Rule2024-28264
Lifejacket Approval Harmonization
Primary source
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Published
December 6, 2024
Effective
January 6, 2025
Issuing agencies
Homeland Security DepartmentCoast Guard
Abstract
The Coast Guard amends the approval requirements and follow-up program requirements for lifejackets by incorporating new standards to replace existing legacy standards. The Coast Guard further amends lifejacket and personal flotation device (PFD) carriage requirements to allow for the use of equipment approved to the new standards and removes obsolete equipment approval requirements. The amendments streamline the process for the approval of PFDs and allow manufacturers the opportunity to produce innovative equipment that complies with standards in both Canada and the United States. Manufacturing firms also stand to benefit through a reduced production-inspections burden.
Full Text
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[Federal Register Volume 89, Number 235 (Friday, December 6, 2024)]
[Rules and Regulations]
[Pages 97356-97402]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-28264]
[[Page 97355]]
Vol. 89
Friday,
No. 235
December 6, 2024
Part III
Department of Homeland Security
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Coast Guard
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33 CFR Part 181
46 CFR Parts 25, 28, 108, et al.
Lifejacket Approval Harmonization; Final Rule
Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 /
Rules and Regulations
[[Page 97356]]
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DEPARTMENT OF HOMELAND SECURITY
Coast Guard
33 CFR Part 181
46 CFR Parts 25, 28, 108, 117, 133, 141, 160, 169, 180 and 199
[Docket No. USCG-2022-0120]
RIN 1625-AC62
Lifejacket Approval Harmonization
AGENCY: Coast Guard, DHS.
ACTION: Final rule.
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SUMMARY: The Coast Guard amends the approval requirements and follow-up
program requirements for lifejackets by incorporating new standards to
replace existing legacy standards. The Coast Guard further amends
lifejacket and personal flotation device (PFD) carriage requirements to
allow for the use of equipment approved to the new standards and
removes obsolete equipment approval requirements. The amendments
streamline the process for the approval of PFDs and allow manufacturers
the opportunity to produce innovative equipment that complies with
standards in both Canada and the United States. Manufacturing firms
also stand to benefit through a reduced production-inspections burden.
DATES:
Effective dates: This final rule is effective January 6, 2025. The
incorporation by reference of certain publications listed in the rule
is approved by the Director of the Federal Register as of January 6,
2025.
Compliance date: The Coast Guard will begin enforcing this rule on
June 4, 2025.
ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to <a href="http://www.regulations.gov">www.regulations.gov</a>, type USCG-2022-0120
in the search box and click ``Search.'' Next, in the Document Type
column, select ``Supporting & Related Material.''
FOR FURTHER INFORMATION CONTACT: For information about this document
call or email Jacqueline Yurkovich, Coast Guard; telephone 571-607-
4931, email <a href="/cdn-cgi/l/email-protection#8fc5eeecfefaeae3e6e1eaa1c2a1d6fafde4e0f9e6ece7cffafcece8a1e2e6e3"><span class="__cf_email__" data-cfemail="551f3436242030393c3b307b187b0c20273e3a233c363d15202636327b383c39">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Table of Contents for Preamble
I. Abbreviations
II. Background, Basis, and Purpose
III. Discussion of Comments
IV. Discussion of the Rule
V. Incorporation by Reference
VI. Regulatory Analyses
A. Regulatory Planning and Review
B. Small Entities
C. Assistance for Small Entities
D. Collection of Information
E. Federalism
F. Unfunded Mandates
G. Taking of Private Property
H. Civil Justice Reform
I. Protection of Children
J. Indian Tribal Governments
K. Energy Effects
L. Technical Standards
M. Environment
I. Abbreviations
ANSI American National Standards Institute
CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
FRFA Final Regulatory Flexibility Analysis
IBR Incorporation by reference
ISO International Organization for Standardization
NAICS North American Industry Classification System
NBSAC National Boating Safety Advisory Committee
NIH National Institutes of Health
NPRM Notice of proposed rulemaking
OMB Office of Management and Budget
PFD Personal flotation device
QMS Quality management system
RA Regulatory analysis
RFA Regulatory Flexibility Act
Sec. Section
SBA Small Business Administration
SME Subject matter expert
SOLAS International Convention for the Safety of Life at Sea
U.S.C. United States Code
II. Background, Basis, and Purpose
The Coast Guard has statutory authority under Title 46 of the
United States Code (U.S.C.), Sections 3306(a) and (b), 4102(b), 4302(a)
and (c), and 4502(a) and (c)(2)(B), to prescribe regulations for the
design, construction, performance, testing, carriage, use, and
inspection of lifesaving equipment on commercial and recreational
vessels. Under Department of Homeland Security (DHS) Delegation
00170.1, Revision No. 01.4, paragraph (II)(92)(b), the Secretary
delegated authority under these statutes to the Commandant of the Coast
Guard.
With this rulemaking, we are incorporating the American National
Standards Institute (ANSI) standards ANSI/CAN/UL 12402-5 for Level 50
and Level 70 personal flotation devices (PFDs), ANSI/CAN/UL 12402-4 for
Level 100 PFDs, and ANSI/CAN/UL 9595 for quality assurance. In
addition, we are incorporating the ANSI/UL 1123 and ANSI/UL 1175
standards for marine buoyant devices and inherently buoyant and
inflatable throwable PFDs, respectively. The Coast Guard currently
approves some inherently buoyant and inflatable throwable PFDs that
meet these standards because we have determined that a throwable PFD
meeting the requirements in ANSI/UL 1123 or ANSI/UL 1175 provides an
equivalent level of safety as a throwable PFD currently described in 46
CFR 160.064. Therefore, incorporating these standards in the Code of
Federal Regulations (CFR) will not result in any changes in practice
but will improve transparency.
We are also removing portions of title 46 in part 160 of the CFR,
where the new incorporated standards supersede the previous standards
or requirements. Additionally, we are adding amendments to lifesaving
equipment carriage requirements that permit the use of Level 50, Level
70, and Level 100 PFDs approved to the new standards.
The Coast Guard actively participates in the development of ANSI-
accredited industry consensus standards for lifesaving equipment. In
that capacity, the Coast Guard worked with Transport Canada and United
States and Canadian stakeholders in the development of the suite of
harmonized ANSI/CAN/UL standards to streamline the process for approval
of PFDs. Additionally, the harmonization allows manufacturers the
opportunity to produce more innovative equipment that meets approval
requirements in both Canada and the United States.
On September 22, 2014, the Coast Guard published a final rule in
the Federal Register titled Personal Flotation Devices Labeling and
Standards (79 FR 56491).\1\ That rule removed references to type codes
in its regulations on the carriage and labeling of Coast Guard approved
PFDs to facilitate the future incorporation by reference (IBR) of new
industry consensus standards. In April 2017, the Coast Guard and
Transport Canada signed a Memorandum of Understanding outlining an
intended cooperation for the approval of personal lifesaving appliances
that comply with mutually acceptable standards, are tested by mutually
accepted conformity assessment bodies or independent test laboratories,
and are covered by a mutually acceptable follow-up program.\2\
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\1\ <a href="https://www.federalregister.gov/documents/2014/09/22/2014-22373/personal-flotation-devices-labeling-and-standards">https://www.federalregister.gov/documents/2014/09/22/2014-22373/personal-flotation-devices-labeling-and-standards</a> (last
accessed November 15, 2024).
\2\ <a href="https://downloads.regulations.gov/USCG-2018-0565-0002/content.pdf">https://downloads.regulations.gov/USCG-2018-0565-0002/content.pdf</a> (last accessed November 15, 2024).
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On April 3, 2012, the Coast Guard published a final rule titled
Inflatable Personal Flotation Devices (77 FR 19937), incorporating by
reference updated revisions of industry consensus
[[Page 97357]]
standards for PFDs including UL 1180, ``UL Standard for Safety for
Fully Inflatable Recreational Personal Flotation Devices,'' Second
Edition (including revisions through December 3, 2010).\3\ The
discussion and response to comments in that rulemaking included a
discussion on inflatable PFDs for users less than 16 years of age. UL
1180 limits the approval of inflatable PFDs to persons of at least 16
years of age, and thus the 2012 final rule retained that age limit for
approved users of inflatable PFDs. No age limit was included in the
regulatory text to allow for a possible future rulemaking to
incorporate by reference a standard that sufficiently addresses the
needs of younger wearers.
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\3\ <a href="https://www.federalregister.gov/documents/2012/04/03/2012-7791/inflatable-personal-flotation-devices">https://www.federalregister.gov/documents/2012/04/03/2012-7791/inflatable-personal-flotation-devices</a> (last accessed November
15, 2024).
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On August 17, 2018, the Coast Guard published a notice in the
Federal Register (83 FR 41095) regarding a policy letter and
deregulatory savings analysis on accepting the standard ANSI/CAN/UL
12402-5 for Level 70 PFDs, not including inflatable PFDs for use by
persons less than 16 years old.\4\ On November 15, 2019, the Coast
Guard published a notice (84 FR 62546) that finalized this policy.\5\
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\4\ <a href="https://www.federalregister.gov/documents/2018/08/17/2018-17799/lifejacket-approval-harmonization">https://www.federalregister.gov/documents/2018/08/17/2018-17799/lifejacket-approval-harmonization</a>. (last accessed November 7,
2024).
\5\ <a href="https://www.federalregister.gov/documents/2019/11/15/2019-24836/lifejacket-approval-harmonization">https://www.federalregister.gov/documents/2019/11/15/2019-24836/lifejacket-approval-harmonization</a>. (last accessed November 7,
2024).
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III. Discussion of Comments
On April 7, 2023, the Coast Guard published a notice of proposed
rulemaking (NPRM) titled Lifejacket Approval Harmonization (88 FR
21016) requesting comments on the proposed changes implemented by this
final rule.\6\ In response to the NPRM, we received 390 written
submissions, nearly all of which were supportive of this rulemaking.
Several commenters observed that performance-based standards such as
those incorporated by this final rule allow manufacturers to design
more innovative, comfortable, and stylish personal flotation devices
and give manufacturers more flexibility when selecting materials,
design, and construction. Others commented that aligning standards with
Canada would promote consistency and enhance boating safety through
improved lifejacket usage. We appreciate these supportive comments.
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\6\ <a href="https://www.federalregister.gov/documents/2023/04/07/2023-06504/lifejacket-approval-harmonization">https://www.federalregister.gov/documents/2023/04/07/2023-06504/lifejacket-approval-harmonization</a>. (last accessed November 7,
2024).
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We received 370 comments as part of a write-in campaign. Of these
comments, 368 were identical or nearly identical in content and
supported the harmonization of lifejacket standards between the United
States and Canada. The commenters noted several benefits of
harmonization, including streamlined processes, reduced costs, and
enhanced cooperation between the United States and Canada.
Two commenters submitted comments that were nearly identical to the
content of the write-in comments but offered opposition or an
additional comment. One commenter used the supportive content of the
write-in letter but indicated he was writing against the proposed
changes. This commenter did not offer any reasoning for opposing the
changes and cited the same benefits of harmonization as the other
write-in commenters.
The other commenter wrote ``not in support'' of the rule, but also
used the full text of the write-in letter, including the referenced
benefits of harmonization. However, this commenter added a comment that
urged the Coast Guard to actively develop our own standard. The
standards were not developed solely by Canada, but also by the Coast
Guard, Transport Canada, and industry organizations from both countries
working in coordination. The Coast Guard actively participates in the
development of lifejacket standards, including the standards being
incorporated here.
One commenter suggested that if the new Level 50 devices do result
in increased lifejacket usage and thus more lives saved, then the Coast
Guard should consider mandating lifejacket wear in other circumstances.
We may consider this suggestion for a future rulemaking.
One commenter questioned why 33 CFR subchapters N and NN were
omitted from this rulemaking. These subchapters are out of scope for
this rulemaking. Lifejackets approved under approval series 160.255
will not satisfy the requirements of 33 CFR 142.45 or 149.316 at this
time. However, we thank the commenter and may consider updates to
subchapters N and NN in a future rulemaking.
One commenter questioned what this rule means for current PFD
devices, and specifically wondered if PFDs currently in use will need
to be replaced. As explained in this preamble, PFDs that satisfied
carriage requirements prior to publication of this final rule will
continue to do so. It is not necessary for owners and operators to
purchase new equipment if their current equipment is in good and
serviceable condition.
One commenter stated that PFDs should not be mandated by any
government. The Coast Guard considers PFDs critical lifesaving
equipment, for each person on each vessel. With this rulemaking, the
Coast Guard amends current carriage requirements to include new
approval series to allow owners, operators, and users the option of
using PFDs approved to newly incorporated standards. We have not
modified the requirement to carry PFDs; doing so would be outside the
scope of this rulemaking.
One commenter noted that several subsections of the proposed rule
reference 46 CFR 159.010, which in turn includes references to the
older International Organization for Standardization (ISO) standard
ISO/IEC 17025:2005 (covering accreditation of third party independent
laboratories), with ISO/IEC 17025:2017 being the most current standard.
The Coast Guard thanks the commenter for their thorough review, but
criteria for acceptance, recognition, and accreditation of third party
independent laboratories are outside the scope of this rulemaking
project. Therefore, we did not make changes in response to this
comment.
One commenter fully supported the rulemaking but suggested some
minor corrections. The commenter noted that Sec. 160.077 is referenced
in Sec. Sec. 199.620 and 169.539, but those sections do not include an
additional effective date requirement. We did not make changes in
response to this comment. The Coast Guard does not believe it is
necessary to include an effective date requirement in either of those
sections, since an effective date is only needed in sections mentioning
a commercial hybrid PFD. The commenter also noted that the definition
of inspector in 46 CFR 160.060-3 references Sec. 160.255-15, but
instead should reference Sec. 160.060-15. That was an error in the
NPRM which is corrected in this final rule. In addition to the
reference in Sec. 160.060-3 identified by the commenter, we discovered
similar errors in Sec. Sec. 160.055-3 and 160.064-3 and corrected the
reference in those sections.
One commenter stated that the changes proposed in the NPRM were
``great'' but sought clarification on the replacement of the two-word
term ``life jacket'' with the one-word term ``lifejacket'' and asked us
to use the two-word term rather than the proposed one-word term. The
commenter asserted that the two-word term has always been used in the
United States and suggested this clarification avoids the appearance
that this document is proposing that the United States needs to change
the way the term ``life jacket'' is spelled in so many other places. We
did not make changes based on this suggestion. The two-word term has
not always been
[[Page 97358]]
used in the United States. The Coast Guard, industry, stakeholders, and
user groups use the terms ``lifejacket'' and ``life jacket''
interchangeably. In the NPRM, the Coast Guard proposed to standardize
the term to the one-word variation and we are finalizing that proposal
here. We specifically selected the one-word term for use in our
regulations to align with the use of the one-word term in the ANSI/CAN/
UL 12402 standard, which is one of the standards incorporated by
reference. However, industry, stakeholders, and user groups can
continue to use the term ``life jacket'' if that is their preference.
One commenter fully supported the rule, specifically noting that
PFDs would become stylish, comfortable, and appealing to the boating
public, ultimately saving lives because they will wear them. The
commenter suggested that the Coast Guard should permit anyone over 13
years old to wear an inflatable PFD to fulfill the mandated PFD
carriage requirements. We agree with the commenter. The proposed rule
did not include an age restriction for inflatable PFDs, which is
finalized in this final rule.
One commenter noted that there seemed to be inconsistencies in the
proposed requirements for back-up chambers, specifically that back-up
chambers are required for lifejackets in 46 CFR 117.71 and 180.71 but
not elsewhere. Another commenter requested clarification on why back-up
chambers are required for lifejackets in 46 CFR 117.71, 180.71, and
199.620, but not 46 CFR 141.340.\7\ These differences are intentional.
Because the incorporated standard ANSI/CAN/UL 12402-4 does not require
back up chambers for inflatable Level 100 lifejackets, the proposed
rule included the additional requirement that inflatable Level 100
lifejackets must have a back-up chamber to meet carriage requirements
for passenger vessels, and this final rule retains that requirement.
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\7\ The commenter actually specified 46 CFR 141.349, a section
which does not exist. From context, we assume this was a
typographical error and the commenter actually meant 46 CFR 141.340.
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One commenter supported the amendments to Requirements for
Instruction Pamphlets for PFDs and suggested that the Coast Guard
engage the Technical Committee 1123 to develop a ``label standard'' to
address outstanding issues, such as the prospect that the placard would
not effectively replace the pamphlet for products with legacy labels.
The Coast Guard is fully engaged in UL Technical Committee 1123--
Personal Flotation Devices and would be open to the development of a
label standard in the future.
The Coast Guard notes the suggestion from another commenter to
include an icon on the lifejacket itself indicating Coast Guard
approval. While there is no Coast Guard icon required to be printed
directly on the device, the device must be marked with the words ``USCG
Approved'' followed by the unique approval number and must also be
marked with the laboratory's certification mark. Additionally, the
information placard at the point of sale clearly indicates with a check
mark if the device is Coast Guard approved.
IV. Discussion of the Rule
A. General Discussion
By means of this final rule, the Coast Guard makes seven main
amendments to our regulations:
(1) Adding new subpart 160.255, which incorporates by reference
ANSI/CAN/UL 12402-4 for approval of Level 100 PFDs, and removing
sections of subpart 160.055 related to materials and construction,
marking, and procedure for approval because no new approvals will be
granted under approval series 160.055;
(2) Adding new subparts 160.264 (Wearable Recreational PFDs) and
160.276 (Wearable Recreational Inflatable PFDs), both of which
incorporate by reference ANSI/CAN/UL 12402-5 for approval of Level 50
and Level 70 PFDs without additional buoyancy or age restrictions;
removing the sections of subparts 160.060, 160.064, and 160.076
pertaining to the approval of new wearable PFDs; relocating the
sections pertaining to throwable PFDs from subpart 160.064 to new
subpart 160.045 and incorporating by reference ANSI/UL 1123 and ANSI/UL
1175; and removing subpart 160.077 (Hybrid Inflatable PFDs) in its
entirety;
(3) Incorporating by reference ANSI/CAN/UL 9595 for quality
assurance requirements in subparts 160.045, 160.055, 160.060, 160.064,
160.076, 160.255, 160.264, and 160.276;
(4) Removing subparts 160.001, 160.002, 160.005, 160.006, 160.047,
160.048, and 160.052, as these subparts are mostly or entirely
obsolete, and moving the remaining relevant material from subpart
160.001 to subpart 160.055;
(5) Amending lifesaving equipment carriage requirements to include
the new approval categories, where appropriate, and removing any
remaining references to type codes;
(6) Amending the requirements for instruction pamphlets for PFDs to
also include the placard specified in part 181 subpart G in subparts
160.055, 160.060, 160.076, 160.255, 160.264, and 160.276, while
retaining the option of instruction pamphlets for lifejackets approved
under subparts 160.055, 160.060, 160.064, and 160.076; and
(7) Amending the existing regulatory text to make editorial
corrections and increase clarity.
We provide additional details and discussion on each of these seven
main categories of amendments below. Under 46 U.S.C. 4302(b), the
effective (implementation) date of provisions in this final rule
applying to recreational vessels must be at least 180 days after
publication. For simplicity, the implementation date of the entire rule
will be 180 days after the date of publication. While we have specified
an effective date 30 days after publication of this final rule, we have
also specified that we will not enforce these regulations until 180
days after publication in the DATES section above.
We consulted the National Boating Safety Advisory Committee (NBSAC)
regarding the updated standards in this rule, as shown by NBSAC
Resolutions 2009-83-01 \8\ and 2011-87-01,\9\ and the revalidation of
those resolutions found in Resolution 2022-03-01.\10\
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\8\ Available at <a href="https://homeport.uscg.mil/Lists/Content/Attachments/449/NBSAC%20Resolution%202009-83-01%20Changes%20to%20Approval%20Process%20for%20PFD_s.pdf">https://homeport.uscg.mil/Lists/Content/Attachments/449/NBSAC%20Resolution%202009-83-01%20Changes%20to%20Approval%20Process%20for%20PFD_s.pdf</a> (last
accessed November 12, 2024).
\9\ Available at <a href="https://homeport.uscg.mil/Lists/Content/Attachments/459/NBSAC%202011-87-01%20-%20Signed_2.pdf">https://homeport.uscg.mil/Lists/Content/Attachments/459/NBSAC%202011-87-01%20-%20Signed_2.pdf</a> (last accessed
November 12, 2024).
\10\ Available at <a href="https://homeport.uscg.mil/Lists/Content/Attachments/75876/Recommendation-2022-03-01--Signed.pdf">https://homeport.uscg.mil/Lists/Content/Attachments/75876/Recommendation-2022-03-01--Signed.pdf</a> (last
accessed November 12, 2024).
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1. Add New Subpart, 46 CFR 160.255, Incorporate by Reference ANSI/CAN/
UL 12402-4, and Remove Sections of Subpart 160.055
We are adding a new subpart, 160.255, to 46 CFR. PFDs approved
under this new subpart meet the carriage requirements for wearable PFDs
for three groups: (1) inspected vessels; (2) uninspected commercial
vessels over 40 feet (12m) in length; and (3) uninspected passenger
vessels.
New subpart 160.255 contains structural and performance
requirements for approval of Level 100 PFDs, as well as requirements
for production inspections and quality control, markings, information
pamphlets, and associated manuals. ANSI/CAN/UL 12402-4 is incorporated
by reference. PFDs approved under this subpart rely upon inherently
buoyant material, inflation, or a combination of
[[Page 97359]]
the two to achieve the minimum buoyancy.
A Level 100 PFD has the same basic requirements as a PFD meeting
current 46 CFR 160.055 (life preservers). The minimum amount of
buoyancy, basic mechanical properties, and in-water performance
requirements are the same. However, ANSI/CAN/UL 12402-4 is less
prescriptive regarding the design requirements of a Level 100 PFD, so
manufacturing firms can develop more innovative designs. The marking
requirements in ANSI/CAN/UL 12402-4 specify pictorial graphics to
communicate the performance of the PFD and warnings for use. The Coast
Guard conducted research and focus groups to identify issues with the
Type code labels and to evaluate multiple new pictorial labeling
options. Our research indicated that people consistently preferred
pictorial markings.\11\ Therefore, we expect this marking format to be
more easily understandable to both English-speaking and non-English-
speaking populations.
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\11\ ``Revision of Labeling and Classification for Personal
Flotation Devices (PFDs),'' Applied Safety & Ergonomics, Inc.,
December 28, 2004, Young et al.
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ANSI/CAN/UL 12402-4 does not require fully or partially inflatable
Level 100 PFDs to provide redundant back-up inflation chambers. Current
regulations require inflatable lifejackets under approval series
160.176 to have at least two inflation chambers \12\ and to reach
minimum in-water performance with any one chamber deflated.\13\ These
inflatable lifejackets meet the International Maritime Organization
Life-Saving Appliance Code and are intended for use on vessels subject
to SOLAS.
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\12\ 46 CFR 160.176-9(a)(1).
\13\ 46 CFR 160.176-13(j)(3).
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Back-up chambers were originally required for inflatable
lifejackets intended for use on inspected vessels as an additional
safety measure in case the primary inflation chamber failed to inflate
(see 54 FR 50316, 50322, Dec. 5, 1989). In the 1989 interim final rule
``Approval of Inflatable Lifejackets'' preamble, the Coast Guard noted
that we would continue discussions with industry, standards
organizations, and state boating law administrators regarding the
reliability of inflatable PFDs (54 FR 50317). We also indicated that
when new developments or innovations reduced the risk of inflation
failure to an acceptable level, we could address this issue with a
subsequent rulemaking. Since the publication of that rule in 1989, the
Coast Guard has no evidence that a well-maintained PFD with a single
inflation chamber is less reliable in the event of an emergency than an
inherently buoyant PFD. Additionally, the Coast Guard has approved
inflatable PFDs without back-up chambers under approval series 160.076.
Such devices have been in use in the United States on uninspected
commercial vessels less than 12 meters in length, and by recreational
vessels and in Canada on small vessels, for over a decade. Therefore,
the Coast Guard believes that the material testing of the PFD
components coupled with the required annual servicing of inflatable
Level 100 PFDs is sufficient, and that redundant back-up inflation
chambers are not necessary to provide an equivalent level of safety to
PFDs meeting current 46 CFR 160.055.
Because new subpart 160.255 supersedes the requirements for life
preservers in subpart 160.055, we are removing structural and
performance requirements for approval of life preservers in subpart
160.055, but maintaining the requirements for production inspections,
tests, and quality assurance. Manufacturers can continue to produce
life preservers currently approved under subpart 160.055, while all new
lifejackets will require Coast Guard approval under new subpart
160.255.
At the same time, we are restructuring subpart 160.055 to include a
statement of the subpart's scope and to mirror the structure of other
PFD-related subparts. We are adding sections for scope in Sec.
160.055-1 and definitions in Sec. 160.055-3, and standards
incorporated by reference are moved from Sec. 160.055-1 to Sec.
160.055-5. Because no new approvals are granted under Sec. 160.055, we
are removing existing requirements for materials and construction,
marking, and procedure for approval, including current 46 CFR 160.055-
3, 160.055-4, 160.055-5, 160.055-6, 160.055-8, and 160.055-9. We are
adding independent laboratory requirements in new Sec. 160.055-11. We
move sampling, tests, and inspections from Sec. 160.055-7 to newly
created Sec. 160.055-15 and include pamphlet requirements in new Sec.
160.055-19. We include procedures for the approval of design or
material changes in new Sec. 160.055-23 and information on suspension
or termination of approval in new Sec. 160.055-25.
2. Add New Subparts 46 CFR 160.045, 160.264, and 160.276, Incorporate
by Reference ANSI/CAN/UL 12402-5, ANSI/UL 1123, and ANSI/UL 1175,
Remove Sections of Subparts 160.060, 160.064, and 160.076, and Remove
Subpart 160.077 in Its Entirety
We are adding three new subparts in 46 CFR: 160.045, 160.264, and
160.276. PFDs approved under these subparts meet the carriage
requirements for recreational boats, in accordance with 33 CFR part
175. Wearable PFDs approved under subparts 160.264 and 160.276 also
meet the carriage requirements for uninspected commercial vessels less
than 40 feet (12m) in length and not carrying passengers for hire in
accordance with 46 CFR subpart 25.25.
New subpart 160.264 contains structural and performance
requirements for approval of Level 50 and Level 70 inherently buoyant
PFDs, as well as requirements for production inspections and quality
control, markings, information placards, and associated manuals. New
subpart 160.276 contains structural and performance requirements for
approval of Level 50 and Level 70 fully and partially inflatable
recreational PFDs, as well as requirements for production inspections
and quality control, associated manuals, information placards, and
markings. ANSI/CAN/UL 12402-5 is incorporated by reference in both
subparts.
ANSI/CAN/UL 12402-5 prescribes minimum performance requirements
instead of prescribing design requirements. This performance-based
standard allows manufacturing firms to design more innovative,
comfortable, and stylish PFDs. New PFD designs could lead to more
individuals choosing to wear their PFDs, resulting in fewer
drownings.\14\ Drowning is the leading cause of death in recreational
boating accidents, accounting for 79 percent of all recreational
boating casualties where the cause of death is known.\15\ Of those
[[Page 97360]]
who drowned, 86 percent were not wearing lifejackets. Wearing a
lifejacket is one of the best means available of preventing accidental
drowning in recreational boating. Unfortunately, recreational boaters
only wear lifejackets about 24 percent of the time.\16\
---------------------------------------------------------------------------
\14\ Readers should reference the National Center for
Biotechnology Information, which is part of the National Library of
Medicine at the National Institutes of Health (NIH), and perform a
literature search for articles on the topic of PFDs and their usage.
Readers can access this website at <a href="https://pubmed.ncbi.nlm.nih.gov">https://pubmed.ncbi.nlm.nih.gov</a>.
More specifically, readers should reference the following articles
for further information: ``Personal, social, and environmental
factors associated with lifejacket wear in adults and children: A
systematic literature review'' (<a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5931488">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5931488</a>) and ``Barriers to life jacket use among adult
recreational boaters.'' (<a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4310692">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4310692</a>) (last accessed April 23, 2024).
\15\ United States Coast Guard, ``2019 Recreational Boating
Statistics.'' <a href="https://safe.menlosecurity.com/doc/docview/viewer/docN0C8787B5BC27b941976de80db865a89b27e43db4732447826e405d5b93b8a0a1dd64625cf817">https://safe.menlosecurity.com/doc/docview/viewer/docN0C8787B5BC27b941976de80db865a89b27e43db4732447826e405d5b93b8a0a1dd64625cf817</a> (last accessed April 23, 2024).
\16\ United States Coast Guard, ``2019 Life Jacket Wear Rate
Observation Study.'' <a href="https://uscgboating.org/library/national-live-jacket-wear-study/2019-Life-Jacket-Wear-Rate-Report.pdf">https://uscgboating.org/library/national-live-jacket-wear-study/2019-Life-Jacket-Wear-Rate-Report.pdf</a> (last
accessed April 23, 2024).
---------------------------------------------------------------------------
Discomfort, whether real or perceived, is negatively associated
with PFD wear.\17\ ANSI/CAN/UL 12402-5 allows manufacturers more
flexibility when selecting materials, design, and construction of new
PFDs. Because manufacturers will be less limited in the materials,
design, and construction, we expect that new PFDs might be slimmer,
lighter in weight, or more comfortable to wear than PFDs approved under
the current requirements.
---------------------------------------------------------------------------
\17\ Amy Peden, Daniel Demant, Martin Hagger, and Kyra Hamilton,
``Personal, social, and environmental factors associated with
lifejacket wear in adults and children: A systematic literature
review.'' <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5931488/">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5931488/</a>
(last accessed April 23, 2024).
---------------------------------------------------------------------------
In our 2018 policy letter, CG-ENG Policy 02-18, titled Adoption of
ANSI/CAN/UL 12402-5 and 9,\18\ the Coast Guard determined that Level 70
inherently buoyant devices, Level 70 inflatable devices, and Level 70
multi-chamber devices that meet the requirements of ANSI/CAN/UL 12402-5
provide equivalent performance to wearable PFDs meeting the
requirements in current 46 CFR 160.064 or 160.076.\19\
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\18\ <a href="https://www.dco.uscg.mil/Portals/9/DCO%20Documents/5p/5ps/Design%20and%20Engineering%20Standards/Life%20Saving%20and%20Fire%20Safety/Docs/L%20A%20HARM%20POLICY%2020180801-Signed.pdf?ver=2018-08-01-131843-173">https://www.dco.uscg.mil/Portals/9/DCO%20Documents/5p/5ps/Design%20and%20Engineering%20Standards/Life%20Saving%20and%20Fire%20Safety/Docs/L%20A%20HARM%20POLICY%2020180801-Signed.pdf?ver=2018-08-01-131843-173</a> (last accessed April 23, 2024).
\19\ 83 FR 41095
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The Coast Guard has now determined that a Level 50 PFD, when worn
and used in accordance with the label, provides an equivalent level of
safety as a wearable PFD that meets current subpart 160.064 or 160.076
requirements. A Level 50 PFD has a lower minimum amount of buoyancy
than the current minimum requirement for Coast Guard approved PFDs.
However, ANSI/CAN/UL 12402-5 requires that a Level 50 PFD keep the
user's airway above the water, as demonstrated by in-water performance
testing. A Level 50 PFD is intended for use by those who can swim and
who have help or rescue nearby. As required in ANSI/CAN/UL 12402-5,
Level 50 PFDs must be marked: ``Not recommended for weak or non-
swimmers.'' Every PFD offered for sale must have a placard providing
users with information on how to select the appropriate PFD and
reminding users to try the PFD on in the water to ensure proper fit and
performance. To satisfy requirements of ANSI/CAN/UL 12402-5, Level 50
PFDs must be worn and must be marked: ``Approval conditions state that
this device must be worn to be counted as equipment required by vessels
meeting Transport Canada or USCG regulations.'' A Level 50 PFD, when
worn by a person who can swim and used in accordance with ANSI/CAN/UL
12402-5, provides an equivalent level of safety as a PFD meeting the
current requirements in 46 CFR 160.064 or 160.076. By approving Level
50 PFDs, the Coast Guard provides a critical level of oversight to the
currently unregulated Level 50 competition watersports PFDs, resulting
in safer products for the public.
In this final rule, we are not adding requirements that limit users
of inflatable PFDs based on age. There are already requirements in
ANSI/CAN/UL 12402-5 addressing inflatable PFDs for users less than 16
years of age. To be certified as meeting ANSI/CAN/UL 12402-5, an
inflatable PFD intended for wearers less than 16 years of age must
automatically inflate, must not require secondary donning, must be
worn, and must include a warning statement about adult supervision. The
Coast Guard believes these requirements are adequate to ensure safety
for wearers less than 16 years of age, so we are fully incorporating
ANSI/CAN/UL 12402-5 without any additional age restrictions beyond
those included in the standard.
New subparts 160.264 and 160.276 supersede the requirements for
foam buoyant vests in subpart 160.060, marine buoyancy devices in
subpart 160.064, inflatable recreational personal flotation devices in
subpart 160.076, and hybrid inflatable personal flotation devices in
subpart 160.077.
We are removing the structural and performance requirements for the
approval of foam buoyant vests, marine buoyant devices, and inflatable
recreational flotation devices in subparts 160.060, 160.064, and
160.076, respectively, but retaining the requirements for production
inspections, tests, and quality control of wearable PFDs. We are
deleting subpart 160.077 entirely and modifying the scope of subpart
160.076 to include PFDs previously approved under subpart 160.077. By
retaining the requirements for production inspections, tests, and
quality control, we ensure that manufacturing firms producing PFDs
currently approved under approval series 160.060, 160.064, 160.076, or
160.077 can continue to manufacture and sell these PFDs, but the Coast
Guard will not approve new products under these approval series. At the
same time, we are reformatting the remaining text of subparts 160.060,
160.064, and 160.076, without amending the language, to align with the
other subparts related to PFDs and increase the ease of understanding
for the reader.
To eliminate confusion over approval categories, we are relocating
the requirements for throwable PFDs from subpart 160.064 to new subpart
160.045. The new subpart 160.045 is dedicated to throwable PFDs
intended for carriage on recreational boats. We permit the use of
inflatable compartments to meet the minimum required buoyancy in Sec.
160.045-7. This new subpart incorporates by reference the ANSI/UL 1175
standard for inherently buoyant and inflatable throwable PFDs and the
ANSI/UL 1123 standard for marine buoyant devices. The Coast Guard
already approves throwable PFDs to these standards; we are formally
incorporating them by reference in this rulemaking to increase clarity
and transparency of the approval requirements.
3. Incorporate by Reference ANSI/CAN/UL 9595
We are incorporating by reference new industry consensus standard
ANSI/CAN/UL 9595, ``Standard for factory follow-up of Personal
Flotation Devices (PFDs)'' (First Edition, June 4, 2020), into subparts
160.045, 160.055, 160.060, 160.064, 160.076, 160.255, 160.264, and
160.276. This standard covers the basic elements of a production
inspection program for various types of PFDs.
The Coast Guard currently requires a satisfactory follow-up
(production testing and inspection) program administered by an
independent laboratory recognized by the Coast Guard for each approved
PFD. A task group of experts and stakeholders convened over the past
decade to develop ANSI/CAN/UL 9595 to improve the consistency of
follow-up programs among different recognized independent laboratories
and to provide a binational harmonized standard for production testing
acceptable to the Coast Guard and Transport Canada.
ANSI/CAN/UL 9595 establishes a set of Process Ratings (A, B, and C)
based on the quality management system (QMS) at each facility. Process
Rating A is reserved for facilities that have
[[Page 97361]]
demonstrated a superior QMS meeting ISO standard ISO 9001. Process
Rating B is assigned to facilities with a good QMS including a Quality
Manual that incorporates the requirements in ANSI/CAN/UL 9595 but is
not approved by a third party. Process Rating C provides a minimum
requirement for production inspections that is equivalent to current
industry practice for follow-up programs and meets the minimum
requirements currently accepted by the Commandant.
At Process Ratings A and B, ANSI/CAN/UL 9595 provides the option
for the manufacturer to implement a QMS to reduce the number of
inspections required. ANSI/CAN/UL 9595 lists roles and
responsibilities; required tests, sample sizes, and acceptability
criteria; and specific requirements for inspection frequency,
traceability of components, critical dimensions verification, visual
inspection of completed PFDs, and review of records. Annex A provides
test methods and Annex B provides information on the elements of a QMS.
We include ANSI/CAN/UL 9595 in the new subparts 160.045, 160.255,
160.264, and 160.276 and in existing subparts 160.055, 160.060,
160.064, and 160.076, to allow manufacturers that implement a QMS to be
evaluated as Process Rating A or B, resulting in fewer required
inspections. A QMS can result in greater production consistency, a
reduction in defects and errors, increased efficiency, and continuous
improvement.
4. Remove Obsolete Material and Relocate Pertinent Material
We are removing subparts 160.002, 160.005, 160.006, 160.047,
160.048, and 160.052, while also removing or relocating the entirety of
subpart 160.001. Subpart 160.001 provides general requirements for all
life preservers. Most of this information is either obsolete or found
elsewhere in the CFR. We are removing subpart 160.001, while preserving
the still-pertinent information on production oversight by relocating
it to Sec. 160.055-15.
Subpart 160.006 provides two paragraphs related to the repairing of
life preservers. Subpart 160.006 is no longer relevant and is not
referenced in any approval or carriage requirement; therefore, we are
removing it.
Subparts 160.002, 160.005, 160.047, and 160.048 provide
specifications and requirements for kapok and fibrous glass life
preservers. Subpart 160.052 provides specifications and requirements
for a unicellular plastic foam buoyant vest. Manufacturers no longer
produce any of these types of life preservers due to the unavailability
of material, the advancement of foam technology, and improvements to
the fit and function of PFDs industry-wide. With no current approvals
for equipment under any of these subparts, these approval categories
have become obsolete. Therefore, we are removing subparts 160.002,
160.005, 160.047, 160.048, and 160.052. All new PFD approvals will have
to meet the requirements in subparts 160.255, 160.264, and 160.276,
which incorporate current industry standards.
5. Amend Lifesaving Equipment Carriage Requirements
Where existing carriage requirements specify approval series for
PFDs, we are adding the new approval series, as applicable. The
affected subchapters are subchapter C (Uninspected Commercial Vessels),
subchapters K and T (Small Passenger Vessels), subchapter L (Offshore
Supply Vessels), subchapter M (Towing Vessels), and subchapter W
(Lifesaving Appliances for Certain Inspected Vessels). If we identify
other affected subchapters in the future, we could address them in a
future rulemaking or guidance document.
For example, according to the existing requirements under
subchapter C, an uninspected vessel carrying passengers for hire must
have at least one PFD approved under approval series 160.055, 160.155,
or 160.176 for each person on board (46 CFR 25.25-5). We are adding
approval series 160.255 to the list of approval series to permit the
use of PFDs approved under this new approval series. We are not
removing any of the currently accepted approval series from the
carriage requirements. Therefore, it will not be necessary for owners
and operators to purchase new equipment if their current equipment is
in good and serviceable condition.
We are also removing references to PFDs approved under approval
series 160.177 because there have never been any approvals granted
under that series. All new commercial PFDs, including commercial hybrid
PFDs, will be approved under approval series 160.255.
6. Amend the Requirements for Instruction Pamphlets for PFDs
We are amending the requirements for instruction pamphlets for PFDs
in 33 CFR 181 to allow both pamphlets and placards to meet the
requirements for information furnished with each PFD sold or offered
for sale for use on recreational boats. As previously described, we are
incorporating both ANSI/CAN/UL 12402-4 and ANSI/CAN/UL 12402-5 with
respect to the approval of PFDs. Both standards require that a PFD
include an informational placard in a pictographic format containing
specific information on PFD performance, selection, approval, and
maintenance, as well as general water safety information. To permit the
placard to be used in place of the currently required pamphlet, the
Coast Guard is adding the term ``placard'' to 33 CFR 181.702. We are
also removing 33 CFR 181.703, which requires that placards conform with
UL 1123, and adding text to 33 CFR 181.702 specifying that a pamphlet
or placard must meet the requirements in the applicable subpart of 46
CFR part 160 or be accepted by the Commandant. All currently approved
PFDs have pamphlets or placards that have been accepted by the
Commandant. Removing 33 CFR 181.703 eliminates all references to UL
1123 in this subpart, so we are removing 33 CFR 181.4, which
incorporates that standard, as well. Finally, we are removing the
separate requirements for hybrid and inflatable PFDs in 33 CFR 181.704
and 181.705, respectively, and including requirements for all PFDs in
33 CFR 181.702.
7. Amend the Existing Regulatory Text To Make Editorial Corrections and
Increase Clarity
We are updating the introductory IBR text, in accordance with
current practice, in 46 CFR 160.055, 160.060, 160.064, and 160.076. We
are amending Table 28.110 to replace ``Do'' (meaning ``ditto'') with
the actual text to clarify the requirements in plain language, and to
remove references to type codes from the table without modifying the
intent or application of the requirements. We are also removing
reference to approval series 160.177 in 46 CFR 108, 133 and 199 because
this approval series has never been used, and removing outdated
provisions allowing cork and balsa wood lifejackets until March 11,
1999, from 46 CFR 117 and 180. Finally, we are consistently using the
term ``lifejacket'' by amending instances of ``life jacket'' from two
words to one.
B. Standards Incorporated by Reference To Be Updated or Added
Following this paragraph, we include an alphabetical list of the
standards we are adding, each with a listing of the sections in which
they appear in 46 CFR. For each standard listed, we describe the topics
covered by the standard, the edition adopted, and a list of subparts or
sections that reference the standard.
<bullet> ANSI/CAN/UL 9595, Standard for Safety Factory Follow-Up on
Personal
[[Page 97362]]
Flotation Devices (PFDs), First Edition, June 4, 2020 (including
revisions through September 9, 2021). This standard is incorporated by
reference in Sec. Sec. 160.045-15, 160.055-15, 160.060-15, 160.064-15,
160.076-29, 160.255-15, 160.264-15, and 160.276-15. This binational
standard covers the basic elements of a production inspection program
for various types of PFDs, and formalizes and modifies current industry
standards.
<bullet> ANSI/CAN/UL 12402-4, Standard for Safety Personal
Flotation Devices--Part 4: Lifejackets, Performance Level 100--Safety
Requirements, First Edition, July 9, 2020. This standard is
incorporated by reference in Sec. Sec. 160.255-7, 160.255-13, 160.255-
17, 160.255-19, and 160.255-21. This binational standard specifies the
safety requirements for lifejackets that provide face-up flotation for
use in sheltered or calm water, where users may have to wait for
rescue. A lifejacket meeting the requirements of ANSI/CAN/UL 12402-4
provides an equivalent level of safety to a lifejacket currently
approved under current 46 CFR subpart 160.055.
<bullet> ANSI/CAN/UL 12402-5, Standard for Safety Personal
Flotation Devices--Part 5: Buoyancy Aids (Level 50)--Safety
Requirements, First Edition, December 31, 2015 (including revisions
through January 27, 2022). This standard is incorporated by reference
in Sec. Sec. 160.264-7, 160.264-13, 160.264-17, 160.264-19, 160.264-
21, 160.276-7, 160.276-13, 160.276-17, 160.276-19, and 160.276-21. This
binational standard specifies the safety requirements for buoyancy aids
used in sheltered waters with help and rescue nearby. A PFD meeting the
requirements of ANSI/CAN/UL 12402-5 provides an equivalent level of
safety as a PFD currently approved under 46 CFR 160.064 or 160.076.
<bullet> ANSI/UL 1123, Standard for Safety Marine Buoyant Devices,
Seventh Edition, October 1, 2008 (including revisions through November
23, 2020). This standard is incorporated by reference in Sec. Sec.
160.045-7 and 160.045-13. ANSI/UL 1123 provides requirements for Type
II, Type III, and Type IV marine buoyant devices, including vests,
jackets, horseshoe buoys and ring buoys, with or without lifelines,
intended for recreational use, and throwable cushions.
<bullet> ANSI/UL 1175, Standard for Safety Buoyant Cushions, Fourth
Edition, April 20, 2007 (including revisions through January 10, 2020).
This standard is incorporated by reference in Sec. Sec. 160.045-7 and
160.045-13. This standard provides requirements for throwable PFDs
using inherent or inflatable buoyancy that are intended to be used in
accordance with applicable Coast Guard regulations.
C. Standards Incorporated by Reference To Be Removed
Following this paragraph, we include an alphabetical list of the
standards we are removing as a result of this final rule. These
standards are being removed because the regulatory text applying to
these standards has been removed, and the newly incorporated standards
supersede and replace these standards.
<bullet> ASTM B117-97, Standard Practice for Operating Salt Spray
(Fog) Apparatus.
<bullet> ASTM D413-82, Standard Test Methods for Rubber Property--
Adhesion to Flexible Substrate.
<bullet> ASTM D570-95, Standard Test Method for Water Absorption of
Plastics.
<bullet> ASTM D751-95, Standard Test Method for Coated Fabrics.
<bullet> ASTM D882-97, Standard Test Method for Tensile Properties
of Thin Plastic Sheeting.
<bullet> ASTM D1004-94a, Standard Test Method for Initial Tear
Resistance of Plastic Film and Sheeting.
<bullet> ASTM D1434-82 (Reapproved 2009), Standard Test Method for
Determining Gas Permeability Characteristics of Plastic Film and
Sheeting.
<bullet> CCC-C-426D, Cloth, Cotton Drill.
<bullet> CCC-C-700G, Cloth, Coated, Vinal, Coated (Artificial
Leather).
<bullet> Color Names Dictionary, ``The Universal Color Language''
and ``The Color Names Dictionary'' in Color: Universal Language and
Dictionary of Names, National Institute of Standards Special
Publication 440.
<bullet> Federal Standard No. 595A, Color.
<bullet> Federal Standards No. 751 and 751A, Stitches, Seams, and
Stitchings.
<bullet> Federal Test Method Standard No. 191, Textile Test
Methods, including:
[cir] Method 5100, Strength and Elongation, Breaking of Woven
Cloth; Grab Method;
[cir] Method 5132, Strength of Cloth, Tearing; Falling-Pendulum
Method;
[cir] Method 5134, Strength of Cloth, Tearing; Tongue Method;
[cir] Method 5804.1, Weathering Resistance of Cloth; Accelerated
Weathering Method; and
[cir] Method 5762, Mildew Resistance of Textile Materials; Soil
Burial Method.
<bullet> L-P-375 and L-P-375C, Plastic Film, Flexible, Vinyl
Chloride.
<bullet> MIL-C-43006D, Cloth and Strip Laminated, Vinyl-Nylon High
Strength, Flexible.
<bullet> MIL-L-24611(SH), Life Preserver Support Package for Life
Preserver, MK 4.
<bullet> MIL-B-2766 and MIL-R-2766B, Batt, Fibrous Glass,
Lifesaving Equipment.
<bullet> MIL-T-3530E, Thread and Twine; Mildew Resistant or Water
Repellant Treated.
<bullet> MIL-W-530 and MIL-W-530F, Webbing, Textiles, Cotton,
General Purpose, Natural and in Colors.
<bullet> MIL-W-17337D, Webbing, Woven, Nylon.
<bullet> UL 1123, UL Standard for Safety for Marine Buoyant
Devices.
<bullet> UL 1180, UL Standard for Safety for Fully Inflatable
Recreational Personal Flotation Devices.
<bullet> UL 1191, Components for Personal Flotation Devices.
<bullet> UL 1517, Standard for Hybrid Personal Flotation Devices.
D. Changes to the Regulatory Text From the NPRM
As discussed in Section III of this preamble, Discussion of
Comments, we corrected three errors in cross-references that were the
result of typographical errors in the NPRM. We updated the definition
for inspector in 46 CFR 160.055-3 to now cross-reference Sec. 160.055-
15 rather than Sec. 160.255-15; in Sec. 160.060-3 to now cross-
reference Sec. 160.060-15 rather than Sec. 160.255-15; and in Sec.
160.064-3 to now cross-reference Sec. 160.064-15 rather than Sec.
160.264-15. We also corrected the definition for inspector in 46 CFR
160.276-15 to cross-reference Sec. 160.276-15 rather than ``part 15 of
this guideline.''
In Sec. 160.076-1 (``Scope''), we added a paragraph, (c), to help
explain and clarify the applicability of subpart 160.076. We also added
additional amendatory instructions that were inadvertently missed in
the NPRM. These include removing Sec. 160.076-3 and redesignating
Sec. 160.076-3 as Sec. 160.076-5, redesignating Sec. 160.076-11 as
Sec. 160.076-5, and revising the newly redesignated Sec. 160.076-5.
There are no other changes to the regulatory text from the NPRM.
V. Incorporation by Reference
Material for incorporation by reference appears in 46 CFR 160.045-
5, 160.055-5, 160.060-5, 160.064-5, 160.076-5, 160.255-5, 160.264-5,
and 160.276-5 and is summarized in section IV.B of this preamble,
Standards Incorporated by Reference to be Updated or Added. Copies of
the material are available either at the publisher's web address listed
in the incorporation by reference sections in 46 CFR 160.045-5,
160.055-5, 160.060-5, 160.064-5, 160.076-5, 160.255-5, 160.264-5, and
160.276-5, or by
[[Page 97363]]
contacting the publisher listed for those standards. We reviewed and
updated all the publisher's web addresses listed in the parts to ensure
they are current. You may also contact the person in the FOR FURTHER
INFORMATION CONTACT section for additional direction on how to obtain
access to electronic copies of the materials.
We believe industry already has access to and uses these new
standards. The affected industry, in particular recognized independent
laboratories, typically obtains the most recent editions of standards
in the course of their business to address advancements in technology.
The Director of the Federal Register approved the material in 46
CFR 160.045-5, 160.055-5, 160.060-5, 160.064-5, 160.076-5, 160.255-5,
160.264-5, and 160.276-5 for incorporation by reference under 5 U.S.C.
552 and 1 CFR part 51.
VI. Regulatory Analyses
We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. We have prepared a full
regulatory analysis (RA) based on these statutes and Executive orders
and have placed it in the docket where indicated under the ADDRESSES
portion of the preamble. A summary of our analysis follows. Where we
mention the analysis in the RA, we are referring the reader to the RA
in the docket.
A. Regulatory Planning and Review
Executive Order 12866 (Regulatory Planning and Review), as amended
by Executive Order 14094 (Modernizing Regulatory Review), and Executive
Order 13563 (Improving Regulation and Regulatory Review) direct
agencies to assess the costs and benefits of available regulatory
alternatives and, if regulation is necessary, to select regulatory
approaches that maximize net benefits (including potential economic,
environmental, public health and safety effects, distributive impacts,
and equity). Executive Order 13563 emphasizes the importance of
quantifying both costs and benefits, of reducing costs, of harmonizing
rules, and of promoting flexibility.
Two additional Executive orders promote the goals of Executive
Order 13563: Executive Order 13609 (Promoting International Regulatory
Cooperation) and Executive Order 13610 (Identifying and Reducing
Regulatory Burdens). Executive Order 13609 targets international
regulatory cooperation to reduce, eliminate, or prevent unnecessary
differences in regulatory requirements. Executive Order 13610 aims to
modernize the regulatory systems and to reduce unjustified regulatory
burdens and costs on the public.
The Office of Management and Budget (OMB) has not designated this
rule a significant regulatory action under section 3(f) of Executive
Order 12866, as amended by Executive Order 14094 (Modernizing
Regulatory Review). A summary of the RA follows; see the docket for our
full analysis.
Table 1--Summary of Impacts of the Final Rule
------------------------------------------------------------------------
------------------------------------------------------------------------
Category Summary
------------------------------------------------------------------------
Applicability................... IBR of ANSI/CAN/UL 9595, ANSI/CAN/UL
12402-5, and ANSI/CAN/UL 12402-4.
---------------------------------------
Affected Population............. 2 recognized independent laboratories
(1 U.S. and 1 foreign), 61 PFD
manufacturing firms (39 U.S. and 22
foreign), the Coast Guard,
recreational vessel operators, and
commercial vessel operators.
------------------------------------------------------------------------
Costs to American Firms ($2023, 10-year........... $1,865,564
2% discount rate).
Annualized........ 207,687
Costs to Foreign Firms ($2023, 10-year........... 455,782
2% discount rate).
Annualized........ 50,741
Total Costs ($2023, 2% discount 10-year........... 2,321,343
rate).
Annualized........ 258,427
Benefits to American Firms 10-year........... 8,871,985
($2023, 2% discount rate).
Annualized........ 987,687
Benefits to Foreign Firms 10-year........... 2,222,303
($2023, 2% discount rate).
Annualized........ 247,401
Benefits to the United States 10-year........... 38,895
Government ($2023, 2% discount
rate).
Annualized........ 4,330
Total Benefits to All Entities 10-year........... 11,133,183
($2023, 2% discount rate).
Annualized........ 1,239,419
Net Benefits to American Firms 10-year........... 7,006,423
($2023, 2% discount rate).
Annualized........ 780,001
Net Benefits to Foreign Firms 10-year........... 1,766,522
($2023, 2% discount rate).
Annualized........ 196,661
Net Benefits to the United 10-year........... 38,895
States Government ($2023, 2%
discount rate).
Annualized........ 4,330
Net Benefits to All Entities 10-year........... 8,811,839
($2023, 2% discount rate).
Annualized........ 980,991
---------------------------------------
Unquantified Benefits........... The newer performance-based standards
will allow for the development of
more innovative PFD designs that
might better meet boaters' needs. New
PFD designs that may be more form
fitting, in addition to the
requirement that Level 50 devices be
worn to count for carriage, could
lead to higher PFD wear rates and
additional lives saved from drowning.
Placards are cheaper to produce than
pamphlets and provide pictorial
instructions, understandable by non-
English reading populations.
------------------------------------------------------------------------
[[Page 97364]]
By means of this final rule, the Coast Guard harmonizes its
approval process for PFDs with that of Canada, resulting in cost
savings from eliminating a second set of approval requirements for PFD
manufacturers wishing to sell in both Canada and the United States and
reducing the required amount of product inspections depending on the
quality management system in place at a given manufacturing facility.
This rule removes barriers to entry for future innovative personal
flotation devices and will save manufacturers money from reducing
regulatory burdens without sacrificing quality. On net, the Coast Guard
projects that manufacturers and the Coast Guard will save over
$1,000,000 annually on reduced production inspections.
Additionally, the Coast Guard expects that the introduction of
Level 50 devices, coupled with the requirement to wear them if they are
to count for the purposes of PFD carriage requirements, will lead to an
unquantifiable increase in PFD wear rates among recreational boaters,
and thereby potentially decrease the rate of drowning in the event of
an accident. Only Coast Guard approved devices are eligible to count
for PFD carriage requirements, and, for Level 50 devices to count, they
must be worn. The Coast Guard therefore expects that recreational
boaters purchasing Level 50 PFDs for the purposes of carriage are more
likely to wear them. Drowning is the leading cause of death in
recreational boating accident and a study of drowning incidents found
that, 86 percent of the time, individuals who drowned were not wearing
a PFD.\20\ Absent these regulations, Level 50 devices cannot be sold as
Coast Guard approved devices, and the expected increase in PFD wear
rates among recreational boaters will not materialize.
---------------------------------------------------------------------------
\20\ United States Coast Guard. ``2019 Recreational Boating
Statistics.'' <a href="https://uscgboating.org/library/accident-statistics/Recreational-Boating-Statistics-2019.pdf">https://uscgboating.org/library/accident-statistics/Recreational-Boating-Statistics-2019.pdf</a> (last accessed April 22,
2024).
---------------------------------------------------------------------------
The final rule introduces harmonized performance standards instead
of design standards for PFDs. It amends PFD approval and follow-up
program requirements by incorporating three new binational standards
into regulations, amending PFD carriage requirements to allow for the
use of equipment approved to the new standards, and removing obsolete
equipment approval requirements. The performance-based standards are
more current and intended to replace the legacy design standards. The
amendments allow manufacturers to produce more innovative equipment
that meets the approval requirements of Canada and the United States
and reduce the burden for manufacturers in the approval process and
follow-up program.
Specifically, the Coast Guard incorporates by reference the
following binational industry consensus standards:
(1) ANSI/CAN/UL 12402-4. This binational standard specifies the
safety requirements for lifejackets that provide face-up flotation for
use in sheltered or calm water, where users may have to wait for
rescue. A lifejacket meeting the requirements of ANSI/CAN/UL 12402-4
provides an equivalent level of safety to a lifejacket currently
approved under 46 CFR subpart 160.055.
(2) ANSI/CAN/UL 12402-5. This binational standard specifies the
safety requirements for buoyancy aids used in sheltered waters with
help and rescue nearby. A PFD meeting the requirements of ANSI/CAN/UL
12402-5 provides an equivalent level of safety as a PFD currently
approved under 46 CFR 160.064 or 160.076.
(3) ANSI/CAN/UL 9595. This binational standard covers the basic
elements of a production inspection program for various types of PFDs
and formalizes and modifies current industry standards.
Additionally, the Coast Guard incorporates two national standards
(ANSI/UL 1123 and ANSI/UL 1175) and amends numerous CFR parts to remove
obsolete PFD design standards and update carriage requirements to
include PFDs approved to the new subparts. As mentioned earlier, ANSI/
UL 1123 and ANSI/UL 1175 are both currently in use as a matter of
policy and are being incorporated by reference for the sake of clarity.
We do not estimate any costs or benefits from their incorporation by
reference into the CFR. Similarly, we do not anticipate any
quantifiable costs or benefits from the removal of obsolete design
standards, as these design standards are not currently in use.
In moving from the NPRM to this final rule, we made the following
changes to the RA and small entities section:
(1) Updated wage figures to use the most recently available data.
(2) Updated deflators and costs to 2023.
(3) Added a Final Regulatory Flexibility Act Analysis (FRFA).
(4) Updated the affected population numbers based on more recent
data.
(5) Included descriptions of public comments that supported
assumptions we made in the NPRM. As noted above, public comments
overwhelmingly supported this rule. Some of those comments supported
assumptions we made in the NPRM. We did not receive any comments that
disagreed with our assumptions or offered new information that would
require changes to the analysis.
Affected Population
To determine the affected population of the rule, it is first
necessary to describe the economic impacts from this final rule. The
economic impacts stem from the following four provisions:
(1) The IBR of ANSI/CAN/UL 12402-4 in 46 CFR 160.255 to replace the
design requirements in 46 CFR 160.055;
(2) The IBR of ANSI/CAN/UL 12402-5 in 46 CFR 160.264 and 160.276 to
replace the design standards in 46 CFR 160.064, 160.076, and 160.077;
(3) The IBR of ANSI/CAN/UL 9595 for follow-up service into the PFD
approval requirements of existing subparts 46 CFR 160.055, 160.060,
160.064, 160.076 and new subparts of 46 CFR 160.045, 160.255, 160.264,
and 160.276; and
(4) The edits to 33 CFR 181 subpart G, which permit manufacturers
of all PFDs to provide placards instead of information pamphlets.
These four provisions affect PFD manufacturers, the two recognized
independent laboratories, and the Coast Guard. Before we present the
affected population for each of these provisions, we present the
overall PFD manufacturing firm population.
As of 2023, there are over 800 models of PFDs approved by the Coast
Guard, manufactured by 61 separate manufacturing firms worldwide.\21\
Based on a review of publicly available information across the 61
manufacturing firms, the Coast Guard estimates that 39 are U.S. firms
and 22 are foreign firms. Market share and production volumes are not
equal across the firms.\22\
---------------------------------------------------------------------------
\21\ The Coast Guard lists all approved products on the Coast
Guard Maritime Information Exchange website, <a href="https://cgmix.uscg.mil/">https://cgmix.uscg.mil/</a>
. Last accessed April 25, 2024.
\22\ We used the headquarters location of a firm's parent
company, as indicated on the company website, to determine whether a
firm was U.S. or foreign.
[[Page 97365]]
Table 2--Distribution of Market Share of PFD Manufacturers
----------------------------------------------------------------------------------------------------------------
U.S. firm Foreign firm
Manufacturing firms Total market market share market share
share (%) (%) (%)
----------------------------------------------------------------------------------------------------------------
Top 5 Manufacturing Firms....................................... 75 65.00 10.00
Manufacturing Firms 6-13........................................ 20 12.50 7.50
All Other Manufacturing Firms................................... 5 3.125 1.875
-----------------------------------------------
Total....................................................... 100 80.625 19.375
----------------------------------------------------------------------------------------------------------------
The first provision, the IBR of ANSI/CAN/UL 12402-4, affects three
populations:
(1) PFD manufacturers that seek approval to manufacture devices
meeting the requirements of ANSI/CAN/UL 12402-4;
(2) The two recognized independent laboratories that review and
certify these devices; and
(3) The Coast Guard, which corresponds with the recognized
independent laboratories and manufacturers on device approval.
In table 3, we list the number of PFD manufacturing firms that are
affected by ANSI/CAN/UL 12402-4. We estimate that each of the top 13
firms that produce ANSI/CAN/UL 12402-4 devices or components of those
devices at 2 facilities each and firms outside of the top 13 firms that
produce ANSI/CAN/UL 12402-4 devices at 1 facility each.\23\
---------------------------------------------------------------------------
\23\ The PFD manufacturing firm does not necessarily own the
facilities where its products are produced. Instead, the facility
may be producing PFDs on contract for the PFD manufacturing firm.
Additionally, much production for U.S. firms occurs at overseas
facilities. We call these ``U.S. Associated Facilities'' not because
they are in the United States but because they have a longstanding
relationship with U.S. firms, while ``Foreign Facilities'' have
longstanding relationships with foreign firms.
Table 3--Manufacturing Firms and Facilities Impacted by ANSI/CAN/UL 12402-4
----------------------------------------------------------------------------------------------------------------
U.S.
Firm ownership U.S. firms Foreign firms associated Foreign Total
facilities facilities facilities
----------------------------------------------------------------------------------------------------------------
Firms in top 13................. 5 3 10 6 16
All other firms................. 4 2 4 2 6
-------------------------------------------------------------------------------
Total facilities............ 9 5 14 8 22
----------------------------------------------------------------------------------------------------------------
In the second provision, by incorporating by reference ANSI/CAN/UL
12402-5, the Coast Guard introduces new categories for youth
inflatables and Level 50 PFDs for approval. Permitting youth
inflatables and Level 50 devices affects three populations:
(1) PFD manufacturers that seek Coast Guard approval to produce
youth inflatables or Level 50 devices;
(2) The two recognized independent laboratories that review and
certify youth inflatables and Level 50 devices; and
(3) The boating public that purchases youth inflatables or Level 50
devices instead of Level 70 or Type III devices, because youth
inflatables and Level 50 devices are likely to be more form-fitting
than Level 70 or Type III devices.
In the third provision, the Coast Guard intends to incorporate by
reference ANSI/CAN/UL 9595, covering production inspections and
inspection frequency, into multiple new and existing subparts in 46
CFR, as listed in table 4.
Table 4--PFDs Impacted by ANSI/CAN/UL 9595
------------------------------------------------------------------------
New or existing
Subpart PFD type subpart
------------------------------------------------------------------------
160.045....................... Throwable PFDs....... New.
160.255....................... Level 100 PFDs....... New.
160.264....................... Inherently Buoyant New.
Level 50 and Level
70 PFDs.
160.276....................... Inflatable Level 50 New.
and Level 70 PFDs.
160.055....................... Life Preservers...... Existing.
160.060....................... Buoyant Vests........ Existing.
160.064....................... Marine Buoyant Existing.
Devices.
160.076....................... Inflatable PFDs...... Existing.
------------------------------------------------------------------------
ANSI/CAN/UL 9595 establishes a set of Process Ratings (A, B, and C)
based on the QMS at each facility. Process Rating A is reserved for
facilities that have demonstrated a superior QMS. Process Rating B is
assigned to facilities with a good QMS. Process Rating C is assigned to
facilities with a minimally compliant QMS. The requirements for Process
Rating C are equivalent to the current minimum requirements. Because
Process Rating C is equivalent to current industry practice, the
affected population for the IBR of ANSI/CAN/UL 9595 are any PFD
manufacturer
[[Page 97366]]
producing a device approved under one of the subparts listed in table 4
and eligible to gain a Process Rating of A or B.
In table 5, we estimate the market share likely to be at Process
Rating A, B, or C and whether they are foreign or domestic firms.\24\
Because a QMS system is expensive to set up, industry stakeholders
informed the Coast Guard that firms are not expected to develop a QMS
solely to secure the cost savings of ANSI/CAN/UL 9595. However, a
number of firms have already established QMS systems at their
facilities because of other benefits, such as production consistency
and quality control. The firms that have already established a QMS
system will experience net cost savings from the IBR of ANSI/CAN/UL
9595. As a result, we estimated the process rating distribution
recorded in table 5.
---------------------------------------------------------------------------
\24\ The process rating applies to a facility owned by a PFD
manufacturing firm. The lowest process rating is C; if manufacturers
seek a higher process rating of A or B, then an independent
laboratory must certify that each facility owned by a manufacturing
firm meets the standard of the higher rating, which is determined
through an audit of a facility. A PFD manufacturing firm incurs the
cost of a higher process rating at each facility. A PFD
manufacturing firm who currently has a QMS (at least partially in
place) will be able to seek a higher process rating, A or B, for
each facility it owns (process rating C is the current baseline or
default rating and represents the current inspection volume at
facilities). A separate QMS inspection or audit is necessary for
this to occur. A higher process rating will result in a reduction in
the inspection volume at facilities, which will save PFD
manufacturing firms money.
Table 5--Market Share of Production Likely To Be at Each Process Rating
------------------------------------------------------------------------
Market share
Firm category Process rating (%)
------------------------------------------------------------------------
U.S. Firms.................. A......................... 26.5
Foreign Firms............... A......................... 15.0
U.S. Firms.................. B......................... 51.0
Foreign Firms............... B......................... 2.5
U.S. and Foreign Firms...... C......................... 5.0
-------------------------------------------
Total................... .......................... 100.0
------------------------------------------------------------------------
The fourth provision, permitting the option for placards to replace
instruction pamphlets, affects all firms manufacturing PFDs approved to
any of the categories in table 6 that list placards as permitted under
the final rule.
Table 6--Device Category and Permitted Instruction Types
------------------------------------------------------------------------
Types of
instructions Types of
Device category allowed by the instructions
final rule currently in use
------------------------------------------------------------------------
New Level 50 Devices (ANSI/CAN/ Placard........... N/A because these
UL 12402-5). devices are not
yet produced.
New Level 70 Devices (ANSI/CAN/ Placard........... Placard.
UL 12402-5).
New Level 100 Devices (ANSI/CAN/ Placard........... N/A because these
UL 12402-4). devices are not
yet produced.
Existing Type I Commercial Placard or Information
Devices. Information Pamphlet.
Pamphlet.
Existing Type II Recreational Placard or Information
Devices. Information Pamphlet.
Pamphlet.
Existing Type III Recreational Placard or Information
Devices. Information Pamphlet.
Pamphlet.
Existing Type IV Throwable Information Information
Devices. Pamphlet. Pamphlet.
------------------------------------------------------------------------
Costs and Cost Savings of the Four Provisions of This Rule
1. ANSI/CAN/UL 12402-4
Costs
There are two sources of costs from this provision: (1) independent
laboratories will need to train their staff to these new standards and
(2) manufacturing firms that intend to sell in only one market (the
United States or Canada) will experience additional costs due to an
increase in the cost of testing according to ANSI/CAN/UL 12402-4 when
compared to the cost of testing to the legacy standards.\25\
---------------------------------------------------------------------------
\25\ We estimate the increase in the cost of testing based upon
data provided by representatives of independent laboratories.
---------------------------------------------------------------------------
We provide our estimate for the total costs of the IBR of ANSI/CAN/
UL 12402-4 to U.S. firms in table 7. These costs include $29,500 paid
by independent laboratories in the first year to develop the
instructions and manuals on how to conduct the new ANSI/CAN/UL 12402-4
testing and the estimated $1,659 per year manufacturers will spend on
the more expensive ANSI/CAN/UL 12402-4 certification as opposed to the
legacy certification.\26\
---------------------------------------------------------------------------
\26\ We estimate the cost of Level 100 testing and approval to
be about $52,250 and we estimate the cost for the new Type I
approval to be about $47,200. The Coast Guard estimates 0.45 new
approvals annually for products intended for sale exclusively in the
United States. Therefore, the total additional cost to manufacturers
for the more expensive Level 100 certification will be about $2,273.
There are currently 51 products approved as Type I devices under 46
CFR part 160.055, of which 37 (73 percent) are produced by U.S. PFD
firms and 14 (27 percent) are produced by foreign PFD firms.
Therefore, we estimate the cost to U.S. PFD firms for the new UL
12402-4 approval will be about $1,659 annually. We estimate the cost
to foreign PFD firms will be about $614 annually.
[[Page 97367]]
Table 7--Estimated Costs to U.S. Firms for Level 100 Devices Under
Standard ANSI/CAN/UL 12402-4
[2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
Discounted
Total costs
Year undiscounted ---------------
costs 2%
------------------------------------------------------------------------
1....................................... $31,159 $30,548
2....................................... 1,659 1,595
3....................................... 1,659 1,563
4....................................... 1,659 1,533
5....................................... 1,659 1,503
6....................................... 1,659 1,473
7....................................... 1,659 1,444
8....................................... 1,659 1,416
9....................................... 1,659 1,388
10...................................... 1,659 1,361
-------------------------------
Total............................... 46,090 43,824
-------------------------------
Annualized.......................... .............. 4,879
------------------------------------------------------------------------
We present the 10-year total costs to foreign firms from the IBR of
ANSI/CAN/UL 12402-4 in table 8. Foreign firms will experience
additional approval costs of $614 per year.
Table 8--Estimated Costs to Foreign Firms for Level 100 Devices Under
Standard ANSI/CAN/UL 12402-4
[2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
Discounted
Total costs
Year undiscounted ---------------
costs 2%
------------------------------------------------------------------------
1....................................... $614 $602
2....................................... 614 590
3....................................... 614 579
4....................................... 614 567
5....................................... 614 556
6....................................... 614 545
7....................................... 614 535
8....................................... 614 524
9....................................... 614 514
10...................................... 614 504
-------------------------------
Total............................... 6,140 5,515
-------------------------------
Annualized.......................... .............. 614
------------------------------------------------------------------------
We present the 10-year total costs to U.S. and foreign firms from
the IBR of ANSI/CAN/UL 12402-4 in table 9.
Table 9--Estimated Total Cost to All Firms for Level 100 Devices Under
Standard ANSI/CAN/UL 12402-4
[2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
Discounted
Total costs
Year undiscounted ---------------
costs 2%
------------------------------------------------------------------------
1....................................... $31,773 $31,150
2....................................... 2,273 2,185
3....................................... 2,273 2,142
4....................................... 2,273 2,100
5....................................... 2,273 2,059
6....................................... 2,273 2,018
7....................................... 2,273 1,979
8....................................... 2,273 1,940
9....................................... 2,273 1,902
[[Page 97368]]
10...................................... 2,273 1,865
-------------------------------
Total............................... 52,230 49,339
-------------------------------
Annualized.......................... .............. 5,493
------------------------------------------------------------------------
Cost Savings
By adopting ANSI/CAN/UL 12402-4, the Coast Guard can harmonize
commercial PFD requirements of the United States with those of
Transport Canada. Harmonization of commercial PFD standards will lead
to cost savings for PFD manufacturing firms through less expensive
approval requirements and less frequent ongoing facility inspections.
Additionally, as a performance-based standard, ANSI/CAN/UL 12402-4
allows for more innovative designs than the current standards and
regulations, which might better meet boater needs. Seven commenters
noted that permission to create more innovative designs is a benefit.
The adoption of a performance-based standard spares the Coast Guard
from making the equivalency determinations frequently necessary when
using the current prescriptive requirements. Consequently, the Coast
Guard will experience time savings from reducing the review time of new
device applications during the approval process.
In total, we estimate three sources of quantified cost savings
associated with the IBR of ANSI/CAN/UL 12402-4:
(1) The Coast Guard will spend less time reviewing approval
applications and making equivalency determinations for the approval of
innovative PFDs because ANSI/CAN/UL 12402-4 is a performance-based
rather than prescriptive standard and allows more innovative designs to
meet the standard;
(2) All firms that apply for approval in both United States and
Canadian markets will save the difference between one certification to
ANSI/CAN/UL 12402-4 and separate United States and Canadian
certifications to legacy standards; and
(3) Manufacturing facilities producing devices meeting the
requirements of ANSI/CAN/UL 12402-4 for the United States and Canadian
markets will be able to be inspected just once for approval, instead of
the current requirement to be inspected twice; once for United States
approval and once for Canadian approval.
We summarize the total quantified benefits for the cost savings of
the IBR of ANSI/CAN/UL 12402-4 by reporting the annual undiscounted
cost savings in table 10.
Table 10--Estimated Annual Cost Savings of ANSI/CAN/UL 12402-4 to the
Industry and the U.S. Government
[2023 Dollars]
------------------------------------------------------------------------
Cost savings Cost savings
Annual cost savings item to U.S. to foreign
entities entities
------------------------------------------------------------------------
Value of Coast Guard time saved......... $4,330 $0
Canadian and United States approval 27,779 10,274
savings................................
Billed facility inspection savings...... 15,372 8,784
Quality manager's time saved............ 3,359 1,334
-------------------------------
Total............................... 50,840 20,392
------------------------------------------------------------------------
In table 11 and table 12, we record the 10-year cost savings from
the adoption of ANSI/CAN/UL 12402-4 to U.S. and foreign firms,
respectively. In table 13, we record the total 10-year cost savings
from this provision to the U.S. Government.
Table 11--Estimated Cost Savings to U.S. Firms From ANSI/CAN/UL 12402-4
[2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
Discounted
Total cost savings
Year undiscounted ---------------
cost savings 2%
------------------------------------------------------------------------
1....................................... $46,510 $45,598
2....................................... 46,510 44,704
3....................................... 46,510 43,827
4....................................... 46,510 42,968
5....................................... 46,510 42,126
[[Page 97369]]
6....................................... 46,510 41,300
7....................................... 46,510 40,490
8....................................... 46,510 39,696
9....................................... 46,510 38,917
10...................................... 46,510 38,154
-------------------------------
Total............................... 465,100 417,780
-------------------------------
Annualized.......................... .............. 46,510
------------------------------------------------------------------------
Table 12--Estimated Cost Savings to Foreign Firms From Adopting ANSI/CAN/
UL 12402-4
[2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
Discounted
Total cost savings
Year undiscounted ---------------
cost savings 2%
------------------------------------------------------------------------
1....................................... $20,392 $19,992
2....................................... 20,392 19,600
3....................................... 20,392 19,216
4....................................... 20,392 18,839
5....................................... 20,392 18,470
6....................................... 20,392 18,108
7....................................... 20,392 17,752
8....................................... 20,392 17,404
9....................................... 20,392 17,063
10...................................... 20,392 16,729
-------------------------------
Total............................... 203,920 183,173
-------------------------------
Annualized.......................... .............. 20,392
------------------------------------------------------------------------
Table 13--Estimated Cost Savings to the U.S. Government of ANSI/CAN/UL
12402-4
[2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
Discounted
Total cost savings
Year undiscounted ---------------
cost savings 2%
------------------------------------------------------------------------
1....................................... $4,330 $4,245
2....................................... 4,330 4,162
3....................................... 4,330 4,080
4....................................... 4,330 4,000
5....................................... 4,330 3,922
6....................................... 4,330 3,845
7....................................... 4,330 3,770
8....................................... 4,330 3,696
9....................................... 4,330 3,623
10...................................... 4,330 3,552
-------------------------------
Total............................... 43,300 38,895
-------------------------------
Annualized.......................... .............. 4,330
------------------------------------------------------------------------
In table 14, we record the total discounted 10-year cost savings to
the U.S. and foreign PFD industry for the ANSI/CAN/UL 12402-4 portion
of this final rule. We estimate that this provision saves the U.S. and
foreign PFD industry about $66,902 annually and produces cost savings
for the industry of about $600,953 over a 10-year period of analysis
using a 2-percent discount rate.
[[Page 97370]]
Table 14--Total Estimated Cost Savings to Industry of the Final Rule for
ANSI/CAN/UL 12402-4
[2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
Discounted
Total cost savings
Year undiscounted ---------------
cost savings 2%
------------------------------------------------------------------------
1....................................... $66,902 $65,590
2....................................... 66,902 64,304
3....................................... 66,902 63,043
4....................................... 66,902 61,807
5....................................... 66,902 60,595
6....................................... 66,902 59,407
7....................................... 66,902 58,242
8....................................... 66,902 57,100
9....................................... 66,902 55,981
10...................................... 66,902 54,883
-------------------------------
Total............................... 669,020 600,953
-------------------------------
Annualized.......................... .............. 66,902
------------------------------------------------------------------------
2. ANSI/CAN/UL 12402-5
Costs
The PFD industry also incurs an increase in costs from this final
rule because, based on consultation with industry experts, we estimate
that this rule will increase the PFD market by 5 percent, meaning
manufacturing firms would seek new device approvals and produce more
devices.\27\ (In the NPRM, we requested public comment on the
possibility that this rule would increase the PFD market by 5 percent,
and no commenter disagreed with this estimate.) We estimate the costs
of this provision as the costs of the additional device approvals and
the costs of the additional production inspections for the greater
volume of production that we expect this rule to generate.\28\
---------------------------------------------------------------------------
\27\ As part of our discussion with PFD manufacturing firms, we
asked their representatives whether the introduction of Level 50
devices would lead to a net growth in the PFD market (inclusive of
substitution out of existing types of products). Manufacturing firm
representatives stated that they would expect the PFD market would
grow by about 5 percent from this provision. We interpret the 5-
percent growth as a one-time growth in the level of manufacturing
spread over a 2-year period.
\28\ We estimate the additional production inspections based on
the current production inspection requirements, and we estimate the
reduction in these inspections through the incorporation by
reference of ANSI/CAN/UL 9595 in its associated section.
---------------------------------------------------------------------------
In table 15, table 16, and table 17, we present the discounted
costs of introducing Level 50 devices over the 10-year period of
analysis to U.S. firms, foreign firms, and all firms, respectively. The
tables include the estimated costs of Level 50 devices approved and
inspected under the current inspections regime. In Year 1, the
undiscounted costs are only the costs of Level 50 approval for
manufacturers, or $610,299 for U.S. manufacturers and $146,661 for
foreign manufacturers. For Year 2, the undiscounted costs are the costs
of Level 50 approvals to manufacturers ($610,299 for U.S. firms and
$146,661 for foreign firms) plus the cost of inspections ($33,900 for
U.S. firms and $7,587 for foreign firms), for a total of about $644,199
($610,299 + $33,900) for U.S. firms and $154,248 ($146,661 + $7,587)
for foreign firms. The estimated 10-year cost, discounted at 2 percent,
is $1,694,898, or $188,687 annualized, for U.S. firms, and $398,884, or
$44,406 annualized, for foreign firms.
Table 15--Estimated Costs to U.S. Firms From Introducing Level 50
Devices
[2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
Discounted
Total cost
Year undiscounted ---------------
cost 2%
------------------------------------------------------------------------
1....................................... $610,299 $598,332
2....................................... 644,199 619,184
3....................................... 67,800 63,889
4....................................... 67,800 62,637
5....................................... 67,800 61,409
6....................................... 67,800 60,204
7....................................... 67,800 59,024
8....................................... 67,800 57,867
9....................................... 67,800 56,732
10...................................... 67,800 55,620
-------------------------------
Total............................... 1,796,898 1,694,898
-------------------------------
Annualized.......................... .............. 188,687
------------------------------------------------------------------------
[[Page 97371]]
Table 16--Estimated Costs to Foreign Firms From the Introduction of
Level 50 Devices
[2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
Discounted
Total cost
Year undiscounted ---------------
cost 2%
------------------------------------------------------------------------
1....................................... $146,661 $143,785
2....................................... 154,248 148,258
3....................................... 15,174 14,299
4....................................... 15,174 14,018
5....................................... 15,174 13,744
6....................................... 15,174 13,474
7....................................... 15,174 13,210
8....................................... 15,174 12,951
9....................................... 15,174 12,697
10...................................... 15,174 12,448
-------------------------------
Total............................... 422,301 398,884
-------------------------------
Annualized.......................... .............. 44,406
------------------------------------------------------------------------
Table 17--Total Estimated Costs to PFD Manufacturers From the
Introduction of Level 50 Devices
[2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
Discounted
Total cost
Year undiscounted ---------------
cost 2%
------------------------------------------------------------------------
1....................................... $756,960 $742,118
2....................................... 798,447 767,442
3....................................... 82,974 78,188
4....................................... 82,974 76,655
5....................................... 82,974 75,152
6....................................... 82,974 73,679
7....................................... 82,974 72,234
8....................................... 82,974 70,818
9....................................... 82,974 69,429
10...................................... 82,974 68,068
-------------------------------
Total............................... 2,219,199 2,093,782
-------------------------------
Annualized.......................... .............. 233,093
------------------------------------------------------------------------
Qualitative Benefits
The Coast Guard believes that the introduction of Level 50 devices,
coupled with the requirement to wear them if they are to count for the
purposes of PFD carriage requirements, may lead to an unquantifiable
increase in PFD wear rates among recreational boaters and thereby
potentially decrease the rate of drowning. Drowning is the leading
cause of death in recreational boating accidents, accounting for 79
percent of all recreational boating casualties where we know the cause
of death.\29\ Of those who drowned, 86 percent were not wearing a
lifejacket. Wearing a lifejacket is one of the best means available of
preventing accidental drowning in recreational boating. Unfortunately,
recreational boaters only wear lifejackets about 24 percent of the
time.\30\
---------------------------------------------------------------------------
\29\ United States Coast Guard, ``2019 Recreational Boating
Statistics.'' <a href="https://uscgboating.org/library/accident-statistics/Recreational-Boating-Statistics-2019.pdf">https://uscgboating.org/library/accident-statistics/Recreational-Boating-Statistics-2019.pdf</a> (last accessed April 25th,
2024).
\30\ United States Coast Guard, ``2019 Life Jacket Wear Rate
Observation Study.'' <a href="https://uscgboating.org/library/national-live-jacket-wear-study/2019-Life-Jacket-Wear-Rate-Report.pdf">https://uscgboating.org/library/national-live-jacket-wear-study/2019-Life-Jacket-Wear-Rate-Report.pdf</a> (last
accessed April 25, 2024).
---------------------------------------------------------------------------
Level 50 devices are likely to be slimmer, lighter in weight, and
more comfortable to wear than current Type III and Level 70 devices.
Additionally, the Coast Guard will require recreational boaters to wear
Level 50 devices for such devices to count towards PFD carriage
requirements. Individuals who purchase Level 50 devices are more likely
to wear PFDs than similar individuals who purchase bulkier Type III or
Level 70 devices without a requirement that they be worn for the
purposes of carriage. The NIH conducted a literature review, and, among
other factors, found discomfort to be negatively associated with
lifejacket wear [NIH, 2018].\31\ It is the Coast Guard's view that PFDs
worn are more effective than PFDs carried on board if a person
overboard situation occurs. As a result, it is possible that the public
is safer due to recreational boaters wearing a greater number of PFDs
while boating.
---------------------------------------------------------------------------
\31\ We cited this review from the NIH earlier in the preamble
in footnote number 8. Readers should reference that footnote for a
link to this article and other articles by the NIH for more
information on PFD usage.
---------------------------------------------------------------------------
Since the Level 50 devices provide a lower level of buoyancy than
Level 70 devices, a direct comparison is not possible. However, the
view of the subject matter experts (SMEs) in the Coast Guard's Office
of Boating Safety is that the wearing of Level 50 PFDs by recreational
boaters and the general boating public improves safety on the water.
Recreational boaters fail to wear lifejackets 76 percent of the time,
[[Page 97372]]
leaving themselves vulnerable to drowning. The Coast Guard believes
that, by offering recreational boaters an additional choice of a Level
50 PFD, which is required to be worn, more recreational boaters will
choose to wear their lifejacket while engaged in boating activities. A
lifejacket that is worn by the user is more effective than a lifejacket
stowed on the boat.
3. ANSI/CAN/UL 9595
The third provision incorporates by reference the consensus
standard ANSI/CAN/UL 9595 to cover follow-up inspections and inspection
frequency for Coast Guard approved PFDs. Currently, when a
manufacturing firm produces a Coast Guard approved PFD, there is a
required follow-up inspection regime to ensure that the devices
continue to meet the specifications under which the Coast Guard
approved them. Although the Coast Guard has not previously published a
substantive minimum requirement for what constitutes a follow-up
inspections regime, we set out general requirements in 46 CFR 159,
160.064-4, and 160.076-29. The Coast Guard reviews each recognized
independent laboratory's follow-up services program to ensure
compliance with these regulations.
Incorporating by reference ANSI/CAN/UL 9595 provides a few key
benefits to the regulated public and the testing laboratories. First,
ANSI/CAN/UL 9595 is one standard, ensuring consistency across all
accepted and recognized independent laboratories. Second, ANSI/CAN/UL
9595 is a standard that is widely available to the industry and
transparently clarifies guidance on what constitutes a follow-up
inspection regime. Third, and most importantly, ANSI/CAN/UL 9595
establishes a rating system for each facility, which results in cost
savings for the firms manufacturing at facilities with a good or
superior QMS rating.
Costs
There are three cost items associated with the adoption of ANSI/
CAN/UL 9595. These costs are based on input from PFD industry SMEs on
how ANSI/CAN/UL 9595 is likely to be implemented.
(1) The two recognized independent laboratories will need to train
their staff to implement ANSI/CAN/UL 9595.
(2) Manufacturing firms could request a special inspection in the
first year to certify their QMS at a given facility meets the
requirements for Process Rating of A or B. We expect the top 13 firms
to request this certification across all 27 facilities at which they
manufacture. This special inspection is expected to be in addition to
the regular production inspections required for Process Rating C.
(3) After the first year, where the QMS inspection is supplemental
to standard inspections, the QMS inspection could replace one of the
mandatory inspections, but could cost more than a standard inspection,
at the top 13 firms with 27 facilities.
We estimate the 10-year discounted cost for inspections under this
provision that are associated with U.S. firms is approximately
$126,840, or $14,121 annualized using a 2-percent discount rate. We
estimate the total 10-year discounted cost for inspections that are
associated with foreign firms is approximately $51,382, or $5,720
annualized using a 2-percent discount rate. In total, we estimate the
10-year discounted costs from ANSI/CAN/UL 9595 are $178,223 or $19,841
annualized using a 2-percent discount rate. We present these costs to
U.S., foreign, and both U.S. and foreign firms in table 18, table 19,
and table 20, respectively.
Table 18--Estimated QMS Inspection Costs to U.S. Firms From ANSI/CAN/UL
9595
[2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
Discounted
Total cost
Year undiscounted ---------------
cost 2%
------------------------------------------------------------------------
1....................................... $61,296 $60,094
2....................................... 8,341 8,017
3....................................... 8,341 7,860
4....................................... 8,341 7,706
5....................................... 8,341 7,555
6....................................... 8,341 7,407
7....................................... 8,341 7,261
8....................................... 8,341 7,119
9....................................... 8,341 6,979
10...................................... 8,341 6,843
-------------------------------
Total............................... 136,365 126,841
-------------------------------
Annualized.......................... .............. 14,121
------------------------------------------------------------------------
Table 19--Estimated QMS Inspection Costs to Foreign Firms From ANSI/CAN/
UL 9595
[2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
Discounted
Total cost
Year undiscounted ---------------
cost 2%
------------------------------------------------------------------------
1....................................... $23,744 $23,278
2....................................... 3,512 3,376
3....................................... 3,512 3,309
4....................................... 3,512 3,245
5....................................... 3,512 3,181
6....................................... 3,512 3,119
7....................................... 3,512 3,057
[[Page 97373]]
8....................................... 3,512 2,997
9....................................... 3,512 2,939
10...................................... 3,512 2,881
-------------------------------
Total............................... 55,352 51,382
-------------------------------
Annualized.......................... .............. 5,720
------------------------------------------------------------------------
Table 20--Total Estimated QMS Inspection Costs for ANSI/CAN/UL 9595
[2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
Discounted
Total cost
Year undiscounted ---------------
cost 2%
------------------------------------------------------------------------
1....................................... $85,040 $83,373
2....................................... 11,853 11,393
3....................................... 11,853 11,169
4....................................... 11,853 10,950
5....................................... 11,853 10,736
6....................................... 11,853 10,525
7....................................... 11,853 10,319
8....................................... 11,853 10,116
9....................................... 11,853 9,918
10...................................... 11,853 9,724
-------------------------------
Total............................... 191,717 178,223
-------------------------------
Annualized.......................... .............. 19,841
------------------------------------------------------------------------
Cost Savings
The IBR of ANSI/CAN/UL 9595 generates benefits in the form of cost
savings for PFD manufacturing firms who have a QMS in place.
Manufacturers with an audited QMS can secure a higher Process Rating,
which, in turn, reduces the frequency of production inspections for
PFDs based upon their higher Process Rating.
We estimate this provision to generate cost savings for U.S. firms
of $8,454,204, or $941,177, annualized, over a 10-year period of
analysis using a 2-percent discount rate. We similarly estimate cost
savings of $2,039,131, or $227,009, annualized, to foreign firms over a
10-year period of analysis, discounted at 2 percent. In total, we
estimate $10,493,335, or $1,168,187 annualized, in cost savings to all
firms under this provision using a 10-year period of analysis and a 2-
percent discount rate. We present these 10-year cost savings to U.S.,
foreign, and both U.S. and foreign firms in table 21, table 22, and
table 23, respectively.
Table 21--Estimated Cost Savings to U.S. Firms From ANSI/CAN/UL 9595
[2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
Discounted
Total cost savings
Year undiscounted ---------------
cost savings 2%
------------------------------------------------------------------------
1....................................... $0 $0
2....................................... 1,037,396 997,113
3....................................... 1,059,092 998,006
4....................................... 1,059,092 978,437
5....................................... 1,059,092 959,252
6....................................... 1,059,092 940,443
7....................................... 1,059,092 922,003
8....................................... 1,059,092 903,925
9....................................... 1,059,092 886,201
10...................................... 1,059,092 868,824
-------------------------------
Total............................... 9,510,132 8,454,204
-------------------------------
Annualized.......................... .............. 941,177
------------------------------------------------------------------------
[[Page 97374]]
Table 22--Estimated Cost Savings to Foreign Firms From ANSI/CAN/UL 9595
[2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
Discounted
Total cost savings
Year undiscounted ---------------
cost savings 2%
------------------------------------------------------------------------
1....................................... $0 $0
2....................................... 250,371 240,649
3....................................... 255,429 240,696
4....................................... 255,429 235,977
5....................................... 255,429 231,350
6....................................... 255,429 226,814
7....................................... 255,429 222,366
8....................................... 255,429 218,006
9....................................... 255,429 213,732
10...................................... 255,429 209,541
-------------------------------
Total............................... 2,293,803 2,039,131
-------------------------------
Annualized.......................... .............. 227,009
------------------------------------------------------------------------
Table 23--Estimated Cost Savings to All Firms From ANSI/CAN/UL 9595
[2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
Discounted
Total cost savings
Year undiscounted ---------------
cost savings 2%
------------------------------------------------------------------------
1....................................... $0 $0
2....................................... 1,287,767 1,237,761
3....................................... 1,314,521 1,238,702
4....................................... 1,314,521 1,214,414
5....................................... 1,314,521 1,190,602
6....................................... 1,314,521 1,167,257
7....................................... 1,314,521 1,144,370
8....................................... 1,314,521 1,121,931
9....................................... 1,314,521 1,099,932
10...................................... 1,314,521 1,078,365
-------------------------------
Total............................... 11,803,935 10,493,334
-------------------------------
Annualized.......................... .............. 1,168,186
------------------------------------------------------------------------
4. Placards in Lieu of Information Pamphlets
The fourth provision in the rule comes from details contained
within ANSI/CAN/UL 12402-4 and ANSI/CAN/UL 12402-5. These standards
specify requirements for a placard to be attached to all devices
certified to those standards. The placard provides information on PFD
performance, selection, and approval, warnings, maintenance, and
general water safety information in a pictographic format. This rule
amends 33 CFR 181 to permit manufacturing firms to use a placard in
lieu of the informational pamphlet.
Costs
For the convenience of the reader, table 24 reproduces table 6 from
the Affected Population section of this preamble to list the various
types of PFDs impacted by this rule, and whether they are required to
use placards to convey safety instructions or whether they could use
either placards or information pamphlets.\32\
---------------------------------------------------------------------------
\32\ Current marking requirements require a pamphlet, while the
new marking requirement will be for a placard or pamphlet. Because
these placards and pamphlets are both produced in factories, the
Coast Guard estimates that it will take the same amount of time to
produce and include either a pamphlet or a placard with a newly
manufactured PFD for sale. As a result, we do not estimate there
will be any changes in the Paperwork Reduction Act burden brought on
by the switch from pamphlets to placards.
Table 24--Device Category and Permitted Instruction Types
------------------------------------------------------------------------
Types of
instructions Types of
Device category allowed by the instructions
final rule currently in use
------------------------------------------------------------------------
New Level 50 Devices (ANSI/CAN/ Placard........... N/A because these
UL 12402-5). devices are not
yet produced.
New Level 70 Devices (ANSI/CAN/ Placard........... Placard.
UL 12402-5).
New Level 100 Devices (ANSI/CAN/ Placard........... N/A because these
UL 12402-4). devices are not
yet produced.
[[Page 97375]]
Existing Type I Commercial Placard or Information
Devices. Information Pamphlet.
Pamphlet.
Existing Type II Recreational Placard or Information
Devices. Information Pamphlet.
Pamphlet.
Existing Type III Recreational Placard or Information
Devices. Information Pamphlet.
Pamphlet.
Existing Type IV Throwable Information Information
Devices. Pamphlet. Pamphlet.
------------------------------------------------------------------------
As shown in table 24, the changes in instruction information either
applies to PFD categories not yet produced or permits an additional
compliance option. No devices would have fewer options for instruction
materials than under current regulations. As a result, we estimate no
additional costs from replacing safety information pamphlets with
placards because firms could either continue their current activities
or produce placards instead.
Unquantified Benefits
There are two sources of unquantified benefits from the requirement
for the use of placards on new device categories and the permitting of
placard use on existing device categories. The first source of
unquantified benefits occurs because a placard may be less expensive to
produce than an information pamphlet. A representative from the PFD
manufacturing industry stated that the placard could be around $0.05
cheaper to produce than the information pamphlet, because the placard
contains fewer materials than the information pamphlet. However, we did
not find (nor did we receive) any data on the costs to produce
information pamphlets and the costs to produce placards, so we cannot
determine the relative size of this cost savings. We believe, based on
the full discussion in the RA, that the $0.05 estimate expresses the
fact that placards are slightly less expensive than information
pamphlets but, ultimately, about the same price. Additionally, we have
no way of estimating how large a share of current production will
switch from producing information pamphlets to placards, as placards
will not be required. Due to these factors, we did not produce a
quantitative estimate of the cost savings due to placards.
The second unquantified benefit comes from the fact that placards
use pictorial images to communicate safety information, while
information pamphlets use English-language text. Pictorial information
is superior to text at communicating information to non-English-reading
audiences. We do not have a way of quantifying this benefit but would
like to note that approximately 21 percent of the U.S. population has a
``low'' level of English literacy. For those populations, pictorial
information may be better than text-based information.\33\
---------------------------------------------------------------------------
\33\ U.S. Department of Education, ``Data Point: Adult Literacy
in the United States'' (July 2019). <a href="https://nces.ed.gov/pubs2019/2019179.pdf">https://nces.ed.gov/pubs2019/2019179.pdf</a> (last accessed April 25, 2024).
---------------------------------------------------------------------------
Total Costs
We display the total costs from this final rule to U.S. entities,
foreign entities, and both U.S. and foreign entities, using a 10-year
period of analysis, discounted at 2 percent, in table 25, table 26, and
table 27, respectively.
Table 25--Estimated Costs for U.S. Firms
[2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
Discounted
Total costs
Year undiscounted ---------------
costs 2%
------------------------------------------------------------------------
1....................................... $702,754 $688,975
2....................................... 654,199 628,796
3....................................... 77,800 73,313
4....................................... 77,800 71,875
5....................................... 77,800 70,466
6....................................... 77,800 69,084
7....................................... 77,800 67,730
8....................................... 77,800 66,402
9....................................... 77,800 65,100
10...................................... 77,800 63,823
-------------------------------
Total............................... 1,979,353 1,865,564
-------------------------------
Annualized.......................... .............. 207,687
------------------------------------------------------------------------
Table 26--Estimated Costs for Foreign Firms
[2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
Discounted
Total costs
Year undiscounted ---------------
costs 2%
------------------------------------------------------------------------
1....................................... $171,019 $167,666
2....................................... 158,374 152,224
[[Page 97376]]
3....................................... 19,300 18,187
4....................................... 19,300 17,830
5....................................... 19,300 17,481
6....................................... 19,300 17,138
7....................................... 19,300 16,802
8....................................... 19,300 16,472
9....................................... 19,300 16,149
10...................................... 19,300 15,833
-------------------------------
Total............................... 483,793 455,782
-------------------------------
Annualized.......................... .............. 50,741
------------------------------------------------------------------------
Table 27--Total Estimated Costs for U.S. and Foreign Firms
[2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
Discounted
Total costs
Year undiscounted ---------------
costs 2%
------------------------------------------------------------------------
1....................................... $873,773 $856,640
2....................................... 812,573 781,020
3....................................... 97,100 91,499
4....................................... 97,100 89,705
5....................................... 97,100 87,946
6....................................... 97,100 86,222
7....................................... 97,100 84,531
8....................................... 97,100 82,874
9....................................... 97,100 81,249
10...................................... 97,100 79,656
-------------------------------
Total............................... 2,463,146 2,321,343
-------------------------------
Annualized.......................... .............. 258,427
------------------------------------------------------------------------
Total Cost Savings
We display the total cost savings from this final rule to U.S.
firms, the U.S. government, foreign firms, and all entities using a 10-
year period of analysis discounted at 2 percent in table 28, table 29,
table 30, and table 31, respectively.
Table 28--Total Estimated Cost Savings to U.S. Firms
[2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
Discounted
Total cost savings
Year undiscounted ---------------
cost savings 2%
------------------------------------------------------------------------
1....................................... $46,510 $45,598
2....................................... 1,083,906 1,041,817
3....................................... 1,105,602 1,041,833
4....................................... 1,105,602 1,021,405
5....................................... 1,105,602 1,001,378
6....................................... 1,105,602 981,743
7....................................... 1,105,602 962,493
8....................................... 1,105,602 943,621
9....................................... 1,105,602 925,118
10...................................... 1,105,602 906,979
-------------------------------
Total............................... 9,975,232 8,871,985
-------------------------------
Annualized.......................... .............. 987,687
------------------------------------------------------------------------
[[Page 97377]]
Table 29--Total Estimated Cost Savings to Foreign Firms
[2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
Discounted
Total cost savings
Year undiscounted ---------------
cost savings 2%
------------------------------------------------------------------------
1....................................... $20,392 $19,992
2....................................... 270,763 260,249
3....................................... 275,821 259,912
4....................................... 275,821 254,816
5....................................... 275,821 249,820
6....................................... 275,821 244,921
7....................................... 275,821 240,119
8....................................... 275,821 235,411
9....................................... 275,821 230,795
10...................................... 275,821 226,269
-------------------------------
Total............................... 2,497,723 2,222,303
-------------------------------
Annualized.......................... .............. 247,401
------------------------------------------------------------------------
Table 30--Total Estimated Cost Savings to the U.S. Government
[2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
Discounted
Total cost savings
Year undiscounted ---------------
cost savings 2%
------------------------------------------------------------------------
1....................................... $4,330 $4,245
2....................................... 4,330 4,162
3....................................... 4,330 4,080
4....................................... 4,330 4,000
5....................................... 4,330 3,922
6....................................... 4,330 3,845
7....................................... 4,330 3,770
8....................................... 4,330 3,696
9....................................... 4,330 3,623
10...................................... 4,330 3,552
-------------------------------
Total............................... 43,300 38,895
-------------------------------
Annualized.......................... .............. 4,330
------------------------------------------------------------------------
Table 31--Total Estimated Cost Savings to U.S. and Foreign Manufacturing
Firms and the U.S. Government
[2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
Discounted
Total cost savings
Year undiscounted ---------------
cost savings 2%
------------------------------------------------------------------------
1....................................... $71,232 $69,835
2....................................... 1,358,999 1,306,227
3....................................... 1,385,753 1,305,826
4....................................... 1,385,753 1,280,222
5....................................... 1,385,753 1,255,119
6....................................... 1,385,753 1,230,509
7....................................... 1,385,753 1,206,381
8....................................... 1,385,753 1,182,727
9....................................... 1,385,753 1,159,536
10...................................... 1,385,753 1,136,800
-------------------------------
Total............................... 12,516,255 11,133,183
-------------------------------
Annualized.......................... .............. 1,239,419
------------------------------------------------------------------------
[[Page 97378]]
Net Cost Savings
We display the total net cost savings from this final rule to U.S.
firms, the U.S. government, foreign firms, and all entities using a 10-
year period of analysis discounted at 2 percent in table 32, table 33,
table 34, and table 35, respectively.
Table 32--Total Estimated Net Cost Savings to U.S. Firms
[2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
Net discounted
Net cost savings
Year undiscounted ---------------
cost savings 2%
------------------------------------------------------------------------
1....................................... -$656,244 -$643,376
2....................................... 429,707 413,021
3....................................... 1,027,802 968,521
4....................................... 1,027,802 949,530
5....................................... 1,027,802 930,912
6....................................... 1,027,802 912,659
7....................................... 1,027,802 894,763
8....................................... 1,027,802 877,219
9....................................... 1,027,802 860,019
10...................................... 1,027,802 843,156
-------------------------------
Total............................... 7,995,879 7,006,423
-------------------------------
Annualized.......................... .............. 780,001
------------------------------------------------------------------------
Table 33--Total Estimated Net Cost Savings to Foreign Firms
[2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
Net discounted
Net cost savings
Year undiscounted ---------------
cost savings 2%
------------------------------------------------------------------------
1....................................... -$150,627 -$147,674
2....................................... 112,389 108,025
3....................................... 256,521 241,725
4....................................... 256,521 236,986
5....................................... 256,521 232,339
6....................................... 256,521 227,783
7....................................... 256,521 223,317
8....................................... 256,521 218,938
9....................................... 256,521 214,645
10...................................... 256,521 210,437
-------------------------------
Total............................... 2,013,930 1,766,522
-------------------------------
Annualized.......................... .............. 196,661
------------------------------------------------------------------------
Table 34--Total Estimated Cost Savings to the U.S. Government
[2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
Net discounted
Net cost savings
Year undiscounted ---------------
cost savings 2%
------------------------------------------------------------------------
1....................................... $4,330 $4,245
2....................................... 4,330 4,162
3....................................... 4,330 4,080
4....................................... 4,330 4,000
5....................................... 4,330 3,922
6....................................... 4,330 3,845
7....................................... 4,330 3,770
8....................................... 4,330 3,696
9....................................... 4,330 3,623
10...................................... 4,330 3,552
-------------------------------
Total............................... 43,300 38,895
-------------------------------
[[Page 97379]]
Annualized.......................... .............. 4,330
------------------------------------------------------------------------
Table 35--Total Estimated Net Cost Savings to All Entities
[2023 Dollars, 10-year period of analysis]
------------------------------------------------------------------------
Net discounted
Net cost savings
Year undiscounted ---------------
cost savings 2%
------------------------------------------------------------------------
1....................................... -$802,541 -$786,805
2....................................... 546,426 525,208
3....................................... 1,288,653 1,214,327
4....................................... 1,288,653 1,190,516
5....................................... 1,288,653 1,167,173
6....................................... 1,288,653 1,144,287
7....................................... 1,288,653 1,121,850
8....................................... 1,288,653 1,099,853
9....................................... 1,288,653 1,078,287
10...................................... 1,288,653 1,057,144
-------------------------------
Total............................... 10,053,109 8,811,839
-------------------------------
Annualized.......................... .............. 980,991
------------------------------------------------------------------------
Alternatives
We identified three alternatives to this final rule:
(1) Incorporate ANSI/CAN/UL 12402-5 for the approval of Level 70
PFDs only, prohibiting the approval of Level 50 PFDs;
(2) Require placards for existing Type I, II, and III PFDs instead
of providing the option to continue the use of informational pamphlets;
and
(3) Adopt ANSI/CAN/UL 12402-4 and ANSI/CAN/UL 12402-5 by policy.
Alternative 1: Incorporate ANSI/CAN/UL 12402-5 for Level 70 PFDs Only
We considered an alternative that would incorporate ANSI/CAN/UL
12402-5, but limit approval to Level 70 PFDs only. Level 50 PFDs would
not be eligible for Coast Guard approval and would not meet carriage
requirements on any vessel. If the Coast Guard were to choose this
alternative, the market for Level 50 devices would not be viable
because Level 50 devices would no longer meet carriage requirements.
Without a viable market, the costs of compliance estimated in the
section of ANSI/CAN/UL 12402-5 would not exist. However, the benefits
from a new market and increased wear-rates would be lost were these
devices to not be sold. We would also be restricting recreational
boaters to one category of PFD when Level 50 PFDs could better suit
their purposes. As a result, we rejected this alternative because we
expect that wear rates, and therefore benefits, would be lower without
the option of a Level 50 PFD.
Alternative 2: Require placards Instead of the Option of Placards or
Pamphlets
Under this final rule, we require that only new Level 50, 70, and
100 devices use placards. We considered the alternative of requiring
that PFD manufacturers use placards instead of information pamphlets
for all existing PFDs and not just new devices. While we observe that
the cost of producing a placard is generally less than the cost of
producing an information pamphlet, we also observe that some
manufacturers may have already printed pamphlets or may not choose to
use placards. As a result, we rejected this alternative.
Alternative 3: Adopt ANSI/CAN/UL 12402-4 and ANSI/CAN/UL 12402-5 by
Policy
Another alternative we considered would be to adopt ANSI/CAN/UL
12402-4 and ANSI/CAN/UL 12402-5 by policy instead of incorporating them
by reference into the CFR. Under 46 CFR 159.005-7(c), the Coast Guard
has the authority to approve an item of equipment that does not meet
all the requirements of 46 CFR 160.055 if it has equivalent performance
characteristics. The Coast Guard has already used this authority to
partially adopt ANSI/CAN/UL 12402-4 and ANSI/CAN/UL 12402-5 by policy.
Because this authority is limited to the approval of equipment with
equivalent performance characteristics, we cannot adopt the portion of
standards not already equivalent to existing types of equipment. In
particular, Level 50 PFDs, youth inflatable PFDs, and inflatable Level
100 PFDs could not be approved by policy because they are not
equivalent to any current Coast Guard standards. For that reason, we
rejected this alternative.
B. Small Entities
Under the Regulatory Flexibility Act, (RFA) 5 U.S.C. 601-612, we
have considered whether this rule has a significant economic impact on
a substantial number of small entities.
The RFA (Public Law 96-354) establishes ``as a principle of
regulatory issuance that agencies shall endeavor, consistent with the
objectives of the rule and of applicable statutes, to fit regulatory
and informational requirements to the scale of the businesses,
organizations, and governmental jurisdictions subject to
[[Page 97380]]
regulation. To achieve this principle, agencies are required to solicit
and consider flexible regulatory proposals and to explain the rationale
for their actions to assure that such proposals are given serious
consideration.''
When an agency promulgates a final rule under section 553 of the
RFA, after being required by that section or any other law to publish a
general notice of proposed rulemaking, or promulgates a final
interpretative rule involving the internal revenue laws of the United
States as described in section 603(a), the agency must prepare a final
Regulatory Flexibility Analysis (FRFA) or have the head of the agency
certify pursuant to RFA section 605(b) that the rule will not, if
promulgated, have a significant economic impact on a substantial number
of small entities. The RFA prescribes the content of the FRFA in
section 604(a), which we discuss as follows.
In accordance with the RFA (5 U.S.C. 601-612), the Coast Guard
prepared this FRFA that examines the impacts of the final rule on small
entities (5 U.S.C. 601, et seq.). A small entity may be:
<bullet> 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);
<bullet> A small not-for-profit organization; and
<bullet> A small governmental jurisdiction (locality with fewer
than 50,000 people).
This FRFA addresses the following:
(1) A statement of the need for, and objectives of, the rule;
(2) A statement of the significant issues raised by the public
comments in response to the initial regulatory flexibility analysis, a
statement of the assessment of the agency of such issues, and a
statement of any changes made in the proposed rule as a result of such
comments;
(3) The response of the agency to any comments filed by the Chief
Counsel for Advocacy of the Small Business Administration (SBA) in
response to the proposed rule, and a detailed statement of any change
made to the proposed rule in the final rule as a result of the
comments;
(4) A description of and an estimate of the number of small
entities to which the rule will apply or an explanation of why no such
estimate is available;
(5) A description of the projected reporting, recordkeeping and
other compliance requirements of the rule, including an estimate of the
classes of small entities which will be subject to the requirement and
the type of professional skills necessary for preparation of the report
or record; and
(6) A description of the steps the agency has taken to minimize the
significant economic impact on small entities consistent with the
stated objectives of applicable statutes, including a statement of the
factual, policy, and legal reasons for selecting the alternative
adopted in the final rule and why each one of the other significant
alternatives to the rule considered by the agency which affect the
impact on small entities was rejected.
Below is a discussion of FRFA analysis by each of these six
elements:
(1) A statement of the need for, and objectives of, the rule.
The Coast Guard amends the lifejacket approval requirements and
follow-up program requirements by incorporating three new binational
standards. At the same time, the Coast Guard amends lifejacket and PFD
carriage requirements to allow for the use of equipment approved to the
new standards, and to remove obsolete equipment approval requirements.
The new standards are state-of-the-art and are intended to replace the
legacy standards. The amendments will streamline the process for
approval of PFDs and allow manufacturers to produce more innovative
equipment that meets the approval requirements of both the United
States and Canada; and will reduce the burden for manufacturers in both
the approval process and follow-up program. Absent this regulation, the
United States and Canada would continue to have two different PFD
standards, resulting in additional costs for manufacturers.
(2) A statement of the significant issues raised by the public
comments in response to the initial regulatory flexibility analysis, a
statement of the assessment of the agency of such issues, and a
statement of any changes made in the proposed rule as a result of such
comments.
The Coast Guard received no public comments in response to the
initial Regulatory Flexibility Analysis.
(3) The response of the agency to any comments filed by the Chief
Counsel for Advocacy of the SBA in response to the proposed rule, and a
detailed statement of any change made to the proposed rule in the final
rule as a result of the comments.
The Coast Guard received no comments filed by the Chief Counsel for
Advocacy of the SBA in response to the proposed rule.
(4) A description of and an estimate of the number of small
entities to which the rule will apply or an explanation of why no such
estimate is available.
This rule has four major provisions: (1) The incorporation by
reference of ANSI/CAN/UL 12402-4 replacing Type I device approval with
Level 100 device approval; (2) The incorporation by reference of ANSI/
CAN/UL 12402-5 introducing new Level 50 device approvals; (3) The
incorporation by reference of ANSI/CAN/UL 9595 for new follow-on
production inspection standards; and (4) The option to use placards in
lieu of information pamphlets on currently approved devices and the
requirement to use placards for new Level 50, Level 70, and Level 100
devices. Across these four provisions, we estimate that this rule
affects two Coast Guard recognized laboratories and 61 PFD
manufacturers.
We researched these two Coast Guard recognized independent
laboratories and 61 PFD manufacturers to determine if they are U.S.
companies or foreign companies based on the location of their parent
company's headquarters. We found one Coast Guard recognized laboratory
to be a U.S. company and one to be a foreign company. We found 39 of
the 61 PFD manufacturers to be U.S. companies and 22 to be foreign
companies. We then researched each of these 40 U.S. companies (1
testing laboratory and 39 PFD manufacturers) to determine its North
American Industry Classification System (NAICS) code and its size
standard using the SBA's size standard table. Next, we reviewed each
U.S. parent company's revenue or employee information to determine
whether the company is small or not small, according to SBA size
standards. We present the results of our research in table 36. The
Coast Guard recognized independent laboratory is not a small entity. Of
39 U.S. manufacturers, 32 are small entities according to SBA size
standards. We did not find any U.S. small entities to be small
governmental jurisdictions or not-for-profit organizations.
[[Page 97381]]
Table 36--Number of Small Entities Affected by the Rule
----------------------------------------------------------------------------------------------------------------
NAICS code and Size standard Number of U.S. Number of
NAICS code industry type Size standard type used * companies small entities
----------------------------------------------------------------------------------------------------------------
314910............... Textile Bag and Employees........... 500 1 1
Canvas Mills.
314999............... All Other Revenue............. $8.0 2 2
Miscellaneous
Store Retailers
(except Tobacco
Stores).
315280............... Other Cut and Sew Employees........... 750 1 1
Apparel
Manufacturing.
315990............... Apparel Employees........... 500 1 1
Accessories and
Other Apparel
Manufacturing.
326199............... All Other Employees........... 750 2 0
Plastics Product
Manufacturing.
326299............... All Other Rubber Employees........... 500 1 1
Product
Manufacturing.
327120............... Clay Building Employees........... 750 1 1
Material and
Refractories
Manufacturing.
336612............... Boat Building.... Employees........... 1,000 2 2
339920............... Sporting and Employees........... 750 4 3
Athletic Goods
Manufacturing.
339999............... All Other Employees........... 500 1 1
Miscellaneous
Manufacturing.
423910............... Sporting and Employees........... 100 1 1
Recreational
Goods and
Supplies
Merchant
Wholesalers.
441222............... Boat Dealers..... Revenue............. $35.0 5 4
448140............... Family Clothing Revenue............. $41.5 1 0
Stores.
448150............... Clothing Revenue............. $16.5 2 1
Accessories
Stores.
451110............... Sporting Goods Revenue............. $16.5 2 2
Stores.
452319............... All Other General Revenue............. $35.0 1 1
Merchandise
Stores.
453930............... Manufactured Revenue............. $16.5 1 0
(Mobile) Home
Dealers.
541380............... Testing Revenue............. $16.5 1 0
Laboratories.
541870............... Advertising Revenue............. $16.5 1 1
Material
Distribution
Services.
561990............... All Other Support Revenue............. $12.0 1 1
Services.
713930............... Marinas.......... Revenue............. $8.0 1 1
Unknown.............. Unknown.......... Unknown............. Unknown 7 7
---------------------------------
40 32
----------------------------------------------------------------------------------------------------------------
* Some size standards are based on the number of employees and others on the firm's total revenue.
Each of the four provisions in this final rule affects a different
subset of the 32 small entities and has a different distribution of
costs and cost savings across those small entities. We discuss each
provision separately in the following sections, and then summarize each
provision's impacts.
Provision 1: Incorporation by Reference of ANSI/CAN/UL 12402-4
The first provision, ANSI/CAN/UL 12402-4, affects seven small
entities, six of which have known revenues. The first provision results
in costs to small entities that intend to sell Level 100 devices in
only one market (United States or Canada). Firms wishing to sell Level
100 devices in both United States and Canadian markets will reduce
costs by no longer conducting duplicative approvals and facility
inspections.
Whether small entities will or will not experience cost savings
depends on whether each small entity prefers to sell their device in
only the United States or Canada or in both markets. The Coast Guard
does not know which small entities will prefer a cheaper set of product
approval tests with only the ability to sell in one market and which
will prefer a more expensive set of product approval tests with the
ability to sell in both markets. Therefore, we compare both the costs
and cost savings estimates to each small entity.
In the RA, we estimate the Level 100 approval to be $5,050 more
expensive than the current Type I approval. We estimate that testing
laboratories receive an application for approval to Level 100 standards
0.45 times per year. Each small entity will apply for an approval once
they develop a new device and will experience this cost only when they
submit a new application. The Coast Guard cannot predict when each
small entity might submit a new application; instead, we use the cost
of $5,050 as an estimate of a one-time (initial-year cost) per-small-
entity-cost of ANSI/CAN/UL 12402-4.
We estimate the cost savings for small entities that wish to sell
in two markets as $42,150 per new Level 100 approval, $5,594 per
modification of an existing approval with testing, and $1,373 per
revision of an existing approval without testing. As with the costs of
ANSI/CAN/UL 12402-4, each small entity will experience the cost savings
only when it submits each application. The Coast Guard does not know
when small entities might seek new approvals or revisions in the
future, so we estimate these as one-time cost savings to small entities
from ANSI/CAN/UL 12402-4. Specifically, we estimate that each small
entity will experience a one-time total cost savings of $41,638 for
each approval, which is the sum of the Level 100 approvals and
revisions to approvals with or without testing ($42,150 + $7,605 +
$1,373). These seven small entities will also experience an ongoing
(annual) cost savings of $1,338.00 from reduced facility inspection
frequency.\34\
---------------------------------------------------------------------------
\34\ Facility inspections last 4 hours and include the billed
cost of an inspector's time, or $274.50, and the opportunity cost of
a Quality Manager's time, or $60 per hour as a loaded weighted
average. The cost savings is therefore 4 x $274.50 + 4 x $60 or
$1,338. Readers should refer to section 7 of the RA discussing the
ANSI/CAN/UL 12402-4 standard for more detail.
---------------------------------------------------------------------------
Provision 2: Incorporation by Reference of ANSI/CAN/UL 12402-5
Incorporating by reference ANSI/CAN/UL 12402-5 permits small
entities to seek Coast Guard approval to produce and sell Level 50
devices. The Coast Guard has not previously approved these devices. We
estimate that this provision affects all 32 small entities, 24 of which
have known revenues.
In the RA, we estimate that the introduction of Level 50 devices
will cause the North American PFD market to grow by 5 percent. We
interpret the 5-percent growth in terms of the number of approved
devices (a growth of 38 device approvals). The initial approvals
represent a one-time (initial year) cost to small entities. Small
entities will also experience an annual cost of additional production
inspections based on the volume of Level 50 PFDs produced.
[[Page 97382]]
We estimate a new Level 50 device approval costs a small entity
about $39,840. We do not know which small entities will seek Coast
Guard approval for a Level 50 device or how many devices each small
entity might seek approval for. As a result, we treat each small entity
as seeking approval for one Level 50 device costing $39,840. This will
be a one-time (initial year) cost to small entities.
Production is not distributed equally across the small entities
that produce PFDs for the North American market. Instead, some small
entities produce vastly more PFDs than others. In the RA, we estimate
the market share of the 13 largest firms to be collectively about 95
percent. We estimate the remaining 44 firms' market share collectively
to be about 5 percent. We do not know the relative market share of the
44 firms, so we divide the 5 percent equally across the 44 firms.
Therefore, we treat each of the 44 firms as accounting for about 0.11
percent of the PFD market.\35\
---------------------------------------------------------------------------
\35\ We divided 5 percent or 0.05 by 44 companies to obtain 0.11
percent of the market for each one.
---------------------------------------------------------------------------
For the 32 small entities that would use the ANSI/CAN/UL 12402-5
standard, 24 are in the set of 44 firms collectively having 5 percent
market share, and therefore we assume each has a market share of 0.11
percent. Based on conversations with PFD manufacturing executives, we
estimate 5 of the 32 firms have a market share of 2.5 percent each, 1
has a market share of 7.5 percent, 1 has a market share of 15 percent,
and 1 has a market share of 25 percent. We could not find revenue data
for eight small entities. We display this information in table 37
below.
Table 37--Market Size of Small Entities Affected by the Rule
------------------------------------------------------------------------
Market share
Number of small entities of each entity
(%)
------------------------------------------------------------------------
24...................................................... 0.11
5....................................................... 2.5
1....................................................... 7.5
1....................................................... 15
1....................................................... 25
------------------------------------------------------------------------
In the RA, we estimate the annual cost of production inspections
across the whole industry to be $82,974. Because we do not know which
small entities will seek Level 50 approval, we estimate the additional
costs from production inspections from Level 50 device sales for each
small entity by multiplying each small entity's market share by the
total costs. For example, if we use a small entity that has a market
share of 0.11 percent, then we estimate the small entity's additional
production inspection costs to be about $91.27 ($82,974 x 0.0011,
rounded) annually.
Provision 3: Incorporation by Reference of ANSI/CAN/UL 9595
Incorporating ANSI/CAN/UL 9595 by reference establishes production
testing standards for the PFD manufacturing industry. ANSI/CAN/UL 9595
will lead to reductions in testing frequency for PFD manufacturing
entities with a QMS in place. We estimate that eight small entities
would be affected by this provision, seven of which have known revenue.
Small entities will experience one-time costs of an initial QMS
inspection, and ongoing costs because a QMS inspection is more
expensive than the facility inspection it replaces in subsequent years.
We estimate that each small entity has two facilities, with the largest
small entity having three facilities, and QMS inspection costs occur
per facility. In the RA, we estimate that the total costs to U.S. firms
for the ANSI/CAN/UL 9595 standard will be about $61,296 for 19
facilities. We estimate that 7 of the firms in the top 13 are small
entities, including the top firm. Because we do not know where each
small entity's facilities are located, to estimate each small entity's
one-time costs, we multiply $61,296 by each small entity's share of the
19 facilities, yielding $6,452 ((2 / 19) x $61,296) for all but the
largest small entity and $9,678 ((3 / 19) x $61,296) for the largest
small entity. We estimate annual costs to be about $439 per facility,
which is the difference between 8 hours of billed QMS inspector time
and 8 hours of a regular inspector's time.\36\ The largest small entity
has three facilities, so will experience $1,316 ($439 x 3) in
additional costs. All the other small entities have two facilities, and
they will experience $878 ($439 x 2) in annual costs. We reflect this
information in table 38.
---------------------------------------------------------------------------
\36\ Independent laboratories bill QMS inspections at $329.40
per hour, while they bill normal inspections at $274.50 per hour.
Thus, the additional cost is $54.90 per hour ($329.40-$274.50), or
$439 in an 8-hour workday ($54.90 x 8). See section 9.1.2 in the RA.
Table 38--Costs per Small Entity From UL 9595
----------------------------------------------------------------------------------------------------------------
Number of Total one-time
Entity type facilities costs Annual costs
----------------------------------------------------------------------------------------------------------------
The Largest..................................................... 3 $9,678 $1,317
All Others...................................................... 2 6,452 878
----------------------------------------------------------------------------------------------------------------
Small entities that achieve a higher process rating according to
the ANSI/CAN/UL 9595 standard will also experience annual cost savings
based on each small entity's market share and the rigor of the QMS
system in place. As mentioned previously, we estimate that only the top
13 firms will experience savings from ANSI/CAN/UL 9595, and we estimate
that 7 of those firms are small entities.
Cost savings will be different for each of the seven small
entities. To estimate the cost savings per small entity, we need to
estimate the number of reductions in inspections per small entity and
then multiply by $2,712 ($2,196 of billed inspector time and $516 of
weighted average quality manager loaded wages). To calculate the
reductions in inspections for each small entity, we take the share of
current inspections for each small entity and then estimate the number
of inspections that would take place under Process Rating A or B for
each small entity. Next, we subtract the reduced inspection frequency
per small entity from the current inspection frequency, yielding a
reduction in inspection frequency for current production. In the RA, we
also estimate that U.S. firms will experience 16 fewer inspections on
Level 50 devices that they do not yet produce, resulting in cost
savings from reduced inspection frequency. We then multiply the 16
inspections by each small entity's share of reduction in current
inspections.
For example, assume that a small entity had a 10-percent market
share, half of which would be at Process Rating A and half of which
would be at Process Rating B. We first take the total number of current
inspections on U.S. firms (587) and multiply by the small entity's
market share relative to the total affected U.S. market share, or 10
percent
[[Page 97383]]
/ 77.5 percent x 587, yielding 76 rounded. Then we derive the reduced
number of inspections at B and the reduced number of inspections at A
by multiplying the reduced inspection frequency at B (194) by the share
of the small entity's Process Rating at B relative to all other U.S.
firms at B, or 5 percent / 51 percent, yielding 19 rounded. To estimate
the reduced inspection frequency at A, we take the number of facilities
at A (one) and multiply by two, accounting for the number of
inspections that occur once the facility is at Process Rating A. Next,
we add to it the multiplication of the number of commercial PFD
production inspections at A (7) and the small entity's relative share
of production at A, or 5 percent / 26.5 percent, yielding 3 rounded (2
x 1) + (7 x 5 percent / 26.5 percent). Taken together, the small
entity's reduced inspection frequency is 22 (19 + 3), meaning the small
entity experiences 54 fewer production inspections annually (76-22). To
calculate the number of reduced Level 50 inspections for each small
entity, we take the small entity's share of U.S. firm inspection
reduction divided by the total estimated reduction in U.S. firm
inspections from Table 42 in the RA (54 / 376) and multiply by the 16
total reduction in inspections, yielding 2 rounded. We add the
reduction in Level 50 inspections (2) and the reduction in current
inspections (54) together and multiply by the cost of each inspection
($2,712), yielding $151,872 ((2+54) x $2,712), or the small entity's
annual cost savings from reduced inspection frequency. We perform this
process for each of the eight small entities. We record these
calculations in table 39; the results are rounded.
Table 39--Annual Cost Savings for a Representative Small Entity in 2023 Dollars
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Total market share Market Market Current inspection Inspection Inspection inspection Reduced level 50 Total annual
share at B share at A frequency frequency at B frequency at A reduction inspections cost savings
A B = A / 2 C = A / 2 D = 587 x A / 77.5% E = 194 x B / 51% F = (2 x 1) + G = D-E-F H = G / 376 x 16 (G + H) x $2,712
(7 x C / 26.5%)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
10%.................................................... 5% 5% 76 19 3 54 2 $151,872
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Provision 4: Replacement of Information Pamphlets With Booklets
We did not estimate any costs or cost savings from this provision,
so we do not estimate that there will be any impact on small entities.
We summarize the number of small entities affected, cost impacts,
cost savings impacts, and transfers per provision in table 40.
Table 40--Number of Affected Small Entities, Costs, and Cost Savings per Provision
----------------------------------------------------------------------------------------------------------------
PFD manufacturing
Provision population affected Costs Cost savings
----------------------------------------------------------------------------------------------------------------
ANSI/CAN/UL 12402-4 \37\........... 7 small entities of One-time testing to Level One-time testing to
the 30; 6 small 100 will cost $5,050 Level 100 will be
entities with known more than testing to $42,150 less than
revenues. Legacy Type I standards testing to Type I
for entities wishing to standards for entities
sell in only Canada or wishing to sell in both
the United States. the United States and
Canada. Small entities
will also save costs
from cheaper revisions
with and without
testing, $5,594 and
$1,373 respectively.
Together, small
entities will save
$49,117. Small entities
will also experience
$1,338 in annual cost
savings from reduced
facility inspections.
ANSI/CAN/UL 12402-5 \38\........... 32 small entities, 24 One-time (initial year) No estimated cost
small entities with testing to Level 50 savings for these small
known revenues. standards will cost entities.
about $39,840.
Additional ongoing costs
from inspections will be
between $91.27 and
$20,743.50 based on each
small entity's market
share (small entities
with larger market
shares will experience
greater costs).
ANSI/CAN/UL 9595 \39\.............. 8 small entities, 7 One-time (initial year) Small entities will save
small entities with cost from an additional through reduced
known revenues. QMS inspection of about inspection frequencies
$9,678.32 for the based on each small
largest small entity entity's market share
based on three and each small entity's
facilities and $6,452.21 QMS in place. We
for all other small estimate these 8 small
entities with two entities will
facilities. Ongoing experience between
(annual) costs will $24,408 and $265,776 in
result from a QMS savings per year based
inspection and will be upon their market share
more than a regular and QMS ratings.
inspection. We estimate
ongoing costs to be
about $439 per facility
or $1,317 for the
largest small entity
with three facilities
and $878 for each other
small entity with two
facilities.
Information Pamphlets.............. 32 small entities, 24 No estimated costs....... No estimated cost
small entities with savings.
known revenues.
----------------------------------------------------------------------------------------------------------------
We provide a list of the range of costs, cost savings, and net cost
savings per entity in table 41. Because each entity is subject to a
different subset of provisions, this table should be interpreted as the
minimum and maximum, cost, cost savings, and net cost savings per
entity. Specifically, the cost, cost savings, and net cost savings rows
are the minimum or maximum observed across the range of entities.
[[Page 97384]]
Net cost savings is therefore not a function of the cost and cost
savings in Table 41. For example, the lowest net cost savings in Table
40, -$46,292.21, demonstrates a cost greater than the lowest cost that
will be experienced by an entity, or $39,840, which is why it is not
the lowest cost per entity. Similarly, lowest and highest ongoing
impacts do not necessarily match to the lowest and highest one-time
impacts. We are simply reporting the lowest and highest impacts per
entity across costs, cost savings, and net cost savings.
---------------------------------------------------------------------------
\37\ See Section 7 of the RA for more detail about the costs and
cost savings of ANSI/CAN/UL 12402-4. Numbers in this table may not
match precisely numbers in the RA as this FRFA adjust costs to be on
a per entity basis accounting for market share.
\38\ See Section 8 of the RA for more detail about the costs and
cost savings of ANSI/CAN/UL 12402-5. Numbers in this table may not
match precisely numbers in the RA as this FRFA adjust costs to be on
a per entity basis accounting for market share.
\39\ See Section 9 of the RA for more detail about the costs and
cost savings of ANSI/CAN/UL 9595. Numbers in this table may not
match precisely numbers in the RA as this FRFA adjust costs to be on
a per entity basis accounting for market share.
Table 41--Range of Impacts per Entity
----------------------------------------------------------------------------------------------------------------
One-time impacts Ongoing impacts
---------------------------------------------------------------
Lowest per Highest per Lowest per Highest per
entity entity entity entity
----------------------------------------------------------------------------------------------------------------
Cost............................................ $39,840.00 $54,568.32 $91.27 $71,177.50
Cost Savings.................................... .............. 49,117.00 .............. 267,114.00
Net Cost Savings................................ (46,292.21) 4,227.00 (47,870.27) 195,936.50
----------------------------------------------------------------------------------------------------------------
In table 42, we report the estimated overall net cost savings
revenue impact per small entity of this final rule across all
provisions.
Table 42--Percentage of Estimated Revenue Impact on Small Entities From Overall Impact (Net Cost Savings) of
This Final Rule
----------------------------------------------------------------------------------------------------------------
One-time net impacts Ongoing net impacts
-------------------------------------------------------------------------------
Portion of small Portion of small
% Revenue impact Small entities with entities with Small entities with entities with
known revenue known revenue known revenue known revenue
(%) (%)
----------------------------------------------------------------------------------------------------------------
<1.............................. 17 71 20 83
1-3%............................ 2 8 2 8
>3.............................. 5 21 2 8
----------------------------------------------------------------------------------------------------------------
(5) A description of the projected reporting, recordkeeping and
other compliance requirements of the rule, including an estimate of the
classes of small entities which will be subject to the requirement and
the type of professional skills necessary for preparation of the report
or record.
This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3520.
(6) A description of the steps the agency has taken to minimize the
significant economic impact on small entities consistent with the
stated objectives of applicable statutes, including a statement of the
factual, policy, and legal reasons for selecting the alternative
adopted in the final rule and why each one of the other significant
alternatives to the rule considered by the agency which affect the
impact on small entities was rejected.
The Coast Guard identified three alternatives:
(1) Incorporate ANSI/CAN/UL 12402-5 for the approval of Level 70
PFDs only, prohibiting the approval of Level 50 PFDs;
(2) Require placards instead of pamphlets; and
(3) Adopt ANSI/CAN/UL 12402-4 and ANSI/CAN/UL 12402-5 by policy.
Alternative 1: Incorporate by Reference ANSI/CAN/UL 12402-5 for Level
70 PFDs Only
Under the first alternative, we could have chosen to incorporate
ANSI/CAN/UL 12402-5 but limit approval to Level 70 PFDs only. Level 50
PFDs would not be eligible for Coast Guard approval and would not meet
carriage requirements on any vessel, severely restricting their use. If
the Coast Guard chose this alternative, the market for Level 50 devices
would not be viable because Level 50 devices would no longer partially
substitute for Level 70 or Type III devices. Small entities would be
unable to sell these new devices and would not experience a positive
revenue impact from this alternative.
As a result, we rejected this alternative because it does not
maximize small entities' revenue.
Alternative 2: Require Placards Instead of Pamphlets
We considered the alternative of requiring that PFD manufacturers
use placards instead of information pamphlets for the mandatory PFD
instructional materials. While the Coast Guard observes that the cost
of producing placards is generally less than the costs of producing
information pamphlets, the Coast Guard observes that some manufacturers
may not have switched to producing placards yet. As such, if we
required that manufacturers use placards, we could place undue burden
on small entities in the PFD industry by requiring that they acquire
new equipment to produce placards. We do not know how large these costs
could be, but small entities would experience greater compliance costs.
As a result, we ultimately rejected this alternative.
Alternative 3: Adopt ANSI/CAN/UL 12402-4 and ANSI/CAN/UL 12402-5 by
Policy
The third alternative we considered was to adopt ANSI/CAN/UL 12402-
4 and ANSI/CAN/UL 12402-5 by policy instead of incorporating them by
reference in the regulations. Under 46 CFR 159.005-7(c), the Coast
Guard has the authority to approve an item of equipment that does not
meet all the requirements of 46 CFR 160.055 if it has equivalent
performance characteristics. The Coast Guard has utilized this
authority to partially adopt ANSI/CAN/UL 12402-4 and ANSI/CAN/UL 12402-
5 by policy. However, because this authority is limited to the approval
of equipment with equivalent performance characteristics, we cannot
adopt the portion of standards not already equivalent to existing types
of equipment. In particular, Level 50 PFDs,
[[Page 97385]]
youth inflatable PFDs, and inflatable Level 100 PFDs cannot be approved
by policy because they are not equivalent to any current Coast Guard
standards. As a result, small entities would not receive the additional
revenue from the sale of Level 50 devices or the cost savings on Level
100 inflatable device approvals as compared to Type I device approvals.
For these reasons, we rejected this alternative.
C. Assistance for Small Entities
Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996, Public Law 104-121, we offer to assist small
entities in understanding this rule so that they can better evaluate
its effects on them and participate in the rulemaking. The Coast Guard
will not retaliate against small entities that question or complain
about this rule or any policy or action of the Coast Guard.
Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247).
D. Collection of Information
This rule calls for no new or revised collection of information
under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3520.
E. Federalism
A rule has implications for federalism under Executive Order 13132
(Federalism) if it has a substantial direct effect on States, on the
relationship between the National Government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this final rule under Executive Order
13132 and have determined that it is consistent with the fundamental
federalism principles and preemption requirements described in
Executive Order 13132. Our analysis follows.
It is well settled that States may not regulate in categories
reserved for regulation by the Coast Guard. It is also well settled
that all the categories covered in 46 U.S.C. 3306, 3703, 7101, and 8101
(design, construction, alteration, repair, maintenance, operation,
equipping, personnel qualification, and manning of vessels), as well as
the reporting of casualties and any other category in which Congress
intended the Coast Guard to be the sole source of a vessel's
obligations, are within the field foreclosed from regulation by the
States. The statutory authorities upon which this rulemaking is based--
46 U.S.C. 3306(a), 4102(a), 4302(a), and 4502(a) and (c)(2)(B)--are
areas in which Congress intended the Coast Guard to be the sole source
of a vessel's obligations and, as such, are within the field foreclosed
from regulation by the States. See, e.g., United States v. Locke, 529
U.S. 89 (2000) (finding that the states are foreclosed from regulating
tanker vessels), see also Ray v. Atla
[…truncated; see source link]Indexed from Federal Register on December 6, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.