97356 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations 

1https://www.federalregister.gov/documents/ 

2014/09/22/2014-22373/personal-flotation-deviceslabeling-and-standards (last accessed November 15, 

2024). 

2https://downloads.regulations.gov/USCG-2018- 

0565-0002/content.pdf (last accessed November 15, 

2024). 

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

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 


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3https://www.federalregister.gov/documents/ 

2012/04/03/2012-7791/inflatable-personalflotation-devices (last accessed November 15, 2024). 

4https://www.federalregister.gov/documents/ 

2018/08/17/2018-17799/lifejacket-approvalharmonization. (last accessed November 7, 2024). 

5https://www.federalregister.gov/documents/ 

2019/11/15/2019-24836/lifejacket-approvalharmonization. (last accessed November 7, 2024). 

6https://www.federalregister.gov/documents/ 

2023/04/07/2023-06504/lifejacket-approvalharmonization. (last accessed November 7, 2024). 

standards for PFDs including UL 1180, 

‘‘UL Standard for Safety for Fully 

Inflatable Recreational Personal 

Flotation Devices,’’ Second Edition 

(including revisions through December 

3, 2010).3 The discussion and response 

to comments in that rulemaking 

included a discussion on inflatable 

PFDs for users less than 16 years of age. 

UL 1180 limits the approval of inflatable 

PFDs to persons of at least 16 years of 

age, and thus the 2012 final rule 

retained that age limit for approved 

users of inflatable PFDs. No age limit 

was included in the regulatory text to 

allow for a possible future rulemaking to 

incorporate by reference a standard that 

sufficiently addresses the needs of 

younger wearers. 

On August 17, 2018, the Coast Guard 

published a notice in the Federal 

Register (83 FR 41095) regarding a 

policy letter and deregulatory savings 

analysis on accepting the standard 

ANSI/CAN/UL 12402–5 for Level 70 

PFDs, not including inflatable PFDs for 

use by persons less than 16 years old.4

On November 15, 2019, the Coast Guard 

published a notice (84 FR 62546) that 

finalized this policy.5

III. Discussion of Comments 

On April 7, 2023, the Coast Guard 

published a notice of proposed 

rulemaking (NPRM) titled Lifejacket 

Approval Harmonization (88 FR 21016) 

requesting comments on the proposed 

changes implemented by this final rule.6

In response to the NPRM, we received 

390 written submissions, nearly all of 

which were supportive of this 

rulemaking. Several commenters 

observed that performance-based 

standards such as those incorporated by 

this final rule allow manufacturers to 

design more innovative, comfortable, 

and stylish personal flotation devices 

and give manufacturers more flexibility 

when selecting materials, design, and 

construction. Others commented that 

aligning standards with Canada would 

promote consistency and enhance 

boating safety through improved 

lifejacket usage. We appreciate these 

supportive comments. 

We received 370 comments as part of 

a write-in campaign. Of these 

comments, 368 were identical or nearly 

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. 

One commenter stated that the 

changes proposed in the NPRM were 

‘‘great’’ but sought clarification on the 

replacement of the two-word term ‘‘life 

jacket’’ with the one-word term 

‘‘lifejacket’’ and asked us to use the twoword term rather than the proposed oneword term. The commenter asserted that 

the two-word term has always been 

used in the United States and suggested 

this clarification avoids the appearance 

that this document is proposing that the 

United States needs to change the way 

the term ‘‘life jacket’’ is spelled in so 

many other places. We did not make 

changes based on this suggestion. The 

two-word term has not always been 


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7The 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. 

8Available 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). 

9Available at https://homeport.uscg.mil/Lists/ 

Content/Attachments/459/NBSAC%202011-87- 

01%20-%20Signed_2.pdf (last accessed November 

12, 2024). 

10Available at https://homeport.uscg.mil/Lists/ 

Content/Attachments/75876/Recommendation2022-03-01--Signed.pdf (last accessed November 12, 

2024). 

used in the United States. The Coast 

Guard, industry, stakeholders, and user 

groups use the terms ‘‘lifejacket’’ and 

‘‘life jacket’’ interchangeably. In the 

NPRM, the Coast Guard proposed to 

standardize the term to the one-word 

variation and we are finalizing that 

proposal here. We specifically selected 

the one-word term for use in our 

regulations to align with the use of the 

one-word term in the ANSI/CAN/UL 

12402 standard, which is one of the 

standards incorporated by reference. 

However, industry, stakeholders, and 

user groups can continue to use the term 

‘‘life jacket’’ if that is their preference. 

One commenter fully supported the 

rule, specifically noting that PFDs 

would become stylish, comfortable, and 

appealing to the boating public, 

ultimately saving lives because they will 

wear them. The commenter suggested 

that the Coast Guard should permit 

anyone over 13 years old to wear an 

inflatable PFD to fulfill the mandated 

PFD carriage requirements. We agree 

with the commenter. The proposed rule 

did not include an age restriction for 

inflatable PFDs, which is finalized in 

this final rule. 

One commenter noted that there 

seemed to be inconsistencies in the 

proposed requirements for back-up 

chambers, specifically that back-up 

chambers are required for lifejackets in 

46 CFR 117.71 and 180.71 but not 

elsewhere. Another commenter 

requested clarification on why back-up 

chambers are required for lifejackets in 

46 CFR 117.71, 180.71, and 199.620, but 

not 46 CFR 141.340.7 These differences 

are intentional. Because the 

incorporated standard ANSI/CAN/UL 

12402–4 does not require back up 

chambers for inflatable Level 100 

lifejackets, the proposed rule included 

the additional requirement that 

inflatable Level 100 lifejackets must 

have a back-up chamber to meet carriage 

requirements for passenger vessels, and 

this final rule retains that requirement. 

One commenter supported the 

amendments to Requirements for 

Instruction Pamphlets for PFDs and 

suggested that the Coast Guard engage 

the Technical Committee 1123 to 

develop a ‘‘label standard’’ to address 

outstanding issues, such as the prospect 

that the placard would not effectively 

replace the pamphlet for products with 

legacy labels. The Coast Guard is fully 

engaged in UL Technical Committee 

1123—Personal Flotation Devices and 

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

1. Add New Subpart, 46 CFR 160.255, 

Incorporate by Reference ANSI/CAN/UL 

12402–4, and Remove Sections of 

Subpart 160.055 

We are adding a new subpart, 

160.255, to 46 CFR. PFDs approved 

under this new subpart meet the 

carriage requirements for wearable PFDs 

for three groups: (1) inspected vessels; 

(2) uninspected commercial vessels over 

40 feet (12m) in length; and (3) 

uninspected passenger vessels. 

New subpart 160.255 contains 

structural and performance 

requirements for approval of Level 100 

PFDs, as well as requirements for 

production inspections and quality 

control, markings, information 

pamphlets, and associated manuals. 

ANSI/CAN/UL 12402–4 is incorporated 

by reference. PFDs approved under this 

subpart rely upon inherently buoyant 

material, inflation, or a combination of 


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11 ‘‘Revision of Labeling and Classification for 

Personal Flotation Devices (PFDs),’’ Applied Safety 

& Ergonomics, Inc., December 28, 2004, Young et 

al. 12 46 CFR 160.176–9(a)(1). 13 46 CFR 160.176–13(j)(3). 

14Readers 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). 

15United States Coast Guard, ‘‘2019 Recreational 

Boating Statistics.’’ https://safe.menlosecurity.com/ 

Continued 

the two to achieve the minimum 

buoyancy. 

A Level 100 PFD has the same basic 

requirements as a PFD meeting current 

46 CFR 160.055 (life preservers). The 

minimum amount of buoyancy, basic 

mechanical properties, and in-water 

performance requirements are the same. 

However, ANSI/CAN/UL 12402–4 is 

less prescriptive regarding the design 

requirements of a Level 100 PFD, so 

manufacturing firms can develop more 

innovative designs. The marking 

requirements in ANSI/CAN/UL 12402– 

4 specify pictorial graphics to 

communicate the performance of the 

PFD and warnings for use. The Coast 

Guard conducted research and focus 

groups to identify issues with the Type 

code labels and to evaluate multiple 

new pictorial labeling options. Our 

research indicated that people 

consistently preferred pictorial 

markings.11 Therefore, we expect this 

marking format to be more easily 

understandable to both Englishspeaking and non-English-speaking 

populations. 

ANSI/CAN/UL 12402–4 does not 

require fully or partially inflatable Level 

100 PFDs to provide redundant back-up 

inflation chambers. Current regulations 

require inflatable lifejackets under 

approval series 160.176 to have at least 

two inflation chambers 12 and to reach 

minimum in-water performance with 

any one chamber deflated.13 These 

inflatable lifejackets meet the 

International Maritime Organization 

Life-Saving Appliance Code and are 

intended for use on vessels subject to 

SOLAS. 

Back-up chambers were originally 

required for inflatable lifejackets 

intended for use on inspected vessels as 

an additional safety measure in case the 

primary inflation chamber failed to 

inflate (see 54 FR 50316, 50322, Dec. 5, 

1989). In the 1989 interim final rule 

‘‘Approval of Inflatable Lifejackets’’ 

preamble, the Coast Guard noted that 

we would continue discussions with 

industry, standards organizations, and 

state boating law administrators 

regarding the reliability of inflatable 

PFDs (54 FR 50317). We also indicated 

that when new developments or 

innovations reduced the risk of inflation 

failure to an acceptable level, we could 

address this issue with a subsequent 

rulemaking. Since the publication of 

that rule in 1989, the Coast Guard has 

no evidence that a well-maintained PFD 

with a single inflation chamber is less 

reliable in the event of an emergency 

than an inherently buoyant PFD. 

Additionally, the Coast Guard has 

approved inflatable PFDs without backup chambers under approval series 

160.076. Such devices have been in use 

in the United States on uninspected 

commercial vessels less than 12 meters 

in length, and by recreational vessels 

and in Canada on small vessels, for over 

a decade. Therefore, the Coast Guard 

believes that the material testing of the 

PFD components coupled with the 

required annual servicing of inflatable 

Level 100 PFDs is sufficient, and that 

redundant back-up inflation chambers 

are not necessary to provide an 

equivalent level of safety to PFDs 

meeting current 46 CFR 160.055. 

Because new subpart 160.255 

supersedes the requirements for life 

preservers in subpart 160.055, we are 

removing structural and performance 

requirements for approval of life 

preservers in subpart 160.055, but 

maintaining the requirements for 

production inspections, tests, and 

quality assurance. Manufacturers can 

continue to produce life preservers 

currently approved under subpart 

160.055, while all new lifejackets will 

require Coast Guard approval under 

new subpart 160.255. 

At the same time, we are restructuring 

subpart 160.055 to include a statement 

of the subpart’s scope and to mirror the 

structure of other PFD-related subparts. 

We are adding sections for scope in 

§ 160.055–1 and definitions in 

§ 160.055–3, and standards incorporated 

by reference are moved from § 160.055– 

1 to § 160.055–5. Because no new 

approvals are granted under § 160.055, 

we are removing existing requirements 

for materials and construction, marking, 

and procedure for approval, including 

current 46 CFR 160.055–3, 160.055–4, 

160.055–5, 160.055–6, 160.055–8, and 

160.055–9. We are adding independent 

laboratory requirements in new 

§ 160.055–11. We move sampling, tests, 

and inspections from § 160.055–7 to 

newly created § 160.055–15 and include 

pamphlet requirements in new 

§ 160.055–19. We include procedures 

for the approval of design or material 

changes in new § 160.055–23 and 

information on suspension or 

termination of approval in new 

§ 160.055–25. 

2. Add New Subparts 46 CFR 160.045, 

160.264, and 160.276, Incorporate by 

Reference ANSI/CAN/UL 12402–5, 

ANSI/UL 1123, and ANSI/UL 1175, 

Remove Sections of Subparts 160.060, 

160.064, and 160.076, and Remove 

Subpart 160.077 in Its Entirety 

We are adding three new subparts in 

46 CFR: 160.045, 160.264, and 160.276. 

PFDs approved under these subparts 

meet the carriage requirements for 

recreational boats, in accordance with 

33 CFR part 175. Wearable PFDs 

approved under subparts 160.264 and 

160.276 also meet the carriage 

requirements for uninspected 

commercial vessels less than 40 feet 

(12m) in length and not carrying 

passengers for hire in accordance with 

46 CFR subpart 25.25. 

New subpart 160.264 contains 

structural and performance 

requirements for approval of Level 50 

and Level 70 inherently buoyant PFDs, 

as well as requirements for production 

inspections and quality control, 

markings, information placards, and 

associated manuals. New subpart 

160.276 contains structural and 

performance requirements for approval 

of Level 50 and Level 70 fully and 

partially inflatable recreational PFDs, as 

well as requirements for production 

inspections and quality control, 

associated manuals, information 

placards, and markings. ANSI/CAN/UL 

12402–5 is incorporated by reference in 

both subparts. 

ANSI/CAN/UL 12402–5 prescribes 

minimum performance requirements 

instead of prescribing design 

requirements. This performance-based 

standard allows manufacturing firms to 

design more innovative, comfortable, 

and stylish PFDs. New PFD designs 

could lead to more individuals choosing 

to wear their PFDs, resulting in fewer 

drownings.14 Drowning is the leading 

cause of death in recreational boating 

accidents, accounting for 79 percent of 

all recreational boating casualties where 

the cause of death is known.15 Of those 


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97360 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations 

doc/docview/viewer/docN0C8787B5BC27

b941976de80db865a89b27e43db4732447826e405

d5b93b8a0a1dd64625cf817 (last accessed April 23, 

2024). 

16United States Coast Guard, ‘‘2019 Life Jacket 

Wear Rate Observation Study.’’ https://

uscgboating.org/library/national-live-jacket-wearstudy/2019-Life-Jacket-Wear-Rate-Report.pdf (last 

accessed April 23, 2024). 

17Amy 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). 

18https://www.dco.uscg.mil/Portals/9/ 

DCO%20Documents/5p/5ps/Design%20and%20

Engineering%20Standards/Life%20Saving%20

and%20Fire%20Safety/Docs/L%20A%20HARM%

20POLICY%2020180801-Signed.pdf?ver=2018-08- 

01-131843-173 (last accessed April 23, 2024). 

19 83 FR 41095 

who drowned, 86 percent were not 

wearing lifejackets. Wearing a lifejacket 

is one of the best means available of 

preventing accidental drowning in 

recreational boating. Unfortunately, 

recreational boaters only wear 

lifejackets about 24 percent of the 

time.16

Discomfort, whether real or perceived, 

is negatively associated with PFD 

wear.17 ANSI/CAN/UL 12402–5 allows 

manufacturers more flexibility when 

selecting materials, design, and 

construction of new PFDs. Because 

manufacturers will be less limited in the 

materials, design, and construction, we 

expect that new PFDs might be slimmer, 

lighter in weight, or more comfortable to 

wear than PFDs approved under the 

current requirements. 

In our 2018 policy letter, CG–ENG 

Policy 02–18, titled Adoption of ANSI/ 

CAN/UL 12402–5 and 9,18 the Coast 

Guard determined that Level 70 

inherently buoyant devices, Level 70 

inflatable devices, and Level 70 multichamber devices that meet the 

requirements of ANSI/CAN/UL 12402–5 

provide equivalent performance to 

wearable PFDs meeting the 

requirements in current 46 CFR 160.064 

or 160.076.19

The Coast Guard has now determined 

that a Level 50 PFD, when worn and 

used in accordance with the label, 

provides an equivalent level of safety as 

a wearable PFD that meets current 

subpart 160.064 or 160.076 

requirements. A Level 50 PFD has a 

lower minimum amount of buoyancy 

than the current minimum requirement 

for Coast Guard approved PFDs. 

However, ANSI/CAN/UL 12402–5 

requires that a Level 50 PFD keep the 

user’s airway above the water, as 

demonstrated by in-water performance 

testing. A Level 50 PFD is intended for 

use by those who can swim and who 

have help or rescue nearby. As required 

in ANSI/CAN/UL 12402–5, Level 50 

PFDs must be marked: ‘‘Not 

recommended for weak or nonswimmers.’’ Every PFD offered for sale 

must have a placard providing users 

with information on how to select the 

appropriate PFD and reminding users to 

try the PFD on in the water to ensure 

proper fit and performance. To satisfy 

requirements of ANSI/CAN/UL 12402– 

5, Level 50 PFDs must be worn and 

must be marked: ‘‘Approval conditions 

state that this device must be worn to 

be counted as equipment required by 

vessels meeting Transport Canada or 

USCG regulations.’’ A Level 50 PFD, 

when worn by a person who can swim 

and used in accordance with ANSI/ 

CAN/UL 12402–5, provides an 

equivalent level of safety as a PFD 

meeting the current requirements in 46 

CFR 160.064 or 160.076. By approving 

Level 50 PFDs, the Coast Guard 

provides a critical level of oversight to 

the currently unregulated Level 50 

competition watersports PFDs, resulting 

in safer products for the public. 

In this final rule, we are not adding 

requirements that limit users of 

inflatable PFDs based on age. There are 

already requirements in ANSI/CAN/UL 

12402–5 addressing inflatable PFDs for 

users less than 16 years of age. To be 

certified as meeting ANSI/CAN/UL 

12402–5, an inflatable PFD intended for 

wearers less than 16 years of age must 

automatically inflate, must not require 

secondary donning, must be worn, and 

must include a warning statement about 

adult supervision. The Coast Guard 

believes these requirements are 

adequate to ensure safety for wearers 

less than 16 years of age, so we are fully 

incorporating ANSI/CAN/UL 12402–5 

without any additional age restrictions 

beyond those included in the standard. 

New subparts 160.264 and 160.276 

supersede the requirements for foam 

buoyant vests in subpart 160.060, 

marine buoyancy devices in subpart 

160.064, inflatable recreational personal 

flotation devices in subpart 160.076, 

and hybrid inflatable personal flotation 

devices in subpart 160.077. 

We are removing the structural and 

performance requirements for the 

approval of foam buoyant vests, marine 

buoyant devices, and inflatable 

recreational flotation devices in 

subparts 160.060, 160.064, and 160.076, 

respectively, but retaining the 

requirements for production 

inspections, tests, and quality control of 

wearable PFDs. We are deleting subpart 

160.077 entirely and modifying the 

scope of subpart 160.076 to include 

PFDs previously approved under 

subpart 160.077. By retaining the 

requirements for production 

inspections, tests, and quality control, 

we ensure that manufacturing firms 

producing PFDs currently approved 

under approval series 160.060, 160.064, 

160.076, or 160.077 can continue to 

manufacture and sell these PFDs, but 

the Coast Guard will not approve new 

products under these approval series. At 

the same time, we are reformatting the 

remaining text of subparts 160.060, 

160.064, and 160.076, without 

amending the language, to align with 

the other subparts related to PFDs and 

increase the ease of understanding for 

the reader. 

To eliminate confusion over approval 

categories, we are relocating the 

requirements for throwable PFDs from 

subpart 160.064 to new subpart 160.045. 

The new subpart 160.045 is dedicated to 

throwable PFDs intended for carriage on 

recreational boats. We permit the use of 

inflatable compartments to meet the 

minimum required buoyancy in 

§ 160.045–7. This new subpart 

incorporates by reference the ANSI/UL 

1175 standard for inherently buoyant 

and inflatable throwable PFDs and the 

ANSI/UL 1123 standard for marine 

buoyant devices. The Coast Guard 

already approves throwable PFDs to 

these standards; we are formally 

incorporating them by reference in this 

rulemaking to increase clarity and 

transparency of the approval 

requirements. 

3. Incorporate by Reference ANSI/CAN/ 

UL 9595 

We are incorporating by reference 

new industry consensus standard ANSI/ 

CAN/UL 9595, ‘‘Standard for factory 

follow-up of Personal Flotation Devices 

(PFDs)’’ (First Edition, June 4, 2020), 

into subparts 160.045, 160.055, 160.060, 

160.064, 160.076, 160.255, 160.264, and 

160.276. This standard covers the basic 

elements of a production inspection 

program for various types of PFDs. 

The Coast Guard currently requires a 

satisfactory follow-up (production 

testing and inspection) program 

administered by an independent 

laboratory recognized by the Coast 

Guard for each approved PFD. A task 

group of experts and stakeholders 

convened over the past decade to 

develop ANSI/CAN/UL 9595 to improve 

the consistency of follow-up programs 

among different recognized independent 

laboratories and to provide a binational 

harmonized standard for production 

testing acceptable to the Coast Guard 

and Transport Canada. 

ANSI/CAN/UL 9595 establishes a set 

of Process Ratings (A, B, and C) based 

on the quality management system 

(QMS) at each facility. Process Rating A 

is reserved for facilities that have 


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demonstrated a superior QMS meeting 

ISO standard ISO 9001. Process Rating 

B is assigned to facilities with a good 

QMS including a Quality Manual that 

incorporates the requirements in ANSI/ 

CAN/UL 9595 but is not approved by a 

third party. Process Rating C provides a 

minimum requirement for production 

inspections that is equivalent to current 

industry practice for follow-up 

programs and meets the minimum 

requirements currently accepted by the 

Commandant. 

At Process Ratings A and B, ANSI/ 

CAN/UL 9595 provides the option for 

the manufacturer to implement a QMS 

to reduce the number of inspections 

required. ANSI/CAN/UL 9595 lists roles 

and responsibilities; required tests, 

sample sizes, and acceptability criteria; 

and specific requirements for inspection 

frequency, traceability of components, 

critical dimensions verification, visual 

inspection of completed PFDs, and 

review of records. Annex A provides 

test methods and Annex B provides 

information on the elements of a QMS. 

We include ANSI/CAN/UL 9595 in 

the new subparts 160.045, 160.255, 

160.264, and 160.276 and in existing 

subparts 160.055, 160.060, 160.064, and 

160.076, to allow manufacturers that 

implement a QMS to be evaluated as 

Process Rating A or B, resulting in fewer 

required inspections. A QMS can result 

in greater production consistency, a 

reduction in defects and errors, 

increased efficiency, and continuous 

improvement. 

4. Remove Obsolete Material and 

Relocate Pertinent Material 

We are removing subparts 160.002, 

160.005, 160.006, 160.047, 160.048, and 

160.052, while also removing or 

relocating the entirety of subpart 

160.001. Subpart 160.001 provides 

general requirements for all life 

preservers. Most of this information is 

either obsolete or found elsewhere in 

the CFR. We are removing subpart 

160.001, while preserving the stillpertinent information on production 

oversight by relocating it to § 160.055– 

15. 

Subpart 160.006 provides two 

paragraphs related to the repairing of 

life preservers. Subpart 160.006 is no 

longer relevant and is not referenced in 

any approval or carriage requirement; 

therefore, we are removing it. 

Subparts 160.002, 160.005, 160.047, 

and 160.048 provide specifications and 

requirements for kapok and fibrous glass 

life preservers. Subpart 160.052 

provides specifications and 

requirements for a unicellular plastic 

foam buoyant vest. Manufacturers no 

longer produce any of these types of life 

preservers due to the unavailability of 

material, the advancement of foam 

technology, and improvements to the fit 

and function of PFDs industry-wide. 

With no current approvals for 

equipment under any of these subparts, 

these approval categories have become 

obsolete. Therefore, we are removing 

subparts 160.002, 160.005, 160.047, 

160.048, and 160.052. All new PFD 

approvals will have to meet the 

requirements in subparts 160.255, 

160.264, and 160.276, which 

incorporate current industry standards. 

5. Amend Lifesaving Equipment 

Carriage Requirements 

Where existing carriage requirements 

specify approval series for PFDs, we are 

adding the new approval series, as 

applicable. The affected subchapters are 

subchapter C (Uninspected Commercial 

Vessels), subchapters K and T (Small 

Passenger Vessels), subchapter L 

(Offshore Supply Vessels), subchapter 

M (Towing Vessels), and subchapter W 

(Lifesaving Appliances for Certain 

Inspected Vessels). If we identify other 

affected subchapters in the future, we 

could address them in a future 

rulemaking or guidance document. 

For example, according to the existing 

requirements under subchapter C, an 

uninspected vessel carrying passengers 

for hire must have at least one PFD 

approved under approval series 

160.055, 160.155, or 160.176 for each 

person on board (46 CFR 25.25–5). We 

are adding approval series 160.255 to 

the list of approval series to permit the 

use of PFDs approved under this new 

approval series. We are not removing 

any of the currently accepted approval 

series from the carriage requirements. 

Therefore, it will not be necessary for 

owners and operators to purchase new 

equipment if their current equipment is 

in good and serviceable condition. 

We are also removing references to 

PFDs approved under approval series 

160.177 because there have never been 

any approvals granted under that series. 

All new commercial PFDs, including 

commercial hybrid PFDs, will be 

approved under approval series 

160.255. 

6. Amend the Requirements for 

Instruction Pamphlets for PFDs 

We are amending the requirements for 

instruction pamphlets for PFDs in 33 

CFR 181 to allow both pamphlets and 

placards to meet the requirements for 

information furnished with each PFD 

sold or offered for sale for use on 

recreational boats. As previously 

described, we are incorporating both 

ANSI/CAN/UL 12402–4 and ANSI/ 

CAN/UL 12402–5 with respect to the 

approval of PFDs. Both standards 

require that a PFD include an 

informational placard in a pictographic 

format containing specific information 

on PFD performance, selection, 

approval, and maintenance, as well as 

general water safety information. To 

permit the placard to be used in place 

of the currently required pamphlet, the 

Coast Guard is adding the term 

‘‘placard’’ to 33 CFR 181.702. We are 

also removing 33 CFR 181.703, which 

requires that placards conform with UL 

1123, and adding text to 33 CFR 181.702 

specifying that a pamphlet or placard 

must meet the requirements in the 

applicable subpart of 46 CFR part 160 or 

be accepted by the Commandant. All 

currently approved PFDs have 

pamphlets or placards that have been 

accepted by the Commandant. 

Removing 33 CFR 181.703 eliminates all 

references to UL 1123 in this subpart, so 

we are removing 33 CFR 181.4, which 

incorporates that standard, as well. 

Finally, we are removing the separate 

requirements for hybrid and inflatable 

PFDs in 33 CFR 181.704 and 181.705, 

respectively, and including 

requirements for all PFDs in 33 CFR 

181.702. 

7. Amend the Existing Regulatory Text 

To Make Editorial Corrections and 

Increase Clarity 

We are updating the introductory IBR 

text, in accordance with current 

practice, in 46 CFR 160.055, 160.060, 

160.064, and 160.076. We are amending 

Table 28.110 to replace ‘‘Do’’ (meaning 

‘‘ditto’’) with the actual text to clarify 

the requirements in plain language, and 

to remove references to type codes from 

the table without modifying the intent 

or application of the requirements. We 

are also removing reference to approval 

series 160.177 in 46 CFR 108, 133 and 

199 because this approval series has 

never been used, and removing outdated 

provisions allowing cork and balsa 

wood lifejackets until March 11, 1999, 

from 46 CFR 117 and 180. Finally, we 

are consistently using the term 

‘‘lifejacket’’ by amending instances of 

‘‘life jacket’’ from two words to one. 

B. Standards Incorporated by Reference 

To Be Updated or Added 

Following this paragraph, we include 

an alphabetical list of the standards we 

are adding, each with a listing of the 

sections in which they appear in 46 

CFR. For each standard listed, we 

describe the topics covered by the 

standard, the edition adopted, and a list 

of subparts or sections that reference the 

standard. 

• ANSI/CAN/UL 9595, Standard for 

Safety Factory Follow-Up on Personal 


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Flotation Devices (PFDs), First Edition, 

June 4, 2020 (including revisions 

through September 9, 2021). This 

standard is incorporated by reference in 

§§ 160.045–15, 160.055–15, 160.060–15, 

160.064–15, 160.076–29, 160.255–15, 

160.264–15, and 160.276–15. This 

binational standard covers the basic 

elements of a production inspection 

program for various types of PFDs, and 

formalizes and modifies current 

industry standards. 

• ANSI/CAN/UL 12402–4, Standard 

for Safety Personal Flotation Devices— 

Part 4: Lifejackets, Performance Level 

100—Safety Requirements, First 

Edition, July 9, 2020. This standard is 

incorporated by reference in 

§§ 160.255–7, 160.255–13, 160.255–17, 

160.255–19, and 160.255–21. This 

binational standard specifies the safety 

requirements for lifejackets that provide 

face-up flotation for use in sheltered or 

calm water, where users may have to 

wait for rescue. A lifejacket meeting the 

requirements of ANSI/CAN/UL 12402–4 

provides an equivalent level of safety to 

a lifejacket currently approved under 

current 46 CFR subpart 160.055. 

• ANSI/CAN/UL 12402–5, Standard 

for Safety Personal Flotation Devices— 

Part 5: Buoyancy Aids (Level 50)— 

Safety Requirements, First Edition, 

December 31, 2015 (including revisions 

through January 27, 2022). This 

standard is incorporated by reference in 

§§ 160.264–7, 160.264–13, 160.264–17, 

160.264–19, 160.264–21, 160.276–7, 

160.276–13, 160.276–17, 160.276–19, 

and 160.276–21. This binational 

standard specifies the safety 

requirements for buoyancy aids used in 

sheltered waters with help and rescue 

nearby. A PFD meeting the requirements 

of ANSI/CAN/UL 12402–5 provides an 

equivalent level of safety as a PFD 

currently approved under 46 CFR 

160.064 or 160.076. 

• ANSI/UL 1123, Standard for Safety 

Marine Buoyant Devices, Seventh 

Edition, October 1, 2008 (including 

revisions through November 23, 2020). 

This standard is incorporated by 

reference in §§ 160.045–7 and 160.045– 

13. ANSI/UL 1123 provides 

requirements for Type II, Type III, and 

Type IV marine buoyant devices, 

including vests, jackets, horseshoe 

buoys and ring buoys, with or without 

lifelines, intended for recreational use, 

and throwable cushions. 

• ANSI/UL 1175, Standard for Safety 

Buoyant Cushions, Fourth Edition, 

April 20, 2007 (including revisions 

through January 10, 2020). This 

standard is incorporated by reference in 

§§ 160.045–7 and 160.045–13. This 

standard provides requirements for 

throwable PFDs using inherent or 

inflatable buoyancy that are intended to 

be used in accordance with applicable 

Coast Guard regulations. 

C. Standards Incorporated by Reference 

To Be Removed 

Following this paragraph, we include 

an alphabetical list of the standards we 

are removing as a result of this final 

rule. These standards are being removed 

because the regulatory text applying to 

these standards has been removed, and 

the newly incorporated standards 

supersede and replace these standards. 

• ASTM B117–97, Standard Practice 

for Operating Salt Spray (Fog) 

Apparatus. 

• ASTM D413–82, Standard Test 

Methods for Rubber Property— 

Adhesion to Flexible Substrate. 

• ASTM D570–95, Standard Test 

Method for Water Absorption of 

Plastics. 

• ASTM D751–95, Standard Test 

Method for Coated Fabrics. 

• ASTM D882–97, Standard Test 

Method for Tensile Properties of Thin 

Plastic Sheeting. 

• ASTM D1004–94a, Standard Test 

Method for Initial Tear Resistance of 

Plastic Film and Sheeting. 

• ASTM D1434–82 (Reapproved 

2009), Standard Test Method for 

Determining Gas Permeability 

Characteristics of Plastic Film and 

Sheeting. 

• CCC–C–426D, Cloth, Cotton Drill. 

• CCC–C–700G, Cloth, Coated, Vinal, 

Coated (Artificial Leather). 

• Color Names Dictionary, ‘‘The 

Universal Color Language’’ and ‘‘The 

Color Names Dictionary’’ in Color: 

Universal Language and Dictionary of 

Names, National Institute of Standards 

Special Publication 440. 

• Federal Standard No. 595A, Color. 

• Federal Standards No. 751 and 

751A, Stitches, Seams, and Stitchings. 

• Federal Test Method Standard No. 

191, Textile Test Methods, including: 

Æ Method 5100, Strength and 

Elongation, Breaking of Woven Cloth; 

Grab Method; 

Æ Method 5132, Strength of Cloth, 

Tearing; Falling-Pendulum Method; 

Æ Method 5134, Strength of Cloth, 

Tearing; Tongue Method; 

Æ Method 5804.1, Weathering 

Resistance of Cloth; Accelerated 

Weathering Method; and 

Æ Method 5762, Mildew Resistance of 

Textile Materials; Soil Burial Method. 

• L–P–375 and L–P–375C, Plastic 

Film, Flexible, Vinyl Chloride. 

• MIL–C–43006D, Cloth and Strip 

Laminated, Vinyl-Nylon High Strength, 

Flexible. 

• MIL–L–24611(SH), Life Preserver 

Support Package for Life Preserver, MK 

4. 

• MIL–B–2766 and MIL–R–2766B, 

Batt, Fibrous Glass, Lifesaving 

Equipment. 

• MIL–T–3530E, Thread and Twine; 

Mildew Resistant or Water Repellant 

Treated. 

• MIL–W–530 and MIL–W–530F, 

Webbing, Textiles, Cotton, General 

Purpose, Natural and in Colors. 

• MIL–W–17337D, Webbing, Woven, 

Nylon. 

• UL 1123, UL Standard for Safety for 

Marine Buoyant Devices. 

• UL 1180, UL Standard for Safety for 

Fully Inflatable Recreational Personal 

Flotation Devices. 

• UL 1191, Components for Personal 

Flotation Devices. 

• UL 1517, Standard for Hybrid 

Personal Flotation Devices. 

D. Changes to the Regulatory Text From 

the NPRM 

As discussed in Section III of this 

preamble, Discussion of Comments, we 

corrected three errors in cross-references 

that were the result of typographical 

errors in the NPRM. We updated the 

definition for inspector in 46 CFR 

160.055–3 to now cross-reference 

§ 160.055–15 rather than § 160.255–15; 

in § 160.060–3 to now cross-reference 

§ 160.060–15 rather than § 160.255–15; 

and in § 160.064–3 to now crossreference § 160.064–15 rather than 

§ 160.264–15. We also corrected the 

definition for inspector in 46 CFR 

160.276–15 to cross-reference 

§ 160.276–15 rather than ‘‘part 15 of this 

guideline.’’ 

In § 160.076–1 (‘‘Scope’’), we added a 

paragraph, (c), to help explain and 

clarify the applicability of subpart 

160.076. We also added additional 

amendatory instructions that were 

inadvertently missed in the NPRM. 

These include removing § 160.076–3 

and redesignating § 160.076–3 as 

§ 160.076–5, redesignating § 160.076–11 

as § 160.076–5, and revising the newly 

redesignated § 160.076–5. 

There are no other changes to the 

regulatory text from the NPRM. 

V. Incorporation by Reference 

Material for incorporation by 

reference appears in 46 CFR 160.045–5, 

160.055–5, 160.060–5, 160.064–5, 

160.076–5, 160.255–5, 160.264–5, and 

160.276–5 and is summarized in section 

IV.B of this preamble, Standards 

Incorporated by Reference to be 

Updated or Added. Copies of the 

material are available either at the 

publisher’s web address listed in the 

incorporation by reference sections in 

46 CFR 160.045–5, 160.055–5, 160.060– 

5, 160.064–5, 160.076–5, 160.255–5, 

160.264–5, and 160.276–5, or by 


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contacting the publisher listed for those 

standards. We reviewed and updated all 

the publisher’s web addresses listed in 

the parts to ensure they are current. You 

may also contact the person in the FOR

FURTHER INFORMATION CONTACT section 

for additional direction on how to 

obtain access to electronic copies of the 

materials. 

We believe industry already has 

access to and uses these new standards. 

The affected industry, in particular 

recognized independent laboratories, 

typically obtains the most recent 

editions of standards in the course of 

their business to address advancements 

in technology. 

The Director of the Federal Register 

approved the material in 46 CFR 

160.045–5, 160.055–5, 160.060–5, 

160.064–5, 160.076–5, 160.255–5, 

160.264–5, and 160.276–5 for 

incorporation by reference under 5 

U.S.C. 552 and 1 CFR part 51. 

VI. Regulatory Analyses 

We developed this rule after 

considering numerous statutes and 

Executive orders related to rulemaking. 

We have prepared a full regulatory 

analysis (RA) based on these statutes 

and Executive orders and have placed it 

in the docket where indicated under the 

ADDRESSES portion of the preamble. A 

summary of our analysis follows. Where 

we mention the analysis in the RA, we 

are referring the reader to the RA in the 

docket. 

A. Regulatory Planning and Review 

Executive Order 12866 (Regulatory 

Planning and Review), as amended by 

Executive Order 14094 (Modernizing 

Regulatory Review), and Executive 

Order 13563 (Improving Regulation and 

Regulatory Review) direct agencies to 

assess the costs and benefits of available 

regulatory alternatives and, if regulation 

is necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). Executive Order 13563 

emphasizes the importance of 

quantifying both costs and benefits, of 

reducing costs, of harmonizing rules, 

and of promoting flexibility. 

Two additional Executive orders 

promote the goals of Executive Order 

13563: Executive Order 13609 

(Promoting International Regulatory 

Cooperation) and Executive Order 

13610 (Identifying and Reducing 

Regulatory Burdens). Executive Order 

13609 targets international regulatory 

cooperation to reduce, eliminate, or 

prevent unnecessary differences in 

regulatory requirements. Executive 

Order 13610 aims to modernize the 

regulatory systems and to reduce 

unjustified regulatory burdens and costs 

on the public. 

The Office of Management and Budget 

(OMB) has not designated this rule a 

significant regulatory action under 

section 3(f) of Executive Order 12866, as 

amended by Executive Order 14094 

(Modernizing Regulatory Review). A 

summary of the RA follows; see the 

docket for our full analysis. 

TABLE 1—SUMMARY OF IMPACTS OF THE FINAL RULE

Category Summary 

Applicability ............................................................................................................. IBR of ANSI/CAN/UL 9595, ANSI/CAN/UL 12402–5, and 

ANSI/CAN/UL 12402–4. 

Affected Population ................................................................................................. 2 recognized independent laboratories (1 U.S. and 1 foreign), 

61 PFD manufacturing firms (39 U.S. and 22 foreign), the 

Coast Guard, recreational vessel operators, and commercial 

vessel operators. 

Costs to American Firms ($2023, 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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20United States Coast Guard. ‘‘2019 Recreational 

Boating Statistics.’’ https://uscgboating.org/library/ 

accident-statistics/Recreational-Boating-Statistics2019.pdf (last accessed April 22, 2024). 

21The Coast Guard lists all approved products on 

the Coast Guard Maritime Information Exchange 

website, https://cgmix.uscg.mil/. Last accessed 

April 25, 2024. 

22We 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. 

By means of this final rule, the Coast 

Guard harmonizes its approval process 

for PFDs with that of Canada, resulting 

in cost savings from eliminating a 

second set of approval requirements for 

PFD manufacturers wishing to sell in 

both Canada and the United States and 

reducing the required amount of 

product inspections depending on the 

quality management system in place at 

a given manufacturing facility. This rule 

removes barriers to entry for future 

innovative personal flotation devices 

and will save manufacturers money 

from reducing regulatory burdens 

without sacrificing quality. On net, the 

Coast Guard projects that manufacturers 

and the Coast Guard will save over 

$1,000,000 annually on reduced 

production inspections. 

Additionally, the Coast Guard expects 

that the introduction of Level 50 

devices, coupled with the requirement 

to wear them if they are to count for the 

purposes of PFD carriage requirements, 

will lead to an unquantifiable increase 

in PFD wear rates among recreational 

boaters, and thereby potentially 

decrease the rate of drowning in the 

event of an accident. Only Coast Guard 

approved devices are eligible to count 

for PFD carriage requirements, and, for 

Level 50 devices to count, they must be 

worn. The Coast Guard therefore 

expects that recreational boaters 

purchasing Level 50 PFDs for the 

purposes of carriage are more likely to 

wear them. Drowning is the leading 

cause of death in recreational boating 

accident and a study of drowning 

incidents found that, 86 percent of the 

time, individuals who drowned were 

not wearing a PFD.20 Absent these 

regulations, Level 50 devices cannot be 

sold as Coast Guard approved devices, 

and the expected increase in PFD wear 

rates among recreational boaters will not 

materialize. 

The final rule introduces harmonized 

performance standards instead of design 

standards for PFDs. It amends PFD 

approval and follow-up program 

requirements by incorporating three 

new binational standards into 

regulations, amending PFD carriage 

requirements to allow for the use of 

equipment approved to the new 

standards, and removing obsolete 

equipment approval requirements. The 

performance-based standards are more 

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


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23The PFD manufacturing firm does not 

necessarily own the facilities where its products are 

produced. Instead, the facility may be producing 

PFDs on contract for the PFD manufacturing firm. 

Additionally, much production for U.S. firms 

occurs at overseas facilities. We call these ‘‘U.S. 

Associated Facilities’’ not because they are in the 

United States but because they have a longstanding 

relationship with U.S. firms, while ‘‘Foreign 

Facilities’’ have longstanding relationships with 

foreign firms. 

TABLE 2—DISTRIBUTION OF MARKET SHARE OF PFD MANUFACTURERS

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

TABLE 3—MANUFACTURING FIRMS AND FACILITIES IMPACTED BY ANSI/CAN/UL 12402–4 

Firm ownership U.S. firms Foreign firms 

U.S. 

associated 

facilities 

Foreign 

facilities Total facilities 

Firms in top 13 ..................................................................... 5 3 10 6 16 

All other firms ....................................................................... 4 2 4 2 6 

Total facilities ................................................................ 9 5 14 8 22 

In the second provision, by 

incorporating by reference ANSI/CAN/ 

UL 12402–5, the Coast Guard introduces 

new categories for youth inflatables and 

Level 50 PFDs for approval. Permitting 

youth inflatables and Level 50 devices 

affects three populations: 

(1) PFD manufacturers that seek Coast 

Guard approval to produce youth 

inflatables or Level 50 devices; 

(2) The two recognized independent 

laboratories that review and certify 

youth inflatables and Level 50 devices; 

and 

(3) The boating public that purchases 

youth inflatables or Level 50 devices 

instead of Level 70 or Type III devices, 

because youth inflatables and Level 50 

devices are likely to be more form-fitting 

than Level 70 or Type III devices. 

In the third provision, the Coast 

Guard intends to incorporate by 

reference ANSI/CAN/UL 9595, covering 

production inspections and inspection 

frequency, into multiple new and 

existing subparts in 46 CFR, as listed in 

table 4. 

TABLE 4—PFDS IMPACTED BY ANSI/CAN/UL 9595 

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. 

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 


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24The 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. 25We estimate the increase in the cost of testing 

based upon data provided by representatives of 

independent laboratories. 

26We 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. 

producing a device approved under one 

of the subparts listed in table 4 and 

eligible to gain a Process Rating of A or 

B. 

In table 5, we estimate the market 

share likely to be at Process Rating A, 

B, or C and whether they are foreign or 

domestic firms.24 Because a QMS 

system is expensive to set up, industry 

stakeholders informed the Coast Guard 

that firms are not expected to develop 

a QMS solely to secure the cost savings 

of ANSI/CAN/UL 9595. However, a 

number of firms have already 

established QMS systems at their 

facilities because of other benefits, such 

as production consistency and quality 

control. The firms that have already 

established a QMS system will 

experience net cost savings from the IBR 

of ANSI/CAN/UL 9595. As a result, we 

estimated the process rating distribution 

recorded in table 5. 

TABLE 5—MARKET SHARE OF PRODUCTION LIKELY TO BE AT EACH PROCESS RATING

Firm category Process rating 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. 

TABLE 6—DEVICE CATEGORY AND PERMITTED INSTRUCTION TYPES

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

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


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TABLE 7—ESTIMATED COSTS TO U.S. FIRMS FOR LEVEL 100 DEVICES UNDER STANDARD ANSI/CAN/UL 12402–4 

[2023 Dollars, 10-year period of analysis] 

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. 

TABLE 8—ESTIMATED COSTS TO FOREIGN FIRMS FOR LEVEL 100 DEVICES UNDER STANDARD ANSI/CAN/UL 12402–4 

[2023 Dollars, 10-year period of analysis] 

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. 

TABLE 9—ESTIMATED TOTAL COST TO ALL FIRMS FOR LEVEL 100 DEVICES UNDER STANDARD ANSI/CAN/UL 12402–4 

[2023 Dollars, 10-year period of analysis] 

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 


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TABLE 9—ESTIMATED TOTAL COST TO ALL FIRMS FOR LEVEL 100 DEVICES UNDER STANDARD ANSI/CAN/UL 12402– 

4—Continued 

[2023 Dollars, 10-year period of analysis] 

Year 

Total 

undiscounted 

costs 

Discounted 

costs 

2% 

10 ............................................................................................................................................................................. 2,273 1,865 

Total .................................................................................................................................................................. 52,230 49,339 

Annualized ........................................................................................................................................................ ........................ 5,493 

Cost Savings 

By adopting ANSI/CAN/UL 12402–4, 

the Coast Guard can harmonize 

commercial PFD requirements of the 

United States with those of Transport 

Canada. Harmonization of commercial 

PFD standards will lead to cost savings 

for PFD manufacturing firms through 

less expensive approval requirements 

and less frequent ongoing facility 

inspections. 

Additionally, as a performance-based 

standard, ANSI/CAN/UL 12402–4 

allows for more innovative designs than 

the current standards and regulations, 

which might better meet boater needs. 

Seven commenters noted that 

permission to create more innovative 

designs is a benefit. The adoption of a 

performance-based standard spares the 

Coast Guard from making the 

equivalency determinations frequently 

necessary when using the current 

prescriptive requirements. 

Consequently, the Coast Guard will 

experience time savings from reducing 

the review time of new device 

applications during the approval 

process. 

In total, we estimate three sources of 

quantified cost savings associated with 

the IBR of ANSI/CAN/UL 12402–4: 

(1) The Coast Guard will spend less 

time reviewing approval applications 

and making equivalency determinations 

for the approval of innovative PFDs 

because ANSI/CAN/UL 12402–4 is a 

performance-based rather than 

prescriptive standard and allows more 

innovative designs to meet the standard; 

(2) All firms that apply for approval 

in both United States and Canadian 

markets will save the difference 

between one certification to ANSI/CAN/ 

UL 12402–4 and separate United States 

and Canadian certifications to legacy 

standards; and 

(3) Manufacturing facilities producing 

devices meeting the requirements of 

ANSI/CAN/UL 12402–4 for the United 

States and Canadian markets will be 

able to be inspected just once for 

approval, instead of the current 

requirement to be inspected twice; once 

for United States approval and once for 

Canadian approval. 

We summarize the total quantified 

benefits for the cost savings of the IBR 

of ANSI/CAN/UL 12402–4 by reporting 

the annual undiscounted cost savings in 

table 10. 

TABLE 10—ESTIMATED ANNUAL COST SAVINGS OF ANSI/CAN/UL 12402–4 TO THE INDUSTRY AND THE U.S. 

GOVERNMENT

[2023 Dollars] 

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. 

TABLE 11—ESTIMATED COST SAVINGS TO U.S. FIRMS FROM ANSI/CAN/UL 12402–4 

[2023 Dollars, 10-year period of analysis] 

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 


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TABLE 11—ESTIMATED COST SAVINGS TO U.S. FIRMS FROM ANSI/CAN/UL 12402–4—Continued 

[2023 Dollars, 10-year period of analysis] 

Year 

Total 

undiscounted 

cost savings 

Discounted 

cost savings 

2% 

6 ............................................................................................................................................................................... 46,510 41,300 

7 ............................................................................................................................................................................... 46,510 40,490 

8 ............................................................................................................................................................................... 46,510 39,696 

9 ............................................................................................................................................................................... 46,510 38,917 

10 ............................................................................................................................................................................. 46,510 38,154 

Total .................................................................................................................................................................. 465,100 417,780 

Annualized ........................................................................................................................................................ ........................ 46,510 

TABLE 12—ESTIMATED COST SAVINGS TO FOREIGN FIRMS FROM ADOPTING ANSI/CAN/UL 12402–4 

[2023 Dollars, 10-year period of analysis] 

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 

TABLE 13—ESTIMATED COST SAVINGS TO THE U.S. GOVERNMENT OF ANSI/CAN/UL 12402–4 

[2023 Dollars, 10-year period of analysis] 

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 

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. 


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27As 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. 

28We 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. 

TABLE 14—TOTAL ESTIMATED COST SAVINGS TO INDUSTRY OF THE FINAL RULE FOR ANSI/CAN/UL 12402–4 

[2023 Dollars, 10-year period of analysis] 

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

In table 15, table 16, and table 17, we 

present the discounted costs of 

introducing Level 50 devices over the 

10-year period of analysis to U.S. firms, 

foreign firms, and all firms, respectively. 

The tables include the estimated costs of 

Level 50 devices approved and 

inspected under the current inspections 

regime. In Year 1, the undiscounted 

costs are only the costs of Level 50 

approval for manufacturers, or $610,299 

for U.S. manufacturers and $146,661 for 

foreign manufacturers. For Year 2, the 

undiscounted costs are the costs of 

Level 50 approvals to manufacturers 

($610,299 for U.S. firms and $146,661 

for foreign firms) plus the cost of 

inspections ($33,900 for U.S. firms and 

$7,587 for foreign firms), for a total of 

about $644,199 ($610,299 + $33,900) for 

U.S. firms and $154,248 ($146,661 + 

$7,587) for foreign firms. The estimated 

10-year cost, discounted at 2 percent, is 

$1,694,898, or $188,687 annualized, for 

U.S. firms, and $398,884, or $44,406 

annualized, for foreign firms. 

TABLE 15—ESTIMATED COSTS TO U.S. FIRMS FROM INTRODUCING LEVEL 50 DEVICES

[2023 Dollars, 10-year period of analysis] 

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 


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29United States Coast Guard, ‘‘2019 Recreational 

Boating Statistics.’’ https://uscgboating.org/library/ 

accident-statistics/Recreational-Boating-Statistics2019.pdf (last accessed April 25th, 2024). 

30United States Coast Guard, ‘‘2019 Life Jacket 

Wear Rate Observation Study.’’ https://

uscgboating.org/library/national-live-jacket-wearstudy/2019-Life-Jacket-Wear-Rate-Report.pdf (last 

accessed April 25, 2024). 

31We 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. 

TABLE 16—ESTIMATED COSTS TO FOREIGN FIRMS FROM THE INTRODUCTION OF LEVEL 50 DEVICES

[2023 Dollars, 10-year period of analysis] 

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 

TABLE 17—TOTAL ESTIMATED COSTS TO PFD MANUFACTURERS FROM THE INTRODUCTION OF LEVEL 50 DEVICES

[2023 Dollars, 10-year period of analysis] 

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

Level 50 devices are likely to be 

slimmer, lighter in weight, and more 

comfortable to wear than current Type 

III and Level 70 devices. Additionally, 

the Coast Guard will require 

recreational boaters to wear Level 50 

devices for such devices to count 

towards PFD carriage requirements. 

Individuals who purchase Level 50 

devices are more likely to wear PFDs 

than similar individuals who purchase 

bulkier Type III or Level 70 devices 

without a requirement that they be worn 

for the purposes of carriage. The NIH 

conducted a literature review, and, 

among other factors, found discomfort 

to be negatively associated with 

lifejacket wear [NIH, 2018].31 It is the 

Coast Guard’s view that PFDs worn are 

more effective than PFDs carried on 

board if a person overboard situation 

occurs. As a result, it is possible that the 

public is safer due to recreational 

boaters wearing a greater number of 

PFDs while boating. 

Since the Level 50 devices provide a 

lower level of buoyancy than Level 70 

devices, a direct comparison is not 

possible. However, the view of the 

subject matter experts (SMEs) in the 

Coast Guard’s Office of Boating Safety is 

that the wearing of Level 50 PFDs by 

recreational boaters and the general 

boating public improves safety on the 

water. Recreational boaters fail to wear 

lifejackets 76 percent of the time, 


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leaving themselves vulnerable to 

drowning. The Coast Guard believes 

that, by offering recreational boaters an 

additional choice of a Level 50 PFD, 

which is required to be worn, more 

recreational boaters will choose to wear 

their lifejacket while engaged in boating 

activities. A lifejacket that is worn by 

the user is more effective than a 

lifejacket stowed on the boat. 

3. ANSI/CAN/UL 9595 

The third provision incorporates by 

reference the consensus standard ANSI/ 

CAN/UL 9595 to cover follow-up 

inspections and inspection frequency 

for Coast Guard approved PFDs. 

Currently, when a manufacturing firm 

produces a Coast Guard approved PFD, 

there is a required follow-up inspection 

regime to ensure that the devices 

continue to meet the specifications 

under which the Coast Guard approved 

them. Although the Coast Guard has not 

previously published a substantive 

minimum requirement for what 

constitutes a follow-up inspections 

regime, we set out general requirements 

in 46 CFR 159, 160.064–4, and 160.076– 

29. The Coast Guard reviews each 

recognized independent laboratory’s 

follow-up services program to ensure 

compliance with these regulations. 

Incorporating by reference ANSI/ 

CAN/UL 9595 provides a few key 

benefits to the regulated public and the 

testing laboratories. First, ANSI/CAN/ 

UL 9595 is one standard, ensuring 

consistency across all accepted and 

recognized independent laboratories. 

Second, ANSI/CAN/UL 9595 is a 

standard that is widely available to the 

industry and transparently clarifies 

guidance on what constitutes a followup inspection regime. Third, and most 

importantly, ANSI/CAN/UL 9595 

establishes a rating system for each 

facility, which results in cost savings for 

the firms manufacturing at facilities 

with a good or superior QMS rating. 

Costs 

There are three cost items associated 

with the adoption of ANSI/CAN/UL 

9595. These costs are based on input 

from PFD industry SMEs on how ANSI/ 

CAN/UL 9595 is likely to be 

implemented. 

(1) The two recognized independent 

laboratories will need to train their staff 

to implement ANSI/CAN/UL 9595. 

(2) Manufacturing firms could request 

a special inspection in the first year to 

certify their QMS at a given facility 

meets the requirements for Process 

Rating of A or B. We expect the top 13 

firms to request this certification across 

all 27 facilities at which they 

manufacture. This special inspection is 

expected to be in addition to the regular 

production inspections required for 

Process Rating C. 

(3) After the first year, where the QMS 

inspection is supplemental to standard 

inspections, the QMS inspection could 

replace one of the mandatory 

inspections, but could cost more than a 

standard inspection, at the top 13 firms 

with 27 facilities. 

We estimate the 10-year discounted 

cost for inspections under this provision 

that are associated with U.S. firms is 

approximately $126,840, or $14,121 

annualized using a 2-percent discount 

rate. We estimate the total 10-year 

discounted cost for inspections that are 

associated with foreign firms is 

approximately $51,382, or $5,720 

annualized using a 2-percent discount 

rate. In total, we estimate the 10-year 

discounted costs from ANSI/CAN/UL 

9595 are $178,223 or $19,841 

annualized using a 2-percent discount 

rate. We present these costs to U.S., 

foreign, and both U.S. and foreign firms 

in table 18, table 19, and table 20, 

respectively. 

TABLE 18—ESTIMATED QMS INSPECTION COSTS TO U.S. FIRMS FROM ANSI/CAN/UL 9595 

[2023 Dollars, 10-year period of analysis] 

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 

TABLE 19—ESTIMATED QMS INSPECTION COSTS TO FOREIGN FIRMS FROM ANSI/CAN/UL 9595 

[2023 Dollars, 10-year period of analysis] 

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 


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TABLE 19—ESTIMATED QMS INSPECTION COSTS TO FOREIGN FIRMS FROM ANSI/CAN/UL 9595—Continued 

[2023 Dollars, 10-year period of analysis] 

Year 

Total 

undiscounted 

cost 

Discounted 

cost 

2% 

8 ............................................................................................................................................................................... 3,512 2,997 

9 ............................................................................................................................................................................... 3,512 2,939 

10 ............................................................................................................................................................................. 3,512 2,881 

Total .................................................................................................................................................................. 55,352 51,382 

Annualized ........................................................................................................................................................ ........................ 5,720 

TABLE 20—TOTAL ESTIMATED QMS INSPECTION COSTS FOR ANSI/CAN/UL 9595 

[2023 Dollars, 10-year period of analysis] 

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. 

TABLE 21—ESTIMATED COST SAVINGS TO U.S. FIRMS FROM ANSI/CAN/UL 9595 

[2023 Dollars, 10-year period of analysis] 

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 


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32Current marking requirements require a 

pamphlet, while the new marking requirement will 

be for a placard or pamphlet. Because these 

placards and pamphlets are both produced in 

factories, the Coast Guard estimates that it will take 

the same amount of time to produce and include 

either a pamphlet or a placard with a newly 

manufactured PFD for sale. As a result, we do not 

estimate there will be any changes in the Paperwork 

Reduction Act burden brought on by the switch 

from pamphlets to placards. 

TABLE 22—ESTIMATED COST SAVINGS TO FOREIGN FIRMS FROM ANSI/CAN/UL 9595 

[2023 Dollars, 10-year period of analysis] 

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 

TABLE 23—ESTIMATED COST SAVINGS TO ALL FIRMS FROM ANSI/CAN/UL 9595 

[2023 Dollars, 10-year period of analysis] 

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

TABLE 24—DEVICE CATEGORY AND PERMITTED INSTRUCTION TYPES

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. 


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33U.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). 

TABLE 24—DEVICE CATEGORY AND PERMITTED INSTRUCTION TYPES—Continued 

Device category Types of instructions allowed by 

the final rule 

Types of instructions currently in 

use 

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 nonEnglish-reading audiences. We do not 

have a way of quantifying this benefit 

but would like to note that 

approximately 21 percent of the U.S. 

population has a ‘‘low’’ level of English 

literacy. For those populations, pictorial 

information may be better than textbased information.33

Total Costs 

We display the total costs from this 

final rule to U.S. entities, foreign 

entities, and both U.S. and foreign 

entities, using a 10-year period of 

analysis, discounted at 2 percent, in 

table 25, table 26, and table 27, 

respectively. 

TABLE 25—ESTIMATED COSTS FOR U.S. FIRMS

[2023 Dollars, 10-year period of analysis] 

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 

TABLE 26—ESTIMATED COSTS FOR FOREIGN FIRMS

[2023 Dollars, 10-year period of analysis] 

Year 

Total 

undiscounted 

costs 

Discounted 

costs 

2% 

1 ............................................................................................................................................................................... $171,019 $167,666 

2 ............................................................................................................................................................................... 158,374 152,224 


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TABLE 26—ESTIMATED COSTS FOR FOREIGN FIRMS—Continued 

[2023 Dollars, 10-year period of analysis] 

Year 

Total 

undiscounted 

costs 

Discounted 

costs 

2% 

3 ............................................................................................................................................................................... 19,300 18,187 

4 ............................................................................................................................................................................... 19,300 17,830 

5 ............................................................................................................................................................................... 19,300 17,481 

6 ............................................................................................................................................................................... 19,300 17,138 

7 ............................................................................................................................................................................... 19,300 16,802 

8 ............................................................................................................................................................................... 19,300 16,472 

9 ............................................................................................................................................................................... 19,300 16,149 

10 ............................................................................................................................................................................. 19,300 15,833 

Total .................................................................................................................................................................. 483,793 455,782 

Annualized ........................................................................................................................................................ ........................ 50,741 

TABLE 27—TOTAL ESTIMATED COSTS FOR U.S. AND FOREIGN FIRMS

[2023 Dollars, 10-year period of analysis] 

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. 

TABLE 28—TOTAL ESTIMATED COST SAVINGS TO U.S. FIRMS

[2023 Dollars, 10-year period of analysis] 

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 


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TABLE 29—TOTAL ESTIMATED COST SAVINGS TO FOREIGN FIRMS

[2023 Dollars, 10-year period of analysis] 

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 

TABLE 30—TOTAL ESTIMATED COST SAVINGS TO THE U.S. GOVERNMENT

[2023 Dollars, 10-year period of analysis] 

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 

TABLE 31—TOTAL ESTIMATED COST SAVINGS TO U.S. AND FOREIGN MANUFACTURING FIRMS AND THE U.S. 

GOVERNMENT

[2023 Dollars, 10-year period of analysis] 

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 


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Net Cost Savings 

We display the total net cost savings 

from this final rule to U.S. firms, the 

U.S. government, foreign firms, and all 

entities using a 10-year period of 

analysis discounted at 2 percent in table 

32, table 33, table 34, and table 35, 

respectively. 

TABLE 32—TOTAL ESTIMATED NET COST SAVINGS TO U.S. FIRMS

[2023 Dollars, 10-year period of analysis] 

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 

TABLE 33—TOTAL ESTIMATED NET COST SAVINGS TO FOREIGN FIRMS

[2023 Dollars, 10-year period of analysis] 

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 

TABLE 34—TOTAL ESTIMATED COST SAVINGS TO THE U.S. GOVERNMENT

[2023 Dollars, 10-year period of analysis] 

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 


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TABLE 34—TOTAL ESTIMATED COST SAVINGS TO THE U.S. GOVERNMENT—Continued 

[2023 Dollars, 10-year period of analysis] 

Year 

Net 

undiscounted 

cost savings 

Net 

discounted 

cost savings 

2% 

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

TABLE 35—TOTAL ESTIMATED NET COST SAVINGS TO ALL ENTITIES

[2023 Dollars, 10-year period of analysis] 

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. 

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 


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regulation. To achieve this principle, 

agencies are required to solicit and 

consider flexible regulatory proposals 

and to explain the rationale for their 

actions to assure that such proposals are 

given serious consideration.’’ 

When an agency promulgates a final 

rule under section 553 of the RFA, after 

being required by that section or any 

other law to publish a general notice of 

proposed rulemaking, or promulgates a 

final interpretative rule involving the 

internal revenue laws of the United 

States as described in section 603(a), the 

agency must prepare a final Regulatory 

Flexibility Analysis (FRFA) or have the 

head of the agency certify pursuant to 

RFA section 605(b) that the rule will 

not, if promulgated, have a significant 

economic impact on a substantial 

number of small entities. The RFA 

prescribes the content of the FRFA in 

section 604(a), which we discuss as 

follows. 

In accordance with the RFA (5 U.S.C. 

601–612), the Coast Guard prepared this 

FRFA that examines the impacts of the 

final rule on small entities (5 U.S.C. 601, 

et seq.). A small entity may be: 

• A small independent business, 

defined as any independently owned 

and operated business not dominant in 

its field that qualifies as a small 

business per the Small Business Act (5 

U.S.C. 632); 

• A small not-for-profit organization; 

and 

• A small governmental jurisdiction 

(locality with fewer than 50,000 people). 

This FRFA addresses the following: 

(1) A statement of the need for, and 

objectives of, the rule; 

(2) A statement of the significant 

issues raised by the public comments in 

response to the initial regulatory 

flexibility analysis, a statement of the 

assessment of the agency of such issues, 

and a statement of any changes made in 

the proposed rule as a result of such 

comments; 

(3) The response of the agency to any 

comments filed by the Chief Counsel for 

Advocacy of the Small Business 

Administration (SBA) in response to the 

proposed rule, and a detailed statement 

of any change made to the proposed rule 

in the final rule as a result of the 

comments; 

(4) A description of and an estimate 

of the number of small entities to which 

the rule will apply or an explanation of 

why no such estimate is available; 

(5) A description of the projected 

reporting, recordkeeping and other 

compliance requirements of the rule, 

including an estimate of the classes of 

small entities which will be subject to 

the requirement and the type of 

professional skills necessary for 

preparation of the report or record; and 

(6) A description of the steps the 

agency has taken to minimize the 

significant economic impact on small 

entities consistent with the stated 

objectives of applicable statutes, 

including a statement of the factual, 

policy, and legal reasons for selecting 

the alternative adopted in the final rule 

and why each one of the other 

significant alternatives to the rule 

considered by the agency which affect 

the impact on small entities was 

rejected. 

Below is a discussion of FRFA 

analysis by each of these six elements: 

(1) A statement of the need for, and 

objectives of, the rule. 

The Coast Guard amends the lifejacket 

approval requirements and follow-up 

program requirements by incorporating 

three new binational standards. At the 

same time, the Coast Guard amends 

lifejacket and PFD carriage requirements 

to allow for the use of equipment 

approved to the new standards, and to 

remove obsolete equipment approval 

requirements. The new standards are 

state-of-the-art and are intended to 

replace the legacy standards. The 

amendments will streamline the process 

for approval of PFDs and allow 

manufacturers to produce more 

innovative equipment that meets the 

approval requirements of both the 

United States and Canada; and will 

reduce the burden for manufacturers in 

both the approval process and follow-up 

program. Absent this regulation, the 

United States and Canada would 

continue to have two different PFD 

standards, resulting in additional costs 

for manufacturers. 

(2) A statement of the significant 

issues raised by the public comments in 

response to the initial regulatory 

flexibility analysis, a statement of the 

assessment of the agency of such issues, 

and a statement of any changes made in 

the proposed rule as a result of such 

comments. 

The Coast Guard received no public 

comments in response to the initial 

Regulatory Flexibility Analysis. 

(3) The response of the agency to any 

comments filed by the Chief Counsel for 

Advocacy of the SBA in response to the 

proposed rule, and a detailed statement 

of any change made to the proposed rule 

in the final rule as a result of the 

comments. 

The Coast Guard received no 

comments filed by the Chief Counsel for 

Advocacy of the SBA in response to the 

proposed rule. 

(4) A description of and an estimate 

of the number of small entities to which 

the rule will apply or an explanation of 

why no such estimate is available. 

This rule has four major provisions: 

(1) The incorporation by reference of 

ANSI/CAN/UL 12402–4 replacing Type 

I device approval with Level 100 device 

approval; (2) The incorporation by 

reference of ANSI/CAN/UL 12402–5 

introducing new Level 50 device 

approvals; (3) The incorporation by 

reference of ANSI/CAN/UL 9595 for 

new follow-on production inspection 

standards; and (4) The option to use 

placards in lieu of information 

pamphlets on currently approved 

devices and the requirement to use 

placards for new Level 50, Level 70, and 

Level 100 devices. Across these four 

provisions, we estimate that this rule 

affects two Coast Guard recognized 

laboratories and 61 PFD manufacturers. 

We researched these two Coast Guard 

recognized independent laboratories 

and 61 PFD manufacturers to determine 

if they are U.S. companies or foreign 

companies based on the location of their 

parent company’s headquarters. We 

found one Coast Guard recognized 

laboratory to be a U.S. company and one 

to be a foreign company. We found 39 

of the 61 PFD manufacturers to be U.S. 

companies and 22 to be foreign 

companies. We then researched each of 

these 40 U.S. companies (1 testing 

laboratory and 39 PFD manufacturers) to 

determine its North American Industry 

Classification System (NAICS) code and 

its size standard using the SBA’s size 

standard table. Next, we reviewed each 

U.S. parent company’s revenue or 

employee information to determine 

whether the company is small or not 

small, according to SBA size standards. 

We present the results of our research in 

table 36. The Coast Guard recognized 

independent laboratory is not a small 

entity. Of 39 U.S. manufacturers, 32 are 

small entities according to SBA size 

standards. We did not find any U.S. 

small entities to be small governmental 

jurisdictions or not-for-profit 

organizations. 


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34Facility 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. 

TABLE 36—NUMBER OF SMALL ENTITIES AFFECTED BY THE RULE

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

Provision 2: Incorporation by Reference 

of ANSI/CAN/UL 12402–5 

Incorporating by reference ANSI/ 

CAN/UL 12402–5 permits small entities 

to seek Coast Guard approval to produce 

and sell Level 50 devices. The Coast 

Guard has not previously approved 

these devices. We estimate that this 

provision affects all 32 small entities, 24 

of which have known revenues. 

In the RA, we estimate that the 

introduction of Level 50 devices will 

cause the North American PFD market 

to grow by 5 percent. We interpret the 

5-percent growth in terms of the number 

of approved devices (a growth of 38 

device approvals). The initial approvals 

represent a one-time (initial year) cost to 

small entities. Small entities will also 

experience an annual cost of additional 

production inspections based on the 

volume of Level 50 PFDs produced. 


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35We divided 5 percent or 0.05 by 44 companies 

to obtain 0.11 percent of the market for each one. 

36 Independent laboratories bill QMS inspections 

at $329.40 per hour, while they bill normal 

inspections at $274.50 per hour. Thus, the 

additional cost is $54.90 per hour 

($329.40¥$274.50), or $439 in an 8-hour workday 

($54.90 × 8). See section 9.1.2 in the RA. 

We estimate a new Level 50 device 

approval costs a small entity about 

$39,840. We do not know which small 

entities will seek Coast Guard approval 

for a Level 50 device or how many 

devices each small entity might seek 

approval for. As a result, we treat each 

small entity as seeking approval for one 

Level 50 device costing $39,840. This 

will be a one-time (initial year) cost to 

small entities. 

Production is not distributed equally 

across the small entities that produce 

PFDs for the North American market. 

Instead, some small entities produce 

vastly more PFDs than others. In the RA, 

we estimate the market share of the 13 

largest firms to be collectively about 95 

percent. We estimate the remaining 44 

firms’ market share collectively to be 

about 5 percent. We do not know the 

relative market share of the 44 firms, so 

we divide the 5 percent equally across 

the 44 firms. Therefore, we treat each of 

the 44 firms as accounting for about 0.11 

percent of the PFD market.35

For the 32 small entities that would 

use the ANSI/CAN/UL 12402–5 

standard, 24 are in the set of 44 firms 

collectively having 5 percent market 

share, and therefore we assume each has 

a market share of 0.11 percent. Based on 

conversations with PFD manufacturing 

executives, we estimate 5 of the 32 firms 

have a market share of 2.5 percent each, 

1 has a market share of 7.5 percent, 1 

has a market share of 15 percent, and 1 

has a market share of 25 percent. We 

could not find revenue data for eight 

small entities. We display this 

information in table 37 below. 

TABLE 37—MARKET SIZE OF SMALL

ENTITIES AFFECTED BY THE RULE

Number of small entities 

Market share 

of each entity 

(%) 

24 .......................................... 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 onetime costs of an initial QMS inspection, 

and ongoing costs because a QMS 

inspection is more expensive than the 

facility inspection it replaces in 

subsequent years. We estimate that each 

small entity has two facilities, with the 

largest small entity having three 

facilities, and QMS inspection costs 

occur per facility. In the RA, we 

estimate that the total costs to U.S. firms 

for the ANSI/CAN/UL 9595 standard 

will be about $61,296 for 19 facilities. 

We estimate that 7 of the firms in the 

top 13 are small entities, including the 

top firm. Because we do not know 

where each small entity’s facilities are 

located, to estimate each small entity’s 

one-time costs, we multiply $61,296 by 

each small entity’s share of the 19 

facilities, yielding $6,452 ((2 ÷ 19) × 

$61,296) for all but the largest small 

entity and $9,678 ((3 ÷ 19) × $61,296) for 

the largest small entity. We estimate 

annual costs to be about $439 per 

facility, which is the difference between 

8 hours of billed QMS inspector time 

and 8 hours of a regular inspector’s 

time.36 The largest small entity has three 

facilities, so will experience $1,316 

($439 × 3) in additional costs. All the 

other small entities have two facilities, 

and they will experience $878 ($439 × 

2) in annual costs. We reflect this 

information in table 38. 

TABLE 38—COSTS PER SMALL ENTITY FROM UL 9595 

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. 

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 


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37See 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. 

38See 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. 

39See 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. 

÷ 77.5 percent × 587, yielding 76 

rounded. Then we derive the reduced 

number of inspections at B and the 

reduced number of inspections at A by 

multiplying the reduced inspection 

frequency at B (194) by the share of the 

small entity’s Process Rating at B 

relative to all other U.S. firms at B, or 

5 percent ÷ 51 percent, yielding 19 

rounded. To estimate the reduced 

inspection frequency at A, we take the 

number of facilities at A (one) and 

multiply by two, accounting for the 

number of inspections that occur once 

the facility is at Process Rating A. Next, 

we add to it the multiplication of the 

number of commercial PFD production 

inspections at A (7) and the small 

entity’s relative share of production at 

A, or 5 percent ÷ 26.5 percent, yielding 

3 rounded (2 × 1) + (7 × 5 percent ÷ 26.5 

percent). Taken together, the small 

entity’s reduced inspection frequency is 

22 (19 + 3), meaning the small entity 

experiences 54 fewer production 

inspections annually (76¥22). To 

calculate the number of reduced Level 

50 inspections for each small entity, we 

take the small entity’s share of U.S. firm 

inspection reduction divided by the 

total estimated reduction in U.S. firm 

inspections from Table 42 in the RA (54 

÷ 376) and multiply by the 16 total 

reduction in inspections, yielding 2 

rounded. We add the reduction in Level 

50 inspections (2) and the reduction in 

current inspections (54) together and 

multiply by the cost of each inspection 

($2,712), yielding $151,872 ((2+54) × 

$2,712), or the small entity’s annual cost 

savings from reduced inspection 

frequency. We perform this process for 

each of the eight small entities. We 

record these calculations in table 39; the 

results are rounded. 

TABLE 39—ANNUAL COST SAVINGS FOR A REPRESENTATIVE SMALL ENTITY IN 2023 DOLLARS

Total market 

share 

Market 

share at B 

Market 

share at A 

Current 

inspection 

frequency 

Inspection 

frequency at B 

Inspection 

frequency at A 

Total 

inspection 

reduction 

Reduced level 50 

inspections 

Total annual cost 

savings 

A B = A ÷ 2 C = A ÷ 2 D = 587 × A ÷ 77.5% E = 194 × B ÷ 

51% 

F = (2 × 1) + 

(7 × C ÷ 26.5%) 

G = D¥E¥F H = G ÷ 376 × 16 (G + H) × $2,712 

10% ............. 5% 5% 76 19 3 54 2 $151,872 

Provision 4: Replacement of Information 

Pamphlets With Booklets 

We did not estimate any costs or cost 

savings from this provision, so we do 

not estimate that there will be any 

impact on small entities. 

We summarize the number of small 

entities affected, cost impacts, cost 

savings impacts, and transfers per 

provision in table 40. 

TABLE 40—NUMBER OF AFFECTED SMALL ENTITIES, COSTS, AND COST SAVINGS PER PROVISION

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. 

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. 


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Net cost savings is therefore not a 

function of the cost and cost savings in 

Table 41. For example, the lowest net 

cost savings in Table 40, ¥$46,292.21, 

demonstrates a cost greater than the 

lowest cost that will be experienced by 

an entity, or $39,840, which is why it 

is not the lowest cost per entity. 

Similarly, lowest and highest ongoing 

impacts do not necessarily match to the 

lowest and highest one-time impacts. 

We are simply reporting the lowest and 

highest impacts per entity across costs, 

cost savings, and net cost savings. 

TABLE 41—RANGE OF IMPACTS PER ENTITY

One-time impacts Ongoing impacts 

Lowest per 

entity 

Highest per 

entity 

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. 

TABLE 42—PERCENTAGE OF ESTIMATED REVENUE IMPACT ON SMALL ENTITIES FROM OVERALL IMPACT (NET COST

SAVINGS) OF THIS FINAL RULE

% Revenue impact 

One-time net impacts Ongoing net impacts 

Small entities 

with known revenue 

Portion of small 

entities with 

known revenue 

(%) 

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 

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, 


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youth inflatable PFDs, and inflatable 

Level 100 PFDs cannot be approved by 

policy because they are not equivalent 

to any current Coast Guard standards. 

As a result, small entities would not 

receive the additional revenue from the 

sale of Level 50 devices or the cost 

savings on Level 100 inflatable device 

approvals as compared to Type I device 

approvals. For these reasons, we 

rejected this alternative. 

C. Assistance for Small Entities 

Under section 213(a) of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, Public Law 104– 

121, we offer to assist small entities in 

understanding this rule so that they can 

better evaluate its effects on them and 

participate in the rulemaking. The Coast 

Guard will not retaliate against small 

entities that question or complain about 

this rule or any policy or action of the 

Coast Guard. 

Small businesses may send comments 

on the actions of Federal employees 

who enforce, or otherwise determine 

compliance with, Federal regulations to 

the Small Business and Agriculture 

Regulatory Enforcement Ombudsman 

and the Regional Small Business 

Regulatory Fairness Boards. The 

Ombudsman evaluates these actions 

annually and rates each agency’s 

responsiveness to small business. If you 

wish to comment on actions by 

employees of the Coast Guard, call 1– 

888–REG–FAIR (1–888–734–3247). 

D. Collection of Information 

This rule calls for no new or revised 

collection of information under the 

Paperwork Reduction Act of 1995, 44 

U.S.C. 3501–3520. 

E. Federalism 

A rule has implications for federalism 

under Executive Order 13132 

(Federalism) if it has a substantial direct 

effect on States, on the relationship 

between the National Government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government. We have 

analyzed this final rule under Executive 

Order 13132 and have determined that 

it is consistent with the fundamental 

federalism principles and preemption 

requirements described in Executive 

Order 13132. Our analysis follows. 

It is well settled that States may not 

regulate in categories reserved for 

regulation by the Coast Guard. It is also 

well settled that all the categories 

covered in 46 U.S.C. 3306, 3703, 7101, 

and 8101 (design, construction, 

alteration, repair, maintenance, 

operation, equipping, personnel 

qualification, and manning of vessels), 

as well as the reporting of casualties and 

any other category in which Congress 

intended the Coast Guard to be the sole 

source of a vessel’s obligations, are 

within the field foreclosed from 

regulation by the States. The statutory 

authorities upon which this rulemaking 

is based—46 U.S.C. 3306(a), 4102(a), 

4302(a), and 4502(a) and (c)(2)(B)—are 

areas in which Congress intended the 

Coast Guard to be the sole source of a 

vessel’s obligations and, as such, are 

within the field foreclosed from 

regulation by the States. See, e.g., 

United States v. Locke, 529 U.S. 89 

(2000) (finding that the states are 

foreclosed from regulating tanker 

vessels), see also Ray v. Atlantic 

Richfield Co., 435 U.S. 151, 157 (1978) 

(state regulation is preempted where 

‘‘the scheme of federal regulation may 

be so pervasive as to make reasonable 

the inference that Congress left no room 

for the States to supplement it [or 

where] the Act of Congress may touch 

a field in which the federal interest is 

so dominant that the federal system will 

be assumed to preclude enforcement of 

state laws on the same subject.’’ 

(citations omitted)). Therefore, because 

the States may not regulate within these 

categories, this rule is consistent with 

the fundamental federalism principles 

and preemption requirements described 

in Executive Order 13132. 

F. Unfunded Mandates 

The Unfunded Mandates Reform Act 

of 1995, 2 U.S.C. 1531–1538, requires 

Federal agencies to assess the effects of 

their discretionary regulatory actions. In 

particular, the Act addresses actions 

that may result in the expenditure by a 

State, local, or tribal government, in the 

aggregate, or by the private sector of 

$100,000,000 (adjusted for inflation) or 

more in any one year. Although this rule 

does not result in such expenditure, we 

do discuss the effects of this rule 

elsewhere in this preamble. 

G. Taking of Private Property 

This rule will not cause a taking of 

private property or otherwise have 

taking implications under Executive 

Order 12630 (Governmental Actions and 

Interference with Constitutionally 

Protected Property Rights). 

H. Civil Justice Reform 

This rule meets applicable standards 

in sections 3(a) and 3(b)(2) of Executive 

Order 12988 (Civil Justice Reform) to 

minimize litigation, eliminate 

ambiguity, and reduce burden. 

I. Protection of Children 

We have analyzed this rule under 

Executive Order 13045 (Protection of 

Children from Environmental Health 

Risks and Safety Risks). This rule is not 

an economically significant rule and 

will not create an environmental risk to 

health or risk to safety that might 

disproportionately affect children. 

J. Indian Tribal Governments 

This rule does not have tribal 

implications under Executive Order 

13175 (Consultation and Coordination 

with Indian Tribal Governments), 

because it will not have a substantial 

direct effect on one or more Indian 

tribes, on the relationship between the 

Federal Government and Indian tribes, 

or on the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes. 

K. Energy Effects 

We have analyzed this rule under 

Executive Order 13211 (Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use). We have 

determined that it is not a ‘‘significant 

energy action’’ under that order because 

it is not a ‘‘significant regulatory action’’ 

under Executive Order 12866 and is not 

likely to have a significant adverse effect 

on the supply, distribution, or use of 

energy. 

L. Technical Standards 

The National Technology Transfer 

and Advancement Act, codified as a 

note to 15 U.S.C. 272, directs agencies 

to use voluntary consensus standards in 

their regulatory activities unless the 

agency provides Congress, through 

OMB, with an explanation of why using 

these standards are inconsistent with 

applicable law or otherwise impractical. 

Voluntary consensus standards are 

technical standards (e.g., specifications 

of materials, performance, design, or 

operation; test methods; sampling 

procedures; and related management 

systems practices) that are developed or 

adopted by voluntary consensus 

standards bodies. 

This rule uses the following voluntary 

consensus standards: 

• ANSI/CAN/UL 9595, Standard for 

Safety Factory Follow-Up on Personal 

Flotation Devices (PFDs), First Edition, 

June 4, 2020 (including revisions 

through September 9, 2021). 

• ANSI/CAN/UL 12402–4, Standard 

for Safety Personal Flotation Devices— 

Part 4: Lifejackets, Performance Level 

100—Safety Requirements, First 

Edition, July 9, 2020. 

• ANSI/CAN/UL 12402–5, Standard 

for Safety Personal Flotation Devices— 

Part 5: Buoyancy Aids (Level 50)— 

Safety Requirements, First Edition, 


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97386 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations 

December 31, 2015 (including revisions 

through January 27, 2022). 

• ANSI/UL 1123, Standard for Safety 

Marine Buoyant Devices, Seventh 

Edition, October 1, 2008 (including 

revisions through November 23, 2020). 

• ANSI/UL 1175, Standard for Safety 

Buoyant Cushions, Fourth Edition, 

April 20, 2007 (including revisions 

through January 10, 2020). 

The sections that reference these 

standards and the locations where these 

standards are available are listed in 46 

CFR 160.045–5, 160.055–5, 160.060–5, 

160.064–5, 160.076–5, 160.255–5, 

160.264–5, and 160.276–5. 

The Director of the Federal Register 

has approved the material in 46 CFR 

160.045–5, 160.055–5, 160.060–5, 

160.064–5, 160.076–5, 160.255–5, 

160.264–5, and 160.276–5 for 

incorporation by reference under 5 

U.S.C. 552 and 1 CFR part 51. Copies of 

the material are available from the 

sources listed in 46 CFR 160.045–5, 

160.055–5, 160.060–5, 160.064–5, 

160.076–5, 160.255–5, 160.264–5, and 

160.276–5. 

Consistent with 1 CFR part 51 

incorporation by reference provisions, 

this material is reasonably available. 

Interested persons have access to it 

through their normal course of business, 

may purchase it from the organization 

identified in 46 CFR 160.045–5, 

160.055–5, 160.060–5, 160.064–5, 

160.076–5, 160.255–5, 160.264–5, and 

160.276–5, or may view a copy by 

means we have identified in that 

section. 

M. Environment 

We have analyzed this rule under 

Department of Homeland Security 

Management Directive 023–01, Rev. 1, 

associated implementing instructions, 

and Environmental Planning 

COMDTINST 5090.1 (series), which 

guide the Coast Guard in complying 

with the National Environmental Policy 

Act of 1969 (42 U.S.C. 4321–4370f), and 

have made a determination that this 

action is one of a category of actions that 

do not individually or cumulatively 

have a significant effect on the human 

environment. A Record of 

Environmental Consideration 

supporting this determination is 

available in the docket. For instructions 

on locating the docket, see the 

ADDRESSES section of this preamble. 

This final rule is categorically excluded 

under paragraph L52 and L58 of 

Appendix A, Table 1 of DHS Instruction 

Manual 023–01–001–01, Rev. 1. 

Paragraph L52 pertains to regulations 

concerning vessel operation safety 

standards. Paragraph L58 pertains to 

regulations concerning equipment 

approval and carriage requirements. 

This final rule involves approval 

requirements and follow-up program 

requirements for lifejackets by 

incorporating new standards to replace 

existing legacy standards. The rule 

further amends lifejacket and PFD 

carriage requirements to allow for the 

use of equipment approved to the new 

standards and remove obsolete 

equipment approval requirements. The 

amendments streamline the process for 

the approval of PFDs and allow 

manufacturers the opportunity to 

produce more innovative equipment 

that meet approval requirements in both 

the United States and Canada while also 

reducing the burden of the approval 

process and the production inspections 

on manufacturing firms. 

List of Subjects 

33 CFR Part 181 

Labeling, Marine safety, Reporting 

and recordkeeping requirements. 

46 CFR Part 25 

Fire prevention, Marine safety, 

Reporting and recordkeeping 

requirements. 

46 CFR Part 28 

Alaska, Fire prevention, Fishing 

vessels, Marine safety, Occupational 

safety and health, Reporting and 

recordkeeping requirements, Seamen. 

46 CFR Part 108 

Fire prevention, Marine safety, 

Occupational safety and health, Oil and 

gas exploration, Vessels. 

46 CFR Part 117 

Marine safety, Passenger vessels. 

46 CFR Part 133 

Cargo vessels, Marine safety, 

Reporting and recordkeeping 

requirements. 

46 CFR Part 141 

Marine safety, Occupational health 

and safety, Reporting and recordkeeping 

requirements, Towing vessels. 

46 CFR Part 160 

Incorporation by reference, Marine 

safety, Reporting and recordkeeping 

requirements. 

46 CFR Part 169 

Fire prevention, Marine safety, 

Reporting and recordkeeping 

requirements, Schools, Vessels. 

46 CFR Part 180 

Marine safety, Passenger vessels. 

46 CFR Part 199 

Cargo vessels, Marine safety, Oil and 

gas exploration, Passenger vessels, 

Reporting and recordkeeping 

requirements. 

For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR part 181 and 46 CFR parts 25, 28, 

108, 117, 133, 141, 160, 169, 180, and 

199 as follows: 

Title 33—Navigation and Navigable 

Waters 

PART 181—MANUFACTURER 

REQUIREMENTS 

■ 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. 


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■ 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. 

TABLE 1 TO § 28.110—PERSONAL FLOTATION DEVICES AND IMMERSION SUITS

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. 

1A 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. 

* * * * * 

(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 


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conditions marked on the PFD and in 

the owner’s manual, of the same or 

similar design, and has the same 

method of operation as each other 

hybrid PFD carried on board. 

PART 133—LIFESAVING SYSTEMS 

■ 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. 

(b) Designs and constructions. 

Throwable PFDs must not provide 

means for adjustment or close fitting to 


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the body. Methods of construction must 

provide strengths, with reinforcements 

where necessary, to be adequate for the 

intended use and purpose of the device. 

(c) Materials. All materials used in 

any device covered by this subpart must 

meet the applicable requirements of 

subpart 164.019 of this chapter, must be 

all new materials, must be suitable for 

the purpose intended, and must be at 

least equivalent to corresponding 

materials specified for standard buoyant 

cushions. Hardware or fastenings must 

be of sufficient strength for the purpose 

of the device and must be of inherently 

corrosion-resistant material, such as 

stainless steel, brass, bronze, certain 

plastics, etc. Decorative platings of any 

thickness are permissible. Fabrics, 

coated fabrics, tapes, and webbing must 

be either mildew-resistant or treated for 

mildew resistance. Buoyancy provided 

by inherently buoyant material must not 

be dependent upon loose, granulated 

material. 

(d) Standard construction. A standard 

foam cushion that is designed to be 

thrown must be 2 inches or more in 

thickness and must have 225 or more 

square inches of top surface area. 

(e) Nonstandard construction. A 

nonstandard throwable PFD must meet 

the requirements in ANSI/UL 1123 or 

ANSI/UL 1175 (both incorporated by 

reference, see § 160.045–5) and any 

additional requirements that the 

Commandant may prescribe to approve 

unique or novel designs. 

(f) Buoyancy. (1) Ring life buoys must 

have 161⁄2 pounds or more of buoyancy. 

(2) Foam cushions must have 18 

pounds or more of buoyancy. 

(3) A device other than those standard 

devices specified in paragraph (f)(1) or 

(2) of this section must have 20 pounds 

or more of buoyancy. 

(g) Workmanship. Throwable PFDs 

must be of first quality workmanship 

and must be free from any defects 

materially affecting their appearance or 

serviceability. 

§ 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 

(6) Any limitations or restrictions on 

approval or special instructions for use. 


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(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). 

1A 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: 


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§ 160.055–15 Production inspections, 

tests, and quality control of life preservers. 

(a) General. Production tests and 

inspections must be conducted in 

accordance with this section, subpart 

159.007 of this chapter, and the 

independent laboratory’s procedures for 

production inspections and tests as 

accepted by the Commandant. The 

Commandant may prescribe additional 

production tests and inspections 

necessary to maintain quality control 

and to monitor compliance with the 

requirements of this subchapter. A 

follow-up program in accordance with 

ANSI/CAN/UL 9595 (incorporated by 

reference, see § 160.055–5), meets the 

requirements of this subpart. 

(b) Oversight. In addition to 

responsibilities set out in part 159 of 

this chapter and the accepted laboratory 

procedures for production inspections 

and tests, each manufacturer of a life 

preserver and each laboratory inspector 

must comply with the following, as 

applicable: 

(1) Manufacturer. Each manufacturer 

must— 

(i) Perform all tests and examinations 

necessary to show compliance with this 

subpart on each lot before any 

inspector’s tests and inspection of the 

lot; 

(ii) Follow established procedures for 

maintaining quality control of the 

materials used, manufacturing 

operations, and the finished product; 

and 

(iii) Allow an inspector to take 

samples of completed units or of 

component materials for tests required 

by this subpart and for tests relating to 

the safety of the design. 

(2) Laboratory. An inspector from the 

accepted laboratory must oversee 

production in accordance with the 

laboratory’s procedures for production 

inspections and tests accepted by the 

Commandant. During production 

oversight, the inspector must not 

perform or supervise any production 

test or inspection unless— 

(i) The manufacturer has a valid 

approval certificate; and 

(ii) The inspector has first observed 

the manufacturer’s production methods 

and any revisions to those methods. 

(3) At least quarterly, the inspector 

must check the manufacturer’s 

compliance with the company’s quality 

control procedures, examine the 

manufacturer’s required records, and 

observe the manufacturer perform each 

of the required production tests. 

(c) Test facilities. The manufacturer 

must provide a suitable place and 

apparatus for conducting the tests and 

inspections necessary to determine 

compliance of life preservers with this 

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. 

TABLE 1 TO § 160.055–15(e)(1)— 

SAMPLING FOR BUOYANCY TESTS

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: 


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§ 160.055–23 Procedure for approval of 

design or material change. 

(a) The manufacturer must submit any 

proposed changes in design, material, or 

construction to typeapproval@uscg.mil 

for approval before changing life 

preserver production methods. 

(b) Only the Commandant or a 

designated representative may make 

determinations of equivalence of design, 

construction, and materials. 

■ 39. Add § 160.055–25 to read as 

follows: 

§ 160.055–25 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). 

1A 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; 

(4) The manufacturer must select 

samples in accordance with the 


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requirements in Table 1 to § 160.060– 

15(b)(4) from each lot of buoyant vests 

to be tested for buoyancy in accordance 

with paragraph (e) of this section; and 

TABLE 1 TO § 160.060–15(b)(4)— 

SAMPLE FOR BUOYANCY TESTS

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 151⁄2 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. 

Recognized laboratory means an 

independent laboratory accepted by the 

Commandant in accordance with 46 

CFR subpart 159.010, with a valid 


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97394 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations 

memorandum of understanding in 

accordance with 46 CFR 159.010–7. 

§ 160.064–4 [Removed and Reserved] 

■ 55. Remove and reserve § 160.064–4. 

■ 56. Add § 160.064–5 to read as 

follows: 

§ 160.064–5 Incorporation by reference. 

Certain material is incorporated by 

reference into this part with the 

approval of the Director of the Federal 

Register in accordance with 5 U.S.C. 

552(a) and 1 CFR part 51. All approved 

incorporation by reference (IBR) 

material is available for inspection at 

the Coast Guard Headquarters and at the 

National Archives and Records 

Administration (NARA). Contact 

Commandant (CG–ENG–4), Attn: 

Lifesaving and Fire Safety Division, U.S. 

Coast Guard Stop 7509, 2703 Martin 

Luther King Jr. Avenue SE, Washington, 

DC 20593–7509. For information on the 

availability of this material at NARA, 

visit www.archives.gov/federal-register/ 

cfr/ibr-locations or email fr.inspection@

nara.gov. The material may be obtained 

from UL, 333 Pfingsten Road, 

Northbrook, IL 60062–2002; phone (847) 

272–8800; website: www.ul.com. 

(a) ANSI/CAN/UL 9595:2021, 

Standard for Safety Factory Follow-Up 

on Personal Flotation Devices (PFDs), 

First Edition, June 4, 2020 (including 

revisions through September 9, 2021) 

(‘‘ANSI/CAN/UL 9595’’); IBR approved 

for § 160.064–15(e). 

(b) [Reserved] 

§§ 160.064–6 and 160.064–7 [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. 

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. 


lotter on DSK11XQN23PROD with RULES3
Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Rules and Regulations 97395 

Coast Guard Stop 7509, 2703 Martin 

Luther King Jr. Avenue SE, Washington, 

DC 20593–7509. For information on the 

availability of this material at NARA, 

visit www.archives.gov/federal-register/ 

cfr/ibr-locations or email fr.inspection@

nara.gov. The material may be obtained 

from UL, 333 Pfingsten Road, 

Northbrook, IL 60062–2002; phone (847) 

272–8800; website: www.ul.com. 

(a) ANSI/CAN/UL 9595:2021, 

Standard for Safety Factory Follow-Up 

on Personal Flotation Devices (PFDs), 

First Edition, June 4, 2020 (including 

revisions through September 9, 2021) 

(‘‘ANSI/CAN/UL 9595’’); IBR approved 

for § 160.076–29(a). 

(b) [Reserved]. 

§ 160.076–13 [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: 

Commandant means the Chief of the 

Lifesaving and Fire Safety Standards 


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Division. Address: Commandant (CG– 

ENG–4), Attn: Lifesaving and Fire Safety 

Division, U.S. Coast Guard Stop 7509, 

2703 Martin Luther King Jr. Avenue SE, 

Washington, DC 20593–7509; email 

TypeApproval@uscg.mil. 

First quality workmanship means 

construction that is free from any defect 

materially affecting appearance or 

serviceability. 

Inspector means a recognized 

laboratory representative assigned to 

perform, supervise, or oversee the duties 

described in § 160.255–15 or any Coast 

Guard representative performing duties 

related to the approval. 

Recognized laboratory means an 

independent laboratory accepted by the 

Commandant in accordance with 46 

CFR subpart 159.010, with a valid 

memorandum of understanding in 

accordance with 46 CFR 159.010–7. 

§ 160.255–5 Incorporation by reference. 

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. 


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§ 160.255–17 Marking and labeling. 

(a) Each lifejacket must be marked 

with the appropriate label as specified 

in Figure 6DV of ANSI/CAN/UL 12402– 

4 (incorporated by reference, see 

§ 160.255–5). 

(b) The Commandant may prescribe 

additional marking requirements for 

special purpose devices or unique or 

novel designs. 

§ 160.255–19 Placard. 

Each lifejacket sold or offered for sale 

must be provided with a placard that a 

prospective purchaser can read prior to 

purchase, as specified in Figure 

8DV.1.1a and Figure 8DV.1.1b, Choose 

the Device You Will Want to Wear, of 

ANSI/CAN/UL 12402–4 (incorporated 

by reference, see § 160.255–5). The 

required placard text must be printed 

exactly as set out in ANSI/CAN/UL 

12402–4, unless otherwise approved by 

the Commandant. 

§ 160.255–21 Lifejacket manuals. 

(a) An owner’s manual in accordance 

with Figure 7DV of ANSI/CAN/UL 

12402–4 (incorporated by reference, see 

§ 160.255–5), must be provided with 

each inflatable lifejacket sold or offered 

for sale. The text of each manual is 

reviewed with the application for 

approval. 

(b) The Commandant may prescribe 

additional information in the manual for 

special purpose devices or unique or 

novel designs. 

(c) Additional information, 

instructions, or illustrations may be 

included in the owner’s manual if there 

is no contradiction to the required 

information. 

§ 160.255–23 Procedure for approval of 

design or material change. 

(a) The manufacturer must submit any 

proposed changes in design, material, or 

construction to the recognized 

laboratory for approval before changing 

lifejacket production methods. 

(b) Determinations of equivalence of 

design, construction, and materials must 

be made only by the Commandant or a 

designated representative. 

§ 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; 

(iv) Ensure each inflatable lifejacket 

serviced under the facility’s Coast Guard 

approval is serviced by or under the 

supervision of a servicing technician 


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who meets the requirements of 

paragraph (d)(3) of this section; 

(v) Specify each make and model of 

lifejacket the facility is approved to 

service when it represents itself as 

approved by the U.S. Coast Guard; and 

(vi) Not service any lifejacket for a 

U.S. registered commercial vessel, 

unless it is approved by the U.S. Coast 

Guard to service the make and model of 

lifejacket. 

(e) Servicing records. Each servicing 

facility must maintain records of all 

completed servicing. These records 

must be retained for at least 5 years after 

they are made, be made available to any 

Coast Guard representative and 

independent laboratory inspector upon 

request, and include at least the 

following: 

(1) Date of servicing, number of 

lifejackets serviced, lot identification, 

approval number, and test results data 

for the lifejackets serviced; 

(2) Identification of the person 

conducting the servicing; 

(3) Identity of the vessel receiving the 

serviced lifejackets; and 

(4) Date of return to the vessel. 

■ 79. Add subpart 160.264, consisting of 

§§ 160.264–1 through 160.264–25, to 

read as follows: 

Subpart 160.264—Wearable Recreational 

Personal Flotation Devices (PFDs) 

Sec. 

160.264–1 Scope. 

160.264–3 Definitions. 

160.264–5 Incorporation by reference. 

160.264–7 Design, construction, and 

performance of PFDs. 

160.264–9 Approval procedures for PFDs. 

160.264–11 Recognized laboratory. 

160.264–13 Approval inspections and tests. 

160.264–15 Production inspections, tests, 

and quality control of PFDs. 

160.264–17 Marking and labeling. 

160.264–19 Placard. 

160.264–21 PFD manuals. 

160.264–23 Procedure for approval of 

design or material change. 

160.264–25 Suspension or termination of 

approval. 

Subpart 160.264—Wearable 

Recreational Personal Flotation 

Devices (PFDs) 

§ 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. 

(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 


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available from the Commandant and 

online at https://cgmix.uscg.mil. 

(b) Production oversight must be 

performed by the same laboratory that 

performs the approval tests unless, as 

determined by the Commandant, the 

employees of the laboratory performing 

production oversight receive training 

and support equal to that of the 

laboratory that performed the approval 

testing. 

§ 160.264–13 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. 

(c) PFDs approved under this subpart 

are intended to meet the carriage 

requirements for uninspected 


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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. 

§ 160.276–3 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. 

(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. 


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(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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§ 199.70 Personal lifesaving appliances. 

* * * * * 

(b) Lifejackets. Each vessel must carry 

lifejackets approved under approval 

series 160.155 or 160.176. If the vessel 

carries inflatable lifejackets, they must 

be of the same or similar design and 

have the same method of operation. 

* * * * * 

■ 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 


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