89 FR 235 pgs. 97356-97402 - Lifejacket Approval Harmonization
Type: RULEVolume: 89Number: 235Pages: 97356 - 97402
Pages: 97356, 97357, 97358, 97359, 97360, 97361, 97362, 97363, 97364, 97365, 97366, 97367, 97368, 97369, 97370, 97371, 97372, 97373, 97374, 97375, 97376, 97377, 97378, 97379, 97380, 97381, 97382, 97383, 97384, 97385, 97386, 97387, 97388, 97389, 97390, 9739197392, 97393, 97394, 97395, 97396, 97397, 97398, 97399, 97400, 97401, 97402, Docket number: [Docket No. USCG-2022-0120]
FR document: [FR Doc. 2024-28264 Filed 12-5-24; 8:45 am]
Agency: Homeland Security Department
Sub Agency: Coast Guard
Official PDF Version: PDF Version
[top]
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.
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 Jacqueline.M.Yurkovich@uscg.mil .
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
§ 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
Footnotes:
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).
[top] 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
Footnotes:
3 ? https://www.federalregister.gov/documents/2012/04/03/2012-7791/inflatable-personal-flotation-devices (last accessed November 15, 2024).
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
Footnotes:
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).
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.
Footnotes:
6 ? https://www.federalregister.gov/documents/2023/04/07/2023-06504/lifejacket-approval-harmonization . (last accessed November 7, 2024).
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 §?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.
[top] 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
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.
Footnotes:
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
Footnotes:
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.
[top] 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
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.
Footnotes:
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.
Footnotes:
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 §?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.
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.
[top] 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
Footnotes:
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.
Footnotes:
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
Footnotes:
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 §?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.
[top] 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
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 §?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.
[top] • ANSI/CAN/UL 9595, Standard for Safety Factory Follow-Up on Personal
• 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 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:
? Method 5100, Strength and Elongation, Breaking of Woven Cloth; Grab Method;
? Method 5132, Strength of Cloth, Tearing; Falling-Pendulum Method;
? Method 5134, Strength of Cloth, Tearing; Tongue Method;
? Method 5804.1, Weathering Resistance of Cloth; Accelerated Weathering Method; and
? 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 §?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 cross-reference §?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
[top] 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
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.
| 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 | $1,865,564 |
| Annualized | 207,687 | |
| Costs to Foreign Firms ($2023, 2% discount rate) | 10-year | 455,782 |
| Annualized | 50,741 | |
| Total Costs ($2023, 2% discount rate) | 10-year | 2,321,343 |
| Annualized | 258,427 | |
| Benefits to American Firms ($2023, 2% discount rate) | 10-year | 8,871,985 |
| Annualized | 987,687 | |
| Benefits to Foreign Firms ($2023, 2% discount rate) | 10-year | 2,222,303 |
| Annualized | 247,401 | |
| Benefits to the United States Government ($2023, 2% discount rate) | 10-year | 38,895 |
| Annualized | 4,330 | |
| Total Benefits to All Entities ($2023, 2% discount rate) | 10-year | 11,133,183 |
| Annualized | 1,239,419 | |
| Net Benefits to American Firms ($2023, 2% discount rate) | 10-year | 7,006,423 |
| Annualized | 780,001 | |
| Net Benefits to Foreign Firms ($2023, 2% discount rate) | 10-year | 1,766,522 |
| Annualized | 196,661 | |
| Net Benefits to the United States Government ($2023, 2% discount rate) | 10-year | 38,895 |
| Annualized | 4,330 | |
| Net Benefits to All Entities ($2023, 2% discount rate) | 10-year | 8,811,839 |
| 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. |
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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.
Footnotes:
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
Footnotes:
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.
[top]
| Manufacturing firms | Total market share (%) | U.S. firm market share (%) | Foreign firm market 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
Footnotes:
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.
| Firm ownership | U.S. firms | Foreign firms | U.S. associated facilities | Foreign facilities | Total 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.
| Subpart | PFD type | New or existing subpart |
|---|---|---|
| 160.045 | Throwable PFDs | New. |
| 160.255 | Level 100 PFDs | New. |
| 160.264 | Inherently Buoyant Level 50 and Level 70 PFDs | New. |
| 160.276 | Inflatable Level 50 and Level 70 PFDs | New. |
| 160.055 | Life Preservers | Existing. |
| 160.060 | Buoyant Vests | Existing. |
| 160.064 | Marine Buoyant Devices | Existing. |
| 160.076 | Inflatable PFDs | Existing. |
[top] 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
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.
Footnotes:
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.
| Firm category | Process rating | Market share (%) |
|---|---|---|
| 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.
| Device category | Types of instructions allowed by the final rule | Types of instructions currently in use |
|---|---|---|
| New Level 50 Devices (ANSI/CAN/UL 12402-5) | Placard | N/A because these devices are not yet produced. |
| New Level 70 Devices (ANSI/CAN/UL 12402-5) | Placard | Placard. |
| New Level 100 Devices (ANSI/CAN/UL 12402-4) | Placard | N/A because these devices are not yet produced. |
| Existing Type I Commercial Devices | Placard or Information Pamphlet | Information Pamphlet. |
| Existing Type II Recreational Devices | Placard or Information Pamphlet | Information Pamphlet. |
| Existing Type III Recreational Devices | Placard or Information Pamphlet | Information Pamphlet. |
| Existing Type IV Throwable Devices | Information Pamphlet | Information 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
Footnotes:
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
Footnotes:
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.
[top]
| Year | Total undiscounted costs | Discounted 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.
| Year | Total undiscounted costs | Discounted 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.
[top]
| Year | Total undiscounted costs | Discounted 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 | |
| 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.
| Annual cost savings item | Cost savings to U.S. entities | Cost savings to foreign entities |
|---|---|---|
| Value of Coast Guard time saved | $4,330 | $0 |
| Canadian and United States approval savings | 27,779 | 10,274 |
| 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.
[top]
| Year | Total undiscounted cost savings | Discounted 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 | |
| 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 |
| Year | Total undiscounted cost savings | Discounted 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 |
| Year | Total undiscounted cost savings | Discounted 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 |
[top] 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.
| Year | Total undiscounted cost savings | Discounted 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
Footnotes:
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.
| Year | Total undiscounted cost | Discounted 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 |
[top]
| Year | Total undiscounted cost | Discounted 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 |
| Year | Total undiscounted cost | Discounted 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
Footnotes:
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.
Footnotes:
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.
[top] 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,
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.
| Year | Total undiscounted cost | Discounted 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 |
[top]
| Year | Total undiscounted cost | Discounted 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 | |
| 8 | 3,512 | 2,997 | |
| 9 | 3,512 | 2,939 | |
| 10 | 3,512 | 2,881 | |
| Total | 55,352 | 51,382 | |
| Annualized | 5,720 |
| Year | Total undiscounted cost | Discounted 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.
| Year | Total undiscounted cost savings | Discounted 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 |
[top]
| Year | Total undiscounted cost savings | Discounted 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 |
| Year | Total undiscounted cost savings | Discounted 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
Footnotes:
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.
[top]
| Device category | Types of instructions allowed by the final rule | Types of instructions currently in use |
|---|---|---|
| New Level 50 Devices (ANSI/CAN/UL 12402-5) | Placard | N/A because these devices are not yet produced. |
| New Level 70 Devices (ANSI/CAN/UL 12402-5) | Placard | Placard. |
| New Level 100 Devices (ANSI/CAN/UL 12402-4) | Placard | N/A because these devices are not yet produced. |
| Existing Type I Commercial Devices | Placard or Information Pamphlet | Information Pamphlet. |
| Existing Type II Recreational Devices | Placard or Information Pamphlet | Information Pamphlet. |
| Existing Type III Recreational Devices | Placard or Information Pamphlet | Information Pamphlet. |
| Existing Type IV Throwable Devices | Information Pamphlet | Information 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
Footnotes:
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.
| Year | Total undiscounted costs | Discounted 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 |
[top]
| Year | Total undiscounted costs | Discounted costs | 2% |
|---|---|---|---|
| 1 | $171,019 | $167,666 | |
| 2 | 158,374 | 152,224 | |
| 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 |
| Year | Total undiscounted costs | Discounted 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.
| Year | Total undiscounted cost savings | Discounted 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 |
[top]
| Year | Total undiscounted cost savings | Discounted 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 |
| Year | Total undiscounted cost savings | Discounted 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 |
| Year | Total undiscounted cost savings | Discounted 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 |
[top]
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.
| Year | Net undiscounted cost savings | Net discounted 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 |
| Year | Net undiscounted cost savings | Net discounted 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 |
[top]
| Year | Net undiscounted cost savings | Net discounted 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 |
| Year | Net undiscounted cost savings | Net discounted 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.
[top] 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
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.
[top] 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.
| NAICS code | NAICS code and industry type | Size standard type | Size standard used?* | Number of U.S. companies | Number of small entities |
|---|---|---|---|---|---|
| 314910 | Textile Bag and Canvas Mills | Employees | 500 | 1 | 1 |
| 314999 | All Other Miscellaneous Store Retailers (except Tobacco Stores) | Revenue | $8.0 | 2 | 2 |
| 315280 | Other Cut and Sew Apparel Manufacturing | Employees | 750 | 1 | 1 |
| 315990 | Apparel Accessories and Other Apparel Manufacturing | Employees | 500 | 1 | 1 |
| 326199 | All Other Plastics Product Manufacturing | Employees | 750 | 2 | 0 |
| 326299 | All Other Rubber Product Manufacturing | Employees | 500 | 1 | 1 |
| 327120 | Clay Building Material and Refractories Manufacturing | Employees | 750 | 1 | 1 |
| 336612 | Boat Building | Employees | 1,000 | 2 | 2 |
| 339920 | Sporting and Athletic Goods Manufacturing | Employees | 750 | 4 | 3 |
| 339999 | All Other Miscellaneous Manufacturing | Employees | 500 | 1 | 1 |
| 423910 | Sporting and Recreational Goods and Supplies Merchant Wholesalers | Employees | 100 | 1 | 1 |
| 441222 | Boat Dealers | Revenue | $35.0 | 5 | 4 |
| 448140 | Family Clothing Stores | Revenue | $41.5 | 1 | 0 |
| 448150 | Clothing Accessories Stores | Revenue | $16.5 | 2 | 1 |
| 451110 | Sporting Goods Stores | Revenue | $16.5 | 2 | 2 |
| 452319 | All Other General Merchandise Stores | Revenue | $35.0 | 1 | 1 |
| 453930 | Manufactured (Mobile) Home Dealers | Revenue | $16.5 | 1 | 0 |
| 541380 | Testing Laboratories | Revenue | $16.5 | 1 | 0 |
| 541870 | Advertising Material Distribution Services | Revenue | $16.5 | 1 | 1 |
| 561990 | All Other Support Services | Revenue | $12.0 | 1 | 1 |
| 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
Footnotes:
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.
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.
[top] 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.
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
Footnotes:
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.
| Number of small entities | Market share 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 × 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) × $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.
Footnotes:
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.
| Entity type | Number of facilities | Total one-time 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.
[top] 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
| 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 |
| 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.
| 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 | 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. |
| ANSI/CAN/UL 12402-5? 38 | 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) | No estimated cost savings for these small entities. |
| ANSI/CAN/UL 9595? 39 | 8 small entities, 7 small entities with known revenues | 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 | 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. |
| Information Pamphlets | 32 small entities, 24 small entities with known revenues | No estimated costs | No estimated cost savings. |
[top] 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.
Footnotes:
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.
| One-time impacts | Lowest per entity | Highest per entity | Ongoing impacts | Lowest per entity | Highest per 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.
| % Revenue impact | One-time net impacts | Small entities with known revenue | Portion of small entities with known revenue (%) | Ongoing net impacts | Small entities with known revenue | Portion of small entities with 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
[top] 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,
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.
[top] • ANSI/CAN/UL 12402-5, Standard for Safety Personal Flotation Devices-Part 5: Buoyancy Aids (Level 50)-Safety Requirements, First Edition,
• 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
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 [Removed and Reserved]
2. Remove and reserve §?181.4.
Subpart G-Information Pamphlet or Placard for Personal Flotation Devices
3. Revise the heading of Subpart G to read as set forth above.
§?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.
(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.
§§?181.703 through 181.705 [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.
[top]
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:
§?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
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.
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 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.
| Applicable waters | Vessel type | Devices required | Other regulations |
|---|---|---|---|
| Seaward of the Boundary Line and North of 32° N or South of 32° S; and Lake Superior | Documented Vessel | Immersion suit or exposure suit | 28.135; 25.25-9(a); 25.25-13; 25.25-15. |
| Coastal Waters on the West Coast of the United States north of Point Reyes, CA; Beyond Coastal Waters, cold water; and Lake Superior | All vessels | Immersion suit or exposure suit | 28.135; 25.25-9(a); 25.25-13; 25.25-15. |
| All other waters (Includes all Great Lakes except Lake Superior) | 40 feet (12.2 meters) or more in length | Wearable PFD approved under approval series 160.055, 160.155, or 160.176, or 160.255 immersion suit, or exposure suit. 1 | 28.135; 25.25-5; 25.25-9(a); 25.25-13; 25.25-15. |
| Less than 40 feet (12.2 meters) in length | 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. | |
| 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.
(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
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 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.
[top] (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
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 Lifejackets.
(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.
Subpart 160.002 [Removed and Reserved]
22. Remove and reserve subpart 160.002, consisting of §§?160.002-1 through 160.002-7.
Subpart 160.005 [Removed and Reserved]
23. Remove and reserve subpart 160.005, consisting of §§?160.005-1 through 160.005-7.
Subpart 160.006 [Removed and Reserved]
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
§?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, 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.
[top] (b) Designs and constructions. Throwable PFDs must not provide means for adjustment or close fitting to
(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 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.
§?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.
§?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 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 §?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 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
[top] (6) Any limitations or restrictions on approval or special instructions for use.
(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 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]
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.
Subpart 160.052 [Removed and Reserved]
28. Remove and reserve subpart 160.052, consisting of §§?160.052-1 through 160.052-9.
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 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 §?160.055-15 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.
§?160.055-4 [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 [Removed and Reserved]
34. Remove and reserve §§?160.055-6 through 160.055-9.
35. Add §?160.055-11 to read as follows:
§?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:
[top]
(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 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 §?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.
| Lot size | Number of life 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.
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:
[top]
(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 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
40. Revise §?160.060-1 to read as follows:
§?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.
§?160.060-2 [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) ("ANSI/CAN/UL 9595"); IBR approved for §?160.060-15(h).
(b) [Reserved]
§§?160.060-6 through 160.060-9 [Removed and Reserved]
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;
[top] (4) The manufacturer must select samples in accordance with the
| Lot size | Number of 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 §?160.060-5) meets the requirements of this section.
49. Add §?160.060-19 to read as follows:
§?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.
50. Add §?160.060-23 to read as follows:
§?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 typeapproval@uscg.mil 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.
51. Add §?160.060-25 to read as follows:
§?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
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.
[top] Recognized laboratory means an independent laboratory accepted by the Commandant in accordance with 46 CFR subpart 159.010, with a valid
§?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 [Removed and Reserved]
57. Remove and reserve §§?160.064-6 and 160.064-7.
58. Add §?160.064-11 to read as follows:
§?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:
§?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 §?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 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 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
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 [Redesignated as §?160.076-5]
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.
[top] 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.
(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 [Removed and Reserved]
67. Remove and reserve §?160.076-13.
§?160.076-21 [Removed and Reserved]
68. Remove and reserve §?160.076-21.
§?160.076-23 [Removed and Reserved]
69. Remove and reserve §?160.076-23.
§?160.076-25 [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:
§?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:
§?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-
§?160.076-33 [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 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 §?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 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:
[top] Commandant means the Chief of the Lifesaving and Fire Safety Standards
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.
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 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 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 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 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 §?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 §?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.
[top]
(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.
§?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.
§?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 §?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 §?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;
[top] (iv) Ensure each inflatable lifejacket serviced under the facility's Coast Guard approval is serviced by or under the supervision of a servicing technician
(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)
§?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.
§?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 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 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).
§?160.264-7 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 §?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 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 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.
[top] (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
(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 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 §?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.
§?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 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.
(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 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.
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.
[top] (c) PFDs approved under this subpart are intended to meet the carriage requirements for uninspected
§?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 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.
§?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/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).
§?160.276-7 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 §?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 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 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 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 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 §?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.
[top] (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.
§?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.
§?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.
(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 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
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:
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:
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(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:
§?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 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