2023-06504. Lifejacket Approval Harmonization

AGENCY:

Coast Guard, DHS.

ACTION:

Notice of proposed rulemaking.

SUMMARY:

The Coast Guard proposes to amend the approval requirements and follow-up program requirements for lifejackets by incorporating new standards to replace existing legacy standards. The Coast Guard further proposes to amend lifejacket and personal flotation device (PFD) carriage requirements to allow for the use of equipment approved to the new standards and remove obsolete equipment approval requirements. The proposed amendments would streamline the process for the approval of PFDs and allow manufacturers the opportunity to produce more innovative equipment that would meet approval requirements in both Canada and the United States while also reducing the burden of the approval process and the production inspections on manufacturing firms.

DATES:

Comments and related material must be received by the Coast Guard on or before June 6, 2023.

ADDRESSES:

You may submit comments identified by docket number USCG–2022–0120 using the Federal Decision Making Portal at www.regulations.gov. See the “Public Participation and Request for Comments” portion of the SUPPLEMENTARY INFORMATION section for further instructions on submitting comments.

Viewing material proposed for incorporation by reference. Make arrangements to view this material by calling the person identified in the FOR FURTHER INFORMATION CONTACT section of this document.

FOR FURTHER INFORMATION CONTACT:

For further information about this document call or email Jacqueline Yurkovich, Coast Guard; telephone [phone], email [e-mail].

SUPPLEMENTARY INFORMATION:

Table of Contents for Preamble

I. Public Participation and Request for Comments

II. Abbreviations

III. Background, Basis, and Purpose

IV. Discussion of Proposed 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. Public Participation and Request for Comments

The Coast Guard views public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment may help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.

Submitting comments. We encourage you to submit comments through the Federal Decision Making Portal at www.regulations.gov. To do so, go to www.regulations.gov, type USCG–2022–0120 in the search box, and click “Search.” Next, look for this document in the Search Results column, and click on it. Then click on the Comment option. If you cannot submit your material using www.regulations.gov, call or email the person in the FOR FURTHER INFORMATION CONTACT section of this proposed rule for alternate instructions.

Viewing material in docket. To view documents mentioned in this proposed rule as being available in the docket, find the docket as described in the previous paragraph, and then select “Supporting & Related Material” in the Document Type column. Public comments will also be placed in our online docket and can be viewed by following instructions on the www.regulations.gov Frequently Asked Questions web page. That web page also explains how to subscribe for email alerts that will notify you when comments are posted or if a final rule is published. We review all comments received, but we will only post comments that address the topic of the proposed rule. We may choose not to post off-topic, inappropriate, or duplicate comments that we receive.

Personal information. We accept anonymous comments. Comments we post to www.regulations.gov will include any personal information you have provided. For more about privacy and submissions in response to this document, see the Department of Homeland Security's eRulemaking System of Records notice (85 FR 14226, March 11, 2020).

Public meeting. We do not plan to hold a public meeting but we will consider doing so if we determine from public comments that a meeting would be helpful. We would issue a separate Federal Register notice to announce the date, time, and location of such a meeting.

II. Abbreviations

ANSI American National Standards Institute

CFR Code of Federal Regulations

DHS Department of Homeland Security

FR Federal Register

IBR Incorporation by reference

IRFA Initial Regulatory Flexibility Analysis

ISO International Organization for Standardization

NAICS North American Industry Classification System

NBSAC National Boating Safety Advisory Committee

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

SOLAS International Convention for the Safety of Life at Sea

U.S.C. United States Code

III. Background, Basis, and Purpose

The Coast Guard has statutory authority under Title 46, U.S. Code, 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. 01.2, paragraph (II)(92)(b), the Secretary delegated authority under these statutes to the Commandant of the Coast Guard.

With this rulemaking, we are proposing to incorporate 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 propose to incorporate 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 inherently buoyant and inflatable throwable PFDs to these standards as a matter of policy, so incorporating them in the Code of Federal Regulations (CFR) would not result in any changes in practice but would improve transparency.

We are also proposing to remove portions of Title 46 in part 160 of the CFR, where the newly incorporated standards would supersede the previous standards or requirements. Additionally, we are proposing amendments to lifesaving equipment carriage requirements that would 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 has 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 would allow manufacturers the opportunity to produce more innovative equipment that would still meet approval requirements in both Canada and the United States. PFD manufacturers largely drove the development of these standards; therefore, we expect PFD manufacturers to generally support this proposed rulemaking.

To further those efforts, on September 22, 2014, the Coast Guard published a final rule to remove 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 (79 FR 56491, September 22, 2014). 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.

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. On November 15, 2019, the Coast Guard published a notice (84 FR 62546) that finalized this policy.

The Coast Guard published a final rule (77 FR 19937, April 3, 2012) incorporating by reference updated revisions of industry consensus 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). 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 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.

IV. Discussion of Proposed Rule

The Coast Guard is proposing seven main amendments to our regulations:

(1) Adding new subpart 160.255 and incorporating by reference ANSI/CAN/UL 12402–4 for approval of Level 100 PFDs, and removing sections of subpart 160.055.

(2) Adding new subparts 160.264 and 160.276, 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 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, 160.047, 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 include the placard specified in subparts 160.055, 160.060, 160.255, 160.264, and 160.276.

(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. If we finalize this proposed rule, then under 46 U.S.C. 4302(b) the effective date of provisions applying to recreational vessels would be at least 180 days after publication. For simplicity, we would likely delay the effective date of the entire rule until 180 days after publication. We invite public comments on that timing.

The National Boating Safety Advisory Committee (NBSAC) was consulted regarding the updated standards proposed in this rule, as shown by NBSAC Resolutions 2009–83–01 and 2011–87–01, and the revalidation of those resolutions found in Resolution 2022–03–01. We also welcome comments from NBSAC on this proposed rule.

1. Add New Subpart, 46 CFR 160.255, and Incorporate by Reference ANSI/CAN/UL 12402–4

We propose adding a new subpart, 160.255, to title 46 of the CFR. PFDs approved under this new subpart would meet the carriage requirements for wearable PFDs for inspected vessels that are neither on an international voyage nor subject to the International Convention for the Safety of Life at Sea (SOLAS), uninspected commercial vessels over 40 feet (12m) in length, and uninspected passenger vessels.

Newly proposed 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 would be incorporated by reference. PFDs approved under this subpart could rely upon inherently buoyant material, inflation, or a combination of the two to achieve the minimum buoyancy.

A Level 100 PFD has the same basic requirements as a PFD meeting 46 CFR 160.055. 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 would be able to 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.^[1] Therefore, we expect this marking format to be more easily understandable to both English-speaking 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 and to reach minimum in-water performance with any one chamber deflated. 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 (54 FR 50320). In that rulemaking, the Coast Guard noted that we would continue discussions with industry, standards organizations, and state boating law administrators regarding the reliability of inflatable PFDs. 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 than an inherently buoyant PFD. Additionally, the Coast Guard has approved inflatable PFDs without back-up chambers under approval series 160.076. Such devices have been in use in the United States on uninspected commercial vessels less than 12 m in length and 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 46 CFR 160.055.

Because newly proposed subpart 160.255 would supersede the requirements for life preservers in subpart 160.055, we propose to delete structural and performance requirements for approval of life preservers in subpart 160.055, but maintain the requirements for production inspections, tests, and quality assurance. Manufacturers could continue to produce life preservers currently approved under subpart 160.055, while all new lifejackets would require Coast Guard approval under new subpart 160.255.

At the same time, we propose to restructure subpart 160.055 to include a statement of the subpart's scope and to mirror the structure of other PFD-related subparts. We would add the scope as § 160.055–1 and definitions in § 160.055–3, and the documents incorporated by reference would be moved from § 160.055–1 to § 160.055–5. Because no new approvals would be granted under § 160.055, we propose to remove 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 propose independent laboratory requirements for addition in § 160.055–11. We would move sampling, tests, and inspections from § 160.055–7 to newly created § 160.055–15 and pamphlet requirements would be included in new § 160.055–19. Procedures for the approval of design or material changes would be included in new § 160.055–23 and information on suspension or termination of approval would be included in new § 160.055–25.

2. Add New Subparts 46 CFR 160.045, 160.264, and 160.276, and Incorporate by Reference ANSI/CAN/UL 12402–5, ANSI/UL 1123, and ANSI/UL 1175

We propose three new subparts in Title 46 of the CFR: 160.045, 160.264, and 160.276. PFDs approved under these subparts would meet the carriage requirements for uninspected commercial vessels less than 40 feet (12m) in length and not carrying passengers for hire, and recreational boats, in accordance with 33 part CFR 175 and 46 CFR subpart 25.25.

Newly proposed 46 CFR 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 pamphlets, and associated manuals. Newly proposed 46 CFR 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 pamphlets, and markings. ANSI/CAN/UL 12402–5 would be incorporated by reference in both subparts.

ANSI/CAN/UL 12402–5 prescribes minimum performance requirements instead of prescribing design requirements. These performance-based standards allow 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.^[2] 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.^[3] 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.^[4]

Discomfort, whether real or perceived, is negatively associated with PFD wear.^[5] ANSI/CAN/UL 12402–5 allows manufacturers more flexibility when selecting materials, design, and construction of new PFDs. Because manufacturers would be less limited in the materials, design, and construction, we expect 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, the Coast Guard determined that Level 70 inherently buoyant devices, Level 70 inflatable devices, and Level 70 multi-chamber devices that meet the requirements of ANSI/CAN/UL 12402–5 provide equivalent performance to wearable PFDs meeting 46 CFR 160.064 or 160.076.

Now, the Coast Guard is proposing this rule based on our assessment that a Level 50 PFD, when worn and used in accordance with the label, provides an equivalent level of safety as a wearable PFD meeting subpart 160.064 or 160.076. A Level 50 PFD has a lower minimum amount of buoyancy than the current minimum requirement for Coast Guard approved PFDs. However, ANSI/CAN/UL 12402–5 requires that a Level 50 PFD keep the user's airway above the water, as demonstrated by in-water performance testing. A Level 50 PFD is intended for use by those who can swim and who have help or rescue nearby. As required in ANSI/CAN/UL 12402–5, Level 50 PFDs must be marked: “Not recommended for weak or non-swimmers.” Every PFD offered for sale must have a placard providing users with information on how to select the appropriate PFD, and reminding users to try the PFD on in the water to ensure proper fit and performance. To satisfy requirements of ANSI/CAN/UL 12402–5, Level 50 PFDs must be worn and must be marked: “Approval conditions state that this device must be worn to be counted as equipment required by vessels meeting Transport Canada or USCG regulations.” A Level 50 PFD, when worn by a person who can swim and used in accordance with ANSI/CAN/UL 12402–5, provides an equivalent level of safety as a PFD meeting 46 CFR 160.064 or 160.076. By approving Level 50 PFDs, the Coast Guard would provide a critical level of oversight to the currently unregulated Level 50 competition watersports PFDs, resulting in safer products for the public.

In this proposed rule, we are not proposing additional requirements that would 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 proposing to fully incorporate ANSI/CAN/UL 12402–5 without any additional age restrictions beyond those included in the standard.

New proposed subparts 160.264 and 160.276 would 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 propose 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 proposing to delete subpart 160.077 entirely and modify 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, the Coast Guard would ensure that manufacturing firms producing PFDs currently approved under approval series 160.060, 160.064, 160.076, or 160.077 could continue to manufacture and sell these PFDs, but would not approve new products under these approval series. At the same time, we are proposing to reformat 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 proposing to relocate the requirements for throwable PFDs from subpart 160.064 to newly proposed subpart 160.045. Newly proposed subpart 160.045 would be dedicated to throwable PFDs intended for carriage on recreational boats. We propose to permit the use of inflatable compartments to meet the minimum required buoyancy in § 160.045–7. This proposed new subpart would incorporate 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 propose to incorporate 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 160.055, 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 C is equivalent to current industry practice for follow-up programs and meets the current minimum requirements. 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 A is reserved for facilities that have demonstrated a superior QMS that meets International Organization for Standardization (ISO) standard ISO 9001 or a comparable quality standard, either by audits or acceptance of a third-party registration.^[6]

For Process Rating C, ANSI/CAN/UL 9595 provides a minimum requirement for production inspections that is equivalent to the production inspection programs currently accepted by the Commandant. For Process Ratings A and B, this standard provides the option for the manufacturer to implement a QMS to reduce the number of inspections required. ANSI/CAN/UL 9595 sets forth 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 propose to include ANSI/CAN/UL 9595 in the newly proposed subparts 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 propose to remove subparts 160.002, 160.005, 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 propose to delete subpart 160.001, preserving the still-pertinent information on production oversight by relocating it to § 160.055–15.

Subpart 160.006 provides two paragraphs related to the repairing of life preservers. Subpart 160.006 is no longer relevant and is not referenced in any approval or carriage requirement; therefore, we propose to remove 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 propose to delete subparts 160.002, 160.005, 160.047, 160.048, and 160.052. All new PFD approvals would have to meet the requirements in proposed subparts 160.255, 160.264, and 160.276, which incorporate current industry standards.

5. Amend Lifesaving Equipment Carriage Requirements

Where current carriage requirements specify approval series for PFDs, we propose to add the new proposed 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).

For example, according to the current requirements, 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. We propose to add 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 proposing to remove any of the currently accepted approval series from the carriage requirements. Therefore, it would not be necessary for owners and operators to purchase new equipment if their current equipment is in good and serviceable condition.

We also propose to remove 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, would be approved under approval series 160.255.

6. Amend the Requirements for Instruction Pamphlets for PFDs

We propose to amend 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 propose to incorporate both ANSI/CAN/UL 12402–4 and ANSI/CAN/UL 12402–5 with respect to the approval of PFDs. Both these 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 proposing to add the term “placard” to 33 CFR 181.701–702. We also propose to remove 33 CFR 181.703, which requires that placards conform with UL 1123, and would add 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 would eliminate all references to UL 1123 in this subpart, so we would remove 33 CFR 181.4, which incorporates that standard, as well. Finally, we propose to remove the separate requirements for hybrid and inflatable PFDs in 33 CFR 181.704 and 181.705, respectively, and include requirements for all PFDs in 33 CFR 181.702.

7. Amend the Existing Regulatory Text To Make Editorial Corrections and Increase Clarity

We propose to update the introductory IBR text, in accordance with current practice, in 46 CFR 160.055, 160.060, 160.064, and 160.076. We propose to amend 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 further propose to remove reference to approval series 160.177 in 46 CFR 108, 133 and 199, because this unused approval series does not exist, and to remove outdated provisions allowing cork and balsa wood lifejackets until March 11, 1999, from 46 CFR 117 and 180. Finally, we are proposing to consistently use the term “lifejacket” by amending instances of “life jacket” from two words to one.

V. Incorporation by Reference

Material proposed for IBR appears in 46 CFR 160.045, 160.055, 160.060, 160.064, 160.076, 160.255, 160.264, and 160.276. The standards proposed for IBR are summarized in section IV, paragraphs (1) through (3), of this preamble. They are:

(1) ANSI/CAN/UL 9595:2021, Standard for Factory Follow-Up on Personal Flotation Devices (PFDs), First Edition, June 4, 2020 (including revisions through September 9, 2021) (“ANSI/CAN/UL 9595”). This standard specifies the basic elements of a production inspection program for various types of PFDs.

(2) ANSI/CAN/UL 12402–4:2020, Standard for Personal Flotation Devices—Part 4: Lifejackets, Performance Level 100—Safety Requirements, First Edition, July 9, 2020 (“ANSI/CAN/UL 12402–4”). This standard specifies safety requirements for Level 100 lifejackets for use by adults, children, and infants.

(3) ANSI/CAN/UL 12402–5:2022, Standard for 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”). This standard specifies safety requirements for Level 50 and Level 70 buoyancy aids for use by children and adults.

(4) ANSI/UL 1123, Standard for Marine Buoyant Devices, Seventh Edition, October 1, 2008 (including revisions through November 23, 2020) (“ANSI/UL 1123”). This standard specifies requirements for marine buoyant devices intended for recreational use.

(5) ANSI/UL 1175, Standard for Buoyant Cushions, Fourth Edition, April 20, 2007 (including revisions through January 10, 2020) (“ANSI/UL 1175”). This standard specifies construction, performance, and markings requirements for inherently buoyant and inflatable throwable PFDs.

These standards are reasonably available to, and usable by, the class of persons affected by this proposed rule. PFD manufacturing firms have access to these standards in their normal course of business. These standards are available for free digital viewing with the creation of a free account at https://shopulstandards.com. Copies of the material are also available for purchase from the publishers listed in 46 CFR 160.045, 160.055, 160.060, 160.064, 160.076, 160.255, 160.264, and 160.276. In addition, any person may view the standards at a Coast Guard facility, by making arrangements with the person in the FOR FURTHER INFORMATION CONTACT section of this preamble. Before publishing a final rule, we will submit this material to the Director of the Federal Register for approval of the IBR. We are also accepting comments on whether you use the substance of these standards, or if certain standards can be simply referenced where we no longer need to incorporate the full text of the reference.

VI. Regulatory Analyses

We developed this proposed 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; a summary of our analysis follows.

A. Regulatory Planning and Review

Executive Orders 12866 (“Regulatory Planning and Review”) and 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.

The Office of Management and Budget (OMB) has not designated this proposed rule a significant regulatory action under section 3(f) of Executive Order 12866. OMB has not reviewed this proposed rule. A regulatory analysis (RA) is available in the docket and a summary follows. Table 1 summarizes the impacts of this rulemaking.

Table 1—Summary of Impacts of the Proposed 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), 57 PFD manufacturing firms (37 U.S. and 20 foreign), the Coast Guard, recreational vessel operators, and commercial vessel operators.
Costs to U.S. Firms ($2019, 7% discount rate)	10-year total: $1,401,108.
	Annualized: $199,486.
Costs to Foreign Firms ($2019, 7% discount rate)	10-year total: $340,229.
	Annualized: $48,441.
Total Costs ($2019, 7% discount rate)	10-year total: $1,741,338.
	Annualized: $247,927.
Cost Savings to U.S. Firms ($2019, 7% discount rate)	10-year total: $5,841,460.
	Annualized: $831,693.
Cost Savings to Foreign Firms ($2019, 7% discount rate)	10-year total: $1,453,901.
	Annualized: $207,003.
Cost Savings to the U.S. Government ($2019, 7% discount rate)	10-year total: $27,414.
	Annualized: $3,903.
Total Cost Savings to All Entities ($2019, 7% discount rate)	10-year total: $7,322,776.
	Annualized: $1,042,599.
Net Cost Savings to U.S. Firms ($2019, 7% discount rate)	10-year total: $18,405,217.
	Annualized: $2,620,489.
Net Cost Savings to Foreign Firms ($2019, 7% discount rate)	10-year total: $4,401,743.
	Annualized: $626,709.
Net Cost Savings to the U.S. Government ($2019, 7% discount rate)	10-year total: $22,806,961.
	Annualized: $3,247,198.
Net Cost Savings to All Entities ($2019, 7% discount rate)	10-year total: $4,440,352.
	Annualized: $632,206.
Unquantified Benefits	The newer performance-based standards would 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.

The Coast Guard proposes to harmonize its approval process for PFDs with that of Canada, resulting in cost savings from eliminating duplicative requirements. The proposed rule would introduce harmonized performance standards instead of design standards for PFDs, allowing manufacturers the opportunity to produce more innovative equipment that meets the approval requirements of both Canada and the United States. The proposed rule would amend PFD approval and follow-up program requirements by incorporating three new binational standards into regulations, amend PFD carriage requirements to allow for the use of equipment approved to the new standards, and remove obsolete equipment approval requirements. The proposed performance-based standards are more current and intended to replace the legacy design standards. The proposed amendments would streamline the process for approval of PFDs and allow manufacturers the opportunity to produce more innovative equipment that meets the approval requirements of Canada and the United States, while reducing the burden for manufacturers in the approval process and follow-up program.

Specifically, the Coast Guard proposes to incorporate 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 proposes to incorporate two national standards (ANSI/UL/1123 and ANSI/UL/1175) and to amend numerous CFR parts to remove obsolete PFD design standards and update carriage requirements to include PFDs approved to the new proposed 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, so 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.

Affected Population

To determine the affected population of the rule, it is first necessary to describe the economic impacts from this proposed rule. The economic impacts would stem from the following proposed 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 proposed subparts of 46 CFR 160.045, 160.255, 160.264, and 160.276.

(4) The proposed edits to 33 CFR 181 subpart G, which would permit manufacturers of all PFDs to provide placards instead of information pamphlets.

These four provisions would 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 2021, there are over 800 models of PFDs approved by the Coast Guard, manufactured by 57 separate manufacturing firms worldwide.⁷ Based on a review of publicly available information across the 57 manufacturing firms, the Coast Guard estimates that 37 are U.S. firms and 20 are foreign firms. Market share and production volumes are not equal across the firms.⁸

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	3.20	1.80
Total	100	80.70	19.30

The first provision, the IBR of ANSI/CAN/UL 12402–4, would affect three populations:

(1) PFD manufacturers that would seek approval to manufacture devices meeting the requirements of ANSI/CAN/UL 12402–4;

(2) The two recognized independent laboratories that would review and certify these devices; and

(3) The Coast Guard, which would correspond with the recognized independent laboratories and manufacturers on device approval.

In table 3, we list the number of PFD manufacturing firms that would be affected by ANSI/CAN/UL 12402–4. We estimate that each of the top 13 firms would produce ANSI/CAN/UL 12402–4 devices or components of those devices at 2 facilities each and firms outside of the top 13 firms would produce ANSI/CAN/UL 12402–4 devices at 1 facility each.^[9]

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 would introduce new categories for youth inflatables and Level 50 PFDs for approval. Permitting youth inflatables and Level 50 devices would affect three populations:

(1) PFD manufacturers that would seek Coast Guard approval to produce youth inflatables or Level 50 devices;

(2) The two recognized independent laboratories that would review and certify youth inflatables and Level 50 devices; and

(3) The boating public that would purchase 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 newly proposed and existing subparts in Title 46, as listed in table 4.

Table 4—PFDs Impacted by ANSI/CAN/UL 9595

Subpart	PFD type	Proposed or existing subpart
160.045	Throwable PFDs	Proposed.
160.255	Level 100 PFDs	Proposed.
160.264	Inherently Buoyant Level 50 and Level 70 PFDs	Proposed.
160.276	Inflatable Level 50 and Level 70 PFDs	Proposed.
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 C is assigned to facilities with a minimally compliant QMS. The requirements for Process Rating C are equivalent to the current minimum requirements. Process Rating B is assigned to facilities with a good QMS, and Process Rating A is reserved for facilities that have demonstrated a superior QMS. Because Process Rating C is equivalent to current industry practice, the affected population for the IBR of ANSI/CAN/UL 9595 would be any PFD manufacturer 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.^[10] 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 would experience net cost savings from the proposed IBR of ANSI/CAN/UL 9595. As a result, we estimate 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, would affect all firms manufacturing PFDs approved to any of the categories in table 6 that list placards as permitted under the proposed rule.

Table 6—Device Category and Permitted Instruction Types

Device category	Types of instructions allowed by the proposed 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.

ANSI/CAN/UL 12402–4

Costs

There are two sources of costs from this provision: (1) independent laboratories would 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) would 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.^[11]

We provide our estimate for the total costs of the proposed IBR of ANSI/CAN/UL 12402–4 to U.S. firms in table 7. These costs would include $25,000 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 $1,406 per year manufacturers would spend on the more expensive ANSI/CAN/UL 12402–4 certification as opposed to the legacy certification.^[12]

Table 7—Estimated Costs to U.S. Firms for Level 100 Devices Under Standard ANSI/CAN/UL 12402–4

[2019 dollars, 10-year period of analysis]

Year	Total undiscounted costs	Discounted costs
		7%	3%
1	$26,406	$24,678	$25,637
2	1,406	1,228	1,325
3	1,406	1,148	1,287
4	1,406	1,073	1,249
5	1,406	1,002	1,213
6	1,406	937	1,177
7	1,406	876	1,143
8	1,406	818	1,110
9	1,406	765	1,078
10	1,406	715	1,046
Total	39,060	33,240	36,265
Annualized		$4,733	$4,251

We present the 10-year total costs to foreign firms from the proposed IBR of ANSI/CAN/UL 12402–4 in table 8. Foreign firms would only experience the additional approval costs of $520 per year.

Table 8—Estimated Costs to Foreign Firms for Level 100 Devices Under Standard ANSI/CAN/UL 12402–4

[2019 dollars, 10-year period of analysis]

Year	Total undiscounted costs	Discounted costs
		7%	3%
1	$520	$486	$505
2	520	454	490
3	520	424	476
4	520	397	462
5	520	371	449
6	520	347	436
7	520	324	423
8	520	303	411
9	520	283	399
10	520	264	387
Total	5,200	3,652	4,436
Annualized		520	520

We present the 10-year total costs to U.S. and foreign firms from the proposed 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

[2019 dollars, 10-year period of analysis]

Year	Total undiscounted costs	Discounted costs
		7%	3%
1	$26,926	$25,164	$26,142
2	1,926	1,682	1,815
3	1,926	1,572	1,763
4	1,926	1,469	1,711
5	1,926	1,373	1,661
6	1,926	1,283	1,613
7	1,926	1,199	1,566
8	1,926	1,121	1,520
9	1,926	1,048	1,476
10	1,926	979	1,433
Total	44,260	36,892	40,701
Annualized		5,253	4,771

Cost Savings

By adopting ANSI/CAN/UL 12402–4, the Coast Guard would be able to harmonize commercial PFD requirements of the United States with those of Transport Canada. Harmonization of commercial PFD standards would 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 would allow for more innovative designs than the current standards and regulations. The newer performance-based standards would allow for the development of more innovative PFD designs that might better meet boaters' needs. The adoption of a performance-based standard would spare the Coast Guard from making the equivalency determinations frequently necessary when using the current prescriptive requirements. Consequently, the Coast Guard would experience time savings from reducing the review time of new device applications during the approval process.

In total, we estimate three sources of quantifiable benefits in the form of cost savings associated with the proposed IBR of ANSI/CAN/UL 12402–4:

(1) The Coast Guard would 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 would allow more innovative designs to meet the standard;

(2) All firms that would apply for approval in both Canadian and United States markets would 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 could be inspected just once for both United States and Canadian 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 proposed 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

[2019 Dollars]

Annual cost savings item	Cost savings to U.S. entities	Cost savings to foreign entities
Value of Coast Guard time saved	$3,903	$0
Canadian and United States approval savings	23,551	8,711
Billed facility inspection savings	13,129	7,502
Quality manager's time saved	3,054	1,182
Total	43,637	17,395

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

Table 11—Estimated Cost Savings to U.S. Firms From ANSI/CAN/UL 12402–4

[2019 Dollars, 10-year period of analysis]

Year	Total undiscounted cost savings	Discounted cost savings
		7%	3%
1	$39,734	$37,135	$38,577
2	39,734	34,705	37,453
3	39,734	32,435	36,362
4	39,734	30,313	35,303
5	39,734	28,330	34,275
6	39,734	26,476	33,277
7	39,734	24,744	32,307
8	39,734	23,126	31,366
9	39,734	21,613	30,453
10	39,734	20,199	29,566
Total	397,340	279,075	338,939
Annualized		39,734	39,734

Table 12—Estimated Cost Savings to Foreign Firms From Adopting ANSI/CAN/UL 12402–4

[2019 Dollars, 10-year period of analysis]

Year	Total undiscounted cost savings	Discounted cost savings
		7%	3%
1	$17,395	$16,257	$16,888
2	17,395	15,193	16,396
3	17,395	14,200	15,919
4	17,395	13,271	15,455
5	17,395	12,402	15,005
6	17,395	11,591	14,568
7	17,395	10,833	14,144
8	17,395	10,124	13,732
9	17,395	9,462	13,332
10	17,395	8,843	12,944
Total	173,950	122,175	148,383
Annualized		17,395	17,395

Table 13—Estimated Cost Savings to the United States Government of ANSI/CAN/UL 12402–4

[2019 Dollars, 10-year period of analysis]

Year	Total undiscounted cost savings	Discounted cost savings
		7%	3%
1	$3,903	$3,648	$3,789
2	3,903	3,409	3,679
3	3,903	3,186	3,572
4	3,903	2,978	3,468
5	3,903	2,783	3,367
6	3,903	2,601	3,269
7	3,903	2,431	3,174
8	3,903	2,272	3,081
9	3,903	2,123	2,991
10	3,903	1,984	2,904
Total	39,032	27,414	33,295
Annualized		3,903	3,903

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 proposed rule. We estimate this proposed provision would save the U.S. and foreign PFD industry about $57,129 annually and produce cost savings for the industry of about $401,250 over a 10-year period of analysis using a 7-percent discount rate.

Table 14—Total Estimated Cost Savings to Industry of the Proposed Rule for ANSI/CAN/UL 12402–4

[2019 Dollars, 10-year period of analysis]

Year	Total undiscounted cost savings	Discounted cost savings
		7%	3%
1	$57,129	$53,392	$55,465
2	57,129	49,899	53,850
3	57,129	46,634	52,281
4	57,129	43,583	50,758
5	57,129	40,732	49,280
6	57,129	38,067	47,845
7	57,129	35,577	46,451
8	57,129	33,250	45,098
9	57,129	31,074	43,785
10	57,129	29,041	42,509
Total	571,290	401,250	487,322
Annualized		57,129	57,129

ANSI/CAN/UL 12402–5

Costs

The PFD industry would also incur an increase in costs from this proposed rule because, based on consultation with industry experts, we estimate this rule would increase the PFD market by 5 percent (meaning manufacturing firms would seek new device approvals and produce more devices).^[13] The Coast Guard requests public comment on the possibility that this rule would increase the PFD market by 5 percent. We estimate the costs of this proposed 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 estimate this rule would generate.^[14]

We present in table 15, table 16, and table 17 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, undiscounted costs would only be the costs of Level 50 approval for manufacturers, or $521,751 for U.S. manufacturers and $124,781 for foreign manufacturers. For Year 2, the undiscounted costs would be the costs of Level 50 approvals to manufacturers ($521,751 for U.S. firms and $124,781 for foreign firms) plus the cost of inspections ($29,325 for U.S. firms and $6,516 for foreign firms), for a total of about $551,076 ($521,751 + $29,325) to U.S. firms and $131,297 ($124,781 + $6,516) to foreign firms. In Years 3–10, the costs would be the cost of inspections of $71,682 ($58,650 for U.S. firms and $13,032 for foreign firms). The estimated 10-year cost discounted at 7 percent would be $1,274,842 or $181,509 annualized for U.S. firms, and the 10-year cost discounted at 7 percent would be $299,267 or $42,609 annualized for foreign firms.

Table 15—Estimated Costs to U.S. Firms From Introducing Level 50 Devices

[2019 Dollars, 10-year period of analysis]

Year	Total undiscounted costs	Discounted costs
		7%	3%
1	$521,751	$487,618	$506,554
2	551,076	481,331	519,442
3	58,650	47,876	53,673
4	58,650	44,744	52,110
5	58,650	41,817	50,592
6	58,650	39,081	49,118
7	58,650	36,524	47,688
8	58,650	34,135	46,299
9	58,650	31,902	44,950
10	58,650	29,815	43,641
Total	1,542,027	1,274,842	1,414,068
Annualized		181,509	165,772

Table 16—Estimated Costs to Foreign Firms From the Introduction of Level 50 Devices

[2019 Dollars, 10-year period of analysis]

Year	Total undiscounted costs	Discounted costs
		7%	3%
1	$124,781	$116,618	$121,147
2	131,297	114,680	123,760
3	13,032	10,638	11,926
4	13,032	9,942	11,579
5	13,032	9,292	11,242
6	13,032	8,684	10,914
7	13,032	8,116	10,596
8	13,032	7,585	10,288
9	13,032	7,089	9,988
10	13,032	6,625	9,697
Total	360,334	299,267	331,136
Annualized		42,609	38,819

Table 17—Total Estimated Costs to PFD Manufacturers From the Introduction of Level 50 Devices

[2019 Dollars, 10-year period of analysis]

Year	Total undiscounted costs	Discounted costs
		7%	3%
1	$646,532	$604,236	$627,701
2	682,373	596,011	643,202
3	71,682	58,514	65,599
4	71,682	54,686	63,689
5	71,682	51,108	61,834
6	71,682	47,765	60,033
7	71,682	44,640	58,284
8	71,682	41,720	56,586
9	71,682	38,990	54,938
10	71,682	36,439	53,338
Total	1,902,361	1,574,109	1,745,204
Annualized		224,118	204,591

Qualitative Benefits of ANSI/CAN/UL 12402–5

The Coast Guard believes that the proposed 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. The Coast Guard requests public comment on whether Level 50 devices could lead to an increase in PFD wear rates among recreational boaters. 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.^[15] 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.^[16]

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 would require recreational boaters to wear Level 50 devices to count towards PFD carriage requirements. Individuals who purchase Level 50 devices would be more likely to wear PFDs than similar individuals who purchase bulkier Level 70 or Type III devices without a requirement that they be worn for the purposes of carriage. The National Institutes of Health (NIH) conducted a literature review, and among other factors, found discomfort to be negatively associated with lifejacket wear [NIH, 2018].^[17] It is the Coast Guard's view that PFDs worn are more effective than PFDs carried on board if a man overboard situation occurs. As a result, it is possible that the public would be 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 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 would improve safety on the water. Recreational boaters fail to wear lifejackets 76 percent of the time, 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.

ANSI/CAN/UL 9595

The third proposed change 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, 46 CFR 160.064–4, and 46 CFR 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 would provide a few key benefits to the regulated public and the testing laboratories. First, ANSI/CAN/UL 9595 is one standard to ensure consistency across all accepted and recognized independent laboratories. Second, ANSI/CAN/UL 9595 is a standard that would be widely available to the industry and transparently clarifies guidance on what constitutes a follow-up inspection regime. Third, and most importantly, ANSI/CAN/UL 9595 establishes a rating system for each facility, which would result in cost savings for the firms manufacturing at facilities with a good or superior QMS.

Costs

There are three cost items associated with the proposed adoption of ANSI/CAN/UL 9595. These costs are based on input from subject matter experts from the PFD industry on how ANSI/CAN/UL 9595 is likely to be implemented:

(1) The two recognized independent laboratories would 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 would be expected to be in addition to the regular production inspections required for Process Rating C; and

(3) After the first year where the QMS inspection would be 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 proposed provision that are associated with U.S. firms would be approximately $93,027, or $13,245 annualized using a 7-percent discount rate. We estimate the total 10-year discounted cost for inspections that are associated with foreign firms would be approximately $37,310, or $3,000 annualized using a 7-percent discount rate. In total, we estimate the 10-year discounted costs from ANSI/CAN/UL 9595 would be $130,337 or $18,557 annualized using a 7-percent discount rate. We present these amounts in table 18, table 19, and table 20.

Table 18—Estimated QMS Inspection Costs to U.S. Firms From ANSI/CAN/UL 9595

[2019 Dollars, 10-year period of analysis]

Year	Total undiscounted costs	Discounted costs
		7%	3%
1	$53,118	$49,643	$51,571
2	7,125	6,223	6,716
3	7,125	5,816	6,520
4	7,125	5,436	6,330
5	7,125	5,080	6,146
6	7,125	4,748	5,967
7	7,125	4,437	5,793
8	7,125	4,147	5,625
9	7,125	3,876	5,461
10	7,125	3,622	5,302
Total	117,243	93,027	105,431
Annualized		13,245	12,360

Table 19—Estimated QMS Inspection Costs to Foreign Firms From ANSI/CAN/UL 9595

[2019 Dollars, 10-year period of analysis]

Year	Total undiscounted costs	Discounted costs
		7%	3%
1	$20,376	$19,043	$19,783
2	3,000	2,620	2,828
3	3,000	2,449	2,745
4	3,000	2,289	2,665
5	3,000	2,139	2,588
6	3,000	1,999	2,512
7	3,000	1,868	2,439
8	3,000	1,746	2,368
9	3,000	1,632	2,299
10	3,000	1,525	2,232
Total	47,376	37,310	42,461
Annualized		5,312	4,978

Table 20—Total Estimated QMS Inspection Costs for ANSI/CAN/UL 9595

[2019 Dollars, 10-year period of analysis]

Year	Total undiscounted costs	Discounted costs
		7%	3%
1	$73,494	$68,686	$71,353
2	10,125	8,844	9,544
3	10,125	8,265	9,266
4	10,125	7,724	8,996
5	10,125	7,219	8,734
6	10,125	6,747	8,480
7	10,125	6,305	8,233
8	10,125	5,893	7,993
9	10,125	5,507	7,760
10	10,125	5,147	7,534
Total	164,619	130,337	147,892
Annualized		18,557	17,337

Cost Savings

The proposed IBR of ANSI/CAN/UL 9595 would generate benefits in the form of cost savings for PFD manufacturing firms who have a QMS in place. Manufacturers with an audited QMS would be able to secure a higher Process Rating, which in turn, would reduce the frequency of production inspections for PFDs based upon their higher Process Rating.

We estimate this proposed provision would generate benefits in the form of cost savings for U.S. firms of $5,562,385, or $791,959 annualized, over a 10-year period of analysis using a 7-percent discount rate, and we similarly estimate cost savings of $1,331,726, or $189,608 annualized, to foreign firms over a 10-year period of analysis discounted at 7 percent. In total, we estimate $6,894,111, or $981,566 annualized, in cost savings to all firms under this proposed provision using a 10-year period of analysis and a 7-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

[2019 Dollars, 10-year period of analysis]

Year	Total undiscounted cost savings	Discounted cost savings
		7%	3%
1	$0	$0	$0
2	897,438	783,857	845,921
3	916,206	747,897	838,458
4	916,206	698,969	814,037
5	916,206	653,242	790,327
6	916,206	610,506	767,308
7	916,206	570,567	744,959
8	916,206	533,240	723,261
9	916,206	498,355	702,195
10	916,206	465,752	681,743
Total	8,227,082	5,562,385	6,908,209
Annualized		791,959	809,853

Table 22—Estimated Cost Savings to Foreign Firms From ANSI/CAN/UL 9595

[2019 Dollars, 10-year period of analysis]

Year	Total undiscounted cost savings	Discounted cost savings
		7%	3%
1	$0	$0	$0
2	214,989	187,780	202,648
3	219,333	179,041	200,721
4	219,333	167,328	194,875
5	219,333	156,382	189,199
6	219,333	146,151	183,688
7	219,333	136,590	178,338
8	219,333	127,654	173,144
9	219,333	119,303	168,101
10	219,333	111,498	163,204
Total	1,969,655	1,331,726	1,653,917
Annualized		189,608	193,890

Table 23—Estimated Cost Savings to All Firms From ANSI/CAN/UL 9595

[2019 Dollars, 10-year period of analysis]

Year	Total undiscounted cost savings	Discounted costs savings
		7%	3%
1	$0	$0	$0
2	1,112,427	971,637	1,048,569
3	1,135,539	926,938	1,039,179
4	1,135,539	866,297	1,008,912
5	1,135,539	809,623	979,526
6	1,135,539	756,657	950,996
7	1,135,539	707,156	923,297
8	1,135,539	660,894	896,405
9	1,135,539	617,658	870,296
10	1,135,539	577,250	844,948
Total	10,196,737	6,894,111	8,562,126
Annualized		981,566	1,003,742

Placards in Lieu of Information Pamphlets

The fourth change in the proposed 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 PFDs' performance, selection, and approval, warnings, maintenance, and general water safety information in a pictographic format. This proposed rule would amend 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 to list the various types of PFDs impacted by this rule, and whether they would be required to use placards to covey safety instructions or whether they could use either placards or information pamphlets.^[18]

Table 24—Device Category and Permitted Instruction Types

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

As shown in table 24 above, the proposed changes in instruction information would either apply to PFD categories not yet produced or permit an additional compliance option. No devices would have fewer options for instruction materials than under current regulations. As a result, we estimate there would be 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 proposed requirement for the use of placards on new device categories and the proposed permitting of placard use on existing device categories. The first source of unquantified benefits would occur because a placard is likely less expensive to produce than an information pamphlet. A representative from the PFD manufacturing industry told us that the placard would likely be around $0.05 cheaper to produce than the information pamphlet because the placard would contain fewer materials than the information pamphlet. However, we could not find 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 that the $0.05 estimate is a rough approximation of 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 would switch from producing information pamphlets to placards, as placards would 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 would come from the fact that placards use pictorial images to communicate safety information, while information pamphlets use English-language text. Pictorial information is superior to text at communicating information to non-English-reading audiences. We do not have a way of quantifying this benefit, but would like to note that approximately 21 percent of the U.S. population has a “low” level of English literacy. For those populations, pictorial information may be better than text-based information.^[19]

Total Costs

We display the total costs from this proposed rule to U.S. entities, foreign entities, and both U.S. and foreign entities using a 10-year period of analysis discounted at 7 percent in table 25, table 26, and table 27, respectively.

Table 25—Estimated Costs for U.S. Firms

[2019 Dollars, 10-year period of analysis]

Year	Total undiscounted costs	Discounted costs
		7%	3%
1	$601,275	$561,939	$583,762
2	559,607	488,782	527,483
3	67,181	54,840	61,480
4	67,181	51,252	59,689
5	67,181	47,899	57,951
6	67,181	44,766	56,263
7	67,181	41,837	54,624
8	67,181	39,100	53,033
9	67,181	36,542	51,489
10	67,181	34,151	49,989
Total	1,698,330	1,401,108	1,555,764
Annualized		199,486	182,383

Table 26—Estimated Costs for Foreign Firms

[2019 Dollars, 10-year period of analysis]

Year	Total undiscounted costs	Discounted costs
		7%	3%
1	$145,677	$136,147	$141,434
2	134,817	117,754	127,078
3	16,552	13,511	15,147
4	16,552	12,627	14,706
5	16,552	11,801	14,278
6	16,552	11,029	13,862
7	16,552	10,308	13,458
8	16,552	9,633	13,066
9	16,552	9,003	12,686
10	16,552	8,414	12,316
Total	412,910	340,229	378,032
Annualized		48,441	44,317

Table 27—Total Estimated Costs for U.S. and Foreign Firms

[2019 Dollars, 10-year period of analysis]

Year	Total undiscounted costs	Discounted costs
		7%	3%
1	$746,952	$698,086	$725,196
2	694,424	606,537	654,561
3	83,733	68,351	76,628
4	83,733	63,880	74,396
5	83,733	59,700	72,229
6	83,733	55,795	70,125
7	83,733	52,145	68,083
8	83,733	48,733	66,100
9	83,733	45,545	64,174
10	83,733	42,566	62,305
Total	2,111,240	1,741,338	1,933,796
Annualized		247,927	226,700

Total Cost Savings

We display the total cost savings from this proposed rule to U.S. firms, the U.S. government, foreign firms, and all firms using a 10-year period of analysis discounted at 7 percent in table 28, table 29, table 30, and table 31, respectively.

Table 28—Total Estimated Cost Savings to U.S. Firms

[2019 Dollars, 10-year period of analysis]

Year	Total undiscounted cost savings	Discounted costs savings
		7%	3%
1	$39,734	$37,135	$38,577
2	937,172	818,562	883,374
3	955,940	780,331	874,820
4	955,940	729,282	849,340
5	955,940	681,572	824,602
6	955,940	636,983	800,584
7	955,940	595,311	777,266
8	955,940	556,366	754,628
9	955,940	519,968	732,648
10	955,940	485,951	711,309
Total	8,624,422	5,841,460	7,247,148
Annualized		831,693	849,587

Table 29—Total Estimated Cost Savings to Foreign Firms

[2019 Dollars, 10-year period of analysis]

Year	Total undiscounted cost savings	Discounted costs savings
		7%	3%
1	$17,395	$16,257	$16,888
2	232,384	202,973	219,044
3	236,728	193,241	216,640
4	236,728	180,599	210,330
5	236,728	168,784	204,204
6	236,728	157,742	198,256
7	236,728	147,422	192,482
8	236,728	137,778	186,875
9	236,728	128,764	181,432
10	236,728	120,341	176,148
Total	2,143,605	1,453,901	1,802,300
Annualized		207,003	211,285

Table 30—Total Estimated Cost Savings to the United States Government

[2019 Dollars, 10-year period of analysis]

Year	Total undiscounted cost savings	Discounted costs savings
		7%	3%
1	$3,903	$3,648	$3,789
2	3,903	3,409	3,679
3	3,903	3,186	3,572
4	3,903	2,978	3,468
5	3,903	2,783	3,367
6	3,903	2,601	3,269
7	3,903	2,431	3,174
8	3,903	2,272	3,081
9	3,903	2,123	2,991
10	3,903	1,984	2,904
Total	39,032	27,414	33,295
Annualized		3,903	3,903

Table 31—Total Estimated Cost Savings to U.S. and Foreign Manufacturing Firms and the U.S. Government

[2019 Dollars, 10-year period of analysis]

Year	Total undiscounted cost savings	Discounted costs savings
		7%	3%
1	$61,032	$57,039	$59,255
2	1,173,459	1,024,945	1,106,098
3	1,196,571	976,758	1,095,032
4	1,196,571	912,858	1,063,138
5	1,196,571	853,139	1,032,173
6	1,196,571	797,326	1,002,109
7	1,196,571	745,164	972,922
8	1,196,571	696,415	944,584
9	1,196,571	650,855	917,072
10	1,196,571	608,276	890,361
Total	10,807,059	7,322,776	9,082,743
Annualized		1,042,599	1,064,775

Net Cost Savings

We display the total net cost savings from this proposed rule to U.S. firms, the U.S. government, foreign firms, and all entities using a 10-year period of analysis discounted at 7 percent in table 32, table 33, table 34, and table 35, respectively.

Table 32—Total Estimated Net Cost Savings to U.S. Firms

[2019 Dollars, 10-year period of analysis]

Year	Net undiscounted cost savings	Net discounted costs savings
		7%	3%
1	−$561,541	−$524,805	−$545,185
2	377,565	329,780	355,891
3	888,759	725,492	813,340
4	888,759	678,030	789,651
5	888,759	633,673	766,651
6	888,759	592,217	744,321
7	888,759	553,474	722,642
8	888,759	517,266	701,594
9	888,759	483,426	681,159
10	888,759	451,800	661,320
Total	6,926,092	4,440,352	5,691,384
Annualized		632,206	667,204

Table 33—Total Estimated Net Cost Savings to Foreign Firms

[2019 Dollars, 10-year period of analysis]

Year	Net undiscounted cost savings	Net discounted costs savings
		7%	3%
1	−$128,282	−$119,890	−$124,546
2	97,567	85,219	91,966
3	220,176	179,729	201,492
4	220,176	167,971	195,624
5	220,176	156,983	189,926
6	220,176	146,713	184,394
7	220,176	137,115	179,023
8	220,176	128,145	173,809
9	220,176	119,761	168,747
10	220,176	111,926	163,832
Total	1,730,695	1,113,672	1,424,268
Annualized		158,562	166,968

Table 34—Total Estimated Cost Savings to the United States Government

[2019 Dollars, 10-year period of analysis]

Year	Net undiscounted cost savings	Net discounted costs savings
		7%	3%
1	$3,903	$3,648	$3,789
2	3,903	3,409	3,679
3	3,903	3,186	3,572
4	3,903	2,978	3,468
5	3,903	2,783	3,367
6	3,903	2,601	3,269
7	3,903	2,431	3,174
8	3,903	2,272	3,081
9	3,903	2,123	2,991
10	3,903	1,984	2,904
Total	39,032	27,414	33,295
Annualized		3,903	3,903

Table 35—Total Estimated Net Cost Savings to All Entities

[2019 Dollars, 10-year period of analysis]

Year	Net undiscounted cost savings	Net discounted costs savings
		7%	3%
1	−$685,920	−$641,047	−$665,942
2	479,035	418,408	451,536
3	1,112,838	908,407	1,018,404
4	1,112,838	848,979	988,742
5	1,112,838	793,438	959,944
6	1,112,838	741,531	931,984
7	1,112,838	693,020	904,839
8	1,112,838	647,682	878,485
9	1,112,838	605,310	852,898
10	1,112,838	565,710	828,056
Total	8,695,819	5,581,438	7,148,947
Annualized		794,671	838,075

Alternatives

We identified three alternatives to the current proposed 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. We therefore expect there would be no benefits from a new market as the market would not exist. The expected qualitative benefit of increased wear-rates associated with more comfortable and innovative Level 50 PFDs would be lost with this alternative. We would also be restricting recreational boaters to one category of PFD when Level 50 PFDs could better suit their purpose. As a result, we rejected this alternative because we expect wear rates and therefore benefits would be lower.

Alternative 2: Require Placards Instead of the Option of Placards or Pamphlets

Under this proposed 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. 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 fully adopt these standards by policy. 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 United States Code (U.S.C.) 601–612, we have prepared this Initial Regulatory Flexibility Analysis (IRFA) that examines the impacts of the proposed rule on small entities.

Per the RFA, a small entity may be a small independent business, defined as one independently owned and operated, organized for profit, and not dominant in its field under the Small Business Act (5 U.S.C. 632); a small not-for-profit organization, defined as any not-for-profit enterprise which is independently owned and operated and is not dominant in its field; or a small governmental jurisdiction, defined as a locality with fewer than 50,000 people.

Section 603(b) of the RFA prescribes the content of the IRFA, which addresses the following:

(1) A description of the reasons why action by the agency is being considered;

(2) A succinct statement of the objectives of, and legal basis for, the proposed rule;

(3) A description of and, where feasible, an estimate of the number of small entities to which the proposed rule will apply;

(4) A description of the projected reporting, recordkeeping, and other compliance requirements of the proposed rule, including an estimate of the classes of small entities that will be subject to the requirement and the type of professional skills necessary for preparation of the report or record;

(5) An identification, to the extent practicable, of all relevant Federal rules that may duplicate, overlap, or conflict with the proposed rule; and

(6) A description of any significant alternatives to the rule that accomplish the stated objectives of applicable statutes and that minimize any significant economic impact of the proposed rule on small entities.

1. A Description of the Reasons Why Action by the Agency Is Being Considered

The Coast Guard proposes to amend the lifejacket approval requirements and follow-up program requirements by incorporating three new binational standards. At the same time, the Coast Guard proposes to amend 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 intended to replace the legacy standards. The proposed amendments will streamline the process for approval of PFDs and allow manufacturers the opportunity to produce equipment that meets the approval requirements of both Canada and the United States, while reducing the burden for manufacturers in both the approval process and follow-up program.

2. A Succinct Statement of the Objective of, and Legal Basis for, the Proposed Rule

This proposed rule would harmonize PFD approval standards with those used in Canada, lead to net cost savings for PFD manufacturers, and introduce a new type of PFD that may better meet the needs of some recreational boaters.

This proposed rule is discretionary and not issued because of a statutory mandate. The Coast Guard will use its existing rulemaking authority provided under Title 46, U.S. Code, sections 3306(a), 4102(a) and (b), 4302(a) and (c), and 4502(a) and (c)(2)(B).

Title 46 U.S.C. 3306 provides the Coast Guard with the general authority to prescribe regulations for the design, construction, performance, testing, carriage, use, and inspection of lifesaving equipment on commercial and recreational vessels. Title 46 U.S.C. 4102 and 4302 provide more specific authority to prescribe regulations about life preservers and other life saving devices on uninspected and recreational vessels, respectively.

3. A Description—and, Where Feasible, an Estimate of the Number—of Small Entities to Which the Proposed Rule Will Apply

This proposed rule has four major provisions:

(1) It would incorporate by reference ANSI/CAN/UL 12402–4, replacing Type I device approval with Level 100 device approval.

(2) It would incorporate by reference ANSI/CAN/UL 12402–5, introducing new Level 50 device approvals.

(3) It would incorporate by reference ANSI/CAN/UL 9595, setting new standards for follow-on production inspections.

(4) It would permit the use of placards in lieu of instruction pamphlets.

Across these four provisions, we estimate that this proposed rule would directly affect two Coast Guard recognized laboratories and 57 PFD manufacturers.

We researched these two Coast Guard recognized laboratories and 57 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 37 of the 57 PFD manufacturers to be U.S. companies and 20 to be foreign companies. We then researched each of these 38 U.S. companies (1 testing laboratory and 37 PFD manufacturers) to determine its North American Industry Classification System (NAICS) code and its size standard using the Small Business Administration's (SBA) size standard table. Next, we reviewed each U.S. parent company's revenue or employee information to determine whether the company would be small or not small according to SBA size standards. We present the results of our research in table 36. We found the U.S. Coast Guard recognized laboratory to be small, and of the 37 U.S. manufacturers, we found 30 of them to be small entities according to SBA size standards; we did not find any U.S. small entities to be small governmental jurisdictions.

Table 36—Number of Small Entities Affected by the Proposed 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	5	5
				38	30

Each proposed provision would affect a different subset of the 30 small entities from above and have a different distribution of costs, cost savings, and transfers across those small entities. We will discuss each proposed provision separately below and then summarize each provision's impacts.

Provision 1: Incorporation by Reference of ANSI/CAN/UL 12402–4

The first proposed provision, the IBR of ANSI/CAN/UL 12402–4, would affect seven small entities, six of which have known revenues. The first provision would result in costs to PFD manufacturing firms that are small entities that would intend to sell Level 100 devices in only one market (the United States or Canada). Firms wishing to sell Level 100 devices in both United States and Canadian markets would no longer conduct duplicative approvals and facility inspections, leading to cost savings.

Whether small entities would or would not experience cost savings depends on whether each small entity would prefer to sell their device in only the United States or Canada or in both markets. The Coast Guard does not know which small entities would prefer a cheaper set of tests with only the ability to sell in one market and which would prefer a more expensive set of tests with the ability to sell in both markets. We therefore compare both the costs and cost savings estimates to each small entity.

In the RA, we estimate the Level 100 approval would be $4,280 more expensive than the current Type I approval. While in the RA we estimate that testing laboratories would receive an application for approval to Level 100 standards 0.45 times per year, each small entity would experience this cost only when they submit a new application. Each small entity would likely apply for an approval once they develop a new device. The Coast Guard cannot ascertain when each small entity might submit a new application, so instead we retain the cost of $4,280 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 would be $35,720 per new Level 100 approval, $4,746 per revision of an existing approval with testing, and $1,172 per revision of an existing approval without testing. As with costs of ANSI/CAN/UL 12402–4, each small entity would 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 each small entity would 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 ($35,720 + $4,746 + $1,172). Each of these seven small entities would also experience an ongoing (annual) cost savings of $1,155.92 from reduced facility inspection frequency.^[20]

Provision 2: Incorporation by Reference of ANSI/CAN/UL 12402–5

Incorporating by reference ANSI/CAN/UL 12402–5 would permit 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 would affect all 30 small entities, 24 of which have known revenues.

In the RA, we estimate that the introduction of Level 50 devices would most likely result in a 5-percent growth in the North American PFD market. The growth in the market would be composed of new types of PFDs. We assume the 5-percent growth in the market would also be a proxy for the growth in the number of approved devices (for a growth of 38 device approvals). The initial approvals would represent a one-time (initial year) cost to small entities. Small entities would also experience an annual cost of additional production inspections based on the volume of Level 50 PFDs produced.

We estimate a new Level 50 device approval would cost a small entity about $34,028. We do not know which small entities would seek Coast Guard approval for a Level 50 device or how many devices for which each small entity might seek approval. As a result, we treat each small entity as seeking approval for one Level 50 device costing $34,028. This would be a one-time (initial year) cost to small entities.

Production and revenue are 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, and 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 roughly about 0.11 percent of the PFD market.^[21] For the 30 small entities that would use the ANSI/CAN/UL 12402–5 standard, 22 of them are in the set of 44 firms composing 5 percent of the market, and we assume each has a market share of 0.11 percent. Based on conversations with PFD manufacturing executives, we estimate 5 of the 30 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.^[22] We could not find revenue data for six small entities.

In the RA, we estimate that the annual cost of production inspections across the whole industry would be $71,682. Because we do not know which small entities would 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 would estimate the small entity's additional production inspection costs would be about $78.85 ($71,682 × 0.0011, rounded) annually.

Provision 3: Incorporation by Reference of ANSI/CAN/UL 9595

Incorporating ANSI/CAN/UL 9595 by reference would establish production testing standards for the PFD manufacturing industry. ANSI/CAN/UL 9595 would 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 would experience one-time costs of an initial QMS inspection, and they would experience ongoing costs because a QMS inspection is more expensive than the facility inspection it would replace in years after the first year. We estimate that each small entity has two facilities with the largest small entity having three facilities, and QMS inspection costs would occur per facility. We estimated 7 of the firms in the top 13 are small entities, including the top firm. In the RA, we estimate that the total costs to U.S. firms for the ANSI/CAN/UL 9595 standard would be about $53,118 for 19 facilities. Because we do not know where each small entity's facilities are located, to estimate each small entity's one-time costs, we multiply $53,118 by each small entity's share of the 19 facilities yielding $5,591.37 (2 ÷ 19 × $53,118) for all but the largest small entity and $8,387.05 (3 ÷ 19 × $53,118) for the largest small entity. We estimate annual costs would be about $375 per facility, which is the difference between eight hours of billed QMS inspector time and eight hours of a regular inspector's time. The largest small entity has three facilities, so would experience $1,125 ($375 × 3) in additional costs. All the other small entities have two facilities, and they would experience about $750 ($375 × 2) in annual costs. In table 37, we present the costs per small entity from the IBR of ANSI/CAN/UL 9595.

Table 37—Costs per Small Entity From ANSI/CAN/UL 9595

Entity type	Number of facilities	Total one-time costs	Annual costs
The largest	3	$8,387.05	$1,125
All others	2	5,591.37	750

The small entities that would achieve a higher process rating according to the ANSI/CAN/UL 9595 standard would also experience annual cost savings based on each small entity's market share and the rigor of the QMS system that would be in place. As mentioned previously, we estimate that only the top 13 firms would experience savings from ANSI/CAN/UL 9595, and we estimate 7 of those firms are small entities.

Cost savings would 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 $2,346 ($1,876 of billed inspector time and $470 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. 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 cost savings from reduced inspection frequency on Level 50 devices that entities do not yet produce. In the RA, we estimate that U.S. firms would experience 16 fewer inspections on Level 50 devices. 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 would 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 ÷ 77.5 percent × 587, yielding 76 rounded. Then we would 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 would 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 would be 22 (19 + 3) meaning the small entity would experience 54 fewer production inspections annually (76−22). To calculate the number of reduced Level 50 inspections, we take the small entity's share of U.S. firm inspection reduction (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 ($2,346) yielding $131,376 ([2 + 54] × $2,346) 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 38; the results are rounded.

Table 38—Cost Savings for a Representative Small Entity

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 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) × $2,346
10%	5%	5%	76	19	3	54	2	$131,376

Provision 4: Replacement of Information Pamphlets With Placards

We did not predict any costs or cost savings from this provision, so we do not project any impact on small entities. We summarize the number of small entities affected, cost impacts, cost savings impacts, and transfers per provision in table 39.

Table 39—Number of Affected Small Entities, Costs, and Cost Savings per Provision

Provision	PFD manufacturing population affected	Costs	Cost savings
ANSI/CAN/UL 12402–4	7 small entities of the 30; 6 small entities with known revenues	One-time testing to Level 100 would cost $4,280 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 would be $35,720 less than testing to Type I standards for entities wishing to sell in both the United States and Canada. Small entities would also save costs from cheaper revisions with and without testing, $4,746 and $1,172 respectively. Together, small entities would save $41,638. Small entities would also experience $1,155.92 in annual cost savings from reduced facility inspections.
ANSI/CAN/UL 12402–5	30 small entities, 24 small entities with known revenues	One-time (initial year) testing to Level 50 standards would cost about $34,028. Additional ongoing costs from inspections would be between $78.85 and $17,920.50 based on each small entity's market share (small entities with larger market shares would experience greater costs)	No estimated cost savings for these small entities.
ANSI/CAN/UL 9595	8 small entities, 7 small entities with known revenues	One-time (initial year) cost from an additional QMS inspection of about $8,387.05 for the largest small entity based on three facilities and $5,591.37 for all other small entities with two facilities Ongoing (annual) costs would result from a QMS inspection and would be more than a regular inspection. We estimate ongoing costs to be about $375 per facility or $1,125 for the largest small entity with three facilities and $750 for each other small entity with two facilities	Small entities would 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 would experience between $21,114 and $229,908 in savings based on their market share and QMS ratings per year.
Information Pamphlets	30 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 40. We report the estimated overall net cost savings revenue impact per small entity of this proposed rule across all provisions from total costs in table 41.

Table 40—Range of Impacts per Entity

	One-time impacts		Ongoing impacts
	Lowest per entity	Highest per entity	Lowest per entity	Highest per entity
Cost	$34,028.00	$46,695.05	$78.85	$60,683.50
Cost Savings		41,638.00		231,063.92
Net Cost Savings	(39,619.37)	3,330.00	(40,560.93)	170,380.42

Table 41—Percentage of Estimated Revenue Impact on Small Entities From Overall Impact (Net Cost Savings) of This Proposed Rule

% Revenue impact	One-time net cost savings		Ongoing net cost savings
	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

4. A Description of the Projected Reporting, Recordkeeping, and Other Compliance Requirements of the Proposed Rule, Including an Estimate of the Classes of Small Entities Which Will Be Subject to the Requirements 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.

5. An Identification, to the Extent Practicable, of All Relevant Federal Rules That May Duplicate, Overlap, or Conflict With the Proposed Rule

There are no relevant Federal rules that may duplicate, overlap, or conflict with this NPRM.

6. A Description of Any Significant Alternatives to the Rule Which Accomplish the Stated Objectives of Applicable Statutes and Which Minimize any Significant Economic Impact of the Proposed Rule on Small Entities

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 permitting either placards or 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. 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 Permitting Either Placards or Pamphlets

We considered the alternative of requiring that PFD manufacturers use placards instead of their choice of either placards or information pamphlets for the mandatory PFD instructional materials. While the cost of producing placards is generally less than the costs of producing information pamphlets, some manufacturers may not be ready to switch to producing placards. 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

Another alternative that 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 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 used 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 fully adopt these standards by policy. Namely, Level 50 PFDs, youth inflatable PFDs, and inflatable Level 100 PFDs cannot be approved by policy. 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.

7. Conclusion

We are interested in the potential impacts from this rule on small businesses and we request public comment on these potential impacts. If you think that this rule will have a significant economic impact on you, your business, or your organization, please submit a comment to the docket at the address under the Public Participation and Request for Comments section of this preamble. In your comment, explain why, how, and to what degree you think this rule will have an economic impact on you.

C. Assistance for Small Entities

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996, Public Law 104–121, we want to assist small entities in understanding this proposed rule so that they can better evaluate its effects on them and participate in the rulemaking. If the proposed rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call or email the person in the FOR FURTHER INFORMATION CONTACT section of this proposed rule. The Coast Guard will not retaliate against small entities that question or complain about this proposed 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 proposed rule would call for no new 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 proposed 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. See the Supreme Court's decision in United States v. Locke and Intertanko v. Locke, 529 U.S. 89, 120 S.Ct. 1135 (2000). 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)—all generally preempt State and local law. 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 0336; 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 million (adjusted for inflation) or more in any one year. Although this proposed rule would not result in such an expenditure, we do discuss the effects of this proposed rule elsewhere in this preamble.

G. Taking of Private Property

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

J. Indian Tribal Governments

This proposed rule does not have tribal implications under Executive Order 13175 (Consultation and Coordination with Indian Tribal Governments), because it would 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 proposed 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 would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (such as 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 proposed rule uses the following voluntary consensus standards:

• ANSI/CAN/UL 9595, Standard for Buoyant Cushions, Fourth Edition, April 20, 2007 (including revisions through January 10, 2020).
• ANSI/CAN/UL 12402–4, Standard for Personal Flotation Devices—Part 4: Lifejackets, Performance Level 100—Safety Requirements, First Edition, July 9, 2020.
• ANSI/CAN/UL 12402–5, Standard for Personal Flotation Devices—Part 5: Buoyancy Aids (Level 50)—Safety Requirements, First Edition, December 31, 2015 (including revisions through January 27, 2022).
• ANSI/UL 1123, Standard for Marine Buoyant Devices, Seventh Edition, October 1, 2008 (including revisions through November 23, 2020).
• ANSI/UL 1175, Standard for Buoyant Cushions, Fourth Edition, April 20, 2007 (including revisions through January 10, 2020).

The proposed 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.

M. Environment

We have analyzed this proposed 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 preliminary 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 preliminary 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 proposed rule would be categorically excluded under paragraph L52 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.

This proposed rule involves approval requirements and follow-up program requirements for lifejackets. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.

List of Subjects

33 CFR Part 181

• Incorporation by reference
• 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

• Incorporation by reference
• 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 proposes to amend 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. 01.2, paragraph (II)(92)(a).

2. Revise the title of Subpart G to read as follows:

Subpart G—Instruction Pamphlet or Placard for Personal Flotation Devices

§ 181.4

[Removed and Reserved]

3. Remove and reserve § 181.4.

§ 181.701

[Amended]

4. Amend § 181.701 by adding the words “Coast Guard approved” after the word “all”.

5. Revise § 181.702 to read as follows:

§ 181.702

Information pamphlet or placard: requirement to furnish.

(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

[Removed]

6. Remove § 181.703.

§ 181.704

[Removed]

7. Remove § 181.704.

§ 181.705

[Removed]

8. Remove § 181.705.

Title 46—Shipping

PART 25—REQUIREMENTS

9. 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. 01.2, paragraphs (II)(77), (92)(a), 92(b).

10. 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 addition and revision read as follows:

§ 25.25–5

Life preservers and other lifesaving equipment required.

* * * * *

(c) * * *

(2) On each vessel, regardless of length and regardless of whether carrying passengers for hire, a commercial hybrid PFD approved under former approval series 160.077 prior to [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 and—

* * * * *

PART 28—REQUIREMENTS FOR COMMERCIAL FISHING INDUSTRY VESSELS

11. 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. 01.2, paragraph (II)(92)(a).

12. Revise § 28.110(a) 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(a) 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.

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(e); 25.25–5(f); 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 suit1	28.135; 25.25–5(e); 25.25–5(f); 25.25–9(a); 25.25–13; 25.25–15.
1  A commercial hybrid approved under former approval series 160.077 prior to [EFFECTIVE DATE OF FINAL RULE] may be substituted for a PFD approved under approval series 160.055, 160.155, 160.176, or 160.255 if it is in good and serviceable condition, used in accordance with the conditions marked on the PFD and in the owner's manual, and labeled for use on commercial vessels.

PART 108—DESIGN AND EQUIPMENT

13. The authority citation for part 108 is revised to read as follows:

Authority: 43 U.S.C. 1333; 46 U.S.C. 3102, 3306; DHS Delegation 00170.1, Revision No. 01–2, paragraph (II)(92)(a).

§ 108.580

[Amended]

14. Amend § 108.580(b) introductory text by removing the text “, 160.176 or 160.177” and replace it with the text “or 160.176”.

PART 117—LIFESAVING EQUIPMENT AND ARRANGEMENTS

15. The authority citation of 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. 01.2, paragraph (II)(92)(a).

16. 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.

* * * * *

17. 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 [EFFECTIVE DATE OF FINAL RULE] 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, 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

18. 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. 01.2, paragraph (II)(92)(a).

§ 133.70

[Amended]

19. Amend § 133.70(b) introductory text by removing the text “160.177” and adding, in its place, the text “160.255”.

PART 141—LIFESAVING

20. 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. 01.2, paragraph (II)(92)(a).

§ 141.340

[Amended]

21. 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 new paragraph (i).

The additions read 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

22. The authority citation for part 160 is revised 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. 01.2, paragraph (II)(92)(a).

Subpart 160.001 [Removed and Reserved]

23. Remove and reserve subpart 160.001, consisting of §§ 160.001–1 through 160.001–5.

Subpart 160.002 [Removed and Reserved]

24. Remove and reserve subpart 160.002, consisting of §§ 160.002–1 through 160.002–7.

Subpart 160.005 [Removed and Reserved]

25. Remove and reserve subpart 160.005, consisting of §§ 160.005–1 through 160.005–7.

Subpart 160.006 [Removed and Reserved]

26. Remove and reserve subpart 160.006, consisting of § 160.006–2.

27. Add subpart 160.045, consisting of §§ 160.045–1 through 160.045–25, to read as follows:

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 [e-mail].

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 46 CFR subpart 159.010, with a valid memorandum of understanding in accordance with 46 CFR 159.010–7.

§ 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 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.html or email: [e-mail]. The material may be obtained from UL, 333 Pfingsten Road, Northbrook, IL 60062–2002; phone [phone]; website: www.ul.com.

(a) ANSI/CAN/UL 9595:2021, Standard for 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 Marine Buoyant Devices, Seventh Edition, October 1, 2008 (including revisions through November 23, 2020) (“ANSI/UL 1123”); IBR approved for §§ 160.045–7(e); 160.045–13(d).

(c) ANSI/UL 1175, Standard for Buoyant Cushions, Fourth Edition, April 20, 2007 (including revisions through January 10, 2020) (“ANSI/UL 1175”); 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 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 16 1/2 pounds or more of buoyancy.

(2) Foam cushions must have 18 pounds or more of buoyancy.

(3) A device other than those standard devices specified in paragraph (f)(1) or (2) of this section must have 20 pounds or more of buoyancy.

(g) Workmanship. Throwable PFDs must be of first quality workmanship and must be free from any defects materially affecting their appearance or serviceability.

§ 160.045–9

Approval procedures for throwable PFDs.

(a) Each application for approval of a throwable PFD must be submitted directly to a Coast Guard recognized laboratory.

(b) The recognized laboratory must determine if a throwable PFD with novel design features requires a preliminary review by the Coast Guard prior to testing. Submissions requiring preliminary review must be sent to [e-mail], 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.

(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]

28. Remove and reserve subpart 160.047, consisting of §§ 160.047–1 through 160.047–7.

Subpart 160.048 [Removed and Reserved]

29. Remove and reserve subpart 160.048, consisting of §§ 160.048–1 through 160.048–8.

Subpart 160.052 [Removed and Reserved]

30. 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

31. 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 [EFFECTIVE DATE OF FINAL RULE].

(b) Life preservers approved under this subpart rely upon inherently buoyant material to achieve the minimum buoyancy.

(c) Life preservers approved under this subpart are intended to meet the carriage requirements for wearable PFDs for uninspected passenger vessels, uninspected commercial vessels over 40 ft (12m), and for inspected vessels.

(d) Each life preserver specified in this subpart is a:

(1) Standard, bib type, vinyl dip coated:

(i) Model 62, adult (for persons weighing over 90 pounds); or

(ii) Model 66, child (for persons weighing less than 90 pounds); or

(2) Standard, bib type, cloth covered;

(i) Model 63, adult (for persons weighing over 90 pounds); or

(ii) Model 67, child (for persons weighing less than 90 pounds); or

(3) Nonstandard, shaped type:

(i) Model,¹ adult (for persons weighing over 90 pounds); or

(ii) Model,¹ child (for persons weighing less than 90 pounds).

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

§ 160.055–2

[Removed and Reserved]

32. Remove and reserve § 160.055–2.

33. 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 [e-mail].

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 159.010, with a valid memorandum of understanding in accordance with 46 CFR 159.010–7.

§ 160.055–4

[Removed and Reserved]

34. Remove and reserve § 160.055–4.

35. Revise § 160.055–5 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 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.html or email: [e-mail]. The material may be obtained from UL, 333 Pfingsten Road, Northbrook, IL 60062–2002 phone [phone]; website: www.ul.com.

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

[Removed and Reserved]

36. Remove and reserve § 160.055–6.

§ 160.055–7

[Removed and Reserved]

37. Remove and reserve § 160.055–7.

§ 160.055–8

[Removed and Reserved]

38. Remove and reserve § 160.055–8.

§ 160.055–9

[Removed and Reserved]

39. Remove and reserve § 160.055–9.

40. 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.

41. Add § 160.055–15 to read as follows:

§ 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.

42. 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.

43. Add § 160.055–23 to read as follows:

§ 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 [e-mail] 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.

44. 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

45. 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 [EFFECTIVE DATE OF FINAL RULE].

(b) Buoyant vests approved under this subpart rely upon inherently buoyant material to achieve the minimum buoyancy.

(c) Buoyant vests approved under this subpart are intended to meet the carriage requirements for wearable PFDs for uninspected passenger vessels, uninspected commercial vessels over 40 ft (12m), and for inspected vessels.

(d) Each buoyant vest specified in this subpart is a standard model:

(1) Standard:

(i) Model AY, adult (for persons weighing over 90 pounds); or

(ii) Model CYM, child, medium (for children weighing from 50 to 90 pounds); or

(iii) Model CYS, child, small (for children weighing less than 50 pounds).

(2) Nonstandard:

(i) Model,¹ adult (for persons weighing over 90 pounds); or

(ii) Model,¹ child, medium (for persons weighing from 50 to 90 pounds); or

(iii) Model,¹ child, small (for persons weighing less than 50 pounds).

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

§ 160.060–2

[Removed and Reserved]

46. Remove and reserve § 160.060–2.

47. 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 [e-mail].

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.

§ 160.060–3a

[Removed and Reserved]

48. Remove and reserve § 160.060–3a.

§ 160.060–4

[Removed and Reserved]

49. Remove and reserve § 160.060–4.

50. 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 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.html or email: [e-mail]. The material may be obtained from UL, 333 Pfingsten Road, Northbrook, IL 60062–2002; phone [phone]; website: www.ul.com.

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

[Removed and Reserved]

51. Remove and reserve § 160.060–6.

§ 160.060–7

[Removed and Reserved]

52. Remove and reserve § 160.060–7.

§ 160.060–8

[Removed and Reserved]

53. Remove and reserve § 160.060–8.

§ 160.060–9

[Removed and Reserved]

54. Remove and reserve § 160.060–9.

55. 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 46 CFR 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.

56. 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 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 2044;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.

57. 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.

58. 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 [e-mail] 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.

59. 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

60. 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 [EFFECTIVE DATE OF FINAL RULE].

(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]

61. Remove and reserve § 160.064–2.

62. 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 [e-mail].

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 § 160.264–15 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.

§ 160.064–4

[Removed and Reserved]

63. Remove and reserve § 160.064–4.

64. 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 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.html or email: [e-mail]. The material may be obtained from UL, 333 Pfingsten Road, Northbrook, IL 60062–2002; phone [phone]; website: www.ul.com.

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

[Removed and Reserved]

65. Remove and reserve § 160.064–6.

§ 160.064–7

[Removed and Reserved]

66. Remove and reserve § 160.064–7.

67. 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.

68. 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.

69. 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.

70. 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

71. Revise § 160.076–1 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 [EFFECTIVE DATE OF FINAL RULE].

(b) Inflatable PFDs approved under this subpart rely partially or entirely upon inflation for buoyancy.

72. Revise § 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 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.html or email: [e-mail]. The material may be obtained from UL, 333 Pfingsten Road, Northbrook, IL 60062–2002; phone [phone] website: www.ul.com.

(a) ANSI/CAN/UL 9595:2021, Standard for 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].

§ 160.076–11

[Removed and Reserved]

73. Remove and reserve § 160.076–11.

§ 160.076–13

[Removed and Reserved]

74. Remove and reserve § 160.076–13.

§ 160.076–21

[Removed and Reserved]

75. Remove and reserve § 160.076–21.

§ 160.076–23

[Removed and Reserved]

76. Remove and reserve § 160.076–23.

§ 160.076–25

[Removed and Reserved]

77. Remove and reserve § 160.076–25.

78. Amend § 160.076–29 by:

a. Revising the first sentence of paragraph (a);

b. Removing in paragraph (c)(1)(i), the text “Except as provided in paragraph (e)(2) of this section, perform” and adding, in its place, the text “Perform”;

c. Removing paragraphs (c)(5), (6), (e)(3) through (5), (f), and (g); and

d. 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. * * *

* * * * *

§ 160.76–31

[Amended]

79. Amend § 160.076–31 by:

a. Removing in paragraph (a), the text “§ 160.076–29(e)” and adding, in its place, the words “the sampling plan accepted by the Commandant”;

b. Removing in paragraph (b)(1), the text “in paragraphs (c)(2) through (c)(8) of this section” and adding, in its place, the words “specified in the follow-up program accepted by the Commandant”;

c. Removing in paragraph (b)(2), the text “in paragraphs (c)(4) through (c)(8) of this section” and adding, in its place, the words “specified in the follow-up program accepted by the Commandant”;

d. Removing paragraph (c);

e. Redesignating paragraphs (d) and (e) as (c) and (d); and

f. Removing the second sentence of redesignated paragraph (c)(1).

§ 160.76–33

[Amended]

80. Amend § 160.076–33 by removing and reserving paragraph (b)(6).

81. 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.

82. 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.

§ 160.076–39

[Amended]

83. In the introductory text to § 160.076–39, removing the text “specified in UL 1180 (incorporated by reference, see § 160.076–11)” and adding, in its place, the words “approved by the Commandant”.

Subpart 160.077 [Removed and Reserved]

84. Remove and reserve subpart 160.077, consisting of §§ 160.077–1 through 160.077–31.

85. Add subpart 160.255, consisting of §§ 160.255–1 through 160.255–27, to read as follows:

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 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 [e-mail].

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 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.html or email: [e-mail]. The material may be obtained from UL, 333 Pfingsten Road, Northbrook, IL 60062–2002; phone [phone]; website: www.ul.com.

(a) ANSI/CAN/UL 9595:2021, Standard for 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 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 [e-mail], 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.

§ 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) of this part.

(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) of this part.

(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 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.

86. Add new 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)

§ 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 [e-mail].

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 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.html or email: [e-mail]. The material may be obtained from UL, 333 Pfingsten Road, Northbrook, IL 60062–2002; phone [phone]; website: www.ul.com.

(a) ANSI/CAN/UL 9595:2021, Standard for 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 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 [e-mail], 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 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.

87. 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.

(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 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 [e-mail].

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 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.html or email: [e-mail]. The material may be obtained from UL, 333 Pfingsten Road, Northbrook, IL 60062–2022; phone [phone]; website: www.ul.com.

(a1) ANSI/CAN/UL 9595:2021, Standard for 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 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 [e-mail], 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.

(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

88. The authority citation for part 169 is revised to read as follows:

Authority: 33 U.S.C. 1321(j); 46 U.S.C. 3306, 6101; Pub. L. 103–206, 107 Stat. 2439; E.O. 11735, 38 FR 21243, 3 CFR, 1971–1975 Comp., p. 793; DHS Delegation 00170.1, Revision No. 01.2, paragraph (II)(92)(a); § 169.117 also issued under the authority of 44 U.S.C. 3507.

§ 169.539

[Amended]

89. Amend § 169.539 by:

a. Removing in paragraph (a), the text “160.055, 160.002, or 160.005”, and adding in its place the text “160.002, 160.005, 160.055, or 160.255,”;

b. Removing in paragraph (b), the text “or 160.077”, and adding in its place the text “, 160.077, or 160.264”; and

c. Removing in paragraph (c), the text “160.064”, and adding in its place the text “160.064 or 160.264”.

PART 180—LIFESAVING EQUIPMENT AND ARRANGEMENTS

90. 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. 01.2, paragraph (II)(92)(a).

91. 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 160.002, 160.005, 160.055, 160.115, 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.

* * * * *

92. Amend § 180.72 by:

a. Revising the section heading;

b. Removing in paragraph (a), the words “life jackets” wherever they appear and adding, in their place, the word “lifejackets”; and

c. Revising paragraphs (b) and (d).

The revisions read as follows:

§ 180.72

Personal flotation devices carried in addition to lifejackets.

* * * * *

(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 [EFFECTIVE DATE OF FINAL RULE] 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

93. The authority citation for part 199 is revised to read as follows:

Authority: 46 U.S.C. 3306, 3703; Pub. L. 103–206, 107 Stat. 2439; DHS Delegation 00170.1, Revision No. 01.2, paragraph (II)(92)(a).

§ 199.70

[Amended]

94. Amend § 199.70(b) introductory text by removing the text “, 160.176 or 160.177”, and adding, in its place, the text “or 160.176”.

§ 199.620

[Amended]

95. 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 160.002, 160.005, 160.055, or 160.077, or 160.255. An inflatable lifejacket approved under approval series 160.255 must include a full back-up inflation chamber.

* * * * *

Dated: March 24, 2023.

W.R. Arguin,

Rear Admiral, U.S. Coast Guard, Assistant Commandant for Prevention Policy.

Footnotes

1.  “Revision of Labeling and Classification for Personal Flotation Devices (PFDs),” Applied Safety & Ergonomics, Inc., December 28, 2004, Young et al.

2.  Readers should reference the National Center for Biotechnology Information (NCBI), which is part of the National Library of Medicine (NLM) 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).

3.  United States Coast Guard, “2019 Recreational Boating Statistics.” https://uscgboating.org/​library/​accident-statistics/​Recreational-Boating-Statistics-2019.pdf.

4.  United States Coast Guard, “2019 Life Jacket Wear Rate Observation Study.” https://uscgboating.org/​library/​national-live-jacket-wear-study/​2019-Life-Jacket-Wear-Rate-Report.pdf.

5.  Amy Peden, Daniel Demant, Martin Hagger, and Kyra Hamilton, “Personal, social, and environmental factors associated with lifejacket wear in adults and children: A systematic literature review.” https://www.ncbi.nlm.nih.gov/​pmc/​articles/​PMC5931488/​.

6.  For more information on process ratings, see the preliminary regulatory analysis in the docket.

7.  The Coast Guard lists all approved products on the Coast Guard Maritime Information Exchange website, https://cgmix.uscg.mil/​.

8.  We used the headquarters location of a firm's parent company, as indicated on the company website, to determine whether a firm was U.S. or foreign.

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

10.  The process rating applies to a facility owned by a PFD manufacturing firm. The lowest process rating is C; if manufacturers seek a higher process rating of A or B, then an independent laboratory must certify that each facility owned by a manufacturing firm meets the standard of the higher rating, which is determined through an audit of a facility. A PFD manufacturing firm incurs the cost of a higher process rating at each facility. A PFD manufacturing firm who currently has a QMS (at least partially in place) would 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 would result in a reduction in the inspection volume at facilities, which would save PFD manufacturing firms money.

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

12.  We estimate the cost of Level 100 testing and approval to be about $44,280 and we estimate the cost for the new Type I approval to be about $40,000. 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 would be about $1,926 ($4,280 × 0.45). 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 would be about $1,406 annually ($1,926 × 0.73). We estimate the cost to foreign PFD firms would be about $520 ($1,926 × 0.27) annually.

13.  As part of our discussion with PFD manufacturing firms, we asked their representatives whether the introduction of Level 50 devices would lead to a net growth in the PFD market (inclusive of substitution out of existing types of products). Manufacturing firm representatives stated that they would expect the PFD market would grow by about 5 percent from this provision. We interpret the 5 percent growth as a one-time growth in the level of manufacturing spread over a 2-year period.

14.  We estimate the additional production inspections based on the current production inspection requirements, and we estimate the reduction in these inspections through the proposed incorporation by reference of ANSI/CAN/UL 9595 in its associated section.

15.  United States Coast Guard, “2019 Recreational Boating Statistics.” https://uscgboating.org/​library/​accident-statistics/​Recreational-Boating-Statistics-2019.pdf.

16.  United States Coast Guard, “2019 Life Jacket Wear Rate Observation Study.” https://uscgboating.org/​library/​national-live-jacket-wear-study/​2019-Life-Jacket-Wear-Rate-Report.pdf.

17.  We cited this review from the NIH earlier in the preamble in footnote number 2. Readers should reference that footnote for a link to this article and other articles by the NIH for more information on PFD usage.

18.  Current marking requirements require a pamphlet, while the proposed new marking requirement would be for a placard or pamphlet. Because these placards and pamphlets are both produced in factories, the Coast Guard estimates that it takes 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 would be any changes in the PRA burden brought on by the switch from pamphlets to placards.

19.  U.S. Department of Education, “Data Point: Adult Literacy in the United States” (July 2019). https://nces.ed.gov/​pubs2019/​2019179.pdf.

20.  Facility inspections last four hours and include the billed cost of the inspector's time, or $234.45, and the opportunity cost of a Quality Manager's time, or $54.53 per hour as a loaded weighted average. ($234.45 + $54.53) × 4 = $1,155.92. Readers should refer to the section of the RA discussing the ANSI/CAN/UL 12402–4 standard.

21.  We divided 5 percent (or 0.05) by 44 firms to obtain 0.11 percent of the market for each one.

22.  For more details on how we calculated market share, see the initial regulatory analysis in the docket.