2024-28264. Lifejacket Approval Harmonization

Table 1—Summary of Impacts of the Final Rule

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

( print page 97364)

By means of this final rule, the Coast Guard harmonizes its approval process for PFDs with that of Canada, resulting in cost savings from eliminating a second set of approval requirements for PFD manufacturers wishing to sell in both Canada and the United States and reducing the required amount of product inspections depending on the quality management system in place at a given manufacturing facility. This rule removes barriers to entry for future innovative personal flotation devices and will save manufacturers money from reducing regulatory burdens without sacrificing quality. On net, the Coast Guard projects that manufacturers and the Coast Guard will save over $1,000,000 annually on reduced production inspections.

Additionally, the Coast Guard expects that the introduction of Level 50 devices, coupled with the requirement to wear them if they are to count for the purposes of PFD carriage requirements, will lead to an unquantifiable increase in PFD wear rates among recreational boaters, and thereby potentially decrease the rate of drowning in the event of an accident. Only Coast Guard approved devices are eligible to count for PFD carriage requirements, and, for Level 50 devices to count, they must be worn. The Coast Guard therefore expects that recreational boaters purchasing Level 50 PFDs for the purposes of carriage are more likely to wear them. Drowning is the leading cause of death in recreational boating accident and a study of drowning incidents found that, 86 percent of the time, individuals who drowned were not wearing a PFD.^[20] Absent these regulations, Level 50 devices cannot be sold as Coast Guard approved devices, and the expected increase in PFD wear rates among recreational boaters will not materialize.

The final rule introduces harmonized performance standards instead of design standards for PFDs. It amends PFD approval and follow-up program requirements by incorporating three new binational standards into regulations, amending PFD carriage requirements to allow for the use of equipment approved to the new standards, and removing obsolete equipment approval requirements. The performance-based standards are more current and intended to replace the legacy design standards. The amendments allow manufacturers to produce more innovative equipment that meets the approval requirements of Canada and the United States and reduce the burden for manufacturers in the approval process and follow-up program.

Specifically, the Coast Guard incorporates by reference the following binational industry consensus standards:

(1) ANSI/CAN/UL 12402-4. This binational standard specifies the safety requirements for lifejackets that provide face-up flotation for use in sheltered or calm water, where users may have to wait for rescue. A lifejacket meeting the requirements of ANSI/CAN/UL 12402-4 provides an equivalent level of safety to a lifejacket currently approved under 46 CFR subpart 160.055.

(2) ANSI/CAN/UL 12402-5. This binational standard specifies the safety requirements for buoyancy aids used in sheltered waters with help and rescue nearby. A PFD meeting the requirements of ANSI/CAN/UL 12402-5 provides an equivalent level of safety as a PFD currently approved under 46 CFR 160.064 or 160.076.

(3) ANSI/CAN/UL 9595. This binational standard covers the basic elements of a production inspection program for various types of PFDs and formalizes and modifies current industry standards.

Additionally, the Coast Guard incorporates two national standards (ANSI/UL 1123 and ANSI/UL 1175) and amends numerous CFR parts to remove obsolete PFD design standards and update carriage requirements to include PFDs approved to the new subparts. As mentioned earlier, ANSI/UL 1123 and ANSI/UL 1175 are both currently in use as a matter of policy and are being incorporated by reference for the sake of clarity. We do not estimate any costs or benefits from their incorporation by reference into the CFR. Similarly, we do not anticipate any quantifiable costs or benefits from the removal of obsolete design standards, as these design standards are not currently in use.

In moving from the NPRM to this final rule, we made the following changes to the RA and small entities section:

(1) Updated wage figures to use the most recently available data.

(2) Updated deflators and costs to 2023.

(3) Added a Final Regulatory Flexibility Act Analysis (FRFA).

(4) Updated the affected population numbers based on more recent data.

(5) Included descriptions of public comments that supported assumptions we made in the NPRM. As noted above, public comments overwhelmingly supported this rule. Some of those comments supported assumptions we made in the NPRM. We did not receive any comments that disagreed with our assumptions or offered new information that would require changes to the analysis.

Affected Population

To determine the affected population of the rule, it is first necessary to describe the economic impacts from this final rule. The economic impacts stem from the following four provisions:

(1) The IBR of ANSI/CAN/UL 12402-4 in 46 CFR 160.255 to replace the design requirements in 46 CFR 160.055;

(2) The IBR of ANSI/CAN/UL 12402-5 in 46 CFR 160.264 and 160.276 to replace the design standards in 46 CFR 160.064, 160.076, and 160.077;

(3) The IBR of ANSI/CAN/UL 9595 for follow-up service into the PFD approval requirements of existing subparts 46 CFR 160.055, 160.060, 160.064, 160.076 and new subparts of 46 CFR 160.045, 160.255, 160.264, and 160.276; and

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

These four provisions affect PFD manufacturers, the two recognized independent laboratories, and the Coast Guard. Before we present the affected population for each of these provisions, we present the overall PFD manufacturing firm population.

As of 2023, there are over 800 models of PFDs approved by the Coast Guard, manufactured by 61 separate manufacturing firms worldwide.^[21] Based on a review of publicly available information across the 61 manufacturing firms, the Coast Guard estimates that 39 are U.S. firms and 22 are foreign firms. Market share and production volumes are not equal across the firms.^[22]

( print page 97365)

Table 2—Distribution of Market Share of PFD Manufacturers

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

The first provision, the IBR of ANSI/CAN/UL 12402-4, affects three populations:

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

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

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

In table 3, we list the number of PFD manufacturing firms that are affected by ANSI/CAN/UL 12402-4. We estimate that each of the top 13 firms that produce ANSI/CAN/UL 12402-4 devices or components of those devices at 2 facilities each and firms outside of the top 13 firms that produce ANSI/CAN/UL 12402-4 devices at 1 facility each.^[23]

Table 3—Manufacturing Firms and Facilities Impacted by ANSI/CAN/UL 12402-4

Firm ownership	U.S. firms	Foreign firms	U.S. associated facilities	Foreign facilities	Total facilities
Firms in top 13	5	3	10	6	16
All other firms	4	2	4	2	6
Total facilities	9	5	14	8	22

In the second provision, by incorporating by reference ANSI/CAN/UL 12402-5, the Coast Guard introduces new categories for youth inflatables and Level 50 PFDs for approval. Permitting youth inflatables and Level 50 devices affects three populations:

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

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

(3) The boating public that purchases youth inflatables or Level 50 devices instead of Level 70 or Type III devices, because youth inflatables and Level 50 devices are likely to be more form-fitting than Level 70 or Type III devices.

In the third provision, the Coast Guard intends to incorporate by reference ANSI/CAN/UL 9595, covering production inspections and inspection frequency, into multiple new and existing subparts in 46 CFR, as listed in table 4.

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

Subpart	PFD type	New or existing subpart
160.045	Throwable PFDs	New.
160.255	Level 100 PFDs	New.
160.264	Inherently Buoyant Level 50 and Level 70 PFDs	New.
160.276	Inflatable Level 50 and Level 70 PFDs	New.
160.055	Life Preservers	Existing.
160.060	Buoyant Vests	Existing.
160.064	Marine Buoyant Devices	Existing.
160.076	Inflatable PFDs	Existing.

ANSI/CAN/UL 9595 establishes a set of Process Ratings (A, B, and C) based on the QMS at each facility. Process Rating A is reserved for facilities that have demonstrated a superior QMS. Process Rating B is assigned to facilities with a good QMS. Process Rating C is assigned to facilities with a minimally compliant QMS. The requirements for Process Rating C are equivalent to the current minimum requirements. Because Process Rating C is equivalent to current industry practice, the affected population for the IBR of ANSI/CAN/UL 9595 are any PFD manufacturer ( print page 97366) producing a device approved under one of the subparts listed in table 4 and eligible to gain a Process Rating of A or B.

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

Table 5—Market Share of Production Likely To Be at Each Process Rating

Firm category	Process rating	Market share (%)
U.S. Firms	A	26.5
Foreign Firms	A	15.0
U.S. Firms	B	51.0
Foreign Firms	B	2.5
U.S. and Foreign Firms	C	5.0
Total		100.0

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

Table 6—Device Category and Permitted Instruction Types

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

Costs and Cost Savings of the Four Provisions of This Rule

1. ANSI/CAN/UL 12402-4

Costs

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

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

( print page 97367)

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

[2023 Dollars, 10-year period of analysis]

Year	Total undiscounted costs	Discounted costs
		2%
1	$31,159	$30,548
2	1,659	1,595
3	1,659	1,563
4	1,659	1,533
5	1,659	1,503
6	1,659	1,473
7	1,659	1,444
8	1,659	1,416
9	1,659	1,388
10	1,659	1,361
Total	46,090	43,824
Annualized		4,879

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

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

[2023 Dollars, 10-year period of analysis]

Year	Total undiscounted costs	Discounted costs
		2%
1	$614	$602
2	614	590
3	614	579
4	614	567
5	614	556
6	614	545
7	614	535
8	614	524
9	614	514
10	614	504
Total	6,140	5,515
Annualized		614

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

Table 9—Estimated Total Cost to All Firms for Level 100 Devices Under Standard ANSI/CAN/UL 12402-4

[2023 Dollars, 10-year period of analysis]

Year	Total undiscounted costs	Discounted costs
		2%
1	$31,773	$31,150
2	2,273	2,185
3	2,273	2,142
4	2,273	2,100
5	2,273	2,059
6	2,273	2,018
7	2,273	1,979
8	2,273	1,940
9	2,273	1,902
( print page 97368)
10	2,273	1,865
Total	52,230	49,339
Annualized		5,493

Cost Savings

By adopting ANSI/CAN/UL 12402-4, the Coast Guard can harmonize commercial PFD requirements of the United States with those of Transport Canada. Harmonization of commercial PFD standards will lead to cost savings for PFD manufacturing firms through less expensive approval requirements and less frequent ongoing facility inspections.

Additionally, as a performance-based standard, ANSI/CAN/UL 12402-4 allows for more innovative designs than the current standards and regulations, which might better meet boater needs. Seven commenters noted that permission to create more innovative designs is a benefit. The adoption of a performance-based standard spares the Coast Guard from making the equivalency determinations frequently necessary when using the current prescriptive requirements. Consequently, the Coast Guard will experience time savings from reducing the review time of new device applications during the approval process.

In total, we estimate three sources of quantified cost savings associated with the IBR of ANSI/CAN/UL 12402-4:

(1) The Coast Guard will spend less time reviewing approval applications and making equivalency determinations for the approval of innovative PFDs because ANSI/CAN/UL 12402-4 is a performance-based rather than prescriptive standard and allows more innovative designs to meet the standard;

(2) All firms that apply for approval in both United States and Canadian markets will save the difference between one certification to ANSI/CAN/UL 12402-4 and separate United States and Canadian certifications to legacy standards; and

(3) Manufacturing facilities producing devices meeting the requirements of ANSI/CAN/UL 12402-4 for the United States and Canadian markets will be able to be inspected just once for approval, instead of the current requirement to be inspected twice; once for United States approval and once for Canadian approval.

We summarize the total quantified benefits for the cost savings of the IBR of ANSI/CAN/UL 12402-4 by reporting the annual undiscounted cost savings in table 10.

Table 10—Estimated Annual Cost Savings of ANSI/CAN/UL 12402-4 to the Industry and the U.S. Government

[2023 Dollars]

Annual cost savings item	Cost savings to U.S. entities	Cost savings to foreign entities
Value of Coast Guard time saved	$4,330	$0
Canadian and United States approval savings	27,779	10,274
Billed facility inspection savings	15,372	8,784
Quality manager's time saved	3,359	1,334
Total	50,840	20,392

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

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

[2023 Dollars, 10-year period of analysis]

Year	Total undiscounted cost savings	Discounted cost savings
		2%
1	$46,510	$45,598
2	46,510	44,704
3	46,510	43,827
4	46,510	42,968
5	46,510	42,126
( print page 97369)
6	46,510	41,300
7	46,510	40,490
8	46,510	39,696
9	46,510	38,917
10	46,510	38,154
Total	465,100	417,780
Annualized		46,510

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

[2023 Dollars, 10-year period of analysis]

Year	Total undiscounted cost savings	Discounted cost savings
		2%
1	$20,392	$19,992
2	20,392	19,600
3	20,392	19,216
4	20,392	18,839
5	20,392	18,470
6	20,392	18,108
7	20,392	17,752
8	20,392	17,404
9	20,392	17,063
10	20,392	16,729
Total	203,920	183,173
Annualized		20,392

Table 13—Estimated Cost Savings to the U.S. Government of ANSI/CAN/UL 12402-4

[2023 Dollars, 10-year period of analysis]

Year	Total undiscounted cost savings	Discounted cost savings
		2%
1	$4,330	$4,245
2	4,330	4,162
3	4,330	4,080
4	4,330	4,000
5	4,330	3,922
6	4,330	3,845
7	4,330	3,770
8	4,330	3,696
9	4,330	3,623
10	4,330	3,552
Total	43,300	38,895
Annualized		4,330

In table 14, we record the total discounted 10-year cost savings to the U.S. and foreign PFD industry for the ANSI/CAN/UL 12402-4 portion of this final rule. We estimate that this provision saves the U.S. and foreign PFD industry about $66,902 annually and produces cost savings for the industry of about $600,953 over a 10-year period of analysis using a 2-percent discount rate. ( print page 97370)

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

[2023 Dollars, 10-year period of analysis]

Year	Total undiscounted cost savings	Discounted cost savings
		2%
1	$66,902	$65,590
2	66,902	64,304
3	66,902	63,043
4	66,902	61,807
5	66,902	60,595
6	66,902	59,407
7	66,902	58,242
8	66,902	57,100
9	66,902	55,981
10	66,902	54,883
Total	669,020	600,953
Annualized		66,902

2. ANSI/CAN/UL 12402-5

Costs

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

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

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

[2023 Dollars, 10-year period of analysis]

Year	Total undiscounted cost	Discounted cost
		2%
1	$610,299	$598,332
2	644,199	619,184
3	67,800	63,889
4	67,800	62,637
5	67,800	61,409
6	67,800	60,204
7	67,800	59,024
8	67,800	57,867
9	67,800	56,732
10	67,800	55,620
Total	1,796,898	1,694,898
Annualized		188,687

( print page 97371)

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

[2023 Dollars, 10-year period of analysis]

Year	Total undiscounted cost	Discounted cost
		2%
1	$146,661	$143,785
2	154,248	148,258
3	15,174	14,299
4	15,174	14,018
5	15,174	13,744
6	15,174	13,474
7	15,174	13,210
8	15,174	12,951
9	15,174	12,697
10	15,174	12,448
Total	422,301	398,884
Annualized		44,406

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

[2023 Dollars, 10-year period of analysis]

Year	Total undiscounted cost	Discounted cost
		2%
1	$756,960	$742,118
2	798,447	767,442
3	82,974	78,188
4	82,974	76,655
5	82,974	75,152
6	82,974	73,679
7	82,974	72,234
8	82,974	70,818
9	82,974	69,429
10	82,974	68,068
Total	2,219,199	2,093,782
Annualized		233,093

Qualitative Benefits

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

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

Since the Level 50 devices provide a lower level of buoyancy than Level 70 devices, a direct comparison is not possible. However, the view of the subject matter experts (SMEs) in the Coast Guard's Office of Boating Safety is that the wearing of Level 50 PFDs by recreational boaters and the general boating public improves safety on the water. Recreational boaters fail to wear lifejackets 76 percent of the time, ( print page 97372) leaving themselves vulnerable to drowning. The Coast Guard believes that, by offering recreational boaters an additional choice of a Level 50 PFD, which is required to be worn, more recreational boaters will choose to wear their lifejacket while engaged in boating activities. A lifejacket that is worn by the user is more effective than a lifejacket stowed on the boat.

3. ANSI/CAN/UL 9595

The third provision incorporates by reference the consensus standard ANSI/CAN/UL 9595 to cover follow-up inspections and inspection frequency for Coast Guard approved PFDs. Currently, when a manufacturing firm produces a Coast Guard approved PFD, there is a required follow-up inspection regime to ensure that the devices continue to meet the specifications under which the Coast Guard approved them. Although the Coast Guard has not previously published a substantive minimum requirement for what constitutes a follow-up inspections regime, we set out general requirements in 46 CFR 159, 160.064-4, and 160.076-29. The Coast Guard reviews each recognized independent laboratory's follow-up services program to ensure compliance with these regulations.

Incorporating by reference ANSI/CAN/UL 9595 provides a few key benefits to the regulated public and the testing laboratories. First, ANSI/CAN/UL 9595 is one standard, ensuring consistency across all accepted and recognized independent laboratories. Second, ANSI/CAN/UL 9595 is a standard that is widely available to the industry and transparently clarifies guidance on what constitutes a follow-up inspection regime. Third, and most importantly, ANSI/CAN/UL 9595 establishes a rating system for each facility, which results in cost savings for the firms manufacturing at facilities with a good or superior QMS rating.

Costs

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

(1) The two recognized independent laboratories will need to train their staff to implement ANSI/CAN/UL 9595.

(2) Manufacturing firms could request a special inspection in the first year to certify their QMS at a given facility meets the requirements for Process Rating of A or B. We expect the top 13 firms to request this certification across all 27 facilities at which they manufacture. This special inspection is expected to be in addition to the regular production inspections required for Process Rating C.

(3) After the first year, where the QMS inspection is supplemental to standard inspections, the QMS inspection could replace one of the mandatory inspections, but could cost more than a standard inspection, at the top 13 firms with 27 facilities.

We estimate the 10-year discounted cost for inspections under this provision that are associated with U.S. firms is approximately $126,840, or $14,121 annualized using a 2-percent discount rate. We estimate the total 10-year discounted cost for inspections that are associated with foreign firms is approximately $51,382, or $5,720 annualized using a 2-percent discount rate. In total, we estimate the 10-year discounted costs from ANSI/CAN/UL 9595 are $178,223 or $19,841 annualized using a 2-percent discount rate. We present these costs to U.S., foreign, and both U.S. and foreign firms in table 18, table 19, and table 20, respectively.

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

[2023 Dollars, 10-year period of analysis]

Year	Total undiscounted cost	Discounted cost
		2%
1	$61,296	$60,094
2	8,341	8,017
3	8,341	7,860
4	8,341	7,706
5	8,341	7,555
6	8,341	7,407
7	8,341	7,261
8	8,341	7,119
9	8,341	6,979
10	8,341	6,843
Total	136,365	126,841
Annualized		14,121

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

[2023 Dollars, 10-year period of analysis]

Year	Total undiscounted cost	Discounted cost
		2%
1	$23,744	$23,278
2	3,512	3,376
3	3,512	3,309
4	3,512	3,245
5	3,512	3,181
6	3,512	3,119
7	3,512	3,057
( print page 97373)
8	3,512	2,997
9	3,512	2,939
10	3,512	2,881
Total	55,352	51,382
Annualized		5,720

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

[2023 Dollars, 10-year period of analysis]

Year	Total undiscounted cost	Discounted cost
		2%
1	$85,040	$83,373
2	11,853	11,393
3	11,853	11,169
4	11,853	10,950
5	11,853	10,736
6	11,853	10,525
7	11,853	10,319
8	11,853	10,116
9	11,853	9,918
10	11,853	9,724
Total	191,717	178,223
Annualized		19,841

Cost Savings

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

We estimate this provision to generate cost savings for U.S. firms of $8,454,204, or $941,177, annualized, over a 10-year period of analysis using a 2-percent discount rate. We similarly estimate cost savings of $2,039,131, or $227,009, annualized, to foreign firms over a 10-year period of analysis, discounted at 2 percent. In total, we estimate $10,493,335, or $1,168,187 annualized, in cost savings to all firms under this provision using a 10-year period of analysis and a 2-percent discount rate. We present these 10-year cost savings to U.S., foreign, and both U.S. and foreign firms in table 21, table 22, and table 23, respectively.

Table 21—Estimated Cost Savings to U.S. Firms From ANSI/CAN/UL 9595

[2023 Dollars, 10-year period of analysis]

Year	Total undiscounted cost savings	Discounted cost savings
		2%
1	$0	$0
2	1,037,396	997,113
3	1,059,092	998,006
4	1,059,092	978,437
5	1,059,092	959,252
6	1,059,092	940,443
7	1,059,092	922,003
8	1,059,092	903,925
9	1,059,092	886,201
10	1,059,092	868,824
Total	9,510,132	8,454,204
Annualized		941,177

( print page 97374)

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

[2023 Dollars, 10-year period of analysis]

Year	Total undiscounted cost savings	Discounted cost savings
		2%
1	$0	$0
2	250,371	240,649
3	255,429	240,696
4	255,429	235,977
5	255,429	231,350
6	255,429	226,814
7	255,429	222,366
8	255,429	218,006
9	255,429	213,732
10	255,429	209,541
Total	2,293,803	2,039,131
Annualized		227,009

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

[2023 Dollars, 10-year period of analysis]

Year	Total undiscounted cost savings	Discounted cost savings
		2%
1	$0	$0
2	1,287,767	1,237,761
3	1,314,521	1,238,702
4	1,314,521	1,214,414
5	1,314,521	1,190,602
6	1,314,521	1,167,257
7	1,314,521	1,144,370
8	1,314,521	1,121,931
9	1,314,521	1,099,932
10	1,314,521	1,078,365
Total	11,803,935	10,493,334
Annualized		1,168,186

4. Placards in Lieu of Information Pamphlets

The fourth provision in the rule comes from details contained within ANSI/CAN/UL 12402-4 and ANSI/CAN/UL 12402-5. These standards specify requirements for a placard to be attached to all devices certified to those standards. The placard provides information on PFD performance, selection, and approval, warnings, maintenance, and general water safety information in a pictographic format. This rule amends 33 CFR 181 to permit manufacturing firms to use a placard in lieu of the informational pamphlet.

Costs

For the convenience of the reader, table 24 reproduces table 6 from the Affected Population section of this preamble to list the various types of PFDs impacted by this rule, and whether they are required to use placards to convey safety instructions or whether they could use either placards or information pamphlets.^[32]

Table 24—Device Category and Permitted Instruction Types

Device category	Types of instructions allowed by the final rule	Types of instructions currently in use
New Level 50 Devices (ANSI/CAN/UL 12402-5)	Placard	N/A because these devices are not yet produced.
New Level 70 Devices (ANSI/CAN/UL 12402-5)	Placard	Placard.
New Level 100 Devices (ANSI/CAN/UL 12402-4)	Placard	N/A because these devices are not yet produced.
( print page 97375)
Existing Type I Commercial Devices	Placard or Information Pamphlet	Information Pamphlet.
Existing Type II Recreational Devices	Placard or Information Pamphlet	Information Pamphlet.
Existing Type III Recreational Devices	Placard or Information Pamphlet	Information Pamphlet.
Existing Type IV Throwable Devices	Information Pamphlet	Information Pamphlet.

As shown in table 24, the changes in instruction information either applies to PFD categories not yet produced or permits an additional compliance option. No devices would have fewer options for instruction materials than under current regulations. As a result, we estimate no additional costs from replacing safety information pamphlets with placards because firms could either continue their current activities or produce placards instead.

Unquantified Benefits

There are two sources of unquantified benefits from the requirement for the use of placards on new device categories and the permitting of placard use on existing device categories. The first source of unquantified benefits occurs because a placard may be less expensive to produce than an information pamphlet. A representative from the PFD manufacturing industry stated that the placard could be around $0.05 cheaper to produce than the information pamphlet, because the placard contains fewer materials than the information pamphlet. However, we did not find (nor did we receive) any data on the costs to produce information pamphlets and the costs to produce placards, so we cannot determine the relative size of this cost savings. We believe, based on the full discussion in the RA, that the $0.05 estimate expresses the fact that placards are slightly less expensive than information pamphlets but, ultimately, about the same price. Additionally, we have no way of estimating how large a share of current production will switch from producing information pamphlets to placards, as placards will not be required. Due to these factors, we did not produce a quantitative estimate of the cost savings due to placards.

The second unquantified benefit comes from the fact that placards use pictorial images to communicate safety information, while information pamphlets use English-language text. Pictorial information is superior to text at communicating information to non-English-reading audiences. We do not have a way of quantifying this benefit but would like to note that approximately 21 percent of the U.S. population has a “low” level of English literacy. For those populations, pictorial information may be better than text-based information.^[33]

Total Costs

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

Table 25—Estimated Costs for U.S. Firms

[2023 Dollars, 10-year period of analysis]

Year	Total undiscounted costs	Discounted costs
		2%
1	$702,754	$688,975
2	654,199	628,796
3	77,800	73,313
4	77,800	71,875
5	77,800	70,466
6	77,800	69,084
7	77,800	67,730
8	77,800	66,402
9	77,800	65,100
10	77,800	63,823
Total	1,979,353	1,865,564
Annualized		207,687

Table 26—Estimated Costs for Foreign Firms

[2023 Dollars, 10-year period of analysis]

Year	Total undiscounted costs	Discounted costs
		2%
1	$171,019	$167,666
2	158,374	152,224
( print page 97376)
3	19,300	18,187
4	19,300	17,830
5	19,300	17,481
6	19,300	17,138
7	19,300	16,802
8	19,300	16,472
9	19,300	16,149
10	19,300	15,833
Total	483,793	455,782
Annualized		50,741

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

[2023 Dollars, 10-year period of analysis]

Year	Total undiscounted costs	Discounted costs
		2%
1	$873,773	$856,640
2	812,573	781,020
3	97,100	91,499
4	97,100	89,705
5	97,100	87,946
6	97,100	86,222
7	97,100	84,531
8	97,100	82,874
9	97,100	81,249
10	97,100	79,656
Total	2,463,146	2,321,343
Annualized		258,427

Total Cost Savings

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

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

[2023 Dollars, 10-year period of analysis]

Year	Total undiscounted cost savings	Discounted cost savings
		2%
1	$46,510	$45,598
2	1,083,906	1,041,817
3	1,105,602	1,041,833
4	1,105,602	1,021,405
5	1,105,602	1,001,378
6	1,105,602	981,743
7	1,105,602	962,493
8	1,105,602	943,621
9	1,105,602	925,118
10	1,105,602	906,979
Total	9,975,232	8,871,985
Annualized		987,687

( print page 97377)

Table 29—Total Estimated Cost Savings to Foreign Firms

[2023 Dollars, 10-year period of analysis]

Year	Total undiscounted cost savings	Discounted cost savings
		2%
1	$20,392	$19,992
2	270,763	260,249
3	275,821	259,912
4	275,821	254,816
5	275,821	249,820
6	275,821	244,921
7	275,821	240,119
8	275,821	235,411
9	275,821	230,795
10	275,821	226,269
Total	2,497,723	2,222,303
Annualized		247,401

Table 30—Total Estimated Cost Savings to the U.S. Government

[2023 Dollars, 10-year period of analysis]

Year	Total undiscounted cost savings	Discounted cost savings
		2%
1	$4,330	$4,245
2	4,330	4,162
3	4,330	4,080
4	4,330	4,000
5	4,330	3,922
6	4,330	3,845
7	4,330	3,770
8	4,330	3,696
9	4,330	3,623
10	4,330	3,552
Total	43,300	38,895
Annualized		4,330

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

[2023 Dollars, 10-year period of analysis]

Year	Total undiscounted cost savings	Discounted cost savings
		2%
1	$71,232	$69,835
2	1,358,999	1,306,227
3	1,385,753	1,305,826
4	1,385,753	1,280,222
5	1,385,753	1,255,119
6	1,385,753	1,230,509
7	1,385,753	1,206,381
8	1,385,753	1,182,727
9	1,385,753	1,159,536
10	1,385,753	1,136,800
Total	12,516,255	11,133,183
Annualized		1,239,419

( print page 97378)

Net Cost Savings

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

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

[2023 Dollars, 10-year period of analysis]

Year	Net undiscounted cost savings	Net discounted cost savings
		2%
1	−$656,244	−$643,376
2	429,707	413,021
3	1,027,802	968,521
4	1,027,802	949,530
5	1,027,802	930,912
6	1,027,802	912,659
7	1,027,802	894,763
8	1,027,802	877,219
9	1,027,802	860,019
10	1,027,802	843,156
Total	7,995,879	7,006,423
Annualized		780,001

Table 33—Total Estimated Net Cost Savings to Foreign Firms

[2023 Dollars, 10-year period of analysis]

Year	Net undiscounted cost savings	Net discounted cost savings
		2%
1	−$150,627	−$147,674
2	112,389	108,025
3	256,521	241,725
4	256,521	236,986
5	256,521	232,339
6	256,521	227,783
7	256,521	223,317
8	256,521	218,938
9	256,521	214,645
10	256,521	210,437
Total	2,013,930	1,766,522
Annualized		196,661

Table 34—Total Estimated Cost Savings to the U.S. Government

[2023 Dollars, 10-year period of analysis]

Year	Net undiscounted cost savings	Net discounted cost savings
		2%
1	$4,330	$4,245
2	4,330	4,162
3	4,330	4,080
4	4,330	4,000
5	4,330	3,922
6	4,330	3,845
7	4,330	3,770
8	4,330	3,696
9	4,330	3,623
10	4,330	3,552
Total	43,300	38,895
( print page 97379)
Annualized		4,330

Table 35—Total Estimated Net Cost Savings to All Entities

[2023 Dollars, 10-year period of analysis]

Year	Net undiscounted cost savings	Net discounted cost savings
		2%
1	−$802,541	−$786,805
2	546,426	525,208
3	1,288,653	1,214,327
4	1,288,653	1,190,516
5	1,288,653	1,167,173
6	1,288,653	1,144,287
7	1,288,653	1,121,850
8	1,288,653	1,099,853
9	1,288,653	1,078,287
10	1,288,653	1,057,144
Total	10,053,109	8,811,839
Annualized		980,991

Alternatives

We identified three alternatives to this final rule:

(1) Incorporate ANSI/CAN/UL 12402-5 for the approval of Level 70 PFDs only, prohibiting the approval of Level 50 PFDs;

(2) Require placards for existing Type I, II, and III PFDs instead of providing the option to continue the use of informational pamphlets; and

(3) Adopt ANSI/CAN/UL 12402-4 and ANSI/CAN/UL 12402-5 by policy.

Alternative 1: Incorporate ANSI/CAN/UL 12402-5 for Level 70 PFDs Only

We considered an alternative that would incorporate ANSI/CAN/UL 12402-5, but limit approval to Level 70 PFDs only. Level 50 PFDs would not be eligible for Coast Guard approval and would not meet carriage requirements on any vessel. If the Coast Guard were to choose this alternative, the market for Level 50 devices would not be viable because Level 50 devices would no longer meet carriage requirements. Without a viable market, the costs of compliance estimated in the section of ANSI/CAN/UL 12402-5 would not exist. However, the benefits from a new market and increased wear-rates would be lost were these devices to not be sold. We would also be restricting recreational boaters to one category of PFD when Level 50 PFDs could better suit their purposes. As a result, we rejected this alternative because we expect that wear rates, and therefore benefits, would be lower without the option of a Level 50 PFD.

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

Under this final rule, we require that only new Level 50, 70, and 100 devices use placards. We considered the alternative of requiring that PFD manufacturers use placards instead of information pamphlets for all existing PFDs and not just new devices. While we observe that the cost of producing a placard is generally less than the cost of producing an information pamphlet, we also observe that some manufacturers may have already printed pamphlets or may not choose to use placards. As a result, we rejected this alternative.

Alternative 3: Adopt ANSI/CAN/UL 12402-4 and ANSI/CAN/UL 12402-5 by Policy

Another alternative we considered would be to adopt ANSI/CAN/UL 12402-4 and ANSI/CAN/UL 12402-5 by policy instead of incorporating them by reference into the CFR. Under 46 CFR 159.005-7(c), the Coast Guard has the authority to approve an item of equipment that does not meet all the requirements of 46 CFR 160.055 if it has equivalent performance characteristics. The Coast Guard has already used this authority to partially adopt ANSI/CAN/UL 12402-4 and ANSI/CAN/UL 12402-5 by policy. Because this authority is limited to the approval of equipment with equivalent performance characteristics, we cannot adopt the portion of standards not already equivalent to existing types of equipment. In particular, Level 50 PFDs, youth inflatable PFDs, and inflatable Level 100 PFDs could not be approved by policy because they are not equivalent to any current Coast Guard standards. For that reason, we rejected this alternative.

B. Small Entities

Under the Regulatory Flexibility Act, (RFA) 5 U.S.C. 601-612, we have considered whether this rule has a significant economic impact on a substantial number of small entities.

The RFA (Public Law 96-354) establishes “as a principle of regulatory issuance that agencies shall endeavor, consistent with the objectives of the rule and of applicable statutes, to fit regulatory and informational requirements to the scale of the businesses, organizations, and governmental jurisdictions subject to ( print page 97380) regulation. To achieve this principle, agencies are required to solicit and consider flexible regulatory proposals and to explain the rationale for their actions to assure that such proposals are given serious consideration.”

When an agency promulgates a final rule under section 553 of the RFA, after being required by that section or any other law to publish a general notice of proposed rulemaking, or promulgates a final interpretative rule involving the internal revenue laws of the United States as described in section 603(a), the agency must prepare a final Regulatory Flexibility Analysis (FRFA) or have the head of the agency certify pursuant to RFA section 605(b) that the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities. The RFA prescribes the content of the FRFA in section 604(a), which we discuss as follows.

In accordance with the RFA (5 U.S.C. 601-612), the Coast Guard prepared this FRFA that examines the impacts of the final rule on small entities (5 U.S.C. 601, et seq.). A small entity may be:

• A small independent business, defined as any independently owned and operated business not dominant in its field that qualifies as a small business per the Small Business Act (5 U.S.C. 632);
• A small not-for-profit organization; and
• A small governmental jurisdiction (locality with fewer than 50,000 people).

This FRFA addresses the following:

(1) A statement of the need for, and objectives of, the rule;

(2) A statement of the significant issues raised by the public comments in response to the initial regulatory flexibility analysis, a statement of the assessment of the agency of such issues, and a statement of any changes made in the proposed rule as a result of such comments;

(3) The response of the agency to any comments filed by the Chief Counsel for Advocacy of the Small Business Administration (SBA) in response to the proposed rule, and a detailed statement of any change made to the proposed rule in the final rule as a result of the comments;

(4) A description of and an estimate of the number of small entities to which the rule will apply or an explanation of why no such estimate is available;

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

(6) A description of the steps the agency has taken to minimize the significant economic impact on small entities consistent with the stated objectives of applicable statutes, including a statement of the factual, policy, and legal reasons for selecting the alternative adopted in the final rule and why each one of the other significant alternatives to the rule considered by the agency which affect the impact on small entities was rejected.

Below is a discussion of FRFA analysis by each of these six elements:

(1) A statement of the need for, and objectives of, the rule.

The Coast Guard amends the lifejacket approval requirements and follow-up program requirements by incorporating three new binational standards. At the same time, the Coast Guard amends lifejacket and PFD carriage requirements to allow for the use of equipment approved to the new standards, and to remove obsolete equipment approval requirements. The new standards are state-of-the-art and are intended to replace the legacy standards. The amendments will streamline the process for approval of PFDs and allow manufacturers to produce more innovative equipment that meets the approval requirements of both the United States and Canada; and will reduce the burden for manufacturers in both the approval process and follow-up program. Absent this regulation, the United States and Canada would continue to have two different PFD standards, resulting in additional costs for manufacturers.

(2) A statement of the significant issues raised by the public comments in response to the initial regulatory flexibility analysis, a statement of the assessment of the agency of such issues, and a statement of any changes made in the proposed rule as a result of such comments.

The Coast Guard received no public comments in response to the initial Regulatory Flexibility Analysis.

(3) The response of the agency to any comments filed by the Chief Counsel for Advocacy of the SBA in response to the proposed rule, and a detailed statement of any change made to the proposed rule in the final rule as a result of the comments.

The Coast Guard received no comments filed by the Chief Counsel for Advocacy of the SBA in response to the proposed rule.

(4) A description of and an estimate of the number of small entities to which the rule will apply or an explanation of why no such estimate is available.

This rule has four major provisions: (1) The incorporation by reference of ANSI/CAN/UL 12402-4 replacing Type I device approval with Level 100 device approval; (2) The incorporation by reference of ANSI/CAN/UL 12402-5 introducing new Level 50 device approvals; (3) The incorporation by reference of ANSI/CAN/UL 9595 for new follow-on production inspection standards; and (4) The option to use placards in lieu of information pamphlets on currently approved devices and the requirement to use placards for new Level 50, Level 70, and Level 100 devices. Across these four provisions, we estimate that this rule affects two Coast Guard recognized laboratories and 61 PFD manufacturers.

We researched these two Coast Guard recognized independent laboratories and 61 PFD manufacturers to determine if they are U.S. companies or foreign companies based on the location of their parent company's headquarters. We found one Coast Guard recognized laboratory to be a U.S. company and one to be a foreign company. We found 39 of the 61 PFD manufacturers to be U.S. companies and 22 to be foreign companies. We then researched each of these 40 U.S. companies (1 testing laboratory and 39 PFD manufacturers) to determine its North American Industry Classification System (NAICS) code and its size standard using the SBA's size standard table. Next, we reviewed each U.S. parent company's revenue or employee information to determine whether the company is small or not small, according to SBA size standards. We present the results of our research in table 36. The Coast Guard recognized independent laboratory is not a small entity. Of 39 U.S. manufacturers, 32 are small entities according to SBA size standards. We did not find any U.S. small entities to be small governmental jurisdictions or not-for-profit organizations. ( print page 97381)

Table 36—Number of Small Entities Affected by the Rule

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

Each of the four provisions in this final rule affects a different subset of the 32 small entities and has a different distribution of costs and cost savings across those small entities. We discuss each provision separately in the following sections, and then summarize each provision's impacts.

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

The first provision, ANSI/CAN/UL 12402-4, affects seven small entities, six of which have known revenues. The first provision results in costs to small entities that intend to sell Level 100 devices in only one market (United States or Canada). Firms wishing to sell Level 100 devices in both United States and Canadian markets will reduce costs by no longer conducting duplicative approvals and facility inspections.

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

In the RA, we estimate the Level 100 approval to be $5,050 more expensive than the current Type I approval. We estimate that testing laboratories receive an application for approval to Level 100 standards 0.45 times per year. Each small entity will apply for an approval once they develop a new device and will experience this cost only when they submit a new application. The Coast Guard cannot predict when each small entity might submit a new application; instead, we use the cost of $5,050 as an estimate of a one-time (initial-year cost) per-small-entity-cost of ANSI/CAN/UL 12402-4.

We estimate the cost savings for small entities that wish to sell in two markets as $42,150 per new Level 100 approval, $5,594 per modification of an existing approval with testing, and $1,373 per revision of an existing approval without testing. As with the costs of ANSI/CAN/UL 12402-4, each small entity will experience the cost savings only when it submits each application. The Coast Guard does not know when small entities might seek new approvals or revisions in the future, so we estimate these as one-time cost savings to small entities from ANSI/CAN/UL 12402-4. Specifically, we estimate that each small entity will experience a one-time total cost savings of $41,638 for each approval, which is the sum of the Level 100 approvals and revisions to approvals with or without testing ($42,150 + $7,605 + $1,373). These seven small entities will also experience an ongoing (annual) cost savings of $1,338.00 from reduced facility inspection frequency.^[34]

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

Incorporating by reference ANSI/CAN/UL 12402-5 permits small entities to seek Coast Guard approval to produce and sell Level 50 devices. The Coast Guard has not previously approved these devices. We estimate that this provision affects all 32 small entities, 24 of which have known revenues.

In the RA, we estimate that the introduction of Level 50 devices will cause the North American PFD market to grow by 5 percent. We interpret the 5-percent growth in terms of the number of approved devices (a growth of 38 device approvals). The initial approvals represent a one-time (initial year) cost to small entities. Small entities will also experience an annual cost of additional production inspections based on the volume of Level 50 PFDs produced. ( print page 97382)

We estimate a new Level 50 device approval costs a small entity about $39,840. We do not know which small entities will seek Coast Guard approval for a Level 50 device or how many devices each small entity might seek approval for. As a result, we treat each small entity as seeking approval for one Level 50 device costing $39,840. This will be a one-time (initial year) cost to small entities.

Production is not distributed equally across the small entities that produce PFDs for the North American market. Instead, some small entities produce vastly more PFDs than others. In the RA, we estimate the market share of the 13 largest firms to be collectively about 95 percent. We estimate the remaining 44 firms' market share collectively to be about 5 percent. We do not know the relative market share of the 44 firms, so we divide the 5 percent equally across the 44 firms. Therefore, we treat each of the 44 firms as accounting for about 0.11 percent of the PFD market.^[35]

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

Table 37—Market Size of Small Entities Affected by the Rule

Number of small entities	Market share of each entity (%)
24	0.11
5	2.5
1	7.5
1	15
1	25

In the RA, we estimate the annual cost of production inspections across the whole industry to be $82,974. Because we do not know which small entities will seek Level 50 approval, we estimate the additional costs from production inspections from Level 50 device sales for each small entity by multiplying each small entity's market share by the total costs. For example, if we use a small entity that has a market share of 0.11 percent, then we estimate the small entity's additional production inspection costs to be about $91.27 ($82,974 × 0.0011, rounded) annually.

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

Incorporating ANSI/CAN/UL 9595 by reference establishes production testing standards for the PFD manufacturing industry. ANSI/CAN/UL 9595 will lead to reductions in testing frequency for PFD manufacturing entities with a QMS in place. We estimate that eight small entities would be affected by this provision, seven of which have known revenue.

Small entities will experience one-time costs of an initial QMS inspection, and ongoing costs because a QMS inspection is more expensive than the facility inspection it replaces in subsequent years. We estimate that each small entity has two facilities, with the largest small entity having three facilities, and QMS inspection costs occur per facility. In the RA, we estimate that the total costs to U.S. firms for the ANSI/CAN/UL 9595 standard will be about $61,296 for 19 facilities. We estimate that 7 of the firms in the top 13 are small entities, including the top firm. Because we do not know where each small entity's facilities are located, to estimate each small entity's one-time costs, we multiply $61,296 by each small entity's share of the 19 facilities, yielding $6,452 ((2 ÷ 19) × $61,296) for all but the largest small entity and $9,678 ((3 ÷ 19) × $61,296) for the largest small entity. We estimate annual costs to be about $439 per facility, which is the difference between 8 hours of billed QMS inspector time and 8 hours of a regular inspector's time.^[36] The largest small entity has three facilities, so will experience $1,316 ($439 × 3) in additional costs. All the other small entities have two facilities, and they will experience $878 ($439 × 2) in annual costs. We reflect this information in table 38.

Table 38—Costs per Small Entity From UL 9595

Entity type	Number of facilities	Total one-time costs	Annual costs
The Largest	3	$9,678	$1,317
All Others	2	6,452	878

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

Cost savings will be different for each of the seven small entities. To estimate the cost savings per small entity, we need to estimate the number of reductions in inspections per small entity and then multiply by $2,712 ($2,196 of billed inspector time and $516 of weighted average quality manager loaded wages). To calculate the reductions in inspections for each small entity, we take the share of current inspections for each small entity and then estimate the number of inspections that would take place under Process Rating A or B for each small entity. Next, we subtract the reduced inspection frequency per small entity from the current inspection frequency, yielding a reduction in inspection frequency for current production. In the RA, we also estimate that U.S. firms will experience 16 fewer inspections on Level 50 devices that they do not yet produce, resulting in cost savings from reduced inspection frequency. We then multiply the 16 inspections by each small entity's share of reduction in current inspections.

For example, assume that a small entity had a 10-percent market share, half of which would be at Process Rating A and half of which would be at Process Rating B. We first take the total number of current inspections on U.S. firms (587) and multiply by the small entity's market share relative to the total affected U.S. market share, or 10 percent ( print page 97383) ÷ 77.5 percent × 587, yielding 76 rounded. Then we derive the reduced number of inspections at B and the reduced number of inspections at A by multiplying the reduced inspection frequency at B (194) by the share of the small entity's Process Rating at B relative to all other U.S. firms at B, or 5 percent ÷ 51 percent, yielding 19 rounded. To estimate the reduced inspection frequency at A, we take the number of facilities at A (one) and multiply by two, accounting for the number of inspections that occur once the facility is at Process Rating A. Next, we add to it the multiplication of the number of commercial PFD production inspections at A (7) and the small entity's relative share of production at A, or 5 percent ÷ 26.5 percent, yielding 3 rounded (2 × 1) + (7 × 5 percent ÷ 26.5 percent). Taken together, the small entity's reduced inspection frequency is 22 (19 + 3), meaning the small entity experiences 54 fewer production inspections annually (76−22). To calculate the number of reduced Level 50 inspections for each small entity, we take the small entity's share of U.S. firm inspection reduction divided by the total estimated reduction in U.S. firm inspections from Table 42 in the RA (54 ÷ 376) and multiply by the 16 total reduction in inspections, yielding 2 rounded. We add the reduction in Level 50 inspections (2) and the reduction in current inspections (54) together and multiply by the cost of each inspection ($2,712), yielding $151,872 ((2+54) × $2,712), or the small entity's annual cost savings from reduced inspection frequency. We perform this process for each of the eight small entities. We record these calculations in table 39; the results are rounded.

Table 39—Annual Cost Savings for a Representative Small Entity in 2023 Dollars

Total market share	Market share at B	Market share at A	Current inspection frequency	Inspection frequency at B	Inspection frequency at A	Total inspection reduction	Reduced level 50 inspections	Total annual cost savings
A	B = A ÷ 2	C = A ÷ 2	D = 587 × A ÷ 77.5%	E = 194 × B ÷ 51%	F = (2 × 1) + (7 × C ÷ 26.5%)	G = D−E−F	H = G ÷ 376 × 16	(G + H) × $2,712
10%	5%	5%	76	19	3	54	2	$151,872

Provision 4: Replacement of Information Pamphlets With Booklets

We did not estimate any costs or cost savings from this provision, so we do not estimate that there will be any impact on small entities.

We summarize the number of small entities affected, cost impacts, cost savings impacts, and transfers per provision in table 40.

Table 40—Number of Affected Small Entities, Costs, and Cost Savings per Provision

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

We provide a list of the range of costs, cost savings, and net cost savings per entity in table 41. Because each entity is subject to a different subset of provisions, this table should be interpreted as the minimum and maximum, cost, cost savings, and net cost savings per entity. Specifically, the cost, cost savings, and net cost savings rows are the minimum or maximum observed across the range of entities. ( print page 97384) Net cost savings is therefore not a function of the cost and cost savings in Table 41. For example, the lowest net cost savings in Table 40, −$46,292.21, demonstrates a cost greater than the lowest cost that will be experienced by an entity, or $39,840, which is why it is not the lowest cost per entity. Similarly, lowest and highest ongoing impacts do not necessarily match to the lowest and highest one-time impacts. We are simply reporting the lowest and highest impacts per entity across costs, cost savings, and net cost savings.

Table 41—Range of Impacts per Entity

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

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

Table 42—Percentage of Estimated Revenue Impact on Small Entities From Overall Impact (Net Cost Savings) of This Final Rule

% Revenue impact	One-time net impacts		Ongoing net impacts
	Small entities with known revenue	Portion of small entities with known revenue (%)	Small entities with known revenue	Portion of small entities with known revenue (%)
<1	17	71	20	83
1-3%	2	8	2	8
>3	5	21	2	8

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

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

(6) A description of the steps the agency has taken to minimize the significant economic impact on small entities consistent with the stated objectives of applicable statutes, including a statement of the factual, policy, and legal reasons for selecting the alternative adopted in the final rule and why each one of the other significant alternatives to the rule considered by the agency which affect the impact on small entities was rejected.

The Coast Guard identified three alternatives:

(1) Incorporate ANSI/CAN/UL 12402-5 for the approval of Level 70 PFDs only, prohibiting the approval of Level 50 PFDs;

(2) Require placards instead of pamphlets; and

(3) Adopt ANSI/CAN/UL 12402-4 and ANSI/CAN/UL 12402-5 by policy.

Alternative 1: Incorporate by Reference ANSI/CAN/UL 12402-5 for Level 70 PFDs Only

Under the first alternative, we could have chosen to incorporate ANSI/CAN/UL 12402-5 but limit approval to Level 70 PFDs only. Level 50 PFDs would not be eligible for Coast Guard approval and would not meet carriage requirements on any vessel, severely restricting their use. If the Coast Guard chose this alternative, the market for Level 50 devices would not be viable because Level 50 devices would no longer partially substitute for Level 70 or Type III devices. Small entities would be unable to sell these new devices and would not experience a positive revenue impact from this alternative.

As a result, we rejected this alternative because it does not maximize small entities' revenue.

Alternative 2: Require Placards Instead of Pamphlets

We considered the alternative of requiring that PFD manufacturers use placards instead of information pamphlets for the mandatory PFD instructional materials. While the Coast Guard observes that the cost of producing placards is generally less than the costs of producing information pamphlets, the Coast Guard observes that some manufacturers may not have switched to producing placards yet. As such, if we required that manufacturers use placards, we could place undue burden on small entities in the PFD industry by requiring that they acquire new equipment to produce placards. We do not know how large these costs could be, but small entities would experience greater compliance costs. As a result, we ultimately rejected this alternative.

Alternative 3: Adopt ANSI/CAN/UL 12402-4 and ANSI/CAN/UL 12402-5 by Policy

The third alternative we considered was to adopt ANSI/CAN/UL 12402-4 and ANSI/CAN/UL 12402-5 by policy instead of incorporating them by reference in the regulations. Under 46 CFR 159.005-7(c), the Coast Guard has the authority to approve an item of equipment that does not meet all the requirements of 46 CFR 160.055 if it has equivalent performance characteristics. The Coast Guard has utilized this authority to partially adopt ANSI/CAN/UL 12402-4 and ANSI/CAN/UL 12402-5 by policy. However, because this authority is limited to the approval of equipment with equivalent performance characteristics, we cannot adopt the portion of standards not already equivalent to existing types of equipment. In particular, Level 50 PFDs, ( print page 97385) youth inflatable PFDs, and inflatable Level 100 PFDs cannot be approved by policy because they are not equivalent to any current Coast Guard standards. As a result, small entities would not receive the additional revenue from the sale of Level 50 devices or the cost savings on Level 100 inflatable device approvals as compared to Type I device approvals. For these reasons, we rejected this alternative.

C. Assistance for Small Entities

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996, Public Law 104-121, we offer to assist small entities in understanding this rule so that they can better evaluate its effects on them and participate in the rulemaking. The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

D. Collection of Information

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

E. Federalism

A rule has implications for federalism under Executive Order 13132 (Federalism) if it has a substantial direct effect on States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this final rule under Executive Order 13132 and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132. Our analysis follows.

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

F. Unfunded Mandates

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

G. Taking of Private Property

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

H. Civil Justice Reform

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

I. Protection of Children

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

J. Indian Tribal Governments

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

K. Energy Effects

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

L. Technical Standards

The National Technology Transfer and Advancement Act, codified as a note to 15 U.S.C. 272, directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through OMB, with an explanation of why using these standards are inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.

This rule uses the following voluntary consensus standards:

• ANSI/CAN/UL 9595, Standard for Safety Factory Follow-Up on Personal Flotation Devices (PFDs), First Edition, June 4, 2020 (including revisions through September 9, 2021).
• ANSI/CAN/UL 12402-4, Standard for Safety Personal Flotation Devices—Part 4: Lifejackets, Performance Level 100—Safety Requirements, First Edition, July 9, 2020.
• ANSI/CAN/UL 12402-5, Standard for Safety Personal Flotation Devices—Part 5: Buoyancy Aids (Level 50)—Safety Requirements, First Edition, ( print page 97386) December 31, 2015 (including revisions through January 27, 2022).
• ANSI/UL 1123, Standard for Safety Marine Buoyant Devices, Seventh Edition, October 1, 2008 (including revisions through November 23, 2020).
• ANSI/UL 1175, Standard for Safety Buoyant Cushions, Fourth Edition, April 20, 2007 (including revisions through January 10, 2020).

The sections that reference these standards and the locations where these standards are available are listed in 46 CFR 160.045-5, 160.055-5, 160.060-5, 160.064-5, 160.076-5, 160.255-5, 160.264-5, and 160.276-5.

The Director of the Federal Register has approved the material in 46 CFR 160.045-5, 160.055-5, 160.060-5, 160.064-5, 160.076-5, 160.255-5, 160.264-5, and 160.276-5 for incorporation by reference under 5 U.S.C. 552 and 1 CFR part 51. Copies of the material are available from the sources listed in 46 CFR 160.045-5, 160.055-5, 160.060-5, 160.064-5, 160.076-5, 160.255-5, 160.264-5, and 160.276-5.

Consistent with 1 CFR part 51 incorporation by reference provisions, this material is reasonably available. Interested persons have access to it through their normal course of business, may purchase it from the organization identified in 46 CFR 160.045-5, 160.055-5, 160.060-5, 160.064-5, 160.076-5, 160.255-5, 160.264-5, and 160.276-5, or may view a copy by means we have identified in that section.

M. Environment

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

List of Subjects

33 CFR Part 181

• Labeling
• Marine safety
• Reporting and recordkeeping requirements

46 CFR Part 25

• Fire prevention
• Marine safety
• Reporting and recordkeeping requirements

46 CFR Part 28

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

46 CFR Part 108

• Fire prevention
• Marine safety
• Occupational safety and health
• Oil and gas exploration
• Vessels

46 CFR Part 117

• Marine safety
• Passenger vessels

46 CFR Part 133

• Cargo vessels
• Marine safety
• Reporting and recordkeeping requirements

46 CFR Part 141

• Marine safety
• Occupational health and safety
• Reporting and recordkeeping requirements
• Towing vessels

46 CFR Part 160

• Incorporation by reference
• Marine safety
• Reporting and recordkeeping requirements

46 CFR Part 169

• Fire prevention
• Marine safety
• Reporting and recordkeeping requirements
• Schools
• Vessels

46 CFR Part 180

• Marine safety
• Passenger vessels

46 CFR Part 199

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

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

Title 33—Navigation and Navigable Waters

PART 181—MANUFACTURER REQUIREMENTS

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

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

§ 181.4

[Removed and Reserved]

2. Remove and reserve § 181.4.

Subpart G—Information Pamphlet or Placard for Personal Flotation Devices

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

§ 181.701

[Amended]

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

5. Revise § 181.702 to read as follows:

§ 181.702

Information pamphlet or placard: requirement to furnish.

(a) Each manufacturer of a Coast Guard approved personal flotation device (PFD) must furnish, with each PFD that is sold or offered for sale for use on a recreational boat, an information pamphlet or placard accepted by the Commandant (CG-ENG-4) or meeting the requirements in the applicable subpart of 46 CFR part 160.

(b) No person may sell or offer for sale for use on a recreational boat a Coast Guard approved PFD unless an information pamphlet or placard required by this section is attached in such a way that it can be read prior to purchase.

§§ 181.703 through 181.705

[Removed]

6. Remove §§ 181.703 through 181.705.

Title 46—Shipping

PART 25—REQUIREMENTS

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

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

( print page 97387)

8. Amend § 25.25-5 by:

a. Removing in paragraph (b)(2), the text “or 160.176” and adding, in its place, the text “160.176, or 160.255”; and

b. Revising the introductory text to paragraph (c)(2).

The revision reads as follows:

§ 25.25-5

Life preservers and other lifesaving equipment required.

* * * * *

(c) * * *

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

* * * * *

PART 28—REQUIREMENTS FOR COMMERCIAL FISHING INDUSTRY VESSELS

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

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

10. Revise § 28.110 to read as follows:

§ 28.110

Life preservers or other personal flotation devices.

(a) Except as provided by § 28.305 of this chapter, each vessel must be equipped with at least one immersion suit, exposure suit, or wearable personal flotation device of the proper size for each individual on board as specified in table 1 to § 28.110 and part 25, subpart 25.25 of this chapter. Notwithstanding the provisions of paragraphs (c) and (d) of § 25.25-1 of this chapter, each commercial fishing industry vessel propelled by sail, and each manned barge employed in commercial fishing activities, must meet the requirements of this paragraph.

(b) Each wearable personal flotation device must be stowed so that it is readily accessible to the individual for whom it is intended, from both the individual's normal work station and berthing area. If there is no location accessible to both the work station and the berthing area, an appropriate device must be stowed in both locations.

Table 1 to § 28.110—Personal Flotation Devices and Immersion Suits

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

PART 108—DESIGN AND EQUIPMENT

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

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

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

§ 108.580

Personal lifesaving appliances.

* * * * *

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

* * * * *

PART 117—LIFESAVING EQUIPMENT AND ARRANGEMENTS

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

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

14. Amend § 117.71 by:

a. Revising the section heading and paragraph (c);

b. Removing paragraph (d); and

c. Redesignating paragraph (e) as paragraph (d).

The revisions read as follows:

§ 117.71

Lifejackets.

* * * * *

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

* * * * *

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

§ 117.72

Personal flotation devices carried in addition to lifejackets.

* * * * *

(b) Wearable PFDs approved in accordance with §§ 160.064, 160.076, 160.264, or 160.276 in subchapter Q of this chapter, or other standard specified by the Commandant, may be carried as additional equipment.

* * * * *

(d) A commercial hybrid PFD approved under former approval series 160.077 prior to January 6, 2025 may be carried as additional equipment for use by persons working near or over the water if it is in good and serviceable condition, used in accordance with the ( print page 97388) conditions marked on the PFD and in the owner's manual, of the same or similar design, and has the same method of operation as each other hybrid PFD carried on board.

PART 133—LIFESAVING SYSTEMS

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

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

§ 133.70

[Amended]

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

PART 141—LIFESAVING

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

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

§ 141.340

[Amended]

19. Amend § 141.340 by:

a. Removing in paragraph (a) the text “or 160.176,” and adding, in its place, the text “160.176, or 160.255”; and

b. Adding paragraph (i).

The addition reads as follows:

§ 141.340

Lifejackets.

* * * * *

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

PART 160—LIFESAVING EQUIPMENT

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

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

Subpart 160.001 [Removed and Reserved]

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

Subpart 160.002 [Removed and Reserved]

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

Subpart 160.005 [Removed and Reserved]

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

Subpart 160.006 [Removed and Reserved]

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

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

Subpart 160.045—Recreational Throwable PFDs

160.045-1

Scope.

160.045-3

Definitions.

160.045-5

Incorporation by reference.

160.045-7

Design, construction, and performance of throwable PFDs.

160.045-9

Approval procedures for throwable PFDs.

160.045-11

Recognized laboratory.

160.045-13

Approval inspections and tests.

160.045-15

Production inspections, tests, and quality control of throwable PFDs.

160.045-17

Marking and Labeling.

160.045-21

PFD manuals.

160.045-23

Procedure for approval of design or material change.

160.045-25

Suspension or termination of approval.

Subpart 160.045—Recreational Throwable PFDs

§ 160.045-1

Scope.

(a) This subpart contains structural and performance standards for approval of throwable PFDs for use on recreational vessels, as well as requirements for production follow-up inspections, associated manuals, information pamphlets or placards, and markings.

(b) Throwable PFDs approved under this subpart may rely entirely on inherently buoyant material, or rely entirely or partially upon inflation to achieve the minimum buoyancy.

(c) Throwable PFDs approved under this subpart are intended to meet the carriage requirements for uninspected commercial vessels under 40 ft (12 m) not carrying passengers for hire and recreational boats, in accordance with 33 CFR part 175.

§ 160.045-3

Definitions.

The following definitions apply to this subpart:

Commandant means the Chief of the Lifesaving and Fire Safety Standards Division. Address: Commandant (CG-ENG-4), Attn: Lifesaving and Fire Safety Division, U.S. Coast Guard Stop 7509, 2703 Martin Luther King Jr. Avenue SE, Washington, DC 20593-7509; email [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 subpart 159.010 of this subchapter, with a valid memorandum of understanding in accordance with § 159.010-7 of this subchapter.

§ 160.045-5

Incorporation by reference.

Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by reference (IBR) material is available for inspection at the Coast Guard Headquarters and at the National Archives and Records Administration (NARA). Contact Commandant (CG-ENG-4), Attn: Lifesaving and Fire Safety Division, U.S. Coast Guard Stop 7509, 2703 Martin Luther King Jr. Avenue SE, Washington, DC 20593-7509. For information on the availability of this material at NARA, visit www.archives.gov/​federal-register/​cfr/​ibr-locations or email: [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 Safety Factory Follow-Up on Personal Flotation Devices (PFDs), First Edition, June 4, 2020 (including revisions through September 9, 2021) (“ANSI/CAN/UL 9595”); IBR approved for § 160.045-15(e).

(b) ANSI/UL 1123, Standard for Safety Marine Buoyant Devices, Seventh Edition, October 1, 2008 (including revisions through November 23, 2020); IBR approved for §§ 160.045-7(e); 160.045-13(d).

(c) ANSI/UL 1175, Standard for Safety Buoyant Cushions, Fourth Edition, April 20, 2007 (including revisions through January 10, 2020); IBR approved for §§ 160.045-7(e); 160.045-13(d).

§ 160.045-7

Design, construction, and performance of throwable PFDs.

(a) General. Every throwable PFD must conform to the requirements as accepted by the Commandant for listing and labeling by a recognized laboratory, and must be of such design, materials, and construction as to meet the requirements specified in this section.

(b) Designs and constructions. Throwable PFDs must not provide means for adjustment or close fitting to ( print page 97389) the body. Methods of construction must provide strengths, with reinforcements where necessary, to be adequate for the intended use and purpose of the device.

(c) Materials. All materials used in any device covered by this subpart must meet the applicable requirements of subpart 164.019 of this chapter, must be all new materials, must be suitable for the purpose intended, and must be at least equivalent to corresponding materials specified for standard buoyant cushions. Hardware or fastenings must be of sufficient strength for the purpose of the device and must be of inherently corrosion-resistant material, such as stainless steel, brass, bronze, certain plastics, etc. Decorative platings of any thickness are permissible. Fabrics, coated fabrics, tapes, and webbing must be either mildew-resistant or treated for mildew resistance. Buoyancy provided by inherently buoyant material must not be dependent upon loose, granulated material.

(d) Standard construction. A standard foam cushion that is designed to be thrown must be 2 inches or more in thickness and must have 225 or more square inches of top surface area.

(e) Nonstandard construction. A nonstandard throwable PFD must meet the requirements in ANSI/UL 1123 or ANSI/UL 1175 (both incorporated by reference, see § 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. ( print page 97390)

(b) Marking must be of a type that will be durable and legible for the expected life of the device.

(c) The Commandant may prescribe additional marking requirements for special purpose devices or unique or novel designs.

§ 160.045-21

PFD manuals.

(a) An owner's manual must be provided with each fully or partially inflatable throwable PFD sold or offered for sale. The text of each manual is reviewed with the application for approval.

(b) The Commandant may prescribe additional information in the manual for special purpose devices or unique or novel designs.

(c) Additional information, instructions, or illustrations may be included in the owner's manual if there is no contradiction to the required information.

§ 160.045-23

Procedure for approval of design or material change.

(a) The manufacturer must submit any proposed changes in design, material, or construction to the recognized laboratory for approval before changing throwable PFD production methods.

(b) Determinations of equivalence of design, construction, and materials may be made only by the Commandant or a designated representative.

§ 160.045-25

Suspension or termination of approval.

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

Subpart 160.047 [Removed and Reserved]

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

Subpart 160.048 [Removed and Reserved]

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

Subpart 160.052 [Removed and Reserved]

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

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

29. Revise § 160.055-1 to read as follows:

§ 160.055-1

Scope.

(a) This subpart contains requirements for production follow-up inspections for life preservers approved under this subpart prior to January 6, 2025.

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

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

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

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

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

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

(2) Standard, bib type, cloth covered;

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

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

(3) Nonstandard, shaped type:

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

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

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

§ 160.055-2

[Removed and Reserved]

30. Remove and reserve § 160.055-2.

31. Revise § 160.055-3 to read as follows:

§ 160.055-3

Definitions.

The following definitions apply to this subpart:

Commandant means the Chief of the Lifesaving and Fire Safety Standards Division. Address: Commandant (CG-ENG-4), Attn: Lifesaving and Fire Safety Division, U.S. Coast Guard Stop 7509, 2703 Martin Luther King Jr. Avenue SE, Washington, DC 20593-7509; email [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 § 160.055-15 or any Coast Guard representative performing duties related to the approval.

Recognized laboratory means an independent laboratory accepted by the Commandant in accordance with 46 CFR 159.010, with a valid memorandum of understanding in accordance with 46 CFR 159.010-7.

§ 160.055-4

[Removed and Reserved]

32. Remove and reserve § 160.055-4.

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

§ 160.055-5

Incorporation by reference.

Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by reference (IBR) material is available for inspection at the Coast Guard Headquarters and at the National Archives and Records Administration (NARA). Contact Commandant (CG-ENG-4), Attn: Lifesaving and Fire Safety Division, U.S. Coast Guard Stop 7509, 2703 Martin Luther King Jr. Avenue SE, Washington, DC 20593-7509. For information on the availability of this material at NARA, visit www.archives.gov/​federal-register/​cfr/​ibr-locations or email [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 Safety Factory Follow-Up on Personal Flotation Devices (PFDs), First Edition, June 4, 2020 (including revisions through September 9, 2021) (“ANSI/CAN/UL 9595”); IBR approved for § 160.055-15(a).

(b) [Reserved]

§§ 160.055-6 through 160.055-9

[Removed and Reserved]

34. Remove and reserve §§ 160.055-6 through 160.055-9.

35. Add § 160.055-11 to read as follows:

§ 160.055-11

Independent laboratory.

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

36. Add § 160.055-15 to read as follows:

( print page 97391)

§ 160.055-15

Production inspections, tests, and quality control of life preservers.

(a) General. Production tests and inspections must be conducted in accordance with this section, subpart 159.007 of this chapter, and the independent laboratory's procedures for production inspections and tests as accepted by the Commandant. The Commandant may prescribe additional production tests and inspections necessary to maintain quality control and to monitor compliance with the requirements of this subchapter. A follow-up program in accordance with ANSI/CAN/UL 9595 (incorporated by reference, see § 160.055-5), meets the requirements of this subpart.

(b) Oversight. In addition to responsibilities set out in part 159 of this chapter and the accepted laboratory procedures for production inspections and tests, each manufacturer of a life preserver and each laboratory inspector must comply with the following, as applicable:

(1) Manufacturer. Each manufacturer must—

(i) Perform all tests and examinations necessary to show compliance with this subpart on each lot before any inspector's tests and inspection of the lot;

(ii) Follow established procedures for maintaining quality control of the materials used, manufacturing operations, and the finished product; and

(iii) Allow an inspector to take samples of completed units or of component materials for tests required by this subpart and for tests relating to the safety of the design.

(2) Laboratory. An inspector from the accepted laboratory must oversee production in accordance with the laboratory's procedures for production inspections and tests accepted by the Commandant. During production oversight, the inspector must not perform or supervise any production test or inspection unless—

(i) The manufacturer has a valid approval certificate; and

(ii) The inspector has first observed the manufacturer's production methods and any revisions to those methods.

(3) At least quarterly, the inspector must check the manufacturer's compliance with the company's quality control procedures, examine the manufacturer's required records, and observe the manufacturer perform each of the required production tests.

(c) Test facilities. The manufacturer must provide a suitable place and apparatus for conducting the tests and inspections necessary to determine compliance of life preservers with this subpart. The manufacturer must provide means to secure any test that is not continuously observed, such as the 48-hour buoyancy test. The manufacturer must have the calibration of all test equipment checked in accordance with the test equipment manufacturer's recommendation and interval but not less than at least once every year.

(d) Lots. A lot must not consist of more than 1000 life preservers. A lot number must be assigned to each group of life preservers produced. Lots must be numbered serially. A new lot must be started whenever any change in materials or a revision to a production method is made, and whenever any substantial discontinuity in the production process occurs. The lot number assigned, along with the approval number, must enable the PFD manufacturer to determine the supplier's identifying information for the component lot.

(e) Samples. (1) From each lot of life preservers, manufacturers must randomly select a number of samples from completed units at least equal to the applicable number required by table 1 to § 160.055-15(e)(1) for buoyancy testing. Additional samples must be selected for any tests, examinations, and inspections required by the laboratory's production inspections and tests procedures.

Table 1 to § 160.055-15( e )(1)—Sampling for Buoyancy Tests

Lot size	Number of life preservers in sample
100 and under	1
101 to 200	2
201 to 300	3
301 to 500	4
501 to 750	6
751 to 1,000	8

(2) For a lot succeeding one from which any sample life preserver failed the buoyancy test, the sample must consist of not less than ten specimen life preservers to be tested for buoyancy in accordance with paragraph (f) of this section.

(f) Buoyancy test. The buoyancy of the life preservers must be determined by measuring the upward force exerted by the individual submerged unit. The buoyancy measurement must be made at the end of the 48 hours of submersion, during which period the pad inserts must not be disturbed.

(g) Buoyancy required. The buoyant pad inserts from Model 3 adult life preservers must provide not less than 25 pounds buoyancy in fresh water, and the pads from Model 5 child life preservers must provide not less than 16.5 pounds buoyancy.

(h) Lot inspection. On each lot, the laboratory inspector must perform a final lot inspection to be satisfied that the life preservers meet this subpart. Each lot must demonstrate—

(1) First quality workmanship;

(2) That the general arrangement and attachment of all components, such as body straps, closures, tie tapes, and drawstrings, are as specified in the approved plans and specifications;

(3) Compliance with the marking requirements; and

(4) The information pamphlet or placard specified in 33 CFR part 181 subpart G, if required, is securely attached to the device, with the PFD selection information visible and accessible prior to purchase.

(i) Lot acceptance. When the independent laboratory has determined that the life preservers in the lot are of a type officially approved in the name of the company, and that such life preservers meet the requirements of this subpart, they must be plainly marked in waterproof ink with the independent laboratory's name or identifying mark.

(j) Lot rejection. Each nonconforming unit must be rejected. If three or more nonconforming units are rejected for the same kind of defect, lot inspection must be discontinued and the lot rejected. The inspector must discontinue lot inspection and reject the lot if examination of individual units or the records for the lot shows noncompliance with either this subchapter or the laboratory's or the manufacturer's quality control procedures. A rejected unit or lot may be resubmitted for testing and inspection if the manufacturer first removes and destroys each defective unit or, if authorized by the laboratory, reworks the unit or lot to correct the defect. A rejected lot or rejected unit must not be sold or offered for sale under the representation that it meets this subpart or that it is Coast Guard approved.

37. Add § 160.055-19 to read as follows:

§ 160.055-19

Pamphlet or Placard.

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

38. Add § 160.055-23 to read as follows:

( print page 97392)

§ 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.

39. Add § 160.055-25 to read as follows:

§ 160.055-25

Suspension or termination of approval.

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

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

40. Revise § 160.060-1 to read as follows:

§ 160.060-1

Scope.

(a) This subpart contains requirements for production follow-up inspections for buoyant vests approved under this subpart prior to January 6, 2025.

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

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

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

(1) Standard:

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

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

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

(2) Nonstandard:

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

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

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

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

§ 160.060-2

[Removed and Reserved]

41. Remove and reserve § 160.060-2.

42. Revise § 160.060-3 to read as follows:

§ 160.060-3

Definitions.

The following definitions apply to this subpart:

Commandant means the Chief of the Lifesaving and Fire Safety Standards Division. Address: Commandant (CG-ENG-4), Attn: Lifesaving and Fire Safety Division, U.S. Coast Guard Stop 7509, 2703 Martin Luther King Jr. Avenue SE, Washington, DC 20593-7509; email [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 § 160.060-15 or any Coast Guard representative performing duties related to the approval.

Recognized laboratory means an independent laboratory accepted by the Commandant in accordance with 46 CFR subpart 159.010, with a valid memorandum of understanding in accordance with 46 CFR 159.010-7.

§ 160.060-3a

[Removed and Reserved]

43. Remove and reserve § 160.060-3a.

§ 160.060-4

[Removed and Reserved]

44. Remove and reserve § 160.060-4.

45. Revise § 160.060-5 to read as follows:

§ 160.060-5

Incorporation by reference.

Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by reference (IBR) material is available for inspection at the Coast Guard Headquarters and at the National Archives and Records Administration (NARA). Contact Commandant (CG-ENG-4), Attn: Lifesaving and Fire Safety Division, U.S. Coast Guard Stop 7509, 2703 Martin Luther King Jr. Avenue SE, Washington, DC 20593-7509. For information on the availability of this material at NARA, visit www.archives.gov/​federal-register/​cfr/​ibr-locations or email [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 Safety Factory Follow-Up on Personal Flotation Devices (PFDs), First Edition, June 4, 2020 (including revisions through September 9, 2021) (“ANSI/CAN/UL 9595”); IBR approved for § 160.060-15(h).

(b) [Reserved]

§§ 160.060-6 through 160.060-9

[Removed and Reserved]

46. Remove and reserve §§ 160.060-6 through 160.060-9.

47. Add § 160.060-11 to read as follows:

§ 160.060-11

Independent laboratory.

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

(b) The same laboratory that performs the approval tests must also perform production oversight unless the employees of the laboratory performing production oversight receive training and support equal to that of the laboratory that performed the approval testing, as determined by the Commandant.

48. Add § 160.060-15 to read as follows:

§ 160.060-15

Production inspections, tests, and quality control.

(a) General. Manufacturers of listed and labeled buoyant vests must—

(1) Maintain quality control of the materials used, the manufacturing methods, and the finished product to meet the applicable requirements of this subpart by conducting sufficient inspections and tests of representative samples and components produced;

(2) Make available to the recognized laboratory inspector or the Coast Guard inspector, upon request, records of tests conducted by the manufacturer and records of materials used during production of the device, including affidavits by suppliers; and

(3) Permit any examination, inspection, or test required by the recognized laboratory or the Coast Guard for a produced listed and labeled device, either at the place of manufacture or some other location.

(b) Lot size and sampling. (1) A lot must consist of 500 buoyant vests or fewer;

(2) A new lot begins after any change or modification in materials used or manufacturing methods employed;

(3) The manufacturer of the buoyant vests must notify the recognized laboratory when a lot is ready for inspection;

(4) The manufacturer must select samples in accordance with the ( print page 97393) 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