064–15(e). (b) [Reserved] §§ 160.064–6 and 160.064–7 Reserved] [Removed and 57. Remove and reserve §§ 160.064–6 and 160.064–7. ■ 58. Add § 160.064–11 to read as follows: ■ lotter on DSK11XQN23PROD with RULES3 § 160.064–11 Recognized laboratory. (a) The production inspections, tests, and quality control required by this subpart must be conducted by an independent laboratory recognized by the Coast Guard under 46 CFR subpart 159.010 to perform such functions. A list of recognized independent laboratories is available from the Commandant and online at https:// cgmix.uscg.mil. (b) The same laboratory that performs the approval tests must also perform production oversight unless the employees of the laboratory performing production oversight receive training and support equal to that of the laboratory that performed the approval testing, as determined by the Commandant. ■ 59. Add § 160.064–15 to read as follows: VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 (a) Manufacturer’s inspection and tests. Manufacturers of approved PFDs must maintain quality control of the materials used, manufacturing methods, and the finished product to meet the applicable requirements, and make sufficient inspections and tests of representative samples and components produced to maintain the quality of the finished product. Records of tests conducted by the manufacturer and records of materials, including affidavits by suppliers that applicable requirements are met, must be made available to the recognized laboratory inspector or to the Coast Guard marine inspector, or both, for review upon request. (b) Laboratory inspections and tests. The laboratory inspector will conduct examinations, inspections, and tests for listed and labeled devices, as required by the recognized laboratory, at the place of manufacture or other location at the option of the laboratory. (c) Test facilities. The laboratory inspector, or the Coast Guard marine inspector assigned by the Commander of the District in which the factory is located, or both, must be admitted to any place in the factory where work is being done on listed and labeled products. Either or both inspectors may take samples of parts or materials entering construction or final assemblies, for further examinations, inspections, or tests. The manufacturer must provide a suitable place and the apparatus necessary for the performance of the tests done at the place of manufacture. (d) Additional tests, etc. Unannounced examinations, tests, and inspections of samples obtained either directly from the manufacturer or through commercial channels may be made to determine the suitability of a product for listing and labeling, or to determine conformance of a labeled product to the applicable requirements. These may be conducted by the recognized laboratory or the United States Coast Guard. (e) Follow-up program. A follow-up program in accordance with ANSI/CAN/ UL 9595 (incorporated by reference, see § 160.064–5) meets the requirements of this section. ■ 60. Add § 160.064–23 to read as follows: § 160.064–23 Procedure for approval of design or material change. (a) The manufacturer must submit any proposed changes in design, material, or construction to the recognized PO 00000 Frm 00040 Fmt 4701 Sfmt 4700 laboratory for approval before changing PFD production methods. (b) Determinations of equivalence of design, construction, and materials must be made only by the Commandant or a designated representative. ■ 61. Add § 160.064–25 to read as follows: § 160.064–25 approval. Suspension or termination of As provided in 46 CFR 159.005–15, the Commandant may suspend or terminate the approval of a PFD design if the manufacturer fails to comply with this subpart or the recognized laboratory’s accepted procedures or requirements. Subpart 160.076—Inflatable Recreational Personal Flotation Devices 62. Amend § 160.076–1 by revising paragraphs (a) and (b) and adding new paragraph (c) to read as follows: ■ § 160.076–1 Scope. (a) This subpart contains requirements for production follow-up inspections for inflatable recreational personal flotation devices (PFDs) approved prior to January 6, 2025. (b) Inflatable PFDs approved under this subpart rely partially or entirely upon inflation for buoyancy. (c) PFDs approved under this subpart are intended to meet the carriage requirements for wearable PFDs for recreational vessels and uninspected recreational submersible vessels, in accordance with 33 CFR 175.15 and 175.17. § 160.076–3 ■ [Removed] 63. Remove § 160.076–3. § 160.076–5 [Redesignated as § 160.076–3] 64. Redesignate § 160.076–5 as § 160.076–3. ■ § 160.076–11 5] [Redesignated as § 160.076– 65. Redesignate § 160.076–11 as § 160.076–5. ■ 66. Revise newly redesignated § 160.076–5 to read as follows: ■ § 160.076–5 Incorporation by reference. Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by reference (IBR) material is available for inspection at the Coast Guard Headquarters and at the National Archives and Records Administration (NARA). Contact Commandant (CG–ENG–4), Attn: Lifesaving and Fire Safety Division, U.S. E:\FR\FM\06DER3.SGM 06DER3 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations Coast Guard Stop 7509, 2703 Martin Luther King Jr. Avenue SE, Washington, DC 20593–7509. For information on the availability of this material at NARA, visit www.archives.gov/federal-register/ cfr/ibr-locations or email fr.inspection@ nara.gov. The material may be obtained from UL, 333 Pfingsten Road, Northbrook, IL 60062–2002; phone (847) 272–8800; website: www.ul.com. (a) ANSI/CAN/UL 9595:2021, Standard for Safety Factory Follow-Up on Personal Flotation Devices (PFDs), First Edition, June 4, 2020 (including revisions through September 9, 2021) (‘‘ANSI/CAN/UL 9595’’); IBR approved for § 160.076–29(a). (b) [Reserved]. § 160.076–13 ■ § 160.076–21 ■ [Removed and Reserved] 68. Remove and reserve § 160.076–21. § 160.076–23 ■ [Removed and Reserved] 67. Remove and reserve § 160.076–13. [Removed and Reserved] [Removed and Reserved] 70. Remove and reserve § 160.076–25. ■ 71. Amend § 160.076–29 by: ■ a. Revising paragraphs (a) and (c)(1)(i); ■ b. Removing paragraphs (c)(5) and (6), (e)(3) through (5), (f), and (g); and ■ c. Redesignating paragraph (h) as paragraph (f). The revisions read as follows: ■ lotter on DSK11XQN23PROD with RULES3 § 160.076–29 Production oversight. (a) Production tests and inspections must be conducted in accordance with ANSI/CAN/UL 9595 (incorporated by reference, see § 160.076–5) or an alternative follow-up procedure accepted by the Commandant. The Commandant may prescribe additional production tests and inspections necessary to maintain quality control and to monitor compliance with the requirements of this subpart. * * * * * (c) * * * (1) * * * (i) Perform all required tests and examinations on each PFD lot before any required inspector’s tests and inspection of the lot; * * * * * ■ 72. Amend § 160.076–31 by: ■ a. Revising paragraphs (a), (b)(1) and (2); ■ b. Removing paragraph (c); ■ c. Redesignating paragraphs (d) and (e) as (c) and (d); and ■ d. Revising newly redesignated paragraph (c)(1) introductory text. The revisions read as follows: VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 (a) Samples used in testing must be selected in accordance with the sampling plan accepted by the Commandant. (b) On each sample selected— (1) The manufacturer must conduct the tests specified in the follow-up program accepted by the Commandant; (2) The recognized laboratory inspector must conduct or supervise the tests specified in the follow-up program accepted by the Commandant; and * * * * * (c) Final lot examination and inspection—(1) General. On each PFD lot that passes production testing, the manufacturer must perform a final lot examination and, on every fifth lot, a laboratory inspector must perform a final lot inspection. Each final lot must demonstrate— * * * * * § 160.076–33 69. Remove and reserve § 160.076–23. § 160.076–25 § 160.076–31 Production tests and examinations. [Amended] 73. Amend § 160.076–33 by removing paragraph (b)(6), and redesignating paragraphs (b)(7), (8), and (9) as paragraphs (b)(6), (7), and (8). ■ 74. Revise § 160.076–35 to read as follows: ■ § 160.076–35 placard. Information pamphlet or A pamphlet or placard accepted by the Commandant must be attached to each inflatable PFD sold or offered for sale in such a way that a prospective purchaser can read the pamphlet prior to purchase. The pamphlet or placard text and layout must be submitted to the Commandant for approval. The text must be printed in each pamphlet or placard exactly as approved by the Commandant. Additional information, instructions, or illustrations must not be included within the approved text and layout. Sample pamphlet text and layout may be obtained by contacting the Commandant. This pamphlet or placard may be combined with the manual required by § 160.076–37 if PFD selection and warning information is provided on the PFD packaging in such a way that it remains visible until purchase. ■ 75. Revise § 160.076–37 to read as follows: § 160.076–37 Owner’s manual. (a) General. The manufacturer must provide an owner’s manual with each inflatable PFD sold or offered for sale. (b) Manual contents. The manual must contain the information as approved by the Commandant. If the PFD is conditionally approved, an explanation of the meaning of and PO 00000 Frm 00041 Fmt 4701 Sfmt 4700 97395 reasons for the approval conditions must be included. ■ 76. In § 160.076–39, revise the introductory text to read as follows: § 160.076–39 Marking. Each inflatable PFD must be marked as approved by the Commandant. At a minimum, all labels must include— * * * * * Subpart 160.077 [Removed and Reserved] 77. Remove and reserve subpart 160.077, consisting of §§ 160.077–1 through 160.077–31. ■ 78. Add subpart 160.255, consisting of §§ 160.255–1 through 160.255–27, to read as follows: ■ Subpart 160.255—Commercial Lifejackets Sec. 160.255–1 Scope. 160–255–3 Definitions. 160.255–5 Incorporation by reference. 160.255–7 Design, construction, and performance of lifejackets. 160.255–9 Approval procedures for lifejackets. 160.255–11 Recognized laboratory. 160.255–13 Approval inspections and tests. 160.255–15 Production inspections, tests, and quality control of lifejackets. 160.255–17 Marking and labeling. 160.255–19 Placard. 160.255–21 Lifejacket manuals. 160.255–23 Procedure for approval of design or material change. 160.255–25 Suspension or termination of approval. 160.255–27 Servicing for fully and partially inflatable lifejackets. Subpart 160.255—Commercial Lifejackets § 160.255–1 Scope. (a) This subpart contains structural and performance standards for approval of Level 100 lifejackets, as well as requirements for production follow-up inspections, markings, information placards, and associated manuals. (b) Lifejackets approved under this subpart must rely upon inherently buoyant material, inflation, or a combination to achieve the minimum buoyancy. (c) Lifejackets approved under this subpart are intended to meet the carriage requirements for wearable PFDs for uninspected passenger vessels, uninspected commercial vessels over 40 ft (12m) and for inspected vessels. § 160.255–3 Definitions. The following definitions apply to this subpart: Commandant means the Chief of the Lifesaving and Fire Safety Standards E:\FR\FM\06DER3.SGM 06DER3 97396 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations Division. Address: Commandant (CG– ENG–4), Attn: Lifesaving and Fire Safety Division, U.S. Coast Guard Stop 7509, 2703 Martin Luther King Jr. Avenue SE, Washington, DC 20593–7509; email TypeApproval@uscg.mil. First quality workmanship means construction that is free from any defect materially affecting appearance or serviceability. Inspector means a recognized laboratory representative assigned to perform, supervise, or oversee the duties described in § 160.255–15 or any Coast Guard representative performing duties related to the approval. Recognized laboratory means an independent laboratory accepted by the Commandant in accordance with 46 CFR subpart 159.010, with a valid memorandum of understanding in accordance with 46 CFR 159.010–7. § 160.255–5 Incorporation by reference. lotter on DSK11XQN23PROD with RULES3 Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by reference (IBR) material is available for inspection at the Coast Guard Headquarters and at the National Archives and Records Administration (NARA). Contact Commandant (CG–ENG–4), Attn: Lifesaving and Fire Safety Division, U.S. Coast Guard Stop 7509, 2703 Martin Luther King Jr. Avenue SE, Washington, DC 20593–7509. For information on the availability of this material at NARA, visit www.archives.gov/federal-register/ cfr/ibr-locations or email fr.inspection@ nara.gov. The material may be obtained from UL, 333 Pfingsten Road, Northbrook, IL 60062–2002; phone (847) 272–8800; website: www.ul.com. (a) ANSI/CAN/UL 9595:2021, Standard for Safety Factory Follow-Up on Personal Flotation Devices (PFDs), First Edition, June 4, 2020 (including revisions through September 9, 2021) (‘‘ANSI/CAN/UL 9595’’); IBR approved for § 160.255–15(a). (b) ANSI/CAN/UL 12402–4:2020, Standard for Safety Personal Flotation Devices—Part 4: Lifejackets, Performance Level 100—Safety Requirements, First Edition, July 9, 2020 (‘‘ANSI/CAN/UL 12402–4’’); IBR approved for §§ 160.255–7(a); 160.255– 13(a) and (b); 160.255–17(a); 160.255– 19; 160.255–21(a). § 160.255–7 Design, construction, and performance of lifejackets. (a) Each Level 100 lifejacket design must— (1) Meet the requirements in ANSI/ CAN/UL 12402–4 (incorporated by VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 reference, see § 160.255–5) for a Level 100 device, and the requirements of this subpart; and (2) For novel or unique designs, meet any additional requirements that the Commandant may prescribe. (b) Lifejackets must be of first quality workmanship and must be free from any defects materially affecting their appearance or serviceability. (c) Lifejackets must not provide means intended for fastening or securing the device to a boat. § 160.255–9 lifejackets. Approval procedures for (a) Each application for approval of a Level 100 lifejacket must be submitted directly to a Coast Guard recognized laboratory. (b) The recognized laboratory must determine if a lifejacket with novel design features requires a preliminary review by the Coast Guard prior to testing. Submissions requiring preliminary review must be sent to TypeApproval@uscg.mil, and must include a full description and drawings. Pictures, samples, and preliminary test results may also be submitted. § 160.255–11 Recognized laboratory. (a) The approval inspections and tests, production inspections, tests, and quality control required by this subpart must be conducted by an independent laboratory recognized by the Coast Guard under 46 CFR subpart 159.010 to perform such functions. A list of recognized independent laboratories is available from the Commandant and online at https://cgmix.uscg.mil. (b) The same laboratory that performs the approval tests must also perform production oversight unless the employees of the laboratory performing production oversight receive training and support equal to that of the laboratory that performed the approval testing, as determined by the Commandant. § 160.255–13 tests. Approval inspections and (a) Each lifejacket must be certified by a recognized laboratory as meeting the requirements of ANSI/CAN/UL 12402–4 (incorporated by reference, see § 160.255–5). Approval tests specified in ANSI/CAN/UL 12402–4 must be conducted or supervised by a recognized laboratory using prototype lifejackets constructed in accordance with the plans and specifications submitted with the application for approval. (b) Each lifejacket design must be visually examined for compliance with the construction and performance PO 00000 Frm 00042 Fmt 4701 Sfmt 4700 requirements of this subpart and ANSI/ CAN/UL 12402–4 (incorporated by reference, see § 160.255–5). (c) The Commandant may prescribe additional tests for approval of novel or unique designs. § 160.255–15 Production inspections, tests, and quality control of lifejackets. (a) General. Production tests and inspections must be conducted in accordance with ANSI/CAN/UL 9595 (incorporated by reference, see § 160.255–5), or an alternative follow-up procedure accepted by the Commandant. To maintain approval, the manufacturer must be in good standing under an accepted follow-up procedure. (b) Manufacturer’s inspection and tests. Manufacturers of approved lifejackets must maintain quality control of the materials used, manufacturing methods, and the finished product so as to meet the applicable requirements, and make sufficient inspections and tests of representative samples and components produced to maintain the quality of the finished product. Records of tests conducted by the manufacturer and records of materials, including affidavits by suppliers that applicable requirements are met, must be made available to the recognized laboratory inspector or to the Coast Guard marine inspector, or both, for review upon request. (c) Laboratory inspections and tests. The laboratory inspector will conduct examinations, inspections, and tests for listed and labeled devices, as required by the recognized laboratory, at the place of manufacture or other location at the option of the laboratory. (d) Test facilities. The inspector must be admitted to any place in the factory where work is being done on listed and labeled products, and the inspector may take samples of parts or materials entering construction or final assemblies, for further examinations, inspections, or tests. The manufacturer must provide a suitable place and the apparatus necessary for the performance of the tests done at the place of manufacture. (e) Additional tests, etc. Unannounced examinations, tests, and inspections of samples obtained either directly from the manufacturer or through commercial channels may be made to determine the suitability of a product for listing and labeling, or to determine conformance of a labeled product to the applicable requirements. These may be conducted by the recognized laboratory or the United States Coast Guard. E:\FR\FM\06DER3.SGM 06DER3 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations § 160.255–17 Marking and labeling. (a) Each lifejacket must be marked with the appropriate label as specified in Figure 6DV of ANSI/CAN/UL 12402– 4 (incorporated by reference, see § 160.255–5). (b) The Commandant may prescribe additional marking requirements for special purpose devices or unique or novel designs. § 160.255–19 Placard. Each lifejacket sold or offered for sale must be provided with a placard that a prospective purchaser can read prior to purchase, as specified in Figure 8DV.1.1a and Figure 8DV.1.1b, Choose the Device You Will Want to Wear, of ANSI/CAN/UL 12402–4 (incorporated by reference, see § 160.255–5). The required placard text must be printed exactly as set out in ANSI/CAN/UL 12402–4, unless otherwise approved by the Commandant. § 160.255–21 Lifejacket manuals. (a) An owner’s manual in accordance with Figure 7DV of ANSI/CAN/UL 12402–4 (incorporated by reference, see § 160.255–5), must be provided with each inflatable lifejacket sold or offered for sale. The text of each manual is reviewed with the application for approval. (b) The Commandant may prescribe additional information in the manual for special purpose devices or unique or novel designs. (c) Additional information, instructions, or illustrations may be included in the owner’s manual if there is no contradiction to the required information. § 160.255–23 Procedure for approval of design or material change. (a) The manufacturer must submit any proposed changes in design, material, or construction to the recognized laboratory for approval before changing lifejacket production methods. (b) Determinations of equivalence of design, construction, and materials must be made only by the Commandant or a designated representative. lotter on DSK11XQN23PROD with RULES3 § 160.255–25 approval. Suspension or termination of As provided in 46 CFR 159.005–15, the Commandant may suspend or terminate the approval of a lifejacket design if the manufacturer fails to comply with this subpart or the recognized laboratory’s accepted procedures or requirements. § 160.255–27 Servicing for fully and partially inflatable lifejackets. (a) General. Each lifejacket that relies fully or partially on inflation and is VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 approved under this subchapter must be serviced at approved facilities at 12month intervals according to this section. (1) Each manufacturer of an approved inflatable lifejacket must provide one or more Coast Guard-approved facilities for servicing those lifejackets. The manufacturer must notify the Commandant whenever an approved facility under its organization no longer provides servicing of a lifejacket make and model listed in the guidelines required by paragraph (d) of this section. (2) Each manufacturer of an approved inflatable lifejacket must make replacement parts available to Coast Guard-approved independent servicing facilities. (b) Servicing facilities. Each Coast Guard-approved servicing facility must meet the requirements of this paragraph and paragraph (d) of this section to receive and keep its approval for each make and model of lifejacket. Approval is obtained according to § 160.255–5(c). (1) Each servicing facility must conduct lifejacket servicing according to its servicing guidelines and follow the procedures in the service manual required by this section. (2) Each servicing facility must have a suitable site for servicing that must be clean, well lit, free from excessive dust, drafts, and strong sunlight, and have appropriate temperature and humidity control as specified in the service manual. (3) Each servicing facility must have the appropriate service, repair, and test equipment and spare parts for performing required tests and repairs. (4) Each servicing facility must have a current manufacturer’s service manual for each make and model of lifejacket serviced. (5) A servicing facility may have more than one servicing site provided that each site meets the requirements of paragraph (b)(2) of this section. (6) Each servicing facility must be inspected at intervals not exceeding six months by an accepted independent laboratory, and a report of the inspections must be submitted to the Commandant at least annually. The report must contain enough information to show compliance with paragraphs (b)(1) through (4) of this section and paragraph (d) of this section. Where a facility uses more than one site the report must show compliance at each site at least biennially. (c) Service manual. (1) Each manufacturer of an approved inflatable lifejacket must prepare a service manual for the lifejacket. The service manual PO 00000 Frm 00043 Fmt 4701 Sfmt 4700 97397 must be approved by the Commandant according to § 160.176–5(b). (2) The manufacturer must make the service manual, service manual revisions, and service bulletins available to each approved servicing facility. (3) Each service manual must contain the following: (i) Detailed procedures for inspecting, servicing, and repackaging the lifejacket; (ii) A list of approved replacement parts and materials to be used for servicing and repairs, if any; (iii) A requirement to mark the date and servicing facility name on each lifejacket serviced; (iv) Frequency of servicing; and (v) Any specific restrictions or special procedures prescribed by the Coast Guard or manufacturer. (4) Each service manual revision and service bulletin which authorizes the modification of a lifejacket, or which affects a requirement under this subpart, must be approved by the Commandant. Other revisions and service bulletins are not required to be approved, but a copy of each must be sent to the Commandant when it is issued. At least once each year, the manufacturer must provide to the Commandant and to each servicing facility approved to service its lifejackets a bulletin listing each service manual revision and bulletin in effect. (d) Servicing facilities guidelines. Each servicing facility must have written guidelines that include the following: (1) Identification of each make and model of lifejacket that may be serviced by the facility as well as the manual and revision to be used for servicing; (2) Identification of the person, by title or position, who is responsible for the servicing program; (3) Training and qualifications of servicing technicians; (4) Provisions for the facility to retain a copy of its current letter of approval from the Coast Guard at each site; and (5) Requirements to— (i) Ensure each inflatable lifejacket serviced under its Coast Guard approval is serviced in accordance with the manufacturer’s service manual; (ii) Keep servicing technicians informed of each approved servicing manual revision and bulletin and ensure servicing technicians understand each change and new technique related to the lifejackets serviced by the facility; (iii) Calibrate each pressure gauge, weighing scale, and mechanically operated barometer at intervals of not more than one year; (iv) Ensure each inflatable lifejacket serviced under the facility’s Coast Guard approval is serviced by or under the supervision of a servicing technician E:\FR\FM\06DER3.SGM 06DER3 97398 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations who meets the requirements of paragraph (d)(3) of this section; (v) Specify each make and model of lifejacket the facility is approved to service when it represents itself as approved by the U.S. Coast Guard; and (vi) Not service any lifejacket for a U.S. registered commercial vessel, unless it is approved by the U.S. Coast Guard to service the make and model of lifejacket. (e) Servicing records. Each servicing facility must maintain records of all completed servicing. These records must be retained for at least 5 years after they are made, be made available to any Coast Guard representative and independent laboratory inspector upon request, and include at least the following: (1) Date of servicing, number of lifejackets serviced, lot identification, approval number, and test results data for the lifejackets serviced; (2) Identification of the person conducting the servicing; (3) Identity of the vessel receiving the serviced lifejackets; and (4) Date of return to the vessel. ■ 79. Add subpart 160.264, consisting of §§ 160.264–1 through 160.264–25, to read as follows: Subpart 160.264—Wearable Recreational Personal Flotation Devices (PFDs) Sec. 160.264–1 Scope. 160.264–3 Definitions. 160.264–5 Incorporation by reference. 160.264–7 Design, construction, and performance of PFDs. 160.264–9 Approval procedures for PFDs. 160.264–11 Recognized laboratory. 160.264–13 Approval inspections and tests. 160.264–15 Production inspections, tests, and quality control of PFDs. 160.264–17 Marking and labeling. 160.264–19 Placard. 160.264–21 PFD manuals. 160.264–23 Procedure for approval of design or material change. 160.264–25 Suspension or termination of approval. Subpart 160.264—Wearable Recreational Personal Flotation Devices (PFDs) lotter on DSK11XQN23PROD with RULES3 § 160.264–1 Scope. (a) This subpart contains structural and performance standards for approval of Level 50 and Level 70 inherently buoyant personal flotation devices (PFDs), as well as requirements for production follow-up inspections, markings, information placards, and associated manuals. (b) PFDs approved under this subpart rely entirely upon inherently buoyant material to achieve the minimum buoyancy. VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 (c) PFDs approved under this subpart are intended to meet the carriage requirements for wearable PFDs for uninspected commercial vessels under 40 ft (12m) not carrying passengers for hire and recreational boats, in accordance with 33 CFR part 175 and 46 CFR 25.25. Devices—Part 5: Buoyancy Aids (Level 50)—Safety Requirements, First Edition, December 31, 2015 (including revisions through January 27, 2022) (‘‘ANSI/CAN/ UL 12402–5’’); IBR approved for §§ 160.264–7(a) and (b); 160.264–13(a) and (b); 160.264–17(a); 160.264–19; 160.264–21(a). § 160.264–3 § 160.264–7 Design, construction, and performance of PFDs. Definitions. The following definitions apply to this subpart: Commandant means the Chief of the Lifesaving and Fire Safety Standards Division. Address: Commandant (CG– ENG–4), Attn: Lifesaving and Fire Safety Division, U.S. Coast Guard Stop 7509, 2703 Martin Luther King Jr. Avenue SE, Washington, DC 20593–7509; email TypeApproval@uscg.mil. First quality workmanship means construction that is free from any defect materially affecting appearance or serviceability. Inspector means a recognized laboratory representative assigned to perform, supervise, or oversee the duties described in § 160.264–15 or any Coast Guard representative performing duties related to the approval. Recognized laboratory means an independent laboratory accepted by the Commandant in accordance with 46 CFR subpart 159.010, with a valid memorandum of understanding in accordance with 46 CFR 159.010–7. § 160.264–5 Incorporation by reference. Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by reference (IBR) material is available for inspection at the Coast Guard Headquarters and at the National Archives and Records Administration (NARA). Contact Commandant (CG–ENG–4), Attn: Lifesaving and Fire Safety Division, U.S. Coast Guard Stop 7509, 2703 Martin Luther King Jr. Avenue SE, Washington, DC 20593–7509. For information on the availability of this material at NARA, visit www.archives.gov/federal-register/ cfr/ibr-locations or email fr.inspection@ nara.gov. The material may be obtained from UL, 333 Pfingsten Road, Northbrook, IL 60062–2002; phone (847) 272–8800; website: www.ul.com. (a) ANSI/CAN/UL 9595:2021, Standard for Safety Factory Follow-Up on Personal Flotation Devices (PFDs), First Edition, June 4, 2020 (including revisions through September 9, 2021) (‘‘ANSI/CAN/UL 9595’’); IBR approved for § 160.264–15(a). (b) ANSI/CAN/UL 12402–5:2022, Standard for Safety Personal Flotation PO 00000 Frm 00044 Fmt 4701 Sfmt 4700 (a) Each Level 70 PFD design must— (1) Meet the requirements in ANSI/ CAN/UL 12402–5 (incorporated by reference, see § 160.264–5) for a Level 70 device; and (2) For novel or unique designs, meet any additional requirements that the Commandant may prescribe. (b) Each Level 50 PFD design must— (1) Meet the requirements in ANSI/ CAN/UL 12402–5 (incorporated by reference, see § 160.264–5) for a Level 50 device; (2) Be marked to indicate that the device must be worn to be counted as equipment required by vessels meeting USCG regulations; and (3) For novel or unique designs, meet any additional requirements that the Commandant may prescribe. (c) Buoyancy is to be provided by inherently buoyant material and not depend on loose, granulated material, gas compartments, or inflation. (d) PFDs must be of first quality workmanship and must be free from any defects materially affecting their appearance or serviceability. (e) PFDs must not provide means intended for fastening or securing the device to a boat. § 160.264–9 PFDs. Approval procedures for (a) Each application for approval of a Level 50 or Level 70 PFD must be submitted directly to a Coast Guard recognized laboratory. (b) The recognized laboratory must determine if a PFD with novel design features requires a preliminary review by the Coast Guard prior to testing. Submissions requiring preliminary review must be sent to TypeApproval@ uscg.mil, and must include a full description and drawings. Pictures, samples, and preliminary test results may also be submitted. § 160.264–11 Recognized laboratory. (a) The approval inspections and tests, production inspections, tests, and quality control required by this subpart must be conducted by an independent laboratory recognized by the Coast Guard under 46 CFR subpart 159.010 to perform such functions. A list of recognized independent laboratories is E:\FR\FM\06DER3.SGM 06DER3 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations available from the Commandant and online at https://cgmix.uscg.mil. (b) Production oversight must be performed by the same laboratory that performs the approval tests unless, as determined by the Commandant, the employees of the laboratory performing production oversight receive training and support equal to that of the laboratory that performed the approval testing. § 160.264–13 tests. Approval inspections and (a) Each PFD must be certified by a recognized laboratory as meeting the requirements of ANSI/CAN/UL 12402–5 (incorporated by reference, see § 160.264–5) for an inherently buoyant Level 50 or Level 70 PFD. Approval tests specified in ANSI/CAN/UL 12402– 5 must be conducted or supervised by a recognized laboratory using PFDs constructed in accordance with the plans and specifications submitted with the application for approval. (b) Each PFD design must be visually examined for compliance with the construction and performance requirements of this subpart and ANSI/ CAN/UL 12402–5 (incorporated by reference, see § 160.264–5). (c) The Commandant may prescribe additional tests for approval of novel or unique designs. lotter on DSK11XQN23PROD with RULES3 § 160.264–15 Production inspections, tests, and quality control of PFDs. (a) General. Production tests and inspections must be conducted in accordance with ANSI/CAN/UL 9595 (incorporated by reference, see § 160.264–5) or an alternative follow-up procedure accepted by the Commandant. To maintain approval, the manufacturer must be in good standing under an accepted follow-up procedure. (b) Manufacturer’s inspection and tests. Manufacturers of approved PFDs must maintain quality control of the materials used, manufacturing methods, and the finished product to meet the applicable requirements, and make sufficient inspections and tests of representative samples and components produced to maintain the quality of the finished product. Records of tests conducted by the manufacturer and records of materials, including affidavits by suppliers that applicable requirements are met, must be made available to the recognized laboratory inspector or to the Coast Guard marine inspector, or both, for review upon request. (c) Laboratory inspections and tests. The laboratory inspector will conduct examinations, inspections, and tests for listed and labeled devices, as required VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 by the recognized laboratory, at the place of manufacture or other location at the option of the laboratory. (d) Test facilities. The laboratory inspector, or the Coast Guard marine inspector assigned by the Commander of the District in which the factory is located, or both, must be admitted to any place in the factory where work is being done on listed and labeled products. Either or both inspectors may take samples of parts or materials entering construction or final assemblies, for further examinations, inspections, or tests. The manufacturer must provide a suitable place and the apparatus necessary for the performance of the tests done at the place of manufacture. (e) Additional tests, etc. Unannounced examinations, tests, and inspections of samples obtained either directly from the manufacturer or through commercial channels may be made to determine the suitability of a product for listing and labeling, or to determine conformance of a labeled product to the applicable requirements. These may be conducted by the recognized laboratory or the United States Coast Guard. § 160.264–17 Marking and labeling. (a) Each PFD must be marked with the appropriate label as specified in Figure 6DV of ANSI/CAN/UL 12402–5 (incorporated by reference, see § 160.264–5). (b) The Commandant may prescribe additional marking requirements for special purpose devices or unique or novel designs. § 160.264–19 Placard. Each PFD sold or offered for sale must be provided with a placard that a prospective purchaser can read prior to purchase, as specified in Figure 8DV.1.1a and Figure 8DV.1.1b, Choose the Device You Will Want to Wear, of ANSI/CAN/UL 12402–5 (incorporated by reference, see § 160.264–5). The required placard text must be printed exactly as set out in ANSI/CAN/UL 12402–5. § 160.264–21 PFD manuals. (a) An owner’s manual in accordance with Figure 7DV of ANSI/CAN/UL 12402–5 (incorporated by reference, see § 160.264–5), may be provided with each inherently buoyant PFD sold or offered for sale. The text of each manual is reviewed with the application for approval. (b) The Commandant may prescribe additional information in the manual for special purpose devices or unique or novel designs. PO 00000 Frm 00045 Fmt 4701 Sfmt 4700 97399 (c) Additional information, instructions, or illustrations may be included in the owner’s manual if there is no contradiction to the required information. § 160.264–23 Procedure for approval of design or material change. (a) The manufacturer must submit any proposed changes in design, material, or construction to the recognized laboratory for approval before changing PFD production methods. (b) Determinations of equivalence of design, construction, and materials must be made only by the Commandant or a designated representative. § 160.264–25 approval. Suspension or termination of As provided in 46 CFR 159.005–15, the Commandant may suspend or terminate the approval of a PFD design if the manufacturer fails to comply with this subpart or the recognized laboratory’s accepted procedures or requirements. ■ 80. Add subpart 160.276, consisting of §§ 160.276–1 through 160.276–25, to read as follows: Subpart 160.276—Wearable Recreational Inflatable Personal Flotation Devices 160.276–1 Scope. 160.276–3 Definitions. 160.276–5 Incorporation by reference. 160.276–7 Design, construction, and performance of PFDs. 160.276–9 Approval procedures for PFDs. 160.276–11 Recognized laboratory. 160.276–13 Approval inspections and tests. 160.276–15 Production inspections, tests, and quality control of PFDs. 160.276–17 Marking and labeling. 160.276–19 Placard. 160.276–21 PFD manuals. 160.276–23 Procedure for approval of design or material change. 160.276–25 Suspension or termination of approval. Subpart 160.276—Wearable Recreational Inflatable Personal Flotation Devices § 160.276–1 Scope. (a) This subpart contains structural and performance standards for approval of Level 50 and Level 70 inflatable recreational personal flotation devices (PFDs), as well as requirements for production follow-up inspections, associated manuals, information placards, and markings. (b) Inflatable PFDs approved under this subpart rely entirely or partially upon inflation to achieve the minimum buoyancy. (c) PFDs approved under this subpart are intended to meet the carriage requirements for uninspected E:\FR\FM\06DER3.SGM 06DER3 97400 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations commercial vessels under 40 ft (12m) not carrying passengers for hire and recreational boats, in accordance with 33 CFR part 175 and 46 CFR 25.25. UL 12402–5’’); IBR approved for §§ 160.276–7(a) and (b); 160.276–13(a) and (b); 160.276–17(a) and (b); 160.276– 19; 160.276–21(a). § 160.276–3 § 160.276–7 Design, construction, and performance of inflatable PFDs. Definitions. The following definitions apply to this subpart: Commandant means the Chief of the Lifesaving and Fire Safety Standards Division. Address: Commandant (CG– ENG–4), Attn: Lifesaving and Fire Safety Division, U.S. Coast Guard Stop 7509, 2703 Martin Luther King Jr. Avenue SE, Washington, DC 20593–7509; email TypeApproval@uscg.mil. First quality workmanship means construction that is free from any defect materially affecting appearance or serviceability. Inspector means a recognized laboratory representative assigned to perform, supervise, or oversee the duties described in § 160.276–15 or any Coast Guard representative performing duties related to the approval. Recognized laboratory means an independent laboratory accepted by the Commandant in accordance with 46 CFR 159.010, with a valid memorandum of understanding in accordance with 46 CFR 159.010–7. lotter on DSK11XQN23PROD with RULES3 § 160.276–5 Incorporation by reference. Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by reference (IBR) material is available for inspection at the Coast Guard Headquarters and at the National Archives and Records Administration (NARA). Contact Commandant (CG–ENG–4), Attn: Lifesaving and Fire Safety Division, U.S. Coast Guard Stop 7509, 2703 Martin Luther King Jr. Avenue SE, Washington, DC 20593–7509. For information on the availability of this material at NARA, visit www.archives.gov/federal-register/ cfr/ibr-locations or email fr.inspection@ nara.gov. The material may be obtained from UL, 333 Pfingsten Road, Northbrook, IL 60062–2022; phone (847) 272–8800; website: www.ul.com. (a) ANSI/CAN/UL 9595:2021, Standard for Safety Factory Follow-Up on Personal Flotation Devices (PFDs), First Edition, June 4, 2020 (including revisions through September 9, 2021) (‘‘ANSI/CAN/UL 9595’’); IBR approved for § 160.276–15(a). (b) ANSI/CAN/UL 12402–5:2022, Standard for Safety Personal Flotation Devices—Part 5: Buoyancy Aids (Level 50)—Safety Requirements, First Edition, December 31, 2015 (including revisions through January 27, 2022) (‘‘ANSI/CAN/ VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 (a) Each Level 70 inflatable PFD design must— (1) Meet the requirements in ANSI/ CAN/UL 12402–5 (incorporated by reference, see § 160.276–5) for a Level 70 device; and (2) For novel or unique designs, meet any additional requirements that the Commandant may prescribe. (b) Each Level 50 inflatable PFD design must— (1) Meet the requirements in ANSI/ CAN/UL 12402–5 (incorporated by reference, see § 160.276–5) for a Level 50 device; (2) Be marked to indicate that the device must be worn to be counted as equipment required by vessels meeting USCG regulations; and (3) For novel or unique designs, meet any additional requirements that the Commandant may prescribe. (c) Buoyancy is to be provided by inflation, or a combination of inherently buoyant material and inflation. (d) PFDs must be of first quality workmanship and must be free from any defects materially affecting their appearance or serviceability. (e) PFDs must not provide means intended for fastening or securing the device to a boat. § 160.276–9 PFDs. Approval procedures for (a) Each application for approval of a Level 50 or Level 70 PFD must be submitted directly to a Coast Guard recognized laboratory. (b) The recognized laboratory must determine if a PFD with novel design features requires a preliminary review by the Coast Guard prior to testing. Submissions requiring preliminary review must be sent to TypeApproval@ uscg.mil, and must include a full description and drawings. Pictures, samples, and preliminary test results may also be submitted. § 160.276–11 Recognized laboratory. (a) The approval inspections and tests and production inspections, tests, and quality control required by this subpart must be conducted by an independent laboratory recognized by the Coast Guard under 46 CFR subpart 159.010 to perform such functions. A list of recognized independent laboratories is available from the Commandant and online at https://cgmix.uscg.mil. (b) The same laboratory that performs the approval tests must also perform PO 00000 Frm 00046 Fmt 4701 Sfmt 4700 production oversight unless the employees of the laboratory performing production oversight receive training and support equal to that of the laboratory that performed the approval testing, as determined by the Commandant. § 160.276–13 tests. Approval inspections and (a) Each PFD must be certified by a recognized laboratory as meeting the requirements of ANSI/CAN/UL 12402–5 (incorporated by reference, see § 160.276–5) for an inflatable Level 50 or Level 70 PFD. Approval tests specified in ANSI/CAN/UL 12402–5 must be conducted or supervised by a recognized laboratory using PFDs constructed in accordance with the plans and specifications submitted with the application for approval. (b) Each PFD design must be visually examined for compliance with the construction and performance requirements of this subpart and ANSI/ CAN/UL 12402–5 (incorporated by reference, see § 160.276–5). (c) The Commandant may prescribe additional tests for approval of novel or unique designs. § 160.276–15 Production inspections, tests, and quality control of PFDs. (a) General. Production tests and inspections must be conducted in accordance with ANSI/CAN/UL 9595 (incorporated by reference, see § 160.276–5) or an alternative follow-up procedure accepted by the Commandant. To maintain approval, the manufacturer must be in good standing under an approved follow-up procedure. (b) Manufacturer’s inspection and tests. Manufacturers of approved PFDs must maintain quality control of the materials used, manufacturing methods, and the finished product to meet the applicable requirements, and make sufficient inspections and tests of representative samples and components produced to maintain the quality of the finished product. Records of tests conducted by the manufacturer and records of materials, including affidavits by suppliers that applicable requirements are met, must be made available to the recognized laboratory inspector or to the Coast Guard marine inspector, or both, for review upon request. (c) Laboratory inspections and tests. The laboratory inspector will conduct examinations, inspections, and tests for listed and labeled devices, as required by the recognized laboratory, at the place of manufacture or other location at the option of the laboratory. E:\FR\FM\06DER3.SGM 06DER3 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations (d) Test facilities. The laboratory inspector, or the Coast Guard marine inspector assigned by the Commander of the District in which the factory is located, or both, must be admitted to any place in the factory where work is being done on listed and labeled products. Either or both inspectors may take samples of parts or materials entering construction or final assemblies, for further examinations, inspections, or tests. The manufacturer must provide a suitable place and the apparatus necessary for the performance of the tests done at the place of manufacture. (e) Additional tests, etc. Unannounced examinations, tests, and inspections of samples obtained either directly from the manufacturer or through commercial channels may be made to determine the suitability of a product for listing and labeling, or to determine conformance of a labeled product to the applicable requirements. These may be conducted by the recognized laboratory or the United States Coast Guard. § 160.276–17 Marking and labeling. (a) Each inflatable PFD must be marked as specified in Figure 6DV of ANSI/CAN/UL 12402–5 (incorporated by reference, see § 160.276–5). (b) In addition to the information required by ANSI/CAN/UL 12402–5, Figure 6DV, each Level 50 inflatable PFD must be marked with a statement that the device must be worn to be counted as equipment required by vessels meeting USCG regulations; and (c) The Commandant may prescribe additional marking requirements for special purpose devices or unique or novel designs. § 160.276–19 Placard. Each inflatable PFD sold or offered for sale must be provided with a placard that a prospective purchaser can read prior to purchase, as specified in Figure 8DV.1.1a and Figure 8DV.1.1b, Choose the Device You Will Want to Wear, of ANSI/CAN/UL 12402–5 (incorporated by reference, see § 160.276–5). The required placard text must be printed exactly as set out in ANSI/CAN/UL 12402–5. lotter on DSK11XQN23PROD with RULES3 § 160.276–21 PFD manuals. (a) An owner’s manual in accordance with Figure 7DV of ANSI/CAN/UL 12402–5 (incorporated by reference, see § 160.276–5), must be provided with each inflatable PFD sold or offered for sale. The text of each manual is reviewed with the application for approval. VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 (b) The Commandant may prescribe additional information in the manual for special purpose devices or unique or novel designs. (c) Additional information, instructions, or illustrations may be included in the owner’s manual if there is no contradiction to the required information. § 160.276–23 Procedure for approval of design or material change. (a) The manufacturer must submit any proposed changes in design, material, or construction to the recognized laboratory for approval before changing PFD production methods. (b) Determinations of equivalence of design, construction, and materials must be made only by the Commandant or a designated representative. § 160.276–25 approval. Suspension or termination of As provided in 46 CFR 159.005–15, the Commandant may suspend or terminate the approval of an inflatable PFD design if the manufacturer fails to comply with this subpart or the recognized laboratory’s accepted procedures or requirements. PART 169—SAILING SCHOOL VESSELS 81. The authority citation for part 169 continues to read as follows: ■ Authority: 33 U.S.C. 1321(j); 46 U.S.C. 3306, 6101; Public Law 103–206, 107 Stat. 2439; E.O. 11735, 38 FR 21243, 3 CFR, 1971– 1975 Comp., p. 793; DHS Delegation 00170.1, Revision No. 01.4; § 169.117 also issued under the authority of 44 U.S.C. 3507. 82. Revise § 169.539 to read as follows: ■ § 169.539 Type required. All personal flotation devices (PFDs) must be: (a) Approved under subpart 160.002, 160.005, 160.055, or 160.255 of subchapter Q (specification) of this chapter; (b) Approved specifically for sailing school vessel use under subpart 160.064, 160.077, or 160.264 of Subchapter Q of this chapter; or (c) Approved under subparts 160.047, 160.052, or 160.060 of part 160 of this chapter or approved under subpart 160.064 or 160.264 of part 160 of this chapter if the vessel carries exposure suits or exposure PFDs, in accordance with § 169.551. PART 180—LIFESAVING EQUIPMENT AND ARRANGEMENTS 83. The authority citation for part 180 is revised to read as follows: ■ PO 00000 Frm 00047 Fmt 4701 Sfmt 4700 97401 Authority: 46 U.S.C. 2104, 3306; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; DHS Delegation 00170.1, Revision No. 01.4. 84. Amend § 180.71 by: a. Revising the section heading and paragraph (c); ■ b. Removing paragraph (d); and ■ c. Redesignating paragraph (e) as paragraph (d). The revisions read as follows: ■ ■ § 180.71 Lifejackets. * * * * * (c) Each lifejacket must be approved under approval series in subparts 160.002, 160.005, 160.055, 160.115, 160.176, or 160.255 in part 160 of this chapter, or other standard specified by the Commandant. An inflatable lifejacket approved under approval series in subpart 160.255 of part 160 of this chapter must include a full back-up inflation chamber. * * * * * ■ 85. Amend § 180.72 by revising the section heading and paragraphs (a), (b), and (d) to read as follows: § 180.72 Personal flotation devices carried in addition to lifejackets. (a) Equipment carried under this section is not acceptable in lieu of any portion of the required number of approved lifejackets and must not be substituted for the approved lifejackets required to be worn during drills and emergencies. (b) Wearable marine buoyant devices approved in accordance with § 160.064, 160.076, 160.264, or 160.276 in subchapter Q of this chapter, or other standard specified by the Commandant, may be carried as additional equipment. * * * * * (d) A commercial hybrid approved under former approval series 160.077 prior to January 6, 2025 may be carried as additional equipment for use by persons working near or over the water if it is in good and serviceable condition, used in accordance with the conditions marked on the PFD and in the owner’s manual, and of the same or similar design and has the same method of operation as each other hybrid PFD carried on board. PART 199—LIFESAVING SYSTEMS FOR CERTAIN INSPECTED VESSELS 86. The authority citation for part 199 continues to read as follows: ■ Authority: 46 U.S.C. 3306, 3703; Public Law 103–206, 107 Stat. 2439; DHS Delegation 00170.1, Revision No. 01.4. 87. Revise § 199.70(b) introductory text to read as follows: ■ E:\FR\FM\06DER3.SGM 06DER3 97402 § 199.70 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations Personal lifesaving appliances. * * * * (b) Lifejackets. Each vessel must carry lifejackets approved under approval series 160.155 or 160.176. If the vessel carries inflatable lifejackets, they must be of the same or similar design and have the same method of operation. * * * * * ■ 88. Revise § 199.620(c) to read as follows: lotter on DSK11XQN23PROD with RULES3 * VerDate Sep<11>2014 19:44 Dec 05, 2024 Jkt 265001 § 199.620 Alternatives for all vessels in a specified service. * * * * * (c) Lifejackets approval series. As an alternative to a lifejacket meeting the approval requirements in § 199.70, vessels may carry a lifejacket approved under approval series in subparts 160.002, 160.005, 160.055, 160.077, or 160.255 of part 160 of this chapter. An inflatable lifejacket approved under PO 00000 Frm 00048 Fmt 4701 Sfmt 9990 approval series in subpart 160.255 of part 160 of this chapter must include a full back-up inflation chamber. * * * * * Dated: November 26, 2024. W.R. Arguin, Rear Admiral, U.S. Coast Guard, Assistant Commandant for Prevention Policy. [FR Doc. 2024–28264 Filed 12–5–24; 8:45 am] BILLING CODE 9110–04–P E:\FR\FM\06DER3.SGM 06DER3

Agencies

[Federal Register Volume 89, Number 235 (Friday, December 6, 2024)]
[Rules and Regulations]
[Pages 97356-97402]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-28264]



[[Page 97355]]

Vol. 89

Friday,

No. 235

December 6, 2024

Part III





Department of Homeland Security





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 Coast Guard





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33 CFR Part 181

46 CFR Parts 25, 28, 108, et al.





Lifejacket Approval Harmonization; Final Rule

Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / 
Rules and Regulations

[[Page 97356]]


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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 181

46 CFR Parts 25, 28, 108, 117, 133, 141, 160, 169, 180 and 199

[Docket No. USCG-2022-0120]
RIN 1625-AC62


Lifejacket Approval Harmonization

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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SUMMARY: The Coast Guard amends the approval requirements and follow-up 
program requirements for lifejackets by incorporating new standards to 
replace existing legacy standards. The Coast Guard further amends 
lifejacket and personal flotation device (PFD) carriage requirements to 
allow for the use of equipment approved to the new standards and 
removes obsolete equipment approval requirements. The amendments 
streamline the process for the approval of PFDs and allow manufacturers 
the opportunity to produce innovative equipment that complies with 
standards in both Canada and the United States. Manufacturing firms 
also stand to benefit through a reduced production-inspections burden.

DATES: 
    Effective dates: This final rule is effective January 6, 2025. The 
incorporation by reference of certain publications listed in the rule 
is approved by the Director of the Federal Register as of January 6, 
2025.
    Compliance date: The Coast Guard will begin enforcing this rule on 
June 4, 2025.

ADDRESSES: To view documents mentioned in this preamble as being 
available in the docket, go to www.regulations.gov, type USCG-2022-0120 
in the search box and click ``Search.'' Next, in the Document Type 
column, select ``Supporting & Related Material.''

FOR FURTHER INFORMATION CONTACT:  For information about this document 
call or email Jacqueline Yurkovich, Coast Guard; telephone 571-607-
4931, email [email protected].

SUPPLEMENTARY INFORMATION: 

Table of Contents for Preamble

I. Abbreviations
II. Background, Basis, and Purpose
III. Discussion of Comments
IV. Discussion of the Rule
V. Incorporation by Reference
VI. Regulatory Analyses
    A. Regulatory Planning and Review
    B. Small Entities
    C. Assistance for Small Entities
    D. Collection of Information
    E. Federalism
    F. Unfunded Mandates
    G. Taking of Private Property
    H. Civil Justice Reform
    I. Protection of Children
    J. Indian Tribal Governments
    K. Energy Effects
    L. Technical Standards
    M. Environment

I. Abbreviations

ANSI American National Standards Institute
CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
FRFA Final Regulatory Flexibility Analysis
IBR Incorporation by reference
ISO International Organization for Standardization
NAICS North American Industry Classification System
NBSAC National Boating Safety Advisory Committee
NIH National Institutes of Health
NPRM Notice of proposed rulemaking
OMB Office of Management and Budget
PFD Personal flotation device
QMS Quality management system
RA Regulatory analysis
RFA Regulatory Flexibility Act
Sec.  Section
SBA Small Business Administration
SME Subject matter expert
SOLAS International Convention for the Safety of Life at Sea
U.S.C. United States Code

II. Background, Basis, and Purpose

    The Coast Guard has statutory authority under Title 46 of the 
United States Code (U.S.C.), Sections 3306(a) and (b), 4102(b), 4302(a) 
and (c), and 4502(a) and (c)(2)(B), to prescribe regulations for the 
design, construction, performance, testing, carriage, use, and 
inspection of lifesaving equipment on commercial and recreational 
vessels. Under Department of Homeland Security (DHS) Delegation 
00170.1, Revision No. 01.4, paragraph (II)(92)(b), the Secretary 
delegated authority under these statutes to the Commandant of the Coast 
Guard.
    With this rulemaking, we are incorporating the American National 
Standards Institute (ANSI) standards ANSI/CAN/UL 12402-5 for Level 50 
and Level 70 personal flotation devices (PFDs), ANSI/CAN/UL 12402-4 for 
Level 100 PFDs, and ANSI/CAN/UL 9595 for quality assurance. In 
addition, we are incorporating the ANSI/UL 1123 and ANSI/UL 1175 
standards for marine buoyant devices and inherently buoyant and 
inflatable throwable PFDs, respectively. The Coast Guard currently 
approves some inherently buoyant and inflatable throwable PFDs that 
meet these standards because we have determined that a throwable PFD 
meeting the requirements in ANSI/UL 1123 or ANSI/UL 1175 provides an 
equivalent level of safety as a throwable PFD currently described in 46 
CFR 160.064. Therefore, incorporating these standards in the Code of 
Federal Regulations (CFR) will not result in any changes in practice 
but will improve transparency.
    We are also removing portions of title 46 in part 160 of the CFR, 
where the new incorporated standards supersede the previous standards 
or requirements. Additionally, we are adding amendments to lifesaving 
equipment carriage requirements that permit the use of Level 50, Level 
70, and Level 100 PFDs approved to the new standards.
    The Coast Guard actively participates in the development of ANSI-
accredited industry consensus standards for lifesaving equipment. In 
that capacity, the Coast Guard worked with Transport Canada and United 
States and Canadian stakeholders in the development of the suite of 
harmonized ANSI/CAN/UL standards to streamline the process for approval 
of PFDs. Additionally, the harmonization allows manufacturers the 
opportunity to produce more innovative equipment that meets approval 
requirements in both Canada and the United States.
    On September 22, 2014, the Coast Guard published a final rule in 
the Federal Register titled Personal Flotation Devices Labeling and 
Standards (79 FR 56491).\1\ That rule removed references to type codes 
in its regulations on the carriage and labeling of Coast Guard approved 
PFDs to facilitate the future incorporation by reference (IBR) of new 
industry consensus standards. In April 2017, the Coast Guard and 
Transport Canada signed a Memorandum of Understanding outlining an 
intended cooperation for the approval of personal lifesaving appliances 
that comply with mutually acceptable standards, are tested by mutually 
accepted conformity assessment bodies or independent test laboratories, 
and are covered by a mutually acceptable follow-up program.\2\
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    \1\ https://www.federalregister.gov/documents/2014/09/22/2014-22373/personal-flotation-devices-labeling-and-standards (last 
accessed November 15, 2024).
    \2\ https://downloads.regulations.gov/USCG-2018-0565-0002/content.pdf (last accessed November 15, 2024).
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    On April 3, 2012, the Coast Guard published a final rule titled 
Inflatable Personal Flotation Devices (77 FR 19937), incorporating by 
reference updated revisions of industry consensus

[[Page 97357]]

standards for PFDs including UL 1180, ``UL Standard for Safety for 
Fully Inflatable Recreational Personal Flotation Devices,'' Second 
Edition (including revisions through December 3, 2010).\3\ The 
discussion and response to comments in that rulemaking included a 
discussion on inflatable PFDs for users less than 16 years of age. UL 
1180 limits the approval of inflatable PFDs to persons of at least 16 
years of age, and thus the 2012 final rule retained that age limit for 
approved users of inflatable PFDs. No age limit was included in the 
regulatory text to allow for a possible future rulemaking to 
incorporate by reference a standard that sufficiently addresses the 
needs of younger wearers.
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    \3\ https://www.federalregister.gov/documents/2012/04/03/2012-7791/inflatable-personal-flotation-devices (last accessed November 
15, 2024).
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    On August 17, 2018, the Coast Guard published a notice in the 
Federal Register (83 FR 41095) regarding a policy letter and 
deregulatory savings analysis on accepting the standard ANSI/CAN/UL 
12402-5 for Level 70 PFDs, not including inflatable PFDs for use by 
persons less than 16 years old.\4\ On November 15, 2019, the Coast 
Guard published a notice (84 FR 62546) that finalized this policy.\5\
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    \4\ https://www.federalregister.gov/documents/2018/08/17/2018-17799/lifejacket-approval-harmonization. (last accessed November 7, 
2024).
    \5\ https://www.federalregister.gov/documents/2019/11/15/2019-24836/lifejacket-approval-harmonization. (last accessed November 7, 
2024).
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III. Discussion of Comments

    On April 7, 2023, the Coast Guard published a notice of proposed 
rulemaking (NPRM) titled Lifejacket Approval Harmonization (88 FR 
21016) requesting comments on the proposed changes implemented by this 
final rule.\6\ In response to the NPRM, we received 390 written 
submissions, nearly all of which were supportive of this rulemaking. 
Several commenters observed that performance-based standards such as 
those incorporated by this final rule allow manufacturers to design 
more innovative, comfortable, and stylish personal flotation devices 
and give manufacturers more flexibility when selecting materials, 
design, and construction. Others commented that aligning standards with 
Canada would promote consistency and enhance boating safety through 
improved lifejacket usage. We appreciate these supportive comments.
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    \6\ https://www.federalregister.gov/documents/2023/04/07/2023-06504/lifejacket-approval-harmonization. (last accessed November 7, 
2024).
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    We received 370 comments as part of a write-in campaign. Of these 
comments, 368 were identical or nearly identical in content and 
supported the harmonization of lifejacket standards between the United 
States and Canada. The commenters noted several benefits of 
harmonization, including streamlined processes, reduced costs, and 
enhanced cooperation between the United States and Canada.
    Two commenters submitted comments that were nearly identical to the 
content of the write-in comments but offered opposition or an 
additional comment. One commenter used the supportive content of the 
write-in letter but indicated he was writing against the proposed 
changes. This commenter did not offer any reasoning for opposing the 
changes and cited the same benefits of harmonization as the other 
write-in commenters.
    The other commenter wrote ``not in support'' of the rule, but also 
used the full text of the write-in letter, including the referenced 
benefits of harmonization. However, this commenter added a comment that 
urged the Coast Guard to actively develop our own standard. The 
standards were not developed solely by Canada, but also by the Coast 
Guard, Transport Canada, and industry organizations from both countries 
working in coordination. The Coast Guard actively participates in the 
development of lifejacket standards, including the standards being 
incorporated here.
    One commenter suggested that if the new Level 50 devices do result 
in increased lifejacket usage and thus more lives saved, then the Coast 
Guard should consider mandating lifejacket wear in other circumstances. 
We may consider this suggestion for a future rulemaking.
    One commenter questioned why 33 CFR subchapters N and NN were 
omitted from this rulemaking. These subchapters are out of scope for 
this rulemaking. Lifejackets approved under approval series 160.255 
will not satisfy the requirements of 33 CFR 142.45 or 149.316 at this 
time. However, we thank the commenter and may consider updates to 
subchapters N and NN in a future rulemaking.
    One commenter questioned what this rule means for current PFD 
devices, and specifically wondered if PFDs currently in use will need 
to be replaced. As explained in this preamble, PFDs that satisfied 
carriage requirements prior to publication of this final rule will 
continue to do so. It is not necessary for owners and operators to 
purchase new equipment if their current equipment is in good and 
serviceable condition.
    One commenter stated that PFDs should not be mandated by any 
government. The Coast Guard considers PFDs critical lifesaving 
equipment, for each person on each vessel. With this rulemaking, the 
Coast Guard amends current carriage requirements to include new 
approval series to allow owners, operators, and users the option of 
using PFDs approved to newly incorporated standards. We have not 
modified the requirement to carry PFDs; doing so would be outside the 
scope of this rulemaking.
    One commenter noted that several subsections of the proposed rule 
reference 46 CFR 159.010, which in turn includes references to the 
older International Organization for Standardization (ISO) standard 
ISO/IEC 17025:2005 (covering accreditation of third party independent 
laboratories), with ISO/IEC 17025:2017 being the most current standard. 
The Coast Guard thanks the commenter for their thorough review, but 
criteria for acceptance, recognition, and accreditation of third party 
independent laboratories are outside the scope of this rulemaking 
project. Therefore, we did not make changes in response to this 
comment.
    One commenter fully supported the rulemaking but suggested some 
minor corrections. The commenter noted that Sec.  160.077 is referenced 
in Sec. Sec.  199.620 and 169.539, but those sections do not include an 
additional effective date requirement. We did not make changes in 
response to this comment. The Coast Guard does not believe it is 
necessary to include an effective date requirement in either of those 
sections, since an effective date is only needed in sections mentioning 
a commercial hybrid PFD. The commenter also noted that the definition 
of inspector in 46 CFR 160.060-3 references Sec.  160.255-15, but 
instead should reference Sec.  160.060-15. That was an error in the 
NPRM which is corrected in this final rule. In addition to the 
reference in Sec.  160.060-3 identified by the commenter, we discovered 
similar errors in Sec. Sec.  160.055-3 and 160.064-3 and corrected the 
reference in those sections.
    One commenter stated that the changes proposed in the NPRM were 
``great'' but sought clarification on the replacement of the two-word 
term ``life jacket'' with the one-word term ``lifejacket'' and asked us 
to use the two-word term rather than the proposed one-word term. The 
commenter asserted that the two-word term has always been used in the 
United States and suggested this clarification avoids the appearance 
that this document is proposing that the United States needs to change 
the way the term ``life jacket'' is spelled in so many other places. We 
did not make changes based on this suggestion. The two-word term has 
not always been

[[Page 97358]]

used in the United States. The Coast Guard, industry, stakeholders, and 
user groups use the terms ``lifejacket'' and ``life jacket'' 
interchangeably. In the NPRM, the Coast Guard proposed to standardize 
the term to the one-word variation and we are finalizing that proposal 
here. We specifically selected the one-word term for use in our 
regulations to align with the use of the one-word term in the ANSI/CAN/
UL 12402 standard, which is one of the standards incorporated by 
reference. However, industry, stakeholders, and user groups can 
continue to use the term ``life jacket'' if that is their preference.
    One commenter fully supported the rule, specifically noting that 
PFDs would become stylish, comfortable, and appealing to the boating 
public, ultimately saving lives because they will wear them. The 
commenter suggested that the Coast Guard should permit anyone over 13 
years old to wear an inflatable PFD to fulfill the mandated PFD 
carriage requirements. We agree with the commenter. The proposed rule 
did not include an age restriction for inflatable PFDs, which is 
finalized in this final rule.
    One commenter noted that there seemed to be inconsistencies in the 
proposed requirements for back-up chambers, specifically that back-up 
chambers are required for lifejackets in 46 CFR 117.71 and 180.71 but 
not elsewhere. Another commenter requested clarification on why back-up 
chambers are required for lifejackets in 46 CFR 117.71, 180.71, and 
199.620, but not 46 CFR 141.340.\7\ These differences are intentional. 
Because the incorporated standard ANSI/CAN/UL 12402-4 does not require 
back up chambers for inflatable Level 100 lifejackets, the proposed 
rule included the additional requirement that inflatable Level 100 
lifejackets must have a back-up chamber to meet carriage requirements 
for passenger vessels, and this final rule retains that requirement.
---------------------------------------------------------------------------

    \7\ The commenter actually specified 46 CFR 141.349, a section 
which does not exist. From context, we assume this was a 
typographical error and the commenter actually meant 46 CFR 141.340.
---------------------------------------------------------------------------

    One commenter supported the amendments to Requirements for 
Instruction Pamphlets for PFDs and suggested that the Coast Guard 
engage the Technical Committee 1123 to develop a ``label standard'' to 
address outstanding issues, such as the prospect that the placard would 
not effectively replace the pamphlet for products with legacy labels. 
The Coast Guard is fully engaged in UL Technical Committee 1123--
Personal Flotation Devices and would be open to the development of a 
label standard in the future.
    The Coast Guard notes the suggestion from another commenter to 
include an icon on the lifejacket itself indicating Coast Guard 
approval. While there is no Coast Guard icon required to be printed 
directly on the device, the device must be marked with the words ``USCG 
Approved'' followed by the unique approval number and must also be 
marked with the laboratory's certification mark. Additionally, the 
information placard at the point of sale clearly indicates with a check 
mark if the device is Coast Guard approved.

IV. Discussion of the Rule

A. General Discussion

    By means of this final rule, the Coast Guard makes seven main 
amendments to our regulations:
    (1) Adding new subpart 160.255, which incorporates by reference 
ANSI/CAN/UL 12402-4 for approval of Level 100 PFDs, and removing 
sections of subpart 160.055 related to materials and construction, 
marking, and procedure for approval because no new approvals will be 
granted under approval series 160.055;
    (2) Adding new subparts 160.264 (Wearable Recreational PFDs) and 
160.276 (Wearable Recreational Inflatable PFDs), both of which 
incorporate by reference ANSI/CAN/UL 12402-5 for approval of Level 50 
and Level 70 PFDs without additional buoyancy or age restrictions; 
removing the sections of subparts 160.060, 160.064, and 160.076 
pertaining to the approval of new wearable PFDs; relocating the 
sections pertaining to throwable PFDs from subpart 160.064 to new 
subpart 160.045 and incorporating by reference ANSI/UL 1123 and ANSI/UL 
1175; and removing subpart 160.077 (Hybrid Inflatable PFDs) in its 
entirety;
    (3) Incorporating by reference ANSI/CAN/UL 9595 for quality 
assurance requirements in subparts 160.045, 160.055, 160.060, 160.064, 
160.076, 160.255, 160.264, and 160.276;
    (4) Removing subparts 160.001, 160.002, 160.005, 160.006, 160.047, 
160.048, and 160.052, as these subparts are mostly or entirely 
obsolete, and moving the remaining relevant material from subpart 
160.001 to subpart 160.055;
    (5) Amending lifesaving equipment carriage requirements to include 
the new approval categories, where appropriate, and removing any 
remaining references to type codes;
    (6) Amending the requirements for instruction pamphlets for PFDs to 
also include the placard specified in part 181 subpart G in subparts 
160.055, 160.060, 160.076, 160.255, 160.264, and 160.276, while 
retaining the option of instruction pamphlets for lifejackets approved 
under subparts 160.055, 160.060, 160.064, and 160.076; and
    (7) Amending the existing regulatory text to make editorial 
corrections and increase clarity.
    We provide additional details and discussion on each of these seven 
main categories of amendments below. Under 46 U.S.C. 4302(b), the 
effective (implementation) date of provisions in this final rule 
applying to recreational vessels must be at least 180 days after 
publication. For simplicity, the implementation date of the entire rule 
will be 180 days after the date of publication. While we have specified 
an effective date 30 days after publication of this final rule, we have 
also specified that we will not enforce these regulations until 180 
days after publication in the DATES section above.
    We consulted the National Boating Safety Advisory Committee (NBSAC) 
regarding the updated standards in this rule, as shown by NBSAC 
Resolutions 2009-83-01 \8\ and 2011-87-01,\9\ and the revalidation of 
those resolutions found in Resolution 2022-03-01.\10\
---------------------------------------------------------------------------

    \8\ Available at https://homeport.uscg.mil/Lists/Content/Attachments/449/NBSAC%20Resolution%202009-83-01%20Changes%20to%20Approval%20Process%20for%20PFD_s.pdf (last 
accessed November 12, 2024).
    \9\ Available at https://homeport.uscg.mil/Lists/Content/Attachments/459/NBSAC%202011-87-01%20-%20Signed_2.pdf (last accessed 
November 12, 2024).
    \10\ Available at https://homeport.uscg.mil/Lists/Content/Attachments/75876/Recommendation-2022-03-01--Signed.pdf (last 
accessed November 12, 2024).
---------------------------------------------------------------------------

1. Add New Subpart, 46 CFR 160.255, Incorporate by Reference ANSI/CAN/
UL 12402-4, and Remove Sections of Subpart 160.055
    We are adding a new subpart, 160.255, to 46 CFR. PFDs approved 
under this new subpart meet the carriage requirements for wearable PFDs 
for three groups: (1) inspected vessels; (2) uninspected commercial 
vessels over 40 feet (12m) in length; and (3) uninspected passenger 
vessels.
    New subpart 160.255 contains structural and performance 
requirements for approval of Level 100 PFDs, as well as requirements 
for production inspections and quality control, markings, information 
pamphlets, and associated manuals. ANSI/CAN/UL 12402-4 is incorporated 
by reference. PFDs approved under this subpart rely upon inherently 
buoyant material, inflation, or a combination of

[[Page 97359]]

the two to achieve the minimum buoyancy.
    A Level 100 PFD has the same basic requirements as a PFD meeting 
current 46 CFR 160.055 (life preservers). The minimum amount of 
buoyancy, basic mechanical properties, and in-water performance 
requirements are the same. However, ANSI/CAN/UL 12402-4 is less 
prescriptive regarding the design requirements of a Level 100 PFD, so 
manufacturing firms can develop more innovative designs. The marking 
requirements in ANSI/CAN/UL 12402-4 specify pictorial graphics to 
communicate the performance of the PFD and warnings for use. The Coast 
Guard conducted research and focus groups to identify issues with the 
Type code labels and to evaluate multiple new pictorial labeling 
options. Our research indicated that people consistently preferred 
pictorial markings.\11\ Therefore, we expect this marking format to be 
more easily understandable to both English-speaking and non-English-
speaking populations.
---------------------------------------------------------------------------

    \11\ ``Revision of Labeling and Classification for Personal 
Flotation Devices (PFDs),'' Applied Safety & Ergonomics, Inc., 
December 28, 2004, Young et al.
---------------------------------------------------------------------------

    ANSI/CAN/UL 12402-4 does not require fully or partially inflatable 
Level 100 PFDs to provide redundant back-up inflation chambers. Current 
regulations require inflatable lifejackets under approval series 
160.176 to have at least two inflation chambers \12\ and to reach 
minimum in-water performance with any one chamber deflated.\13\ These 
inflatable lifejackets meet the International Maritime Organization 
Life-Saving Appliance Code and are intended for use on vessels subject 
to SOLAS.
---------------------------------------------------------------------------

    \12\ 46 CFR 160.176-9(a)(1).
    \13\ 46 CFR 160.176-13(j)(3).
---------------------------------------------------------------------------

    Back-up chambers were originally required for inflatable 
lifejackets intended for use on inspected vessels as an additional 
safety measure in case the primary inflation chamber failed to inflate 
(see 54 FR 50316, 50322, Dec. 5, 1989). In the 1989 interim final rule 
``Approval of Inflatable Lifejackets'' preamble, the Coast Guard noted 
that we would continue discussions with industry, standards 
organizations, and state boating law administrators regarding the 
reliability of inflatable PFDs (54 FR 50317). We also indicated that 
when new developments or innovations reduced the risk of inflation 
failure to an acceptable level, we could address this issue with a 
subsequent rulemaking. Since the publication of that rule in 1989, the 
Coast Guard has no evidence that a well-maintained PFD with a single 
inflation chamber is less reliable in the event of an emergency than an 
inherently buoyant PFD. Additionally, the Coast Guard has approved 
inflatable PFDs without back-up chambers under approval series 160.076. 
Such devices have been in use in the United States on uninspected 
commercial vessels less than 12 meters in length, and by recreational 
vessels and in Canada on small vessels, for over a decade. Therefore, 
the Coast Guard believes that the material testing of the PFD 
components coupled with the required annual servicing of inflatable 
Level 100 PFDs is sufficient, and that redundant back-up inflation 
chambers are not necessary to provide an equivalent level of safety to 
PFDs meeting current 46 CFR 160.055.
    Because new subpart 160.255 supersedes the requirements for life 
preservers in subpart 160.055, we are removing structural and 
performance requirements for approval of life preservers in subpart 
160.055, but maintaining the requirements for production inspections, 
tests, and quality assurance. Manufacturers can continue to produce 
life preservers currently approved under subpart 160.055, while all new 
lifejackets will require Coast Guard approval under new subpart 
160.255.
    At the same time, we are restructuring subpart 160.055 to include a 
statement of the subpart's scope and to mirror the structure of other 
PFD-related subparts. We are adding sections for scope in Sec.  
160.055-1 and definitions in Sec.  160.055-3, and standards 
incorporated by reference are moved from Sec.  160.055-1 to Sec.  
160.055-5. Because no new approvals are granted under Sec.  160.055, we 
are removing existing requirements for materials and construction, 
marking, and procedure for approval, including current 46 CFR 160.055-
3, 160.055-4, 160.055-5, 160.055-6, 160.055-8, and 160.055-9. We are 
adding independent laboratory requirements in new Sec.  160.055-11. We 
move sampling, tests, and inspections from Sec.  160.055-7 to newly 
created Sec.  160.055-15 and include pamphlet requirements in new Sec.  
160.055-19. We include procedures for the approval of design or 
material changes in new Sec.  160.055-23 and information on suspension 
or termination of approval in new Sec.  160.055-25.
2. Add New Subparts 46 CFR 160.045, 160.264, and 160.276, Incorporate 
by Reference ANSI/CAN/UL 12402-5, ANSI/UL 1123, and ANSI/UL 1175, 
Remove Sections of Subparts 160.060, 160.064, and 160.076, and Remove 
Subpart 160.077 in Its Entirety
    We are adding three new subparts in 46 CFR: 160.045, 160.264, and 
160.276. PFDs approved under these subparts meet the carriage 
requirements for recreational boats, in accordance with 33 CFR part 
175. Wearable PFDs approved under subparts 160.264 and 160.276 also 
meet the carriage requirements for uninspected commercial vessels less 
than 40 feet (12m) in length and not carrying passengers for hire in 
accordance with 46 CFR subpart 25.25.
    New subpart 160.264 contains structural and performance 
requirements for approval of Level 50 and Level 70 inherently buoyant 
PFDs, as well as requirements for production inspections and quality 
control, markings, information placards, and associated manuals. New 
subpart 160.276 contains structural and performance requirements for 
approval of Level 50 and Level 70 fully and partially inflatable 
recreational PFDs, as well as requirements for production inspections 
and quality control, associated manuals, information placards, and 
markings. ANSI/CAN/UL 12402-5 is incorporated by reference in both 
subparts.
    ANSI/CAN/UL 12402-5 prescribes minimum performance requirements 
instead of prescribing design requirements. This performance-based 
standard allows manufacturing firms to design more innovative, 
comfortable, and stylish PFDs. New PFD designs could lead to more 
individuals choosing to wear their PFDs, resulting in fewer 
drownings.\14\ Drowning is the leading cause of death in recreational 
boating accidents, accounting for 79 percent of all recreational 
boating casualties where the cause of death is known.\15\ Of those

[[Page 97360]]

who drowned, 86 percent were not wearing lifejackets. Wearing a 
lifejacket is one of the best means available of preventing accidental 
drowning in recreational boating. Unfortunately, recreational boaters 
only wear lifejackets about 24 percent of the time.\16\
---------------------------------------------------------------------------

    \14\ Readers should reference the National Center for 
Biotechnology Information, which is part of the National Library of 
Medicine at the National Institutes of Health (NIH), and perform a 
literature search for articles on the topic of PFDs and their usage. 
Readers can access this website at https://pubmed.ncbi.nlm.nih.gov. 
More specifically, readers should reference the following articles 
for further information: ``Personal, social, and environmental 
factors associated with lifejacket wear in adults and children: A 
systematic literature review'' (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5931488) and ``Barriers to life jacket use among adult 
recreational boaters.'' (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4310692) (last accessed April 23, 2024).
    \15\ United States Coast Guard, ``2019 Recreational Boating 
Statistics.'' https://safe.menlosecurity.com/doc/docview/viewer/docN0C8787B5BC27b941976de80db865a89b27e43db4732447826e405d5b93b8a0a1dd64625cf817 (last accessed April 23, 2024).
    \16\ United States Coast Guard, ``2019 Life Jacket Wear Rate 
Observation Study.'' https://uscgboating.org/library/national-live-jacket-wear-study/2019-Life-Jacket-Wear-Rate-Report.pdf (last 
accessed April 23, 2024).
---------------------------------------------------------------------------

    Discomfort, whether real or perceived, is negatively associated 
with PFD wear.\17\ ANSI/CAN/UL 12402-5 allows manufacturers more 
flexibility when selecting materials, design, and construction of new 
PFDs. Because manufacturers will be less limited in the materials, 
design, and construction, we expect that new PFDs might be slimmer, 
lighter in weight, or more comfortable to wear than PFDs approved under 
the current requirements.
---------------------------------------------------------------------------

    \17\ Amy Peden, Daniel Demant, Martin Hagger, and Kyra Hamilton, 
``Personal, social, and environmental factors associated with 
lifejacket wear in adults and children: A systematic literature 
review.'' https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5931488/ 
(last accessed April 23, 2024).
---------------------------------------------------------------------------

    In our 2018 policy letter, CG-ENG Policy 02-18, titled Adoption of 
ANSI/CAN/UL 12402-5 and 9,\18\ the Coast Guard determined that Level 70 
inherently buoyant devices, Level 70 inflatable devices, and Level 70 
multi-chamber devices that meet the requirements of ANSI/CAN/UL 12402-5 
provide equivalent performance to wearable PFDs meeting the 
requirements in current 46 CFR 160.064 or 160.076.\19\
---------------------------------------------------------------------------

    \18\ https://www.dco.uscg.mil/Portals/9/DCO%20Documents/5p/5ps/Design%20and%20Engineering%20Standards/Life%20Saving%20and%20Fire%20Safety/Docs/L%20A%20HARM%20POLICY%2020180801-Signed.pdf?ver=2018-08-01-131843-173 (last accessed April 23, 2024).
    \19\ 83 FR 41095
---------------------------------------------------------------------------

    The Coast Guard has now determined that a Level 50 PFD, when worn 
and used in accordance with the label, provides an equivalent level of 
safety as a wearable PFD that meets current subpart 160.064 or 160.076 
requirements. A Level 50 PFD has a lower minimum amount of buoyancy 
than the current minimum requirement for Coast Guard approved PFDs. 
However, ANSI/CAN/UL 12402-5 requires that a Level 50 PFD keep the 
user's airway above the water, as demonstrated by in-water performance 
testing. A Level 50 PFD is intended for use by those who can swim and 
who have help or rescue nearby. As required in ANSI/CAN/UL 12402-5, 
Level 50 PFDs must be marked: ``Not recommended for weak or non-
swimmers.'' Every PFD offered for sale must have a placard providing 
users with information on how to select the appropriate PFD and 
reminding users to try the PFD on in the water to ensure proper fit and 
performance. To satisfy requirements of ANSI/CAN/UL 12402-5, Level 50 
PFDs must be worn and must be marked: ``Approval conditions state that 
this device must be worn to be counted as equipment required by vessels 
meeting Transport Canada or USCG regulations.'' A Level 50 PFD, when 
worn by a person who can swim and used in accordance with ANSI/CAN/UL 
12402-5, provides an equivalent level of safety as a PFD meeting the 
current requirements in 46 CFR 160.064 or 160.076. By approving Level 
50 PFDs, the Coast Guard provides a critical level of oversight to the 
currently unregulated Level 50 competition watersports PFDs, resulting 
in safer products for the public.
    In this final rule, we are not adding requirements that limit users 
of inflatable PFDs based on age. There are already requirements in 
ANSI/CAN/UL 12402-5 addressing inflatable PFDs for users less than 16 
years of age. To be certified as meeting ANSI/CAN/UL 12402-5, an 
inflatable PFD intended for wearers less than 16 years of age must 
automatically inflate, must not require secondary donning, must be 
worn, and must include a warning statement about adult supervision. The 
Coast Guard believes these requirements are adequate to ensure safety 
for wearers less than 16 years of age, so we are fully incorporating 
ANSI/CAN/UL 12402-5 without any additional age restrictions beyond 
those included in the standard.
    New subparts 160.264 and 160.276 supersede the requirements for 
foam buoyant vests in subpart 160.060, marine buoyancy devices in 
subpart 160.064, inflatable recreational personal flotation devices in 
subpart 160.076, and hybrid inflatable personal flotation devices in 
subpart 160.077.
    We are removing the structural and performance requirements for the 
approval of foam buoyant vests, marine buoyant devices, and inflatable 
recreational flotation devices in subparts 160.060, 160.064, and 
160.076, respectively, but retaining the requirements for production 
inspections, tests, and quality control of wearable PFDs. We are 
deleting subpart 160.077 entirely and modifying the scope of subpart 
160.076 to include PFDs previously approved under subpart 160.077. By 
retaining the requirements for production inspections, tests, and 
quality control, we ensure that manufacturing firms producing PFDs 
currently approved under approval series 160.060, 160.064, 160.076, or 
160.077 can continue to manufacture and sell these PFDs, but the Coast 
Guard will not approve new products under these approval series. At the 
same time, we are reformatting the remaining text of subparts 160.060, 
160.064, and 160.076, without amending the language, to align with the 
other subparts related to PFDs and increase the ease of understanding 
for the reader.
    To eliminate confusion over approval categories, we are relocating 
the requirements for throwable PFDs from subpart 160.064 to new subpart 
160.045. The new subpart 160.045 is dedicated to throwable PFDs 
intended for carriage on recreational boats. We permit the use of 
inflatable compartments to meet the minimum required buoyancy in Sec.  
160.045-7. This new subpart incorporates by reference the ANSI/UL 1175 
standard for inherently buoyant and inflatable throwable PFDs and the 
ANSI/UL 1123 standard for marine buoyant devices. The Coast Guard 
already approves throwable PFDs to these standards; we are formally 
incorporating them by reference in this rulemaking to increase clarity 
and transparency of the approval requirements.
3. Incorporate by Reference ANSI/CAN/UL 9595
    We are incorporating by reference new industry consensus standard 
ANSI/CAN/UL 9595, ``Standard for factory follow-up of Personal 
Flotation Devices (PFDs)'' (First Edition, June 4, 2020), into subparts 
160.045, 160.055, 160.060, 160.064, 160.076, 160.255, 160.264, and 
160.276. This standard covers the basic elements of a production 
inspection program for various types of PFDs.
    The Coast Guard currently requires a satisfactory follow-up 
(production testing and inspection) program administered by an 
independent laboratory recognized by the Coast Guard for each approved 
PFD. A task group of experts and stakeholders convened over the past 
decade to develop ANSI/CAN/UL 9595 to improve the consistency of 
follow-up programs among different recognized independent laboratories 
and to provide a binational harmonized standard for production testing 
acceptable to the Coast Guard and Transport Canada.
    ANSI/CAN/UL 9595 establishes a set of Process Ratings (A, B, and C) 
based on the quality management system (QMS) at each facility. Process 
Rating A is reserved for facilities that have

[[Page 97361]]

demonstrated a superior QMS meeting ISO standard ISO 9001. Process 
Rating B is assigned to facilities with a good QMS including a Quality 
Manual that incorporates the requirements in ANSI/CAN/UL 9595 but is 
not approved by a third party. Process Rating C provides a minimum 
requirement for production inspections that is equivalent to current 
industry practice for follow-up programs and meets the minimum 
requirements currently accepted by the Commandant.
    At Process Ratings A and B, ANSI/CAN/UL 9595 provides the option 
for the manufacturer to implement a QMS to reduce the number of 
inspections required. ANSI/CAN/UL 9595 lists roles and 
responsibilities; required tests, sample sizes, and acceptability 
criteria; and specific requirements for inspection frequency, 
traceability of components, critical dimensions verification, visual 
inspection of completed PFDs, and review of records. Annex A provides 
test methods and Annex B provides information on the elements of a QMS.
    We include ANSI/CAN/UL 9595 in the new subparts 160.045, 160.255, 
160.264, and 160.276 and in existing subparts 160.055, 160.060, 
160.064, and 160.076, to allow manufacturers that implement a QMS to be 
evaluated as Process Rating A or B, resulting in fewer required 
inspections. A QMS can result in greater production consistency, a 
reduction in defects and errors, increased efficiency, and continuous 
improvement.
4. Remove Obsolete Material and Relocate Pertinent Material
    We are removing subparts 160.002, 160.005, 160.006, 160.047, 
160.048, and 160.052, while also removing or relocating the entirety of 
subpart 160.001. Subpart 160.001 provides general requirements for all 
life preservers. Most of this information is either obsolete or found 
elsewhere in the CFR. We are removing subpart 160.001, while preserving 
the still-pertinent information on production oversight by relocating 
it to Sec.  160.055-15.
    Subpart 160.006 provides two paragraphs related to the repairing of 
life preservers. Subpart 160.006 is no longer relevant and is not 
referenced in any approval or carriage requirement; therefore, we are 
removing it.
    Subparts 160.002, 160.005, 160.047, and 160.048 provide 
specifications and requirements for kapok and fibrous glass life 
preservers. Subpart 160.052 provides specifications and requirements 
for a unicellular plastic foam buoyant vest. Manufacturers no longer 
produce any of these types of life preservers due to the unavailability 
of material, the advancement of foam technology, and improvements to 
the fit and function of PFDs industry-wide. With no current approvals 
for equipment under any of these subparts, these approval categories 
have become obsolete. Therefore, we are removing subparts 160.002, 
160.005, 160.047, 160.048, and 160.052. All new PFD approvals will have 
to meet the requirements in subparts 160.255, 160.264, and 160.276, 
which incorporate current industry standards.
5. Amend Lifesaving Equipment Carriage Requirements
    Where existing carriage requirements specify approval series for 
PFDs, we are adding the new approval series, as applicable. The 
affected subchapters are subchapter C (Uninspected Commercial Vessels), 
subchapters K and T (Small Passenger Vessels), subchapter L (Offshore 
Supply Vessels), subchapter M (Towing Vessels), and subchapter W 
(Lifesaving Appliances for Certain Inspected Vessels). If we identify 
other affected subchapters in the future, we could address them in a 
future rulemaking or guidance document.
    For example, according to the existing requirements under 
subchapter C, an uninspected vessel carrying passengers for hire must 
have at least one PFD approved under approval series 160.055, 160.155, 
or 160.176 for each person on board (46 CFR 25.25-5). We are adding 
approval series 160.255 to the list of approval series to permit the 
use of PFDs approved under this new approval series. We are not 
removing any of the currently accepted approval series from the 
carriage requirements. Therefore, it will not be necessary for owners 
and operators to purchase new equipment if their current equipment is 
in good and serviceable condition.
    We are also removing references to PFDs approved under approval 
series 160.177 because there have never been any approvals granted 
under that series. All new commercial PFDs, including commercial hybrid 
PFDs, will be approved under approval series 160.255.
6. Amend the Requirements for Instruction Pamphlets for PFDs
    We are amending the requirements for instruction pamphlets for PFDs 
in 33 CFR 181 to allow both pamphlets and placards to meet the 
requirements for information furnished with each PFD sold or offered 
for sale for use on recreational boats. As previously described, we are 
incorporating both ANSI/CAN/UL 12402-4 and ANSI/CAN/UL 12402-5 with 
respect to the approval of PFDs. Both standards require that a PFD 
include an informational placard in a pictographic format containing 
specific information on PFD performance, selection, approval, and 
maintenance, as well as general water safety information. To permit the 
placard to be used in place of the currently required pamphlet, the 
Coast Guard is adding the term ``placard'' to 33 CFR 181.702. We are 
also removing 33 CFR 181.703, which requires that placards conform with 
UL 1123, and adding text to 33 CFR 181.702 specifying that a pamphlet 
or placard must meet the requirements in the applicable subpart of 46 
CFR part 160 or be accepted by the Commandant. All currently approved 
PFDs have pamphlets or placards that have been accepted by the 
Commandant. Removing 33 CFR 181.703 eliminates all references to UL 
1123 in this subpart, so we are removing 33 CFR 181.4, which 
incorporates that standard, as well. Finally, we are removing the 
separate requirements for hybrid and inflatable PFDs in 33 CFR 181.704 
and 181.705, respectively, and including requirements for all PFDs in 
33 CFR 181.702.
7. Amend the Existing Regulatory Text To Make Editorial Corrections and 
Increase Clarity
    We are updating the introductory IBR text, in accordance with 
current practice, in 46 CFR 160.055, 160.060, 160.064, and 160.076. We 
are amending Table 28.110 to replace ``Do'' (meaning ``ditto'') with 
the actual text to clarify the requirements in plain language, and to 
remove references to type codes from the table without modifying the 
intent or application of the requirements. We are also removing 
reference to approval series 160.177 in 46 CFR 108, 133 and 199 because 
this approval series has never been used, and removing outdated 
provisions allowing cork and balsa wood lifejackets until March 11, 
1999, from 46 CFR 117 and 180. Finally, we are consistently using the 
term ``lifejacket'' by amending instances of ``life jacket'' from two 
words to one.

B. Standards Incorporated by Reference To Be Updated or Added

    Following this paragraph, we include an alphabetical list of the 
standards we are adding, each with a listing of the sections in which 
they appear in 46 CFR. For each standard listed, we describe the topics 
covered by the standard, the edition adopted, and a list of subparts or 
sections that reference the standard.
     ANSI/CAN/UL 9595, Standard for Safety Factory Follow-Up on 
Personal

[[Page 97362]]

Flotation Devices (PFDs), First Edition, June 4, 2020 (including 
revisions through September 9, 2021). This standard is incorporated by 
reference in Sec. Sec.  160.045-15, 160.055-15, 160.060-15, 160.064-15, 
160.076-29, 160.255-15, 160.264-15, and 160.276-15. This binational 
standard covers the basic elements of a production inspection program 
for various types of PFDs, and formalizes and modifies current industry 
standards.
     ANSI/CAN/UL 12402-4, Standard for Safety Personal 
Flotation Devices--Part 4: Lifejackets, Performance Level 100--Safety 
Requirements, First Edition, July 9, 2020. This standard is 
incorporated by reference in Sec. Sec.  160.255-7, 160.255-13, 160.255-
17, 160.255-19, and 160.255-21. This binational standard specifies the 
safety requirements for lifejackets that provide face-up flotation for 
use in sheltered or calm water, where users may have to wait for 
rescue. A lifejacket meeting the requirements of ANSI/CAN/UL 12402-4 
provides an equivalent level of safety to a lifejacket currently 
approved under current 46 CFR subpart 160.055.
     ANSI/CAN/UL 12402-5, Standard for Safety Personal 
Flotation Devices--Part 5: Buoyancy Aids (Level 50)--Safety 
Requirements, First Edition, December 31, 2015 (including revisions 
through January 27, 2022). This standard is incorporated by reference 
in Sec. Sec.  160.264-7, 160.264-13, 160.264-17, 160.264-19, 160.264-
21, 160.276-7, 160.276-13, 160.276-17, 160.276-19, and 160.276-21. This 
binational standard specifies the safety requirements for buoyancy aids 
used in sheltered waters with help and rescue nearby. A PFD meeting the 
requirements of ANSI/CAN/UL 12402-5 provides an equivalent level of 
safety as a PFD currently approved under 46 CFR 160.064 or 160.076.
     ANSI/UL 1123, Standard for Safety Marine Buoyant Devices, 
Seventh Edition, October 1, 2008 (including revisions through November 
23, 2020). This standard is incorporated by reference in Sec. Sec.  
160.045-7 and 160.045-13. ANSI/UL 1123 provides requirements for Type 
II, Type III, and Type IV marine buoyant devices, including vests, 
jackets, horseshoe buoys and ring buoys, with or without lifelines, 
intended for recreational use, and throwable cushions.
     ANSI/UL 1175, Standard for Safety Buoyant Cushions, Fourth 
Edition, April 20, 2007 (including revisions through January 10, 2020). 
This standard is incorporated by reference in Sec. Sec.  160.045-7 and 
160.045-13. This standard provides requirements for throwable PFDs 
using inherent or inflatable buoyancy that are intended to be used in 
accordance with applicable Coast Guard regulations.

C. Standards Incorporated by Reference To Be Removed

    Following this paragraph, we include an alphabetical list of the 
standards we are removing as a result of this final rule. These 
standards are being removed because the regulatory text applying to 
these standards has been removed, and the newly incorporated standards 
supersede and replace these standards.
     ASTM B117-97, Standard Practice for Operating Salt Spray 
(Fog) Apparatus.
     ASTM D413-82, Standard Test Methods for Rubber Property--
Adhesion to Flexible Substrate.
     ASTM D570-95, Standard Test Method for Water Absorption of 
Plastics.
     ASTM D751-95, Standard Test Method for Coated Fabrics.
     ASTM D882-97, Standard Test Method for Tensile Properties 
of Thin Plastic Sheeting.
     ASTM D1004-94a, Standard Test Method for Initial Tear 
Resistance of Plastic Film and Sheeting.
     ASTM D1434-82 (Reapproved 2009), Standard Test Method for 
Determining Gas Permeability Characteristics of Plastic Film and 
Sheeting.
     CCC-C-426D, Cloth, Cotton Drill.
     CCC-C-700G, Cloth, Coated, Vinal, Coated (Artificial 
Leather).
     Color Names Dictionary, ``The Universal Color Language'' 
and ``The Color Names Dictionary'' in Color: Universal Language and 
Dictionary of Names, National Institute of Standards Special 
Publication 440.
     Federal Standard No. 595A, Color.
     Federal Standards No. 751 and 751A, Stitches, Seams, and 
Stitchings.
     Federal Test Method Standard No. 191, Textile Test 
Methods, including:
    [cir] Method 5100, Strength and Elongation, Breaking of Woven 
Cloth; Grab Method;
    [cir] Method 5132, Strength of Cloth, Tearing; Falling-Pendulum 
Method;
    [cir] Method 5134, Strength of Cloth, Tearing; Tongue Method;
    [cir] Method 5804.1, Weathering Resistance of Cloth; Accelerated 
Weathering Method; and
    [cir] Method 5762, Mildew Resistance of Textile Materials; Soil 
Burial Method.
     L-P-375 and L-P-375C, Plastic Film, Flexible, Vinyl 
Chloride.
     MIL-C-43006D, Cloth and Strip Laminated, Vinyl-Nylon High 
Strength, Flexible.
     MIL-L-24611(SH), Life Preserver Support Package for Life 
Preserver, MK 4.
     MIL-B-2766 and MIL-R-2766B, Batt, Fibrous Glass, 
Lifesaving Equipment.
     MIL-T-3530E, Thread and Twine; Mildew Resistant or Water 
Repellant Treated.
     MIL-W-530 and MIL-W-530F, Webbing, Textiles, Cotton, 
General Purpose, Natural and in Colors.
     MIL-W-17337D, Webbing, Woven, Nylon.
     UL 1123, UL Standard for Safety for Marine Buoyant 
Devices.
     UL 1180, UL Standard for Safety for Fully Inflatable 
Recreational Personal Flotation Devices.
     UL 1191, Components for Personal Flotation Devices.
     UL 1517, Standard for Hybrid Personal Flotation Devices.

D. Changes to the Regulatory Text From the NPRM

    As discussed in Section III of this preamble, Discussion of 
Comments, we corrected three errors in cross-references that were the 
result of typographical errors in the NPRM. We updated the definition 
for inspector in 46 CFR 160.055-3 to now cross-reference Sec.  160.055-
15 rather than Sec.  160.255-15; in Sec.  160.060-3 to now cross-
reference Sec.  160.060-15 rather than Sec.  160.255-15; and in Sec.  
160.064-3 to now cross-reference Sec.  160.064-15 rather than Sec.  
160.264-15. We also corrected the definition for inspector in 46 CFR 
160.276-15 to cross-reference Sec.  160.276-15 rather than ``part 15 of 
this guideline.''
    In Sec.  160.076-1 (``Scope''), we added a paragraph, (c), to help 
explain and clarify the applicability of subpart 160.076. We also added 
additional amendatory instructions that were inadvertently missed in 
the NPRM. These include removing Sec.  160.076-3 and redesignating 
Sec.  160.076-3 as Sec.  160.076-5, redesignating Sec.  160.076-11 as 
Sec.  160.076-5, and revising the newly redesignated Sec.  160.076-5.
    There are no other changes to the regulatory text from the NPRM.

V. Incorporation by Reference

    Material for incorporation by reference appears in 46 CFR 160.045-
5, 160.055-5, 160.060-5, 160.064-5, 160.076-5, 160.255-5, 160.264-5, 
and 160.276-5 and is summarized in section IV.B of this preamble, 
Standards Incorporated by Reference to be Updated or Added. Copies of 
the material are available either at the publisher's web address listed 
in the incorporation by reference sections in 46 CFR 160.045-5, 
160.055-5, 160.060-5, 160.064-5, 160.076-5, 160.255-5, 160.264-5, and 
160.276-5, or by

[[Page 97363]]

contacting the publisher listed for those standards. We reviewed and 
updated all the publisher's web addresses listed in the parts to ensure 
they are current. You may also contact the person in the FOR FURTHER 
INFORMATION CONTACT section for additional direction on how to obtain 
access to electronic copies of the materials.
    We believe industry already has access to and uses these new 
standards. The affected industry, in particular recognized independent 
laboratories, typically obtains the most recent editions of standards 
in the course of their business to address advancements in technology.
    The Director of the Federal Register approved the material in 46 
CFR 160.045-5, 160.055-5, 160.060-5, 160.064-5, 160.076-5, 160.255-5, 
160.264-5, and 160.276-5 for incorporation by reference under 5 U.S.C. 
552 and 1 CFR part 51.

VI. Regulatory Analyses

    We developed this rule after considering numerous statutes and 
Executive orders related to rulemaking. We have prepared a full 
regulatory analysis (RA) based on these statutes and Executive orders 
and have placed it in the docket where indicated under the ADDRESSES 
portion of the preamble. A summary of our analysis follows. Where we 
mention the analysis in the RA, we are referring the reader to the RA 
in the docket.

A. Regulatory Planning and Review

    Executive Order 12866 (Regulatory Planning and Review), as amended 
by Executive Order 14094 (Modernizing Regulatory Review), and Executive 
Order 13563 (Improving Regulation and Regulatory Review) direct 
agencies to assess the costs and benefits of available regulatory 
alternatives and, if regulation is necessary, to select regulatory 
approaches that maximize net benefits (including potential economic, 
environmental, public health and safety effects, distributive impacts, 
and equity). Executive Order 13563 emphasizes the importance of 
quantifying both costs and benefits, of reducing costs, of harmonizing 
rules, and of promoting flexibility.
    Two additional Executive orders promote the goals of Executive 
Order 13563: Executive Order 13609 (Promoting International Regulatory 
Cooperation) and Executive Order 13610 (Identifying and Reducing 
Regulatory Burdens). Executive Order 13609 targets international 
regulatory cooperation to reduce, eliminate, or prevent unnecessary 
differences in regulatory requirements. Executive Order 13610 aims to 
modernize the regulatory systems and to reduce unjustified regulatory 
burdens and costs on the public.
    The Office of Management and Budget (OMB) has not designated this 
rule a significant regulatory action under section 3(f) of Executive 
Order 12866, as amended by Executive Order 14094 (Modernizing 
Regulatory Review). A summary of the RA follows; see the docket for our 
full analysis.

              Table 1--Summary of Impacts of the Final Rule
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Category                                          Summary
------------------------------------------------------------------------
Applicability...................  IBR of ANSI/CAN/UL 9595, ANSI/CAN/UL
                                   12402-5, and ANSI/CAN/UL 12402-4.
                                 ---------------------------------------
Affected Population.............  2 recognized independent laboratories
                                   (1 U.S. and 1 foreign), 61 PFD
                                   manufacturing firms (39 U.S. and 22
                                   foreign), the Coast Guard,
                                   recreational vessel operators, and
                                   commercial vessel operators.
------------------------------------------------------------------------
Costs to American Firms ($2023,   10-year...........          $1,865,564
 2% discount rate).
                                  Annualized........             207,687
Costs to Foreign Firms ($2023,    10-year...........             455,782
 2% discount rate).
                                  Annualized........              50,741
Total Costs ($2023, 2% discount   10-year...........           2,321,343
 rate).
                                  Annualized........             258,427
Benefits to American Firms        10-year...........           8,871,985
 ($2023, 2% discount rate).
                                  Annualized........             987,687
Benefits to Foreign Firms         10-year...........           2,222,303
 ($2023, 2% discount rate).
                                  Annualized........             247,401
Benefits to the United States     10-year...........              38,895
 Government ($2023, 2% discount
 rate).
                                  Annualized........               4,330
Total Benefits to All Entities    10-year...........          11,133,183
 ($2023, 2% discount rate).
                                  Annualized........           1,239,419
Net Benefits to American Firms    10-year...........           7,006,423
 ($2023, 2% discount rate).
                                  Annualized........             780,001
Net Benefits to Foreign Firms     10-year...........           1,766,522
 ($2023, 2% discount rate).
                                  Annualized........             196,661
Net Benefits to the United        10-year...........              38,895
 States Government ($2023, 2%
 discount rate).
                                  Annualized........               4,330
Net Benefits to All Entities      10-year...........           8,811,839
 ($2023, 2% discount rate).
                                  Annualized........             980,991
                                 ---------------------------------------
Unquantified Benefits...........  The newer performance-based standards
                                   will allow for the development of
                                   more innovative PFD designs that
                                   might better meet boaters' needs. New
                                   PFD designs that may be more form
                                   fitting, in addition to the
                                   requirement that Level 50 devices be
                                   worn to count for carriage, could
                                   lead to higher PFD wear rates and
                                   additional lives saved from drowning.
                                   Placards are cheaper to produce than
                                   pamphlets and provide pictorial
                                   instructions, understandable by non-
                                   English reading populations.
------------------------------------------------------------------------


[[Page 97364]]

    By means of this final rule, the Coast Guard harmonizes its 
approval process for PFDs with that of Canada, resulting in cost 
savings from eliminating a second set of approval requirements for PFD 
manufacturers wishing to sell in both Canada and the United States and 
reducing the required amount of product inspections depending on the 
quality management system in place at a given manufacturing facility. 
This rule removes barriers to entry for future innovative personal 
flotation devices and will save manufacturers money from reducing 
regulatory burdens without sacrificing quality. On net, the Coast Guard 
projects that manufacturers and the Coast Guard will save over 
$1,000,000 annually on reduced production inspections.
    Additionally, the Coast Guard expects that the introduction of 
Level 50 devices, coupled with the requirement to wear them if they are 
to count for the purposes of PFD carriage requirements, will lead to an 
unquantifiable increase in PFD wear rates among recreational boaters, 
and thereby potentially decrease the rate of drowning in the event of 
an accident. Only Coast Guard approved devices are eligible to count 
for PFD carriage requirements, and, for Level 50 devices to count, they 
must be worn. The Coast Guard therefore expects that recreational 
boaters purchasing Level 50 PFDs for the purposes of carriage are more 
likely to wear them. Drowning is the leading cause of death in 
recreational boating accident and a study of drowning incidents found 
that, 86 percent of the time, individuals who drowned were not wearing 
a PFD.\20\ Absent these regulations, Level 50 devices cannot be sold as 
Coast Guard approved devices, and the expected increase in PFD wear 
rates among recreational boaters will not materialize.
---------------------------------------------------------------------------

    \20\ United States Coast Guard. ``2019 Recreational Boating 
Statistics.'' https://uscgboating.org/library/accident-statistics/Recreational-Boating-Statistics-2019.pdf (last accessed April 22, 
2024).
---------------------------------------------------------------------------

    The final rule introduces harmonized performance standards instead 
of design standards for PFDs. It amends PFD approval and follow-up 
program requirements by incorporating three new binational standards 
into regulations, amending PFD carriage requirements to allow for the 
use of equipment approved to the new standards, and removing obsolete 
equipment approval requirements. The performance-based standards are 
more current and intended to replace the legacy design standards. The 
amendments allow manufacturers to produce more innovative equipment 
that meets the approval requirements of Canada and the United States 
and reduce the burden for manufacturers in the approval process and 
follow-up program.
    Specifically, the Coast Guard incorporates by reference the 
following binational industry consensus standards:
    (1) ANSI/CAN/UL 12402-4. This binational standard specifies the 
safety requirements for lifejackets that provide face-up flotation for 
use in sheltered or calm water, where users may have to wait for 
rescue. A lifejacket meeting the requirements of ANSI/CAN/UL 12402-4 
provides an equivalent level of safety to a lifejacket currently 
approved under 46 CFR subpart 160.055.
    (2) ANSI/CAN/UL 12402-5. This binational standard specifies the 
safety requirements for buoyancy aids used in sheltered waters with 
help and rescue nearby. A PFD meeting the requirements of ANSI/CAN/UL 
12402-5 provides an equivalent level of safety as a PFD currently 
approved under 46 CFR 160.064 or 160.076.
    (3) ANSI/CAN/UL 9595. This binational standard covers the basic 
elements of a production inspection program for various types of PFDs 
and formalizes and modifies current industry standards.
    Additionally, the Coast Guard incorporates two national standards 
(ANSI/UL 1123 and ANSI/UL 1175) and amends numerous CFR parts to remove 
obsolete PFD design standards and update carriage requirements to 
include PFDs approved to the new subparts. As mentioned earlier, ANSI/
UL 1123 and ANSI/UL 1175 are both currently in use as a matter of 
policy and are being incorporated by reference for the sake of clarity. 
We do not estimate any costs or benefits from their incorporation by 
reference into the CFR. Similarly, we do not anticipate any 
quantifiable costs or benefits from the removal of obsolete design 
standards, as these design standards are not currently in use.
    In moving from the NPRM to this final rule, we made the following 
changes to the RA and small entities section:
    (1) Updated wage figures to use the most recently available data.
    (2) Updated deflators and costs to 2023.
    (3) Added a Final Regulatory Flexibility Act Analysis (FRFA).
    (4) Updated the affected population numbers based on more recent 
data.
    (5) Included descriptions of public comments that supported 
assumptions we made in the NPRM. As noted above, public comments 
overwhelmingly supported this rule. Some of those comments supported 
assumptions we made in the NPRM. We did not receive any comments that 
disagreed with our assumptions or offered new information that would 
require changes to the analysis.
Affected Population
    To determine the affected population of the rule, it is first 
necessary to describe the economic impacts from this final rule. The 
economic impacts stem from the following four provisions:
    (1) The IBR of ANSI/CAN/UL 12402-4 in 46 CFR 160.255 to replace the 
design requirements in 46 CFR 160.055;
    (2) The IBR of ANSI/CAN/UL 12402-5 in 46 CFR 160.264 and 160.276 to 
replace the design standards in 46 CFR 160.064, 160.076, and 160.077;
    (3) The IBR of ANSI/CAN/UL 9595 for follow-up service into the PFD 
approval requirements of existing subparts 46 CFR 160.055, 160.060, 
160.064, 160.076 and new subparts of 46 CFR 160.045, 160.255, 160.264, 
and 160.276; and
    (4) The edits to 33 CFR 181 subpart G, which permit manufacturers 
of all PFDs to provide placards instead of information pamphlets.
    These four provisions affect PFD manufacturers, the two recognized 
independent laboratories, and the Coast Guard. Before we present the 
affected population for each of these provisions, we present the 
overall PFD manufacturing firm population.
    As of 2023, there are over 800 models of PFDs approved by the Coast 
Guard, manufactured by 61 separate manufacturing firms worldwide.\21\ 
Based on a review of publicly available information across the 61 
manufacturing firms, the Coast Guard estimates that 39 are U.S. firms 
and 22 are foreign firms. Market share and production volumes are not 
equal across the firms.\22\
---------------------------------------------------------------------------

    \21\ The Coast Guard lists all approved products on the Coast 
Guard Maritime Information Exchange website, https://cgmix.uscg.mil/
. Last accessed April 25, 2024.
    \22\ We used the headquarters location of a firm's parent 
company, as indicated on the company website, to determine whether a 
firm was U.S. or foreign.

[[Page 97365]]



                           Table 2--Distribution of Market Share of PFD Manufacturers
----------------------------------------------------------------------------------------------------------------
                                                                                     U.S. firm     Foreign firm
                       Manufacturing firms                         Total market    market share    market share
                                                                     share (%)          (%)             (%)
----------------------------------------------------------------------------------------------------------------
Top 5 Manufacturing Firms.......................................              75           65.00           10.00
Manufacturing Firms 6-13........................................              20           12.50            7.50
All Other Manufacturing Firms...................................               5           3.125           1.875
                                                                 -----------------------------------------------
    Total.......................................................             100          80.625          19.375
----------------------------------------------------------------------------------------------------------------

    The first provision, the IBR of ANSI/CAN/UL 12402-4, affects three 
populations:
    (1) PFD manufacturers that seek approval to manufacture devices 
meeting the requirements of ANSI/CAN/UL 12402-4;
    (2) The two recognized independent laboratories that review and 
certify these devices; and
    (3) The Coast Guard, which corresponds with the recognized 
independent laboratories and manufacturers on device approval.
    In table 3, we list the number of PFD manufacturing firms that are 
affected by ANSI/CAN/UL 12402-4. We estimate that each of the top 13 
firms that produce ANSI/CAN/UL 12402-4 devices or components of those 
devices at 2 facilities each and firms outside of the top 13 firms that 
produce ANSI/CAN/UL 12402-4 devices at 1 facility each.\23\
---------------------------------------------------------------------------

    \23\ The PFD manufacturing firm does not necessarily own the 
facilities where its products are produced. Instead, the facility 
may be producing PFDs on contract for the PFD manufacturing firm. 
Additionally, much production for U.S. firms occurs at overseas 
facilities. We call these ``U.S. Associated Facilities'' not because 
they are in the United States but because they have a longstanding 
relationship with U.S. firms, while ``Foreign Facilities'' have 
longstanding relationships with foreign firms.

                   Table 3--Manufacturing Firms and Facilities Impacted by ANSI/CAN/UL 12402-4
----------------------------------------------------------------------------------------------------------------
                                                                       U.S.
         Firm ownership             U.S. firms     Foreign firms    associated        Foreign          Total
                                                                    facilities      facilities      facilities
----------------------------------------------------------------------------------------------------------------
Firms in top 13.................               5               3              10               6              16
All other firms.................               4               2               4               2               6
                                 -------------------------------------------------------------------------------
    Total facilities............               9               5              14               8              22
----------------------------------------------------------------------------------------------------------------

    In the second provision, by incorporating by reference ANSI/CAN/UL 
12402-5, the Coast Guard introduces new categories for youth 
inflatables and Level 50 PFDs for approval. Permitting youth 
inflatables and Level 50 devices affects three populations:
    (1) PFD manufacturers that seek Coast Guard approval to produce 
youth inflatables or Level 50 devices;
    (2) The two recognized independent laboratories that review and 
certify youth inflatables and Level 50 devices; and
    (3) The boating public that purchases youth inflatables or Level 50 
devices instead of Level 70 or Type III devices, because youth 
inflatables and Level 50 devices are likely to be more form-fitting 
than Level 70 or Type III devices.
    In the third provision, the Coast Guard intends to incorporate by 
reference ANSI/CAN/UL 9595, covering production inspections and 
inspection frequency, into multiple new and existing subparts in 46 
CFR, as listed in table 4.

               Table 4--PFDs Impacted by ANSI/CAN/UL 9595
------------------------------------------------------------------------
                                                        New or existing
            Subpart                    PFD type             subpart
------------------------------------------------------------------------
160.045.......................  Throwable PFDs.......  New.
160.255.......................  Level 100 PFDs.......  New.
160.264.......................  Inherently Buoyant     New.
                                 Level 50 and Level
                                 70 PFDs.
160.276.......................  Inflatable Level 50    New.
                                 and Level 70 PFDs.
160.055.......................  Life Preservers......  Existing.
160.060.......................  Buoyant Vests........  Existing.
160.064.......................  Marine Buoyant         Existing.
                                 Devices.
160.076.......................  Inflatable PFDs......  Existing.
------------------------------------------------------------------------

    ANSI/CAN/UL 9595 establishes a set of Process Ratings (A, B, and C) 
based on the QMS at each facility. Process Rating A is reserved for 
facilities that have demonstrated a superior QMS. Process Rating B is 
assigned to facilities with a good QMS. Process Rating C is assigned to 
facilities with a minimally compliant QMS. The requirements for Process 
Rating C are equivalent to the current minimum requirements. Because 
Process Rating C is equivalent to current industry practice, the 
affected population for the IBR of ANSI/CAN/UL 9595 are any PFD 
manufacturer

[[Page 97366]]

producing a device approved under one of the subparts listed in table 4 
and eligible to gain a Process Rating of A or B.
    In table 5, we estimate the market share likely to be at Process 
Rating A, B, or C and whether they are foreign or domestic firms.\24\ 
Because a QMS system is expensive to set up, industry stakeholders 
informed the Coast Guard that firms are not expected to develop a QMS 
solely to secure the cost savings of ANSI/CAN/UL 9595. However, a 
number of firms have already established QMS systems at their 
facilities because of other benefits, such as production consistency 
and quality control. The firms that have already established a QMS 
system will experience net cost savings from the IBR of ANSI/CAN/UL 
9595. As a result, we estimated the process rating distribution 
recorded in table 5.
---------------------------------------------------------------------------

    \24\ The process rating applies to a facility owned by a PFD 
manufacturing firm. The lowest process rating is C; if manufacturers 
seek a higher process rating of A or B, then an independent 
laboratory must certify that each facility owned by a manufacturing 
firm meets the standard of the higher rating, which is determined 
through an audit of a facility. A PFD manufacturing firm incurs the 
cost of a higher process rating at each facility. A PFD 
manufacturing firm who currently has a QMS (at least partially in 
place) will be able to seek a higher process rating, A or B, for 
each facility it owns (process rating C is the current baseline or 
default rating and represents the current inspection volume at 
facilities). A separate QMS inspection or audit is necessary for 
this to occur. A higher process rating will result in a reduction in 
the inspection volume at facilities, which will save PFD 
manufacturing firms money.

 Table 5--Market Share of Production Likely To Be at Each Process Rating
------------------------------------------------------------------------
                                                           Market share
        Firm category               Process rating              (%)
------------------------------------------------------------------------
U.S. Firms..................  A.........................            26.5
Foreign Firms...............  A.........................            15.0
U.S. Firms..................  B.........................            51.0
Foreign Firms...............  B.........................             2.5
U.S. and Foreign Firms......  C.........................             5.0
                             -------------------------------------------
    Total...................  ..........................           100.0
------------------------------------------------------------------------

    The fourth provision, permitting the option for placards to replace 
instruction pamphlets, affects all firms manufacturing PFDs approved to 
any of the categories in table 6 that list placards as permitted under 
the final rule.

        Table 6--Device Category and Permitted Instruction Types
------------------------------------------------------------------------
                                       Types of
                                     instructions          Types of
         Device category            allowed by the       instructions
                                      final rule       currently in use
------------------------------------------------------------------------
New Level 50 Devices (ANSI/CAN/   Placard...........  N/A because these
 UL 12402-5).                                          devices are not
                                                       yet produced.
New Level 70 Devices (ANSI/CAN/   Placard...........  Placard.
 UL 12402-5).
New Level 100 Devices (ANSI/CAN/  Placard...........  N/A because these
 UL 12402-4).                                          devices are not
                                                       yet produced.
Existing Type I Commercial        Placard or          Information
 Devices.                          Information         Pamphlet.
                                   Pamphlet.
Existing Type II Recreational     Placard or          Information
 Devices.                          Information         Pamphlet.
                                   Pamphlet.
Existing Type III Recreational    Placard or          Information
 Devices.                          Information         Pamphlet.
                                   Pamphlet.
Existing Type IV Throwable        Information         Information
 Devices.                          Pamphlet.           Pamphlet.
------------------------------------------------------------------------

Costs and Cost Savings of the Four Provisions of This Rule
1. ANSI/CAN/UL 12402-4
Costs
    There are two sources of costs from this provision: (1) independent 
laboratories will need to train their staff to these new standards and 
(2) manufacturing firms that intend to sell in only one market (the 
United States or Canada) will experience additional costs due to an 
increase in the cost of testing according to ANSI/CAN/UL 12402-4 when 
compared to the cost of testing to the legacy standards.\25\
---------------------------------------------------------------------------

    \25\ We estimate the increase in the cost of testing based upon 
data provided by representatives of independent laboratories.
---------------------------------------------------------------------------

    We provide our estimate for the total costs of the IBR of ANSI/CAN/
UL 12402-4 to U.S. firms in table 7. These costs include $29,500 paid 
by independent laboratories in the first year to develop the 
instructions and manuals on how to conduct the new ANSI/CAN/UL 12402-4 
testing and the estimated $1,659 per year manufacturers will spend on 
the more expensive ANSI/CAN/UL 12402-4 certification as opposed to the 
legacy certification.\26\
---------------------------------------------------------------------------

    \26\ We estimate the cost of Level 100 testing and approval to 
be about $52,250 and we estimate the cost for the new Type I 
approval to be about $47,200. The Coast Guard estimates 0.45 new 
approvals annually for products intended for sale exclusively in the 
United States. Therefore, the total additional cost to manufacturers 
for the more expensive Level 100 certification will be about $2,273. 
There are currently 51 products approved as Type I devices under 46 
CFR part 160.055, of which 37 (73 percent) are produced by U.S. PFD 
firms and 14 (27 percent) are produced by foreign PFD firms. 
Therefore, we estimate the cost to U.S. PFD firms for the new UL 
12402-4 approval will be about $1,659 annually. We estimate the cost 
to foreign PFD firms will be about $614 annually.

[[Page 97367]]



   Table 7--Estimated Costs to U.S. Firms for Level 100 Devices Under
                      Standard ANSI/CAN/UL 12402-4
               [2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
                                                            Discounted
                                               Total           costs
                  Year                     undiscounted  ---------------
                                               costs            2%
------------------------------------------------------------------------
1.......................................         $31,159         $30,548
2.......................................           1,659           1,595
3.......................................           1,659           1,563
4.......................................           1,659           1,533
5.......................................           1,659           1,503
6.......................................           1,659           1,473
7.......................................           1,659           1,444
8.......................................           1,659           1,416
9.......................................           1,659           1,388
10......................................           1,659           1,361
                                         -------------------------------
    Total...............................          46,090          43,824
                                         -------------------------------
    Annualized..........................  ..............           4,879
------------------------------------------------------------------------

    We present the 10-year total costs to foreign firms from the IBR of 
ANSI/CAN/UL 12402-4 in table 8. Foreign firms will experience 
additional approval costs of $614 per year.

  Table 8--Estimated Costs to Foreign Firms for Level 100 Devices Under
                      Standard ANSI/CAN/UL 12402-4
               [2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
                                                            Discounted
                                               Total           costs
                  Year                     undiscounted  ---------------
                                               costs            2%
------------------------------------------------------------------------
1.......................................            $614            $602
2.......................................             614             590
3.......................................             614             579
4.......................................             614             567
5.......................................             614             556
6.......................................             614             545
7.......................................             614             535
8.......................................             614             524
9.......................................             614             514
10......................................             614             504
                                         -------------------------------
    Total...............................           6,140           5,515
                                         -------------------------------
    Annualized..........................  ..............             614
------------------------------------------------------------------------

    We present the 10-year total costs to U.S. and foreign firms from 
the IBR of ANSI/CAN/UL 12402-4 in table 9.

 Table 9--Estimated Total Cost to All Firms for Level 100 Devices Under
                      Standard ANSI/CAN/UL 12402-4
               [2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
                                                            Discounted
                                               Total           costs
                  Year                     undiscounted  ---------------
                                               costs            2%
------------------------------------------------------------------------
1.......................................         $31,773         $31,150
2.......................................           2,273           2,185
3.......................................           2,273           2,142
4.......................................           2,273           2,100
5.......................................           2,273           2,059
6.......................................           2,273           2,018
7.......................................           2,273           1,979
8.......................................           2,273           1,940
9.......................................           2,273           1,902

[[Page 97368]]

 
10......................................           2,273           1,865
                                         -------------------------------
    Total...............................          52,230          49,339
                                         -------------------------------
    Annualized..........................  ..............           5,493
------------------------------------------------------------------------

Cost Savings
    By adopting ANSI/CAN/UL 12402-4, the Coast Guard can harmonize 
commercial PFD requirements of the United States with those of 
Transport Canada. Harmonization of commercial PFD standards will lead 
to cost savings for PFD manufacturing firms through less expensive 
approval requirements and less frequent ongoing facility inspections.
    Additionally, as a performance-based standard, ANSI/CAN/UL 12402-4 
allows for more innovative designs than the current standards and 
regulations, which might better meet boater needs. Seven commenters 
noted that permission to create more innovative designs is a benefit. 
The adoption of a performance-based standard spares the Coast Guard 
from making the equivalency determinations frequently necessary when 
using the current prescriptive requirements. Consequently, the Coast 
Guard will experience time savings from reducing the review time of new 
device applications during the approval process.
    In total, we estimate three sources of quantified cost savings 
associated with the IBR of ANSI/CAN/UL 12402-4:
    (1) The Coast Guard will spend less time reviewing approval 
applications and making equivalency determinations for the approval of 
innovative PFDs because ANSI/CAN/UL 12402-4 is a performance-based 
rather than prescriptive standard and allows more innovative designs to 
meet the standard;
    (2) All firms that apply for approval in both United States and 
Canadian markets will save the difference between one certification to 
ANSI/CAN/UL 12402-4 and separate United States and Canadian 
certifications to legacy standards; and
    (3) Manufacturing facilities producing devices meeting the 
requirements of ANSI/CAN/UL 12402-4 for the United States and Canadian 
markets will be able to be inspected just once for approval, instead of 
the current requirement to be inspected twice; once for United States 
approval and once for Canadian approval.
    We summarize the total quantified benefits for the cost savings of 
the IBR of ANSI/CAN/UL 12402-4 by reporting the annual undiscounted 
cost savings in table 10.

  Table 10--Estimated Annual Cost Savings of ANSI/CAN/UL 12402-4 to the
                    Industry and the U.S. Government
                             [2023 Dollars]
------------------------------------------------------------------------
                                           Cost savings    Cost savings
        Annual cost savings item              to U.S.       to foreign
                                             entities        entities
------------------------------------------------------------------------
Value of Coast Guard time saved.........          $4,330              $0
Canadian and United States approval               27,779          10,274
 savings................................
Billed facility inspection savings......          15,372           8,784
Quality manager's time saved............           3,359           1,334
                                         -------------------------------
    Total...............................          50,840          20,392
------------------------------------------------------------------------

    In table 11 and table 12, we record the 10-year cost savings from 
the adoption of ANSI/CAN/UL 12402-4 to U.S. and foreign firms, 
respectively. In table 13, we record the total 10-year cost savings 
from this provision to the U.S. Government.

 Table 11--Estimated Cost Savings to U.S. Firms From ANSI/CAN/UL 12402-4
               [2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
                                                            Discounted
                                               Total       cost savings
                  Year                     undiscounted  ---------------
                                           cost savings         2%
------------------------------------------------------------------------
1.......................................         $46,510         $45,598
2.......................................          46,510          44,704
3.......................................          46,510          43,827
4.......................................          46,510          42,968
5.......................................          46,510          42,126

[[Page 97369]]

 
6.......................................          46,510          41,300
7.......................................          46,510          40,490
8.......................................          46,510          39,696
9.......................................          46,510          38,917
10......................................          46,510          38,154
                                         -------------------------------
    Total...............................         465,100         417,780
                                         -------------------------------
    Annualized..........................  ..............          46,510
------------------------------------------------------------------------


Table 12--Estimated Cost Savings to Foreign Firms From Adopting ANSI/CAN/
                               UL 12402-4
               [2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
                                                            Discounted
                                               Total       cost savings
                  Year                     undiscounted  ---------------
                                           cost savings         2%
------------------------------------------------------------------------
1.......................................         $20,392         $19,992
2.......................................          20,392          19,600
3.......................................          20,392          19,216
4.......................................          20,392          18,839
5.......................................          20,392          18,470
6.......................................          20,392          18,108
7.......................................          20,392          17,752
8.......................................          20,392          17,404
9.......................................          20,392          17,063
10......................................          20,392          16,729
                                         -------------------------------
    Total...............................         203,920         183,173
                                         -------------------------------
    Annualized..........................  ..............          20,392
------------------------------------------------------------------------


 Table 13--Estimated Cost Savings to the U.S. Government of ANSI/CAN/UL
                                 12402-4
               [2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
                                                            Discounted
                                               Total       cost savings
                  Year                     undiscounted  ---------------
                                           cost savings         2%
------------------------------------------------------------------------
1.......................................          $4,330          $4,245
2.......................................           4,330           4,162
3.......................................           4,330           4,080
4.......................................           4,330           4,000
5.......................................           4,330           3,922
6.......................................           4,330           3,845
7.......................................           4,330           3,770
8.......................................           4,330           3,696
9.......................................           4,330           3,623
10......................................           4,330           3,552
                                         -------------------------------
    Total...............................          43,300          38,895
                                         -------------------------------
    Annualized..........................  ..............           4,330
------------------------------------------------------------------------

    In table 14, we record the total discounted 10-year cost savings to 
the U.S. and foreign PFD industry for the ANSI/CAN/UL 12402-4 portion 
of this final rule. We estimate that this provision saves the U.S. and 
foreign PFD industry about $66,902 annually and produces cost savings 
for the industry of about $600,953 over a 10-year period of analysis 
using a 2-percent discount rate.

[[Page 97370]]



Table 14--Total Estimated Cost Savings to Industry of the Final Rule for
                           ANSI/CAN/UL 12402-4
               [2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
                                                            Discounted
                                               Total       cost savings
                  Year                     undiscounted  ---------------
                                           cost savings         2%
------------------------------------------------------------------------
1.......................................         $66,902         $65,590
2.......................................          66,902          64,304
3.......................................          66,902          63,043
4.......................................          66,902          61,807
5.......................................          66,902          60,595
6.......................................          66,902          59,407
7.......................................          66,902          58,242
8.......................................          66,902          57,100
9.......................................          66,902          55,981
10......................................          66,902          54,883
                                         -------------------------------
    Total...............................         669,020         600,953
                                         -------------------------------
    Annualized..........................  ..............          66,902
------------------------------------------------------------------------

2. ANSI/CAN/UL 12402-5
Costs
    The PFD industry also incurs an increase in costs from this final 
rule because, based on consultation with industry experts, we estimate 
that this rule will increase the PFD market by 5 percent, meaning 
manufacturing firms would seek new device approvals and produce more 
devices.\27\ (In the NPRM, we requested public comment on the 
possibility that this rule would increase the PFD market by 5 percent, 
and no commenter disagreed with this estimate.) We estimate the costs 
of this provision as the costs of the additional device approvals and 
the costs of the additional production inspections for the greater 
volume of production that we expect this rule to generate.\28\
---------------------------------------------------------------------------

    \27\ As part of our discussion with PFD manufacturing firms, we 
asked their representatives whether the introduction of Level 50 
devices would lead to a net growth in the PFD market (inclusive of 
substitution out of existing types of products). Manufacturing firm 
representatives stated that they would expect the PFD market would 
grow by about 5 percent from this provision. We interpret the 5-
percent growth as a one-time growth in the level of manufacturing 
spread over a 2-year period.
    \28\ We estimate the additional production inspections based on 
the current production inspection requirements, and we estimate the 
reduction in these inspections through the incorporation by 
reference of ANSI/CAN/UL 9595 in its associated section.
---------------------------------------------------------------------------

    In table 15, table 16, and table 17, we present the discounted 
costs of introducing Level 50 devices over the 10-year period of 
analysis to U.S. firms, foreign firms, and all firms, respectively. The 
tables include the estimated costs of Level 50 devices approved and 
inspected under the current inspections regime. In Year 1, the 
undiscounted costs are only the costs of Level 50 approval for 
manufacturers, or $610,299 for U.S. manufacturers and $146,661 for 
foreign manufacturers. For Year 2, the undiscounted costs are the costs 
of Level 50 approvals to manufacturers ($610,299 for U.S. firms and 
$146,661 for foreign firms) plus the cost of inspections ($33,900 for 
U.S. firms and $7,587 for foreign firms), for a total of about $644,199 
($610,299 + $33,900) for U.S. firms and $154,248 ($146,661 + $7,587) 
for foreign firms. The estimated 10-year cost, discounted at 2 percent, 
is $1,694,898, or $188,687 annualized, for U.S. firms, and $398,884, or 
$44,406 annualized, for foreign firms.

    Table 15--Estimated Costs to U.S. Firms From Introducing Level 50
                                 Devices
               [2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
                                                            Discounted
                                               Total           cost
                  Year                     undiscounted  ---------------
                                               cost             2%
------------------------------------------------------------------------
1.......................................        $610,299        $598,332
2.......................................         644,199         619,184
3.......................................          67,800          63,889
4.......................................          67,800          62,637
5.......................................          67,800          61,409
6.......................................          67,800          60,204
7.......................................          67,800          59,024
8.......................................          67,800          57,867
9.......................................          67,800          56,732
10......................................          67,800          55,620
                                         -------------------------------
    Total...............................       1,796,898       1,694,898
                                         -------------------------------
    Annualized..........................  ..............         188,687
------------------------------------------------------------------------


[[Page 97371]]


   Table 16--Estimated Costs to Foreign Firms From the Introduction of
                            Level 50 Devices
               [2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
                                                            Discounted
                                               Total           cost
                  Year                     undiscounted  ---------------
                                               cost             2%
------------------------------------------------------------------------
1.......................................        $146,661        $143,785
2.......................................         154,248         148,258
3.......................................          15,174          14,299
4.......................................          15,174          14,018
5.......................................          15,174          13,744
6.......................................          15,174          13,474
7.......................................          15,174          13,210
8.......................................          15,174          12,951
9.......................................          15,174          12,697
10......................................          15,174          12,448
                                         -------------------------------
    Total...............................         422,301         398,884
                                         -------------------------------
    Annualized..........................  ..............          44,406
------------------------------------------------------------------------


      Table 17--Total Estimated Costs to PFD Manufacturers From the
                    Introduction of Level 50 Devices
               [2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
                                                            Discounted
                                               Total           cost
                  Year                     undiscounted  ---------------
                                               cost             2%
------------------------------------------------------------------------
1.......................................        $756,960        $742,118
2.......................................         798,447         767,442
3.......................................          82,974          78,188
4.......................................          82,974          76,655
5.......................................          82,974          75,152
6.......................................          82,974          73,679
7.......................................          82,974          72,234
8.......................................          82,974          70,818
9.......................................          82,974          69,429
10......................................          82,974          68,068
                                         -------------------------------
    Total...............................       2,219,199       2,093,782
                                         -------------------------------
    Annualized..........................  ..............         233,093
------------------------------------------------------------------------

Qualitative Benefits
    The Coast Guard believes that the introduction of Level 50 devices, 
coupled with the requirement to wear them if they are to count for the 
purposes of PFD carriage requirements, may lead to an unquantifiable 
increase in PFD wear rates among recreational boaters and thereby 
potentially decrease the rate of drowning. Drowning is the leading 
cause of death in recreational boating accidents, accounting for 79 
percent of all recreational boating casualties where we know the cause 
of death.\29\ Of those who drowned, 86 percent were not wearing a 
lifejacket. Wearing a lifejacket is one of the best means available of 
preventing accidental drowning in recreational boating. Unfortunately, 
recreational boaters only wear lifejackets about 24 percent of the 
time.\30\
---------------------------------------------------------------------------

    \29\ United States Coast Guard, ``2019 Recreational Boating 
Statistics.'' https://uscgboating.org/library/accident-statistics/Recreational-Boating-Statistics-2019.pdf (last accessed April 25th, 
2024).
    \30\ United States Coast Guard, ``2019 Life Jacket Wear Rate 
Observation Study.'' https://uscgboating.org/library/national-live-jacket-wear-study/2019-Life-Jacket-Wear-Rate-Report.pdf (last 
accessed April 25, 2024).
---------------------------------------------------------------------------

    Level 50 devices are likely to be slimmer, lighter in weight, and 
more comfortable to wear than current Type III and Level 70 devices. 
Additionally, the Coast Guard will require recreational boaters to wear 
Level 50 devices for such devices to count towards PFD carriage 
requirements. Individuals who purchase Level 50 devices are more likely 
to wear PFDs than similar individuals who purchase bulkier Type III or 
Level 70 devices without a requirement that they be worn for the 
purposes of carriage. The NIH conducted a literature review, and, among 
other factors, found discomfort to be negatively associated with 
lifejacket wear [NIH, 2018].\31\ It is the Coast Guard's view that PFDs 
worn are more effective than PFDs carried on board if a person 
overboard situation occurs. As a result, it is possible that the public 
is safer due to recreational boaters wearing a greater number of PFDs 
while boating.
---------------------------------------------------------------------------

    \31\ We cited this review from the NIH earlier in the preamble 
in footnote number 8. Readers should reference that footnote for a 
link to this article and other articles by the NIH for more 
information on PFD usage.
---------------------------------------------------------------------------

    Since the Level 50 devices provide a lower level of buoyancy than 
Level 70 devices, a direct comparison is not possible. However, the 
view of the subject matter experts (SMEs) in the Coast Guard's Office 
of Boating Safety is that the wearing of Level 50 PFDs by recreational 
boaters and the general boating public improves safety on the water. 
Recreational boaters fail to wear lifejackets 76 percent of the time,

[[Page 97372]]

leaving themselves vulnerable to drowning. The Coast Guard believes 
that, by offering recreational boaters an additional choice of a Level 
50 PFD, which is required to be worn, more recreational boaters will 
choose to wear their lifejacket while engaged in boating activities. A 
lifejacket that is worn by the user is more effective than a lifejacket 
stowed on the boat.
3. ANSI/CAN/UL 9595
    The third provision incorporates by reference the consensus 
standard ANSI/CAN/UL 9595 to cover follow-up inspections and inspection 
frequency for Coast Guard approved PFDs. Currently, when a 
manufacturing firm produces a Coast Guard approved PFD, there is a 
required follow-up inspection regime to ensure that the devices 
continue to meet the specifications under which the Coast Guard 
approved them. Although the Coast Guard has not previously published a 
substantive minimum requirement for what constitutes a follow-up 
inspections regime, we set out general requirements in 46 CFR 159, 
160.064-4, and 160.076-29. The Coast Guard reviews each recognized 
independent laboratory's follow-up services program to ensure 
compliance with these regulations.
    Incorporating by reference ANSI/CAN/UL 9595 provides a few key 
benefits to the regulated public and the testing laboratories. First, 
ANSI/CAN/UL 9595 is one standard, ensuring consistency across all 
accepted and recognized independent laboratories. Second, ANSI/CAN/UL 
9595 is a standard that is widely available to the industry and 
transparently clarifies guidance on what constitutes a follow-up 
inspection regime. Third, and most importantly, ANSI/CAN/UL 9595 
establishes a rating system for each facility, which results in cost 
savings for the firms manufacturing at facilities with a good or 
superior QMS rating.
Costs
    There are three cost items associated with the adoption of ANSI/
CAN/UL 9595. These costs are based on input from PFD industry SMEs on 
how ANSI/CAN/UL 9595 is likely to be implemented.
    (1) The two recognized independent laboratories will need to train 
their staff to implement ANSI/CAN/UL 9595.
    (2) Manufacturing firms could request a special inspection in the 
first year to certify their QMS at a given facility meets the 
requirements for Process Rating of A or B. We expect the top 13 firms 
to request this certification across all 27 facilities at which they 
manufacture. This special inspection is expected to be in addition to 
the regular production inspections required for Process Rating C.
    (3) After the first year, where the QMS inspection is supplemental 
to standard inspections, the QMS inspection could replace one of the 
mandatory inspections, but could cost more than a standard inspection, 
at the top 13 firms with 27 facilities.
    We estimate the 10-year discounted cost for inspections under this 
provision that are associated with U.S. firms is approximately 
$126,840, or $14,121 annualized using a 2-percent discount rate. We 
estimate the total 10-year discounted cost for inspections that are 
associated with foreign firms is approximately $51,382, or $5,720 
annualized using a 2-percent discount rate. In total, we estimate the 
10-year discounted costs from ANSI/CAN/UL 9595 are $178,223 or $19,841 
annualized using a 2-percent discount rate. We present these costs to 
U.S., foreign, and both U.S. and foreign firms in table 18, table 19, 
and table 20, respectively.

 Table 18--Estimated QMS Inspection Costs to U.S. Firms From ANSI/CAN/UL
                                  9595
               [2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
                                                            Discounted
                                               Total           cost
                  Year                     undiscounted  ---------------
                                               cost             2%
------------------------------------------------------------------------
1.......................................         $61,296         $60,094
2.......................................           8,341           8,017
3.......................................           8,341           7,860
4.......................................           8,341           7,706
5.......................................           8,341           7,555
6.......................................           8,341           7,407
7.......................................           8,341           7,261
8.......................................           8,341           7,119
9.......................................           8,341           6,979
10......................................           8,341           6,843
                                         -------------------------------
    Total...............................         136,365         126,841
                                         -------------------------------
    Annualized..........................  ..............          14,121
------------------------------------------------------------------------


Table 19--Estimated QMS Inspection Costs to Foreign Firms From ANSI/CAN/
                                 UL 9595
               [2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
                                                            Discounted
                                               Total           cost
                  Year                     undiscounted  ---------------
                                               cost             2%
------------------------------------------------------------------------
1.......................................         $23,744         $23,278
2.......................................           3,512           3,376
3.......................................           3,512           3,309
4.......................................           3,512           3,245
5.......................................           3,512           3,181
6.......................................           3,512           3,119
7.......................................           3,512           3,057

[[Page 97373]]

 
8.......................................           3,512           2,997
9.......................................           3,512           2,939
10......................................           3,512           2,881
                                         -------------------------------
    Total...............................          55,352          51,382
                                         -------------------------------
    Annualized..........................  ..............           5,720
------------------------------------------------------------------------


   Table 20--Total Estimated QMS Inspection Costs for ANSI/CAN/UL 9595
               [2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
                                                            Discounted
                                               Total           cost
                  Year                     undiscounted  ---------------
                                               cost             2%
------------------------------------------------------------------------
1.......................................         $85,040         $83,373
2.......................................          11,853          11,393
3.......................................          11,853          11,169
4.......................................          11,853          10,950
5.......................................          11,853          10,736
6.......................................          11,853          10,525
7.......................................          11,853          10,319
8.......................................          11,853          10,116
9.......................................          11,853           9,918
10......................................          11,853           9,724
                                         -------------------------------
    Total...............................         191,717         178,223
                                         -------------------------------
    Annualized..........................  ..............          19,841
------------------------------------------------------------------------

Cost Savings
    The IBR of ANSI/CAN/UL 9595 generates benefits in the form of cost 
savings for PFD manufacturing firms who have a QMS in place. 
Manufacturers with an audited QMS can secure a higher Process Rating, 
which, in turn, reduces the frequency of production inspections for 
PFDs based upon their higher Process Rating.
    We estimate this provision to generate cost savings for U.S. firms 
of $8,454,204, or $941,177, annualized, over a 10-year period of 
analysis using a 2-percent discount rate. We similarly estimate cost 
savings of $2,039,131, or $227,009, annualized, to foreign firms over a 
10-year period of analysis, discounted at 2 percent. In total, we 
estimate $10,493,335, or $1,168,187 annualized, in cost savings to all 
firms under this provision using a 10-year period of analysis and a 2-
percent discount rate. We present these 10-year cost savings to U.S., 
foreign, and both U.S. and foreign firms in table 21, table 22, and 
table 23, respectively.

  Table 21--Estimated Cost Savings to U.S. Firms From ANSI/CAN/UL 9595
               [2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
                                                            Discounted
                                               Total       cost savings
                  Year                     undiscounted  ---------------
                                           cost savings         2%
------------------------------------------------------------------------
1.......................................              $0              $0
2.......................................       1,037,396         997,113
3.......................................       1,059,092         998,006
4.......................................       1,059,092         978,437
5.......................................       1,059,092         959,252
6.......................................       1,059,092         940,443
7.......................................       1,059,092         922,003
8.......................................       1,059,092         903,925
9.......................................       1,059,092         886,201
10......................................       1,059,092         868,824
                                         -------------------------------
    Total...............................       9,510,132       8,454,204
                                         -------------------------------
    Annualized..........................  ..............         941,177
------------------------------------------------------------------------


[[Page 97374]]


 Table 22--Estimated Cost Savings to Foreign Firms From ANSI/CAN/UL 9595
               [2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
                                                            Discounted
                                               Total       cost savings
                  Year                     undiscounted  ---------------
                                           cost savings         2%
------------------------------------------------------------------------
1.......................................              $0              $0
2.......................................         250,371         240,649
3.......................................         255,429         240,696
4.......................................         255,429         235,977
5.......................................         255,429         231,350
6.......................................         255,429         226,814
7.......................................         255,429         222,366
8.......................................         255,429         218,006
9.......................................         255,429         213,732
10......................................         255,429         209,541
                                         -------------------------------
    Total...............................       2,293,803       2,039,131
                                         -------------------------------
    Annualized..........................  ..............         227,009
------------------------------------------------------------------------


   Table 23--Estimated Cost Savings to All Firms From ANSI/CAN/UL 9595
               [2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
                                                            Discounted
                                               Total       cost savings
                  Year                     undiscounted  ---------------
                                           cost savings         2%
------------------------------------------------------------------------
1.......................................              $0              $0
2.......................................       1,287,767       1,237,761
3.......................................       1,314,521       1,238,702
4.......................................       1,314,521       1,214,414
5.......................................       1,314,521       1,190,602
6.......................................       1,314,521       1,167,257
7.......................................       1,314,521       1,144,370
8.......................................       1,314,521       1,121,931
9.......................................       1,314,521       1,099,932
10......................................       1,314,521       1,078,365
                                         -------------------------------
    Total...............................      11,803,935      10,493,334
                                         -------------------------------
    Annualized..........................  ..............       1,168,186
------------------------------------------------------------------------

4. Placards in Lieu of Information Pamphlets
    The fourth provision in the rule comes from details contained 
within ANSI/CAN/UL 12402-4 and ANSI/CAN/UL 12402-5. These standards 
specify requirements for a placard to be attached to all devices 
certified to those standards. The placard provides information on PFD 
performance, selection, and approval, warnings, maintenance, and 
general water safety information in a pictographic format. This rule 
amends 33 CFR 181 to permit manufacturing firms to use a placard in 
lieu of the informational pamphlet.
Costs
    For the convenience of the reader, table 24 reproduces table 6 from 
the Affected Population section of this preamble to list the various 
types of PFDs impacted by this rule, and whether they are required to 
use placards to convey safety instructions or whether they could use 
either placards or information pamphlets.\32\
---------------------------------------------------------------------------

    \32\ Current marking requirements require a pamphlet, while the 
new marking requirement will be for a placard or pamphlet. Because 
these placards and pamphlets are both produced in factories, the 
Coast Guard estimates that it will take the same amount of time to 
produce and include either a pamphlet or a placard with a newly 
manufactured PFD for sale. As a result, we do not estimate there 
will be any changes in the Paperwork Reduction Act burden brought on 
by the switch from pamphlets to placards.

        Table 24--Device Category and Permitted Instruction Types
------------------------------------------------------------------------
                                       Types of
                                     instructions          Types of
         Device category            allowed by the       instructions
                                      final rule       currently in use
------------------------------------------------------------------------
New Level 50 Devices (ANSI/CAN/   Placard...........  N/A because these
 UL 12402-5).                                          devices are not
                                                       yet produced.
New Level 70 Devices (ANSI/CAN/   Placard...........  Placard.
 UL 12402-5).
New Level 100 Devices (ANSI/CAN/  Placard...........  N/A because these
 UL 12402-4).                                          devices are not
                                                       yet produced.

[[Page 97375]]

 
Existing Type I Commercial        Placard or          Information
 Devices.                          Information         Pamphlet.
                                   Pamphlet.
Existing Type II Recreational     Placard or          Information
 Devices.                          Information         Pamphlet.
                                   Pamphlet.
Existing Type III Recreational    Placard or          Information
 Devices.                          Information         Pamphlet.
                                   Pamphlet.
Existing Type IV Throwable        Information         Information
 Devices.                          Pamphlet.           Pamphlet.
------------------------------------------------------------------------

    As shown in table 24, the changes in instruction information either 
applies to PFD categories not yet produced or permits an additional 
compliance option. No devices would have fewer options for instruction 
materials than under current regulations. As a result, we estimate no 
additional costs from replacing safety information pamphlets with 
placards because firms could either continue their current activities 
or produce placards instead.
Unquantified Benefits
    There are two sources of unquantified benefits from the requirement 
for the use of placards on new device categories and the permitting of 
placard use on existing device categories. The first source of 
unquantified benefits occurs because a placard may be less expensive to 
produce than an information pamphlet. A representative from the PFD 
manufacturing industry stated that the placard could be around $0.05 
cheaper to produce than the information pamphlet, because the placard 
contains fewer materials than the information pamphlet. However, we did 
not find (nor did we receive) any data on the costs to produce 
information pamphlets and the costs to produce placards, so we cannot 
determine the relative size of this cost savings. We believe, based on 
the full discussion in the RA, that the $0.05 estimate expresses the 
fact that placards are slightly less expensive than information 
pamphlets but, ultimately, about the same price. Additionally, we have 
no way of estimating how large a share of current production will 
switch from producing information pamphlets to placards, as placards 
will not be required. Due to these factors, we did not produce a 
quantitative estimate of the cost savings due to placards.
    The second unquantified benefit comes from the fact that placards 
use pictorial images to communicate safety information, while 
information pamphlets use English-language text. Pictorial information 
is superior to text at communicating information to non-English-reading 
audiences. We do not have a way of quantifying this benefit but would 
like to note that approximately 21 percent of the U.S. population has a 
``low'' level of English literacy. For those populations, pictorial 
information may be better than text-based information.\33\
---------------------------------------------------------------------------

    \33\ U.S. Department of Education, ``Data Point: Adult Literacy 
in the United States'' (July 2019). https://nces.ed.gov/pubs2019/2019179.pdf (last accessed April 25, 2024).
---------------------------------------------------------------------------

Total Costs
    We display the total costs from this final rule to U.S. entities, 
foreign entities, and both U.S. and foreign entities, using a 10-year 
period of analysis, discounted at 2 percent, in table 25, table 26, and 
table 27, respectively.

                Table 25--Estimated Costs for U.S. Firms
               [2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
                                                            Discounted
                                               Total           costs
                  Year                     undiscounted  ---------------
                                               costs            2%
------------------------------------------------------------------------
1.......................................        $702,754        $688,975
2.......................................         654,199         628,796
3.......................................          77,800          73,313
4.......................................          77,800          71,875
5.......................................          77,800          70,466
6.......................................          77,800          69,084
7.......................................          77,800          67,730
8.......................................          77,800          66,402
9.......................................          77,800          65,100
10......................................          77,800          63,823
                                         -------------------------------
    Total...............................       1,979,353       1,865,564
                                         -------------------------------
    Annualized..........................  ..............         207,687
------------------------------------------------------------------------


               Table 26--Estimated Costs for Foreign Firms
               [2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
                                                            Discounted
                                               Total           costs
                  Year                     undiscounted  ---------------
                                               costs            2%
------------------------------------------------------------------------
1.......................................        $171,019        $167,666
2.......................................         158,374         152,224

[[Page 97376]]

 
3.......................................          19,300          18,187
4.......................................          19,300          17,830
5.......................................          19,300          17,481
6.......................................          19,300          17,138
7.......................................          19,300          16,802
8.......................................          19,300          16,472
9.......................................          19,300          16,149
10......................................          19,300          15,833
                                         -------------------------------
    Total...............................         483,793         455,782
                                         -------------------------------
    Annualized..........................  ..............          50,741
------------------------------------------------------------------------


       Table 27--Total Estimated Costs for U.S. and Foreign Firms
               [2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
                                                            Discounted
                                               Total           costs
                  Year                     undiscounted  ---------------
                                               costs            2%
------------------------------------------------------------------------
1.......................................        $873,773        $856,640
2.......................................         812,573         781,020
3.......................................          97,100          91,499
4.......................................          97,100          89,705
5.......................................          97,100          87,946
6.......................................          97,100          86,222
7.......................................          97,100          84,531
8.......................................          97,100          82,874
9.......................................          97,100          81,249
10......................................          97,100          79,656
                                         -------------------------------
    Total...............................       2,463,146       2,321,343
                                         -------------------------------
    Annualized..........................  ..............         258,427
------------------------------------------------------------------------

Total Cost Savings
    We display the total cost savings from this final rule to U.S. 
firms, the U.S. government, foreign firms, and all entities using a 10-
year period of analysis discounted at 2 percent in table 28, table 29, 
table 30, and table 31, respectively.

          Table 28--Total Estimated Cost Savings to U.S. Firms
               [2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
                                                            Discounted
                                               Total       cost savings
                  Year                     undiscounted  ---------------
                                           cost savings         2%
------------------------------------------------------------------------
1.......................................         $46,510         $45,598
2.......................................       1,083,906       1,041,817
3.......................................       1,105,602       1,041,833
4.......................................       1,105,602       1,021,405
5.......................................       1,105,602       1,001,378
6.......................................       1,105,602         981,743
7.......................................       1,105,602         962,493
8.......................................       1,105,602         943,621
9.......................................       1,105,602         925,118
10......................................       1,105,602         906,979
                                         -------------------------------
    Total...............................       9,975,232       8,871,985
                                         -------------------------------
    Annualized..........................  ..............         987,687
------------------------------------------------------------------------


[[Page 97377]]


         Table 29--Total Estimated Cost Savings to Foreign Firms
               [2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
                                                            Discounted
                                               Total       cost savings
                  Year                     undiscounted  ---------------
                                           cost savings         2%
------------------------------------------------------------------------
1.......................................         $20,392         $19,992
2.......................................         270,763         260,249
3.......................................         275,821         259,912
4.......................................         275,821         254,816
5.......................................         275,821         249,820
6.......................................         275,821         244,921
7.......................................         275,821         240,119
8.......................................         275,821         235,411
9.......................................         275,821         230,795
10......................................         275,821         226,269
                                         -------------------------------
    Total...............................       2,497,723       2,222,303
                                         -------------------------------
    Annualized..........................  ..............         247,401
------------------------------------------------------------------------


      Table 30--Total Estimated Cost Savings to the U.S. Government
               [2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
                                                            Discounted
                                               Total       cost savings
                  Year                     undiscounted  ---------------
                                           cost savings         2%
------------------------------------------------------------------------
1.......................................          $4,330          $4,245
2.......................................           4,330           4,162
3.......................................           4,330           4,080
4.......................................           4,330           4,000
5.......................................           4,330           3,922
6.......................................           4,330           3,845
7.......................................           4,330           3,770
8.......................................           4,330           3,696
9.......................................           4,330           3,623
10......................................           4,330           3,552
                                         -------------------------------
    Total...............................          43,300          38,895
                                         -------------------------------
    Annualized..........................  ..............           4,330
------------------------------------------------------------------------


Table 31--Total Estimated Cost Savings to U.S. and Foreign Manufacturing
                      Firms and the U.S. Government
               [2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
                                                            Discounted
                                               Total       cost savings
                  Year                     undiscounted  ---------------
                                           cost savings         2%
------------------------------------------------------------------------
1.......................................         $71,232         $69,835
2.......................................       1,358,999       1,306,227
3.......................................       1,385,753       1,305,826
4.......................................       1,385,753       1,280,222
5.......................................       1,385,753       1,255,119
6.......................................       1,385,753       1,230,509
7.......................................       1,385,753       1,206,381
8.......................................       1,385,753       1,182,727
9.......................................       1,385,753       1,159,536
10......................................       1,385,753       1,136,800
                                         -------------------------------
    Total...............................      12,516,255      11,133,183
                                         -------------------------------
    Annualized..........................  ..............       1,239,419
------------------------------------------------------------------------


[[Page 97378]]

Net Cost Savings
    We display the total net cost savings from this final rule to U.S. 
firms, the U.S. government, foreign firms, and all entities using a 10-
year period of analysis discounted at 2 percent in table 32, table 33, 
table 34, and table 35, respectively.

        Table 32--Total Estimated Net Cost Savings to U.S. Firms
               [2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
                                                          Net discounted
                                                Net        cost savings
                  Year                     undiscounted  ---------------
                                           cost savings         2%
------------------------------------------------------------------------
1.......................................       -$656,244       -$643,376
2.......................................         429,707         413,021
3.......................................       1,027,802         968,521
4.......................................       1,027,802         949,530
5.......................................       1,027,802         930,912
6.......................................       1,027,802         912,659
7.......................................       1,027,802         894,763
8.......................................       1,027,802         877,219
9.......................................       1,027,802         860,019
10......................................       1,027,802         843,156
                                         -------------------------------
    Total...............................       7,995,879       7,006,423
                                         -------------------------------
    Annualized..........................  ..............         780,001
------------------------------------------------------------------------


       Table 33--Total Estimated Net Cost Savings to Foreign Firms
               [2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
                                                          Net discounted
                                                Net        cost savings
                  Year                     undiscounted  ---------------
                                           cost savings         2%
------------------------------------------------------------------------
1.......................................       -$150,627       -$147,674
2.......................................         112,389         108,025
3.......................................         256,521         241,725
4.......................................         256,521         236,986
5.......................................         256,521         232,339
6.......................................         256,521         227,783
7.......................................         256,521         223,317
8.......................................         256,521         218,938
9.......................................         256,521         214,645
10......................................         256,521         210,437
                                         -------------------------------
    Total...............................       2,013,930       1,766,522
                                         -------------------------------
    Annualized..........................  ..............         196,661
------------------------------------------------------------------------


      Table 34--Total Estimated Cost Savings to the U.S. Government
               [2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
                                                          Net discounted
                                                Net        cost savings
                  Year                     undiscounted  ---------------
                                           cost savings         2%
------------------------------------------------------------------------
1.......................................          $4,330          $4,245
2.......................................           4,330           4,162
3.......................................           4,330           4,080
4.......................................           4,330           4,000
5.......................................           4,330           3,922
6.......................................           4,330           3,845
7.......................................           4,330           3,770
8.......................................           4,330           3,696
9.......................................           4,330           3,623
10......................................           4,330           3,552
                                         -------------------------------
    Total...............................          43,300          38,895
                                         -------------------------------

[[Page 97379]]

 
    Annualized..........................  ..............           4,330
------------------------------------------------------------------------


       Table 35--Total Estimated Net Cost Savings to All Entities
               [2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
                                                          Net discounted
                                                Net        cost savings
                  Year                     undiscounted  ---------------
                                           cost savings         2%
------------------------------------------------------------------------
1.......................................       -$802,541       -$786,805
2.......................................         546,426         525,208
3.......................................       1,288,653       1,214,327
4.......................................       1,288,653       1,190,516
5.......................................       1,288,653       1,167,173
6.......................................       1,288,653       1,144,287
7.......................................       1,288,653       1,121,850
8.......................................       1,288,653       1,099,853
9.......................................       1,288,653       1,078,287
10......................................       1,288,653       1,057,144
                                         -------------------------------
    Total...............................      10,053,109       8,811,839
                                         -------------------------------
    Annualized..........................  ..............         980,991
------------------------------------------------------------------------

Alternatives
    We identified three alternatives to this final rule:
    (1) Incorporate ANSI/CAN/UL 12402-5 for the approval of Level 70 
PFDs only, prohibiting the approval of Level 50 PFDs;
    (2) Require placards for existing Type I, II, and III PFDs instead 
of providing the option to continue the use of informational pamphlets; 
and
    (3) Adopt ANSI/CAN/UL 12402-4 and ANSI/CAN/UL 12402-5 by policy.
Alternative 1: Incorporate ANSI/CAN/UL 12402-5 for Level 70 PFDs Only
    We considered an alternative that would incorporate ANSI/CAN/UL 
12402-5, but limit approval to Level 70 PFDs only. Level 50 PFDs would 
not be eligible for Coast Guard approval and would not meet carriage 
requirements on any vessel. If the Coast Guard were to choose this 
alternative, the market for Level 50 devices would not be viable 
because Level 50 devices would no longer meet carriage requirements. 
Without a viable market, the costs of compliance estimated in the 
section of ANSI/CAN/UL 12402-5 would not exist. However, the benefits 
from a new market and increased wear-rates would be lost were these 
devices to not be sold. We would also be restricting recreational 
boaters to one category of PFD when Level 50 PFDs could better suit 
their purposes. As a result, we rejected this alternative because we 
expect that wear rates, and therefore benefits, would be lower without 
the option of a Level 50 PFD.
Alternative 2: Require placards Instead of the Option of Placards or 
Pamphlets
    Under this final rule, we require that only new Level 50, 70, and 
100 devices use placards. We considered the alternative of requiring 
that PFD manufacturers use placards instead of information pamphlets 
for all existing PFDs and not just new devices. While we observe that 
the cost of producing a placard is generally less than the cost of 
producing an information pamphlet, we also observe that some 
manufacturers may have already printed pamphlets or may not choose to 
use placards. As a result, we rejected this alternative.
Alternative 3: Adopt ANSI/CAN/UL 12402-4 and ANSI/CAN/UL 12402-5 by 
Policy
    Another alternative we considered would be to adopt ANSI/CAN/UL 
12402-4 and ANSI/CAN/UL 12402-5 by policy instead of incorporating them 
by reference into the CFR. Under 46 CFR 159.005-7(c), the Coast Guard 
has the authority to approve an item of equipment that does not meet 
all the requirements of 46 CFR 160.055 if it has equivalent performance 
characteristics. The Coast Guard has already used this authority to 
partially adopt ANSI/CAN/UL 12402-4 and ANSI/CAN/UL 12402-5 by policy. 
Because this authority is limited to the approval of equipment with 
equivalent performance characteristics, we cannot adopt the portion of 
standards not already equivalent to existing types of equipment. In 
particular, Level 50 PFDs, youth inflatable PFDs, and inflatable Level 
100 PFDs could not be approved by policy because they are not 
equivalent to any current Coast Guard standards. For that reason, we 
rejected this alternative.

B. Small Entities

    Under the Regulatory Flexibility Act, (RFA) 5 U.S.C. 601-612, we 
have considered whether this rule has a significant economic impact on 
a substantial number of small entities.
    The RFA (Public Law 96-354) establishes ``as a principle of 
regulatory issuance that agencies shall endeavor, consistent with the 
objectives of the rule and of applicable statutes, to fit regulatory 
and informational requirements to the scale of the businesses, 
organizations, and governmental jurisdictions subject to

[[Page 97380]]

regulation. To achieve this principle, agencies are required to solicit 
and consider flexible regulatory proposals and to explain the rationale 
for their actions to assure that such proposals are given serious 
consideration.''
    When an agency promulgates a final rule under section 553 of the 
RFA, after being required by that section or any other law to publish a 
general notice of proposed rulemaking, or promulgates a final 
interpretative rule involving the internal revenue laws of the United 
States as described in section 603(a), the agency must prepare a final 
Regulatory Flexibility Analysis (FRFA) or have the head of the agency 
certify pursuant to RFA section 605(b) that the rule will not, if 
promulgated, have a significant economic impact on a substantial number 
of small entities. The RFA prescribes the content of the FRFA in 
section 604(a), which we discuss as follows.
    In accordance with the RFA (5 U.S.C. 601-612), the Coast Guard 
prepared this FRFA that examines the impacts of the final rule on small 
entities (5 U.S.C. 601, et seq.). A small entity may be:
     A small independent business, defined as any independently 
owned and operated business not dominant in its field that qualifies as 
a small business per the Small Business Act (5 U.S.C. 632);
     A small not-for-profit organization; and
     A small governmental jurisdiction (locality with fewer 
than 50,000 people).
    This FRFA addresses the following:
    (1) A statement of the need for, and objectives of, the rule;
    (2) A statement of the significant issues raised by the public 
comments in response to the initial regulatory flexibility analysis, a 
statement of the assessment of the agency of such issues, and a 
statement of any changes made in the proposed rule as a result of such 
comments;
    (3) The response of the agency to any comments filed by the Chief 
Counsel for Advocacy of the Small Business Administration (SBA) in 
response to the proposed rule, and a detailed statement of any change 
made to the proposed rule in the final rule as a result of the 
comments;
    (4) A description of and an estimate of the number of small 
entities to which the rule will apply or an explanation of why no such 
estimate is available;
    (5) A description of the projected reporting, recordkeeping and 
other compliance requirements of the rule, including an estimate of the 
classes of small entities which will be subject to the requirement and 
the type of professional skills necessary for preparation of the report 
or record; and
    (6) A description of the steps the agency has taken to minimize the 
significant economic impact on small entities consistent with the 
stated objectives of applicable statutes, including a statement of the 
factual, policy, and legal reasons for selecting the alternative 
adopted in the final rule and why each one of the other significant 
alternatives to the rule considered by the agency which affect the 
impact on small entities was rejected.
    Below is a discussion of FRFA analysis by each of these six 
elements:
    (1) A statement of the need for, and objectives of, the rule.
    The Coast Guard amends the lifejacket approval requirements and 
follow-up program requirements by incorporating three new binational 
standards. At the same time, the Coast Guard amends lifejacket and PFD 
carriage requirements to allow for the use of equipment approved to the 
new standards, and to remove obsolete equipment approval requirements. 
The new standards are state-of-the-art and are intended to replace the 
legacy standards. The amendments will streamline the process for 
approval of PFDs and allow manufacturers to produce more innovative 
equipment that meets the approval requirements of both the United 
States and Canada; and will reduce the burden for manufacturers in both 
the approval process and follow-up program. Absent this regulation, the 
United States and Canada would continue to have two different PFD 
standards, resulting in additional costs for manufacturers.
    (2) A statement of the significant issues raised by the public 
comments in response to the initial regulatory flexibility analysis, a 
statement of the assessment of the agency of such issues, and a 
statement of any changes made in the proposed rule as a result of such 
comments.
    The Coast Guard received no public comments in response to the 
initial Regulatory Flexibility Analysis.
    (3) The response of the agency to any comments filed by the Chief 
Counsel for Advocacy of the SBA in response to the proposed rule, and a 
detailed statement of any change made to the proposed rule in the final 
rule as a result of the comments.
    The Coast Guard received no comments filed by the Chief Counsel for 
Advocacy of the SBA in response to the proposed rule.
    (4) A description of and an estimate of the number of small 
entities to which the rule will apply or an explanation of why no such 
estimate is available.
    This rule has four major provisions: (1) The incorporation by 
reference of ANSI/CAN/UL 12402-4 replacing Type I device approval with 
Level 100 device approval; (2) The incorporation by reference of ANSI/
CAN/UL 12402-5 introducing new Level 50 device approvals; (3) The 
incorporation by reference of ANSI/CAN/UL 9595 for new follow-on 
production inspection standards; and (4) The option to use placards in 
lieu of information pamphlets on currently approved devices and the 
requirement to use placards for new Level 50, Level 70, and Level 100 
devices. Across these four provisions, we estimate that this rule 
affects two Coast Guard recognized laboratories and 61 PFD 
manufacturers.
    We researched these two Coast Guard recognized independent 
laboratories and 61 PFD manufacturers to determine if they are U.S. 
companies or foreign companies based on the location of their parent 
company's headquarters. We found one Coast Guard recognized laboratory 
to be a U.S. company and one to be a foreign company. We found 39 of 
the 61 PFD manufacturers to be U.S. companies and 22 to be foreign 
companies. We then researched each of these 40 U.S. companies (1 
testing laboratory and 39 PFD manufacturers) to determine its North 
American Industry Classification System (NAICS) code and its size 
standard using the SBA's size standard table. Next, we reviewed each 
U.S. parent company's revenue or employee information to determine 
whether the company is small or not small, according to SBA size 
standards. We present the results of our research in table 36. The 
Coast Guard recognized independent laboratory is not a small entity. Of 
39 U.S. manufacturers, 32 are small entities according to SBA size 
standards. We did not find any U.S. small entities to be small 
governmental jurisdictions or not-for-profit organizations.

[[Page 97381]]



                             Table 36--Number of Small Entities Affected by the Rule
----------------------------------------------------------------------------------------------------------------
                         NAICS code and                          Size standard   Number of U.S.      Number of
      NAICS code         industry type     Size standard type       used *          companies     small entities
----------------------------------------------------------------------------------------------------------------
314910...............  Textile Bag and    Employees...........             500                 1               1
                        Canvas Mills.
314999...............  All Other          Revenue.............            $8.0                 2               2
                        Miscellaneous
                        Store Retailers
                        (except Tobacco
                        Stores).
315280...............  Other Cut and Sew  Employees...........             750                 1               1
                        Apparel
                        Manufacturing.
315990...............  Apparel            Employees...........             500                 1               1
                        Accessories and
                        Other Apparel
                        Manufacturing.
326199...............  All Other          Employees...........             750                 2               0
                        Plastics Product
                        Manufacturing.
326299...............  All Other Rubber   Employees...........             500                 1               1
                        Product
                        Manufacturing.
327120...............  Clay Building      Employees...........             750                 1               1
                        Material and
                        Refractories
                        Manufacturing.
336612...............  Boat Building....  Employees...........           1,000                 2               2
339920...............  Sporting and       Employees...........             750                 4               3
                        Athletic Goods
                        Manufacturing.
339999...............  All Other          Employees...........             500                 1               1
                        Miscellaneous
                        Manufacturing.
423910...............  Sporting and       Employees...........             100                 1               1
                        Recreational
                        Goods and
                        Supplies
                        Merchant
                        Wholesalers.
441222...............  Boat Dealers.....  Revenue.............           $35.0                 5               4
448140...............  Family Clothing    Revenue.............           $41.5                 1               0
                        Stores.
448150...............  Clothing           Revenue.............           $16.5                 2               1
                        Accessories
                        Stores.
451110...............  Sporting Goods     Revenue.............           $16.5                 2               2
                        Stores.
452319...............  All Other General  Revenue.............           $35.0                 1               1
                        Merchandise
                        Stores.
453930...............  Manufactured       Revenue.............           $16.5                 1               0
                        (Mobile) Home
                        Dealers.
541380...............  Testing            Revenue.............           $16.5                 1               0
                        Laboratories.
541870...............  Advertising        Revenue.............           $16.5                 1               1
                        Material
                        Distribution
                        Services.
561990...............  All Other Support  Revenue.............           $12.0                 1               1
                        Services.
713930...............  Marinas..........  Revenue.............            $8.0                 1               1
Unknown..............  Unknown..........  Unknown.............         Unknown                 7               7
                                                                               ---------------------------------
                                                                                              40              32
----------------------------------------------------------------------------------------------------------------
* Some size standards are based on the number of employees and others on the firm's total revenue.

    Each of the four provisions in this final rule affects a different 
subset of the 32 small entities and has a different distribution of 
costs and cost savings across those small entities. We discuss each 
provision separately in the following sections, and then summarize each 
provision's impacts.
Provision 1: Incorporation by Reference of ANSI/CAN/UL 12402-4
    The first provision, ANSI/CAN/UL 12402-4, affects seven small 
entities, six of which have known revenues. The first provision results 
in costs to small entities that intend to sell Level 100 devices in 
only one market (United States or Canada). Firms wishing to sell Level 
100 devices in both United States and Canadian markets will reduce 
costs by no longer conducting duplicative approvals and facility 
inspections.
    Whether small entities will or will not experience cost savings 
depends on whether each small entity prefers to sell their device in 
only the United States or Canada or in both markets. The Coast Guard 
does not know which small entities will prefer a cheaper set of product 
approval tests with only the ability to sell in one market and which 
will prefer a more expensive set of product approval tests with the 
ability to sell in both markets. Therefore, we compare both the costs 
and cost savings estimates to each small entity.
    In the RA, we estimate the Level 100 approval to be $5,050 more 
expensive than the current Type I approval. We estimate that testing 
laboratories receive an application for approval to Level 100 standards 
0.45 times per year. Each small entity will apply for an approval once 
they develop a new device and will experience this cost only when they 
submit a new application. The Coast Guard cannot predict when each 
small entity might submit a new application; instead, we use the cost 
of $5,050 as an estimate of a one-time (initial-year cost) per-small-
entity-cost of ANSI/CAN/UL 12402-4.
    We estimate the cost savings for small entities that wish to sell 
in two markets as $42,150 per new Level 100 approval, $5,594 per 
modification of an existing approval with testing, and $1,373 per 
revision of an existing approval without testing. As with the costs of 
ANSI/CAN/UL 12402-4, each small entity will experience the cost savings 
only when it submits each application. The Coast Guard does not know 
when small entities might seek new approvals or revisions in the 
future, so we estimate these as one-time cost savings to small entities 
from ANSI/CAN/UL 12402-4. Specifically, we estimate that each small 
entity will experience a one-time total cost savings of $41,638 for 
each approval, which is the sum of the Level 100 approvals and 
revisions to approvals with or without testing ($42,150 + $7,605 + 
$1,373). These seven small entities will also experience an ongoing 
(annual) cost savings of $1,338.00 from reduced facility inspection 
frequency.\34\
---------------------------------------------------------------------------

    \34\ Facility inspections last 4 hours and include the billed 
cost of an inspector's time, or $274.50, and the opportunity cost of 
a Quality Manager's time, or $60 per hour as a loaded weighted 
average. The cost savings is therefore 4 x $274.50 + 4 x $60 or 
$1,338. Readers should refer to section 7 of the RA discussing the 
ANSI/CAN/UL 12402-4 standard for more detail.
---------------------------------------------------------------------------

Provision 2: Incorporation by Reference of ANSI/CAN/UL 12402-5
    Incorporating by reference ANSI/CAN/UL 12402-5 permits small 
entities to seek Coast Guard approval to produce and sell Level 50 
devices. The Coast Guard has not previously approved these devices. We 
estimate that this provision affects all 32 small entities, 24 of which 
have known revenues.
    In the RA, we estimate that the introduction of Level 50 devices 
will cause the North American PFD market to grow by 5 percent. We 
interpret the 5-percent growth in terms of the number of approved 
devices (a growth of 38 device approvals). The initial approvals 
represent a one-time (initial year) cost to small entities. Small 
entities will also experience an annual cost of additional production 
inspections based on the volume of Level 50 PFDs produced.

[[Page 97382]]

    We estimate a new Level 50 device approval costs a small entity 
about $39,840. We do not know which small entities will seek Coast 
Guard approval for a Level 50 device or how many devices each small 
entity might seek approval for. As a result, we treat each small entity 
as seeking approval for one Level 50 device costing $39,840. This will 
be a one-time (initial year) cost to small entities.
    Production is not distributed equally across the small entities 
that produce PFDs for the North American market. Instead, some small 
entities produce vastly more PFDs than others. In the RA, we estimate 
the market share of the 13 largest firms to be collectively about 95 
percent. We estimate the remaining 44 firms' market share collectively 
to be about 5 percent. We do not know the relative market share of the 
44 firms, so we divide the 5 percent equally across the 44 firms. 
Therefore, we treat each of the 44 firms as accounting for about 0.11 
percent of the PFD market.\35\
---------------------------------------------------------------------------

    \35\ We divided 5 percent or 0.05 by 44 companies to obtain 0.11 
percent of the market for each one.
---------------------------------------------------------------------------

    For the 32 small entities that would use the ANSI/CAN/UL 12402-5 
standard, 24 are in the set of 44 firms collectively having 5 percent 
market share, and therefore we assume each has a market share of 0.11 
percent. Based on conversations with PFD manufacturing executives, we 
estimate 5 of the 32 firms have a market share of 2.5 percent each, 1 
has a market share of 7.5 percent, 1 has a market share of 15 percent, 
and 1 has a market share of 25 percent. We could not find revenue data 
for eight small entities. We display this information in table 37 
below.

      Table 37--Market Size of Small Entities Affected by the Rule
------------------------------------------------------------------------
                                                           Market share
                Number of small entities                  of each entity
                                                                (%)
------------------------------------------------------------------------
24......................................................            0.11
5.......................................................             2.5
1.......................................................             7.5
1.......................................................              15
1.......................................................              25
------------------------------------------------------------------------

    In the RA, we estimate the annual cost of production inspections 
across the whole industry to be $82,974. Because we do not know which 
small entities will seek Level 50 approval, we estimate the additional 
costs from production inspections from Level 50 device sales for each 
small entity by multiplying each small entity's market share by the 
total costs. For example, if we use a small entity that has a market 
share of 0.11 percent, then we estimate the small entity's additional 
production inspection costs to be about $91.27 ($82,974 x 0.0011, 
rounded) annually.
Provision 3: Incorporation by Reference of ANSI/CAN/UL 9595
    Incorporating ANSI/CAN/UL 9595 by reference establishes production 
testing standards for the PFD manufacturing industry. ANSI/CAN/UL 9595 
will lead to reductions in testing frequency for PFD manufacturing 
entities with a QMS in place. We estimate that eight small entities 
would be affected by this provision, seven of which have known revenue.
    Small entities will experience one-time costs of an initial QMS 
inspection, and ongoing costs because a QMS inspection is more 
expensive than the facility inspection it replaces in subsequent years. 
We estimate that each small entity has two facilities, with the largest 
small entity having three facilities, and QMS inspection costs occur 
per facility. In the RA, we estimate that the total costs to U.S. firms 
for the ANSI/CAN/UL 9595 standard will be about $61,296 for 19 
facilities. We estimate that 7 of the firms in the top 13 are small 
entities, including the top firm. Because we do not know where each 
small entity's facilities are located, to estimate each small entity's 
one-time costs, we multiply $61,296 by each small entity's share of the 
19 facilities, yielding $6,452 ((2 / 19) x $61,296) for all but the 
largest small entity and $9,678 ((3 / 19) x $61,296) for the largest 
small entity. We estimate annual costs to be about $439 per facility, 
which is the difference between 8 hours of billed QMS inspector time 
and 8 hours of a regular inspector's time.\36\ The largest small entity 
has three facilities, so will experience $1,316 ($439 x 3) in 
additional costs. All the other small entities have two facilities, and 
they will experience $878 ($439 x 2) in annual costs. We reflect this 
information in table 38.
---------------------------------------------------------------------------

    \36\ Independent laboratories bill QMS inspections at $329.40 
per hour, while they bill normal inspections at $274.50 per hour. 
Thus, the additional cost is $54.90 per hour ($329.40-$274.50), or 
$439 in an 8-hour workday ($54.90 x 8). See section 9.1.2 in the RA.

                                  Table 38--Costs per Small Entity From UL 9595
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Total one-time
                           Entity type                              facilities         costs       Annual costs
----------------------------------------------------------------------------------------------------------------
The Largest.....................................................               3          $9,678          $1,317
All Others......................................................               2           6,452             878
----------------------------------------------------------------------------------------------------------------

    Small entities that achieve a higher process rating according to 
the ANSI/CAN/UL 9595 standard will also experience annual cost savings 
based on each small entity's market share and the rigor of the QMS 
system in place. As mentioned previously, we estimate that only the top 
13 firms will experience savings from ANSI/CAN/UL 9595, and we estimate 
that 7 of those firms are small entities.
    Cost savings will be different for each of the seven small 
entities. To estimate the cost savings per small entity, we need to 
estimate the number of reductions in inspections per small entity and 
then multiply by $2,712 ($2,196 of billed inspector time and $516 of 
weighted average quality manager loaded wages). To calculate the 
reductions in inspections for each small entity, we take the share of 
current inspections for each small entity and then estimate the number 
of inspections that would take place under Process Rating A or B for 
each small entity. Next, we subtract the reduced inspection frequency 
per small entity from the current inspection frequency, yielding a 
reduction in inspection frequency for current production. In the RA, we 
also estimate that U.S. firms will experience 16 fewer inspections on 
Level 50 devices that they do not yet produce, resulting in cost 
savings from reduced inspection frequency. We then multiply the 16 
inspections by each small entity's share of reduction in current 
inspections.
    For example, assume that a small entity had a 10-percent market 
share, half of which would be at Process Rating A and half of which 
would be at Process Rating B. We first take the total number of current 
inspections on U.S. firms (587) and multiply by the small entity's 
market share relative to the total affected U.S. market share, or 10 
percent

[[Page 97383]]

/ 77.5 percent x 587, yielding 76 rounded. Then we derive the reduced 
number of inspections at B and the reduced number of inspections at A 
by multiplying the reduced inspection frequency at B (194) by the share 
of the small entity's Process Rating at B relative to all other U.S. 
firms at B, or 5 percent / 51 percent, yielding 19 rounded. To estimate 
the reduced inspection frequency at A, we take the number of facilities 
at A (one) and multiply by two, accounting for the number of 
inspections that occur once the facility is at Process Rating A. Next, 
we add to it the multiplication of the number of commercial PFD 
production inspections at A (7) and the small entity's relative share 
of production at A, or 5 percent / 26.5 percent, yielding 3 rounded (2 
x 1) + (7 x 5 percent / 26.5 percent). Taken together, the small 
entity's reduced inspection frequency is 22 (19 + 3), meaning the small 
entity experiences 54 fewer production inspections annually (76-22). To 
calculate the number of reduced Level 50 inspections for each small 
entity, we take the small entity's share of U.S. firm inspection 
reduction divided by the total estimated reduction in U.S. firm 
inspections from Table 42 in the RA (54 / 376) and multiply by the 16 
total reduction in inspections, yielding 2 rounded. We add the 
reduction in Level 50 inspections (2) and the reduction in current 
inspections (54) together and multiply by the cost of each inspection 
($2,712), yielding $151,872 ((2+54) x $2,712), or the small entity's 
annual cost savings from reduced inspection frequency. We perform this 
process for each of the eight small entities. We record these 
calculations in table 39; the results are rounded.

                                                         Table 39--Annual Cost Savings for a Representative Small Entity in 2023 Dollars
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                                  Total
                   Total market share                      Market      Market     Current inspection       Inspection         Inspection       inspection     Reduced level 50    Total annual
                                                         share at B  share at A        frequency         frequency at B     frequency at A      reduction       inspections       cost savings
A                                                         B = A / 2   C = A / 2   D = 587 x A / 77.5%  E = 194 x B / 51%      F = (2 x 1) +       G = D-E-F   H = G / 376 x 16  (G + H) x $2,712
                                                                                                                            (7 x C / 26.5%)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
10%....................................................          5%          5%                    76                 19                  3              54                  2          $151,872
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Provision 4: Replacement of Information Pamphlets With Booklets
    We did not estimate any costs or cost savings from this provision, 
so we do not estimate that there will be any impact on small entities.
    We summarize the number of small entities affected, cost impacts, 
cost savings impacts, and transfers per provision in table 40.

               Table 40--Number of Affected Small Entities, Costs, and Cost Savings per Provision
----------------------------------------------------------------------------------------------------------------
                                        PFD manufacturing
             Provision                 population affected             Costs                  Cost savings
----------------------------------------------------------------------------------------------------------------
ANSI/CAN/UL 12402-4 \37\...........  7 small entities of     One-time testing to Level  One-time testing to
                                      the 30; 6 small         100 will cost $5,050       Level 100 will be
                                      entities with known     more than testing to       $42,150 less than
                                      revenues.               Legacy Type I standards    testing to Type I
                                                              for entities wishing to    standards for entities
                                                              sell in only Canada or     wishing to sell in both
                                                              the United States.         the United States and
                                                                                         Canada. Small entities
                                                                                         will also save costs
                                                                                         from cheaper revisions
                                                                                         with and without
                                                                                         testing, $5,594 and
                                                                                         $1,373 respectively.
                                                                                         Together, small
                                                                                         entities will save
                                                                                         $49,117. Small entities
                                                                                         will also experience
                                                                                         $1,338 in annual cost
                                                                                         savings from reduced
                                                                                         facility inspections.
ANSI/CAN/UL 12402-5 \38\...........  32 small entities, 24   One-time (initial year)    No estimated cost
                                      small entities with     testing to Level 50        savings for these small
                                      known revenues.         standards will cost        entities.
                                                              about $39,840.
                                                              Additional ongoing costs
                                                              from inspections will be
                                                              between $91.27 and
                                                              $20,743.50 based on each
                                                              small entity's market
                                                              share (small entities
                                                              with larger market
                                                              shares will experience
                                                              greater costs).
ANSI/CAN/UL 9595 \39\..............  8 small entities, 7     One-time (initial year)    Small entities will save
                                      small entities with     cost from an additional    through reduced
                                      known revenues.         QMS inspection of about    inspection frequencies
                                                              $9,678.32 for the          based on each small
                                                              largest small entity       entity's market share
                                                              based on three             and each small entity's
                                                              facilities and $6,452.21   QMS in place. We
                                                              for all other small        estimate these 8 small
                                                              entities with two          entities will
                                                              facilities. Ongoing        experience between
                                                              (annual) costs will        $24,408 and $265,776 in
                                                              result from a QMS          savings per year based
                                                              inspection and will be     upon their market share
                                                              more than a regular        and QMS ratings.
                                                              inspection. We estimate
                                                              ongoing costs to be
                                                              about $439 per facility
                                                              or $1,317 for the
                                                              largest small entity
                                                              with three facilities
                                                              and $878 for each other
                                                              small entity with two
                                                              facilities.
Information Pamphlets..............  32 small entities, 24   No estimated costs.......  No estimated cost
                                      small entities with                                savings.
                                      known revenues.
----------------------------------------------------------------------------------------------------------------

    We provide a list of the range of costs, cost savings, and net cost 
savings per entity in table 41. Because each entity is subject to a 
different subset of provisions, this table should be interpreted as the 
minimum and maximum, cost, cost savings, and net cost savings per 
entity. Specifically, the cost, cost savings, and net cost savings rows 
are the minimum or maximum observed across the range of entities.

[[Page 97384]]

Net cost savings is therefore not a function of the cost and cost 
savings in Table 41. For example, the lowest net cost savings in Table 
40, -$46,292.21, demonstrates a cost greater than the lowest cost that 
will be experienced by an entity, or $39,840, which is why it is not 
the lowest cost per entity. Similarly, lowest and highest ongoing 
impacts do not necessarily match to the lowest and highest one-time 
impacts. We are simply reporting the lowest and highest impacts per 
entity across costs, cost savings, and net cost savings.
---------------------------------------------------------------------------

    \37\ See Section 7 of the RA for more detail about the costs and 
cost savings of ANSI/CAN/UL 12402-4. Numbers in this table may not 
match precisely numbers in the RA as this FRFA adjust costs to be on 
a per entity basis accounting for market share.
    \38\ See Section 8 of the RA for more detail about the costs and 
cost savings of ANSI/CAN/UL 12402-5. Numbers in this table may not 
match precisely numbers in the RA as this FRFA adjust costs to be on 
a per entity basis accounting for market share.
    \39\ See Section 9 of the RA for more detail about the costs and 
cost savings of ANSI/CAN/UL 9595. Numbers in this table may not 
match precisely numbers in the RA as this FRFA adjust costs to be on 
a per entity basis accounting for market share.

                                      Table 41--Range of Impacts per Entity
----------------------------------------------------------------------------------------------------------------
                                                         One-time impacts                 Ongoing impacts
                                                 ---------------------------------------------------------------
                                                    Lowest per      Highest per     Lowest per      Highest per
                                                      entity          entity          entity          entity
----------------------------------------------------------------------------------------------------------------
Cost............................................      $39,840.00      $54,568.32          $91.27      $71,177.50
Cost Savings....................................  ..............       49,117.00  ..............      267,114.00
Net Cost Savings................................     (46,292.21)        4,227.00     (47,870.27)      195,936.50
----------------------------------------------------------------------------------------------------------------

    In table 42, we report the estimated overall net cost savings 
revenue impact per small entity of this final rule across all 
provisions.

  Table 42--Percentage of Estimated Revenue Impact on Small Entities From Overall Impact (Net Cost Savings) of
                                                 This Final Rule
----------------------------------------------------------------------------------------------------------------
                                           One-time net impacts                     Ongoing net impacts
                                 -------------------------------------------------------------------------------
                                                        Portion of small                        Portion of small
        % Revenue impact           Small entities with    entities with    Small entities with    entities with
                                      known revenue       known revenue       known revenue       known revenue
                                                               (%)                                     (%)
----------------------------------------------------------------------------------------------------------------
<1..............................                    17                71                    20                83
1-3%............................                     2                 8                     2                 8
>3..............................                     5                21                     2                 8
----------------------------------------------------------------------------------------------------------------

    (5) A description of the projected reporting, recordkeeping and 
other compliance requirements of the rule, including an estimate of the 
classes of small entities which will be subject to the requirement and 
the type of professional skills necessary for preparation of the report 
or record.
    This rule calls for no new collection of information under the 
Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3520.
    (6) A description of the steps the agency has taken to minimize the 
significant economic impact on small entities consistent with the 
stated objectives of applicable statutes, including a statement of the 
factual, policy, and legal reasons for selecting the alternative 
adopted in the final rule and why each one of the other significant 
alternatives to the rule considered by the agency which affect the 
impact on small entities was rejected.
    The Coast Guard identified three alternatives:
    (1) Incorporate ANSI/CAN/UL 12402-5 for the approval of Level 70 
PFDs only, prohibiting the approval of Level 50 PFDs;
    (2) Require placards instead of pamphlets; and
    (3) Adopt ANSI/CAN/UL 12402-4 and ANSI/CAN/UL 12402-5 by policy.
Alternative 1: Incorporate by Reference ANSI/CAN/UL 12402-5 for Level 
70 PFDs Only
    Under the first alternative, we could have chosen to incorporate 
ANSI/CAN/UL 12402-5 but limit approval to Level 70 PFDs only. Level 50 
PFDs would not be eligible for Coast Guard approval and would not meet 
carriage requirements on any vessel, severely restricting their use. If 
the Coast Guard chose this alternative, the market for Level 50 devices 
would not be viable because Level 50 devices would no longer partially 
substitute for Level 70 or Type III devices. Small entities would be 
unable to sell these new devices and would not experience a positive 
revenue impact from this alternative.
    As a result, we rejected this alternative because it does not 
maximize small entities' revenue.
Alternative 2: Require Placards Instead of Pamphlets
    We considered the alternative of requiring that PFD manufacturers 
use placards instead of information pamphlets for the mandatory PFD 
instructional materials. While the Coast Guard observes that the cost 
of producing placards is generally less than the costs of producing 
information pamphlets, the Coast Guard observes that some manufacturers 
may not have switched to producing placards yet. As such, if we 
required that manufacturers use placards, we could place undue burden 
on small entities in the PFD industry by requiring that they acquire 
new equipment to produce placards. We do not know how large these costs 
could be, but small entities would experience greater compliance costs. 
As a result, we ultimately rejected this alternative.
Alternative 3: Adopt ANSI/CAN/UL 12402-4 and ANSI/CAN/UL 12402-5 by 
Policy
    The third alternative we considered was to adopt ANSI/CAN/UL 12402-
4 and ANSI/CAN/UL 12402-5 by policy instead of incorporating them by 
reference in the regulations. Under 46 CFR 159.005-7(c), the Coast 
Guard has the authority to approve an item of equipment that does not 
meet all the requirements of 46 CFR 160.055 if it has equivalent 
performance characteristics. The Coast Guard has utilized this 
authority to partially adopt ANSI/CAN/UL 12402-4 and ANSI/CAN/UL 12402-
5 by policy. However, because this authority is limited to the approval 
of equipment with equivalent performance characteristics, we cannot 
adopt the portion of standards not already equivalent to existing types 
of equipment. In particular, Level 50 PFDs,

[[Page 97385]]

youth inflatable PFDs, and inflatable Level 100 PFDs cannot be approved 
by policy because they are not equivalent to any current Coast Guard 
standards. As a result, small entities would not receive the additional 
revenue from the sale of Level 50 devices or the cost savings on Level 
100 inflatable device approvals as compared to Type I device approvals. 
For these reasons, we rejected this alternative.

C. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement 
Fairness Act of 1996, Public Law 104-121, we offer to assist small 
entities in understanding this rule so that they can better evaluate 
its effects on them and participate in the rulemaking. The Coast Guard 
will not retaliate against small entities that question or complain 
about this rule or any policy or action of the Coast Guard.
    Small businesses may send comments on the actions of Federal 
employees who enforce, or otherwise determine compliance with, Federal 
regulations to the Small Business and Agriculture Regulatory 
Enforcement Ombudsman and the Regional Small Business Regulatory 
Fairness Boards. The Ombudsman evaluates these actions annually and 
rates each agency's responsiveness to small business. If you wish to 
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR 
(1-888-734-3247).

D. Collection of Information

    This rule calls for no new or revised collection of information 
under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3520.

E. Federalism

    A rule has implications for federalism under Executive Order 13132 
(Federalism) if it has a substantial direct effect on States, on the 
relationship between the National Government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government. We have analyzed this final rule under Executive Order 
13132 and have determined that it is consistent with the fundamental 
federalism principles and preemption requirements described in 
Executive Order 13132. Our analysis follows.
    It is well settled that States may not regulate in categories 
reserved for regulation by the Coast Guard. It is also well settled 
that all the categories covered in 46 U.S.C. 3306, 3703, 7101, and 8101 
(design, construction, alteration, repair, maintenance, operation, 
equipping, personnel qualification, and manning of vessels), as well as 
the reporting of casualties and any other category in which Congress 
intended the Coast Guard to be the sole source of a vessel's 
obligations, are within the field foreclosed from regulation by the 
States. The statutory authorities upon which this rulemaking is based--
46 U.S.C. 3306(a), 4102(a), 4302(a), and 4502(a) and (c)(2)(B)--are 
areas in which Congress intended the Coast Guard to be the sole source 
of a vessel's obligations and, as such, are within the field foreclosed 
from regulation by the States. See, e.g., United States v. Locke, 529 
U.S. 89 (2000) (finding that the states are foreclosed from regulating 
tanker vessels), see also Ray v. Atlantic Richfield Co., 435 U.S. 151, 
157 (1978) (state regulation is preempted where ``the scheme of federal 
regulation may be so pervasive as to make reasonable the inference that 
Congress left no room for the States to supplement it [or where] the 
Act of Congress may touch a field in which the federal interest is so 
dominant that the federal system will be assumed to preclude 
enforcement of state laws on the same subject.'' (citations omitted)). 
Therefore, because the States may not regulate within these categories, 
this rule is consistent with the fundamental federalism principles and 
preemption requirements described in Executive Order 13132.

F. Unfunded Mandates

    The Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1531-1538, 
requires Federal agencies to assess the effects of their discretionary 
regulatory actions. In particular, the Act addresses actions that may 
result in the expenditure by a State, local, or tribal government, in 
the aggregate, or by the private sector of $100,000,000 (adjusted for 
inflation) or more in any one year. Although this rule does not result 
in such expenditure, we do discuss the effects of this rule elsewhere 
in this preamble.

G. Taking of Private Property

    This rule will not cause a taking of private property or otherwise 
have taking implications under Executive Order 12630 (Governmental 
Actions and Interference with Constitutionally Protected Property 
Rights).

H. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2) 
of Executive Order 12988 (Civil Justice Reform) to minimize litigation, 
eliminate ambiguity, and reduce burden.

I. Protection of Children

    We have analyzed this rule under Executive Order 13045 (Protection 
of Children from Environmental Health Risks and Safety Risks). This 
rule is not an economically significant rule and will not create an 
environmental risk to health or risk to safety that might 
disproportionately affect children.

J. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order 
13175 (Consultation and Coordination with Indian Tribal Governments), 
because it will not have a substantial direct effect on one or more 
Indian tribes, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes.

K. Energy Effects

    We have analyzed this rule under Executive Order 13211 (Actions 
Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use). We have determined that it is not a 
``significant energy action'' under that order because it is not a 
``significant regulatory action'' under Executive Order 12866 and is 
not likely to have a significant adverse effect on the supply, 
distribution, or use of energy.

L. Technical Standards

    The National Technology Transfer and Advancement Act, codified as a 
note to 15 U.S.C. 272, directs agencies to use voluntary consensus 
standards in their regulatory activities unless the agency provides 
Congress, through OMB, with an explanation of why using these standards 
are inconsistent with applicable law or otherwise impractical. 
Voluntary consensus standards are technical standards (e.g., 
specifications of materials, performance, design, or operation; test 
methods; sampling procedures; and related management systems practices) 
that are developed or adopted by voluntary consensus standards bodies.
    This rule uses the following voluntary consensus standards:
     ANSI/CAN/UL 9595, Standard for Safety Factory Follow-Up on 
Personal Flotation Devices (PFDs), First Edition, June 4, 2020 
(including revisions through September 9, 2021).
     ANSI/CAN/UL 12402-4, Standard for Safety Personal 
Flotation Devices--Part 4: Lifejackets, Performance Level 100--Safety 
Requirements, First Edition, July 9, 2020.
     ANSI/CAN/UL 12402-5, Standard for Safety Personal 
Flotation Devices--Part 5: Buoyancy Aids (Level 50)--Safety 
Requirements, First Edition,

[[Page 97386]]

December 31, 2015 (including revisions through January 27, 2022).
     ANSI/UL 1123, Standard for Safety Marine Buoyant Devices, 
Seventh Edition, October 1, 2008 (including revisions through November 
23, 2020).
     ANSI/UL 1175, Standard for Safety Buoyant Cushions, Fourth 
Edition, April 20, 2007 (including revisions through January 10, 2020).
    The sections that reference these standards and the locations where 
these standards are available are listed in 46 CFR 160.045-5, 160.055-
5, 160.060-5, 160.064-5, 160.076-5, 160.255-5, 160.264-5, and 160.276-
5.
    The Director of the Federal Register has approved the material in 
46 CFR 160.045-5, 160.055-5, 160.060-5, 160.064-5, 160.076-5, 160.255-
5, 160.264-5, and 160.276-5 for incorporation by reference under 5 
U.S.C. 552 and 1 CFR part 51. Copies of the material are available from 
the sources listed in 46 CFR 160.045-5, 160.055-5, 160.060-5, 160.064-
5, 160.076-5, 160.255-5, 160.264-5, and 160.276-5.
    Consistent with 1 CFR part 51 incorporation by reference 
provisions, this material is reasonably available. Interested persons 
have access to it through their normal course of business, may purchase 
it from the organization identified in 46 CFR 160.045-5, 160.055-5, 
160.060-5, 160.064-5, 160.076-5, 160.255-5, 160.264-5, and 160.276-5, 
or may view a copy by means we have identified in that section.

M. Environment

    We have analyzed this rule under Department of Homeland Security 
Management Directive 023-01, Rev. 1, associated implementing 
instructions, and Environmental Planning COMDTINST 5090.1 (series), 
which guide the Coast Guard in complying with the National 
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made 
a determination that this action is one of a category of actions that 
do not individually or cumulatively have a significant effect on the 
human environment. A Record of Environmental Consideration supporting 
this determination is available in the docket. For instructions on 
locating the docket, see the ADDRESSES section of this preamble. This 
final rule is categorically excluded under paragraph L52 and L58 of 
Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. 
Paragraph L52 pertains to regulations concerning vessel operation 
safety standards. Paragraph L58 pertains to regulations concerning 
equipment approval and carriage requirements. This final rule involves 
approval requirements and follow-up program requirements for 
lifejackets by incorporating new standards to replace existing legacy 
standards. The rule further amends lifejacket and PFD carriage 
requirements to allow for the use of equipment approved to the new 
standards and remove obsolete equipment approval requirements. The 
amendments streamline the process for the approval of PFDs and allow 
manufacturers the opportunity to produce more innovative equipment that 
meet approval requirements in both the United States and Canada while 
also reducing the burden of the approval process and the production 
inspections on manufacturing firms.

List of Subjects

33 CFR Part 181

    Labeling, Marine safety, Reporting and recordkeeping requirements.

46 CFR Part 25

    Fire prevention, Marine safety, Reporting and recordkeeping 
requirements.

46 CFR Part 28

    Alaska, Fire prevention, Fishing vessels, Marine safety, 
Occupational safety and health, Reporting and recordkeeping 
requirements, Seamen.

46 CFR Part 108

    Fire prevention, Marine safety, Occupational safety and health, Oil 
and gas exploration, Vessels.

46 CFR Part 117

    Marine safety, Passenger vessels.

46 CFR Part 133

    Cargo vessels, Marine safety, Reporting and recordkeeping 
requirements.

46 CFR Part 141

    Marine safety, Occupational health and safety, Reporting and 
recordkeeping requirements, Towing vessels.

46 CFR Part 160

    Incorporation by reference, Marine safety, Reporting and 
recordkeeping requirements.

46 CFR Part 169

    Fire prevention, Marine safety, Reporting and recordkeeping 
requirements, Schools, Vessels.

46 CFR Part 180

    Marine safety, Passenger vessels.

46 CFR Part 199

    Cargo vessels, Marine safety, Oil and gas exploration, Passenger 
vessels, Reporting and recordkeeping requirements.

    For the reasons discussed in the preamble, the Coast Guard amends 
33 CFR part 181 and 46 CFR parts 25, 28, 108, 117, 133, 141, 160, 169, 
180, and 199 as follows:

Title 33--Navigation and Navigable Waters

PART 181--MANUFACTURER REQUIREMENTS

0
1. The authority citation for part 181 is revised to read as follows:

    Authority: 46 U.S.C. 4302; DHS Delegation 00170.1, Revision No. 
01.4.


Sec.  181.4   [Removed and Reserved]

0
2. Remove and reserve Sec.  181.4.

Subpart G--Information Pamphlet or Placard for Personal Flotation 
Devices

0
3. Revise the heading of Subpart G to read as set forth above.


Sec.  181.701   [Amended]

0
4. Amend Sec.  181.701 by adding the words ``Coast Guard approved'' 
after the word ``all''.

0
5. Revise Sec.  181.702 to read as follows:


Sec.  181.702   Information pamphlet or placard: requirement to 
furnish.

    (a) Each manufacturer of a Coast Guard approved personal flotation 
device (PFD) must furnish, with each PFD that is sold or offered for 
sale for use on a recreational boat, an information pamphlet or placard 
accepted by the Commandant (CG-ENG-4) or meeting the requirements in 
the applicable subpart of 46 CFR part 160.
    (b) No person may sell or offer for sale for use on a recreational 
boat a Coast Guard approved PFD unless an information pamphlet or 
placard required by this section is attached in such a way that it can 
be read prior to purchase.


Sec. Sec.  181.703 through 181.705   [Removed]

0
6. Remove Sec. Sec.  181.703 through 181.705.

Title 46--Shipping

PART 25--REQUIREMENTS

0
7. The authority citation for part 25 is revised to read as follows:

    Authority: 33 U.S.C. 1903(b); 46 U.S.C. 2103, 3306, 4102, 4302; 
DHS Delegation 00170.1, Revision No. 01.4.


[[Page 97387]]



0
8. Amend Sec.  25.25-5 by:
0
a. Removing in paragraph (b)(2), the text ``or 160.176'' and adding, in 
its place, the text ``160.176, or 160.255''; and
0
b. Revising the introductory text to paragraph (c)(2).
    The revision reads as follows:


Sec.  25.25-5   Life preservers and other lifesaving equipment 
required.

* * * * *
    (c) * * *
    (2) On each vessel, regardless of length and regardless of whether 
carrying passengers for hire, a commercial hybrid PFD approved under 
former approval series 160.077 prior to January 6, 2025, may be 
substituted for a PFD approved under approval series 160.055, 160.155, 
160.176, or 160.255 if it is in good and serviceable condition and--
* * * * *

PART 28--REQUIREMENTS FOR COMMERCIAL FISHING INDUSTRY VESSELS

0
9. The authority citation for part 28 is revised to read as follows:

    Authority: 46 U.S.C. 3316, 4502, 4505, 4506, 6104, 8103, 10603; 
DHS Delegation 00170.1, Revision No. 01.4.


0
10. Revise Sec.  28.110 to read as follows:


Sec.  28.110   Life preservers or other personal flotation devices.

    (a) Except as provided by Sec.  28.305 of this chapter, each vessel 
must be equipped with at least one immersion suit, exposure suit, or 
wearable personal flotation device of the proper size for each 
individual on board as specified in table 1 to Sec.  28.110 and part 
25, subpart 25.25 of this chapter. Notwithstanding the provisions of 
paragraphs (c) and (d) of Sec.  25.25-1 of this chapter, each 
commercial fishing industry vessel propelled by sail, and each manned 
barge employed in commercial fishing activities, must meet the 
requirements of this paragraph.
    (b) Each wearable personal flotation device must be stowed so that 
it is readily accessible to the individual for whom it is intended, 
from both the individual's normal work station and berthing area. If 
there is no location accessible to both the work station and the 
berthing area, an appropriate device must be stowed in both locations.

                    Table 1 to Sec.   28.110--Personal Flotation Devices and Immersion Suits
----------------------------------------------------------------------------------------------------------------
          Applicable waters                  Vessel type            Devices required        Other regulations
----------------------------------------------------------------------------------------------------------------
Seaward of the Boundary Line and       Documented Vessel......  Immersion suit or        28.135; 25.25-9(a);
 North of 32[deg] N or South of                                  exposure suit.           25.25-13; 25.25-15.
 32[deg] S; and Lake Superior.
Coastal Waters on the West Coast of    All vessels............  Immersion suit or        28.135; 25.25-9(a);
 the United States north of Point                                exposure suit.           25.25-13; 25.25-15.
 Reyes, CA; Beyond Coastal Waters,
 cold water; and Lake Superior.
All other waters (Includes all Great   40 feet (12.2 meters)    Wearable PFD approved    28.135; 25.25-5; 25.25-
 Lakes except Lake Superior).           or more in length.       under approval series    9(a); 25.25-13; 25.25-
                                                                 160.055, 160.155, or     15.
                                                                 160.176, or 160.255
                                                                 immersion suit, or
                                                                 exposure suit.\1\
                                       Less than 40 feet (12.2  Wearable PFD approved    28.135; 25.25-5; 25.25-
                                        meters) in length.       under subchapter Q of    9(a); 25.25-13; 25.25-
                                                                 this chapter,            15.
                                                                 immersion suit, or
                                                                 exposure suit.\1\
----------------------------------------------------------------------------------------------------------------
\1\ A commercial hybrid approved under former approval series 160.077 prior to [EFFECTIVE DATE OF FINAL RULE]
  may be substituted for a PFD approved under approval series 160.055, 160.155, 160.176, or 160.255 if it is in
  good and serviceable condition, used in accordance with the conditions marked on the PFD and in the owner's
  manual, and labeled for use on commercial vessels.

PART 108--DESIGN AND EQUIPMENT

0
11. The authority citation for part 108 continues to read as follows:

    Authority: 43 U.S.C. 1333; 46 U.S.C. 3102, 3306; DHS Delegation 
00170.1, Revision No. 01.4.


0
12. Amend Sec.  108.580 by revising paragraph (b) introductory text to 
read as follows:


Sec.  108.580   Personal lifesaving appliances.

* * * * *
    (b) Lifejackets. Each unit must carry lifejackets approved under 
approval series 160.155 or 160.176. If the unit carries inflatable 
lifejackets, they must be of the same or similar design and have the 
same method of operation.
* * * * *

PART 117--LIFESAVING EQUIPMENT AND ARRANGEMENTS

0
13. The authority citation for part 117 is revised to read as follows:

    Authority: 46 U.S.C. 2103, 3306; E.O. 12234, 45 FR 58801, 3 CFR, 
1980 Comp., p. 277; DHS Delegation 00170.1, Revision No. 01.4.


0
14. Amend Sec.  117.71 by:
0
a. Revising the section heading and paragraph (c);
0
b. Removing paragraph (d); and
0
c. Redesignating paragraph (e) as paragraph (d).
    The revisions read as follows:


Sec.  117.71   Lifejackets.

* * * * *
    (c) Each lifejacket must be approved under approval series 160.002, 
160.005, 160.055, 160.155, 160.176, or 160.255 in subchapter Q of this 
chapter, or other standard specified by the Commandant. An inflatable 
lifejacket approved under approval series 160.255 must include a full 
back-up inflation chamber.
* * * * *

0
15. Amend Sec.  117.72 by revising the section heading and paragraphs 
(b) and (d) to read as follows:


Sec.  117.72   Personal flotation devices carried in addition to 
lifejackets.

* * * * *
    (b) Wearable PFDs approved in accordance with Sec. Sec.  160.064, 
160.076, 160.264, or 160.276 in subchapter Q of this chapter, or other 
standard specified by the Commandant, may be carried as additional 
equipment.
* * * * *
    (d) A commercial hybrid PFD approved under former approval series 
160.077 prior to January 6, 2025 may be carried as additional equipment 
for use by persons working near or over the water if it is in good and 
serviceable condition, used in accordance with the

[[Page 97388]]

conditions marked on the PFD and in the owner's manual, of the same or 
similar design, and has the same method of operation as each other 
hybrid PFD carried on board.

PART 133--LIFESAVING SYSTEMS

0
16. The authority citation for part 133 is revised to read as follows:

    Authority: 46 U.S.C. 3306, 3307; DHS Delegation 00170.1, 
Revision No. 01.4.


Sec.  133.70   [Amended]

0
17. Amend Sec.  133.70(b) introductory text by removing the text 
``160.177'' and adding, in its place, the text ``160.255''.

PART 141--LIFESAVING

0
18. The authority citation for part 141 is revised to read as follows:

    Authority: 46 U.S.C. 3103, 3301, 3306, 3308, 3316, 8104, 8904; 
33 CFR 1.05; DHS Delegation 00170.1, Revision No. 01.4.


Sec.  141.340   [Amended]

0
19. Amend Sec.  141.340 by:
0
a. Removing in paragraph (a) the text ``or 160.176,'' and adding, in 
its place, the text ``160.176, or 160.255''; and
0
b. Adding paragraph (i).
    The addition reads as follows:


Sec.  141.340   Lifejackets.

* * * * *
    (i) Wearable PFDs approved in accordance with Sec. Sec.  160.064, 
160.076, 160.264, or 160.276 in subchapter Q of this chapter, or other 
standard specified by the Commandant, may be carried as additional 
equipment. Additional equipment is not acceptable in lieu of any 
portion of the required lifejackets.

PART 160--LIFESAVING EQUIPMENT

0
20. The authority citation for part 160 continues to read as follows:

    Authority: 46 U.S.C. 2103, 3306, 3703 and 4302; E.O. 12234; 45 
FR 58801; 3 CFR, 1980 Comp., p. 277; and DHS Delegation 00170.1, 
Revision No. 01.4.

Subpart 160.001 [Removed and Reserved]

0
21. Remove and reserve subpart 160.001, consisting of Sec. Sec.  
160.001-1 through 160.001-5.

Subpart 160.002 [Removed and Reserved]

0
22. Remove and reserve subpart 160.002, consisting of Sec. Sec.  
160.002-1 through 160.002-7.

Subpart 160.005 [Removed and Reserved]

0
23. Remove and reserve subpart 160.005, consisting of Sec. Sec.  
160.005-1 through 160.005-7.

Subpart 160.006 [Removed and Reserved]

0
24. Remove and reserve subpart 160.006, consisting of Sec.  160.006-2.

0
25. Add subpart 160.045, consisting of Sec. Sec.  160.045-1 through 
160.045-25, to read as follows:
Subpart 160.045--Recreational Throwable PFDs
Sec.
160.045-1 Scope.
160.045-3 Definitions.
160.045-5 Incorporation by reference.
160.045-7 Design, construction, and performance of throwable PFDs.
160.045-9 Approval procedures for throwable PFDs.
160.045-11 Recognized laboratory.
160.045-13 Approval inspections and tests.
160.045-15 Production inspections, tests, and quality control of 
throwable PFDs.
160.045-17 Marking and Labeling.
160.045-21 PFD manuals.
160.045-23 Procedure for approval of design or material change.
160.045-25 Suspension or termination of approval.

Subpart 160.045--Recreational Throwable PFDs


Sec.  160.045-1   Scope.

    (a) This subpart contains structural and performance standards for 
approval of throwable PFDs for use on recreational vessels, as well as 
requirements for production follow-up inspections, associated manuals, 
information pamphlets or placards, and markings.
    (b) Throwable PFDs approved under this subpart may rely entirely on 
inherently buoyant material, or rely entirely or partially upon 
inflation to achieve the minimum buoyancy.
    (c) Throwable PFDs approved under this subpart are intended to meet 
the carriage requirements for uninspected commercial vessels under 40 
ft (12 m) not carrying passengers for hire and recreational boats, in 
accordance with 33 CFR part 175.


Sec.  160.045-3   Definitions.

    The following definitions apply to this subpart:
    Commandant means the Chief of the Lifesaving and Fire Safety 
Standards Division. Address: Commandant (CG-ENG-4), Attn: Lifesaving 
and Fire Safety Division, U.S. Coast Guard Stop 7509, 2703 Martin 
Luther King Jr. Avenue SE, Washington, DC 20593-7509; email 
[email protected].
    First quality workmanship means construction that is free from any 
defect materially affecting appearance or serviceability.
    Recognized laboratory means an independent laboratory accepted by 
the Commandant in accordance with subpart 159.010 of this subchapter, 
with a valid memorandum of understanding in accordance with Sec.  
159.010-7 of this subchapter.


Sec.  160.045-5   Incorporation by reference.

    Certain material is incorporated by reference into this part with 
the approval of the Director of the Federal Register in accordance with 
5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by 
reference (IBR) material is available for inspection at the Coast Guard 
Headquarters and at the National Archives and Records Administration 
(NARA). Contact Commandant (CG-ENG-4), Attn: Lifesaving and Fire Safety 
Division, U.S. Coast Guard Stop 7509, 2703 Martin Luther King Jr. 
Avenue SE, Washington, DC 20593-7509. For information on the 
availability of this material at NARA, visit www.archives.gov/federal-register/cfr/ibr-locations or email: [email protected]. The 
material may be obtained from UL, 333 Pfingsten Road, Northbrook, IL 
60062-2002; phone 847-272-8800; website: www.ul.com.
    (a) ANSI/CAN/UL 9595:2021, Standard for Safety Factory Follow-Up on 
Personal Flotation Devices (PFDs), First Edition, June 4, 2020 
(including revisions through September 9, 2021) (``ANSI/CAN/UL 9595''); 
IBR approved for Sec.  160.045-15(e).
    (b) ANSI/UL 1123, Standard for Safety Marine Buoyant Devices, 
Seventh Edition, October 1, 2008 (including revisions through November 
23, 2020); IBR approved for Sec. Sec.  160.045-7(e); 160.045-13(d).
    (c) ANSI/UL 1175, Standard for Safety Buoyant Cushions, Fourth 
Edition, April 20, 2007 (including revisions through January 10, 2020); 
IBR approved for Sec. Sec.  160.045-7(e); 160.045-13(d).


Sec.  160.045-7   Design, construction, and performance of throwable 
PFDs.

    (a) General. Every throwable PFD must conform to the requirements 
as accepted by the Commandant for listing and labeling by a recognized 
laboratory, and must be of such design, materials, and construction as 
to meet the requirements specified in this section.
    (b) Designs and constructions. Throwable PFDs must not provide 
means for adjustment or close fitting to

[[Page 97389]]

the body. Methods of construction must provide strengths, with 
reinforcements where necessary, to be adequate for the intended use and 
purpose of the device.
    (c) Materials. All materials used in any device covered by this 
subpart must meet the applicable requirements of subpart 164.019 of 
this chapter, must be all new materials, must be suitable for the 
purpose intended, and must be at least equivalent to corresponding 
materials specified for standard buoyant cushions. Hardware or 
fastenings must be of sufficient strength for the purpose of the device 
and must be of inherently corrosion-resistant material, such as 
stainless steel, brass, bronze, certain plastics, etc. Decorative 
platings of any thickness are permissible. Fabrics, coated fabrics, 
tapes, and webbing must be either mildew-resistant or treated for 
mildew resistance. Buoyancy provided by inherently buoyant material 
must not be dependent upon loose, granulated material.
    (d) Standard construction. A standard foam cushion that is designed 
to be thrown must be 2 inches or more in thickness and must have 225 or 
more square inches of top surface area.
    (e) Nonstandard construction. A nonstandard throwable PFD must meet 
the requirements in ANSI/UL 1123 or ANSI/UL 1175 (both incorporated by 
reference, see Sec.  160.045-5) and any additional requirements that 
the Commandant may prescribe to approve unique or novel designs.
    (f) Buoyancy. (1) Ring life buoys must have 16\1/2\ pounds or more 
of buoyancy.
    (2) Foam cushions must have 18 pounds or more of buoyancy.
    (3) A device other than those standard devices specified in 
paragraph (f)(1) or (2) of this section must have 20 pounds or more of 
buoyancy.
    (g) Workmanship. Throwable PFDs must be of first quality 
workmanship and must be free from any defects materially affecting 
their appearance or serviceability.


Sec.  160.045-9   Approval procedures for throwable PFDs.

    (a) Each application for approval of a throwable PFD must be 
submitted directly to a Coast Guard recognized laboratory.
    (b) The recognized laboratory must determine if a throwable PFD 
with novel design features requires a preliminary review by the Coast 
Guard prior to testing. Submissions requiring preliminary review must 
be sent to [email protected], and must include a full description 
and drawings. Pictures, samples, and preliminary test results may also 
be submitted.


Sec.  160.045-11  Recognized laboratory.

    (a) The approval inspections and tests required by Sec.  160.045-
13, and production inspections, tests, and quality control required by 
Sec.  160.045-15, must be conducted by an independent laboratory 
recognized by the Coast Guard under 46 CFR subpart 159.010 to perform 
such functions. A list of recognized independent laboratories is 
available from the Commandant and online at: https://cgmix.uscg.mil.
    (b) The same laboratory that performs the approval tests must also 
perform production oversight unless the employees of the laboratory 
performing production oversight receive training and support equal to 
that of the laboratory that performed the approval testing, as 
determined by the Commandant.


Sec.  160.045-13  Approval inspections and tests.

    (a) Each throwable PFD must be certified by a recognized laboratory 
as meeting the requirements of this subpart. Approval tests must be 
conducted or supervised by a recognized laboratory using PFDs 
constructed in accordance with the plans and specifications submitted 
with the application for approval.
    (b) Each throwable PFD design must be visually examined for 
compliance with the construction and performance requirements of this 
subpart.
    (c) Standard PFDs must be submerged in fresh water for 24 or more 
continuous hours. The measured buoyancy after the 24 hours of 
submersion must be the buoyancy specified in Sec.  160.045-7(f).
    (d) Non-standard throwable PFDs must be subjected to approval tests 
specified in ANSI/UL 1123 or ANSI/UL 1175 (both incorporated by 
reference, see Sec.  160.045-5) or another test program accepted by the 
Commandant. Approval tests must be conducted or supervised by a 
recognized laboratory using throwable PFDs constructed in accordance 
with the plans and specifications submitted with the application for 
approval.
    (e) The Commandant may prescribe additional tests for approval of 
novel or unique designs.


Sec.  160.045-15  Production inspections, tests, and quality control of 
throwable PFDs.

    (a) Manufacturer's inspection and tests. Manufacturers of approved 
throwable PFDs must maintain quality control of the materials used, 
manufacturing methods and the finished product to meet the applicable 
requirements, and make sufficient inspections and tests of 
representative samples and components produced to maintain the quality 
of the finished product. Records of tests conducted by the manufacturer 
and records of materials, including affidavits by suppliers that 
applicable requirements are met, must be made available to the 
recognized laboratory inspector or to the Coast Guard marine inspector, 
or both, for review upon request.
    (b) Laboratory inspections and tests. The laboratory inspector will 
conduct examinations, inspections, and tests for listed and labeled 
devices, as required by the recognized laboratory, at the place of 
manufacture or other location at the option of the laboratory.
    (c) Test facilities. The laboratory inspector, or the Coast Guard 
marine inspector assigned by the Commander of the District in which the 
factory is located, or both, must be admitted to any place in the 
factory where work is being done on listed and labeled products. Either 
or both inspectors may take samples of parts or materials entering 
construction or final assemblies, for further examinations, 
inspections, or tests. The manufacturer must provide a suitable place 
and the apparatus necessary for the performance of the tests done at 
the place of manufacture.
    (d) Additional tests, etc. Unannounced examinations, tests, and 
inspections of samples obtained either directly from the manufacturer 
or through commercial channels may be made to determine the suitability 
of a product for listing and labeling, or to determine conformance of a 
labeled product to the applicable requirements. These may be conducted 
by the recognized laboratory or by the United States Coast Guard.
    (e) Follow-up program. A follow-up program in accordance with ANSI/
CAN/UL 9595 (incorporated by reference, see Sec.  160.045-5) meets the 
requirements of this section.


Sec.  160.045-17  Marking and Labeling.

    (a) Each throwable PFD must be marked in accordance with the 
recognized laboratory's listing and labeling requirements in accordance 
with Sec.  160.045-3(a). At a minimum, all labels must include--
    (1) Size information, as appropriate;
    (2) The Coast Guard approval number;
    (3) Manufacturer's contact information;
    (4) Model name/number;
    (5) Lot number, manufacturer date; and
    (6) Any limitations or restrictions on approval or special 
instructions for use.

[[Page 97390]]

    (b) Marking must be of a type that will be durable and legible for 
the expected life of the device.
    (c) The Commandant may prescribe additional marking requirements 
for special purpose devices or unique or novel designs.


Sec.  160.045-21  PFD manuals.

    (a) An owner's manual must be provided with each fully or partially 
inflatable throwable PFD sold or offered for sale. The text of each 
manual is reviewed with the application for approval.
    (b) The Commandant may prescribe additional information in the 
manual for special purpose devices or unique or novel designs.
    (c) Additional information, instructions, or illustrations may be 
included in the owner's manual if there is no contradiction to the 
required information.


Sec.  160.045-23  Procedure for approval of design or material change.

    (a) The manufacturer must submit any proposed changes in design, 
material, or construction to the recognized laboratory for approval 
before changing throwable PFD production methods.
    (b) Determinations of equivalence of design, construction, and 
materials may be made only by the Commandant or a designated 
representative.


Sec.  160.045-25  Suspension or termination of approval.

    As provided in 46 CFR 159.005-15, the Commandant may suspend or 
terminate the approval of a throwable PFD if the manufacturer fails to 
comply with this subpart or the recognized laboratory's accepted 
procedures or requirements.

Subpart 160.047 [Removed and Reserved]

0
26. Remove and reserve subpart 160.047, consisting of Sec. Sec.  
160.047-1 through 160.047-7.

Subpart 160.048 [Removed and Reserved]

0
27. Remove and reserve subpart 160.048, consisting of Sec. Sec.  
160.048-1 through 160.048-8.

Subpart 160.052 [Removed and Reserved]

0
28. Remove and reserve subpart 160.052, consisting of Sec. Sec.  
160.052-1 through 160.052-9.

Subpart 160.055--Life Preservers, Unicellular Plastic Foam, Adult 
and Child, for Merchant Vessels

0
29. Revise Sec.  160.055-1 to read as follows:


Sec.  160.055-1  Scope.

    (a) This subpart contains requirements for production follow-up 
inspections for life preservers approved under this subpart prior to 
January 6, 2025.
    (b) Life preservers approved under this subpart rely upon 
inherently buoyant material to achieve the minimum buoyancy.
    (c) Life preservers approved under this subpart are intended to 
meet the carriage requirements for wearable PFDs for uninspected 
passenger vessels, uninspected commercial vessels over 40 ft (12m), and 
for inspected vessels.
    (d) Each life preserver specified in this subpart is a:
    (1) Standard, bib type, vinyl dip coated:
    (i) Model 62, adult (for persons weighing over 90 pounds); or
    (ii) Model 66, child (for persons weighing less than 90 pounds); or
    (2) Standard, bib type, cloth covered;
    (i) Model 63, adult (for persons weighing over 90 pounds); or
    (ii) Model 67, child (for persons weighing less than 90 pounds); or
    (3) Nonstandard, shaped type:
    (i) Model,\1\ adult (for persons weighing over 90 pounds); or
    (ii) Model,\1\ child (for persons weighing less than 90 pounds).

    \1\ A model designation for each nonstandard life preserver is 
to be assigned by the manufacturer. That designation must be 
different from any standard lifesaving device designation.


Sec.  160.055-2  [Removed and Reserved]

0
30. Remove and reserve Sec.  160.055-2.

0
31. Revise Sec.  160.055-3 to read as follows:


Sec.  160.055-3  Definitions.

    The following definitions apply to this subpart:
    Commandant means the Chief of the Lifesaving and Fire Safety 
Standards Division. Address: Commandant (CG-ENG-4), Attn: Lifesaving 
and Fire Safety Division, U.S. Coast Guard Stop 7509, 2703 Martin 
Luther King Jr. Avenue SE, Washington, DC 20593-7509; email 
[email protected].
    First quality workmanship means construction that is free from any 
defect materially affecting appearance or serviceability.
    Inspector means a recognized laboratory representative assigned to 
perform, supervise, or oversee the duties described in Sec.  160.055-15 
or any Coast Guard representative performing duties related to the 
approval.
    Recognized laboratory means an independent laboratory accepted by 
the Commandant in accordance with 46 CFR 159.010, with a valid 
memorandum of understanding in accordance with 46 CFR 159.010-7.


Sec.  160.055-4  [Removed and Reserved]

0
32. Remove and reserve Sec.  160.055-4.

0
33. Revise Sec.  160.055-5, including the section heading, to read as 
follows:


Sec.  160.055-5  Incorporation by reference.

    Certain material is incorporated by reference into this part with 
the approval of the Director of the Federal Register in accordance with 
5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by 
reference (IBR) material is available for inspection at the Coast Guard 
Headquarters and at the National Archives and Records Administration 
(NARA). Contact Commandant (CG-ENG-4), Attn: Lifesaving and Fire Safety 
Division, U.S. Coast Guard Stop 7509, 2703 Martin Luther King Jr. 
Avenue SE, Washington, DC 20593-7509. For information on the 
availability of this material at NARA, visit www.archives.gov/federal-register/cfr/ibr-locations or email [email protected]. The 
material may be obtained from UL, 333 Pfingsten Road, Northbrook, IL 
60062-2002 phone (847) 272-8800; website: www.ul.com.
    (a) ANSI/CAN/UL 9595:2021, Standard for Safety Factory Follow-Up on 
Personal Flotation Devices (PFDs), First Edition, June 4, 2020 
(including revisions through September 9, 2021) (``ANSI/CAN/UL 9595''); 
IBR approved for Sec.  160.055-15(a).
    (b) [Reserved]


Sec. Sec.  160.055-6 through 160.055-9  [Removed and Reserved]

0
34. Remove and reserve Sec. Sec.  160.055-6 through 160.055-9.

0
35. Add Sec.  160.055-11 to read as follows:


Sec.  160.055-11  Independent laboratory.

    The production inspections, tests, and quality control required by 
this subpart must be conducted by an independent laboratory accepted by 
the Coast Guard under 46 CFR subpart 159.010 to perform such functions. 
A list of accepted independent laboratories is available from the 
Commandant and online at https://cgmix.uscg.mil.

0
36. Add Sec.  160.055-15 to read as follows:

[[Page 97391]]

Sec.  160.055-15  Production inspections, tests, and quality control of 
life preservers.

    (a) General. Production tests and inspections must be conducted in 
accordance with this section, subpart 159.007 of this chapter, and the 
independent laboratory's procedures for production inspections and 
tests as accepted by the Commandant. The Commandant may prescribe 
additional production tests and inspections necessary to maintain 
quality control and to monitor compliance with the requirements of this 
subchapter. A follow-up program in accordance with ANSI/CAN/UL 9595 
(incorporated by reference, see Sec.  160.055-5), meets the 
requirements of this subpart.
    (b) Oversight. In addition to responsibilities set out in part 159 
of this chapter and the accepted laboratory procedures for production 
inspections and tests, each manufacturer of a life preserver and each 
laboratory inspector must comply with the following, as applicable:
    (1) Manufacturer. Each manufacturer must--
    (i) Perform all tests and examinations necessary to show compliance 
with this subpart on each lot before any inspector's tests and 
inspection of the lot;
    (ii) Follow established procedures for maintaining quality control 
of the materials used, manufacturing operations, and the finished 
product; and
    (iii) Allow an inspector to take samples of completed units or of 
component materials for tests required by this subpart and for tests 
relating to the safety of the design.
    (2) Laboratory. An inspector from the accepted laboratory must 
oversee production in accordance with the laboratory's procedures for 
production inspections and tests accepted by the Commandant. During 
production oversight, the inspector must not perform or supervise any 
production test or inspection unless--
    (i) The manufacturer has a valid approval certificate; and
    (ii) The inspector has first observed the manufacturer's production 
methods and any revisions to those methods.
    (3) At least quarterly, the inspector must check the manufacturer's 
compliance with the company's quality control procedures, examine the 
manufacturer's required records, and observe the manufacturer perform 
each of the required production tests.
    (c) Test facilities. The manufacturer must provide a suitable place 
and apparatus for conducting the tests and inspections necessary to 
determine compliance of life preservers with this subpart. The 
manufacturer must provide means to secure any test that is not 
continuously observed, such as the 48-hour buoyancy test. The 
manufacturer must have the calibration of all test equipment checked in 
accordance with the test equipment manufacturer's recommendation and 
interval but not less than at least once every year.
    (d) Lots. A lot must not consist of more than 1000 life preservers. 
A lot number must be assigned to each group of life preservers 
produced. Lots must be numbered serially. A new lot must be started 
whenever any change in materials or a revision to a production method 
is made, and whenever any substantial discontinuity in the production 
process occurs. The lot number assigned, along with the approval 
number, must enable the PFD manufacturer to determine the supplier's 
identifying information for the component lot.
    (e) Samples. (1) From each lot of life preservers, manufacturers 
must randomly select a number of samples from completed units at least 
equal to the applicable number required by table 1 to Sec.  160.055-
15(e)(1) for buoyancy testing. Additional samples must be selected for 
any tests, examinations, and inspections required by the laboratory's 
production inspections and tests procedures.

     Table 1 to Sec.   160.055-15(e)(1)--Sampling for Buoyancy Tests
------------------------------------------------------------------------
                                                          Number of life
                        Lot size                           preservers in
                                                              sample
------------------------------------------------------------------------
100 and under...........................................               1
101 to 200..............................................               2
201 to 300..............................................               3
301 to 500..............................................               4
501 to 750..............................................               6
751 to 1,000............................................               8
------------------------------------------------------------------------

    (2) For a lot succeeding one from which any sample life preserver 
failed the buoyancy test, the sample must consist of not less than ten 
specimen life preservers to be tested for buoyancy in accordance with 
paragraph (f) of this section.
    (f) Buoyancy test. The buoyancy of the life preservers must be 
determined by measuring the upward force exerted by the individual 
submerged unit. The buoyancy measurement must be made at the end of the 
48 hours of submersion, during which period the pad inserts must not be 
disturbed.
    (g) Buoyancy required. The buoyant pad inserts from Model 3 adult 
life preservers must provide not less than 25 pounds buoyancy in fresh 
water, and the pads from Model 5 child life preservers must provide not 
less than 16.5 pounds buoyancy.
    (h) Lot inspection. On each lot, the laboratory inspector must 
perform a final lot inspection to be satisfied that the life preservers 
meet this subpart. Each lot must demonstrate--
    (1) First quality workmanship;
    (2) That the general arrangement and attachment of all components, 
such as body straps, closures, tie tapes, and drawstrings, are as 
specified in the approved plans and specifications;
    (3) Compliance with the marking requirements; and
    (4) The information pamphlet or placard specified in 33 CFR part 
181 subpart G, if required, is securely attached to the device, with 
the PFD selection information visible and accessible prior to purchase.
    (i) Lot acceptance. When the independent laboratory has determined 
that the life preservers in the lot are of a type officially approved 
in the name of the company, and that such life preservers meet the 
requirements of this subpart, they must be plainly marked in waterproof 
ink with the independent laboratory's name or identifying mark.
    (j) Lot rejection. Each nonconforming unit must be rejected. If 
three or more nonconforming units are rejected for the same kind of 
defect, lot inspection must be discontinued and the lot rejected. The 
inspector must discontinue lot inspection and reject the lot if 
examination of individual units or the records for the lot shows 
noncompliance with either this subchapter or the laboratory's or the 
manufacturer's quality control procedures. A rejected unit or lot may 
be resubmitted for testing and inspection if the manufacturer first 
removes and destroys each defective unit or, if authorized by the 
laboratory, reworks the unit or lot to correct the defect. A rejected 
lot or rejected unit must not be sold or offered for sale under the 
representation that it meets this subpart or that it is Coast Guard 
approved.

0
37. Add Sec.  160.055-19 to read as follows:


Sec.  160.055-19  Pamphlet or Placard.

    Each life preserver sold or offered for sale for use on 
recreational boats must be provided with a pamphlet or placard that a 
prospective purchaser can read prior to purchase, as specified in 33 
CFR part 181 subpart G.

0
38. Add Sec.  160.055-23 to read as follows:

[[Page 97392]]

Sec.  160.055-23  Procedure for approval of design or material change.

    (a) The manufacturer must submit any proposed changes in design, 
material, or construction to [email protected] for approval before 
changing life preserver production methods.
    (b) Only the Commandant or a designated representative may make 
determinations of equivalence of design, construction, and materials.

0
39. Add Sec.  160.055-25 to read as follows:


Sec.  160.055-25  Suspension or termination of approval.

    As provided in 46 CFR 159.005-15, the Commandant may suspend or 
terminate the approval if the manufacturer fails to comply with this 
subpart or the recognized laboratory's accepted procedures or 
requirements.

Subpart 160.060--Specification for a Buoyant Vest, Unicellular 
Polyethylene Foam, Adult and Child

0
40. Revise Sec.  160.060-1 to read as follows:


Sec.  160.060-1  Scope.

    (a) This subpart contains requirements for production follow-up 
inspections for buoyant vests approved under this subpart prior to 
January 6, 2025.
    (b) Buoyant vests approved under this subpart rely upon inherently 
buoyant material to achieve the minimum buoyancy.
    (c) Buoyant vests approved under this subpart are intended to meet 
the carriage requirements for wearable PFDs for uninspected passenger 
vessels, uninspected commercial vessels over 40 ft (12m), and for 
inspected vessels.
    (d) Each buoyant vest specified in this subpart is a standard 
model:
    (1) Standard:
    (i) Model AY, adult (for persons weighing over 90 pounds); or
    (ii) Model CYM, child, medium (for children weighing from 50 to 90 
pounds); or
    (iii) Model CYS, child, small (for children weighing less than 50 
pounds).
    (2) Nonstandard:
    (i) Model,\1\ adult (for persons weighing over 90 pounds); or
    (ii) Model,\1\ child, medium (for persons weighing from 50 to 90 
pounds); or
    (iii) Model,\1\ child, small (for persons weighing less than 50 
pounds).

    \1\ A model designation for a nonstandard vest is to be assigned 
by the individual manufactured and must be different from any 
standard vest.


Sec.  160.060-2  [Removed and Reserved]

0
41. Remove and reserve Sec.  160.060-2.

0
42. Revise Sec.  160.060-3 to read as follows:


Sec.  160.060-3  Definitions.

    The following definitions apply to this subpart:
    Commandant means the Chief of the Lifesaving and Fire Safety 
Standards Division. Address: Commandant (CG-ENG-4), Attn: Lifesaving 
and Fire Safety Division, U.S. Coast Guard Stop 7509, 2703 Martin 
Luther King Jr. Avenue SE, Washington, DC 20593-7509; email 
[email protected].
    First quality workmanship means construction that is free from any 
defect materially affecting appearance or serviceability.
    Inspector means a recognized laboratory representative assigned to 
perform, supervise, or oversee the duties described in Sec.  160.060-15 
or any Coast Guard representative performing duties related to the 
approval.
    Recognized laboratory means an independent laboratory accepted by 
the Commandant in accordance with 46 CFR subpart 159.010, with a valid 
memorandum of understanding in accordance with 46 CFR 159.010-7.


Sec.  160.060-3a  [Removed and Reserved]

0
43. Remove and reserve Sec.  160.060-3a.


Sec.  160.060-4  [Removed and Reserved]

0
44. Remove and reserve Sec.  160.060-4.

0
45. Revise Sec.  160.060-5 to read as follows:


Sec.  160.060-5  Incorporation by reference.

    Certain material is incorporated by reference into this part with 
the approval of the Director of the Federal Register in accordance with 
5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by 
reference (IBR) material is available for inspection at the Coast Guard 
Headquarters and at the National Archives and Records Administration 
(NARA). Contact Commandant (CG-ENG-4), Attn: Lifesaving and Fire Safety 
Division, U.S. Coast Guard Stop 7509, 2703 Martin Luther King Jr. 
Avenue SE, Washington, DC 20593-7509. For information on the 
availability of this material at NARA, visit www.archives.gov/federal-register/cfr/ibr-locations or email [email protected]. The 
material may be obtained from UL, 333 Pfingsten Road, Northbrook, IL 
60062-2002; phone (847) 272-8800; website: www.ul.com.
    (a) ANSI/CAN/UL 9595:2021, Standard for Safety Factory Follow-Up on 
Personal Flotation Devices (PFDs), First Edition, June 4, 2020 
(including revisions through September 9, 2021) (``ANSI/CAN/UL 9595''); 
IBR approved for Sec.  160.060-15(h).
    (b) [Reserved]


Sec. Sec.  160.060-6 through 160.060-9  [Removed and Reserved]

0
46. Remove and reserve Sec. Sec.  160.060-6 through 160.060-9.

0
47. Add Sec.  160.060-11 to read as follows:


Sec.  160.060-11  Independent laboratory.

    (a) The production inspections, tests, and quality control required 
by this subpart must be conducted by an independent laboratory 
recognized by the Coast Guard under Sec.  159.010 of this subchapter to 
perform such functions. A list of recognized independent laboratories 
is available from the Commandant and online at https://cgmix.uscg.mil.
    (b) The same laboratory that performs the approval tests must also 
perform production oversight unless the employees of the laboratory 
performing production oversight receive training and support equal to 
that of the laboratory that performed the approval testing, as 
determined by the Commandant.

0
48. Add Sec.  160.060-15 to read as follows:


Sec.  160.060-15  Production inspections, tests, and quality control.

    (a) General. Manufacturers of listed and labeled buoyant vests 
must--
    (1) Maintain quality control of the materials used, the 
manufacturing methods, and the finished product to meet the applicable 
requirements of this subpart by conducting sufficient inspections and 
tests of representative samples and components produced;
    (2) Make available to the recognized laboratory inspector or the 
Coast Guard inspector, upon request, records of tests conducted by the 
manufacturer and records of materials used during production of the 
device, including affidavits by suppliers; and
    (3) Permit any examination, inspection, or test required by the 
recognized laboratory or the Coast Guard for a produced listed and 
labeled device, either at the place of manufacture or some other 
location.
    (b) Lot size and sampling. (1) A lot must consist of 500 buoyant 
vests or fewer;
    (2) A new lot begins after any change or modification in materials 
used or manufacturing methods employed;
    (3) The manufacturer of the buoyant vests must notify the 
recognized laboratory when a lot is ready for inspection;
    (4) The manufacturer must select samples in accordance with the

[[Page 97393]]

requirements in Table 1 to Sec.  160.060-15(b)(4) from each lot of 
buoyant vests to be tested for buoyancy in accordance with paragraph 
(e) of this section; and

      Table 1 to Sec.   160.060-15(b)(4)--Sample for Buoyancy Tests
------------------------------------------------------------------------
                                                             Number of
                        Lot size                             vests in
                                                              sample
------------------------------------------------------------------------
100 and under...........................................               1
101 to 200..............................................               2
201 to 300..............................................               3
301 to 500..............................................               4
------------------------------------------------------------------------

    (5) If a sample vest fails the buoyancy test, the sample from the 
next succeeding lot must consist of 10 specimen vests or more to be 
tested for buoyancy in accordance with paragraph (e) of this section.
    (c) Additional compliance tests. An inspector may conduct an 
examination, test, and inspection of a buoyant device obtained from the 
manufacturer or through commercial channels to determine the 
suitability of the device for listing and labeling, or to determine its 
conformance to applicable requirements.
    (d) Test facilities. The manufacturer must admit the inspector to 
any part of the premises at the place of manufacture of a listed and 
labeled device to--
    (1) Examine, inspect, or test a sample of a part or a material that 
is included in the construction of the device; and
    (2) Conduct any examination, inspection, or test in a suitable 
place and with appropriate apparatus provided by the manufacturer.
    (e) Buoyancy--(1) Buoyancy test method. Remove the buoyant inserts 
from the vests. Securely attach the spring scale in a position directly 
over the test tank. Suspend the weighted wire basket from the scale in 
such a manner that the basket can be weighed while it is completely 
under water. In order to measure the actual buoyancy provided by the 
inserts, the underwater weight of the empty basket must exceed the 
buoyancy of the inserts. To obtain the buoyancy of the inserts, proceed 
as follows:
    (i) Weigh the empty wire basket under water.
    (ii) Place the inserts inside the basket and submerge it so that 
the top of the basket is at least 2 inches below the surface of the 
water. Allow the inserts to remain submerged for 24 hours. The tank 
must be locked or sealed during this 24-hour submergence period. It is 
important that after the inserts have once been submerged they remain 
submerged for the duration of the test, and at no time during the 
course of the test removed from the tank or otherwise exposed to air.
    (iii) After the 24-hour submergence period, unlock or unseal the 
tank and weigh the wire basket with the inserts inside while both are 
still under water.
    (iv) The buoyancy is computed as paragraph (e)(1)(i) of this 
section minus paragraph (e)(1)(iii) of this section.
    (2) Buoyancy required. The buoyant inserts from adult size buoyant 
vests must provide not less than 15\1/2\ pounds of buoyancy in fresh 
water; the inserts from the child medium size buoyant vests must 
provide not less than 11 pounds buoyancy; and the inserts from the 
child small size buoyant vests must provide not less than 7 pounds 
buoyancy.
    (f) Body strap test. The complete body strap assembly, including 
hardware must be tested for strength by attaching the D-ring to a 
suitable support such that the assembly hangs vertically its full 
length. A weight of 150 pounds for an adult size and 115 pounds for a 
child size must be attached to the other end on the snap hook for 10 
minutes. The specified weight must not break or excessively distort the 
body strap assembly.
    (g) Additional approval tests for nonstandard vests. Tests in 
addition to those required by this section may be conducted by the 
inspector for a nonstandard vest to determine performance equivalence 
to a standard vest. Such additional tests may include determining 
performance in water, suitability of materials, donning time, ease of 
adjustment, and similar equivalency tests. Costs for any additional 
tests must be assumed by the manufacturer.
    (h) Follow-up program. A follow-up program in accordance with ANSI/
CAN/UL 9595 (incorporated by reference, see Sec.  160.060-5) meets the 
requirements of this section.

0
49. Add Sec.  160.060-19 to read as follows:


Sec.  160.060-19  Pamphlet or placard.

    Each buoyant vest sold or offered for sale for use on recreational 
boats must be provided with a pamphlet or placard that a prospective 
purchaser can read prior to purchase, as specified in 33 CFR part 181 
subpart G.

0
50. Add Sec.  160.060-23 to read as follows:


Sec.  160.060-23  Procedure for approval of design or material change.

    (a) The manufacturer must submit any proposed changes in design, 
material, or construction to [email protected] for approval before 
changing PFD production methods.
    (b) Only the Commandant or a designated representative may make 
determinations of equivalence of design, construction, and materials.

0
51. Add Sec.  160.060-25 to read as follows:


Sec.  160.060-25  Suspension or termination of approval.

    As provided in 46 CFR 159.005-15, the Commandant may suspend or 
terminate the approval if the manufacturer fails to comply with this 
subpart or the recognized laboratory's accepted procedures or 
requirements.

Subpart 160.064--Marine Buoyant Devices

0
52. Revise Sec.  160.064-1 to read as follows:


Sec.  160.064-1  Scope.

    (a) This subpart contains requirements for production follow-up 
inspections for wearable PFDs and throwable PFDs approved under this 
subpart prior to January 6, 2025.
    (b) PFDs approved under this subpart are intended to meet the 
carriage requirements for PFDs for uninspected commercial vessels under 
40 ft (12m) not carrying passengers for hire and recreational boats, in 
accordance with 33 CFR 175 and 46 CFR 25.25.
    (c) PFDs covered by this subpart are of two general types: those 
intended to be worn on the body and those intended to be thrown.


Sec.  160.064-2  [Removed and Reserved]

0
53. Remove and reserve Sec.  160.064-2.

0
54. Revise Sec.  160.064-3 to read as follows:


Sec.  160.064-3  Definitions.

    The following definitions apply to this subpart:
    Commandant means the Chief of the Lifesaving and Fire Safety 
Standards Division. Address: Commandant (CG-ENG-4), Attn: Lifesaving 
and Fire Safety Division, U.S. Coast Guard Stop 7509, 2703 Martin 
Luther King Jr. Avenue SE, Washington, DC 20593-7509; email 
[email protected].
    First class workmanship means construction that is free from any 
defect materially affecting appearance or serviceability.
    Inspector means a recognized laboratory representative assigned to 
perform, supervise, or oversee the duties described in Sec.  160.064-15 
or any Coast Guard representative performing duties related to the 
approval.
    Recognized laboratory means an independent laboratory accepted by 
the Commandant in accordance with 46 CFR subpart 159.010, with a valid

[[Page 97394]]

memorandum of understanding in accordance with 46 CFR 159.010-7.


Sec.  160.064-4  [Removed and Reserved]

0
55. Remove and reserve Sec.  160.064-4.

0
56. Add Sec.  160.064-5 to read as follows:


Sec.  160.064-5  Incorporation by reference.

    Certain material is incorporated by reference into this part with 
the approval of the Director of the Federal Register in accordance with 
5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by 
reference (IBR) material is available for inspection at the Coast Guard 
Headquarters and at the National Archives and Records Administration 
(NARA). Contact Commandant (CG-ENG-4), Attn: Lifesaving and Fire Safety 
Division, U.S. Coast Guard Stop 7509, 2703 Martin Luther King Jr. 
Avenue SE, Washington, DC 20593-7509. For information on the 
availability of this material at NARA, visit www.archives.gov/federal-register/cfr/ibr-locations or email [email protected]. The 
material may be obtained from UL, 333 Pfingsten Road, Northbrook, IL 
60062-2002; phone (847) 272-8800; website: www.ul.com.
    (a) ANSI/CAN/UL 9595:2021, Standard for Safety Factory Follow-Up on 
Personal Flotation Devices (PFDs), First Edition, June 4, 2020 
(including revisions through September 9, 2021) (``ANSI/CAN/UL 9595''); 
IBR approved for Sec.  160.064-15(e).
    (b) [Reserved]


Sec. Sec.  160.064-6 and 160.064-7  [Removed and Reserved]

0
57. Remove and reserve Sec. Sec.  160.064-6 and 160.064-7.

0
58. Add Sec.  160.064-11 to read as follows:


Sec.  160.064-11  Recognized laboratory.

    (a) The production inspections, tests, and quality control required 
by this subpart must be conducted by an independent laboratory 
recognized by the Coast Guard under 46 CFR subpart 159.010 to perform 
such functions. A list of recognized independent laboratories is 
available from the Commandant and online at https://cgmix.uscg.mil.
    (b) The same laboratory that performs the approval tests must also 
perform production oversight unless the employees of the laboratory 
performing production oversight receive training and support equal to 
that of the laboratory that performed the approval testing, as 
determined by the Commandant.

0
59. Add Sec.  160.064-15 to read as follows:


Sec.  160.064-15  Production inspections, tests, and quality control of 
PFDs.

    (a) Manufacturer's inspection and tests. Manufacturers of approved 
PFDs must maintain quality control of the materials used, manufacturing 
methods, and the finished product to meet the applicable requirements, 
and make sufficient inspections and tests of representative samples and 
components produced to maintain the quality of the finished product. 
Records of tests conducted by the manufacturer and records of 
materials, including affidavits by suppliers that applicable 
requirements are met, must be made available to the recognized 
laboratory inspector or to the Coast Guard marine inspector, or both, 
for review upon request.
    (b) Laboratory inspections and tests. The laboratory inspector will 
conduct examinations, inspections, and tests for listed and labeled 
devices, as required by the recognized laboratory, at the place of 
manufacture or other location at the option of the laboratory.
    (c) Test facilities. The laboratory inspector, or the Coast Guard 
marine inspector assigned by the Commander of the District in which the 
factory is located, or both, must be admitted to any place in the 
factory where work is being done on listed and labeled products. Either 
or both inspectors may take samples of parts or materials entering 
construction or final assemblies, for further examinations, 
inspections, or tests. The manufacturer must provide a suitable place 
and the apparatus necessary for the performance of the tests done at 
the place of manufacture.
    (d) Additional tests, etc. Unannounced examinations, tests, and 
inspections of samples obtained either directly from the manufacturer 
or through commercial channels may be made to determine the suitability 
of a product for listing and labeling, or to determine conformance of a 
labeled product to the applicable requirements. These may be conducted 
by the recognized laboratory or the United States Coast Guard.
    (e) Follow-up program. A follow-up program in accordance with ANSI/
CAN/UL 9595 (incorporated by reference, see Sec.  160.064-5) meets the 
requirements of this section.

0
60. Add Sec.  160.064-23 to read as follows:


Sec.  160.064-23  Procedure for approval of design or material change.

    (a) The manufacturer must submit any proposed changes in design, 
material, or construction to the recognized laboratory for approval 
before changing PFD production methods.
    (b) Determinations of equivalence of design, construction, and 
materials must be made only by the Commandant or a designated 
representative.

0
61. Add Sec.  160.064-25 to read as follows:


Sec.  160.064-25  Suspension or termination of approval.

    As provided in 46 CFR 159.005-15, the Commandant may suspend or 
terminate the approval of a PFD design if the manufacturer fails to 
comply with this subpart or the recognized laboratory's accepted 
procedures or requirements.

Subpart 160.076--Inflatable Recreational Personal Flotation Devices

0
62. Amend Sec.  160.076-1 by revising paragraphs (a) and (b) and adding 
new paragraph (c) to read as follows:


Sec.  160.076-1  Scope.

    (a) This subpart contains requirements for production follow-up 
inspections for inflatable recreational personal flotation devices 
(PFDs) approved prior to January 6, 2025.
    (b) Inflatable PFDs approved under this subpart rely partially or 
entirely upon inflation for buoyancy.
    (c) PFDs approved under this subpart are intended to meet the 
carriage requirements for wearable PFDs for recreational vessels and 
uninspected recreational submersible vessels, in accordance with 33 CFR 
175.15 and 175.17.


Sec.  160.076-3   [Removed]

0
63. Remove Sec.  160.076-3.


Sec.  160.076-5   [Redesignated as Sec.  160.076-3]

0
64. Redesignate Sec.  160.076-5 as Sec.  160.076-3.


Sec.  160.076-11   [Redesignated as Sec.  160.076-5]

0
65. Redesignate Sec.  160.076-11 as Sec.  160.076-5.

0
66. Revise newly redesignated Sec.  160.076-5 to read as follows:


Sec.  160.076-5   Incorporation by reference.

    Certain material is incorporated by reference into this part with 
the approval of the Director of the Federal Register in accordance with 
5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by 
reference (IBR) material is available for inspection at the Coast Guard 
Headquarters and at the National Archives and Records Administration 
(NARA). Contact Commandant (CG-ENG-4), Attn: Lifesaving and Fire Safety 
Division, U.S.

[[Page 97395]]

Coast Guard Stop 7509, 2703 Martin Luther King Jr. Avenue SE, 
Washington, DC 20593-7509. For information on the availability of this 
material at NARA, visit www.archives.gov/federal-register/cfr/ibr-locations or email [email protected]. The material may be obtained 
from UL, 333 Pfingsten Road, Northbrook, IL 60062-2002; phone (847) 
272-8800; website: www.ul.com.
    (a) ANSI/CAN/UL 9595:2021, Standard for Safety Factory Follow-Up on 
Personal Flotation Devices (PFDs), First Edition, June 4, 2020 
(including revisions through September 9, 2021) (``ANSI/CAN/UL 9595''); 
IBR approved for Sec.  160.076-29(a).
    (b) [Reserved].


Sec.  160.076-13   [Removed and Reserved]

0
67. Remove and reserve Sec.  160.076-13.


Sec.  160.076-21   [Removed and Reserved]

0
68. Remove and reserve Sec.  160.076-21.


Sec.  160.076-23   [Removed and Reserved]

0
69. Remove and reserve Sec.  160.076-23.


Sec.  160.076-25   [Removed and Reserved]

0
70. Remove and reserve Sec.  160.076-25.

0
71. Amend Sec.  160.076-29 by:
0
a. Revising paragraphs (a) and (c)(1)(i);
0
b. Removing paragraphs (c)(5) and (6), (e)(3) through (5), (f), and 
(g); and
0
c. Redesignating paragraph (h) as paragraph (f).
    The revisions read as follows:


Sec.  160.076-29   Production oversight.

    (a) Production tests and inspections must be conducted in 
accordance with ANSI/CAN/UL 9595 (incorporated by reference, see Sec.  
160.076-5) or an alternative follow-up procedure accepted by the 
Commandant. The Commandant may prescribe additional production tests 
and inspections necessary to maintain quality control and to monitor 
compliance with the requirements of this subpart.
* * * * *
    (c) * * *
    (1) * * *
    (i) Perform all required tests and examinations on each PFD lot 
before any required inspector's tests and inspection of the lot;
* * * * *

0
72. Amend Sec.  160.076-31 by:
0
a. Revising paragraphs (a), (b)(1) and (2);
0
b. Removing paragraph (c);
0
c. Redesignating paragraphs (d) and (e) as (c) and (d); and
0
d. Revising newly redesignated paragraph (c)(1) introductory text.
    The revisions read as follows:


Sec.  160.076-31   Production tests and examinations.

    (a) Samples used in testing must be selected in accordance with the 
sampling plan accepted by the Commandant.
    (b) On each sample selected--
    (1) The manufacturer must conduct the tests specified in the 
follow-up program accepted by the Commandant;
    (2) The recognized laboratory inspector must conduct or supervise 
the tests specified in the follow-up program accepted by the 
Commandant; and
* * * * *
    (c) Final lot examination and inspection--(1) General. On each PFD 
lot that passes production testing, the manufacturer must perform a 
final lot examination and, on every fifth lot, a laboratory inspector 
must perform a final lot inspection. Each final lot must demonstrate--
* * * * *


Sec.  160.076-33   [Amended]

0
73. Amend Sec.  160.076-33 by removing paragraph (b)(6), and 
redesignating paragraphs (b)(7), (8), and (9) as paragraphs (b)(6), 
(7), and (8).

0
74. Revise Sec.  160.076-35 to read as follows:


Sec.  160.076-35   Information pamphlet or placard.

    A pamphlet or placard accepted by the Commandant must be attached 
to each inflatable PFD sold or offered for sale in such a way that a 
prospective purchaser can read the pamphlet prior to purchase. The 
pamphlet or placard text and layout must be submitted to the Commandant 
for approval. The text must be printed in each pamphlet or placard 
exactly as approved by the Commandant. Additional information, 
instructions, or illustrations must not be included within the approved 
text and layout. Sample pamphlet text and layout may be obtained by 
contacting the Commandant. This pamphlet or placard may be combined 
with the manual required by Sec.  160.076-37 if PFD selection and 
warning information is provided on the PFD packaging in such a way that 
it remains visible until purchase.

0
75. Revise Sec.  160.076-37 to read as follows:


Sec.  160.076-37   Owner's manual.

    (a) General. The manufacturer must provide an owner's manual with 
each inflatable PFD sold or offered for sale.
    (b) Manual contents. The manual must contain the information as 
approved by the Commandant. If the PFD is conditionally approved, an 
explanation of the meaning of and reasons for the approval conditions 
must be included.

0
76. In Sec.  160.076-39, revise the introductory text to read as 
follows:


Sec.  160.076-39   Marking.

    Each inflatable PFD must be marked as approved by the Commandant. 
At a minimum, all labels must include--
* * * * *

Subpart 160.077 [Removed and Reserved]

0
77. Remove and reserve subpart 160.077, consisting of Sec. Sec.  
160.077-1 through 160.077-31.

0
78. Add subpart 160.255, consisting of Sec. Sec.  160.255-1 through 
160.255-27, to read as follows:

Subpart 160.255--Commercial Lifejackets

Sec.
160.255-1 Scope.
160-255-3 Definitions.
160.255-5 Incorporation by reference.
160.255-7 Design, construction, and performance of lifejackets.
160.255-9 Approval procedures for lifejackets.
160.255-11 Recognized laboratory.
160.255-13 Approval inspections and tests.
160.255-15 Production inspections, tests, and quality control of 
lifejackets.
160.255-17 Marking and labeling.
160.255-19 Placard.
160.255-21 Lifejacket manuals.
160.255-23 Procedure for approval of design or material change.
160.255-25 Suspension or termination of approval.
160.255-27 Servicing for fully and partially inflatable lifejackets.

Subpart 160.255--Commercial Lifejackets


Sec.  160.255-1   Scope.

    (a) This subpart contains structural and performance standards for 
approval of Level 100 lifejackets, as well as requirements for 
production follow-up inspections, markings, information placards, and 
associated manuals.
    (b) Lifejackets approved under this subpart must rely upon 
inherently buoyant material, inflation, or a combination to achieve the 
minimum buoyancy.
    (c) Lifejackets approved under this subpart are intended to meet 
the carriage requirements for wearable PFDs for uninspected passenger 
vessels, uninspected commercial vessels over 40 ft (12m) and for 
inspected vessels.


Sec.  160.255-3   Definitions.

    The following definitions apply to this subpart:
    Commandant means the Chief of the Lifesaving and Fire Safety 
Standards

[[Page 97396]]

Division. Address: Commandant (CG-ENG-4), Attn: Lifesaving and Fire 
Safety Division, U.S. Coast Guard Stop 7509, 2703 Martin Luther King 
Jr. Avenue SE, Washington, DC 20593-7509; email [email protected].
    First quality workmanship means construction that is free from any 
defect materially affecting appearance or serviceability.
    Inspector means a recognized laboratory representative assigned to 
perform, supervise, or oversee the duties described in Sec.  160.255-15 
or any Coast Guard representative performing duties related to the 
approval.
    Recognized laboratory means an independent laboratory accepted by 
the Commandant in accordance with 46 CFR subpart 159.010, with a valid 
memorandum of understanding in accordance with 46 CFR 159.010-7.


Sec.  160.255-5   Incorporation by reference.

    Certain material is incorporated by reference into this part with 
the approval of the Director of the Federal Register in accordance with 
5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by 
reference (IBR) material is available for inspection at the Coast Guard 
Headquarters and at the National Archives and Records Administration 
(NARA). Contact Commandant (CG-ENG-4), Attn: Lifesaving and Fire Safety 
Division, U.S. Coast Guard Stop 7509, 2703 Martin Luther King Jr. 
Avenue SE, Washington, DC 20593-7509. For information on the 
availability of this material at NARA, visit www.archives.gov/federal-register/cfr/ibr-locations or email [email protected]. The 
material may be obtained from UL, 333 Pfingsten Road, Northbrook, IL 
60062-2002; phone (847) 272-8800; website: www.ul.com.
    (a) ANSI/CAN/UL 9595:2021, Standard for Safety Factory Follow-Up on 
Personal Flotation Devices (PFDs), First Edition, June 4, 2020 
(including revisions through September 9, 2021) (``ANSI/CAN/UL 9595''); 
IBR approved for Sec.  160.255-15(a).
    (b) ANSI/CAN/UL 12402-4:2020, Standard for Safety Personal 
Flotation Devices--Part 4: Lifejackets, Performance Level 100--Safety 
Requirements, First Edition, July 9, 2020 (``ANSI/CAN/UL 12402-4''); 
IBR approved for Sec. Sec.  160.255-7(a); 160.255-13(a) and (b); 
160.255-17(a); 160.255-19; 160.255-21(a).


Sec.  160.255-7   Design, construction, and performance of lifejackets.

    (a) Each Level 100 lifejacket design must--
    (1) Meet the requirements in ANSI/CAN/UL 12402-4 (incorporated by 
reference, see Sec.  160.255-5) for a Level 100 device, and the 
requirements of this subpart; and
    (2) For novel or unique designs, meet any additional requirements 
that the Commandant may prescribe.
    (b) Lifejackets must be of first quality workmanship and must be 
free from any defects materially affecting their appearance or 
serviceability.
    (c) Lifejackets must not provide means intended for fastening or 
securing the device to a boat.


Sec.  160.255-9   Approval procedures for lifejackets.

    (a) Each application for approval of a Level 100 lifejacket must be 
submitted directly to a Coast Guard recognized laboratory.
    (b) The recognized laboratory must determine if a lifejacket with 
novel design features requires a preliminary review by the Coast Guard 
prior to testing. Submissions requiring preliminary review must be sent 
to [email protected], and must include a full description and 
drawings. Pictures, samples, and preliminary test results may also be 
submitted.


Sec.  160.255-11   Recognized laboratory.

    (a) The approval inspections and tests, production inspections, 
tests, and quality control required by this subpart must be conducted 
by an independent laboratory recognized by the Coast Guard under 46 CFR 
subpart 159.010 to perform such functions. A list of recognized 
independent laboratories is available from the Commandant and online at 
https://cgmix.uscg.mil.
    (b) The same laboratory that performs the approval tests must also 
perform production oversight unless the employees of the laboratory 
performing production oversight receive training and support equal to 
that of the laboratory that performed the approval testing, as 
determined by the Commandant.


Sec.  160.255-13   Approval inspections and tests.

    (a) Each lifejacket must be certified by a recognized laboratory as 
meeting the requirements of ANSI/CAN/UL 12402-4 (incorporated by 
reference, see Sec.  160.255-5). Approval tests specified in ANSI/CAN/
UL 12402-4 must be conducted or supervised by a recognized laboratory 
using prototype lifejackets constructed in accordance with the plans 
and specifications submitted with the application for approval.
    (b) Each lifejacket design must be visually examined for compliance 
with the construction and performance requirements of this subpart and 
ANSI/CAN/UL 12402-4 (incorporated by reference, see Sec.  160.255-5).
    (c) The Commandant may prescribe additional tests for approval of 
novel or unique designs.


Sec.  160.255-15   Production inspections, tests, and quality control 
of lifejackets.

    (a) General. Production tests and inspections must be conducted in 
accordance with ANSI/CAN/UL 9595 (incorporated by reference, see Sec.  
160.255-5), or an alternative follow-up procedure accepted by the 
Commandant. To maintain approval, the manufacturer must be in good 
standing under an accepted follow-up procedure.
    (b) Manufacturer's inspection and tests. Manufacturers of approved 
lifejackets must maintain quality control of the materials used, 
manufacturing methods, and the finished product so as to meet the 
applicable requirements, and make sufficient inspections and tests of 
representative samples and components produced to maintain the quality 
of the finished product. Records of tests conducted by the manufacturer 
and records of materials, including affidavits by suppliers that 
applicable requirements are met, must be made available to the 
recognized laboratory inspector or to the Coast Guard marine inspector, 
or both, for review upon request.
    (c) Laboratory inspections and tests. The laboratory inspector will 
conduct examinations, inspections, and tests for listed and labeled 
devices, as required by the recognized laboratory, at the place of 
manufacture or other location at the option of the laboratory.
    (d) Test facilities. The inspector must be admitted to any place in 
the factory where work is being done on listed and labeled products, 
and the inspector may take samples of parts or materials entering 
construction or final assemblies, for further examinations, 
inspections, or tests. The manufacturer must provide a suitable place 
and the apparatus necessary for the performance of the tests done at 
the place of manufacture.
    (e) Additional tests, etc. Unannounced examinations, tests, and 
inspections of samples obtained either directly from the manufacturer 
or through commercial channels may be made to determine the suitability 
of a product for listing and labeling, or to determine conformance of a 
labeled product to the applicable requirements. These may be conducted 
by the recognized laboratory or the United States Coast Guard.

[[Page 97397]]

Sec.  160.255-17   Marking and labeling.

    (a) Each lifejacket must be marked with the appropriate label as 
specified in Figure 6DV of ANSI/CAN/UL 12402-4 (incorporated by 
reference, see Sec.  160.255-5).
    (b) The Commandant may prescribe additional marking requirements 
for special purpose devices or unique or novel designs.


Sec.  160.255-19   Placard.

    Each lifejacket sold or offered for sale must be provided with a 
placard that a prospective purchaser can read prior to purchase, as 
specified in Figure 8DV.1.1a and Figure 8DV.1.1b, Choose the Device You 
Will Want to Wear, of ANSI/CAN/UL 12402-4 (incorporated by reference, 
see Sec.  160.255-5). The required placard text must be printed exactly 
as set out in ANSI/CAN/UL 12402-4, unless otherwise approved by the 
Commandant.


Sec.  160.255-21   Lifejacket manuals.

    (a) An owner's manual in accordance with Figure 7DV of ANSI/CAN/UL 
12402-4 (incorporated by reference, see Sec.  160.255-5), must be 
provided with each inflatable lifejacket sold or offered for sale. The 
text of each manual is reviewed with the application for approval.
    (b) The Commandant may prescribe additional information in the 
manual for special purpose devices or unique or novel designs.
    (c) Additional information, instructions, or illustrations may be 
included in the owner's manual if there is no contradiction to the 
required information.


Sec.  160.255-23   Procedure for approval of design or material change.

    (a) The manufacturer must submit any proposed changes in design, 
material, or construction to the recognized laboratory for approval 
before changing lifejacket production methods.
    (b) Determinations of equivalence of design, construction, and 
materials must be made only by the Commandant or a designated 
representative.


Sec.  160.255-25   Suspension or termination of approval.

    As provided in 46 CFR 159.005-15, the Commandant may suspend or 
terminate the approval of a lifejacket design if the manufacturer fails 
to comply with this subpart or the recognized laboratory's accepted 
procedures or requirements.


Sec.  160.255-27   Servicing for fully and partially inflatable 
lifejackets.

    (a) General. Each lifejacket that relies fully or partially on 
inflation and is approved under this subchapter must be serviced at 
approved facilities at 12-month intervals according to this section.
    (1) Each manufacturer of an approved inflatable lifejacket must 
provide one or more Coast Guard-approved facilities for servicing those 
lifejackets. The manufacturer must notify the Commandant whenever an 
approved facility under its organization no longer provides servicing 
of a lifejacket make and model listed in the guidelines required by 
paragraph (d) of this section.
    (2) Each manufacturer of an approved inflatable lifejacket must 
make replacement parts available to Coast Guard-approved independent 
servicing facilities.
    (b) Servicing facilities. Each Coast Guard-approved servicing 
facility must meet the requirements of this paragraph and paragraph (d) 
of this section to receive and keep its approval for each make and 
model of lifejacket. Approval is obtained according to Sec.  160.255-
5(c).
    (1) Each servicing facility must conduct lifejacket servicing 
according to its servicing guidelines and follow the procedures in the 
service manual required by this section.
    (2) Each servicing facility must have a suitable site for servicing 
that must be clean, well lit, free from excessive dust, drafts, and 
strong sunlight, and have appropriate temperature and humidity control 
as specified in the service manual.
    (3) Each servicing facility must have the appropriate service, 
repair, and test equipment and spare parts for performing required 
tests and repairs.
    (4) Each servicing facility must have a current manufacturer's 
service manual for each make and model of lifejacket serviced.
    (5) A servicing facility may have more than one servicing site 
provided that each site meets the requirements of paragraph (b)(2) of 
this section.
    (6) Each servicing facility must be inspected at intervals not 
exceeding six months by an accepted independent laboratory, and a 
report of the inspections must be submitted to the Commandant at least 
annually. The report must contain enough information to show compliance 
with paragraphs (b)(1) through (4) of this section and paragraph (d) of 
this section. Where a facility uses more than one site the report must 
show compliance at each site at least biennially.
    (c) Service manual. (1) Each manufacturer of an approved inflatable 
lifejacket must prepare a service manual for the lifejacket. The 
service manual must be approved by the Commandant according to Sec.  
160.176-5(b).
    (2) The manufacturer must make the service manual, service manual 
revisions, and service bulletins available to each approved servicing 
facility.
    (3) Each service manual must contain the following:
    (i) Detailed procedures for inspecting, servicing, and repackaging 
the lifejacket;
    (ii) A list of approved replacement parts and materials to be used 
for servicing and repairs, if any;
    (iii) A requirement to mark the date and servicing facility name on 
each lifejacket serviced;
    (iv) Frequency of servicing; and
    (v) Any specific restrictions or special procedures prescribed by 
the Coast Guard or manufacturer.
    (4) Each service manual revision and service bulletin which 
authorizes the modification of a lifejacket, or which affects a 
requirement under this subpart, must be approved by the Commandant. 
Other revisions and service bulletins are not required to be approved, 
but a copy of each must be sent to the Commandant when it is issued. At 
least once each year, the manufacturer must provide to the Commandant 
and to each servicing facility approved to service its lifejackets a 
bulletin listing each service manual revision and bulletin in effect.
    (d) Servicing facilities guidelines. Each servicing facility must 
have written guidelines that include the following:
    (1) Identification of each make and model of lifejacket that may be 
serviced by the facility as well as the manual and revision to be used 
for servicing;
    (2) Identification of the person, by title or position, who is 
responsible for the servicing program;
    (3) Training and qualifications of servicing technicians;
    (4) Provisions for the facility to retain a copy of its current 
letter of approval from the Coast Guard at each site; and
    (5) Requirements to--
    (i) Ensure each inflatable lifejacket serviced under its Coast 
Guard approval is serviced in accordance with the manufacturer's 
service manual;
    (ii) Keep servicing technicians informed of each approved servicing 
manual revision and bulletin and ensure servicing technicians 
understand each change and new technique related to the lifejackets 
serviced by the facility;
    (iii) Calibrate each pressure gauge, weighing scale, and 
mechanically operated barometer at intervals of not more than one year;
    (iv) Ensure each inflatable lifejacket serviced under the 
facility's Coast Guard approval is serviced by or under the supervision 
of a servicing technician

[[Page 97398]]

who meets the requirements of paragraph (d)(3) of this section;
    (v) Specify each make and model of lifejacket the facility is 
approved to service when it represents itself as approved by the U.S. 
Coast Guard; and
    (vi) Not service any lifejacket for a U.S. registered commercial 
vessel, unless it is approved by the U.S. Coast Guard to service the 
make and model of lifejacket.
    (e) Servicing records. Each servicing facility must maintain 
records of all completed servicing. These records must be retained for 
at least 5 years after they are made, be made available to any Coast 
Guard representative and independent laboratory inspector upon request, 
and include at least the following:
    (1) Date of servicing, number of lifejackets serviced, lot 
identification, approval number, and test results data for the 
lifejackets serviced;
    (2) Identification of the person conducting the servicing;
    (3) Identity of the vessel receiving the serviced lifejackets; and
    (4) Date of return to the vessel.

0
79. Add subpart 160.264, consisting of Sec. Sec.  160.264-1 through 
160.264-25, to read as follows:
Subpart 160.264--Wearable Recreational Personal Flotation Devices 
(PFDs)
Sec.
160.264-1 Scope.
160.264-3 Definitions.
160.264-5 Incorporation by reference.
160.264-7 Design, construction, and performance of PFDs.
160.264-9 Approval procedures for PFDs.
160.264-11 Recognized laboratory.
160.264-13 Approval inspections and tests.
160.264-15 Production inspections, tests, and quality control of 
PFDs.
160.264-17 Marking and labeling.
160.264-19 Placard.
160.264-21 PFD manuals.
160.264-23 Procedure for approval of design or material change.
160.264-25 Suspension or termination of approval.

Subpart 160.264--Wearable Recreational Personal Flotation Devices 
(PFDs)


Sec.  160.264-1   Scope.

    (a) This subpart contains structural and performance standards for 
approval of Level 50 and Level 70 inherently buoyant personal flotation 
devices (PFDs), as well as requirements for production follow-up 
inspections, markings, information placards, and associated manuals.
    (b) PFDs approved under this subpart rely entirely upon inherently 
buoyant material to achieve the minimum buoyancy.
    (c) PFDs approved under this subpart are intended to meet the 
carriage requirements for wearable PFDs for uninspected commercial 
vessels under 40 ft (12m) not carrying passengers for hire and 
recreational boats, in accordance with 33 CFR part 175 and 46 CFR 
25.25.


Sec.  160.264-3   Definitions.

    The following definitions apply to this subpart:
    Commandant means the Chief of the Lifesaving and Fire Safety 
Standards Division. Address: Commandant (CG-ENG-4), Attn: Lifesaving 
and Fire Safety Division, U.S. Coast Guard Stop 7509, 2703 Martin 
Luther King Jr. Avenue SE, Washington, DC 20593-7509; email 
[email protected].
    First quality workmanship means construction that is free from any 
defect materially affecting appearance or serviceability.
    Inspector means a recognized laboratory representative assigned to 
perform, supervise, or oversee the duties described in Sec.  160.264-15 
or any Coast Guard representative performing duties related to the 
approval.
    Recognized laboratory means an independent laboratory accepted by 
the Commandant in accordance with 46 CFR subpart 159.010, with a valid 
memorandum of understanding in accordance with 46 CFR 159.010-7.


Sec.  160.264-5   Incorporation by reference.

    Certain material is incorporated by reference into this part with 
the approval of the Director of the Federal Register in accordance with 
5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by 
reference (IBR) material is available for inspection at the Coast Guard 
Headquarters and at the National Archives and Records Administration 
(NARA). Contact Commandant (CG-ENG-4), Attn: Lifesaving and Fire Safety 
Division, U.S. Coast Guard Stop 7509, 2703 Martin Luther King Jr. 
Avenue SE, Washington, DC 20593-7509. For information on the 
availability of this material at NARA, visit www.archives.gov/federal-register/cfr/ibr-locations or email [email protected]. The 
material may be obtained from UL, 333 Pfingsten Road, Northbrook, IL 
60062-2002; phone (847) 272-8800; website: www.ul.com.
    (a) ANSI/CAN/UL 9595:2021, Standard for Safety Factory Follow-Up on 
Personal Flotation Devices (PFDs), First Edition, June 4, 2020 
(including revisions through September 9, 2021) (``ANSI/CAN/UL 9595''); 
IBR approved for Sec.  160.264-15(a).
    (b) ANSI/CAN/UL 12402-5:2022, Standard for Safety Personal 
Flotation Devices--Part 5: Buoyancy Aids (Level 50)--Safety 
Requirements, First Edition, December 31, 2015 (including revisions 
through January 27, 2022) (``ANSI/CAN/UL 12402-5''); IBR approved for 
Sec. Sec.  160.264-7(a) and (b); 160.264-13(a) and (b); 160.264-17(a); 
160.264-19; 160.264-21(a).


Sec.  160.264-7   Design, construction, and performance of PFDs.

    (a) Each Level 70 PFD design must--
    (1) Meet the requirements in ANSI/CAN/UL 12402-5 (incorporated by 
reference, see Sec.  160.264-5) for a Level 70 device; and
    (2) For novel or unique designs, meet any additional requirements 
that the Commandant may prescribe.
    (b) Each Level 50 PFD design must--
    (1) Meet the requirements in ANSI/CAN/UL 12402-5 (incorporated by 
reference, see Sec.  160.264-5) for a Level 50 device;
    (2) Be marked to indicate that the device must be worn to be 
counted as equipment required by vessels meeting USCG regulations; and
    (3) For novel or unique designs, meet any additional requirements 
that the Commandant may prescribe.
    (c) Buoyancy is to be provided by inherently buoyant material and 
not depend on loose, granulated material, gas compartments, or 
inflation.
    (d) PFDs must be of first quality workmanship and must be free from 
any defects materially affecting their appearance or serviceability.
    (e) PFDs must not provide means intended for fastening or securing 
the device to a boat.


Sec.  160.264-9   Approval procedures for PFDs.

    (a) Each application for approval of a Level 50 or Level 70 PFD 
must be submitted directly to a Coast Guard recognized laboratory.
    (b) The recognized laboratory must determine if a PFD with novel 
design features requires a preliminary review by the Coast Guard prior 
to testing. Submissions requiring preliminary review must be sent to 
[email protected], and must include a full description and 
drawings. Pictures, samples, and preliminary test results may also be 
submitted.


Sec.  160.264-11   Recognized laboratory.

    (a) The approval inspections and tests, production inspections, 
tests, and quality control required by this subpart must be conducted 
by an independent laboratory recognized by the Coast Guard under 46 CFR 
subpart 159.010 to perform such functions. A list of recognized 
independent laboratories is

[[Page 97399]]

available from the Commandant and online at https://cgmix.uscg.mil.
    (b) Production oversight must be performed by the same laboratory 
that performs the approval tests unless, as determined by the 
Commandant, the employees of the laboratory performing production 
oversight receive training and support equal to that of the laboratory 
that performed the approval testing.


Sec.  160.264-13   Approval inspections and tests.

    (a) Each PFD must be certified by a recognized laboratory as 
meeting the requirements of ANSI/CAN/UL 12402-5 (incorporated by 
reference, see Sec.  160.264-5) for an inherently buoyant Level 50 or 
Level 70 PFD. Approval tests specified in ANSI/CAN/UL 12402-5 must be 
conducted or supervised by a recognized laboratory using PFDs 
constructed in accordance with the plans and specifications submitted 
with the application for approval.
    (b) Each PFD design must be visually examined for compliance with 
the construction and performance requirements of this subpart and ANSI/
CAN/UL 12402-5 (incorporated by reference, see Sec.  160.264-5).
    (c) The Commandant may prescribe additional tests for approval of 
novel or unique designs.


Sec.  160.264-15   Production inspections, tests, and quality control 
of PFDs.

    (a) General. Production tests and inspections must be conducted in 
accordance with ANSI/CAN/UL 9595 (incorporated by reference, see Sec.  
160.264-5) or an alternative follow-up procedure accepted by the 
Commandant. To maintain approval, the manufacturer must be in good 
standing under an accepted follow-up procedure.
    (b) Manufacturer's inspection and tests. Manufacturers of approved 
PFDs must maintain quality control of the materials used, manufacturing 
methods, and the finished product to meet the applicable requirements, 
and make sufficient inspections and tests of representative samples and 
components produced to maintain the quality of the finished product. 
Records of tests conducted by the manufacturer and records of 
materials, including affidavits by suppliers that applicable 
requirements are met, must be made available to the recognized 
laboratory inspector or to the Coast Guard marine inspector, or both, 
for review upon request.
    (c) Laboratory inspections and tests. The laboratory inspector will 
conduct examinations, inspections, and tests for listed and labeled 
devices, as required by the recognized laboratory, at the place of 
manufacture or other location at the option of the laboratory.
    (d) Test facilities. The laboratory inspector, or the Coast Guard 
marine inspector assigned by the Commander of the District in which the 
factory is located, or both, must be admitted to any place in the 
factory where work is being done on listed and labeled products. Either 
or both inspectors may take samples of parts or materials entering 
construction or final assemblies, for further examinations, 
inspections, or tests. The manufacturer must provide a suitable place 
and the apparatus necessary for the performance of the tests done at 
the place of manufacture.
    (e) Additional tests, etc. Unannounced examinations, tests, and 
inspections of samples obtained either directly from the manufacturer 
or through commercial channels may be made to determine the suitability 
of a product for listing and labeling, or to determine conformance of a 
labeled product to the applicable requirements. These may be conducted 
by the recognized laboratory or the United States Coast Guard.


Sec.  160.264-17   Marking and labeling.

    (a) Each PFD must be marked with the appropriate label as specified 
in Figure 6DV of ANSI/CAN/UL 12402-5 (incorporated by reference, see 
Sec.  160.264-5).
    (b) The Commandant may prescribe additional marking requirements 
for special purpose devices or unique or novel designs.


Sec.  160.264-19   Placard.

    Each PFD sold or offered for sale must be provided with a placard 
that a prospective purchaser can read prior to purchase, as specified 
in Figure 8DV.1.1a and Figure 8DV.1.1b, Choose the Device You Will Want 
to Wear, of ANSI/CAN/UL 12402-5 (incorporated by reference, see Sec.  
160.264-5). The required placard text must be printed exactly as set 
out in ANSI/CAN/UL 12402-5.


Sec.  160.264-21   PFD manuals.

    (a) An owner's manual in accordance with Figure 7DV of ANSI/CAN/UL 
12402-5 (incorporated by reference, see Sec.  160.264-5), may be 
provided with each inherently buoyant PFD sold or offered for sale. The 
text of each manual is reviewed with the application for approval.
    (b) The Commandant may prescribe additional information in the 
manual for special purpose devices or unique or novel designs.
    (c) Additional information, instructions, or illustrations may be 
included in the owner's manual if there is no contradiction to the 
required information.


Sec.  160.264-23   Procedure for approval of design or material change.

    (a) The manufacturer must submit any proposed changes in design, 
material, or construction to the recognized laboratory for approval 
before changing PFD production methods.
    (b) Determinations of equivalence of design, construction, and 
materials must be made only by the Commandant or a designated 
representative.


Sec.  160.264-25   Suspension or termination of approval.

    As provided in 46 CFR 159.005-15, the Commandant may suspend or 
terminate the approval of a PFD design if the manufacturer fails to 
comply with this subpart or the recognized laboratory's accepted 
procedures or requirements.

0
80. Add subpart 160.276, consisting of Sec. Sec.  160.276-1 through 
160.276-25, to read as follows:
Subpart 160.276--Wearable Recreational Inflatable Personal Flotation 
Devices
160.276-1 Scope.
160.276-3 Definitions.
160.276-5 Incorporation by reference.
160.276-7 Design, construction, and performance of PFDs.
160.276-9 Approval procedures for PFDs.
160.276-11 Recognized laboratory.
160.276-13 Approval inspections and tests.
160.276-15 Production inspections, tests, and quality control of 
PFDs.
160.276-17 Marking and labeling.
160.276-19 Placard.
160.276-21 PFD manuals.
160.276-23 Procedure for approval of design or material change.
160.276-25 Suspension or termination of approval.

Subpart 160.276--Wearable Recreational Inflatable Personal 
Flotation Devices


Sec.  160.276-1   Scope.

    (a) This subpart contains structural and performance standards for 
approval of Level 50 and Level 70 inflatable recreational personal 
flotation devices (PFDs), as well as requirements for production 
follow-up inspections, associated manuals, information placards, and 
markings.
    (b) Inflatable PFDs approved under this subpart rely entirely or 
partially upon inflation to achieve the minimum buoyancy.
    (c) PFDs approved under this subpart are intended to meet the 
carriage requirements for uninspected

[[Page 97400]]

commercial vessels under 40 ft (12m) not carrying passengers for hire 
and recreational boats, in accordance with 33 CFR part 175 and 46 CFR 
25.25.


Sec.  160.276-3   Definitions.

    The following definitions apply to this subpart:
    Commandant means the Chief of the Lifesaving and Fire Safety 
Standards Division. Address: Commandant (CG-ENG-4), Attn: Lifesaving 
and Fire Safety Division, U.S. Coast Guard Stop 7509, 2703 Martin 
Luther King Jr. Avenue SE, Washington, DC 20593-7509; email 
[email protected].
    First quality workmanship means construction that is free from any 
defect materially affecting appearance or serviceability.
    Inspector means a recognized laboratory representative assigned to 
perform, supervise, or oversee the duties described in Sec.  160.276-15 
or any Coast Guard representative performing duties related to the 
approval.
    Recognized laboratory means an independent laboratory accepted by 
the Commandant in accordance with 46 CFR 159.010, with a valid 
memorandum of understanding in accordance with 46 CFR 159.010-7.


Sec.  160.276-5   Incorporation by reference.

    Certain material is incorporated by reference into this part with 
the approval of the Director of the Federal Register in accordance with 
5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by 
reference (IBR) material is available for inspection at the Coast Guard 
Headquarters and at the National Archives and Records Administration 
(NARA). Contact Commandant (CG-ENG-4), Attn: Lifesaving and Fire Safety 
Division, U.S. Coast Guard Stop 7509, 2703 Martin Luther King Jr. 
Avenue SE, Washington, DC 20593-7509. For information on the 
availability of this material at NARA, visit www.archives.gov/federal-register/cfr/ibr-locations or email [email protected]. The 
material may be obtained from UL, 333 Pfingsten Road, Northbrook, IL 
60062-2022; phone (847) 272-8800; website: www.ul.com.
    (a) ANSI/CAN/UL 9595:2021, Standard for Safety Factory Follow-Up on 
Personal Flotation Devices (PFDs), First Edition, June 4, 2020 
(including revisions through September 9, 2021) (``ANSI/CAN/UL 9595''); 
IBR approved for Sec.  160.276-15(a).
    (b) ANSI/CAN/UL 12402-5:2022, Standard for Safety Personal 
Flotation Devices--Part 5: Buoyancy Aids (Level 50)--Safety 
Requirements, First Edition, December 31, 2015 (including revisions 
through January 27, 2022) (``ANSI/CAN/UL 12402-5''); IBR approved for 
Sec. Sec.  160.276-7(a) and (b); 160.276-13(a) and (b); 160.276-17(a) 
and (b); 160.276-19; 160.276-21(a).


Sec.  160.276-7   Design, construction, and performance of inflatable 
PFDs.

    (a) Each Level 70 inflatable PFD design must--
    (1) Meet the requirements in ANSI/CAN/UL 12402-5 (incorporated by 
reference, see Sec.  160.276-5) for a Level 70 device; and
    (2) For novel or unique designs, meet any additional requirements 
that the Commandant may prescribe.
    (b) Each Level 50 inflatable PFD design must--
    (1) Meet the requirements in ANSI/CAN/UL 12402-5 (incorporated by 
reference, see Sec.  160.276-5) for a Level 50 device;
    (2) Be marked to indicate that the device must be worn to be 
counted as equipment required by vessels meeting USCG regulations; and
    (3) For novel or unique designs, meet any additional requirements 
that the Commandant may prescribe.
    (c) Buoyancy is to be provided by inflation, or a combination of 
inherently buoyant material and inflation.
    (d) PFDs must be of first quality workmanship and must be free from 
any defects materially affecting their appearance or serviceability.
    (e) PFDs must not provide means intended for fastening or securing 
the device to a boat.


Sec.  160.276-9   Approval procedures for PFDs.

    (a) Each application for approval of a Level 50 or Level 70 PFD 
must be submitted directly to a Coast Guard recognized laboratory.
    (b) The recognized laboratory must determine if a PFD with novel 
design features requires a preliminary review by the Coast Guard prior 
to testing. Submissions requiring preliminary review must be sent to 
[email protected], and must include a full description and 
drawings. Pictures, samples, and preliminary test results may also be 
submitted.


Sec.  160.276-11   Recognized laboratory.

    (a) The approval inspections and tests and production inspections, 
tests, and quality control required by this subpart must be conducted 
by an independent laboratory recognized by the Coast Guard under 46 CFR 
subpart 159.010 to perform such functions. A list of recognized 
independent laboratories is available from the Commandant and online at 
https://cgmix.uscg.mil.
    (b) The same laboratory that performs the approval tests must also 
perform production oversight unless the employees of the laboratory 
performing production oversight receive training and support equal to 
that of the laboratory that performed the approval testing, as 
determined by the Commandant.


Sec.  160.276-13   Approval inspections and tests.

    (a) Each PFD must be certified by a recognized laboratory as 
meeting the requirements of ANSI/CAN/UL 12402-5 (incorporated by 
reference, see Sec.  160.276-5) for an inflatable Level 50 or Level 70 
PFD. Approval tests specified in ANSI/CAN/UL 12402-5 must be conducted 
or supervised by a recognized laboratory using PFDs constructed in 
accordance with the plans and specifications submitted with the 
application for approval.
    (b) Each PFD design must be visually examined for compliance with 
the construction and performance requirements of this subpart and ANSI/
CAN/UL 12402-5 (incorporated by reference, see Sec.  160.276-5).
    (c) The Commandant may prescribe additional tests for approval of 
novel or unique designs.


Sec.  160.276-15   Production inspections, tests, and quality control 
of PFDs.

    (a) General. Production tests and inspections must be conducted in 
accordance with ANSI/CAN/UL 9595 (incorporated by reference, see Sec.  
160.276-5) or an alternative follow-up procedure accepted by the 
Commandant. To maintain approval, the manufacturer must be in good 
standing under an approved follow-up procedure.
    (b) Manufacturer's inspection and tests. Manufacturers of approved 
PFDs must maintain quality control of the materials used, manufacturing 
methods, and the finished product to meet the applicable requirements, 
and make sufficient inspections and tests of representative samples and 
components produced to maintain the quality of the finished product. 
Records of tests conducted by the manufacturer and records of 
materials, including affidavits by suppliers that applicable 
requirements are met, must be made available to the recognized 
laboratory inspector or to the Coast Guard marine inspector, or both, 
for review upon request.
    (c) Laboratory inspections and tests. The laboratory inspector will 
conduct examinations, inspections, and tests for listed and labeled 
devices, as required by the recognized laboratory, at the place of 
manufacture or other location at the option of the laboratory.

[[Page 97401]]

    (d) Test facilities. The laboratory inspector, or the Coast Guard 
marine inspector assigned by the Commander of the District in which the 
factory is located, or both, must be admitted to any place in the 
factory where work is being done on listed and labeled products. Either 
or both inspectors may take samples of parts or materials entering 
construction or final assemblies, for further examinations, 
inspections, or tests. The manufacturer must provide a suitable place 
and the apparatus necessary for the performance of the tests done at 
the place of manufacture.
    (e) Additional tests, etc. Unannounced examinations, tests, and 
inspections of samples obtained either directly from the manufacturer 
or through commercial channels may be made to determine the suitability 
of a product for listing and labeling, or to determine conformance of a 
labeled product to the applicable requirements. These may be conducted 
by the recognized laboratory or the United States Coast Guard.


Sec.  160.276-17   Marking and labeling.

    (a) Each inflatable PFD must be marked as specified in Figure 6DV 
of ANSI/CAN/UL 12402-5 (incorporated by reference, see Sec.  160.276-
5).
    (b) In addition to the information required by ANSI/CAN/UL 12402-5, 
Figure 6DV, each Level 50 inflatable PFD must be marked with a 
statement that the device must be worn to be counted as equipment 
required by vessels meeting USCG regulations; and
    (c) The Commandant may prescribe additional marking requirements 
for special purpose devices or unique or novel designs.


Sec.  160.276-19   Placard.

    Each inflatable PFD sold or offered for sale must be provided with 
a placard that a prospective purchaser can read prior to purchase, as 
specified in Figure 8DV.1.1a and Figure 8DV.1.1b, Choose the Device You 
Will Want to Wear, of ANSI/CAN/UL 12402-5 (incorporated by reference, 
see Sec.  160.276-5). The required placard text must be printed exactly 
as set out in ANSI/CAN/UL 12402-5.


Sec.  160.276-21   PFD manuals.

    (a) An owner's manual in accordance with Figure 7DV of ANSI/CAN/UL 
12402-5 (incorporated by reference, see Sec.  160.276-5), must be 
provided with each inflatable PFD sold or offered for sale. The text of 
each manual is reviewed with the application for approval.
    (b) The Commandant may prescribe additional information in the 
manual for special purpose devices or unique or novel designs.
    (c) Additional information, instructions, or illustrations may be 
included in the owner's manual if there is no contradiction to the 
required information.


Sec.  160.276-23   Procedure for approval of design or material change.

    (a) The manufacturer must submit any proposed changes in design, 
material, or construction to the recognized laboratory for approval 
before changing PFD production methods.
    (b) Determinations of equivalence of design, construction, and 
materials must be made only by the Commandant or a designated 
representative.


Sec.  160.276-25   Suspension or termination of approval.

    As provided in 46 CFR 159.005-15, the Commandant may suspend or 
terminate the approval of an inflatable PFD design if the manufacturer 
fails to comply with this subpart or the recognized laboratory's 
accepted procedures or requirements.

PART 169--SAILING SCHOOL VESSELS

0
81. The authority citation for part 169 continues to read as follows:

    Authority:  33 U.S.C. 1321(j); 46 U.S.C. 3306, 6101; Public Law 
103-206, 107 Stat. 2439; E.O. 11735, 38 FR 21243, 3 CFR, 1971-1975 
Comp., p. 793; DHS Delegation 00170.1, Revision No. 01.4; Sec.  
169.117 also issued under the authority of 44 U.S.C. 3507.


0
82. Revise Sec.  169.539 to read as follows:


Sec.  169.539   Type required.

    All personal flotation devices (PFDs) must be:
    (a) Approved under subpart 160.002, 160.005, 160.055, or 160.255 of 
subchapter Q (specification) of this chapter;
    (b) Approved specifically for sailing school vessel use under 
subpart 160.064, 160.077, or 160.264 of Subchapter Q of this chapter; 
or
    (c) Approved under subparts 160.047, 160.052, or 160.060 of part 
160 of this chapter or approved under subpart 160.064 or 160.264 of 
part 160 of this chapter if the vessel carries exposure suits or 
exposure PFDs, in accordance with Sec.  169.551.

PART 180--LIFESAVING EQUIPMENT AND ARRANGEMENTS

0
83. The authority citation for part 180 is revised to read as follows:

    Authority:  46 U.S.C. 2104, 3306; E.O. 12234, 45 FR 58801, 3 
CFR, 1980 Comp., p. 277; DHS Delegation 00170.1, Revision No. 01.4.


0
84. Amend Sec.  180.71 by:
0
a. Revising the section heading and paragraph (c);
0
b. Removing paragraph (d); and
0
c. Redesignating paragraph (e) as paragraph (d).
    The revisions read as follows:


Sec.  180.71   Lifejackets.

* * * * *
    (c) Each lifejacket must be approved under approval series in 
subparts 160.002, 160.005, 160.055, 160.115, 160.176, or 160.255 in 
part 160 of this chapter, or other standard specified by the 
Commandant. An inflatable lifejacket approved under approval series in 
subpart 160.255 of part 160 of this chapter must include a full back-up 
inflation chamber.
* * * * *

0
85. Amend Sec.  180.72 by revising the section heading and paragraphs 
(a), (b), and (d) to read as follows:


Sec.  180.72   Personal flotation devices carried in addition to 
lifejackets.

    (a) Equipment carried under this section is not acceptable in lieu 
of any portion of the required number of approved lifejackets and must 
not be substituted for the approved lifejackets required to be worn 
during drills and emergencies.
    (b) Wearable marine buoyant devices approved in accordance with 
Sec.  160.064, 160.076, 160.264, or 160.276 in subchapter Q of this 
chapter, or other standard specified by the Commandant, may be carried 
as additional equipment.
* * * * *
    (d) A commercial hybrid approved under former approval series 
160.077 prior to January 6, 2025 may be carried as additional equipment 
for use by persons working near or over the water if it is in good and 
serviceable condition, used in accordance with the conditions marked on 
the PFD and in the owner's manual, and of the same or similar design 
and has the same method of operation as each other hybrid PFD carried 
on board.

PART 199--LIFESAVING SYSTEMS FOR CERTAIN INSPECTED VESSELS

0
86. The authority citation for part 199 continues to read as follows:

    Authority:  46 U.S.C. 3306, 3703; Public Law 103-206, 107 Stat. 
2439; DHS Delegation 00170.1, Revision No. 01.4.


0
87. Revise Sec.  199.70(b) introductory text to read as follows:

[[Page 97402]]

Sec.  199.70   Personal lifesaving appliances.

* * * * *
    (b) Lifejackets. Each vessel must carry lifejackets approved under 
approval series 160.155 or 160.176. If the vessel carries inflatable 
lifejackets, they must be of the same or similar design and have the 
same method of operation.
* * * * *

0
88. Revise Sec.  199.620(c) to read as follows:


Sec.  199.620   Alternatives for all vessels in a specified service.

* * * * *
    (c) Lifejackets approval series. As an alternative to a lifejacket 
meeting the approval requirements in Sec.  199.70, vessels may carry a 
lifejacket approved under approval series in subparts 160.002, 160.005, 
160.055, 160.077, or 160.255 of part 160 of this chapter. An inflatable 
lifejacket approved under approval series in subpart 160.255 of part 
160 of this chapter must include a full back-up inflation chamber.
* * * * *

    Dated: November 26, 2024.
W.R. Arguin,
Rear Admiral, U.S. Coast Guard, Assistant Commandant for Prevention 
Policy.
[FR Doc. 2024-28264 Filed 12-5-24; 8:45 am]
 BILLING CODE 9110-04-P

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