Lifejacket Approval Harmonization, 21016-21058 [2023-06504]
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21016
Federal Register / Vol. 88, No. 67 / Friday, April 7, 2023 / Proposed Rules
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
Coast Guard, DHS.
Notice of proposed rulemaking.
AGENCY:
ACTION:
The Coast Guard proposes to
amend the approval requirements and
follow-up program requirements for
lifejackets by incorporating new
standards to replace existing legacy
standards. The Coast Guard further
proposes to amend lifejacket and
personal flotation device (PFD) carriage
requirements to allow for the use of
equipment approved to the new
standards and remove obsolete
equipment approval requirements. The
proposed amendments would
streamline the process for the approval
of PFDs and allow manufacturers the
opportunity to produce more innovative
equipment that would meet approval
requirements in both Canada and the
United States while also reducing the
burden of the approval process and the
production inspections on
manufacturing firms.
DATES: Comments and related material
must be received by the Coast Guard on
or before June 6, 2023.
ADDRESSES: You may submit comments
identified by docket number USCG–
2022–0120 using the Federal Decision
Making Portal at www.regulations.gov.
See the ‘‘Public Participation and
Request for Comments’’ portion of the
SUPPLEMENTARY INFORMATION section for
further instructions on submitting
comments.
Viewing material proposed for
incorporation by reference. Make
arrangements to view this material by
calling the person identified in the FOR
FURTHER INFORMATION CONTACT section of
this document.
FOR FURTHER INFORMATION CONTACT: For
further information about this document
call or email Jacqueline Yurkovich,
Coast Guard; telephone 202–372–1389,
email Jacqueline.m.yurkovich@uscg.mil.
SUPPLEMENTARY INFORMATION:
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SUMMARY:
Table of Contents for Preamble
I. Public Participation and Request for
Comments
II. Abbreviations
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III. Background, Basis, and Purpose
IV. Discussion of Proposed Rule
V. Incorporation by Reference
VI. Regulatory Analyses
A. Regulatory Planning and Review
B. Small Entities
C. Assistance for Small Entities
D. Collection of Information
E. Federalism
F. Unfunded Mandates
G. Taking of Private Property
H. Civil Justice Reform
I. Protection of Children
J. Indian Tribal Governments
K. Energy Effects
L. Technical Standards
M. Environment
I. Public Participation and Request for
Comments
The Coast Guard views public
participation as essential to effective
rulemaking, and will consider all
comments and material received during
the comment period. Your comment
may help shape the outcome of this
rulemaking. If you submit a comment,
please include the docket number for
this rulemaking, indicate the specific
section of this document to which each
comment applies, and provide a reason
for each suggestion or recommendation.
Submitting comments. We encourage
you to submit comments through the
Federal Decision Making Portal at
www.regulations.gov. To do so, go to
www.regulations.gov, type USCG–2022–
0120 in the search box, and click
‘‘Search.’’ Next, look for this document
in the Search Results column, and click
on it. Then click on the Comment
option. If you cannot submit your
material using www.regulations.gov, call
or email the person in the FOR FURTHER
INFORMATION CONTACT section of this
proposed rule for alternate instructions.
Viewing material in docket. To view
documents mentioned in this proposed
rule as being available in the docket,
find the docket as described in the
previous paragraph, and then select
‘‘Supporting & Related Material’’ in the
Document Type column. Public
comments will also be placed in our
online docket and can be viewed by
following instructions on the
www.regulations.gov Frequently Asked
Questions web page. That web page also
explains how to subscribe for email
alerts that will notify you when
comments are posted or if a final rule is
published. We review all comments
received, but we will only post
comments that address the topic of the
proposed rule. We may choose not to
post off-topic, inappropriate, or
duplicate comments that we receive.
Personal information. We accept
anonymous comments. Comments we
post to www.regulations.gov will
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include any personal information you
have provided. For more about privacy
and submissions in response to this
document, see the Department of
Homeland Security’s eRulemaking
System of Records notice (85 FR 14226,
March 11, 2020).
Public meeting. We do not plan to
hold a public meeting but we will
consider doing so if we determine from
public comments that a meeting would
be helpful. We would issue a separate
Federal Register notice to announce the
date, time, and location of such a
meeting.
II. Abbreviations
ANSI American National Standards
Institute
CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
IBR Incorporation by reference
IRFA Initial Regulatory Flexibility Analysis
ISO International Organization for
Standardization
NAICS North American Industry
Classification System
NBSAC National Boating Safety Advisory
Committee
NPRM Notice of proposed rulemaking
OMB Office of Management and Budget
PFD Personal flotation device
QMS Quality management system
RA Regulatory analysis
RFA Regulatory Flexibility Act
§ Section
SBA Small Business Administration
SOLAS International Convention for the
Safety of Life at Sea
U.S.C. United States Code
III. Background, Basis, and Purpose
The Coast Guard has statutory
authority under Title 46, U.S. Code,
Sections 3306(a) and (b), 4102(b),
4302(a) and (c), and 4502(a) and
(c)(2)(B), to prescribe regulations for the
design, construction, performance,
testing, carriage, use, and inspection of
lifesaving equipment on commercial
and recreational vessels. Under
Department of Homeland Security
(DHS) Delegation 00170.1, Revision No.
01.2, paragraph (II)(92)(b), the Secretary
delegated authority under these statutes
to the Commandant of the Coast Guard.
With this rulemaking, we are
proposing to incorporate the American
National Standards Institute (ANSI)
standards ANSI/CAN/UL 12402–5 for
Level 50 and Level 70 personal flotation
devices (PFDs), ANSI/CAN/UL 12402–4
for Level 100 PFDs, and ANSI/CAN/UL
9595 for quality assurance. In addition,
we propose to incorporate the ANSI/UL
1123 and ANSI/UL 1175 standards for
marine buoyant devices and inherently
buoyant and inflatable throwable PFDs,
respectively. The Coast Guard currently
approves inherently buoyant and
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inflatable throwable PFDs to these
standards as a matter of policy, so
incorporating them in the Code of
Federal Regulations (CFR) would not
result in any changes in practice but
would improve transparency.
We are also proposing to remove
portions of Title 46 in part 160 of the
CFR, where the newly incorporated
standards would supersede the previous
standards or requirements.
Additionally, we are proposing
amendments to lifesaving equipment
carriage requirements that would permit
the use of Level 50, Level 70, and Level
100 PFDs approved to the new
standards.
The Coast Guard actively participates
in the development of ANSI-accredited
industry consensus standards for
lifesaving equipment. In that capacity,
the Coast Guard has worked with
Transport Canada and United States and
Canadian stakeholders in the
development of the suite of harmonized
ANSI/CAN/UL standards to streamline
the process for approval of PFDs.
Additionally, the harmonization would
allow manufacturers the opportunity to
produce more innovative equipment
that would still meet approval
requirements in both Canada and the
United States. PFD manufacturers
largely drove the development of these
standards; therefore, we expect PFD
manufacturers to generally support this
proposed rulemaking.
To further those efforts, on September
22, 2014, the Coast Guard published a
final rule to remove references to type
codes in its regulations on the carriage
and labeling of Coast Guard approved
PFDs to facilitate the future
incorporation by reference (IBR) of new
industry consensus standards (79 FR
56491, September 22, 2014). In April
2017, the Coast Guard and Transport
Canada signed a Memorandum of
Understanding outlining an intended
cooperation for the approval of personal
lifesaving appliances that comply with
mutually acceptable standards, are
tested by mutually accepted conformity
assessment bodies or independent test
laboratories, and are covered by a
mutually acceptable follow-up program.
On August 17, 2018, the Coast Guard
published a notice in the Federal
Register (83 FR 41095) regarding a
policy letter and deregulatory savings
analysis on accepting the standard
ANSI/CAN/UL 12402–5 for Level 70
PFDs, not including inflatable PFDs for
use by persons less than 16 years old.
On November 15, 2019, the Coast Guard
published a notice (84 FR 62546) that
finalized this policy.
The Coast Guard published a final
rule (77 FR 19937, April 3, 2012)
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incorporating by reference updated
revisions of industry consensus
standards for PFDs including UL 1180,
‘‘UL Standard for Safety for Fully
Inflatable Recreational Personal
Flotation Devices,’’ Second Edition
(including revisions through December
3, 2010). The discussion and response to
comments in that rulemaking included
a discussion on inflatable PFDs for users
less than 16 years of age. UL 1180 limits
the approval of inflatable PFDs to
persons of at least 16 years of age, and
thus the final rule retained that age limit
for approved users of inflatable PFDs.
No age limit was included in the
regulatory text to allow for a possible
future rulemaking to incorporate by
reference a standard that sufficiently
addresses the needs of younger wearers.
categories of amendments below. If we
finalize this proposed rule, then under
46 U.S.C. 4302(b) the effective date of
provisions applying to recreational
vessels would be at least 180 days after
publication. For simplicity, we would
likely delay the effective date of the
entire rule until 180 days after
publication. We invite public comments
on that timing.
The National Boating Safety Advisory
Committee (NBSAC) was consulted
regarding the updated standards
proposed in this rule, as shown by
NBSAC Resolutions 2009–83–01 and
2011–87–01, and the revalidation of
those resolutions found in Resolution
2022–03–01. We also welcome
comments from NBSAC on this
proposed rule.
IV. Discussion of Proposed Rule
The Coast Guard is proposing seven
main amendments to our regulations:
(1) Adding new subpart 160.255 and
incorporating by reference ANSI/CAN/
UL 12402–4 for approval of Level 100
PFDs, and removing sections of subpart
160.055.
(2) Adding new subparts 160.264 and
160.276, which incorporate by reference
ANSI/CAN/UL 12402–5 for approval of
Level 50 and Level 70 PFDs without
additional buoyancy or age restrictions;
removing the sections of subparts
160.060, 160.064, and 160.076
pertaining to the approval of new
wearable PFDs; relocating the sections
pertaining to throwable PFDs from
subpart 160.064 to new subpart 160.045
and incorporating by reference ANSI/UL
1123 and ANSI/UL 1175; and removing
subpart 160.077 in its entirety.
(3) Incorporating by reference ANSI/
CAN/UL 9595 for quality assurance
requirements in subparts 160.045,
160.055, 160.060, 160.064, 160.076,
160.255, 160.264, and 160.276.
(4) Removing subparts 160.001,
160.002, 160.005, 160.047, 160.048, and
160.052, as these subparts are mostly or
entirely obsolete, and moving the
remaining relevant material from
subpart 160.001 to subpart 160.055.
(5) Amending lifesaving equipment
carriage requirements to include the
new approval categories, where
appropriate, and removing any
remaining references to type codes.
(6) Amending the requirements for
instruction pamphlets for PFDs to
include the placard specified in
subparts 160.055, 160.060, 160.255,
160.264, and 160.276.
(7) Amending the existing regulatory
text to make editorial corrections and
increase clarity.
We provide additional details and
discussion on each of these seven main
1. Add New Subpart, 46 CFR 160.255,
and Incorporate by Reference ANSI/
CAN/UL 12402–4
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We propose adding a new subpart,
160.255, to title 46 of the CFR. PFDs
approved under this new subpart would
meet the carriage requirements for
wearable PFDs for inspected vessels that
are neither on an international voyage
nor subject to the International
Convention for the Safety of Life at Sea
(SOLAS), uninspected commercial
vessels over 40 feet (12m) in length, and
uninspected passenger vessels.
Newly proposed subpart 160.255
contains structural and performance
requirements for approval of Level 100
PFDs, as well as requirements for
production inspections and quality
control, markings, information
pamphlets, and associated manuals.
ANSI/CAN/UL 12402–4 would be
incorporated by reference. PFDs
approved under this subpart could rely
upon inherently buoyant material,
inflation, or a combination of the two to
achieve the minimum buoyancy.
A Level 100 PFD has the same basic
requirements as a PFD meeting 46 CFR
160.055. The minimum amount of
buoyancy, basic mechanical properties,
and in-water performance requirements
are the same. However, ANSI/CAN/UL
12402–4 is less prescriptive regarding
the design requirements of a Level 100
PFD, so manufacturing firms would be
able to develop more innovative
designs. The marking requirements in
ANSI/CAN/UL 12402–4 specify
pictorial graphics to communicate the
performance of the PFD and warnings
for use. The Coast Guard conducted
research and focus groups to identify
issues with the Type code labels and to
evaluate multiple new pictorial labeling
options. Our research indicated that
people consistently preferred pictorial
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markings.1 Therefore, we expect this
marking format to be more easily
understandable to both Englishspeaking and non-English-speaking
populations.
ANSI/CAN/UL 12402–4 does not
require fully or partially inflatable Level
100 PFDs to provide redundant back-up
inflation chambers. Current regulations
require inflatable lifejackets under
approval series 160.176 to have at least
two inflation chambers and to reach
minimum in-water performance with
any one chamber deflated. These
inflatable lifejackets meet the
International Maritime Organization
Life-Saving Appliance code and are
intended for use on vessels subject to
SOLAS.
Back-up chambers were originally
required for inflatable lifejackets
intended for use on inspected vessels as
an additional safety measure in case the
primary inflation chamber failed to
inflate (54 FR 50320). In that
rulemaking, the Coast Guard noted that
we would continue discussions with
industry, standards organizations, and
state boating law administrators
regarding the reliability of inflatable
PFDs. We also indicated that when new
developments or innovations reduced
the risk of inflation failure to an
acceptable level, we could address this
issue with a subsequent rulemaking.
Since the publication of that rule in
1989, the Coast Guard has no evidence
that a well-maintained PFD with a
single inflation chamber is less reliable
than an inherently buoyant PFD.
Additionally, the Coast Guard has
approved inflatable PFDs without backup chambers under approval series
160.076. Such devices have been in use
in the United States on uninspected
commercial vessels less than 12 m in
length and recreational vessels and in
Canada on small vessels for over a
decade. Therefore, the Coast Guard
believes that the material testing of the
PFD components coupled with the
required annual servicing of inflatable
Level 100 PFDs is sufficient, and that
redundant back-up inflation chambers
are not necessary to provide an
equivalent level of safety to PFDs
meeting 46 CFR 160.055.
Because newly proposed subpart
160.255 would supersede the
requirements for life preservers in
subpart 160.055, we propose to delete
structural and performance
requirements for approval of life
preservers in subpart 160.055, but
1 ‘‘Revision of Labeling and Classification for
Personal Flotation Devices (PFDs),’’ Applied Safety
& Ergonomics, Inc., December 28, 2004, Young et
al.
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maintain the requirements for
production inspections, tests, and
quality assurance. Manufacturers could
continue to produce life preservers
currently approved under subpart
160.055, while all new lifejackets would
require Coast Guard approval under
new subpart 160.255.
At the same time, we propose to
restructure subpart 160.055 to include a
statement of the subpart’s scope and to
mirror the structure of other PFD-related
subparts. We would add the scope as
§ 160.055–1 and definitions in
§ 160.055–3, and the documents
incorporated by reference would be
moved from § 160.055–1 to § 160.055–5.
Because no new approvals would be
granted under § 160.055, we propose to
remove existing requirements for
materials and construction, marking,
and procedure for approval, including
current 46 CFR 160.055–3, 160.055–4,
160.055–5, 160.055–6, 160.055–8, and
160.055–9. We propose independent
laboratory requirements for addition in
§ 160.055–11. We would move
sampling, tests, and inspections from
§ 160.055–7 to newly created § 160.055–
15 and pamphlet requirements would be
included in new § 160.055–19.
Procedures for the approval of design or
material changes would be included in
new § 160.055–23 and information on
suspension or termination of approval
would be included in new § 160.055–25.
2. Add New Subparts 46 CFR 160.045,
160.264, and 160.276, and Incorporate
by Reference ANSI/CAN/UL 12402–5,
ANSI/UL 1123, and ANSI/UL 1175
We propose three new subparts in
Title 46 of the CFR: 160.045, 160.264,
and 160.276. PFDs approved under
these subparts would meet the carriage
requirements for uninspected
commercial vessels less than 40 feet
(12m) in length and not carrying
passengers for hire, and recreational
boats, in accordance with 33 part CFR
175 and 46 CFR subpart 25.25.
Newly proposed 46 CFR 160.264
contains structural and performance
requirements for approval of Level 50
and Level 70 inherently buoyant PFDs,
as well as requirements for production
inspections and quality control,
markings, information pamphlets, and
associated manuals. Newly proposed 46
CFR 160.276 contains structural and
performance requirements for approval
of Level 50 and Level 70 fully and
partially inflatable recreational PFDs, as
well as requirements for production
inspections and quality control,
associated manuals, information
pamphlets, and markings. ANSI/CAN/
UL 12402–5 would be incorporated by
reference in both subparts.
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ANSI/CAN/UL 12402–5 prescribes
minimum performance requirements
instead of prescribing design
requirements. These performance-based
standards allow manufacturing firms to
design more innovative, comfortable,
and stylish PFDs. New PFD designs
could lead to more individuals choosing
to wear their PFDs, resulting in fewer
drownings.2 Drowning is the leading
cause of death in recreational boating
accidents, accounting for 79 percent of
all recreational boating casualties where
the cause of death is known.3 Of those
who drowned, 86 percent were not
wearing a lifejacket. Wearing a lifejacket
is one of the best means available of
preventing accidental drowning in
recreational boating. Unfortunately,
recreational boaters only wear
lifejackets about 24 percent of the time.4
Discomfort, whether real or perceived,
is negatively associated with PFD wear.5
ANSI/CAN/UL 12402–5 allows
manufacturers more flexibility when
selecting materials, design, and
construction of new PFDs. Because
manufacturers would be less limited in
the materials, design, and construction,
we expect new PFDs might be slimmer,
lighter in weight, or more comfortable to
wear than PFDs approved under the
current requirements.
In our 2018 policy letter, the Coast
Guard determined that Level 70
inherently buoyant devices, Level 70
inflatable devices, and Level 70 multichamber devices that meet the
requirements of ANSI/CAN/UL 12402–5
provide equivalent performance to
wearable PFDs meeting 46 CFR 160.064
or 160.076.
Now, the Coast Guard is proposing
this rule based on our assessment that
2 Readers should reference the National Center for
Biotechnology Information (NCBI), which is part of
the National Library of Medicine (NLM) at the
National Institutes of Health (NIH), and perform a
literature search for articles on the topic of PFDs
and their usage. Readers can access this website at
https://pubmed.ncbi.nlm.nih.gov. More specifically,
readers should reference the following articles for
further information: ‘‘Personal, social, and
environmental factors associated with lifejacket
wear in adults and children: A systematic literature
review’’ (https://www.ncbi.nlm.nih.gov/pmc/
articles/PMC5931488) and ‘‘Barriers to life jacket
use among adult recreational boaters’’ (https://
www.ncbi.nlm.nih.gov/pmc/articles/PMC4310692).
3 United States Coast Guard, ‘‘2019 Recreational
Boating Statistics.’’ https://uscgboating.org/library/
accident-statistics/Recreational-Boating-Statistics2019.pdf.
4 United States Coast Guard, ‘‘2019 Life Jacket
Wear Rate Observation Study.’’ https://
uscgboating.org/library/national-live-jacket-wearstudy/2019-Life-Jacket-Wear-Rate-Report.pdf.
5 Amy Peden, Daniel Demant, Martin Hagger, and
Kyra Hamilton, ‘‘Personal, social, and
environmental factors associated with lifejacket
wear in adults and children: A systematic literature
review.’’ https://www.ncbi.nlm.nih.gov/pmc/
articles/PMC5931488/.
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a Level 50 PFD, when worn and used in
accordance with the label, provides an
equivalent level of safety as a wearable
PFD meeting subpart 160.064 or
160.076. A Level 50 PFD has a lower
minimum amount of buoyancy than the
current minimum requirement for Coast
Guard approved PFDs. However, ANSI/
CAN/UL 12402–5 requires that a Level
50 PFD keep the user’s airway above the
water, as demonstrated by in-water
performance testing. A Level 50 PFD is
intended for use by those who can swim
and who have help or rescue nearby. As
required in ANSI/CAN/UL 12402–5,
Level 50 PFDs must be marked: ‘‘Not
recommended for weak or nonswimmers.’’ Every PFD offered for sale
must have a placard providing users
with information on how to select the
appropriate PFD, and reminding users
to try the PFD on in the water to ensure
proper fit and performance. To satisfy
requirements of ANSI/CAN/UL 12402–
5, Level 50 PFDs must be worn and
must be marked: ‘‘Approval conditions
state that this device must be worn to
be counted as equipment required by
vessels meeting Transport Canada or
USCG regulations.’’ A Level 50 PFD,
when worn by a person who can swim
and used in accordance with ANSI/
CAN/UL 12402–5, provides an
equivalent level of safety as a PFD
meeting 46 CFR 160.064 or 160.076. By
approving Level 50 PFDs, the Coast
Guard would provide a critical level of
oversight to the currently unregulated
Level 50 competition watersports PFDs,
resulting in safer products for the
public.
In this proposed rule, we are not
proposing additional requirements that
would limit users of inflatable PFDs
based on age. There are already
requirements in ANSI/CAN/UL 12402–
5 addressing inflatable PFDs for users
less than 16 years of age. To be certified
as meeting ANSI/CAN/UL 12402–5, an
inflatable PFD intended for wearers less
than 16 years of age must automatically
inflate, must not require secondary
donning, must be worn, and must
include a warning statement about adult
supervision. The Coast Guard believes
these requirements are adequate to
ensure safety for wearers less than 16
years of age, so we are proposing to fully
incorporate ANSI/CAN/UL 12402–5
without any additional age restrictions
beyond those included in the standard.
New proposed subparts 160.264 and
160.276 would supersede the
requirements for foam buoyant vests in
subpart 160.060, marine buoyancy
devices in subpart 160.064, inflatable
recreational personal flotation devices
in subpart 160.076, and hybrid
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inflatable personal flotation devices in
subpart 160.077.
We propose removing the structural
and performance requirements for the
approval of foam buoyant vests, marine
buoyant devices, and inflatable
recreational flotation devices in
subparts 160.060, 160.064, and 160.076,
respectively, but retaining the
requirements for production
inspections, tests, and quality control of
wearable PFDs. We are proposing to
delete subpart 160.077 entirely and
modify the scope of subpart 160.076 to
include PFDs previously approved
under subpart 160.077. By retaining the
requirements for production
inspections, tests, and quality control,
the Coast Guard would ensure that
manufacturing firms producing PFDs
currently approved under approval
series 160.060, 160.064, 160.076, or
160.077 could continue to manufacture
and sell these PFDs, but would not
approve new products under these
approval series. At the same time, we
are proposing to reformat the remaining
text of subparts 160.060, 160.064, and
160.076, without amending the
language, to align with the other
subparts related to PFDs and increase
the ease of understanding for the reader.
To eliminate confusion over approval
categories, we are proposing to relocate
the requirements for throwable PFDs
from subpart 160.064 to newly proposed
subpart 160.045. Newly proposed
subpart 160.045 would be dedicated to
throwable PFDs intended for carriage on
recreational boats. We propose to permit
the use of inflatable compartments to
meet the minimum required buoyancy
in § 160.045–7. This proposed new
subpart would incorporate by reference
the ANSI/UL 1175 standard for
inherently buoyant and inflatable
throwable PFDs and the ANSI/UL 1123
standard for marine buoyant devices.
The Coast Guard already approves
throwable PFDs to these standards; we
are formally incorporating them by
reference in this rulemaking to increase
clarity and transparency of the approval
requirements.
3. Incorporate by Reference ANSI/CAN/
UL 9595
We propose to incorporate by
reference new industry consensus
standard ANSI/CAN/UL 9595,
‘‘Standard for factory follow-up of
Personal Flotation Devices (PFDs)’’
(First Edition, June 4, 2020), into
subparts 160.055, 160.060, 160.064,
160.076, 160.255, 160.264, and 160.276.
This standard covers the basic elements
of a production inspection program for
various types of PFDs.
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The Coast Guard currently requires a
satisfactory follow-up (production
testing and inspection) program
administered by an independent
laboratory recognized by the Coast
Guard for each approved PFD. A task
group of experts and stakeholders
convened over the past decade to
develop ANSI/CAN/UL 9595 to improve
the consistency of follow-up programs
among different recognized independent
laboratories and to provide a binational
harmonized standard for production
testing acceptable to the Coast Guard
and Transport Canada. ANSI/CAN/UL
9595 establishes a set of Process Ratings
(A, B, and C) based on the quality
management system (QMS) at each
facility. Process Rating C is equivalent
to current industry practice for followup programs and meets the current
minimum requirements. Process Rating
B is assigned to facilities with a good
QMS including a Quality Manual that
incorporates the requirements in ANSI/
CAN/UL 9595 but is not approved by a
third party. Process Rating A is reserved
for facilities that have demonstrated a
superior QMS that meets International
Organization for Standardization (ISO)
standard ISO 9001 or a comparable
quality standard, either by audits or
acceptance of a third-party registration.6
For Process Rating C, ANSI/CAN/UL
9595 provides a minimum requirement
for production inspections that is
equivalent to the production inspection
programs currently accepted by the
Commandant. For Process Ratings A
and B, this standard provides the option
for the manufacturer to implement a
QMS to reduce the number of
inspections required. ANSI/CAN/UL
9595 sets forth roles and
responsibilities; required tests, sample
sizes, and acceptability criteria; and
specific requirements for inspection
frequency, traceability of components,
critical dimensions verification, visual
inspection of completed PFDs, and
review of records. Annex A provides
test methods and Annex B provides
information on the elements of a QMS.
We propose to include ANSI/CAN/UL
9595 in the newly proposed subparts
and in existing subparts 160.055,
160.060, 160.064, and 160.076, to allow
manufacturers that implement a QMS to
be evaluated as Process Rating A or B,
resulting in fewer required inspections.
A QMS can result in greater production
consistency, a reduction in defects and
errors, increased efficiency, and
continuous improvement.
6 For more information on process ratings, see the
preliminary regulatory analysis in the docket.
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4. Remove Obsolete Material and
Relocate Pertinent Material
We propose to remove subparts
160.002, 160.005, 160.047, 160.048, and
160.052, while also removing or
relocating the entirety of subpart
160.001.
Subpart 160.001 provides general
requirements for all life preservers. Most
of this information is either obsolete or
found elsewhere in the CFR. We
propose to delete subpart 160.001,
preserving the still-pertinent
information on production oversight by
relocating it to § 160.055–15.
Subpart 160.006 provides two
paragraphs related to the repairing of
life preservers. Subpart 160.006 is no
longer relevant and is not referenced in
any approval or carriage requirement;
therefore, we propose to remove it.
Subparts 160.002, 160.005, 160.047,
and 160.048 provide specifications and
requirements for kapok and fibrous glass
life preservers. Subpart 160.052
provides specifications and
requirements for a unicellular plastic
foam buoyant vest. Manufacturers no
longer produce any of these types of life
preservers due to the unavailability of
material, the advancement of foam
technology, and improvements to the fit
and function of PFDs industry-wide.
With no current approvals for
equipment under any of these subparts,
these approval categories have become
obsolete. Therefore, we propose to
delete subparts 160.002, 160.005,
160.047, 160.048, and 160.052. All new
PFD approvals would have to meet the
requirements in proposed subparts
160.255, 160.264, and 160.276, which
incorporate current industry standards.
ddrumheller on DSK120RN23PROD with PROPOSALS3
5. Amend Lifesaving Equipment
Carriage Requirements
Where current carriage requirements
specify approval series for PFDs, we
propose to add the new proposed
approval series, as applicable. The
affected Subchapters are Subchapter C
(uninspected commercial vessels),
Subchapters K and T (small passenger
vessels), Subchapter L (offshore supply
vessels), Subchapter M (towing vessels),
and Subchapter W (lifesaving
appliances for certain inspected
vessels).
For example, according to the current
requirements, an uninspected vessel
carrying passengers for hire must have
at least one PFD approved under
approval series 160.055, 160.155, or
160.176 for each person on board. We
propose to add approval series 160.255
to the list of approval series, to permit
the use of PFDs approved under this
new approval series. We are not
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proposing to remove any of the
currently accepted approval series from
the carriage requirements. Therefore, it
would not be necessary for owners and
operators to purchase new equipment if
their current equipment is in good and
serviceable condition.
We also propose to remove references
to PFDs approved under approval series
160.177 because there have never been
any approvals granted under that series.
All new commercial PFDs, including
commercial hybrid PFDs, would be
approved under approval series
160.255.
6. Amend the Requirements for
Instruction Pamphlets for PFDs
We propose to amend the
requirements for instruction pamphlets
for PFDs in 33 CFR 181 to allow both
pamphlets and placards to meet the
requirements for information furnished
with each PFD sold or offered for sale
for use on recreational boats. As
previously described, we propose to
incorporate both ANSI/CAN/UL 12402–
4 and ANSI/CAN/UL 12402–5 with
respect to the approval of PFDs. Both
these standards require that a PFD
include an informational placard in a
pictographic format containing specific
information on PFD performance,
selection, approval, and maintenance, as
well as general water safety information.
To permit the placard to be used in
place of the currently required
pamphlet, the Coast Guard is proposing
to add the term ‘‘placard’’ to 33 CFR
181.701–702. We also propose to
remove 33 CFR 181.703, which requires
that placards conform with UL 1123,
and would add text to 33 CFR 181.702
specifying that a pamphlet or placard
must meet the requirements in the
applicable subpart of 46 CFR part 160 or
be accepted by the Commandant. All
currently approved PFDs have
pamphlets or placards that have been
accepted by the Commandant.
Removing 33 CFR 181.703 would
eliminate all references to UL 1123 in
this subpart, so we would remove 33
CFR 181.4, which incorporates that
standard, as well. Finally, we propose to
remove the separate requirements for
hybrid and inflatable PFDs in 33 CFR
181.704 and 181.705, respectively, and
include requirements for all PFDs in 33
CFR 181.702.
7. Amend the Existing Regulatory Text
To Make Editorial Corrections and
Increase Clarity
We propose to update the
introductory IBR text, in accordance
with current practice, in 46 CFR
160.055, 160.060, 160.064, and 160.076.
We propose to amend table 28.110 to
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replace ‘‘Do’’ (meaning ‘‘ditto’’) with the
actual text to clarify the requirements in
plain language, and to remove
references to type codes from the table
without modifying the intent or
application of the requirements. We
further propose to remove reference to
approval series 160.177 in 46 CFR 108,
133 and 199, because this unused
approval series does not exist, and to
remove outdated provisions allowing
cork and balsa wood lifejackets until
March 11, 1999, from 46 CFR 117 and
180. Finally, we are proposing to
consistently use the term ‘‘lifejacket’’ by
amending instances of ‘‘life jacket’’ from
two words to one.
V. Incorporation by Reference
Material proposed for IBR appears in
46 CFR 160.045, 160.055, 160.060,
160.064, 160.076, 160.255, 160.264, and
160.276. The standards proposed for
IBR are summarized in section IV,
paragraphs (1) through (3), of this
preamble. They are:
(1) ANSI/CAN/UL 9595:2021, Standard for
Factory Follow-Up on Personal Flotation
Devices (PFDs), First Edition, June 4,
2020 (including revisions through
September 9, 2021) (‘‘ANSI/CAN/UL
9595’’). This standard specifies the basic
elements of a production inspection
program for various types of PFDs.
(2) ANSI/CAN/UL 12402–4:2020, Standard
for Personal Flotation Devices—Part 4:
Lifejackets, Performance Level 100—
Safety Requirements, First Edition, July
9, 2020 (‘‘ANSI/CAN/UL 12402–4’’).
This standard specifies safety
requirements for Level 100 lifejackets for
use by adults, children, and infants.
(3) ANSI/CAN/UL 12402–5:2022, Standard
for Personal Flotation Devices—Part 5:
Buoyancy Aids (Level 50)—Safety
Requirements, First Edition, December
31, 2015 (including revisions through
January 27, 2022) (‘‘ANSI/CAN/UL
12402–5’’). This standard specifies safety
requirements for Level 50 and Level 70
buoyancy aids for use by children and
adults.
(4) ANSI/UL 1123, Standard for Marine
Buoyant Devices, Seventh Edition,
October 1, 2008 (including revisions
through November 23, 2020) (‘‘ANSI/UL
1123’’). This standard specifies
requirements for marine buoyant devices
intended for recreational use.
(5) ANSI/UL 1175, Standard for Buoyant
Cushions, Fourth Edition, April 20, 2007
(including revisions through January 10,
2020) (‘‘ANSI/UL 1175’’). This standard
specifies construction, performance, and
markings requirements for inherently
buoyant and inflatable throwable PFDs.
These standards are reasonably
available to, and usable by, the class of
persons affected by this proposed rule.
PFD manufacturing firms have access to
these standards in their normal course
of business. These standards are
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available for free digital viewing with
the creation of a free account at https://
shopulstandards.com. Copies of the
material are also available for purchase
from the publishers listed in 46 CFR
160.045, 160.055, 160.060, 160.064,
160.076, 160.255, 160.264, and 160.276.
In addition, any person may view the
standards at a Coast Guard facility, by
making arrangements with the person in
the FOR FURTHER INFORMATION CONTACT
section of this preamble. Before
publishing a final rule, we will submit
this material to the Director of the
Federal Register for approval of the IBR.
We are also accepting comments on
whether you use the substance of these
standards, or if certain standards can be
simply referenced where we no longer
need to incorporate the full text of the
reference.
VI. Regulatory Analyses
We developed this proposed rule after
considering numerous statutes and
Executive orders related to rulemaking.
We have prepared a full regulatory
analysis (RA) based on these statutes
and Executive orders and have placed it
in the docket; a summary of our analysis
follows.
A. Regulatory Planning and Review
Executive Orders 12866 (‘‘Regulatory
Planning and Review’’) and 13563
(‘‘Improving Regulation and Regulatory
Review’’) direct agencies to assess the
costs and benefits of available regulatory
alternatives and, if regulation is
21021
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). Executive Order 13563
emphasizes the importance of
quantifying both costs and benefits, of
reducing costs, of harmonizing rules,
and of promoting flexibility.
The Office of Management and Budget
(OMB) has not designated this proposed
rule a significant regulatory action
under section 3(f) of Executive Order
12866. OMB has not reviewed this
proposed rule. A regulatory analysis
(RA) is available in the docket and a
summary follows. Table 1 summarizes
the impacts of this rulemaking.
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TABLE 1—SUMMARY OF IMPACTS OF THE PROPOSED RULE
Category
Summary
Applicability ...............................................................................................
IBR of ANSI/CAN/UL 9595, ANSI/CAN/UL 12402–5, and ANSI/CAN/UL
12402–4.
Affected Population ..................................................................................
2 recognized independent laboratories (1 U.S. and 1 foreign), 57 PFD
manufacturing firms (37 U.S. and 20 foreign), the Coast Guard, recreational vessel operators, and commercial vessel operators.
Costs to U.S. Firms ($2019, 7% discount rate) .......................................
10-year total: $1,401,108.
Annualized: $199,486.
Costs to Foreign Firms ($2019, 7% discount rate) ..................................
10-year total: $340,229.
Annualized: $48,441.
Total Costs ($2019, 7% discount rate) ....................................................
10-year total: $1,741,338.
Annualized: $247,927.
Cost Savings to U.S. Firms ($2019, 7% discount rate) ...........................
10-year total: $5,841,460.
Annualized: $831,693.
Cost Savings to Foreign Firms ($2019, 7% discount rate) ......................
10-year total: $1,453,901.
Annualized: $207,003.
Cost Savings to the U.S. Government ($2019, 7% discount rate) ..........
10-year total: $27,414.
Annualized: $3,903.
Total Cost Savings to All Entities ($2019, 7% discount rate) ..................
10-year total: $7,322,776.
Annualized: $1,042,599.
Net Cost Savings to U.S. Firms ($2019, 7% discount rate) ....................
10-year total: $18,405,217.
Annualized: $2,620,489.
Net Cost Savings to Foreign Firms ($2019, 7% discount rate) ...............
10-year total: $4,401,743.
Annualized: $626,709.
Net Cost Savings to the U.S. Government ($2019, 7% discount rate) ...
10-year total: $22,806,961.
Annualized: $3,247,198.
Net Cost Savings to All Entities ($2019, 7% discount rate) ....................
10-year total: $4,440,352.
Annualized: $632,206.
Unquantified Benefits ...............................................................................
The newer performance-based standards would allow for the development of more innovative PFD designs that might better meet boaters’
needs. New PFD designs that may be more form fitting, in addition
to the requirement that Level 50 devices be worn to count for carriage, could lead to higher PFD wear rates and additional lives saved
from drowning. Placards are cheaper to produce than pamphlets and
provide pictorial instructions, understandable by non-English reading
populations.
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The Coast Guard proposes to
harmonize its approval process for PFDs
with that of Canada, resulting in cost
savings from eliminating duplicative
requirements. The proposed rule would
introduce harmonized performance
standards instead of design standards
for PFDs, allowing manufacturers the
opportunity to produce more innovative
equipment that meets the approval
requirements of both Canada and the
United States. The proposed rule would
amend PFD approval and follow-up
program requirements by incorporating
three new binational standards into
regulations, amend PFD carriage
requirements to allow for the use of
equipment approved to the new
standards, and remove obsolete
equipment approval requirements. The
proposed performance-based standards
are more current and intended to
replace the legacy design standards. The
proposed amendments would
streamline the process for approval of
PFDs and allow manufacturers the
opportunity to produce more innovative
equipment that meets the approval
requirements of Canada and the United
States, while reducing the burden for
manufacturers in the approval process
and follow-up program.
Specifically, the Coast Guard
proposes to incorporate by reference the
following binational industry consensus
standards:
1. ANSI/CAN/UL 12402–4. This
binational standard specifies the safety
requirements for lifejackets that provide
face-up flotation for use in sheltered or
calm water, where users may have to
wait for rescue. A lifejacket meeting the
requirements of ANSI/CAN/UL 12402–4
provides an equivalent level of safety to
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a lifejacket currently approved under 46
CFR subpart 160.055.
2. ANSI/CAN/UL 12402–5. This
binational standard specifies the safety
requirements for buoyancy aids used in
sheltered waters with help and rescue
nearby. A PFD meeting the requirements
of ANSI/CAN/UL 12402–5 provides an
equivalent level of safety as a PFD
currently approved under 46 CFR
160.064 or 160.076.
3. ANSI/CAN/UL 9595. This
binational standard covers the basic
elements of a production inspection
program for various types of PFDs, and
formalizes and modifies current
industry standards.
Additionally, the Coast Guard
proposes to incorporate two national
standards (ANSI/UL/1123 and ANSI/
UL/1175) and to amend numerous CFR
parts to remove obsolete PFD design
standards and update carriage
requirements to include PFDs approved
to the new proposed subparts. As
mentioned earlier, ANSI/UL/1123 and
ANSI/UL/1175 are both currently in use
as a matter of policy and are being
incorporated by reference for the sake of
clarity, so we do not estimate any costs
or benefits from their incorporation by
reference into the CFR. Similarly, we do
not anticipate any quantifiable costs or
benefits from the removal of obsolete
design standards, as these design
standards are not currently in use.
Affected Population
To determine the affected population
of the rule, it is first necessary to
describe the economic impacts from this
proposed rule. The economic impacts
would stem from the following
proposed provisions:
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(1) The IBR of ANSI/CAN/UL 12402–
4 in 46 CFR 160.255 to replace the
design requirements in 46 CFR 160.055.
(2) The IBR of ANSI/CAN/UL 12402–
5 in 46 CFR 160.264 and 160.276 to
replace the design standards in 46 CFR
160.064, 160.076, and 160.077.
(3) The IBR of ANSI/CAN/UL 9595 for
follow-up service into the PFD approval
requirements of existing subparts 46
CFR 160.055, 160.060, 160.064, 160.076
and new proposed subparts of 46 CFR
160.045, 160.255, 160.264, and 160.276.
(4) The proposed edits to 33 CFR 181
subpart G, which would permit
manufacturers of all PFDs to provide
placards instead of information
pamphlets.
These four provisions would affect
PFD manufacturers, the two recognized
independent laboratories, and the Coast
Guard. Before we present the affected
population for each of these provisions,
we present the overall PFD
manufacturing firm population.
As of 2021, there are over 800 models
of PFDs approved by the Coast Guard,
manufactured by 57 separate
manufacturing firms worldwide.7 Based
on a review of publicly available
information across the 57 manufacturing
firms, the Coast Guard estimates that 37
are U.S. firms and 20 are foreign firms.
Market share and production volumes
are not equal across the firms.8
7 The Coast Guard lists all approved products on
the Coast Guard Maritime Information Exchange
website, https://cgmix.uscg.mil/.
8 We used the headquarters location of a firm’s
parent company, as indicated on the company
website, to determine whether a firm was U.S. or
foreign.
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TABLE 2—DISTRIBUTION OF MARKET SHARE OF PFD MANUFACTURERS
Total market
share
(%)
Manufacturing firms
U.S. firm
market share
(%)
Foreign firm
market share
(%)
Top 5 Manufacturing Firms .........................................................................................................
Manufacturing Firms 6–13 ...........................................................................................................
All Other Manufacturing Firms .....................................................................................................
75
20
5
65.00
12.50
3.20
10.00
7.50
1.80
Total ......................................................................................................................................
100
80.70
19.30
The first provision, the IBR of ANSI/
CAN/UL 12402–4, would affect three
populations:
(1) PFD manufacturers that would
seek approval to manufacture devices
meeting the requirements of ANSI/CAN/
UL 12402–4;
(2) The two recognized independent
laboratories that would review and
certify these devices; and
(3) The Coast Guard, which would
correspond with the recognized
independent laboratories and
manufacturers on device approval.
In table 3, we list the number of PFD
manufacturing firms that would be
affected by ANSI/CAN/UL 12402–4. We
estimate that each of the top 13 firms
would produce ANSI/CAN/UL 12402–4
devices or components of those devices
at 2 facilities each and firms outside of
the top 13 firms would produce ANSI/
CAN/UL 12402–4 devices at 1 facility
each.9
TABLE 3—MANUFACTURING FIRMS AND FACILITIES IMPACTED BY ANSI/CAN/UL 12402–4
Firm ownership
U.S. firms
Foreign firms
U.S. associated
facilities
Foreign
facilities
Total facilities
Firms in top 13 .........................................................
All other firms ...........................................................
5
4
3
2
10
4
6
2
16
6
Total facilities ....................................................
9
5
14
8
22
In the second provision, by
incorporating by reference ANSI/CAN/
UL 12402–5, the Coast Guard would
introduce new categories for youth
inflatables and Level 50 PFDs for
approval. Permitting youth inflatables
and Level 50 devices would affect three
populations:
(1) PFD manufacturers that would
seek Coast Guard approval to produce
youth inflatables or Level 50 devices;
(2) The two recognized independent
laboratories that would review and
certify youth inflatables and Level 50
devices; and
(3) The boating public that would
purchase youth inflatables or Level 50
devices instead of Level 70 or Type III
devices, because youth inflatables and
Level 50 devices are likely to be more
form-fitting than Level 70 or Type III
devices.
In the third provision, the Coast
Guard intends to incorporate by
reference ANSI/CAN/UL 9595 covering
production inspections and inspection
frequency into multiple newly proposed
and existing subparts in Title 46, as
listed in table 4.
TABLE 4—PFDS IMPACTED BY ANSI/CAN/UL 9595
Subpart
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160.045
160.255
160.264
160.276
160.055
160.060
160.064
160.076
Proposed or
existing
subpart
PFD type
......................................................
......................................................
......................................................
......................................................
......................................................
......................................................
......................................................
......................................................
Throwable PFDs ...........................................................................................................
Level 100 PFDs ............................................................................................................
Inherently Buoyant Level 50 and Level 70 PFDs .........................................................
Inflatable Level 50 and Level 70 PFDs ........................................................................
Life Preservers ..............................................................................................................
Buoyant Vests ...............................................................................................................
Marine Buoyant Devices ...............................................................................................
Inflatable PFDs ..............................................................................................................
Proposed.
Proposed.
Proposed.
Proposed.
Existing.
Existing.
Existing.
Existing.
ANSI/CAN/UL 9595 establishes a set
of Process Ratings (A, B, and C) based
on the QMS at each facility. Process
Rating C is assigned to facilities with a
minimally compliant QMS. The
requirements for Process Rating C are
equivalent to the current minimum
requirements. Process Rating B is
assigned to facilities with a good QMS,
and Process Rating A is reserved for
facilities that have demonstrated a
superior QMS. Because Process Rating C
is equivalent to current industry
practice, the affected population for the
IBR of ANSI/CAN/UL 9595 would be
9 The PFD manufacturing firm does not
necessarily own the facilities where its products are
produced. Instead, the facility may be producing
PFDs on contract for the PFD manufacturing firm.
Additionally, much production for U.S. firms
occurs at overseas facilities. We call these ‘‘U.S.
Associated Facilities’’ not because they are in the
United States but because they have a longstanding
relationship with U.S. firms, while ‘‘Foreign
Facilities’’ have longstanding relationships with
foreign firms.
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any PFD manufacturer producing a
device approved under one of the
subparts listed in table 4 and eligible to
gain a Process Rating of A or B.
In table 5, we estimate the market
share likely to be at Process Rating A,
B, or C and whether they are foreign or
domestic firms.10 Because a QMS
system is expensive to set up, industry
stakeholders informed the Coast Guard
that firms are not expected to develop
a QMS solely to secure the cost savings
of ANSI/CAN/UL 9595. However, a
number of firms have already
established QMS systems at their
facilities because of other benefits, such
as production consistency and quality
control. The firms that have already
established a QMS system would
experience net cost savings from the
proposed IBR of ANSI/CAN/UL 9595.
As a result, we estimate the process
rating distribution recorded in table 5.
TABLE 5—MARKET SHARE OF PRODUCTION LIKELY TO BE AT EACH PROCESS RATING
Market share
(%)
Firm category
Process rating
U.S. Firms ................................................................................................................................................................
Foreign Firms ...........................................................................................................................................................
U.S. Firms ................................................................................................................................................................
Foreign Firms ...........................................................................................................................................................
U.S. and Foreign Firms ...........................................................................................................................................
A
A
B
B
C
26.5
15.0
51.0
2.5
5.0
........................
100.0
Total ..................................................................................................................................................................
The fourth provision, permitting the
option for placards to replace
instruction pamphlets, would affect all
firms manufacturing PFDs approved to
any of the categories in table 6 that list
placards as permitted under the
proposed rule.
TABLE 6—DEVICE CATEGORY AND PERMITTED INSTRUCTION TYPES
Device category
Types of instructions allowed by
the proposed rule
Types of instructions currently
in use
New Level 50 Devices (ANSI/CAN/UL 12402–5) ...................................
Placard ...........................................
New Level 70 Devices (ANSI/CAN/UL 12402–5) ...................................
New Level 100 Devices (ANSI/CAN/UL 12402–4) .................................
Placard ...........................................
Placard ...........................................
Existing
Existing
Existing
Existing
Placard or Information Pamphlet ...
Placard or Information Pamphlet ...
Placard or Information Pamphlet ...
Information Pamphlet ....................
N/A because these devices are
not yet produced.
Placard.
N/A because these devices are
not yet produced.
Information Pamphlet.
Information Pamphlet.
Information Pamphlet.
Information Pamphlet.
Type
Type
Type
Type
I Commercial Devices ......................................................
II Recreational Devices ....................................................
III Recreational Devices ...................................................
IV Throwable Devices ......................................................
ANSI/CAN/UL 12402–4
There are two sources of costs from
this provision: (1) independent
laboratories would need to train their
staff to these new standards and (2)
manufacturing firms that intend to sell
in only one market (the United States or
Canada) would experience additional
costs due to an increase in the cost of
testing according to ANSI/CAN/UL
12402–4 when compared to the cost of
testing to the legacy standards.11
We provide our estimate for the total
costs of the proposed IBR of ANSI/CAN/
UL 12402–4 to U.S. firms in table 7.
These costs would include $25,000 paid
by independent laboratories in the first
year to develop the instructions and
manuals on how to conduct the new
ANSI/CAN/UL 12402–4 testing and the
estimated $1,406 per year manufacturers
would spend on the more expensive
ANSI/CAN/UL 12402–4 certification as
opposed to the legacy certification.12
10 The process rating applies to a facility owned
by a PFD manufacturing firm. The lowest process
rating is C; if manufacturers seek a higher process
rating of A or B, then an independent laboratory
must certify that each facility owned by a
manufacturing firm meets the standard of the higher
rating, which is determined through an audit of a
facility. A PFD manufacturing firm incurs the cost
of a higher process rating at each facility. A PFD
manufacturing firm who currently has a QMS (at
least partially in place) would be able to seek a
higher process rating, A or B, for each facility it
owns (process rating C is the current baseline or
default rating and represents the current inspection
volume at facilities). A separate QMS inspection or
audit is necessary for this to occur. A higher process
rating would result in a reduction in the inspection
volume at facilities, which would save PFD
manufacturing firms money.
11 We estimate the increase in the cost of testing
based upon data provided by representatives of
independent laboratories.
12 We estimate the cost of Level 100 testing and
approval to be about $44,280 and we estimate the
cost for the new Type I approval to be about
$40,000. The Coast Guard estimates 0.45 new
approvals annually for products intended for sale
exclusively in the United States. Therefore, the total
additional cost to manufacturers for the more
expensive Level 100 certification would be about
$1,926 ($4,280 × 0.45). There are currently 51
products approved as Type I devices under 46 CFR
part 160.055, of which 37 (73 percent) are produced
by U.S. PFD firms and 14 (27 percent) are produced
by foreign PFD firms. Therefore, we estimate the
cost to U.S. PFD firms for the new UL 12402–4
approval would be about $1,406 annually ($1,926
× 0.73). We estimate the cost to foreign PFD firms
would be about $520 ($1,926 × 0.27) annually.
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TABLE 7—ESTIMATED COSTS TO U.S. FIRMS FOR LEVEL 100 DEVICES UNDER STANDARD ANSI/CAN/UL 12402–4
[2019 dollars, 10-year period of analysis]
Total
undiscounted
costs
Year
Discounted costs
7%
3%
1 ...................................................................................................................................................
2 ...................................................................................................................................................
3 ...................................................................................................................................................
4 ...................................................................................................................................................
5 ...................................................................................................................................................
6 ...................................................................................................................................................
7 ...................................................................................................................................................
8 ...................................................................................................................................................
9 ...................................................................................................................................................
10 .................................................................................................................................................
$26,406
1,406
1,406
1,406
1,406
1,406
1,406
1,406
1,406
1,406
$24,678
1,228
1,148
1,073
1,002
937
876
818
765
715
$25,637
1,325
1,287
1,249
1,213
1,177
1,143
1,110
1,078
1,046
Total ......................................................................................................................................
39,060
33,240
36,265
Annualized ............................................................................................................................
........................
$4,733
$4,251
We present the 10-year total costs to
foreign firms from the proposed IBR of
ANSI/CAN/UL 12402–4 in table 8.
Foreign firms would only experience
the additional approval costs of $520
per year.
TABLE 8—ESTIMATED COSTS TO FOREIGN FIRMS FOR LEVEL 100 DEVICES UNDER STANDARD ANSI/CAN/UL 12402–4
[2019 dollars, 10-year period of analysis]
Total
undiscounted
costs
Year
Discounted costs
7%
3%
1 ...................................................................................................................................................
2 ...................................................................................................................................................
3 ...................................................................................................................................................
4 ...................................................................................................................................................
5 ...................................................................................................................................................
6 ...................................................................................................................................................
7 ...................................................................................................................................................
8 ...................................................................................................................................................
9 ...................................................................................................................................................
10 .................................................................................................................................................
$520
520
520
520
520
520
520
520
520
520
$486
454
424
397
371
347
324
303
283
264
$505
490
476
462
449
436
423
411
399
387
Total ......................................................................................................................................
5,200
3,652
4,436
Annualized ............................................................................................................................
........................
520
520
We present the 10-year total costs to
U.S. and foreign firms from the
proposed IBR of ANSI/CAN/UL 12402–
4 in table 9.
TABLE 9—ESTIMATED TOTAL COST TO ALL FIRMS FOR LEVEL 100 DEVICES UNDER STANDARD ANSI/CAN/UL 12402–4
[2019 dollars, 10-year period of analysis]
Total
undiscounted
costs
ddrumheller on DSK120RN23PROD with PROPOSALS3
Year
Discounted costs
7%
3%
1 ...................................................................................................................................................
2 ...................................................................................................................................................
3 ...................................................................................................................................................
4 ...................................................................................................................................................
5 ...................................................................................................................................................
6 ...................................................................................................................................................
7 ...................................................................................................................................................
8 ...................................................................................................................................................
9 ...................................................................................................................................................
10 .................................................................................................................................................
$26,926
1,926
1,926
1,926
1,926
1,926
1,926
1,926
1,926
1,926
$25,164
1,682
1,572
1,469
1,373
1,283
1,199
1,121
1,048
979
$26,142
1,815
1,763
1,711
1,661
1,613
1,566
1,520
1,476
1,433
Total ......................................................................................................................................
44,260
36,892
40,701
Annualized ............................................................................................................................
........................
5,253
4,771
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Cost Savings
By adopting ANSI/CAN/UL 12402–4,
the Coast Guard would be able to
harmonize commercial PFD
requirements of the United States with
those of Transport Canada.
Harmonization of commercial PFD
standards would lead to cost savings for
PFD manufacturing firms through less
expensive approval requirements and
less frequent ongoing facility
inspections.
Additionally, as a performance-based
standard ANSI/CAN/UL 12402–4 would
allow for more innovative designs than
the current standards and regulations.
The newer performance-based standards
would allow for the development of
more innovative PFD designs that might
better meet boaters’ needs. The adoption
of a performance-based standard would
spare the Coast Guard from making the
equivalency determinations frequently
necessary when using the current
prescriptive requirements.
Consequently, the Coast Guard would
experience time savings from reducing
the review time of new device
applications during the approval
process.
In total, we estimate three sources of
quantifiable benefits in the form of cost
savings associated with the proposed
IBR of ANSI/CAN/UL 12402–4:
(1) The Coast Guard would spend less
time reviewing approval applications
and making equivalency determinations
for the approval of innovative PFDs
because ANSI/CAN/UL 12402–4 is a
performance-based rather than
prescriptive standard and would allow
more innovative designs to meet the
standard;
(2) All firms that would apply for
approval in both Canadian and United
States markets would save the
difference between one certification to
ANSI/CAN/UL 12402–4 and separate
United States and Canadian
certifications to legacy standards; and
(3) Manufacturing facilities producing
devices meeting the requirements of
ANSI/CAN/UL 12402–4 for the United
States and Canadian markets could be
inspected just once for both United
States and Canadian approval instead of
the current requirement to be inspected
twice, once for United States approval
and once for Canadian approval.
We summarize the total quantified
benefits for the cost savings of the
proposed IBR of ANSI/CAN/UL 12402–
4 by reporting the annual undiscounted
cost savings in table 10.
TABLE 10—ESTIMATED ANNUAL COST SAVINGS OF ANSI/CAN/UL 12402–4 TO THE INDUSTRY AND THE U.S.
GOVERNMENT
[2019 Dollars]
Cost savings
to U.S.
entities
Annual cost savings item
Cost savings
to foreign entities
Value of Coast Guard time saved ...........................................................................................................................
Canadian and United States approval savings .......................................................................................................
Billed facility inspection savings ..............................................................................................................................
Quality manager’s time saved .................................................................................................................................
$3,903
23,551
13,129
3,054
$0
8,711
7,502
1,182
Total ..................................................................................................................................................................
43,637
17,395
In table 11 and table 12, we record the
10-year cost savings from the proposed
adoption of ANSI/CAN/UL 12402–4 to
U.S. and foreign firms, separately. In
table 13, we record the total 10-year cost
savings from this proposed provision to
the U.S. government.
TABLE 11—ESTIMATED COST SAVINGS TO U.S. FIRMS FROM ANSI/CAN/UL 12402–4
[2019 Dollars, 10-year period of analysis]
Total
undiscounted
cost savings
ddrumheller on DSK120RN23PROD with PROPOSALS3
Year
Discounted cost savings
7%
3%
1 ...................................................................................................................................................
2 ...................................................................................................................................................
3 ...................................................................................................................................................
4 ...................................................................................................................................................
5 ...................................................................................................................................................
6 ...................................................................................................................................................
7 ...................................................................................................................................................
8 ...................................................................................................................................................
9 ...................................................................................................................................................
10 .................................................................................................................................................
$39,734
39,734
39,734
39,734
39,734
39,734
39,734
39,734
39,734
39,734
$37,135
34,705
32,435
30,313
28,330
26,476
24,744
23,126
21,613
20,199
$38,577
37,453
36,362
35,303
34,275
33,277
32,307
31,366
30,453
29,566
Total ......................................................................................................................................
397,340
279,075
338,939
Annualized ............................................................................................................................
........................
39,734
39,734
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TABLE 12—ESTIMATED COST SAVINGS TO FOREIGN FIRMS FROM ADOPTING ANSI/CAN/UL 12402–4
[2019 Dollars, 10-year period of analysis]
Total
undiscounted
cost savings
Year
Discounted cost savings
7%
3%
1 ...................................................................................................................................................
2 ...................................................................................................................................................
3 ...................................................................................................................................................
4 ...................................................................................................................................................
5 ...................................................................................................................................................
6 ...................................................................................................................................................
7 ...................................................................................................................................................
8 ...................................................................................................................................................
9 ...................................................................................................................................................
10 .................................................................................................................................................
$17,395
17,395
17,395
17,395
17,395
17,395
17,395
17,395
17,395
17,395
$16,257
15,193
14,200
13,271
12,402
11,591
10,833
10,124
9,462
8,843
$16,888
16,396
15,919
15,455
15,005
14,568
14,144
13,732
13,332
12,944
Total ......................................................................................................................................
173,950
122,175
148,383
Annualized ............................................................................................................................
........................
17,395
17,395
TABLE 13—ESTIMATED COST SAVINGS TO THE UNITED STATES GOVERNMENT OF ANSI/CAN/UL 12402–4
[2019 Dollars, 10-year period of analysis]
Total
undiscounted
cost savings
Year
Discounted cost savings
7%
3%
1 ...................................................................................................................................................
2 ...................................................................................................................................................
3 ...................................................................................................................................................
4 ...................................................................................................................................................
5 ...................................................................................................................................................
6 ...................................................................................................................................................
7 ...................................................................................................................................................
8 ...................................................................................................................................................
9 ...................................................................................................................................................
10 .................................................................................................................................................
$3,903
3,903
3,903
3,903
3,903
3,903
3,903
3,903
3,903
3,903
$3,648
3,409
3,186
2,978
2,783
2,601
2,431
2,272
2,123
1,984
$3,789
3,679
3,572
3,468
3,367
3,269
3,174
3,081
2,991
2,904
Total ......................................................................................................................................
39,032
27,414
33,295
Annualized ............................................................................................................................
........................
3,903
3,903
In table 14, we record the total
discounted, 10-year cost savings to the
U.S. and foreign PFD industry for the
ANSI/CAN/UL 12402–4 portion of this
proposed rule. We estimate this
proposed provision would save the U.S.
and foreign PFD industry about $57,129
annually and produce cost savings for
the industry of about $401,250 over a
10-year period of analysis using a 7percent discount rate.
TABLE 14—TOTAL ESTIMATED COST SAVINGS TO INDUSTRY OF THE PROPOSED RULE FOR ANSI/CAN/UL 12402–4
[2019 Dollars, 10-year period of analysis]
Total
undiscounted
cost savings
ddrumheller on DSK120RN23PROD with PROPOSALS3
Year
Discounted cost savings
7%
3%
1 ...................................................................................................................................................
2 ...................................................................................................................................................
3 ...................................................................................................................................................
4 ...................................................................................................................................................
5 ...................................................................................................................................................
6 ...................................................................................................................................................
7 ...................................................................................................................................................
8 ...................................................................................................................................................
9 ...................................................................................................................................................
10 .................................................................................................................................................
$57,129
57,129
57,129
57,129
57,129
57,129
57,129
57,129
57,129
57,129
$53,392
49,899
46,634
43,583
40,732
38,067
35,577
33,250
31,074
29,041
$55,465
53,850
52,281
50,758
49,280
47,845
46,451
45,098
43,785
42,509
Total ......................................................................................................................................
571,290
401,250
487,322
Annualized ............................................................................................................................
........................
57,129
57,129
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ANSI/CAN/UL 12402–5
Costs
The PFD industry would also incur an
increase in costs from this proposed rule
because, based on consultation with
industry experts, we estimate this rule
would increase the PFD market by 5
percent (meaning manufacturing firms
would seek new device approvals and
produce more devices).13 The Coast
Guard requests public comment on the
possibility that this rule would increase
the PFD market by 5 percent. We
estimate the costs of this proposed
provision as the costs of the additional
device approvals and the costs of the
additional production inspections for
the greater volume of production that
we estimate this rule would generate.14
We present in table 15, table 16, and
table 17 the discounted costs of
introducing Level 50 devices over the
10-year period of analysis to U.S. firms,
foreign firms, and all firms, respectively.
The tables include the estimated costs of
Level 50 devices approved and
inspected under the current inspections
regime. In Year 1, undiscounted costs
would only be the costs of Level 50
approval for manufacturers, or $521,751
for U.S. manufacturers and $124,781 for
foreign manufacturers. For Year 2, the
undiscounted costs would be the costs
of Level 50 approvals to manufacturers
($521,751 for U.S. firms and $124,781
for foreign firms) plus the cost of
inspections ($29,325 for U.S. firms and
$6,516 for foreign firms), for a total of
about $551,076 ($521,751 + $29,325) to
U.S. firms and $131,297 ($124,781 +
$6,516) to foreign firms. In Years 3–10,
the costs would be the cost of
inspections of $71,682 ($58,650 for U.S.
firms and $13,032 for foreign firms). The
estimated 10-year cost discounted at 7
percent would be $1,274,842 or
$181,509 annualized for U.S. firms, and
the 10-year cost discounted at 7 percent
would be $299,267 or $42,609
annualized for foreign firms.
TABLE 15—ESTIMATED COSTS TO U.S. FIRMS FROM INTRODUCING LEVEL 50 DEVICES
[2019 Dollars, 10-year period of analysis]
Total
undiscounted
costs
Year
Discounted costs
7%
3%
1 ...................................................................................................................................................
2 ...................................................................................................................................................
3 ...................................................................................................................................................
4 ...................................................................................................................................................
5 ...................................................................................................................................................
6 ...................................................................................................................................................
7 ...................................................................................................................................................
8 ...................................................................................................................................................
9 ...................................................................................................................................................
10 .................................................................................................................................................
$521,751
551,076
58,650
58,650
58,650
58,650
58,650
58,650
58,650
58,650
$487,618
481,331
47,876
44,744
41,817
39,081
36,524
34,135
31,902
29,815
$506,554
519,442
53,673
52,110
50,592
49,118
47,688
46,299
44,950
43,641
Total ......................................................................................................................................
1,542,027
1,274,842
1,414,068
Annualized ............................................................................................................................
........................
181,509
165,772
TABLE 16—ESTIMATED COSTS TO FOREIGN FIRMS FROM THE INTRODUCTION OF LEVEL 50 DEVICES
[2019 Dollars, 10-year period of analysis]
Total
undiscounted
costs
ddrumheller on DSK120RN23PROD with PROPOSALS3
Year
Discounted costs
7%
3%
1 ...................................................................................................................................................
2 ...................................................................................................................................................
3 ...................................................................................................................................................
4 ...................................................................................................................................................
5 ...................................................................................................................................................
6 ...................................................................................................................................................
7 ...................................................................................................................................................
8 ...................................................................................................................................................
9 ...................................................................................................................................................
10 .................................................................................................................................................
$124,781
131,297
13,032
13,032
13,032
13,032
13,032
13,032
13,032
13,032
$116,618
114,680
10,638
9,942
9,292
8,684
8,116
7,585
7,089
6,625
$121,147
123,760
11,926
11,579
11,242
10,914
10,596
10,288
9,988
9,697
Total ......................................................................................................................................
360,334
299,267
331,136
Annualized ............................................................................................................................
........................
42,609
38,819
13 As part of our discussion with PFD
manufacturing firms, we asked their representatives
whether the introduction of Level 50 devices would
lead to a net growth in the PFD market (inclusive
of substitution out of existing types of products).
Manufacturing firm representatives stated that they
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would expect the PFD market would grow by about
5 percent from this provision. We interpret the 5
percent growth as a one-time growth in the level of
manufacturing spread over a 2-year period.
14 We estimate the additional production
inspections based on the current production
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inspection requirements, and we estimate the
reduction in these inspections through the
proposed incorporation by reference of ANSI/CAN/
UL 9595 in its associated section.
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TABLE 17—TOTAL ESTIMATED COSTS TO PFD MANUFACTURERS FROM THE INTRODUCTION OF LEVEL 50 DEVICES
[2019 Dollars, 10-year period of analysis]
Total
undiscounted
costs
ddrumheller on DSK120RN23PROD with PROPOSALS3
Year
Discounted costs
7%
3%
1 ...................................................................................................................................................
2 ...................................................................................................................................................
3 ...................................................................................................................................................
4 ...................................................................................................................................................
5 ...................................................................................................................................................
6 ...................................................................................................................................................
7 ...................................................................................................................................................
8 ...................................................................................................................................................
9 ...................................................................................................................................................
10 .................................................................................................................................................
$646,532
682,373
71,682
71,682
71,682
71,682
71,682
71,682
71,682
71,682
$604,236
596,011
58,514
54,686
51,108
47,765
44,640
41,720
38,990
36,439
$627,701
643,202
65,599
63,689
61,834
60,033
58,284
56,586
54,938
53,338
Total ......................................................................................................................................
1,902,361
1,574,109
1,745,204
Annualized ............................................................................................................................
........................
224,118
204,591
Qualitative Benefits of ANSI/CAN/UL
12402–5
The Coast Guard believes that the
proposed introduction of Level 50
devices coupled with the requirement to
wear them if they are to count for the
purposes of PFD carriage requirements
may lead to an unquantifiable increase
in PFD wear rates among recreational
boaters and thereby potentially decrease
the rate of drowning. The Coast Guard
requests public comment on whether
Level 50 devices could lead to an
increase in PFD wear rates among
recreational boaters. Drowning is the
leading cause of death in recreational
boating accidents, accounting for 79
percent of all recreational boating
casualties where we know the cause of
death.15 Of those who drowned, 86
percent were not wearing a lifejacket.
Wearing a lifejacket is one of the best
means available of preventing
accidental drowning in recreational
boating. Unfortunately, recreational
boaters only wear lifejackets about 24
percent of the time.16
Level 50 devices are likely to be
slimmer, lighter in weight, and more
comfortable to wear than current Type
III and Level 70 devices. Additionally,
the Coast Guard would require
recreational boaters to wear Level 50
devices to count towards PFD carriage
requirements. Individuals who purchase
Level 50 devices would be more likely
to wear PFDs than similar individuals
who purchase bulkier Level 70 or Type
III devices without a requirement that
15 United States Coast Guard, ‘‘2019 Recreational
Boating Statistics.’’ https://uscgboating.org/library/
accident-statistics/Recreational-Boating-Statistics2019.pdf.
16 United States Coast Guard, ‘‘2019 Life Jacket
Wear Rate Observation Study.’’ https://
uscgboating.org/library/national-live-jacket-wearstudy/2019-Life-Jacket-Wear-Rate-Report.pdf.
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they be worn for the purposes of
carriage. The National Institutes of
Health (NIH) conducted a literature
review, and among other factors, found
discomfort to be negatively associated
with lifejacket wear [NIH, 2018].17 It is
the Coast Guard’s view that PFDs worn
are more effective than PFDs carried on
board if a man overboard situation
occurs. As a result, it is possible that the
public would be safer due to
recreational boaters wearing a greater
number of PFDs while boating.
Since the Level 50 devices provide a
lower level of buoyancy than Level 70
devices, a direct comparison is not
possible. However, the view of the
subject matter experts in the Coast
Guard’s Office of Boating Safety is that
the wearing of Level 50 PFDs by
recreational boaters and the general
boating public would improve safety on
the water. Recreational boaters fail to
wear lifejackets 76 percent of the time,
leaving themselves vulnerable to
drowning. The Coast Guard believes
that by offering recreational boaters an
additional choice of a Level 50 PFD,
which is required to be worn, more
recreational boaters will choose to wear
their lifejacket while engaged in boating
activities. A lifejacket that is worn by
the user is more effective than a
lifejacket stowed on the boat.
ANSI/CAN/UL 9595
The third proposed change
incorporates by reference the consensus
standard ANSI/CAN/UL 9595 to cover
follow-up inspections and inspection
frequency for Coast Guard approved
PFDs. Currently, when a manufacturing
17 We cited this review from the NIH earlier in the
preamble in footnote number 2. Readers should
reference that footnote for a link to this article and
other articles by the NIH for more information on
PFD usage.
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firm produces a Coast Guard approved
PFD there is a required follow-up
inspection regime to ensure that the
devices continue to meet the
specifications under which the Coast
Guard approved them. Although the
Coast Guard has not previously
published a substantive minimum
requirement for what constitutes a
follow-up inspections regime, we set out
general requirements in 46 CFR 159, 46
CFR 160.064–4, and 46 CFR 160.076–29.
The Coast Guard reviews each
recognized independent laboratory’s
follow-up services program to ensure
compliance with these regulations.
Incorporating by reference ANSI/
CAN/UL 9595 would provide a few key
benefits to the regulated public and the
testing laboratories. First, ANSI/CAN/
UL 9595 is one standard to ensure
consistency across all accepted and
recognized independent laboratories.
Second, ANSI/CAN/UL 9595 is a
standard that would be widely available
to the industry and transparently
clarifies guidance on what constitutes a
follow-up inspection regime. Third, and
most importantly, ANSI/CAN/UL 9595
establishes a rating system for each
facility, which would result in cost
savings for the firms manufacturing at
facilities with a good or superior QMS.
Costs
There are three cost items associated
with the proposed adoption of ANSI/
CAN/UL 9595. These costs are based on
input from subject matter experts from
the PFD industry on how ANSI/CAN/
UL 9595 is likely to be implemented:
(1) The two recognized independent
laboratories would need to train their
staff to implement ANSI/CAN/UL 9595;
(2) Manufacturing firms could request
a special inspection in the first year to
certify their QMS at a given facility
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meets the requirements for Process
Rating of A or B. We expect the top 13
firms to request this certification across
all 27 facilities at which they
manufacture. This special inspection
would be expected to be in addition to
the regular production inspections
required for Process Rating C; and
(3) After the first year where the QMS
inspection would be supplemental to
standard inspections, the QMS
inspection could replace one of the
mandatory inspections, but could cost
more than a standard inspection at the
top 13 firms with 27 facilities.
We estimate the 10-year discounted
cost for inspections under this proposed
provision that are associated with U.S.
firms would be approximately $93,027,
or $13,245 annualized using a 7-percent
discount rate. We estimate the total 10year discounted cost for inspections that
are associated with foreign firms would
be approximately $37,310, or $3,000
annualized using a 7-percent discount
rate. In total, we estimate the 10-year
discounted costs from ANSI/CAN/UL
9595 would be $130,337 or $18,557
annualized using a 7-percent discount
rate. We present these amounts in table
18, table 19, and table 20.
TABLE 18—ESTIMATED QMS INSPECTION COSTS TO U.S. FIRMS FROM ANSI/CAN/UL 9595
[2019 Dollars, 10-year period of analysis]
Total
undiscounted
costs
Year
Discounted costs
7%
3%
1 ...................................................................................................................................................
2 ...................................................................................................................................................
3 ...................................................................................................................................................
4 ...................................................................................................................................................
5 ...................................................................................................................................................
6 ...................................................................................................................................................
7 ...................................................................................................................................................
8 ...................................................................................................................................................
9 ...................................................................................................................................................
10 .................................................................................................................................................
$53,118
7,125
7,125
7,125
7,125
7,125
7,125
7,125
7,125
7,125
$49,643
6,223
5,816
5,436
5,080
4,748
4,437
4,147
3,876
3,622
$51,571
6,716
6,520
6,330
6,146
5,967
5,793
5,625
5,461
5,302
Total ......................................................................................................................................
117,243
93,027
105,431
Annualized ............................................................................................................................
........................
13,245
12,360
TABLE 19—ESTIMATED QMS INSPECTION COSTS TO FOREIGN FIRMS FROM ANSI/CAN/UL 9595
[2019 Dollars, 10-year period of analysis]
Total
undiscounted
costs
Year
Discounted costs
7%
3%
1 ...................................................................................................................................................
2 ...................................................................................................................................................
3 ...................................................................................................................................................
4 ...................................................................................................................................................
5 ...................................................................................................................................................
6 ...................................................................................................................................................
7 ...................................................................................................................................................
8 ...................................................................................................................................................
9 ...................................................................................................................................................
10 .................................................................................................................................................
$20,376
3,000
3,000
3,000
3,000
3,000
3,000
3,000
3,000
3,000
$19,043
2,620
2,449
2,289
2,139
1,999
1,868
1,746
1,632
1,525
$19,783
2,828
2,745
2,665
2,588
2,512
2,439
2,368
2,299
2,232
Total ......................................................................................................................................
47,376
37,310
42,461
Annualized ............................................................................................................................
........................
5,312
4,978
TABLE 20—TOTAL ESTIMATED QMS INSPECTION COSTS FOR ANSI/CAN/UL 9595
[2019 Dollars, 10-year period of analysis]
Total
undiscounted
costs
ddrumheller on DSK120RN23PROD with PROPOSALS3
Year
1
2
3
4
5
6
7
8
9
...................................................................................................................................................
...................................................................................................................................................
...................................................................................................................................................
...................................................................................................................................................
...................................................................................................................................................
...................................................................................................................................................
...................................................................................................................................................
...................................................................................................................................................
...................................................................................................................................................
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10,125
10,125
10,125
10,125
10,125
10,125
10,125
10,125
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Discounted costs
7%
$68,686
8,844
8,265
7,724
7,219
6,747
6,305
5,893
5,507
3%
$71,353
9,544
9,266
8,996
8,734
8,480
8,233
7,993
7,760
21031
Federal Register / Vol. 88, No. 67 / Friday, April 7, 2023 / Proposed Rules
TABLE 20—TOTAL ESTIMATED QMS INSPECTION COSTS FOR ANSI/CAN/UL 9595—Continued
[2019 Dollars, 10-year period of analysis]
Total
undiscounted
costs
Year
Discounted costs
7%
3%
10 .................................................................................................................................................
10,125
5,147
7,534
Total ......................................................................................................................................
164,619
130,337
147,892
Annualized ............................................................................................................................
........................
18,557
17,337
Cost Savings
The proposed IBR of ANSI/CAN/UL
9595 would generate benefits in the
form of cost savings for PFD
manufacturing firms who have a QMS
in place. Manufacturers with an audited
QMS would be able to secure a higher
Process Rating, which in turn, would
reduce the frequency of production
inspections for PFDs based upon their
higher Process Rating.
We estimate this proposed provision
would generate benefits in the form of
cost savings for U.S. firms of $5,562,385,
or $791,959 annualized, over a 10-year
period of analysis using a 7-percent
discount rate, and we similarly estimate
cost savings of $1,331,726, or $189,608
annualized, to foreign firms over a 10-
year period of analysis discounted at 7
percent. In total, we estimate
$6,894,111, or $981,566 annualized, in
cost savings to all firms under this
proposed provision using a 10-year
period of analysis and a 7-percent
discount rate. We present these 10-year
cost savings to U.S., foreign, and both
U.S. and foreign firms in table 21, table
22, and table 23, respectively.
TABLE 21—ESTIMATED COST SAVINGS TO U.S. FIRMS FROM ANSI/CAN/UL 9595
[2019 Dollars, 10-year period of analysis]
Total
undiscounted
cost savings
Year
Discounted cost savings
7%
3%
1 ...................................................................................................................................................
2 ...................................................................................................................................................
3 ...................................................................................................................................................
4 ...................................................................................................................................................
5 ...................................................................................................................................................
6 ...................................................................................................................................................
7 ...................................................................................................................................................
8 ...................................................................................................................................................
9 ...................................................................................................................................................
10 .................................................................................................................................................
$0
897,438
916,206
916,206
916,206
916,206
916,206
916,206
916,206
916,206
$0
783,857
747,897
698,969
653,242
610,506
570,567
533,240
498,355
465,752
$0
845,921
838,458
814,037
790,327
767,308
744,959
723,261
702,195
681,743
Total ......................................................................................................................................
8,227,082
5,562,385
6,908,209
Annualized ............................................................................................................................
........................
791,959
809,853
TABLE 22—ESTIMATED COST SAVINGS TO FOREIGN FIRMS FROM ANSI/CAN/UL 9595
[2019 Dollars, 10-year period of analysis]
Total
undiscounted
cost savings
ddrumheller on DSK120RN23PROD with PROPOSALS3
Year
Discounted cost savings
7%
3%
1 ...................................................................................................................................................
2 ...................................................................................................................................................
3 ...................................................................................................................................................
4 ...................................................................................................................................................
5 ...................................................................................................................................................
6 ...................................................................................................................................................
7 ...................................................................................................................................................
8 ...................................................................................................................................................
9 ...................................................................................................................................................
10 .................................................................................................................................................
$0
214,989
219,333
219,333
219,333
219,333
219,333
219,333
219,333
219,333
$0
187,780
179,041
167,328
156,382
146,151
136,590
127,654
119,303
111,498
$0
202,648
200,721
194,875
189,199
183,688
178,338
173,144
168,101
163,204
Total ......................................................................................................................................
1,969,655
1,331,726
1,653,917
Annualized ............................................................................................................................
........................
189,608
193,890
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Federal Register / Vol. 88, No. 67 / Friday, April 7, 2023 / Proposed Rules
TABLE 23—ESTIMATED COST SAVINGS TO ALL FIRMS FROM ANSI/CAN/UL 9595
[2019 Dollars, 10-year period of analysis]
Total
undiscounted
cost savings
Year
Discounted costs savings
7%
3%
1 ...................................................................................................................................................
2 ...................................................................................................................................................
3 ...................................................................................................................................................
4 ...................................................................................................................................................
5 ...................................................................................................................................................
6 ...................................................................................................................................................
7 ...................................................................................................................................................
8 ...................................................................................................................................................
9 ...................................................................................................................................................
10 .................................................................................................................................................
$0
1,112,427
1,135,539
1,135,539
1,135,539
1,135,539
1,135,539
1,135,539
1,135,539
1,135,539
$0
971,637
926,938
866,297
809,623
756,657
707,156
660,894
617,658
577,250
$0
1,048,569
1,039,179
1,008,912
979,526
950,996
923,297
896,405
870,296
844,948
Total ......................................................................................................................................
10,196,737
6,894,111
8,562,126
Annualized ............................................................................................................................
........................
981,566
1,003,742
Placards in Lieu of Information
Pamphlets
The fourth change in the proposed
rule comes from details contained
within ANSI/CAN/UL 12402–4 and
ANSI/CAN/UL 12402–5. These
standards specify requirements for a
placard to be attached to all devices
certified to those standards. The placard
provides information on PFDs’
performance, selection, and approval,
warnings, maintenance, and general
water safety information in a
pictographic format. This proposed rule
would amend 33 CFR 181 to permit
manufacturing firms to use a placard in
lieu of the informational pamphlet.
Costs
For the convenience of the reader,
table 24 reproduces table 6 from the
Affected Population section to list the
various types of PFDs impacted by this
rule, and whether they would be
required to use placards to covey safety
instructions or whether they could use
either placards or information
pamphlets.18
TABLE 24—DEVICE CATEGORY AND PERMITTED INSTRUCTION TYPES
Device category
Types of instructions allowed by
the proposed rule
Types of instructions currently in use
New Level 50 Devices (ANSI/CAN/UL 12402–5) ..............
New Level 70 Devices (ANSI/CAN/UL 12402–5) ..............
New Level 100 Devices (ANSI/CAN/UL 12402–4) ............
Existing Type I Commercial Devices .................................
Existing Type II Recreational Devices ...............................
Existing Type III Recreational Devices ..............................
Existing Type IV Throwable Devices .................................
Placard ........................................
Placard ........................................
Placard ........................................
Placard or Information Pamphlet
Placard or Information Pamphlet
Placard or Information Pamphlet
Information Pamphlet ..................
N/A because these devices are not yet produced.
Placard.
N/A because these devices are not yet produced.
Information Pamphlet.
Information Pamphlet.
Information Pamphlet.
Information Pamphlet.
There are two sources of unquantified
benefits from the proposed requirement
for the use of placards on new device
categories and the proposed permitting
of placard use on existing device
categories. The first source of
unquantified benefits would occur
because a placard is likely less
expensive to produce than an
information pamphlet. A representative
from the PFD manufacturing industry
told us that the placard would likely be
around $0.05 cheaper to produce than
the information pamphlet because the
placard would contain fewer materials
than the information pamphlet.
However, we could not find any data on
the costs to produce information
pamphlets and the costs to produce
placards, so we cannot determine the
relative size of this cost savings. We
believe based on the full discussion that
the $0.05 estimate is a rough
approximation of the fact that placards
are slightly less expensive than
information pamphlets but ultimately
about the same price. Additionally, we
have no way of estimating how large a
share of current production would
switch from producing information
pamphlets to placards, as placards
would not be required. Due to these
factors, we did not produce a
quantitative estimate of the cost savings
due to placards.
The second unquantified benefit
would come from the fact that placards
use pictorial images to communicate
safety information, while information
18 Current marking requirements require a
pamphlet, while the proposed new marking
requirement would be for a placard or pamphlet.
Because these placards and pamphlets are both
produced in factories, the Coast Guard estimates
that it takes the same amount of time to produce
and include either a pamphlet or a placard with a
newly manufactured PFD for sale. As a result, we
do not estimate there would be any changes in the
PRA burden brought on by the switch from
pamphlets to placards.
ddrumheller on DSK120RN23PROD with PROPOSALS3
As shown in table 24 above, the
proposed changes in instruction
information would either apply to PFD
categories not yet produced or permit an
additional compliance option. No
devices would have fewer options for
instruction materials than under current
regulations. As a result, we estimate
there would be no additional costs from
replacing safety information pamphlets
with placards because firms could either
continue their current activities or
produce placards instead.
Unquantified Benefits
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Federal Register / Vol. 88, No. 67 / Friday, April 7, 2023 / Proposed Rules
pamphlets use English-language text.
Pictorial information is superior to text
at communicating information to nonEnglish-reading audiences. We do not
have a way of quantifying this benefit,
but would like to note that
approximately 21 percent of the U.S.
population has a ‘‘low’’ level of English
literacy. For those populations, pictorial
information may be better than textbased information.19
Total Costs
We display the total costs from this
proposed rule to U.S. entities, foreign
entities, and both U.S. and foreign
entities using a 10-year period of
analysis discounted at 7 percent in table
25, table 26, and table 27, respectively.
TABLE 25—ESTIMATED COSTS FOR U.S. FIRMS
[2019 Dollars, 10-year period of analysis]
Total
undiscounted
costs
Year
Discounted costs
7%
3%
1 ...................................................................................................................................................
2 ...................................................................................................................................................
3 ...................................................................................................................................................
4 ...................................................................................................................................................
5 ...................................................................................................................................................
6 ...................................................................................................................................................
7 ...................................................................................................................................................
8 ...................................................................................................................................................
9 ...................................................................................................................................................
10 .................................................................................................................................................
$601,275
559,607
67,181
67,181
67,181
67,181
67,181
67,181
67,181
67,181
$561,939
488,782
54,840
51,252
47,899
44,766
41,837
39,100
36,542
34,151
$583,762
527,483
61,480
59,689
57,951
56,263
54,624
53,033
51,489
49,989
Total ......................................................................................................................................
1,698,330
1,401,108
1,555,764
Annualized ............................................................................................................................
........................
199,486
182,383
TABLE 26—ESTIMATED COSTS FOR FOREIGN FIRMS
[2019 Dollars, 10-year period of analysis]
Total
undiscounted
costs
Year
Discounted costs
7%
3%
1 ...................................................................................................................................................
2 ...................................................................................................................................................
3 ...................................................................................................................................................
4 ...................................................................................................................................................
5 ...................................................................................................................................................
6 ...................................................................................................................................................
7 ...................................................................................................................................................
8 ...................................................................................................................................................
9 ...................................................................................................................................................
10 .................................................................................................................................................
$145,677
134,817
16,552
16,552
16,552
16,552
16,552
16,552
16,552
16,552
$136,147
117,754
13,511
12,627
11,801
11,029
10,308
9,633
9,003
8,414
$141,434
127,078
15,147
14,706
14,278
13,862
13,458
13,066
12,686
12,316
Total ......................................................................................................................................
412,910
340,229
378,032
Annualized ............................................................................................................................
........................
48,441
44,317
TABLE 27—TOTAL ESTIMATED COSTS FOR U.S. AND FOREIGN FIRMS
[2019 Dollars, 10-year period of analysis]
Total
undiscounted
costs
ddrumheller on DSK120RN23PROD with PROPOSALS3
Year
1
2
3
4
5
6
7
8
9
...................................................................................................................................................
...................................................................................................................................................
...................................................................................................................................................
...................................................................................................................................................
...................................................................................................................................................
...................................................................................................................................................
...................................................................................................................................................
...................................................................................................................................................
...................................................................................................................................................
$746,952
694,424
83,733
83,733
83,733
83,733
83,733
83,733
83,733
19 U.S. Department of Education, ‘‘Data Point:
Adult Literacy in the United States’’ (July 2019).
https://nces.ed.gov/pubs2019/2019179.pdf.
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Discounted costs
7%
3%
$698,086
606,537
68,351
63,880
59,700
55,795
52,145
48,733
45,545
$725,196
654,561
76,628
74,396
72,229
70,125
68,083
66,100
64,174
21034
Federal Register / Vol. 88, No. 67 / Friday, April 7, 2023 / Proposed Rules
TABLE 27—TOTAL ESTIMATED COSTS FOR U.S. AND FOREIGN FIRMS—Continued
[2019 Dollars, 10-year period of analysis]
Total
undiscounted
costs
Year
Discounted costs
7%
3%
10 .................................................................................................................................................
83,733
42,566
62,305
Total ......................................................................................................................................
2,111,240
1,741,338
1,933,796
Annualized ............................................................................................................................
........................
247,927
226,700
Total Cost Savings
We display the total cost savings from
this proposed rule to U.S. firms, the U.S.
government, foreign firms, and all firms
using a 10-year period of analysis
discounted at 7 percent in table 28, table
29, table 30, and table 31, respectively.
TABLE 28—TOTAL ESTIMATED COST SAVINGS TO U.S. FIRMS
[2019 Dollars, 10-year period of analysis]
Total
undiscounted
cost savings
Year
Discounted costs savings
7%
3%
1 ...................................................................................................................................................
2 ...................................................................................................................................................
3 ...................................................................................................................................................
4 ...................................................................................................................................................
5 ...................................................................................................................................................
6 ...................................................................................................................................................
7 ...................................................................................................................................................
8 ...................................................................................................................................................
9 ...................................................................................................................................................
10 .................................................................................................................................................
$39,734
937,172
955,940
955,940
955,940
955,940
955,940
955,940
955,940
955,940
$37,135
818,562
780,331
729,282
681,572
636,983
595,311
556,366
519,968
485,951
$38,577
883,374
874,820
849,340
824,602
800,584
777,266
754,628
732,648
711,309
Total ......................................................................................................................................
8,624,422
5,841,460
7,247,148
Annualized ............................................................................................................................
........................
831,693
849,587
TABLE 29—TOTAL ESTIMATED COST SAVINGS TO FOREIGN FIRMS
[2019 Dollars, 10-year period of analysis]
Total
undiscounted
cost savings
ddrumheller on DSK120RN23PROD with PROPOSALS3
Year
Discounted costs savings
7%
3%
1 ...................................................................................................................................................
2 ...................................................................................................................................................
3 ...................................................................................................................................................
4 ...................................................................................................................................................
5 ...................................................................................................................................................
6 ...................................................................................................................................................
7 ...................................................................................................................................................
8 ...................................................................................................................................................
9 ...................................................................................................................................................
10 .................................................................................................................................................
$17,395
232,384
236,728
236,728
236,728
236,728
236,728
236,728
236,728
236,728
$16,257
202,973
193,241
180,599
168,784
157,742
147,422
137,778
128,764
120,341
$16,888
219,044
216,640
210,330
204,204
198,256
192,482
186,875
181,432
176,148
Total ......................................................................................................................................
2,143,605
1,453,901
1,802,300
Annualized ............................................................................................................................
........................
207,003
211,285
TABLE 30—TOTAL ESTIMATED COST SAVINGS TO THE UNITED STATES GOVERNMENT
[2019 Dollars, 10-year period of analysis]
Total
undiscounted
cost savings
Year
1
2
3
4
...................................................................................................................................................
...................................................................................................................................................
...................................................................................................................................................
...................................................................................................................................................
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$3,903
3,903
3,903
3,903
07APP3
Discounted costs savings
7%
$3,648
3,409
3,186
2,978
3%
$3,789
3,679
3,572
3,468
21035
Federal Register / Vol. 88, No. 67 / Friday, April 7, 2023 / Proposed Rules
TABLE 30—TOTAL ESTIMATED COST SAVINGS TO THE UNITED STATES GOVERNMENT—Continued
[2019 Dollars, 10-year period of analysis]
Total
undiscounted
cost savings
Year
Discounted costs savings
7%
3%
5 ...................................................................................................................................................
6 ...................................................................................................................................................
7 ...................................................................................................................................................
8 ...................................................................................................................................................
9 ...................................................................................................................................................
10 .................................................................................................................................................
3,903
3,903
3,903
3,903
3,903
3,903
2,783
2,601
2,431
2,272
2,123
1,984
3,367
3,269
3,174
3,081
2,991
2,904
Total ......................................................................................................................................
39,032
27,414
33,295
Annualized ............................................................................................................................
........................
3,903
3,903
TABLE 31—TOTAL ESTIMATED COST SAVINGS TO U.S. AND FOREIGN MANUFACTURING FIRMS AND THE U.S.
GOVERNMENT
[2019 Dollars, 10-year period of analysis]
Total
undiscounted
cost savings
Year
Discounted costs savings
7%
3%
1 ...................................................................................................................................................
2 ...................................................................................................................................................
3 ...................................................................................................................................................
4 ...................................................................................................................................................
5 ...................................................................................................................................................
6 ...................................................................................................................................................
7 ...................................................................................................................................................
8 ...................................................................................................................................................
9 ...................................................................................................................................................
10 .................................................................................................................................................
$61,032
1,173,459
1,196,571
1,196,571
1,196,571
1,196,571
1,196,571
1,196,571
1,196,571
1,196,571
$57,039
1,024,945
976,758
912,858
853,139
797,326
745,164
696,415
650,855
608,276
$59,255
1,106,098
1,095,032
1,063,138
1,032,173
1,002,109
972,922
944,584
917,072
890,361
Total ......................................................................................................................................
10,807,059
7,322,776
9,082,743
Annualized ............................................................................................................................
........................
1,042,599
1,064,775
Net Cost Savings
the U.S. government, foreign firms, and
all entities using a 10-year period of
analysis discounted at 7 percent in table
We display the total net cost savings
from this proposed rule to U.S. firms,
32, table 33, table 34, and table 35,
respectively.
TABLE 32—TOTAL ESTIMATED NET COST SAVINGS TO U.S. FIRMS
[2019 Dollars, 10-year period of analysis]
Net
undiscounted
cost
savings
ddrumheller on DSK120RN23PROD with PROPOSALS3
Year
Net discounted
costs savings
7%
3%
1 ...................................................................................................................................................
2 ...................................................................................................................................................
3 ...................................................................................................................................................
4 ...................................................................................................................................................
5 ...................................................................................................................................................
6 ...................................................................................................................................................
7 ...................................................................................................................................................
8 ...................................................................................................................................................
9 ...................................................................................................................................................
10 .................................................................................................................................................
¥$561,541
377,565
888,759
888,759
888,759
888,759
888,759
888,759
888,759
888,759
¥$524,805
329,780
725,492
678,030
633,673
592,217
553,474
517,266
483,426
451,800
¥$545,185
355,891
813,340
789,651
766,651
744,321
722,642
701,594
681,159
661,320
Total ......................................................................................................................................
6,926,092
4,440,352
5,691,384
Annualized ............................................................................................................................
........................
632,206
667,204
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Federal Register / Vol. 88, No. 67 / Friday, April 7, 2023 / Proposed Rules
TABLE 33—TOTAL ESTIMATED NET COST SAVINGS TO FOREIGN FIRMS
[2019 Dollars, 10-year period of analysis]
Net
undiscounted
cost
savings
Year
Net discounted
costs savings
7%
3%
1 ...................................................................................................................................................
2 ...................................................................................................................................................
3 ...................................................................................................................................................
4 ...................................................................................................................................................
5 ...................................................................................................................................................
6 ...................................................................................................................................................
7 ...................................................................................................................................................
8 ...................................................................................................................................................
9 ...................................................................................................................................................
10 .................................................................................................................................................
¥$128,282
97,567
220,176
220,176
220,176
220,176
220,176
220,176
220,176
220,176
¥$119,890
85,219
179,729
167,971
156,983
146,713
137,115
128,145
119,761
111,926
¥$124,546
91,966
201,492
195,624
189,926
184,394
179,023
173,809
168,747
163,832
Total ......................................................................................................................................
1,730,695
1,113,672
1,424,268
Annualized ............................................................................................................................
........................
158,562
166,968
TABLE 34—TOTAL ESTIMATED COST SAVINGS TO THE UNITED STATES GOVERNMENT
[2019 Dollars, 10-year period of analysis]
Net
undiscounted
cost
savings
Year
Net discounted
costs savings
7%
3%
1 ...................................................................................................................................................
2 ...................................................................................................................................................
3 ...................................................................................................................................................
4 ...................................................................................................................................................
5 ...................................................................................................................................................
6 ...................................................................................................................................................
7 ...................................................................................................................................................
8 ...................................................................................................................................................
9 ...................................................................................................................................................
10 .................................................................................................................................................
$3,903
3,903
3,903
3,903
3,903
3,903
3,903
3,903
3,903
3,903
$3,648
3,409
3,186
2,978
2,783
2,601
2,431
2,272
2,123
1,984
$3,789
3,679
3,572
3,468
3,367
3,269
3,174
3,081
2,991
2,904
Total ......................................................................................................................................
39,032
27,414
33,295
Annualized ............................................................................................................................
........................
3,903
3,903
TABLE 35—TOTAL ESTIMATED NET COST SAVINGS TO ALL ENTITIES
[2019 Dollars, 10-year period of analysis]
Net
undiscounted
cost
savings
ddrumheller on DSK120RN23PROD with PROPOSALS3
Year
Net discounted
costs savings
7%
3%
1 ...................................................................................................................................................
2 ...................................................................................................................................................
3 ...................................................................................................................................................
4 ...................................................................................................................................................
5 ...................................................................................................................................................
6 ...................................................................................................................................................
7 ...................................................................................................................................................
8 ...................................................................................................................................................
9 ...................................................................................................................................................
10 .................................................................................................................................................
¥$685,920
479,035
1,112,838
1,112,838
1,112,838
1,112,838
1,112,838
1,112,838
1,112,838
1,112,838
¥$641,047
418,408
908,407
848,979
793,438
741,531
693,020
647,682
605,310
565,710
¥$665,942
451,536
1,018,404
988,742
959,944
931,984
904,839
878,485
852,898
828,056
Total ......................................................................................................................................
8,695,819
5,581,438
7,148,947
Annualized ............................................................................................................................
........................
794,671
838,075
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Alternatives
We identified three alternatives to the
current proposed rule:
(1) Incorporate ANSI/CAN/UL 12402–
5 for the approval of Level 70 PFDs
only, prohibiting the approval of Level
50 PFDs;
(2) Require placards for existing Type
I, II, and III PFDs instead of providing
the option to continue the use of
informational pamphlets; and
(3) Adopt ANSI/CAN/UL 12402–4
and ANSI/CAN/UL 12402–5 by policy.
Alternative 1: Incorporate ANSI/CAN/
UL 12402–5 for Level 70 PFDs only.
We considered an alternative that
would incorporate ANSI/CAN/UL
12402–5, but limit approval to Level 70
PFDs only. Level 50 PFDs would not be
eligible for Coast Guard approval and
would not meet carriage requirements
on any vessel. If the Coast Guard were
to choose this alternative, the market for
Level 50 devices would not be viable
because Level 50 devices would no
longer meet carriage requirements. We
therefore expect there would be no
benefits from a new market as the
market would not exist. The expected
qualitative benefit of increased wearrates associated with more comfortable
and innovative Level 50 PFDs would be
lost with this alternative. We would also
be restricting recreational boaters to one
category of PFD when Level 50 PFDs
could better suit their purpose. As a
result, we rejected this alternative
because we expect wear rates and
therefore benefits would be lower.
Alternative 2: Require Placards Instead
of the Option of Placards or Pamphlets
ddrumheller on DSK120RN23PROD with PROPOSALS3
Under this proposed rule, we require
that only new Level 50, 70, and 100
devices use placards. We considered the
alternative of requiring that PFD
manufacturers use placards instead of
information pamphlets for all existing
PFDs. While we observe that the cost of
producing a placard is generally less
than the cost of producing an
information pamphlet, we also observe
that some manufacturers may have
already printed pamphlets or may not
choose to use placards. As a result, we
rejected this alternative.
Alternative 3: Adopt ANSI/CAN/UL
12402–4 and ANSI/CAN/UL 12402–5 by
Policy
Another alternative we considered
would be to adopt ANSI/CAN/UL
12402–4 and ANSI/CAN/UL 12402–5 by
policy instead of incorporating them by
reference into the CFR. Under 46 CFR
159.005–7(c), the Coast Guard has the
authority to approve an item of
equipment that does not meet all the
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requirements of 46 CFR 160.055 if it has
equivalent performance characteristics.
The Coast Guard has already used this
authority to partially adopt ANSI/CAN/
UL 12402–4 and ANSI/CAN/UL 12402–
5 by policy. Because this authority is
limited to the approval of equipment
with equivalent performance
characteristics, we cannot fully adopt
these standards by policy. In particular,
Level 50 PFDs, youth inflatable PFDs,
and inflatable Level 100 PFDs could not
be approved by policy because they are
not equivalent to any current Coast
Guard standards. For that reason, we
rejected this alternative.
B. Small Entities
Under the Regulatory Flexibility Act
(RFA), 5 United States Code (U.S.C.)
601–612, we have prepared this Initial
Regulatory Flexibility Analysis (IRFA)
that examines the impacts of the
proposed rule on small entities.
Per the RFA, a small entity may be a
small independent business, defined as
one independently owned and operated,
organized for profit, and not dominant
in its field under the Small Business Act
(5 U.S.C. 632); a small not-for-profit
organization, defined as any not-forprofit enterprise which is independently
owned and operated and is not
dominant in its field; or a small
governmental jurisdiction, defined as a
locality with fewer than 50,000 people.
Section 603(b) of the RFA prescribes
the content of the IRFA, which
addresses the following:
(1) A description of the reasons why
action by the agency is being
considered;
(2) A succinct statement of the
objectives of, and legal basis for, the
proposed rule;
(3) A description of and, where
feasible, an estimate of the number of
small entities to which the proposed
rule will apply;
(4) A description of the projected
reporting, recordkeeping, and other
compliance requirements of the
proposed rule, including an estimate of
the classes of small entities that will be
subject to the requirement and the type
of professional skills necessary for
preparation of the report or record;
(5) An identification, to the extent
practicable, of all relevant Federal rules
that may duplicate, overlap, or conflict
with the proposed rule; and
(6) A description of any significant
alternatives to the rule that accomplish
the stated objectives of applicable
statutes and that minimize any
significant economic impact of the
proposed rule on small entities.
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21037
1. A Description of the Reasons Why
Action by the Agency Is Being
Considered
The Coast Guard proposes to amend
the lifejacket approval requirements and
follow-up program requirements by
incorporating three new binational
standards. At the same time, the Coast
Guard proposes to amend lifejacket and
PFD carriage requirements to allow for
the use of equipment approved to the
new standards, and to remove obsolete
equipment approval requirements. The
new standards are intended to replace
the legacy standards. The proposed
amendments will streamline the process
for approval of PFDs and allow
manufacturers the opportunity to
produce equipment that meets the
approval requirements of both Canada
and the United States, while reducing
the burden for manufacturers in both
the approval process and follow-up
program.
2. A Succinct Statement of the Objective
of, and Legal Basis for, the Proposed
Rule
This proposed rule would harmonize
PFD approval standards with those used
in Canada, lead to net cost savings for
PFD manufacturers, and introduce a
new type of PFD that may better meet
the needs of some recreational boaters.
This proposed rule is discretionary
and not issued because of a statutory
mandate. The Coast Guard will use its
existing rulemaking authority provided
under Title 46, U.S. Code, sections
3306(a), 4102(a) and (b), 4302(a) and (c),
and 4502(a) and (c)(2)(B).
Title 46 U.S.C. 3306 provides the
Coast Guard with the general authority
to prescribe regulations for the design,
construction, performance, testing,
carriage, use, and inspection of
lifesaving equipment on commercial
and recreational vessels. Title 46 U.S.C.
4102 and 4302 provide more specific
authority to prescribe regulations about
life preservers and other life saving
devices on uninspected and recreational
vessels, respectively.
3. A Description—and, Where Feasible,
an Estimate of the Number—of Small
Entities to Which the Proposed Rule
Will Apply
This proposed rule has four major
provisions:
(1) It would incorporate by reference
ANSI/CAN/UL 12402–4, replacing Type
I device approval with Level 100 device
approval.
(2) It would incorporate by reference
ANSI/CAN/UL 12402–5, introducing
new Level 50 device approvals.
(3) It would incorporate by reference
ANSI/CAN/UL 9595, setting new
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standards for follow-on production
inspections.
(4) It would permit the use of placards
in lieu of instruction pamphlets.
Across these four provisions, we
estimate that this proposed rule would
directly affect two Coast Guard
recognized laboratories and 57 PFD
manufacturers.
We researched these two Coast Guard
recognized laboratories and 57 PFD
manufacturers to determine if they are
U.S. companies or foreign companies
based on the location of their parent
company’s headquarters. We found one
Coast Guard recognized laboratory to be
a U.S. company and one to be a foreign
company. We found 37 of the 57 PFD
manufacturers to be U.S. companies and
20 to be foreign companies. We then
researched each of these 38 U.S.
companies (1 testing laboratory and 37
PFD manufacturers) to determine its
North American Industry Classification
System (NAICS) code and its size
standard using the Small Business
Administration’s (SBA) size standard
table. Next, we reviewed each U.S.
parent company’s revenue or employee
information to determine whether the
company would be small or not small
according to SBA size standards. We
present the results of our research in
table 36. We found the U.S. Coast Guard
recognized laboratory to be small, and of
the 37 U.S. manufacturers, we found 30
of them to be small entities according to
SBA size standards; we did not find any
U.S. small entities to be small
governmental jurisdictions.
TABLE 36—NUMBER OF SMALL ENTITIES AFFECTED BY THE PROPOSED RULE
NAICS
code
314910
314999
315280
315990
326199
326299
327120
336612
339920
339999
423910
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
441222 .....
448140 .....
448150 .....
451110 .....
452319 .....
453930 .....
541380 .....
541870 .....
561990 .....
713930 .....
Unknown ..
Textile Bag and Canvas Mills ........................................................
All Other Miscellaneous Store Retailers (except Tobacco Stores)
Other Cut and Sew Apparel Manufacturing ..................................
Apparel Accessories and Other Apparel Manufacturing ...............
All Other Plastics Product Manufacturing .....................................
All Other Rubber Product Manufacturing ......................................
Clay Building Material and Refractories Manufacturing ................
Boat Building .................................................................................
Sporting and Athletic Goods Manufacturing .................................
All Other Miscellaneous Manufacturing .........................................
Sporting and Recreational Goods and Supplies Merchant
Wholesalers.
Boat Dealers ..................................................................................
Family Clothing Stores ..................................................................
Clothing Accessories Stores .........................................................
Sporting Goods Stores ..................................................................
All Other General Merchandise Stores .........................................
Manufactured (Mobile) Home Dealers ..........................................
Testing Laboratories ......................................................................
Advertising Material Distribution Services .....................................
All Other Support Services ............................................................
Marinas ..........................................................................................
Unknown ........................................................................................
Each proposed provision would affect
a different subset of the 30 small entities
from above and have a different
distribution of costs, cost savings, and
transfers across those small entities. We
will discuss each proposed provision
separately below and then summarize
each provision’s impacts.
ddrumheller on DSK120RN23PROD with PROPOSALS3
Provision 1: Incorporation by Reference
of ANSI/CAN/UL 12402–4
The first proposed provision, the IBR
of ANSI/CAN/UL 12402–4, would affect
seven small entities, six of which have
known revenues. The first provision
would result in costs to PFD
manufacturing firms that are small
entities that would intend to sell Level
100 devices in only one market (the
United States or Canada). Firms wishing
to sell Level 100 devices in both United
States and Canadian markets would no
longer conduct duplicative approvals
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type
NAICS code and industry type
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Number of U.S.
companies
Number of
small entities
Employees ..
Revenue ......
Employees ..
Employees ..
Employees ..
Employees ..
Employees ..
Employees ..
Employees ..
Employees ..
Employees ..
500
$8.0
750
500
750
500
750
1,000
750
500
100
1
2
1
1
2
1
1
2
4
1
1
1
2
1
1
0
1
1
2
3
1
1
Revenue ......
Revenue ......
Revenue ......
Revenue ......
Revenue ......
Revenue ......
Revenue ......
Revenue ......
Revenue ......
Revenue ......
Unknown .....
$35.0
$41.5
$16.5
$16.5
$35.0
$16.5
$16.5
$16.5
$12.0
$8.0
Unknown
5
1
2
2
1
1
1
1
1
1
5
4
0
1
2
1
0
0
1
1
1
5
38
30
and facility inspections, leading to cost
savings.
Whether small entities would or
would not experience cost savings
depends on whether each small entity
would prefer to sell their device in only
the United States or Canada or in both
markets. The Coast Guard does not
know which small entities would prefer
a cheaper set of tests with only the
ability to sell in one market and which
would prefer a more expensive set of
tests with the ability to sell in both
markets. We therefore compare both the
costs and cost savings estimates to each
small entity.
In the RA, we estimate the Level 100
approval would be $4,280 more
expensive than the current Type I
approval. While in the RA we estimate
that testing laboratories would receive
an application for approval to Level 100
standards 0.45 times per year, each
small entity would experience this cost
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standard
used
Sfmt 4702
only when they submit a new
application. Each small entity would
likely apply for an approval once they
develop a new device. The Coast Guard
cannot ascertain when each small entity
might submit a new application, so
instead we retain the cost of $4,280 as
an estimate of a one-time (initial year
cost) per small entity cost of ANSI/
CAN/UL 12402–4.
We estimate the cost savings for small
entities that wish to sell in two markets
would be $35,720 per new Level 100
approval, $4,746 per revision of an
existing approval with testing, and
$1,172 per revision of an existing
approval without testing. As with costs
of ANSI/CAN/UL 12402–4, each small
entity would experience the cost savings
only when it submits each application.
The Coast Guard does not know when
small entities might seek new approvals
or revisions in the future, so we estimate
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these as one-time cost savings to small
entities from ANSI/CAN/UL 12402–4.
Specifically, we estimate each small
entity would experience a one-time total
cost savings of $41,638 for each
approval, which is the sum of the Level
100 approvals and revisions to
approvals with or without testing
($35,720 + $4,746 + $1,172). Each of
these seven small entities would also
experience an ongoing (annual) cost
savings of $1,155.92 from reduced
facility inspection frequency.20
Provision 2: Incorporation by Reference
of ANSI/CAN/UL 12402–5
Incorporating by reference ANSI/
CAN/UL 12402–5 would permit small
entities to seek Coast Guard approval to
produce and sell Level 50 devices. The
Coast Guard has not previously
approved these devices. We estimate
that this provision would affect all 30
small entities, 24 of which have known
revenues.
In the RA, we estimate that the
introduction of Level 50 devices would
most likely result in a 5-percent growth
in the North American PFD market. The
growth in the market would be
composed of new types of PFDs. We
assume the 5-percent growth in the
market would also be a proxy for the
growth in the number of approved
devices (for a growth of 38 device
approvals). The initial approvals would
represent a one-time (initial year) cost to
small entities. Small entities would also
experience an annual cost of additional
production inspections based on the
volume of Level 50 PFDs produced.
We estimate a new Level 50 device
approval would cost a small entity
about $34,028. We do not know which
small entities would seek Coast Guard
approval for a Level 50 device or how
many devices for which each small
entity might seek approval. As a result,
we treat each small entity as seeking
approval for one Level 50 device costing
$34,028. This would be a one-time
(initial year) cost to small entities.
Production and revenue are not
distributed equally across the small
entities that produce PFDs for the North
American market. Instead, some small
entities produce vastly more PFDs than
others. In the RA, we estimate the
market share of the 13 largest firms to
be collectively about 95 percent, and we
estimate the remaining 44 firms’ market
share collectively to be about 5 percent.
We do not know the relative market
share of the 44 firms, so we divide the
5 percent equally across the 44 firms.
Therefore, we treat each of the 44 firms
as accounting for roughly about 0.11
percent of the PFD market.21 For the 30
small entities that would use the ANSI/
CAN/UL 12402–5 standard, 22 of them
are in the set of 44 firms composing 5
percent of the market, and we assume
each has a market share of 0.11 percent.
Based on conversations with PFD
manufacturing executives, we estimate 5
of the 30 firms have a market share of
2.5 percent each, 1 has a market share
of 7.5 percent, 1 has a market share of
15 percent, and 1 has a market share of
25 percent.22 We could not find revenue
data for six small entities.
In the RA, we estimate that the annual
cost of production inspections across
the whole industry would be $71,682.
Because we do not know which small
entities would seek Level 50 approval,
we estimate the additional costs from
production inspections from Level 50
device sales for each small entity by
multiplying each small entity’s market
share by the total costs. For example, if
we use a small entity that has a market
share of 0.11 percent, then we would
estimate the small entity’s additional
production inspection costs would be
about $78.85 ($71,682 × 0.0011,
rounded) annually.
21039
Provision 3: Incorporation by Reference
of ANSI/CAN/UL 9595
Incorporating ANSI/CAN/UL 9595 by
reference would establish production
testing standards for the PFD
manufacturing industry. ANSI/CAN/UL
9595 would lead to reductions in testing
frequency for PFD manufacturing
entities with a QMS in place. We
estimate that eight small entities would
be affected by this provision, seven of
which have known revenue.
Small entities would experience onetime costs of an initial QMS inspection,
and they would experience ongoing
costs because a QMS inspection is more
expensive than the facility inspection it
would replace in years after the first
year. We estimate that each small entity
has two facilities with the largest small
entity having three facilities, and QMS
inspection costs would occur per
facility. We estimated 7 of the firms in
the top 13 are small entities, including
the top firm. In the RA, we estimate that
the total costs to U.S. firms for the
ANSI/CAN/UL 9595 standard would be
about $53,118 for 19 facilities. Because
we do not know where each small
entity’s facilities are located, to estimate
each small entity’s one-time costs, we
multiply $53,118 by each small entity’s
share of the 19 facilities yielding
$5,591.37 (2 ÷ 19 × $53,118) for all but
the largest small entity and $8,387.05 (3
÷ 19 × $53,118) for the largest small
entity. We estimate annual costs would
be about $375 per facility, which is the
difference between eight hours of billed
QMS inspector time and eight hours of
a regular inspector’s time. The largest
small entity has three facilities, so
would experience $1,125 ($375 × 3) in
additional costs. All the other small
entities have two facilities, and they
would experience about $750 ($375 × 2)
in annual costs. In table 37, we present
the costs per small entity from the IBR
of ANSI/CAN/UL 9595.
TABLE 37—COSTS PER SMALL ENTITY FROM ANSI/CAN/UL 9595
Number of
facilities
Entity type
ddrumheller on DSK120RN23PROD with PROPOSALS3
The largest ...................................................................................................................................
All others ......................................................................................................................................
Total one-time
costs
3
2
$8,387.05
5,591.37
Annual costs
$1,125
750
The small entities that would achieve
a higher process rating according to the
ANSI/CAN/UL 9595 standard would
also experience annual cost savings
based on each small entity’s market
share and the rigor of the QMS system
that would be in place. As mentioned
previously, we estimate that only the
top 13 firms would experience savings
from ANSI/CAN/UL 9595, and we
estimate 7 of those firms are small
entities.
20 Facility inspections last four hours and include
the billed cost of the inspector’s time, or $234.45,
and the opportunity cost of a Quality Manager’s
time, or $54.53 per hour as a loaded weighted
average. ($234.45 + $54.53) × 4 = $1,155.92. Readers
should refer to the section of the RA discussing the
ANSI/CAN/UL 12402–4 standard.
21 We divided 5 percent (or 0.05) by 44 firms to
obtain 0.11 percent of the market for each one.
22 For more details on how we calculated market
share, see the initial regulatory analysis in the
docket.
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Cost savings would be different for
each of the seven small entities. To
estimate the cost savings per small
entity, we need to estimate the number
of reductions in inspections per small
entity and then multiply by $2,346
($1,876 of billed inspector time and
$470 of weighted average quality
manager loaded wages). To calculate the
reductions in inspections for each small
entity, we take the share of current
inspections for each small entity and
then estimate the number of inspections
that would take place under Process
Rating A or B. Next, we subtract the
reduced inspection frequency per small
entity from the current inspection
frequency yielding a reduction in
inspection frequency for current
production. In the RA, we also estimate
cost savings from reduced inspection
frequency on Level 50 devices that
entities do not yet produce. In the RA,
we estimate that U.S. firms would
experience 16 fewer inspections on
Level 50 devices. We then multiply the
16 inspections by each small entity’s
share of reduction in current
inspections.
For example, assume that a small
entity had a 10 percent market share,
half of which would be at Process
Rating A and half of which would be at
Process Rating B. We first would take
the total number of current inspections
on U.S. firms (587) and multiply by the
small entity’s market share relative to
the total affected U.S. market share, or
10 percent ÷ 77.5 percent × 587,
yielding 76 rounded. Then we would
derive the reduced number of
inspections at B and the reduced
number of inspections at A by
multiplying the reduced inspection
frequency at B (194) by the share of the
small entity’s Process Rating at B
relative to all other U.S. firms at B, or
5 percent ÷ 51 percent, yielding 19
rounded. To estimate the reduced
inspection frequency at A, we take the
number of facilities at A (one) and
multiply by two, accounting for the
number of inspections that would occur
once the facility is at Process Rating A.
Next, we add to it the multiplication of
the number of commercial PFD
production inspections at A (7) and the
small entity’s relative share of
production at A, or 5 percent ÷ 26.5
percent, yielding 3 rounded (2×1 + 7×5
percent ÷ 26.5 percent). Taken together
the small entity’s reduced inspection
frequency would be 22 (19 + 3) meaning
the small entity would experience 54
fewer production inspections annually
(76¥22). To calculate the number of
reduced Level 50 inspections, we take
the small entity’s share of U.S. firm
inspection reduction (54 ÷ 376) and
multiply by the 16 total reduction in
inspections, yielding 2 rounded. We add
the reduction in Level 50 inspections (2)
and the reduction in current inspections
(54) together and multiply by the cost of
each inspection ($2,346) yielding
$131,376 ([2 + 54] × $2,346) or the small
entity’s annual cost savings from
reduced inspection frequency. We
perform this process for each of the
eight small entities. We record these
calculations in table 38; the results are
rounded.
TABLE 38—COST SAVINGS FOR A REPRESENTATIVE SMALL ENTITY
Total market share
Market share
at B
Market share
at A
Current
inspection
frequency
Inspection
frequency
at B
Inspection
frequency
at A
Total
inspection
reduction
Reduced level
50 inspections
Total cost
savings
A
B=A÷2
C=A÷2
D = 587 × A ÷
77.5%
E = 194 × B ÷
51%
F = (2 × 1 + 7
× C ÷ 26.5%)
G = D¥E¥F
H = G ÷ 376 ×
16
(G + H) ×
$2,346
76
19
3
10% ...................................
5%
5%
Provision 4: Replacement of Information
Pamphlets With Placards
We did not predict any costs or cost
savings from this provision, so we do
not project any impact on small entities.
We summarize the number of small
entities affected, cost impacts, cost
54
2
$131,376
savings impacts, and transfers per
provision in table 39.
TABLE 39—NUMBER OF AFFECTED SMALL ENTITIES, COSTS, AND COST SAVINGS PER PROVISION
ddrumheller on DSK120RN23PROD with PROPOSALS3
Provision
PFD manufacturing
population affected
Costs
Cost savings
One-time testing to Level 100 would be
$35,720 less than testing to Type I standards for entities wishing to sell in both the
United States and Canada. Small entities
would also save costs from cheaper revisions with and without testing, $4,746 and
$1,172 respectively. Together, small entities would save $41,638. Small entities
would also experience $1,155.92 in annual
cost savings from reduced facility inspections.
No estimated cost savings for these small entities.
ANSI/CAN/UL 12402–4
7 small entities of the
30; 6 small entities
with known revenues.
One-time testing to Level 100 would cost
$4,280 more than testing to Legacy Type I
standards for entities wishing to sell in only
Canada or the United States.
ANSI/CAN/UL 12402–5
30 small entities, 24
small entities with
known revenues.
One-time (initial year) testing to Level 50
standards would cost about $34,028. Additional ongoing costs from inspections would
be between $78.85 and $17,920.50 based
on each small entity’s market share (small
entities with larger market shares would experience greater costs).
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TABLE 39—NUMBER OF AFFECTED SMALL ENTITIES, COSTS, AND COST SAVINGS PER PROVISION—Continued
Provision
PFD manufacturing
population affected
ANSI/CAN/UL 9595 .....
8 small entities, 7
small entities with
known revenues.
Information Pamphlets
30 small entities, 24
small entities with
known revenues.
We provide a list of the range of costs,
cost savings, and net cost savings per
entity in table 40. We report the
Costs
Cost savings
One-time (initial year) cost from an additional
QMS inspection of about $8,387.05 for the
largest small entity based on three facilities
and $5,591.37 for all other small entities
with two facilities.
Ongoing (annual) costs would result from a
QMS inspection and would be more than a
regular inspection. We estimate ongoing
costs to be about $375 per facility or
$1,125 for the largest small entity with
three facilities and $750 for each other
small entity with two facilities.
No estimated costs .........................................
Small entities would save through reduced inspection frequencies based on each small
entity’s market share and each small entity’s QMS in place. We estimate these 8
small entities would experience between
$21,114 and $229,908 in savings based on
their market share and QMS ratings per
year.
estimated overall net cost savings
revenue impact per small entity of this
No estimated cost savings.
proposed rule across all provisions from
total costs in table 41.
TABLE 40—RANGE OF IMPACTS PER ENTITY
One-time impacts
Lowest per
entity
Cost ..................................................................................................................
Cost Savings ....................................................................................................
Net Cost Savings .............................................................................................
$34,028.00
........................
(39,619.37)
Ongoing impacts
Highest per
entity
$46,695.05
41,638.00
3,330.00
Lowest per
entity
$78.85
........................
(40,560.93)
Highest per
entity
$60,683.50
231,063.92
170,380.42
TABLE 41—PERCENTAGE OF ESTIMATED REVENUE IMPACT ON SMALL ENTITIES FROM OVERALL IMPACT (NET COST
SAVINGS) OF THIS PROPOSED RULE
One-time net cost savings
% Revenue impact
Small entities
with known
revenue
<1% ..................................................................................................................
1–3% ................................................................................................................
>3% ..................................................................................................................
ddrumheller on DSK120RN23PROD with PROPOSALS3
4. A Description of the Projected
Reporting, Recordkeeping, and Other
Compliance Requirements of the
Proposed Rule, Including an Estimate of
the Classes of Small Entities Which Will
Be Subject to the Requirements and the
Type of Professional Skills Necessary
for Preparation of the Report or Record
This rule calls for no new collection
of information under the Paperwork
Reduction Act of 1995, 44 U.S.C. 3501–
3520.
There are no relevant Federal rules
that may duplicate, overlap, or conflict
with this NPRM.
6. A Description of Any Significant
Alternatives to the Rule Which
Accomplish the Stated Objectives of
Applicable Statutes and Which
Minimize any Significant Economic
Impact of the Proposed Rule on Small
Entities
The Coast Guard identified three
alternatives:
(1) Incorporate ANSI/CAN/UL 12402–
5 for the approval of Level 70 PFDs
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Portion of
small entities
with known
revenue
17
2
5
5. An Identification, to the Extent
Practicable, of All Relevant Federal
Rules That May Duplicate, Overlap, or
Conflict With the Proposed Rule
Ongoing net cost savings
71
8
21
Small entities
with known
revenue
20
2
2
Portion of
small entities
with known
revenue
83
8
8
only, prohibiting the approval of Level
50 PFDs;
(2) Require placards instead of
permitting either placards or pamphlets;
and
(3) Adopt ANSI/CAN/UL 12402–4
and ANSI/CAN/UL 12402–5 by policy.
Alternative 1: Incorporate by Reference
ANSI/CAN/UL 12402–5 for Level 70
PFDs Only
Under the first alternative, we could
have chosen to incorporate ANSI/CAN/
UL 12402–5, but limit approval to Level
70 PFDs only. Level 50 PFDs would not
be eligible for Coast Guard approval and
would not meet carriage requirements
on any vessel. If the Coast Guard chose
this alternative, the market for Level 50
devices would not be viable because
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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.
ddrumheller on DSK120RN23PROD with PROPOSALS3
Alternative 2: Require Placards Instead
of Permitting Either Placards or
Pamphlets
We considered the alternative of
requiring that PFD manufacturers use
placards instead of their choice of either
placards or information pamphlets for
the mandatory PFD instructional
materials. While the cost of producing
placards is generally less than the costs
of producing information pamphlets,
some manufacturers may not be ready to
switch to producing placards. As such,
if we required that manufacturers use
placards, we could place undue burden
on small entities in the PFD industry by
requiring that they acquire new
equipment to produce placards. We do
not know how large these costs could
be, but small entities would experience
greater compliance costs. As a result, we
ultimately rejected this alternative.
Alternative 3: Adopt ANSI/CAN/UL
12402–4 and ANSI/CAN/UL 12402–5 by
Policy
Another alternative that we
considered would be to adopt ANSI/
CAN/UL 12402–4 and ANSI/CAN/UL
12402–5 by policy instead of
incorporating them by reference in the
regulations. Under 46 CFR 159.005–7(c),
the Coast Guard has the authority to
approve an item of equipment that does
not meet all the requirements of 46 CFR
160.055 if it has equivalent performance
characteristics. The Coast Guard has
used this authority to partially adopt
ANSI/CAN/UL 12402–4 and ANSI/
CAN/UL 12402–5 by policy. However,
because this authority is limited to the
approval of equipment with equivalent
performance characteristics, we cannot
fully adopt these standards by policy.
Namely, Level 50 PFDs, youth inflatable
PFDs, and inflatable Level 100 PFDs
cannot be approved by policy. As a
result, small entities would not receive
the additional revenue from the sale of
Level 50 devices or the cost savings on
Level 100 inflatable device approvals as
compared to Type I device approvals.
For these reasons, we rejected this
alternative.
7. Conclusion
We are interested in the potential
impacts from this rule on small
businesses and we request public
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comment on these potential impacts. If
you think that this rule will have a
significant economic impact on you,
your business, or your organization,
please submit a comment to the docket
at the address under the Public
Participation and Request for Comments
section of this preamble. In your
comment, explain why, how, and to
what degree you think this rule will
have an economic impact on you.
C. Assistance for Small Entities
Under section 213(a) of the Small
Business Regulatory Enforcement
Fairness Act of 1996, Public Law 104–
121, we want to assist small entities in
understanding this proposed rule so that
they can better evaluate its effects on
them and participate in the rulemaking.
If the proposed rule would affect your
small business, organization, or
governmental jurisdiction and you have
questions concerning its provisions or
options for compliance, please call or
email the person in the FOR FURTHER
INFORMATION CONTACT section of this
proposed rule. The Coast Guard will not
retaliate against small entities that
question or complain about this
proposed rule or any policy or action of
the Coast Guard.
Small businesses may send comments
on the actions of Federal employees
who enforce, or otherwise determine
compliance with, Federal regulations to
the Small Business and Agriculture
Regulatory Enforcement Ombudsman
and the Regional Small Business
Regulatory Fairness Boards. The
Ombudsman evaluates these actions
annually and rates each agency’s
responsiveness to small business. If you
wish to comment on actions by
employees of the Coast Guard, call 1–
888–REG–FAIR (1–888–734–3247).
D. Collection of Information
This proposed rule would call for no
new collection of information under the
Paperwork Reduction Act of 1995, 44
U.S.C. 3501–3520.
E. Federalism
A rule has implications for federalism
under Executive Order 13132
(Federalism) if it has a substantial direct
effect on States, on the relationship
between the National Government and
the States, or on the distribution of
power and responsibilities among the
various levels of government. We have
analyzed this proposed rule under
Executive Order 13132 and have
determined that it is consistent with the
fundamental federalism principles and
preemption requirements described in
Executive Order 13132. Our analysis
follows.
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It is well settled that States may not
regulate in categories reserved for
regulation by the Coast Guard. It is also
well settled that all the categories
covered in 46 U.S.C. 3306, 3703, 7101,
and 8101 (design, construction,
alteration, repair, maintenance,
operation, equipping, personnel
qualification, and manning of vessels),
as well as the reporting of casualties and
any other category in which Congress
intended the Coast Guard to be the sole
source of a vessel’s obligations, are
within the field foreclosed from
regulation by the States. See the
Supreme Court’s decision in United
States v. Locke and Intertanko v. Locke,
529 U.S. 89, 120 S.Ct. 1135 (2000). The
statutory authorities upon which this
rulemaking is based—46 U.S.C. 3306(a),
4102(a), 4302(a), and 4502(a) and
(c)(2)(B)—all generally preempt State
and local law. Therefore, because the
States may not regulate within these
categories, this rule is consistent with
the fundamental federalism principles
and preemption requirements described
in Executive Order 13132.
F. Unfunded Mandates
The Unfunded Mandates Reform Act
of 1995, 2 U.S.C. 1531 0336; 1538,
requires Federal agencies to assess the
effects of their discretionary regulatory
actions. In particular, the Act addresses
actions that may result in the
expenditure by a State, local, or tribal
government, in the aggregate, or by the
private sector of $100 million (adjusted
for inflation) or more in any one year.
Although this proposed rule would not
result in such an expenditure, we do
discuss the effects of this proposed rule
elsewhere in this preamble.
G. Taking of Private Property
This proposed rule would not cause a
taking of private property or otherwise
have taking implications under
Executive Order 12630 (Governmental
Actions and Interference with
Constitutionally Protected Property
Rights).
H. Civil Justice Reform
This proposed rule meets applicable
standards in sections 3(a) and 3(b)(2) of
Executive Order 12988, (Civil Justice
Reform), to minimize litigation,
eliminate ambiguity, and reduce
burden.
I. Protection of Children
We have analyzed this proposed rule
under Executive Order 13045
(Protection of Children from
Environmental Health Risks and Safety
Risks). This proposed rule is not an
economically significant rule and would
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not create an environmental risk to
health or risk to safety that might
disproportionately affect children.
J. Indian Tribal Governments
This proposed rule does not have
tribal implications under Executive
Order 13175 (Consultation and
Coordination with Indian Tribal
Governments), because it would not
have a substantial direct effect on one or
more Indian tribes, on the relationship
between the Federal Government and
Indian tribes, or on the distribution of
power and responsibilities between the
Federal Government and Indian tribes.
K. Energy Effects
We have analyzed this proposed rule
under Executive Order 13211 (Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use). We have
determined that it is not a ‘‘significant
energy action’’ under that order because
it is not a ‘‘significant regulatory action’’
under Executive Order 12866 and is not
likely to have a significant adverse effect
on the supply, distribution, or use of
energy.
ddrumheller on DSK120RN23PROD with PROPOSALS3
L. Technical Standards
The National Technology Transfer
and Advancement Act, codified as a
note to 15 U.S.C. 272, directs agencies
to use voluntary consensus standards in
their regulatory activities unless the
agency provides Congress, through
OMB, with an explanation of why using
these standards would be inconsistent
with applicable law or otherwise
impractical. Voluntary consensus
standards are technical standards (such
as specifications of materials,
performance, design, or operation; test
methods; sampling procedures; and
related management systems practices)
that are developed or adopted by
voluntary consensus standards bodies.
This proposed rule uses the following
voluntary consensus standards:
• ANSI/CAN/UL 9595, Standard for
Buoyant Cushions, Fourth Edition,
April 20, 2007 (including revisions
through January 10, 2020).
• ANSI/CAN/UL 12402–4, Standard
for Personal Flotation Devices—Part 4:
Lifejackets, Performance Level 100—
Safety Requirements, First Edition, July
9, 2020.
• ANSI/CAN/UL 12402–5, Standard
for Personal Flotation Devices—Part 5:
Buoyancy Aids (Level 50)—Safety
Requirements, First Edition, December
31, 2015 (including revisions through
January 27, 2022).
• ANSI/UL 1123, Standard for Marine
Buoyant Devices, Seventh Edition,
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October 1, 2008 (including revisions
through November 23, 2020).
• ANSI/UL 1175, Standard for
Buoyant Cushions, Fourth Edition,
April 20, 2007 (including revisions
through January 10, 2020).
The proposed sections that reference
these standards and the locations where
these standards are available are listed
in 46 CFR 160.045–5, 160.055–5,
160.060–5, 160.064–5, 160.076–5,
160.255–5, 160.264–5, and 160.276–5.
46 CFR Part 108
M. Environment
46 CFR Part 141
We have analyzed this proposed rule
under Department of Homeland
Security Management Directive 023–01,
Rev. 1, associated implementing
instructions, and Environmental
Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in
complying with the National
Environmental Policy Act of 1969 (42
U.S.C. 4321–4370f), and have made a
preliminary determination that this
action is one of a category of actions that
do not individually or cumulatively
have a significant effect on the human
environment. A preliminary Record of
Environmental Consideration
supporting this determination is
available in the docket. For instructions
on locating the docket, see the
ADDRESSES section of this preamble.
This proposed rule would be
categorically excluded under paragraph
L52 of Appendix A, Table 1 of DHS
Instruction Manual 023–01–001–01,
Rev. 1. Paragraph L52 pertains to
regulations concerning vessel operation
safety standards.
This proposed rule involves approval
requirements and follow-up program
requirements for lifejackets. We seek
any comments or information that may
lead to the discovery of a significant
environmental impact from this
proposed rule.
List of Subjects
33 CFR Part 181
Incorporation by reference, Labeling,
Marine safety, Reporting and
recordkeeping requirements.
46 CFR Part 25
Fire prevention, Marine safety,
Occupational safety and health, Oil and
gas exploration, Vessels.
46 CFR Part 117
Marine safety, Passenger vessels.
46 CFR Part 133
Cargo vessels, Marine safety,
Reporting and recordkeeping
requirements.
Incorporation by reference, Marine
safety, Occupational health and safety,
Reporting and recordkeeping
requirements, Towing vessels.
46 CFR Part 160
Incorporation by reference, Marine
safety, Reporting and recordkeeping
requirements.
46 CFR Part 169
Fire prevention, Marine safety,
Reporting and recordkeeping
requirements, Schools, Vessels.
46 CFR Part 180
Marine safety, passenger vessels.
46 CFR Part 199
Cargo vessels, Marine safety, Oil and
gas exploration, Passenger vessels,
Reporting and recordkeeping
requirements.
For the reasons discussed in the
preamble, the Coast Guard proposes to
amend 33 CFR part 181 and 46 CFR
parts 25, 28, 108, 117, 133, 141, 160,
169, 180, and 199 as follows:
Title 33—Navigation and Navigable
Waters
PART 181—MANUFACTURER
REQUIREMENTS
1. The authority citation for part 181
is revised to read as follows:
■
Authority: 46 U.S.C. 4302; DHS Delegation
00170.1, Revision No. 01.2, paragraph
(II)(92)(a).
2. Revise the title of Subpart G to read
as follows:
■
Subpart G—Instruction Pamphlet or
Placard for Personal Flotation Devices
Fire prevention, Marine safety,
Reporting and recordkeeping
requirements.
§ 181.4
46 CFR Part 28
§ 181.701
Alaska, Fire prevention, Fishing
vessels, Marine safety, Occupational
safety and health, Reporting and
recordkeeping requirements, Seamen.
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21043
■
[Removed and Reserved]
3. Remove and reserve § 181.4.
[Amended]
4. Amend § 181.701 by adding the
words ‘‘Coast Guard approved’’ after the
word ‘‘all’’.
■ 5. Revise § 181.702 to read as follows:
■
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§ 181.702 Information pamphlet or placard:
requirement to furnish.
(a) Each manufacturer of a Coast
Guard approved personal flotation
device (PFD) must furnish with each
PFD that is sold or offered for sale for
use on a recreational boat, an
information pamphlet or placard
accepted by the Commandant (CG–
ENG–4) or meeting the requirements in
the applicable subpart of 46 CFR part
160.
(b) No person may sell or offer for sale
for use on a recreational boat, a Coast
Guard approved PFD unless an
information pamphlet or placard
required by this section is attached in
such a way that it can be read prior to
purchase.
§ 181.703
■
§ 181.704
■
[Removed]
7. Remove § 181.704.
§ 181.705
■
[Removed]
6. Remove § 181.703.
[Removed]
8. Remove § 181.705.
Title 46—Shipping
PART 25—REQUIREMENTS
9. The authority citation for part 25 is
revised to read as follows:
■
Authority: 33 U.S.C. 1903(b); 46 U.S.C.
2103, 3306, 4102, 4302; DHS Delegation
00170.1, Revision No. 01.2, paragraphs
(II)(77), (92)(a), 92(b).
10. Amend § 25.25–5 by:
■ a. Removing in paragraph (b)(2), the
text ‘‘or 160.176’’ and adding, in its
place, the text ‘‘160.176, or 160.255’’;
and
■ b. Revising the introductory text to
paragraph (c)(2).
The addition and revision read as
follows:
■
§ 25.25–5 Life preservers and other
lifesaving equipment required.
*
*
*
*
*
(c) * * *
(2) On each vessel, regardless of
length and regardless of whether
carrying passengers for hire, a
commercial hybrid PFD approved under
former approval series 160.077 prior to
[EFFECTIVE DATE OF FINAL RULE],
may be substituted for a PFD approved
under approval series 160.055, 160.155,
160.176, or 160.255 if it is in good and
serviceable condition and—
*
*
*
*
*
PART 28—REQUIREMENTS FOR
COMMERCIAL FISHING INDUSTRY
VESSELS
11. The authority citation for part 28
is revised to read as follows:
■
Authority: 46 U.S.C. 3316, 4502, 4505,
4506, 6104, 8103, 10603; DHS Delegation
00170.1, Revision No. 01.2, paragraph
(II)(92)(a).
12. Revise § 28.110(a) to read as
follows:
■
§ 28.110 Life preservers or other personal
flotation devices.
(a) Except as provided by § 28.305 of
this chapter, each vessel must be
equipped with at least one immersion
suit, exposure suit, or wearable personal
flotation device of the proper size for
each individual on board as specified in
Table 1 to § 28.110(a) and part 25,
subpart 25.25 of this chapter.
Notwithstanding the provisions of
paragraphs (c) and (d) of § 25.25–1 of
this chapter, each commercial fishing
industry vessel propelled by sail, and
each manned barge employed in
commercial fishing activities, must meet
the requirements of this paragraph.
TABLE 1 TO § 28.110—PERSONAL FLOTATION DEVICES AND IMMERSION SUITS
Applicable waters
Vessel type
Devices required
Seaward of the Boundary Line and
North of 32 °N or South of 32
°S; and Lake Superior.
Coastal Waters on the West Coast
of the United States north of
Point Reyes, CA; Beyond Coastal Waters, cold water; and Lake
Superior.
All other waters (Includes all Great
Lakes except Lake Superior).
Documented Vessel .....................
Immersion suit or exposure suit ...
28.135; 25.25–9(a);
25.25–15.
25.25–13;
All vessels .....................................
Immersion suit or exposure suit ...
28.135; 25.25–9(a);
25.25–15.
25.25–13;
40 feet (12.2 meters) or more in
length.
Wearable PFD approved under
approval
series
160.055,
160.155,
or
160.176,
or
160.255 immersion suit, or exposure suit 1.
Wearable PFD approved under
subchapter Q of this chapter
immersion suit, or exposure
suit1.
28.135; 25.25–5(e); 25.25–5(f);
25.25–9(a); 25.25–13; 25.25–
15.
Less than 40 feet (12.2 meters) in
length.
Other regulations
28.135; 25.25–5(e); 25.25–5(f);
25.25–9(a); 25.25–13; 25.25–
15.
1 A commercial hybrid approved under former approval series 160.077 prior to [EFFECTIVE DATE OF FINAL RULE] may be substituted for a
PFD approved under approval series 160.055, 160.155, 160.176, or 160.255 if it is in good and serviceable condition, used in accordance with
the conditions marked on the PFD and in the owner’s manual, and labeled for use on commercial vessels.
ddrumheller on DSK120RN23PROD with PROPOSALS3
PART 108—DESIGN AND EQUIPMENT
13. The authority citation for part 108
is revised to read as follows:
160.177’’ and replace it with the text ‘‘or
160.176’’.
p.277; DHS Delegation 00170.1, Revision No.
01.2, paragraph (II)(92)(a).
PART 117—LIFESAVING EQUIPMENT
AND ARRANGEMENTS
■
■
Authority: 43 U.S.C. 1333; 46 U.S.C. 3102,
3306; DHS Delegation 00170.1, Revision No.
01–2, paragraph (II)(92)(a).
§ 108.580
[Amended]
14. Amend § 108.580(b) introductory
text by removing the text ‘‘, 160.176 or
■
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15. The authority citation of part 117
is revised to read as follows:
■
Authority: 46 U.S.C. 2103, 3306; E.O.
12234, 45 FR 58801, 3 CFR, 1980 Comp.,
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16. Amend § 117.71 by:
a. Revising the section heading and
paragraph (c);
■ b. Removing paragraph (d); and
■ c. Redesignating paragraph (e) as
paragraph (d).
The revisions read as follows:
■
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§ 117.71
Lifejackets.
§ 141.340
*
*
*
*
*
(c) Each lifejacket must be approved
under approval series §§ 160.002,
160.005, 160.055, 160.155, 160.176, or
160.255 in subchapter Q of this chapter,
or other standard specified by the
Commandant. An inflatable lifejacket
approved under approval series 160.255
must include a full back-up inflation
chamber.
*
*
*
*
*
■ 17. Amend § 117.72 by revising the
section heading and paragraphs (b) and
(d) to read as follows:
§ 117.72 Personal flotation devices carried
in addition to lifejackets.
*
*
*
*
*
(b) Wearable PFDs approved in
accordance with §§ 160.064, 160.076,
160.264, or 160.276 in subchapter Q of
this chapter, or other standard specified
by the Commandant, may be carried as
additional equipment.
*
*
*
*
*
(d) A commercial hybrid PFD
approved under former approval series
160.077 prior to [EFFECTIVE DATE OF
FINAL RULE] may be carried as
additional equipment for use by persons
working near or over the water if it is
in good and serviceable condition, used
in accordance with the conditions
marked on the PFD and in the owner’s
manual, of the same or similar design,
and has the same method of operation
as each other hybrid PFD carried on
board.
PART 133—LIFESAVING SYSTEMS
Authority: 46 U.S.C. 3306, 3307; DHS
Delegation 00170.1, Revision No. 01.2,
paragraph (II)(92)(a).
19. Amend § 133.70(b) introductory
text by removing the text ‘‘160.177’’ and
adding, in its place, the text ‘‘160.255’’.
PART 141—LIFESAVING
20. The authority citation for part 141
is revised to read as follows:
ddrumheller on DSK120RN23PROD with PROPOSALS3
■
Authority: 46 U.S.C. 3103, 3301, 3306,
3308, 3316, 8104, 8904; 33 CFR 1.05; DHS
Delegation 00170.1, Revision No. 01.2,
paragraph (II)(92)(a).
[Amended]
21. Amend § 141.340 by:
a. Removing in paragraph (a), the text
‘‘or 160.176,’’ and adding, in its place,
the text ‘‘160.176, or 160.255’’; and
■ b. Adding new paragraph (i).
The additions read as follows:
■
■
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PART 160—LIFESAVING EQUIPMENT
22. The authority citation for part 160
is revised to read as follows:
■
Authority: 46 U.S.C. 2103, 3306, 3703 and
4302; E.O. 12234; 45 FR 58801; 3 CFR, 1980
Comp., p. 277; and DHS Delegation 00170.1,
Revision No. 01.2, paragraph (II)(92)(a).
Subpart 160.001 [Removed and
Reserved]
23. Remove and reserve subpart
160.001, consisting of §§ 160.001–1
through 160.001–5.
■
Subpart 160.002 [Removed and
Reserved]
24. Remove and reserve subpart
160.002, consisting of §§ 160.002–1
through 160.002–7.
■
Subpart 160.005 [Removed and
Reserved]
25. Remove and reserve subpart
160.005, consisting of §§ 160.005–1
through 160.005–7.
■
Subpart 160.006 [Removed and
Reserved]
26. Remove and reserve subpart
160.006, consisting of § 160.006–2.
■ 27. Add subpart 160.045, consisting of
§§ 160.045–1 through 160.045–25, to
read as follows:
Subpart 160.045 Recreational
Throwable PFDs
[Amended]
■
§ 141.340
*
*
*
*
(i) Wearable PFDs approved in
accordance with §§ 160.064, 160.076,
160.264, or 160.276 in subchapter Q of
this chapter, or other standard specified
by the Commandant, may be carried as
additional equipment. Additional
equipment is not acceptable in lieu of
any portion of the required lifejackets.
■
18. The authority citation for part 133
is revised to read as follows:
■
§ 133.70
Lifejackets.
*
§ 160.045–1
Scope.
(a) This subpart contains structural
and performance standards for approval
of throwable PFDs for use on
recreational vessels, as well as
requirements for production follow-up
inspections, associated manuals,
information pamphlets or placards, and
markings.
(b) Throwable PFDs approved under
this subpart may rely entirely on
inherently buoyant material, or rely
entirely or partially upon inflation to
achieve the minimum buoyancy.
(c) Throwable PFDs approved under
this subpart are intended to meet the
carriage requirements for uninspected
commercial vessels under 40 ft (12 m)
not carrying passengers for hire and
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recreational boats, in accordance with
33 CFR part 175.
§ 160.045–3
Definitions.
The following definitions apply to
this subpart:
Commandant means the Chief of the
Lifesaving and Fire Safety Standards
Division. Address: Commandant (CG–
ENG–4), Attn: Lifesaving and Fire Safety
Division, U.S. Coast Guard Stop 7509,
2703 Martin Luther King Jr. Avenue SE,
Washington, DC 20593–7509; email
TypeApproval@uscg.mil.
First quality workmanship means
construction that is free from any defect
materially affecting appearance or
serviceability.
Recognized laboratory means an
independent laboratory accepted by the
Commandant in accordance with 46
CFR subpart 159.010, with a valid
memorandum of understanding in
accordance with 46 CFR 159.010–7.
§ 160.045–5
Incorporation by reference.
Certain material is incorporated by
reference into this part with the
approval of the Director of the Federal
Register in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. All approved
material is available for inspection at
the Coast Guard Headquarters and at the
National Archives and Records
Administration (NARA). Contact
Commandant (CG–ENG–4), Attn:
Lifesaving and Fire Safety Division, U.S.
Coast Guard Stop 7509, 2703 Martin
Luther King Jr. Avenue SE, Washington,
DC 20593–7509. For information on the
availability of this material at NARA,
visit www.archives.gov/federal-register/
cfr/ibr-locations.html or email:
fr.inspection@nara.gov. The material
may be obtained from UL, 333 Pfingsten
Road, Northbrook, IL 60062–2002;
phone 847–272–8800; website:
www.ul.com.
(a) ANSI/CAN/UL 9595:2021,
Standard for Factory Follow-Up on
Personal Flotation Devices (PFDs), First
Edition, June 4, 2020 (including
revisions through September 9, 2021)
(‘‘ANSI/CAN/UL 9595’’); IBR approved
for § 160.045–15(e).
(b) ANSI/UL 1123, Standard for
Marine Buoyant Devices, Seventh
Edition, October 1, 2008 (including
revisions through November 23, 2020)
(‘‘ANSI/UL 1123’’); IBR approved for
§§ 160.045–7(e); 160.045–13(d).
(c) ANSI/UL 1175, Standard for
Buoyant Cushions, Fourth Edition,
April 20, 2007 (including revisions
through January 10, 2020) (‘‘ANSI/UL
1175’’); IBR approved for §§ 160.045–
7(e); 160.045–13(d).
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ddrumheller on DSK120RN23PROD with PROPOSALS3
§ 160.045–7 Design, construction, and
performance of throwable PFDs.
(a) General. Every throwable PFD
must conform to the requirements as
accepted by the Commandant for listing
and labeling by a recognized laboratory,
and must be of such design, materials,
and construction as to meet the
requirements specified in this section.
(b) Designs and constructions.
Throwable PFDs must not provide
means for adjustment or close fitting to
the body. Methods of construction must
provide strengths, with reinforcements
where necessary, to be adequate for the
intended use and purpose of the device.
(c) Materials. All materials used in
any device covered by this subpart must
meet the applicable requirements of
subpart 164.019 of this chapter, must be
all new materials, must be suitable for
the purpose intended, and must be at
least equivalent to corresponding
materials specified for standard buoyant
cushions. Hardware or fastenings must
be of sufficient strength for the purpose
of the device and must be of inherently
corrosion-resistant material, such as
stainless steel, brass, bronze, certain
plastics, etc. Decorative platings of any
thickness are permissible. Fabrics,
coated fabrics, tapes, and webbing must
be either mildew-resistant or treated for
mildew resistance. Buoyancy provided
by inherently buoyant material must not
be dependent upon loose, granulated
material.
(d) Standard construction. A standard
foam cushion that is designed to be
thrown must be 2 inches or more in
thickness and must have 225 or more
square inches of top surface area.
(e) Nonstandard construction. A
nonstandard throwable PFD must meet
the requirements in ANSI/UL 1123 or
ANSI/UL 1175 (both incorporated by
reference, see § 160.045–5) and any
additional requirements that the
Commandant may prescribe to approve
unique or novel designs.
(f) Buoyancy. (1) Ring life buoys must
have 161⁄2 pounds or more of buoyancy.
(2) Foam cushions must have 18
pounds or more of buoyancy.
(3) A device other than those standard
devices specified in paragraph (f)(1) or
(2) of this section must have 20 pounds
or more of buoyancy.
(g) Workmanship. Throwable PFDs
must be of first quality workmanship
and must be free from any defects
materially affecting their appearance or
serviceability.
§ 160.045–9 Approval procedures for
throwable PFDs.
(a) Each application for approval of a
throwable PFD must be submitted
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directly to a Coast Guard recognized
laboratory.
(b) The recognized laboratory must
determine if a throwable PFD with
novel design features requires a
preliminary review by the Coast Guard
prior to testing. Submissions requiring
preliminary review must be sent to
TypeApproval@uscg.mil, and must
include a full description and drawings.
Pictures, samples, and preliminary test
results may also be submitted.
§ 160.045–11
Recognized laboratory.
(a) The approval inspections and tests
required by § 160.045–13, and
production inspections, tests, and
quality control required by § 160.045–
15, must be conducted by an
independent laboratory recognized by
the Coast Guard under 46 CFR subpart
159.010 to perform such functions. A
list of recognized independent
laboratories is available from the
Commandant and online at https://
cgmix.uscg.mil.
(b) The same laboratory that performs
the approval tests must also perform
production oversight unless the
employees of the laboratory performing
production oversight receive training
and support equal to that of the
laboratory that performed the approval
testing, as determined by the
Commandant.
§ 160.045–13
tests.
Approval inspections and
(a) Each throwable PFD must be
certified by a recognized laboratory as
meeting the requirements of this
subpart. Approval tests must be
conducted or supervised by a
recognized laboratory using PFDs
constructed in accordance with the
plans and specifications submitted with
the application for approval.
(b) Each throwable PFD design must
be visually examined for compliance
with the construction and performance
requirements of this subpart.
(c) Standard PFDs must be submerged
in fresh water for 24 or more continuous
hours. The measured buoyancy after the
24 hours of submersion must be the
buoyancy specified in § 160.045–7(f).
(d) Non-standard throwable PFDs
must be subjected to approval tests
specified in ANSI/UL 1123 or ANSI/UL
1175 (both incorporated by reference,
see § 160.045–5) or another test program
accepted by the Commandant. Approval
tests must be conducted or supervised
by a recognized laboratory using
throwable PFDs constructed in
accordance with the plans and
specifications submitted with the
application for approval.
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(e) The Commandant may prescribe
additional tests for approval of novel or
unique designs.
§ 160.045–15 Production inspections,
tests, and quality control of throwable
PFDs.
(a) Manufacturer’s inspection and
tests. Manufacturers of approved
throwable PFDs must maintain quality
control of the materials used,
manufacturing methods and the
finished product to meet the applicable
requirements, and make sufficient
inspections and tests of representative
samples and components produced to
maintain the quality of the finished
product. Records of tests conducted by
the manufacturer and records of
materials, including affidavits by
suppliers that applicable requirements
are met, must be made available to the
recognized laboratory inspector or to the
Coast Guard marine inspector, or both,
for review upon request.
(b) Laboratory inspections and tests.
The laboratory inspector will conduct
examinations, inspections, and tests for
listed and labeled devices, as required
by the recognized laboratory, at the
place of manufacture or other location at
the option of the laboratory.
(c) Test facilities. The laboratory
inspector, or the Coast Guard marine
inspector assigned by the Commander of
the District in which the factory is
located, or both, must be admitted to
any place in the factory where work is
being done on listed and labeled
products. Either or both inspectors may
take samples of parts or materials
entering construction or final
assemblies, for further examinations,
inspections, or tests. The manufacturer
must provide a suitable place and the
apparatus necessary for the performance
of the tests done at the place of
manufacture.
(d) Additional tests, etc.
Unannounced examinations, tests, and
inspections of samples obtained either
directly from the manufacturer or
through commercial channels may be
made to determine the suitability of a
product for listing and labeling, or to
determine conformance of a labeled
product to the applicable requirements.
These may be conducted by the
recognized laboratory or by the United
States Coast Guard.
(e) Follow-up program. A follow-up
program in accordance with ANSI/CAN/
UL 9595 (incorporated by reference, see
§ 160.045–5) meets the requirements of
this section.
§ 160.045–17
Marking and Labeling.
(a) Each throwable PFD must be
marked in accordance with the
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recognized laboratory’s listing and
labeling requirements in accordance
with § 160.045–3(a). At a minimum, all
labels must include—
(1) Size information, as appropriate;
(2) The Coast Guard approval number;
(3) Manufacturer’s contact
information;
(4) Model name/number;
(5) Lot number, manufacturer date;
and
(6) Any limitations or restrictions on
approval or special instructions for use.
(b) Marking must be of a type that will
be durable and legible for the expected
life of the device.
(c) The Commandant may prescribe
additional marking requirements for
special purpose devices or unique or
novel designs.
§ 160.045–21
PFD manuals.
(a) An owner’s manual must be
provided with each fully or partially
inflatable throwable PFD sold or offered
for sale. The text of each manual is
reviewed with the application for
approval.
(b) The Commandant may prescribe
additional information in the manual for
special purpose devices or unique or
novel designs.
(c) Additional information,
instructions, or illustrations may be
included in the owner’s manual if there
is no contradiction to the required
information.
§ 160.045–23 Procedure for approval of
design or material change.
(a) The manufacturer must submit any
proposed changes in design, material, or
construction to the recognized
laboratory for approval before changing
throwable PFD production methods.
(b) Determinations of equivalence of
design, construction, and materials may
be made only by the Commandant or a
designated representative.
ddrumheller on DSK120RN23PROD with PROPOSALS3
§ 160.045–25
approval.
Suspension or termination of
As provided in 46 CFR 159.005–15,
the Commandant may suspend or
terminate the approval of a throwable
PFD if the manufacturer fails to comply
with this subpart or the recognized
laboratory’s accepted procedures or
requirements.
Subpart 160.048 [Removed and
Reserved]
29. Remove and reserve subpart
160.048, consisting of §§ 160.048–1
through 160.048–8.
■
Subpart 160.052 [Removed and
Reserved]
30. Remove and reserve subpart
160.052, consisting of §§ 160.052–1
through 160.052–9.
■
Subpart 160.055—Life Preservers,
Unicellular Plastic Foam, Adult and
Child, for Merchant Vessels
31. Revise § 160.055–1 to read as
follows:
■
§ 160.055–1
Scope.
(a) This subpart contains
requirements for production follow-up
inspections for life preservers approved
under this subpart prior to [EFFECTIVE
DATE OF FINAL RULE].
(b) Life preservers approved under
this subpart rely upon inherently
buoyant material to achieve the
minimum buoyancy.
(c) Life preservers approved under
this subpart are intended to meet the
carriage requirements for wearable PFDs
for uninspected passenger vessels,
uninspected commercial vessels over 40
ft (12m), and for inspected vessels.
(d) Each life preserver specified in
this subpart is a:
(1) Standard, bib type, vinyl dip
coated:
(i) Model 62, adult (for persons
weighing over 90 pounds); or
(ii) Model 66, child (for persons
weighing less than 90 pounds); or
(2) Standard, bib type, cloth covered;
(i) Model 63, adult (for persons
weighing over 90 pounds); or
(ii) Model 67, child (for persons
weighing less than 90 pounds); or
(3) Nonstandard, shaped type:
(i) Model,1 adult (for persons
weighing over 90 pounds); or
(ii) Model,1 child (for persons
weighing less than 90 pounds).
1 A model designation for each
nonstandard life preserver is to be assigned
by the manufacturer. That designation must
be different from any standard lifesaving
device designation.
§ 160.055–2
[Removed and Reserved]
32. Remove and reserve § 160.055–2.
33. Revise § 160.055–3 to read as
follows:
■
■
Subpart 160.047 [Removed and
Reserved]
§ 160.055–3
28. Remove and reserve subpart
160.047, consisting of §§ 160.047–1
through 160.047–7.
The following definitions apply to
this subpart:
Commandant means the Chief of the
Lifesaving and Fire Safety Standards
■
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Fmt 4701
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21047
Division. Address: Commandant (CG–
ENG–4), Attn: Lifesaving and Fire Safety
Division, U.S. Coast Guard Stop 7509,
2703 Martin Luther King Jr. Avenue SE,
Washington, DC 20593–7509; email
TypeApproval@uscg.mil.
First quality workmanship means
construction that is free from any defect
materially affecting appearance or
serviceability.
Inspector means a recognized
laboratory representative assigned to
perform, supervise, or oversee the duties
described in § 160.255–15 or any Coast
Guard representative performing duties
related to the approval.
Recognized laboratory means an
independent laboratory accepted by the
Commandant in accordance with 46
CFR 159.010, with a valid memorandum
of understanding in accordance with 46
CFR 159.010–7.
§ 160.055–4
[Removed and Reserved]
34. Remove and reserve § 160.055–4.
35. Revise § 160.055–5 to read as
follows:
■
■
§ 160.055–5
Incorporation by reference.
Certain material is incorporated by
reference into this part with the
approval of the Director of the Federal
Register in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. All approved
material is available for inspection at
the Coast Guard Headquarters and at the
National Archives and Records
Administration (NARA). Contact
Commandant (CG–ENG–4), Attn:
Lifesaving and Fire Safety Division, U.S.
Coast Guard Stop 7509, 2703 Martin
Luther King Jr. Avenue SE, Washington,
DC 20593–7509. For information on the
availability of this material at NARA,
visit www.archives.gov/federal-register/
cfr/ibr-locations.html or email:
fr.inspection@nara.gov. The material
may be obtained from UL, 333 Pfingsten
Road, Northbrook, IL 60062–2002 phone
(847) 272–8800; website: www.ul.com.
(a) ANSI/CAN/UL 9595:2021,
Standard for Factory Follow-Up on
Personal Flotation Devices (PFDs), First
Edition, June 4, 2020 (including
revisions through September 9, 2021)
(‘‘ANSI/CAN/UL 9595’’); IBR approved
for § 160.055–15(a).
(b) [Reserved]
§ 160.055–6
■
§ 160.055–7
■
[Removed and Reserved]
38. Remove and reserve § 160.055–8.
§ 160.055–9
■
[Removed and Reserved]
37. Remove and reserve § 160.055–7.
§ 160.055–8
■
[Removed and Reserved]
36. Remove and reserve § 160.055–6.
[Removed and Reserved]
39. Remove and reserve § 160.055–9.
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40. Add § 160.055–11 to read as
follows:
■
§ 160.055–11
Independent laboratory.
The production inspections, tests, and
quality control required by this subpart
must be conducted by an independent
laboratory accepted by the Coast Guard
under 46 CFR subpart 159.010 to
perform such functions. A list of
accepted independent laboratories is
available from the Commandant and
online at https://cgmix.uscg.mil.
■ 41. Add § 160.055–15 to read as
follows:
ddrumheller on DSK120RN23PROD with PROPOSALS3
§ 160.055–15 Production inspections,
tests, and quality control of life preservers.
(a) General. Production tests and
inspections must be conducted in
accordance with this section, subpart
159.007 of this chapter, and the
independent laboratory’s procedures for
production inspections and tests as
accepted by the Commandant. The
Commandant may prescribe additional
production tests and inspections
necessary to maintain quality control
and to monitor compliance with the
requirements of this subchapter. A
follow-up program in accordance with
ANSI/CAN/UL 9595 (incorporated by
reference, see § 160.055–5), meets the
requirements of this subpart.
(b) Oversight. In addition to
responsibilities set out in part 159 of
this chapter and the accepted laboratory
procedures for production inspections
and tests, each manufacturer of a life
preserver and each laboratory inspector
must comply with the following, as
applicable:
(1) Manufacturer. Each manufacturer
must—
(i) perform all tests and examinations
necessary to show compliance with this
subpart on each lot before any
inspector’s tests and inspection of the
lot;
(ii) follow established procedures for
maintaining quality control of the
materials used, manufacturing
operations, and the finished product;
and
(iii) allow an inspector to take
samples of completed units or of
component materials for tests required
by this subpart and for tests relating to
the safety of the design.
(2) Laboratory. An inspector from the
accepted laboratory must oversee
production in accordance with the
laboratory’s procedures for production
inspections and tests accepted by the
Commandant. During production
oversight, the inspector must not
perform or supervise any production
test or inspection unless—
(i) the manufacturer has a valid
approval certificate; and
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(ii) the inspector has first observed the
manufacturer’s production methods and
any revisions to those methods.
(3) At least quarterly, the inspector
must check the manufacturer’s
compliance with the company’s quality
control procedures, examine the
manufacturer’s required records, and
observe the manufacturer perform each
of the required production tests.
(c) Test facilities. The manufacturer
must provide a suitable place and
apparatus for conducting the tests and
inspections necessary to determine
compliance of life preservers with this
subpart. The manufacturer must provide
means to secure any test that is not
continuously observed, such as the 48hour buoyancy test. The manufacturer
must have the calibration of all test
equipment checked in accordance with
the test equipment manufacturer’s
recommendation and interval but not
less than at least once every year.
(d) Lots. A lot must not consist of
more than 1000 life preservers. A lot
number must be assigned to each group
of life preservers produced. Lots must
be numbered serially. A new lot must be
started whenever any change in
materials or a revision to a production
method is made, and whenever any
substantial discontinuity in the
production process occurs. The lot
number assigned, along with the
approval number, must enable the PFD
manufacturer to determine the
supplier’s identifying information for
the component lot.
(e) Samples. (1) From each lot of life
preservers, manufacturers must
randomly select a number of samples
from completed units at least equal to
the applicable number required by table
1 to § 160.055–15(e)(1) for buoyancy
testing. Additional samples must be
selected for any tests, examinations, and
inspections required by the laboratory’s
production inspections and tests
procedures.
TABLE 1 TO § 160.055–15(e)(1)—
SAMPLING FOR BUOYANCY TESTS
Number
of life
preservers
in sample
Lot size
100
101
201
301
501
751
and under ..........................
to 200 ................................
to 300 ................................
to 500 ................................
to 750 ................................
to 1,000 .............................
1
2
3
4
6
8
(2) For a lot succeeding one from
which any sample life preserver failed
the buoyancy test, the sample must
consist of not less than ten specimen life
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preservers to be tested for buoyancy in
accordance with paragraph (f) of this
section.
(f) Buoyancy test. The buoyancy of the
life preservers must be determined by
measuring the upward force exerted by
the individual submerged unit. The
buoyancy measurement must be made at
the end of the 48 hours of submersion,
during which period the pad inserts
must not be disturbed.
(g) Buoyancy required. The buoyant
pad inserts from Model 3 adult life
preservers must provide not less than 25
pounds buoyancy in fresh water, and
the pads from Model 5 child life
preservers must provide not less than
16.5 pounds buoyancy.
(h) Lot inspection. On each lot, the
laboratory inspector must perform a
final lot inspection to be satisfied that
the life preservers meet this subpart.
Each lot must demonstrate—
(1) first quality workmanship;
(2) that the general arrangement and
attachment of all components, such as
body straps, closures, tie tapes, and
drawstrings, are as specified in the
approved plans and specifications;
(3) compliance with the marking
requirements; and
(4) the information pamphlet or
placard specified in 33 CFR part 181
subpart G, if required, is securely
attached to the device, with the PFD
selection information visible and
accessible prior to purchase.
(i) Lot acceptance. When the
independent laboratory has determined
that the life preservers in the lot are of
a type officially approved in the name
of the company, and that such life
preservers meet the requirements of this
subpart, they must be plainly marked in
waterproof ink with the independent
laboratory’s name or identifying mark.
(j) Lot rejection. Each nonconforming
unit must be rejected. If three or more
nonconforming units are rejected for the
same kind of defect, lot inspection must
be discontinued and the lot rejected.
The inspector must discontinue lot
inspection and reject the lot if
examination of individual units or the
records for the lot shows
noncompliance with either this
subchapter or the laboratory’s or the
manufacturer’s quality control
procedures. A rejected unit or lot may
be resubmitted for testing and
inspection if the manufacturer first
removes and destroys each defective
unit or, if authorized by the laboratory,
reworks the unit or lot to correct the
defect. A rejected lot or rejected unit
must not be sold or offered for sale
under the representation that it meets
this subpart or that it is Coast Guard
approved.
E:\FR\FM\07APP3.SGM
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42. Add § 160.055–19 to read as
follows:
■
§ 160.055–19
Pamphlet or placard.
Each life preserver sold or offered for
sale for use on recreational boats must
be provided with a pamphlet or placard
that a prospective purchaser can read
prior to purchase, as specified in 33 CFR
part 181 subpart G.
■ 43. Add § 160.055–23 to read as
follows:
§ 160.055–23 Procedure for approval of
design or material change.
Suspension or termination of
As provided in 46 CFR 159.005–15,
the Commandant may suspend or
terminate the approval if the
manufacturer fails to comply with this
subpart or the recognized laboratory’s
accepted procedures or requirements.
Subpart 160.060—Specification for a
Buoyant Vest, Unicellular Polyethylene
Foam, Adult and Child
45. Revise § 160.060–1 to read as
follows:
■
ddrumheller on DSK120RN23PROD with PROPOSALS3
§ 160.060–1
Scope.
(a) This subpart contains
requirements for production follow-up
inspections for buoyant vests approved
under this subpart prior to [EFFECTIVE
DATE OF FINAL RULE].
(b) Buoyant vests approved under this
subpart rely upon inherently buoyant
material to achieve the minimum
buoyancy.
(c) Buoyant vests approved under this
subpart are intended to meet the
carriage requirements for wearable PFDs
for uninspected passenger vessels,
uninspected commercial vessels over 40
ft (12m), and for inspected vessels.
(d) Each buoyant vest specified in this
subpart is a standard model:
(1) Standard:
(i) Model AY, adult (for persons
weighing over 90 pounds); or
(ii) Model CYM, child, medium (for
children weighing from 50 to 90
pounds); or
(iii) Model CYS, child, small (for
children weighing less than 50 pounds).
(2) Nonstandard:
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1A model designation for a nonstandard
vest is to be assigned by the individual
manufactured and must be different from any
standard vest.
§ 160.060–2
[Removed and Reserved]
46. Remove and reserve § 160.060–2.
47. Revise § 160.060–3 to read as
follows:
■
■
(a) The manufacturer must submit any
proposed changes in design, material, or
construction to typeapproval@uscg.mil
for approval before changing life
preserver production methods.
(b) Only the Commandant or a
designated representative may make
determinations of equivalence of design,
construction, and materials.
■ 44. Add § 160.055–25 to read as
follows:
§ 160.055–25
approval.
(i) Model,1 adult (for persons
weighing over 90 pounds); or
(ii) Model,1 child, medium (for
persons weighing from 50 to 90
pounds); or
(iii) Model,1 child, small (for persons
weighing less than 50 pounds).
cfr/ibr-locations.html or email:
fr.inspection@nara.gov. The material
may be obtained from UL, 333 Pfingsten
Road, Northbrook, IL 60062–2002;
phone (847) 272–8800; website:
www.ul.com.
(a) ANSI/CAN/UL 9595:2021,
Standard for Factory Follow-Up on
Personal Flotation Devices (PFDs), First
Edition, June 4, 2020 (including
revisions through September 9, 2021)
(‘‘ANSI/CAN/UL 9595’’); IBR approved
for § 160.060–15(h).
(b) [Reserved]
§ 160.060–6
■
§ 160.060–3
Definitions.
The following definitions apply to
this subpart:
Commandant means the Chief of the
Lifesaving and Fire Safety Standards
Division. Address: Commandant (CG–
ENG–4), Attn: Lifesaving and Fire Safety
Division, U.S. Coast Guard Stop 7509,
2703 Martin Luther King Jr. Avenue SE,
Washington, DC 20593–7509; email
TypeApproval@uscg.mil.
First quality workmanship means
construction that is free from any defect
materially affecting appearance or
serviceability.
Inspector means a recognized
laboratory representative assigned to
perform, supervise, or oversee the duties
described in § 160.255–15 or any Coast
Guard representative performing duties
related to the approval.
Recognized laboratory means an
independent laboratory accepted by the
Commandant in accordance with 46
CFR subpart 159.010, with a valid
memorandum of understanding in
accordance with 46 CFR 159.010–7.
§ 160.060–3a
■
[Removed and Reserved]
48. Remove and reserve § 160.060–3a.
§ 160.060–4
[Removed and Reserved]
49. Remove and reserve § 160.060–4.
50. Revise § 160.060–5 to read as
follows:
■
■
§ 160.060–5
Incorporation by reference.
Certain material is incorporated by
reference into this part with the
approval of the Director of the Federal
Register in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. All approved
material is available for inspection at
the Coast Guard Headquarters and at the
National Archives and Records
Administration (NARA). Contact
Commandant (CG–ENG–4), Attn:
Lifesaving and Fire Safety Division, U.S.
Coast Guard Stop 7509, 2703 Martin
Luther King Jr. Avenue SE, Washington,
DC 20593–7509. For information on the
availability of this material at NARA,
visit www.archives.gov/federal-register/
PO 00000
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21049
§ 160.060–7
■
[Removed and Reserved]
52. Remove and reserve § 160.060–7.
§ 160.060–8
■
[Removed and Reserved]
51. Remove and reserve § 160.060–6.
[Removed and Reserved]
53. Remove and reserve § 160.060–8.
§ 160.060–9
[Removed and Reserved]
54. Remove and reserve § 160.060–9.
55. Add § 160.060–11 to read as
follows:
■
■
§ 160.060–11
Independent laboratory.
(a) The production inspections, tests,
and quality control required by this
subpart must be conducted by an
independent laboratory recognized by
the Coast Guard under 46 CFR 159.010
to perform such functions. A list of
recognized independent laboratories is
available from the Commandant and
online at https://cgmix.uscg.mil.
(b) The same laboratory that performs
the approval tests must also perform
production oversight unless the
employees of the laboratory performing
production oversight receive training
and support equal to that of the
laboratory that performed the approval
testing, as determined by the
Commandant.
■ 56. Add § 160.060–15 to read as
follows:
§ 160.060–15 Production inspections,
tests, and quality control.
(a) General. Manufacturers of listed
and labeled buoyant vests must—
(1) Maintain quality control of the
materials used, the manufacturing
methods, and the finished product to
meet the applicable requirements of this
subpart by conducting sufficient
inspections and tests of representative
samples and components produced;
(2) Make available to the recognized
laboratory inspector or the Coast Guard
inspector, upon request, records of tests
conducted by the manufacturer and
records of materials used during
production of the device, including
affidavits by suppliers; and
(3) Permit any examination,
inspection, or test required by the
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must exceed the buoyancy of the inserts.
To obtain the buoyancy of the inserts,
proceed as follows:
(i) Weigh the empty wire basket under
water.
(ii) Place the inserts inside the basket
and submerge it so that the top of the
basket is at least 2 inches below the
surface of the water. Allow the inserts
to remain submerged for 24 hours. The
tank must be locked or sealed during
this 24-hour submergence period. It is
important that after the inserts have
once been submerged they remain
submerged for the duration of the test,
and at no time during the course of the
test removed from the tank or otherwise
exposed to air.
(iii) After the 24-hour submergence
period, unlock or unseal the tank and
weigh the wire basket with the inserts
TABLE 1 TO § 160.060–15(b)(4)—
inside while both are still under water.
SAMPLE FOR BUOYANCY TESTS
(iv) The buoyancy is computed as
paragraph (e)(1)(i) of this section minus
Number of
Lot size
vests in
paragraph (e)(1)(iii) of this section.
sample
(2) Buoyancy required. The buoyant
inserts
from adult size buoyant vests
100 and under ..........................
1
101 to 200 ................................
2 must provide not less than 151 2044;2
201 to 300 ................................
3 pounds of buoyancy in fresh water; the
301 to 500 ................................
4 inserts from the child medium size
buoyant vests must provide not less
(5) If a sample vest fails the buoyancy than 11 pounds buoyancy; and the
test, the sample from the next
inserts from the child small size
succeeding lot must consist of 10
buoyant vests must provide not less
specimen vests or more to be tested for
than 7 pounds buoyancy.
buoyancy in accordance with paragraph
(f) Body strap test. The complete body
(e) of this section.
strap assembly, including hardware
(c) Additional compliance tests. An
must be tested for strength by attaching
inspector may conduct an examination,
the D-ring to a suitable support such
test, and inspection of a buoyant device that the assembly hangs vertically its
obtained from the manufacturer or
full length. A weight of 150 pounds for
through commercial channels to
an adult size and 115 pounds for a child
determine the suitability of the device
size must be attached to the other end
for listing and labeling, or to determine
on the snap hook for 10 minutes. The
its conformance to applicable
specified weight must not break or
requirements.
excessively distort the body strap
(d) Test facilities. The manufacturer
assembly.
must admit the inspector to any part of
(g) Additional approval tests for
the premises at the place of manufacture
nonstandard vests. Tests in addition to
of a listed and labeled device to—
those required by this section may be
(1) Examine, inspect, or test a sample
conducted by the inspector for a
of a part or a material that is included
nonstandard vest to determine
in the construction of the device; and
performance equivalence to a standard
(2) Conduct any examination,
vest. Such additional tests may include
inspection, or test in a suitable place
determining performance in water,
and with appropriate apparatus
suitability of materials, donning time,
provided by the manufacturer.
ease of adjustment, and similar
(e) Buoyancy.
(1) Buoyancy test method. Remove the equivalency tests. Costs for any
buoyant inserts from the vests. Securely additional tests must be assumed by the
manufacturer.
attach the spring scale in a position
(h) Follow-up program. A follow-up
directly over the test tank. Suspend the
program in accordance with ANSI/CAN/
weighted wire basket from the scale in
UL 9595 (incorporated by reference, see
such a manner that the basket can be
§ 160.060–5) meets the requirements of
weighed while it is completely under
this section.
water. In order to measure the actual
buoyancy provided by the inserts, the
■ 57. Add § 160.060–19 to read as
underwater weight of the empty basket
follows:
ddrumheller on DSK120RN23PROD with PROPOSALS3
recognized laboratory or the Coast
Guard for a produced listed and labeled
device, either at the place of
manufacture or some other location.
(b) Lot size and sampling.
(1) A lot must consist of 500 buoyant
vests or fewer;
(2) A new lot begins after any change
or modification in materials used or
manufacturing methods employed;
(3) The manufacturer of the buoyant
vests must notify the recognized
laboratory when a lot is ready for
inspection;
(4) The manufacturer must select
samples in accordance with the
requirements in Table 1 to § 160.060–
15(b)(4) from each lot of buoyant vests
to be tested for buoyancy in accordance
with paragraph (e) of this section; and
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§ 160.060–19
Pamphlet or placard.
Each buoyant vest sold or offered for
sale for use on recreational boats must
be provided with a pamphlet or placard
that a prospective purchaser can read
prior to purchase, as specified in 33 CFR
part 181 subpart G.
■ 58. Add § 160.060–23 to read as
follows:
§ 160.060–23 Procedure for approval of
design or material change.
(a) The manufacturer must submit any
proposed changes in design, material, or
construction to typeapproval@uscg.mil
for approval before changing PFD
production methods.
(b) Only the Commandant or a
designated representative may make
determinations of equivalence of design,
construction, and materials.
■ 59. Add § 160.060–25 to read as
follows:
§ 160.060–25
approval.
Suspension or termination of
As provided in 46 CFR 159.005–15,
the Commandant may suspend or
terminate the approval if the
manufacturer fails to comply with this
subpart or the recognized laboratory’s
accepted procedures or requirements.
Subpart 160.064—Marine Buoyant
Devices
60. Revise § 160.064–1 to read as
follows:
■
§ 160.064–1
Scope.
(a) This subpart contains
requirements for production follow-up
inspections for wearable PFDs and
throwable PFDs approved under this
subpart prior to [EFFECTIVE DATE OF
FINAL RULE].
(b) PFDs approved under this subpart
are intended to meet the carriage
requirements for PFDs for uninspected
commercial vessels under 40 ft (12m)
not carrying passengers for hire and
recreational boats, in accordance with
33 CFR 175 and 46 CFR 25.25.
(c) PFDs covered by this subpart are
of two general types: those intended to
be worn on the body and those intended
to be thrown.
§ 160.064–2
[Removed and Reserved]
61. Remove and reserve § 160.064–2.
62. Revise § 160.064–3 to read as
follows:
■
■
§ 160.064–3
Definitions.
The following definitions apply to
this subpart:
Commandant means the Chief of the
Lifesaving and Fire Safety Standards
Division. Address: Commandant (CG–
ENG–4), Attn: Lifesaving and Fire Safety
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Division, U.S. Coast Guard Stop 7509,
2703 Martin Luther King Jr. Avenue SE,
Washington, DC 20593–7509; email
TypeApproval@uscg.mil.
First class workmanship means
construction that is free from any defect
materially affecting appearance or
serviceability.
Inspector means a recognized
laboratory representative assigned to
perform, supervise, or oversee the duties
described in § 160.264–15 or any Coast
Guard representative performing duties
related to the approval.
Recognized laboratory means an
independent laboratory accepted by the
Commandant in accordance with 46
CFR subpart 159.010, with a valid
memorandum of understanding in
accordance with 46 CFR 159.010–7.
independent laboratory recognized by
the Coast Guard under 46 CFR subpart
159.010 to perform such functions. A
list of recognized independent
laboratories is available from the
Commandant and online at https://
cgmix.uscg.mil.
(b) The same laboratory that performs
the approval tests must also perform
production oversight unless the
employees of the laboratory performing
production oversight receive training
and support equal to that of the
laboratory that performed the approval
testing, as determined by the
Commandant.
■ 68. Add § 160.064–15 to read as
follows:
§ 160.064–4
(a) Manufacturer’s inspection and
tests. Manufacturers of approved PFDs
must maintain quality control of the
materials used, manufacturing methods,
and the finished product to meet the
applicable requirements, and make
sufficient inspections and tests of
representative samples and components
produced to maintain the quality of the
finished product. Records of tests
conducted by the manufacturer and
records of materials, including affidavits
by suppliers that applicable
requirements are met, must be made
available to the recognized laboratory
inspector or to the Coast Guard marine
inspector, or both, for review upon
request.
(b) Laboratory inspections and tests.
The laboratory inspector will conduct
examinations, inspections, and tests for
listed and labeled devices, as required
by the recognized laboratory, at the
place of manufacture or other location at
the option of the laboratory.
(c) Test facilities. The laboratory
inspector, or the Coast Guard marine
inspector assigned by the Commander of
the District in which the factory is
located, or both, must be admitted to
any place in the factory where work is
being done on listed and labeled
products. Either or both inspectors may
take samples of parts or materials
entering construction or final
assemblies, for further examinations,
inspections, or tests. The manufacturer
must provide a suitable place and the
apparatus necessary for the performance
of the tests done at the place of
manufacture.
(d) Additional tests, etc.
Unannounced examinations, tests, and
inspections of samples obtained either
directly from the manufacturer or
through commercial channels may be
made to determine the suitability of a
product for listing and labeling, or to
[Removed and Reserved]
63. Remove and reserve § 160.064–4.
64. Add § 160.064–5 to read as
follows:
■
■
§ 160.064–5
Incorporation by reference.
Certain material is incorporated by
reference into this part with the
approval of the Director of the Federal
Register in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. All approved
material is available for inspection at
the Coast Guard Headquarters and at the
National Archives and Records
Administration (NARA). Contact
Commandant (CG–ENG–4), Attn:
Lifesaving and Fire Safety Division, U.S.
Coast Guard Stop 7509, 2703 Martin
Luther King Jr. Avenue SE, Washington,
DC 20593–7509. For information on the
availability of this material at NARA,
visit www.archives.gov/federal-register/
cfr/ibr-locations.html or email:
fr.inspection@nara.gov. The material
may be obtained from UL, 333 Pfingsten
Road, Northbrook, IL 60062–2002;
phone (847) 272–8800; website:
www.ul.com.
(a) ANSI/CAN/UL 9595:2021,
Standard for Factory Follow-Up on
Personal Flotation Devices (PFDs), First
Edition, June 4, 2020 (including
revisions through September 9, 2021)
(‘‘ANSI/CAN/UL 9595’’); IBR approved
for § 160.064–15(e).
(b) [Reserved]
§ 160.064–6
ddrumheller on DSK120RN23PROD with PROPOSALS3
■
[Removed and Reserved]
65. Remove and reserve § 160.064–6.
§ 160.064–7
[Removed and Reserved]
66. Remove and reserve § 160.064–7.
67. Add § 160.064–11 to read as
follows:
■
■
§ 160.064–11
Recognized laboratory.
(a) The production inspections, tests,
and quality control required by this
subpart must be conducted by an
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§ 160.064–15 Production inspections,
tests, and quality control of PFDs.
PO 00000
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Fmt 4701
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21051
determine conformance of a labeled
product to the applicable requirements.
These may be conducted by the
recognized laboratory or the United
States Coast Guard.
(e) Follow-up program. A follow-up
program in accordance with ANSI/CAN/
UL 9595 (incorporated by reference, see
§ 160.064–5) meets the requirements of
this section.
■ 69. Add § 160.064–23 to read as
follows:
§ 160.064–23 Procedure for approval of
design or material change.
(a) The manufacturer must submit any
proposed changes in design, material, or
construction to the recognized
laboratory for approval before changing
PFD production methods.
(b) Determinations of equivalence of
design, construction, and materials must
be made only by the Commandant or a
designated representative.
■ 70. Add § 160.064–25 to read as
follows:
§ 160.064–25
approval.
Suspension or termination of
As provided in 46 CFR 159.005–15,
the Commandant may suspend or
terminate the approval of a PFD design
if the manufacturer fails to comply with
this subpart or the recognized
laboratory’s accepted procedures or
requirements.
Subpart 160.076—Inflatable
Recreational Personal Flotation
Devices
71. Revise § 160.076–1 to read as
follows:
■
§ 160.076–1
Scope.
(a) This subpart contains
requirements for production follow-up
inspections for inflatable recreational
personal flotation devices (PFDs)
approved prior to [EFFECTIVE DATE
OF FINAL RULE].
(b) Inflatable PFDs approved under
this subpart rely partially or entirely
upon inflation for buoyancy.
■ 72. Revise § 160.076–5 to read as
follows:
§ 160.076–5
Incorporation by reference.
Certain material is incorporated by
reference into this part with the
approval of the Director of the Federal
Register in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. All approved
material is available for inspection at
the Coast Guard Headquarters and at the
National Archives and Records
Administration (NARA). Contact
Commandant (CG–ENG–4), Attn:
Lifesaving and Fire Safety Division, U.S.
Coast Guard Stop 7509, 2703 Martin
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Luther King Jr. Avenue SE, Washington,
DC 20593–7509. For information on the
availability of this material at NARA,
visit www.archives.gov/federal-register/
cfr/ibr-locations.html or email:
fr.inspection@nara.gov. The material
may be obtained from UL, 333 Pfingsten
Road, Northbrook, IL 60062–2002;
phone (847) 272–8800 website:
www.ul.com.
(a) ANSI/CAN/UL 9595:2021,
Standard for Factory Follow-Up on
Personal Flotation Devices (PFDs), First
Edition, June 4, 2020 (including
revisions through September 9, 2021)
(‘‘ANSI/CAN/UL 9595’’); IBR approved
for § 160.076–29(a).
(b) [Reserved].
§ 160.076–11
■
§ 160.076–13
■
[Removed and Reserved]
75. Remove and reserve § 160.076–21.
§ 160.076–23
■
[Removed and Reserved]
74. Remove and reserve § 160.076–13.
§ 160.076–21
■
[Removed and Reserved]
73. Remove and reserve § 160.076–11.
[Removed and Reserved]
76. Remove and reserve § 160.076–23.
§ 160.076–25
[Removed and Reserved]
77. Remove and reserve § 160.076–25.
78. Amend § 160.076–29 by:
a. Revising the first sentence of
paragraph (a);
■ b. Removing in paragraph (c)(1)(i), the
text ‘‘Except as provided in paragraph
(e)(2) of this section, perform’’ and
adding, in its place, the text ‘‘Perform’’;
■ c. Removing paragraphs (c)(5), (6),
(e)(3) through (5), (f), and (g); and
■ d. Redesignating paragraph (h) as
paragraph (f).
The revisions read as follows:
■
■
■
§ 160.076–29
Production oversight.
■
§ 160.76–33
§ 160.076–35
placard.
§ 160.076–37
■
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Owner’s manual.
(a) General. The manufacturer must
provide an owner’s manual with each
inflatable PFD sold or offered for sale.
(b) Manual contents. The manual
must contain the information as
approved by the Commandant. If the
PFD is conditionally approved, an
explanation of the meaning of and
reasons for the approval conditions
must be included.
§ 160.076–39
79. Amend § 160.076–31 by:
a. Removing in paragraph (a), the text
‘‘§ 160.076–29(e)’’ and adding, in its
place, the words ‘‘the sampling plan
accepted by the Commandant’’;
■ b. Removing in paragraph (b)(1), the
text ‘‘in paragraphs (c)(2) through (c)(8)
of this section’’ and adding, in its place,
the words ‘‘specified in the follow-up
program accepted by the Commandant’’;
■ c. Removing in paragraph (b)(2), the
text ‘‘in paragraphs (c)(4) through (c)(8)
of this section’’ and adding, in its place,
the words ‘‘specified in the follow-up
program accepted by the Commandant’’;
Information pamphlet or
A pamphlet or placard accepted by
the Commandant must be attached to
each inflatable PFD sold or offered for
sale in such a way that a prospective
purchaser can read the pamphlet prior
to purchase. The pamphlet or placard
text and layout must be submitted to the
Commandant for approval. The text
must be printed in each pamphlet or
placard exactly as approved by the
Commandant. Additional information,
instructions, or illustrations must not be
included within the approved text and
layout. Sample pamphlet text and
layout may be obtained by contacting
the Commandant. This pamphlet or
placard may be combined with the
manual required by § 160.076–37 if PFD
selection and warning information is
provided on the PFD packaging in such
a way that it remains visible until
purchase.
■ 82. Revise § 160.076–37 to read as
follows:
§ 160.76–31
[Amended]
[Amended]
80. Amend § 160.076–33 by removing
and reserving paragraph (b)(6).
■ 81. Revise § 160.076–35 to read as
follows:
■
(a) Production tests and inspections
must be conducted in accordance with
ANSI/CAN/UL 9595 (incorporated by
reference, see § 160.076–5) or an
alternative follow-up procedure
accepted by the Commandant. * * *
*
*
*
*
*
■
■
ddrumheller on DSK120RN23PROD with PROPOSALS3
d. Removing paragraph (c);
e. Redesignating paragraphs (d) and
(e) as (c) and (d); and
■ f. Removing the second sentence of
redesignated paragraph (c)(1).
■
[Amended]
83. In the introductory text to
§ 160.076–39, removing the text
‘‘specified in UL 1180 (incorporated by
reference, see § 160.076–11)’’ and
adding, in its place, the words
‘‘approved by the Commandant’’.
Subpart 160.077 [Removed and
Reserved]
84. Remove and reserve subpart
160.077, consisting of §§ 160.077–1
through 160.077–31.
■ 85. Add subpart 160.255, consisting of
§§ 160.255–1 through 160.255–27, to
read as follows:
■
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Subpart 160.255—Commercial
Lifejackets
§ 160.255–1
Scope.
(a) This subpart contains structural
and performance standards for approval
of Level 100 lifejackets, as well as
requirements for production follow-up
inspections, markings, information
placards, and associated manuals.
(b) Lifejackets approved under this
subpart must rely upon inherently
buoyant material, inflation, or a
combination to achieve the minimum
buoyancy.
(c) Lifejackets approved under this
subpart are intended to meet the
carriage requirements for wearable PFDs
for uninspected passenger vessels,
uninspected commercial vessels over 40
ft (12m) and for inspected vessels.
§ 160.255–3
Definitions.
The following definitions apply to
this subpart:
Commandant means the Chief of the
Lifesaving and Fire Safety Standards
Division. Address: Commandant (CG–
ENG–4), Attn: Lifesaving and Fire Safety
Division, U.S. Coast Guard Stop 7509,
2703 Martin Luther King Jr. Avenue SE,
Washington, DC 20593–7509; email
TypeApproval@uscg.mil.
First quality workmanship means
construction that is free from any defect
materially affecting appearance or
serviceability.
Inspector means a recognized
laboratory representative assigned to
perform, supervise, or oversee the duties
described in § 160.255–15 or any Coast
Guard representative performing duties
related to the approval.
Recognized laboratory means an
independent laboratory accepted by the
Commandant in accordance with 46
CFR subpart 159.010, with a valid
memorandum of understanding in
accordance with 46 CFR 159.010–7.
§ 160.255–5
Incorporation by reference.
Certain material is incorporated by
reference into this part with the
approval of the Director of the Federal
Register in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. All approved
material is available for inspection at
the Coast Guard Headquarters and at the
National Archives and Records
Administration (NARA). Contact
Commandant (CG–ENG–4), Attn:
Lifesaving and Fire Safety Division, U.S.
Coast Guard Stop 7509, 2703 Martin
Luther King Jr. Avenue SE, Washington,
DC 20593–7509. For information on the
availability of this material at NARA,
visit www.archives.gov/federal-register/
cfr/ibr-locations.html or email:
fr.inspection@nara.gov. The material
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may be obtained from UL, 333 Pfingsten
Road, Northbrook, IL 60062–2002;
phone (847) 272–8800; website:
www.ul.com.
(a) ANSI/CAN/UL 9595:2021,
Standard for Factory Follow-Up on
Personal Flotation Devices (PFDs), First
Edition, June 4, 2020 (including
revisions through September 9, 2021)
(‘‘ANSI/CAN/UL 9595’’); IBR approved
for § 160.255–15(a).
(b) ANSI/CAN/UL 12402–4:2020,
Standard for Personal Flotation
Devices—Part 4: Lifejackets,
Performance Level 100—Safety
Requirements, First Edition, July 9, 2020
(‘‘ANSI/CAN/UL 12402–4’’); IBR
approved for §§ 160.255–7(a); 160.255–
13(a) and (b); 160.255–17(a); 160.255–
19; 160.255–21(a).
§ 160.255–7 Design, construction, and
performance of lifejackets.
(a) Each Level 100 lifejacket design
must—
(1) Meet the requirements in ANSI/
CAN/UL 12402–4 (incorporated by
reference, see § 160.255–5) for a Level
100 device, and the requirements of this
subpart; and
(2) For novel or unique designs, meet
any additional requirements that the
Commandant may prescribe.
(b) Lifejackets must be of first quality
workmanship and must be free from any
defects materially affecting their
appearance or serviceability.
(c) Lifejackets must not provide
means intended for fastening or
securing the device to a boat.
§ 160.255–9
lifejackets.
Approval procedures for
(a) Each application for approval of a
Level 100 lifejacket must be submitted
directly to a Coast Guard recognized
laboratory.
(b) The recognized laboratory must
determine if a lifejacket with novel
design features requires a preliminary
review by the Coast Guard prior to
testing. Submissions requiring
preliminary review must be sent to
TypeApproval@uscg.mil, and must
include a full description and drawings.
Pictures, samples, and preliminary test
results may also be submitted.
ddrumheller on DSK120RN23PROD with PROPOSALS3
§ 160.255–11
Recognized laboratory.
(a) The approval inspections and
tests, production inspections, tests, and
quality control required by this subpart
must be conducted by an independent
laboratory recognized by the Coast
Guard under 46 CFR subpart 159.010 to
perform such functions. A list of
recognized independent laboratories is
available from the Commandant and
online at https://cgmix.uscg.mil.
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(b) The same laboratory that performs
the approval tests must also perform
production oversight unless the
employees of the laboratory performing
production oversight receive training
and support equal to that of the
laboratory that performed the approval
testing, as determined by the
Commandant.
§ 160.255–13
tests.
Approval inspections and
(a) Each lifejacket must be certified by
a recognized laboratory as meeting the
requirements of ANSI/CAN/UL 12402–4
(incorporated by reference, see
§ 160.255–5). Approval tests specified in
ANSI/CAN/UL 12402–4 must be
conducted or supervised by a
recognized laboratory using prototype
lifejackets constructed in accordance
with the plans and specifications
submitted with the application for
approval.
(b) Each lifejacket design must be
visually examined for compliance with
the construction and performance
requirements of this subpart and ANSI/
CAN/UL 12402–4 (incorporated by
reference, see § 160.255–5).
(c) The Commandant may prescribe
additional tests for approval of novel or
unique designs.
§ 160.255–15 Production inspections,
tests, and quality control of lifejackets.
(a) General. Production tests and
inspections must be conducted in
accordance with ANSI/CAN/UL 9595
(incorporated by reference, see
§ 160.255–5), or an alternative follow-up
procedure accepted by the
Commandant. To maintain approval, the
manufacturer must be in good standing
under an accepted follow-up procedure.
(b) Manufacturer’s inspection and
tests. Manufacturers of approved
lifejackets must maintain quality control
of the materials used, manufacturing
methods, and the finished product so as
to meet the applicable requirements,
and make sufficient inspections and
tests of representative samples and
components produced to maintain the
quality of the finished product. Records
of tests conducted by the manufacturer
and records of materials, including
affidavits by suppliers that applicable
requirements are met, must be made
available to the recognized laboratory
inspector or to the Coast Guard marine
inspector, or both, for review upon
request.
(c) Laboratory inspections and tests.
The laboratory inspector will conduct
examinations, inspections, and tests for
listed and labeled devices, as required
by the recognized laboratory, at the
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21053
place of manufacture or other location at
the option of the laboratory.
(d) Test facilities. The inspector must
be admitted to any place in the factory
where work is being done on listed and
labeled products, and the inspector may
take samples of parts or materials
entering construction or final
assemblies, for further examinations,
inspections, or tests. The manufacturer
must provide a suitable place and the
apparatus necessary for the performance
of the tests done at the place of
manufacture.
(e) Additional tests, etc.
Unannounced examinations, tests, and
inspections of samples obtained either
directly from the manufacturer or
through commercial channels may be
made to determine the suitability of a
product for listing and labeling, or to
determine conformance of a labeled
product to the applicable requirements.
These may be conducted by the
recognized laboratory or the United
States Coast Guard.
§ 160.255–17
Marking and Labeling.
(a) Each lifejacket must be marked
with the appropriate label as specified
in Figure 6DV of ANSI/CAN/UL 12402–
4 (incorporated by reference, see
§ 160.255–5).
(b) The Commandant may prescribe
additional marking requirements for
special purpose devices or unique or
novel designs.
§ 160.255–19
Placard.
Each lifejacket sold or offered for sale
must be provided with a placard that a
prospective purchaser can read prior to
purchase, as specified in Figure
8DV.1.1a and Figure 8DV.1.1b, Choose
the Device You Will Want to Wear, of
ANSI/CAN/UL 12402–4 (incorporated
by reference, see § 160.255–5). The
required placard text must be printed
exactly as set out in ANSI/CAN/UL
12402–4, unless otherwise approved by
the Commandant.
§ 160.255–21
Lifejacket manuals.
(a) An owner’s manual in accordance
with Figure 7DV of ANSI/CAN/UL
12402–4 (incorporated by reference, see
§ 160.255–5), must be provided with
each inflatable lifejacket sold or offered
for sale. The text of each manual is
reviewed with the application for
approval.
(b) The Commandant may prescribe
additional information in the manual for
special purpose devices or unique or
novel designs.
(c) Additional information,
instructions, or illustrations may be
included in the owner’s manual if there
is no contradiction to the required
information.
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§ 160.255–23 Procedure for approval of
design or material change.
(a) The manufacturer must submit any
proposed changes in design, material, or
construction to the recognized
laboratory for approval before changing
lifejacket production methods.
(b) Determinations of equivalence of
design, construction, and materials must
be made only by the Commandant or a
designated representative.
§ 160.255–25
approval.
Suspension or termination of
As provided in 46 CFR 159.005–15,
the Commandant may suspend or
terminate the approval of a lifejacket
design if the manufacturer fails to
comply with this subpart or the
recognized laboratory’s accepted
procedures or requirements.
ddrumheller on DSK120RN23PROD with PROPOSALS3
§ 160.255–27 Servicing for fully and
partially inflatable lifejackets.
(a) General. Each lifejacket that relies
fully or partially on inflation and is
approved under this subchapter must be
serviced at approved facilities at 12month intervals according to this
section.
(1) Each manufacturer of an approved
inflatable lifejacket must provide one or
more Coast Guard-approved facilities for
servicing those lifejackets. The
manufacturer must notify the
Commandant whenever an approved
facility under its organization no longer
provides servicing of a lifejacket make
and model listed in the guidelines
required by paragraph (d) of this
section.
(2) Each manufacturer of an approved
inflatable lifejacket must make
replacement parts available to Coast
Guard-approved independent servicing
facilities.
(b) Servicing facilities. Each Coast
Guard-approved servicing facility must
meet the requirements of this paragraph
and paragraph (d) of this section to
receive and keep its approval for each
make and model of lifejacket. Approval
is obtained according to § 160.255–5(c)
of this part.
(1) Each servicing facility must
conduct lifejacket servicing according to
its servicing guidelines and follow the
procedures in the service manual
required by this section.
(2) Each servicing facility must have
a suitable site for servicing that must be
clean, well lit, free from excessive dust,
drafts, and strong sunlight, and have
appropriate temperature and humidity
control as specified in the service
manual.
(3) Each servicing facility must have
the appropriate service, repair, and test
equipment and spare parts for
performing required tests and repairs.
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(4) Each servicing facility must have
a current manufacturer’s service manual
for each make and model of lifejacket
serviced.
(5) A servicing facility may have more
than one servicing site provided that
each site meets the requirements of
paragraph (b)(2) of this section.
(6) Each servicing facility must be
inspected at intervals not exceeding six
months by an accepted independent
laboratory, and a report of the
inspections must be submitted to the
Commandant at least annually. The
report must contain enough information
to show compliance with paragraphs
(b)(1) through (4) of this section and
paragraph (d) of this section. Where a
facility uses more than one site the
report must show compliance at each
site at least biennially.
(c) Service manual. (1) Each
manufacturer of an approved inflatable
lifejacket must prepare a service manual
for the lifejacket. The service manual
must be approved by the Commandant
according to § 160.176–5(b) of this part.
(2) The manufacturer must make the
service manual, service manual
revisions, and service bulletins available
to each approved servicing facility.
(3) Each service manual must contain
the following:
(i) Detailed procedures for inspecting,
servicing, and repackaging the lifejacket;
(ii) A list of approved replacement
parts and materials to be used for
servicing and repairs, if any;
(iii) A requirement to mark the date
and servicing facility name on each
lifejacket serviced;
(iv) Frequency of servicing; and
(v) Any specific restrictions or special
procedures prescribed by the Coast
Guard or manufacturer.
(4) Each service manual revision and
service bulletin which authorizes the
modification of a lifejacket, or which
affects a requirement under this subpart,
must be approved by the Commandant.
Other revisions and service bulletins are
not required to be approved, but a copy
of each must be sent to the Commandant
when it is issued. At least once each
year, the manufacturer must provide to
the Commandant and to each servicing
facility approved to service its
lifejackets a bulletin listing each service
manual revision and bulletin in effect.
(d) Servicing facilities guidelines.
Each servicing facility must have
written guidelines that include the
following:
(1) Identification of each make and
model of lifejacket that may be serviced
by the facility as well as the manual and
revision to be used for servicing;
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(2) Identification of the person, by
title or position, who is responsible for
the servicing program;
(3) Training and qualifications of
servicing technicians;
(4) Provisions for the facility to retain
a copy of its current letter of approval
from the Coast Guard at each site; and
(5) Requirements to—
(i) Ensure each inflatable lifejacket
serviced under its Coast Guard approval
is serviced in accordance with the
manufacturer’s service manual;
(ii) Keep servicing technicians
informed of each approved servicing
manual revision and bulletin and ensure
servicing technicians understand each
change and new technique related to the
lifejackets serviced by the facility;
(iii) Calibrate each pressure gauge,
weighing scale, and mechanically
operated barometer at intervals of not
more than one year;
(iv) Ensure each inflatable lifejacket
serviced under the facility’s Coast Guard
approval is serviced by or under the
supervision of a servicing technician
who meets the requirements of
paragraph (d)(3) of this section;
(v) Specify each make and model of
lifejacket the facility is approved to
service when it represents itself as
approved by the U.S. Coast Guard; and
(vi) Not service any lifejacket for a
U.S. registered commercial vessel,
unless it is approved by the U.S. Coast
Guard to service the make and model of
lifejacket.
(e) Servicing records. Each servicing
facility must maintain records of all
completed servicing. These records
must be retained for at least 5 years after
they are made, be made available to any
Coast Guard representative and
independent laboratory inspector upon
request, and include at least the
following:
(1) Date of servicing, number of
lifejackets serviced, lot identification,
approval number, and test results data
for the lifejackets serviced;
(2) Identification of the person
conducting the servicing;
(3) Identity of the vessel receiving the
serviced lifejackets; and
(4) Date of return to the vessel.
■ 86. Add new subpart 160.264,
consisting of §§ 160.264–1 through
160.264–25, to read as follows:
Subpart 160.264—Wearable
Recreational Personal Flotation
Devices (PFDs)
§ 160.264–1
Scope.
(a) This subpart contains structural
and performance standards for approval
of Level 50 and Level 70 inherently
buoyant personal flotation devices
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(PFDs), as well as requirements for
production follow-up inspections,
markings, information placards, and
associated manuals.
(b) PFDs approved under this subpart
rely entirely upon inherently buoyant
material to achieve the minimum
buoyancy.
(c) PFDs approved under this subpart
are intended to meet the carriage
requirements for wearable PFDs for
uninspected commercial vessels under
40 ft (12m) not carrying passengers for
hire and recreational boats, in
accordance with 33 CFR part 175 and 46
CFR 25.25.
§ 160.264–3
Definitions.
The following definitions apply to
this subpart:
Commandant means the Chief of the
Lifesaving and Fire Safety Standards
Division. Address: Commandant (CG–
ENG–4), Attn: Lifesaving and Fire Safety
Division, U.S. Coast Guard Stop 7509,
2703 Martin Luther King Jr. Avenue SE,
Washington, DC 20593.–7509; email
TypeApproval@uscg.mil.
First quality workmanship means
construction that is free from any defect
materially affecting appearance or
serviceability.
Inspector means a recognized
laboratory representative assigned to
perform, supervise, or oversee the duties
described in § 160.264–15 or any Coast
Guard representative performing duties
related to the approval.
Recognized laboratory means an
independent laboratory accepted by the
Commandant in accordance with 46
CFR subpart 159.010, with a valid
memorandum of understanding in
accordance with 46 CFR 159.010–7.
ddrumheller on DSK120RN23PROD with PROPOSALS3
§ 160.264–5
Incorporation by reference.
Certain material is incorporated by
reference into this part with the
approval of the Director of the Federal
Register in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. All approved
material is available for inspection at
the Coast Guard Headquarters and at the
National Archives and Records
Administration (NARA). Contact
Commandant (CG–ENG–4), Attn:
Lifesaving and Fire Safety Division, U.S.
Coast Guard Stop 7509, 2703 Martin
Luther King Jr. Avenue SE, Washington,
DC 20593–7509. For information on the
availability of this material at NARA,
visit www.archives.gov/federal-register/
cfr/ibr-locations.html or email:
fr.inspection@nara.gov. The material
may be obtained from UL, 333 Pfingsten
Road, Northbrook, IL 60062–2002;
phone (847) 272–8800; website:
www.ul.com.
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(a) ANSI/CAN/UL 9595:2021,
Standard for Factory Follow-Up on
Personal Flotation Devices (PFDs), First
Edition, June 4, 2020 (including
revisions through September 9, 2021)
(‘‘ANSI/CAN/UL 9595’’); IBR approved
for § 160.264–15(a).
(b) ANSI/CAN/UL 12402–5:2022,
Standard for Personal Flotation
Devices—Part 5: Buoyancy Aids (Level
50)—Safety Requirements, First Edition,
December 31, 2015 (including revisions
through January 27, 2022) (‘‘ANSI/CAN/
UL 12402–5’’); IBR approved for
§§ 160.264–7(a) and (b); 160.264–13(a)
and (b); 160.264–17(a); 160.264–19;
160.264–21(a).
§ 160.264–7 Design, construction, and
performance of PFDs.
(a) Each Level 70 PFD design must—
(1) Meet the requirements in ANSI/
CAN/UL 12402–5 (incorporated by
reference, see § 160.264–5) for a Level
70 device; and
(2) For novel or unique designs, meet
any additional requirements that the
Commandant may prescribe.
(b) Each Level 50 PFD design must—
(1) Meet the requirements in ANSI/
CAN/UL 12402–5 (incorporated by
reference, see § 160.264–5) for a Level
50 device;
(2) Be marked to indicate that the
device must be worn to be counted as
equipment required by vessels meeting
USCG regulations; and
(3) For novel or unique designs, meet
any additional requirements that the
Commandant may prescribe.
(c) Buoyancy is to be provided by
inherently buoyant material and not
depend on loose, granulated material,
gas compartments, or inflation.
(d) PFDs must be of first quality
workmanship and must be free from any
defects materially affecting their
appearance or serviceability.
(e) PFDs must not provide means
intended for fastening or securing the
device to a boat.
§ 160.264–9
PFDs.
Approval procedures for
(a) Each application for approval of a
Level 50 or Level 70 PFD must be
submitted directly to a Coast Guard
recognized laboratory.
(b) The recognized laboratory must
determine if a PFD with novel design
features requires a preliminary review
by the Coast Guard prior to testing.
Submissions requiring preliminary
review must be sent to TypeApproval@
uscg.mil, and must include a full
description and drawings. Pictures,
samples, and preliminary test results
may also be submitted.
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§ 160.264–11
21055
Recognized laboratory.
(a) The approval inspections and
tests, production inspections, tests, and
quality control required by this subpart
must be conducted by an independent
laboratory recognized by the Coast
Guard under 46 CFR subpart 159.010 to
perform such functions. A list of
recognized independent laboratories is
available from the Commandant and
online at https://cgmix.uscg.mil.
(b) Production oversight must be
performed by the same laboratory that
performs the approval tests unless, as
determined by the Commandant, the
employees of the laboratory performing
production oversight receive training
and support equal to that of the
laboratory that performed the approval
testing.
§ 160.264–13
tests.
Approval inspections and
(a) Each PFD must be certified by a
recognized laboratory as meeting the
requirements of ANSI/CAN/UL 12402–5
(incorporated by reference, see
§ 160.264–5) for an inherently buoyant
Level 50 or Level 70 PFD. Approval
tests specified in ANSI/CAN/UL 12402–
5 must be conducted or supervised by
a recognized laboratory using PFDs
constructed in accordance with the
plans and specifications submitted with
the application for approval.
(b) Each PFD design must be visually
examined for compliance with the
construction and performance
requirements of this subpart and ANSI/
CAN/UL 12402–5 (incorporated by
reference, see § 160.264–5).
(c) The Commandant may prescribe
additional tests for approval of novel or
unique designs.
§ 160.264–15 Production inspections,
tests, and quality control of PFDs.
(a) General. Production tests and
inspections must be conducted in
accordance with ANSI/CAN/UL 9595
(incorporated by reference, see
§ 160.264–5) or an alternative follow-up
procedure accepted by the
Commandant. To maintain approval, the
manufacturer must be in good standing
under an accepted follow-up procedure.
(b) Manufacturer’s inspection and
tests. Manufacturers of approved PFDs
must maintain quality control of the
materials used, manufacturing methods,
and the finished product to meet the
applicable requirements, and make
sufficient inspections and tests of
representative samples and components
produced to maintain the quality of the
finished product. Records of tests
conducted by the manufacturer and
records of materials, including affidavits
by suppliers that applicable
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requirements are met, must be made
available to the recognized laboratory
inspector or to the Coast Guard marine
inspector, or both, for review upon
request.
(c) Laboratory inspections and tests.
The laboratory inspector will conduct
examinations, inspections, and tests for
listed and labeled devices, as required
by the recognized laboratory, at the
place of manufacture or other location at
the option of the laboratory.
(d) Test facilities. The laboratory
inspector, or the Coast Guard marine
inspector assigned by the Commander of
the District in which the factory is
located, or both, must be admitted to
any place in the factory where work is
being done on listed and labeled
products. Either or both inspectors may
take samples of parts or materials
entering construction or final
assemblies, for further examinations,
inspections, or tests. The manufacturer
must provide a suitable place and the
apparatus necessary for the performance
of the tests done at the place of
manufacture.
(e) Additional tests, etc.
Unannounced examinations, tests, and
inspections of samples obtained either
directly from the manufacturer or
through commercial channels may be
made to determine the suitability of a
product for listing and labeling, or to
determine conformance of a labeled
product to the applicable requirements.
These may be conducted by the
recognized laboratory or the United
States Coast Guard.
§ 160.264–17
Marking and Labeling.
(a) Each PFD must be marked with the
appropriate label as specified in Figure
6DV of ANSI/CAN/UL 12402–5
(incorporated by reference, see
§ 160.264–5).
(b) The Commandant may prescribe
additional marking requirements for
special purpose devices or unique or
novel designs.
ddrumheller on DSK120RN23PROD with PROPOSALS3
§ 160.264–19
Placard.
Each PFD sold or offered for sale must
be provided with a placard that a
prospective purchaser can read prior to
purchase, as specified in Figure
8DV.1.1a and Figure 8DV.1.1b, Choose
the Device You Will Want to Wear, of
ANSI/CAN/UL 12402–5 (incorporated
by reference, see § 160.264–5). The
required placard text must be printed
exactly as set out in ANSI/CAN/UL
12402–5.
§ 160.264–21
PFD manuals.
(a) An owner’s manual in accordance
with Figure 7DV of ANSI/CAN/UL
12402–5 (incorporated by reference, see
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§ 160.264–5), may be provided with
each inherently buoyant PFD sold or
offered for sale. The text of each manual
is reviewed with the application for
approval.
(b) The Commandant may prescribe
additional information in the manual for
special purpose devices or unique or
novel designs.
(c) Additional information,
instructions, or illustrations may be
included in the owner’s manual if there
is no contradiction to the required
information.
§ 160.264–23 Procedure for approval of
design or material change.
(a) The manufacturer must submit any
proposed changes in design, material, or
construction to the recognized
laboratory for approval before changing
PFD production methods.
(b) Determinations of equivalence of
design, construction, and materials must
be made only by the Commandant or a
designated representative.
§ 160.264–25
approval.
Suspension or termination of
As provided in 46 CFR 159.005–15,
the Commandant may suspend or
terminate the approval of a PFD design
if the manufacturer fails to comply with
this subpart or the recognized
laboratory’s accepted procedures or
requirements.
■ 87. Add subpart 160.276, consisting of
§§ 160.276–1 through 160.276–25, to
read as follows:
Subpart 160.276—Wearable
Recreational Inflatable Personal
Flotation Devices
§ 160.276–1
Scope.
(a) This subpart contains structural
and performance standards for approval
of Level 50 and Level 70 inflatable
recreational personal flotation devices
(PFDs), as well as requirements for
production follow-up inspections,
associated manuals, information
placards, and markings.
(b) Inflatable PFDs approved under
this subpart rely entirely or partially
upon inflation to achieve the minimum
buoyancy.
(c) PFDs approved under this subpart
are intended to meet the carriage
requirements for uninspected
commercial vessels under 40 ft (12m)
not carrying passengers for hire and
recreational boats, in accordance with
33 CFR part 175 and 46 CFR 25.25.
§ 160.276–3
Definitions.
The following definitions apply to
this subpart:
Commandant means the Chief of the
Lifesaving and Fire Safety Standards
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Division. Address: Commandant (CG–
ENG–4), Attn: Lifesaving and Fire Safety
Division, U.S. Coast Guard Stop 7509,
2703 Martin Luther King Jr. Avenue SE,
Washington, DC 20593–7509; email
TypeApproval@uscg.mil.
First quality workmanship means
construction that is free from any defect
materially affecting appearance or
serviceability.
Inspector means a recognized
laboratory representative assigned to
perform, supervise, or oversee the duties
described in § 160.276–15 or any Coast
Guard representative performing duties
related to the approval.
Recognized laboratory means an
independent laboratory accepted by the
Commandant in accordance with 46
CFR 159.010, with a valid memorandum
of understanding in accordance with 46
CFR 159.010–7.
§ 160.276–5
Incorporation by reference.
Certain material is incorporated by
reference into this part with the
approval of the Director of the Federal
Register in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. All approved
material is available for inspection at
the Coast Guard Headquarters and at the
National Archives and Records
Administration (NARA). Contact
Commandant (CG–ENG–4), Attn:
Lifesaving and Fire Safety Division, U.S.
Coast Guard Stop 7509, 2703 Martin
Luther King Jr. Avenue SE, Washington,
DC 20593–7509. For information on the
availability of this material at NARA,
visit www.archives.gov/federal-register/
cfr/ibr-locations.html or email:
fr.inspection@nara.gov. The material
may be obtained from UL, 333 Pfingsten
Road, Northbrook, IL 60062–2022;
phone (847) 272–8800; website:
www.ul.com.
(a1) ANSI/CAN/UL 9595:2021,
Standard for Factory Follow-Up on
Personal Flotation Devices (PFDs), First
Edition, June 4, 2020 (including
revisions through September 9, 2021)
(‘‘ANSI/CAN/UL 9595’’); IBR approved
for § 160.276–15(a).
(b) ANSI/CAN/UL 12402–5:2022,
Standard for Personal Flotation
Devices—Part 5: Buoyancy Aids (Level
50)—Safety Requirements, First Edition,
December 31, 2015 (including revisions
through January 27, 2022) (‘‘ANSI/CAN/
UL 12402–5’’); IBR approved for
§§ 160.276–7(a) and (b); 160.276–13(a)
and (b); 160.276–17(a) and (b); 160.276–
19; 160.276–21(a).
§ 160.276–7 Design, construction, and
performance of inflatable PFDs.
(a) Each Level 70 inflatable PFD
design must—
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(1) Meet the requirements in ANSI/
CAN/UL 12402–5 (incorporated by
reference, see § 160.276–5) for a Level
70 device; and
(2) For novel or unique designs, meet
any additional requirements that the
Commandant may prescribe.
(b) Each Level 50 inflatable PFD
design must—
(1) Meet the requirements in ANSI/
CAN/UL 12402–5 (incorporated by
reference, see § 160.276–5) for a Level
50 device;
(2) Be marked to indicate that the
device must be worn to be counted as
equipment required by vessels meeting
USCG regulations; and
(3) For novel or unique designs, meet
any additional requirements that the
Commandant may prescribe.
(c) Buoyancy is to be provided by
inflation, or a combination of inherently
buoyant material and inflation.
(d) PFDs must be of first quality
workmanship and must be free from any
defects materially affecting their
appearance or serviceability.
(e) PFDs must not provide means
intended for fastening or securing the
device to a boat.
§ 160.276–9
PFDs.
Approval procedures for
(a) Each application for approval of a
Level 50 or Level 70 PFD must be
submitted directly to a Coast Guard
recognized laboratory.
(b) The recognized laboratory must
determine if a PFD with novel design
features requires a preliminary review
by the Coast Guard prior to testing.
Submissions requiring preliminary
review must be sent to TypeApproval@
uscg.mil, and must include a full
description and drawings. Pictures,
samples, and preliminary test results
may also be submitted.
ddrumheller on DSK120RN23PROD with PROPOSALS3
§ 160.276–11
Recognized laboratory.
(a) The approval inspections and tests
and production inspections, tests, and
quality control required by this subpart
must be conducted by an independent
laboratory recognized by the Coast
Guard under 46 CFR subpart 159.010 to
perform such functions. A list of
recognized independent laboratories is
available from the Commandant and
online at https://cgmix.uscg.mil.
(b) The same laboratory that performs
the approval tests must also perform
production oversight unless the
employees of the laboratory performing
production oversight receive training
and support equal to that of the
laboratory that performed the approval
testing, as determined by the
Commandant.
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§ 160.276–13
tests.
Approval inspections and
(a) Each PFD must be certified by a
recognized laboratory as meeting the
requirements of ANSI/CAN/UL 12402–5
(incorporated by reference, see
§ 160.276–5) for an inflatable Level 50
or Level 70 PFD. Approval tests
specified in ANSI/CAN/UL 12402–5
must be conducted or supervised by a
recognized laboratory using PFDs
constructed in accordance with the
plans and specifications submitted with
the application for approval.
(b) Each PFD design must be visually
examined for compliance with the
construction and performance
requirements of this subpart and ANSI/
CAN/UL 12402–5 (incorporated by
reference, see § 160.276–5).
(c) The Commandant may prescribe
additional tests for approval of novel or
unique designs.
§ 160.276–15 Production inspections,
tests, and quality control of PFDs.
(a) General. Production tests and
inspections must be conducted in
accordance with ANSI/CAN/UL 9595
(incorporated by reference, see
§ 160.276–5) or an alternative follow-up
procedure accepted by the
Commandant. To maintain approval, the
manufacturer must be in good standing
under an approved follow-up
procedure.
(b) Manufacturer’s inspection and
tests. Manufacturers of approved PFDs
must maintain quality control of the
materials used, manufacturing methods,
and the finished product to meet the
applicable requirements, and make
sufficient inspections and tests of
representative samples and components
produced to maintain the quality of the
finished product. Records of tests
conducted by the manufacturer and
records of materials, including affidavits
by suppliers that applicable
requirements are met, must be made
available to the recognized laboratory
inspector or to the Coast Guard marine
inspector, or both, for review upon
request.
(c) Laboratory inspections and tests.
The laboratory inspector will conduct
examinations, inspections, and tests for
listed and labeled devices, as required
by the recognized laboratory, at the
place of manufacture or other location at
the option of the laboratory.
(d) Test facilities. The laboratory
inspector, or the Coast Guard marine
inspector assigned by the Commander of
the District in which the factory is
located, or both, must be admitted to
any place in the factory where work is
being done on listed and labeled
products. Either or both inspectors may
PO 00000
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21057
take samples of parts or materials
entering construction or final
assemblies, for further examinations,
inspections, or tests. The manufacturer
must provide a suitable place and the
apparatus necessary for the performance
of the tests done at the place of
manufacture.
(e) Additional tests, etc.
Unannounced examinations, tests, and
inspections of samples obtained either
directly from the manufacturer or
through commercial channels may be
made to determine the suitability of a
product for listing and labeling, or to
determine conformance of a labeled
product to the applicable requirements.
These may be conducted by the
recognized laboratory or the United
States Coast Guard.
§ 160.276–17
Marking and Labeling.
(a) Each inflatable PFD must be
marked as specified in Figure 6DV of
ANSI/CAN/UL 12402–5 (incorporated
by reference, see § 160.276–5).
(b) In addition to the information
required by ANSI/CAN/UL 12402–5,
Figure 6DV, each Level 50 inflatable
PFD must be marked with a statement
that the device must be worn to be
counted as equipment required by
vessels meeting USCG regulations; and
(c) The Commandant may prescribe
additional marking requirements for
special purpose devices or unique or
novel designs.
§ 160.276–19
Placard.
Each inflatable PFD sold or offered for
sale must be provided with a placard
that a prospective purchaser can read
prior to purchase, as specified in Figure
8DV.1.1a and Figure 8DV.1.1b, Choose
the Device You Will Want to Wear, of
ANSI/CAN/UL 12402–5 (incorporated
by reference, see § 160.276–5). The
required placard text must be printed
exactly as set out in ANSI/CAN/UL
12402–5.
§ 160.276–21
PFD manuals.
(a) An owner’s manual in accordance
with Figure 7DV of ANSI/CAN/UL
12402–5 (incorporated by reference, see
§ 160.276–5), must be provided with
each inflatable PFD sold or offered for
sale. The text of each manual is
reviewed with the application for
approval.
(b) The Commandant may prescribe
additional information in the manual for
special purpose devices or unique or
novel designs.
(c) Additional information,
instructions, or illustrations may be
included in the owner’s manual if there
is no contradiction to the required
information.
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§ 160.276–23 Procedure for approval of
design or material change.
PART 180—LIFESAVING EQUIPMENT
AND ARRANGEMENTS
(a) The manufacturer must submit any
proposed changes in design, material, or
construction to the recognized
laboratory for approval before changing
PFD production methods.
(b) Determinations of equivalence of
design, construction, and materials must
be made only by the Commandant or a
designated representative.
§ 160.276–25
approval.
Suspension or termination of
As provided in 46 CFR 159.005–15,
the Commandant may suspend or
terminate the approval of an inflatable
PFD design if the manufacturer fails to
comply with this subpart or the
recognized laboratory’s accepted
procedures or requirements.
PART 169—SAILING SCHOOL
VESSELS
88. The authority citation for part 169
is revised to read as follows:
■
Authority: 33 U.S.C. 1321(j); 46 U.S.C.
3306, 6101; Pub. L. 103–206, 107 Stat. 2439;
E.O. 11735, 38 FR 21243, 3 CFR, 1971–1975
Comp., p. 793; DHS Delegation 00170.1,
Revision No. 01.2, paragraph (II)(92)(a);
§ 169.117 also issued under the authority of
44 U.S.C. 3507.
§ 169.539
[Amended]
89. Amend § 169.539 by:
■ a. Removing in paragraph (a), the text
‘‘160.055, 160.002, or 160.005’’, and
adding in its place the text ‘‘160.002,
160.005, 160.055, or 160.255,’’;
■ b. Removing in paragraph (b), the text
‘‘or 160.077’’, and adding in its place
the text ‘‘, 160.077, or 160.264’’; and
■ c. Removing in paragraph (c), the text
‘‘160.064’’, and adding in its place the
text ‘‘160.064 or 160.264’’.
ddrumheller on DSK120RN23PROD with PROPOSALS3
■
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90. The authority citation for part 180
is revised to read as follows:
■
Authority: 46 U.S.C. 2104, 3306; E.O.
12234, 45 FR 58801, 3 CFR, 1980 Comp., p.
277; DHS Delegation 00170.1, Revision No.
01.2, paragraph (II)(92)(a).
91. Amend § 180.71 by:
a. Revising the section heading and
paragraph (c);
■ b. Removing paragraph (d); and
■ c. Redesignating paragraph (e) as
paragraph (d).
The revisions read as follows:
■
■
§ 180.71
Lifejackets.
*
*
*
*
*
(c) Each lifejacket must be approved
under approval series 160.002, 160.005,
160.055, 160.115, 160.176, or 160.255 in
subchapter Q of this chapter, or other
standard specified by the Commandant.
An inflatable lifejacket approved under
approval series 160.255 must include a
full back-up inflation chamber.
*
*
*
*
*
■ 92. Amend § 180.72 by:
■ a. Revising the section heading;
■ b. Removing in paragraph (a), the
words ‘‘life jackets’’ wherever they
appear and adding, in their place, the
word ‘‘lifejackets’’; and
■ c. Revising paragraphs (b) and (d).
The revisions read as follows:
§ 180.72 Personal flotation devices carried
in addition to lifejackets.
*
*
*
*
*
(b) Wearable marine buoyant devices
approved in accordance with § 160.064,
160.076, 160.264, or 160.276 in
subchapter Q of this chapter, or other
standard specified by the Commandant,
may be carried as additional equipment.
*
*
*
*
*
(d) A commercial hybrid approved
under former approval series 160.077
prior to [EFFECTIVE DATE OF FINAL
PO 00000
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Sfmt 9990
RULE] may be carried as additional
equipment for use by persons working
near or over the water if it is in good and
serviceable condition, used in
accordance with the conditions marked
on the PFD and in the owner’s manual,
and of the same or similar design and
has the same method of operation as
each other hybrid PFD carried on board.
PART 199—LIFESAVING SYSTEMS
FOR CERTAIN INSPECTED VESSELS
93. The authority citation for part 199
is revised to read as follows:
■
Authority: 46 U.S.C. 3306, 3703; Pub. L.
103–206, 107 Stat. 2439; DHS Delegation
00170.1, Revision No. 01.2, paragraph
(II)(92)(a).
§ 199.70
[Amended]
94. Amend § 199.70(b) introductory
text by removing the text ‘‘, 160.176 or
160.177’’, and adding, in its place, the
text ‘‘or 160.176’’.
■
§ 199.620
[Amended]
95. Revise § 199.620(c) to read as
follows:
■
§ 199.620 Alternatives for all vessels in a
specified service.
*
*
*
*
*
(c) Lifejackets approval series. As an
alternative to a lifejacket meeting the
approval requirements in § 199.70,
vessels may carry a lifejacket approved
under approval series 160.002, 160.005,
160.055, or 160.077, or 160.255. An
inflatable lifejacket approved under
approval series 160.255 must include a
full back-up inflation chamber.
*
*
*
*
*
Dated: March 24, 2023.
W.R. Arguin,
Rear Admiral, U.S. Coast Guard, Assistant
Commandant for Prevention Policy.
[FR Doc. 2023–06504 Filed 4–6–23; 8:45 am]
BILLING CODE 9110–04–P
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Agencies
[Federal Register Volume 88, Number 67 (Friday, April 7, 2023)]
[Proposed Rules]
[Pages 21016-21058]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06504]
[[Page 21015]]
Vol. 88
Friday,
No. 67
April 7, 2023
Part III
Department of Homeland Security
-----------------------------------------------------------------------
Coast Guard
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33 CFR Part 181
46 CFR Parts 25, 28, 108, Et al.
Lifejacket Approval Harmonization; Proposed Rule
Federal Register / Vol. 88 , No. 67 / Friday, April 7, 2023 /
Proposed Rules
[[Page 21016]]
-----------------------------------------------------------------------
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: Notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: The Coast Guard proposes to amend the approval requirements
and follow-up program requirements for lifejackets by incorporating new
standards to replace existing legacy standards. The Coast Guard further
proposes to amend lifejacket and personal flotation device (PFD)
carriage requirements to allow for the use of equipment approved to the
new standards and remove obsolete equipment approval requirements. The
proposed amendments would streamline the process for the approval of
PFDs and allow manufacturers the opportunity to produce more innovative
equipment that would meet approval requirements in both Canada and the
United States while also reducing the burden of the approval process
and the production inspections on manufacturing firms.
DATES: Comments and related material must be received by the Coast
Guard on or before June 6, 2023.
ADDRESSES: You may submit comments identified by docket number USCG-
2022-0120 using the Federal Decision Making Portal at
www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.
Viewing material proposed for incorporation by reference. Make
arrangements to view this material by calling the person identified in
the FOR FURTHER INFORMATION CONTACT section of this document.
FOR FURTHER INFORMATION CONTACT: For further information about this
document call or email Jacqueline Yurkovich, Coast Guard; telephone
202-372-1389, email [email protected].
SUPPLEMENTARY INFORMATION:
Table of Contents for Preamble
I. Public Participation and Request for Comments
II. Abbreviations
III. Background, Basis, and Purpose
IV. Discussion of Proposed Rule
V. Incorporation by Reference
VI. Regulatory Analyses
A. Regulatory Planning and Review
B. Small Entities
C. Assistance for Small Entities
D. Collection of Information
E. Federalism
F. Unfunded Mandates
G. Taking of Private Property
H. Civil Justice Reform
I. Protection of Children
J. Indian Tribal Governments
K. Energy Effects
L. Technical Standards
M. Environment
I. Public Participation and Request for Comments
The Coast Guard views public participation as essential to
effective rulemaking, and will consider all comments and material
received during the comment period. Your comment may help shape the
outcome of this rulemaking. If you submit a comment, please include the
docket number for this rulemaking, indicate the specific section of
this document to which each comment applies, and provide a reason for
each suggestion or recommendation.
Submitting comments. We encourage you to submit comments through
the Federal Decision Making Portal at www.regulations.gov. To do so, go
to www.regulations.gov, type USCG-2022-0120 in the search box, and
click ``Search.'' Next, look for this document in the Search Results
column, and click on it. Then click on the Comment option. If you
cannot submit your material using www.regulations.gov, call or email
the person in the FOR FURTHER INFORMATION CONTACT section of this
proposed rule for alternate instructions.
Viewing material in docket. To view documents mentioned in this
proposed rule as being available in the docket, find the docket as
described in the previous paragraph, and then select ``Supporting &
Related Material'' in the Document Type column. Public comments will
also be placed in our online docket and can be viewed by following
instructions on the www.regulations.gov Frequently Asked Questions web
page. That web page also explains how to subscribe for email alerts
that will notify you when comments are posted or if a final rule is
published. We review all comments received, but we will only post
comments that address the topic of the proposed rule. We may choose not
to post off-topic, inappropriate, or duplicate comments that we
receive.
Personal information. We accept anonymous comments. Comments we
post to www.regulations.gov will include any personal information you
have provided. For more about privacy and submissions in response to
this document, see the Department of Homeland Security's eRulemaking
System of Records notice (85 FR 14226, March 11, 2020).
Public meeting. We do not plan to hold a public meeting but we will
consider doing so if we determine from public comments that a meeting
would be helpful. We would issue a separate Federal Register notice to
announce the date, time, and location of such a meeting.
II. Abbreviations
ANSI American National Standards Institute
CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
IBR Incorporation by reference
IRFA Initial Regulatory Flexibility Analysis
ISO International Organization for Standardization
NAICS North American Industry Classification System
NBSAC National Boating Safety Advisory Committee
NPRM Notice of proposed rulemaking
OMB Office of Management and Budget
PFD Personal flotation device
QMS Quality management system
RA Regulatory analysis
RFA Regulatory Flexibility Act
Sec. Section
SBA Small Business Administration
SOLAS International Convention for the Safety of Life at Sea
U.S.C. United States Code
III. Background, Basis, and Purpose
The Coast Guard has statutory authority under Title 46, U.S. Code,
Sections 3306(a) and (b), 4102(b), 4302(a) and (c), and 4502(a) and
(c)(2)(B), to prescribe regulations for the design, construction,
performance, testing, carriage, use, and inspection of lifesaving
equipment on commercial and recreational vessels. Under Department of
Homeland Security (DHS) Delegation 00170.1, Revision No. 01.2,
paragraph (II)(92)(b), the Secretary delegated authority under these
statutes to the Commandant of the Coast Guard.
With this rulemaking, we are proposing to incorporate the American
National Standards Institute (ANSI) standards ANSI/CAN/UL 12402-5 for
Level 50 and Level 70 personal flotation devices (PFDs), ANSI/CAN/UL
12402-4 for Level 100 PFDs, and ANSI/CAN/UL 9595 for quality assurance.
In addition, we propose to incorporate the ANSI/UL 1123 and ANSI/UL
1175 standards for marine buoyant devices and inherently buoyant and
inflatable throwable PFDs, respectively. The Coast Guard currently
approves inherently buoyant and
[[Page 21017]]
inflatable throwable PFDs to these standards as a matter of policy, so
incorporating them in the Code of Federal Regulations (CFR) would not
result in any changes in practice but would improve transparency.
We are also proposing to remove portions of Title 46 in part 160 of
the CFR, where the newly incorporated standards would supersede the
previous standards or requirements. Additionally, we are proposing
amendments to lifesaving equipment carriage requirements that would
permit the use of Level 50, Level 70, and Level 100 PFDs approved to
the new standards.
The Coast Guard actively participates in the development of ANSI-
accredited industry consensus standards for lifesaving equipment. In
that capacity, the Coast Guard has worked with Transport Canada and
United States and Canadian stakeholders in the development of the suite
of harmonized ANSI/CAN/UL standards to streamline the process for
approval of PFDs. Additionally, the harmonization would allow
manufacturers the opportunity to produce more innovative equipment that
would still meet approval requirements in both Canada and the United
States. PFD manufacturers largely drove the development of these
standards; therefore, we expect PFD manufacturers to generally support
this proposed rulemaking.
To further those efforts, on September 22, 2014, the Coast Guard
published a final rule to remove references to type codes in its
regulations on the carriage and labeling of Coast Guard approved PFDs
to facilitate the future incorporation by reference (IBR) of new
industry consensus standards (79 FR 56491, September 22, 2014). In
April 2017, the Coast Guard and Transport Canada signed a Memorandum of
Understanding outlining an intended cooperation for the approval of
personal lifesaving appliances that comply with mutually acceptable
standards, are tested by mutually accepted conformity assessment bodies
or independent test laboratories, and are covered by a mutually
acceptable follow-up program.
On August 17, 2018, the Coast Guard published a notice in the
Federal Register (83 FR 41095) regarding a policy letter and
deregulatory savings analysis on accepting the standard ANSI/CAN/UL
12402-5 for Level 70 PFDs, not including inflatable PFDs for use by
persons less than 16 years old. On November 15, 2019, the Coast Guard
published a notice (84 FR 62546) that finalized this policy.
The Coast Guard published a final rule (77 FR 19937, April 3, 2012)
incorporating by reference updated revisions of industry consensus
standards for PFDs including UL 1180, ``UL Standard for Safety for
Fully Inflatable Recreational Personal Flotation Devices,'' Second
Edition (including revisions through December 3, 2010). The discussion
and response to comments in that rulemaking included a discussion on
inflatable PFDs for users less than 16 years of age. UL 1180 limits the
approval of inflatable PFDs to persons of at least 16 years of age, and
thus the final rule retained that age limit for approved users of
inflatable PFDs. No age limit was included in the regulatory text to
allow for a possible future rulemaking to incorporate by reference a
standard that sufficiently addresses the needs of younger wearers.
IV. Discussion of Proposed Rule
The Coast Guard is proposing seven main amendments to our
regulations:
(1) Adding new subpart 160.255 and incorporating by reference ANSI/
CAN/UL 12402-4 for approval of Level 100 PFDs, and removing sections of
subpart 160.055.
(2) Adding new subparts 160.264 and 160.276, which incorporate by
reference ANSI/CAN/UL 12402-5 for approval of Level 50 and Level 70
PFDs without additional buoyancy or age restrictions; removing the
sections of subparts 160.060, 160.064, and 160.076 pertaining to the
approval of new wearable PFDs; relocating the sections pertaining to
throwable PFDs from subpart 160.064 to new subpart 160.045 and
incorporating by reference ANSI/UL 1123 and ANSI/UL 1175; and removing
subpart 160.077 in its entirety.
(3) Incorporating by reference ANSI/CAN/UL 9595 for quality
assurance requirements in subparts 160.045, 160.055, 160.060, 160.064,
160.076, 160.255, 160.264, and 160.276.
(4) Removing subparts 160.001, 160.002, 160.005, 160.047, 160.048,
and 160.052, as these subparts are mostly or entirely obsolete, and
moving the remaining relevant material from subpart 160.001 to subpart
160.055.
(5) Amending lifesaving equipment carriage requirements to include
the new approval categories, where appropriate, and removing any
remaining references to type codes.
(6) Amending the requirements for instruction pamphlets for PFDs to
include the placard specified in subparts 160.055, 160.060, 160.255,
160.264, and 160.276.
(7) Amending the existing regulatory text to make editorial
corrections and increase clarity.
We provide additional details and discussion on each of these seven
main categories of amendments below. If we finalize this proposed rule,
then under 46 U.S.C. 4302(b) the effective date of provisions applying
to recreational vessels would be at least 180 days after publication.
For simplicity, we would likely delay the effective date of the entire
rule until 180 days after publication. We invite public comments on
that timing.
The National Boating Safety Advisory Committee (NBSAC) was
consulted regarding the updated standards proposed in this rule, as
shown by NBSAC Resolutions 2009-83-01 and 2011-87-01, and the
revalidation of those resolutions found in Resolution 2022-03-01. We
also welcome comments from NBSAC on this proposed rule.
1. Add New Subpart, 46 CFR 160.255, and Incorporate by Reference ANSI/
CAN/UL 12402-4
We propose adding a new subpart, 160.255, to title 46 of the CFR.
PFDs approved under this new subpart would meet the carriage
requirements for wearable PFDs for inspected vessels that are neither
on an international voyage nor subject to the International Convention
for the Safety of Life at Sea (SOLAS), uninspected commercial vessels
over 40 feet (12m) in length, and uninspected passenger vessels.
Newly proposed subpart 160.255 contains structural and performance
requirements for approval of Level 100 PFDs, as well as requirements
for production inspections and quality control, markings, information
pamphlets, and associated manuals. ANSI/CAN/UL 12402-4 would be
incorporated by reference. PFDs approved under this subpart could rely
upon inherently buoyant material, inflation, or a combination of the
two to achieve the minimum buoyancy.
A Level 100 PFD has the same basic requirements as a PFD meeting 46
CFR 160.055. The minimum amount of buoyancy, basic mechanical
properties, and in-water performance requirements are the same.
However, ANSI/CAN/UL 12402-4 is less prescriptive regarding the design
requirements of a Level 100 PFD, so manufacturing firms would be able
to develop more innovative designs. The marking requirements in ANSI/
CAN/UL 12402-4 specify pictorial graphics to communicate the
performance of the PFD and warnings for use. The Coast Guard conducted
research and focus groups to identify issues with the Type code labels
and to evaluate multiple new pictorial labeling options. Our research
indicated that people consistently preferred pictorial
[[Page 21018]]
markings.\1\ Therefore, we expect this marking format to be more easily
understandable to both English-speaking and non-English-speaking
populations.
---------------------------------------------------------------------------
\1\ ``Revision of Labeling and Classification for Personal
Flotation Devices (PFDs),'' Applied Safety & Ergonomics, Inc.,
December 28, 2004, Young et al.
---------------------------------------------------------------------------
ANSI/CAN/UL 12402-4 does not require fully or partially inflatable
Level 100 PFDs to provide redundant back-up inflation chambers. Current
regulations require inflatable lifejackets under approval series
160.176 to have at least two inflation chambers and to reach minimum
in-water performance with any one chamber deflated. These inflatable
lifejackets meet the International Maritime Organization Life-Saving
Appliance code and are intended for use on vessels subject to SOLAS.
Back-up chambers were originally required for inflatable
lifejackets intended for use on inspected vessels as an additional
safety measure in case the primary inflation chamber failed to inflate
(54 FR 50320). In that rulemaking, the Coast Guard noted that we would
continue discussions with industry, standards organizations, and state
boating law administrators regarding the reliability of inflatable
PFDs. We also indicated that when new developments or innovations
reduced the risk of inflation failure to an acceptable level, we could
address this issue with a subsequent rulemaking. Since the publication
of that rule in 1989, the Coast Guard has no evidence that a well-
maintained PFD with a single inflation chamber is less reliable than an
inherently buoyant PFD. Additionally, the Coast Guard has approved
inflatable PFDs without back-up chambers under approval series 160.076.
Such devices have been in use in the United States on uninspected
commercial vessels less than 12 m in length and recreational vessels
and in Canada on small vessels for over a decade. Therefore, the Coast
Guard believes that the material testing of the PFD components coupled
with the required annual servicing of inflatable Level 100 PFDs is
sufficient, and that redundant back-up inflation chambers are not
necessary to provide an equivalent level of safety to PFDs meeting 46
CFR 160.055.
Because newly proposed subpart 160.255 would supersede the
requirements for life preservers in subpart 160.055, we propose to
delete structural and performance requirements for approval of life
preservers in subpart 160.055, but maintain the requirements for
production inspections, tests, and quality assurance. Manufacturers
could continue to produce life preservers currently approved under
subpart 160.055, while all new lifejackets would require Coast Guard
approval under new subpart 160.255.
At the same time, we propose to restructure subpart 160.055 to
include a statement of the subpart's scope and to mirror the structure
of other PFD-related subparts. We would add the scope as Sec. 160.055-
1 and definitions in Sec. 160.055-3, and the documents incorporated by
reference would be moved from Sec. 160.055-1 to Sec. 160.055-5.
Because no new approvals would be granted under Sec. 160.055, we
propose to remove existing requirements for materials and construction,
marking, and procedure for approval, including current 46 CFR 160.055-
3, 160.055-4, 160.055-5, 160.055-6, 160.055-8, and 160.055-9. We
propose independent laboratory requirements for addition in Sec.
160.055-11. We would move sampling, tests, and inspections from Sec.
160.055-7 to newly created Sec. 160.055-15 and pamphlet requirements
would be included in new Sec. 160.055-19. Procedures for the approval
of design or material changes would be included in new Sec. 160.055-23
and information on suspension or termination of approval would be
included in new Sec. 160.055-25.
2. Add New Subparts 46 CFR 160.045, 160.264, and 160.276, and
Incorporate by Reference ANSI/CAN/UL 12402-5, ANSI/UL 1123, and ANSI/UL
1175
We propose three new subparts in Title 46 of the CFR: 160.045,
160.264, and 160.276. PFDs approved under these subparts would meet the
carriage requirements for uninspected commercial vessels less than 40
feet (12m) in length and not carrying passengers for hire, and
recreational boats, in accordance with 33 part CFR 175 and 46 CFR
subpart 25.25.
Newly proposed 46 CFR 160.264 contains structural and performance
requirements for approval of Level 50 and Level 70 inherently buoyant
PFDs, as well as requirements for production inspections and quality
control, markings, information pamphlets, and associated manuals. Newly
proposed 46 CFR 160.276 contains structural and performance
requirements for approval of Level 50 and Level 70 fully and partially
inflatable recreational PFDs, as well as requirements for production
inspections and quality control, associated manuals, information
pamphlets, and markings. ANSI/CAN/UL 12402-5 would be incorporated by
reference in both subparts.
ANSI/CAN/UL 12402-5 prescribes minimum performance requirements
instead of prescribing design requirements. These performance-based
standards allow manufacturing firms to design more innovative,
comfortable, and stylish PFDs. New PFD designs could lead to more
individuals choosing to wear their PFDs, resulting in fewer
drownings.\2\ Drowning is the leading cause of death in recreational
boating accidents, accounting for 79 percent of all recreational
boating casualties where the cause of death is known.\3\ Of those who
drowned, 86 percent were not wearing a lifejacket. Wearing a lifejacket
is one of the best means available of preventing accidental drowning in
recreational boating. Unfortunately, recreational boaters only wear
lifejackets about 24 percent of the time.\4\
---------------------------------------------------------------------------
\2\ Readers should reference the National Center for
Biotechnology Information (NCBI), which is part of the National
Library of Medicine (NLM) at the National Institutes of Health
(NIH), and perform a literature search for articles on the topic of
PFDs and their usage. Readers can access this website at https://pubmed.ncbi.nlm.nih.gov. More specifically, readers should reference
the following articles for further information: ``Personal, social,
and environmental factors associated with lifejacket wear in adults
and children: A systematic literature review'' (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5931488) and ``Barriers to life
jacket use among adult recreational boaters'' (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4310692).
\3\ United States Coast Guard, ``2019 Recreational Boating
Statistics.'' https://uscgboating.org/library/accident-statistics/Recreational-Boating-Statistics-2019.pdf.
\4\ United States Coast Guard, ``2019 Life Jacket Wear Rate
Observation Study.'' https://uscgboating.org/library/national-live-jacket-wear-study/2019-Life-Jacket-Wear-Rate-Report.pdf.
---------------------------------------------------------------------------
Discomfort, whether real or perceived, is negatively associated
with PFD wear.\5\ ANSI/CAN/UL 12402-5 allows manufacturers more
flexibility when selecting materials, design, and construction of new
PFDs. Because manufacturers would be less limited in the materials,
design, and construction, we expect new PFDs might be slimmer, lighter
in weight, or more comfortable to wear than PFDs approved under the
current requirements.
---------------------------------------------------------------------------
\5\ Amy Peden, Daniel Demant, Martin Hagger, and Kyra Hamilton,
``Personal, social, and environmental factors associated with
lifejacket wear in adults and children: A systematic literature
review.'' https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5931488/.
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In our 2018 policy letter, the Coast Guard determined that Level 70
inherently buoyant devices, Level 70 inflatable devices, and Level 70
multi-chamber devices that meet the requirements of ANSI/CAN/UL 12402-5
provide equivalent performance to wearable PFDs meeting 46 CFR 160.064
or 160.076.
Now, the Coast Guard is proposing this rule based on our assessment
that
[[Page 21019]]
a Level 50 PFD, when worn and used in accordance with the label,
provides an equivalent level of safety as a wearable PFD meeting
subpart 160.064 or 160.076. A Level 50 PFD has a lower minimum amount
of buoyancy than the current minimum requirement for Coast Guard
approved PFDs. However, ANSI/CAN/UL 12402-5 requires that a Level 50
PFD keep the user's airway above the water, as demonstrated by in-water
performance testing. A Level 50 PFD is intended for use by those who
can swim and who have help or rescue nearby. As required in ANSI/CAN/UL
12402-5, Level 50 PFDs must be marked: ``Not recommended for weak or
non-swimmers.'' Every PFD offered for sale must have a placard
providing users with information on how to select the appropriate PFD,
and reminding users to try the PFD on in the water to ensure proper fit
and performance. To satisfy requirements of ANSI/CAN/UL 12402-5, Level
50 PFDs must be worn and must be marked: ``Approval conditions state
that this device must be worn to be counted as equipment required by
vessels meeting Transport Canada or USCG regulations.'' A Level 50 PFD,
when worn by a person who can swim and used in accordance with ANSI/
CAN/UL 12402-5, provides an equivalent level of safety as a PFD meeting
46 CFR 160.064 or 160.076. By approving Level 50 PFDs, the Coast Guard
would provide a critical level of oversight to the currently
unregulated Level 50 competition watersports PFDs, resulting in safer
products for the public.
In this proposed rule, we are not proposing additional requirements
that would limit users of inflatable PFDs based on age. There are
already requirements in ANSI/CAN/UL 12402-5 addressing inflatable PFDs
for users less than 16 years of age. To be certified as meeting ANSI/
CAN/UL 12402-5, an inflatable PFD intended for wearers less than 16
years of age must automatically inflate, must not require secondary
donning, must be worn, and must include a warning statement about adult
supervision. The Coast Guard believes these requirements are adequate
to ensure safety for wearers less than 16 years of age, so we are
proposing to fully incorporate ANSI/CAN/UL 12402-5 without any
additional age restrictions beyond those included in the standard.
New proposed subparts 160.264 and 160.276 would supersede the
requirements for foam buoyant vests in subpart 160.060, marine buoyancy
devices in subpart 160.064, inflatable recreational personal flotation
devices in subpart 160.076, and hybrid inflatable personal flotation
devices in subpart 160.077.
We propose removing the structural and performance requirements for
the approval of foam buoyant vests, marine buoyant devices, and
inflatable recreational flotation devices in subparts 160.060, 160.064,
and 160.076, respectively, but retaining the requirements for
production inspections, tests, and quality control of wearable PFDs. We
are proposing to delete subpart 160.077 entirely and modify the scope
of subpart 160.076 to include PFDs previously approved under subpart
160.077. By retaining the requirements for production inspections,
tests, and quality control, the Coast Guard would ensure that
manufacturing firms producing PFDs currently approved under approval
series 160.060, 160.064, 160.076, or 160.077 could continue to
manufacture and sell these PFDs, but would not approve new products
under these approval series. At the same time, we are proposing to
reformat the remaining text of subparts 160.060, 160.064, and 160.076,
without amending the language, to align with the other subparts related
to PFDs and increase the ease of understanding for the reader.
To eliminate confusion over approval categories, we are proposing
to relocate the requirements for throwable PFDs from subpart 160.064 to
newly proposed subpart 160.045. Newly proposed subpart 160.045 would be
dedicated to throwable PFDs intended for carriage on recreational
boats. We propose to permit the use of inflatable compartments to meet
the minimum required buoyancy in Sec. 160.045-7. This proposed new
subpart would incorporate by reference the ANSI/UL 1175 standard for
inherently buoyant and inflatable throwable PFDs and the ANSI/UL 1123
standard for marine buoyant devices. The Coast Guard already approves
throwable PFDs to these standards; we are formally incorporating them
by reference in this rulemaking to increase clarity and transparency of
the approval requirements.
3. Incorporate by Reference ANSI/CAN/UL 9595
We propose to incorporate by reference new industry consensus
standard ANSI/CAN/UL 9595, ``Standard for factory follow-up of Personal
Flotation Devices (PFDs)'' (First Edition, June 4, 2020), into subparts
160.055, 160.060, 160.064, 160.076, 160.255, 160.264, and 160.276. This
standard covers the basic elements of a production inspection program
for various types of PFDs.
The Coast Guard currently requires a satisfactory follow-up
(production testing and inspection) program administered by an
independent laboratory recognized by the Coast Guard for each approved
PFD. A task group of experts and stakeholders convened over the past
decade to develop ANSI/CAN/UL 9595 to improve the consistency of
follow-up programs among different recognized independent laboratories
and to provide a binational harmonized standard for production testing
acceptable to the Coast Guard and Transport Canada. ANSI/CAN/UL 9595
establishes a set of Process Ratings (A, B, and C) based on the quality
management system (QMS) at each facility. Process Rating C is
equivalent to current industry practice for follow-up programs and
meets the current minimum requirements. Process Rating B is assigned to
facilities with a good QMS including a Quality Manual that incorporates
the requirements in ANSI/CAN/UL 9595 but is not approved by a third
party. Process Rating A is reserved for facilities that have
demonstrated a superior QMS that meets International Organization for
Standardization (ISO) standard ISO 9001 or a comparable quality
standard, either by audits or acceptance of a third-party
registration.\6\
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\6\ For more information on process ratings, see the preliminary
regulatory analysis in the docket.
---------------------------------------------------------------------------
For Process Rating C, ANSI/CAN/UL 9595 provides a minimum
requirement for production inspections that is equivalent to the
production inspection programs currently accepted by the Commandant.
For Process Ratings A and B, this standard provides the option for the
manufacturer to implement a QMS to reduce the number of inspections
required. ANSI/CAN/UL 9595 sets forth roles and responsibilities;
required tests, sample sizes, and acceptability criteria; and specific
requirements for inspection frequency, traceability of components,
critical dimensions verification, visual inspection of completed PFDs,
and review of records. Annex A provides test methods and Annex B
provides information on the elements of a QMS.
We propose to include ANSI/CAN/UL 9595 in the newly proposed
subparts and in existing subparts 160.055, 160.060, 160.064, and
160.076, to allow manufacturers that implement a QMS to be evaluated as
Process Rating A or B, resulting in fewer required inspections. A QMS
can result in greater production consistency, a reduction in defects
and errors, increased efficiency, and continuous improvement.
[[Page 21020]]
4. Remove Obsolete Material and Relocate Pertinent Material
We propose to remove subparts 160.002, 160.005, 160.047, 160.048,
and 160.052, while also removing or relocating the entirety of subpart
160.001.
Subpart 160.001 provides general requirements for all life
preservers. Most of this information is either obsolete or found
elsewhere in the CFR. We propose to delete subpart 160.001, preserving
the still-pertinent information on production oversight by relocating
it to 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
propose to remove it.
Subparts 160.002, 160.005, 160.047, and 160.048 provide
specifications and requirements for kapok and fibrous glass life
preservers. Subpart 160.052 provides specifications and requirements
for a unicellular plastic foam buoyant vest. Manufacturers no longer
produce any of these types of life preservers due to the unavailability
of material, the advancement of foam technology, and improvements to
the fit and function of PFDs industry-wide. With no current approvals
for equipment under any of these subparts, these approval categories
have become obsolete. Therefore, we propose to delete subparts 160.002,
160.005, 160.047, 160.048, and 160.052. All new PFD approvals would
have to meet the requirements in proposed subparts 160.255, 160.264,
and 160.276, which incorporate current industry standards.
5. Amend Lifesaving Equipment Carriage Requirements
Where current carriage requirements specify approval series for
PFDs, we propose to add the new proposed approval series, as
applicable. The affected Subchapters are Subchapter C (uninspected
commercial vessels), Subchapters K and T (small passenger vessels),
Subchapter L (offshore supply vessels), Subchapter M (towing vessels),
and Subchapter W (lifesaving appliances for certain inspected vessels).
For example, according to the current requirements, an uninspected
vessel carrying passengers for hire must have at least one PFD approved
under approval series 160.055, 160.155, or 160.176 for each person on
board. We propose to add approval series 160.255 to the list of
approval series, to permit the use of PFDs approved under this new
approval series. We are not proposing to remove any of the currently
accepted approval series from the carriage requirements. Therefore, it
would not be necessary for owners and operators to purchase new
equipment if their current equipment is in good and serviceable
condition.
We also propose to remove references to PFDs approved under
approval series 160.177 because there have never been any approvals
granted under that series. All new commercial PFDs, including
commercial hybrid PFDs, would be approved under approval series
160.255.
6. Amend the Requirements for Instruction Pamphlets for PFDs
We propose to amend the requirements for instruction pamphlets for
PFDs in 33 CFR 181 to allow both pamphlets and placards to meet the
requirements for information furnished with each PFD sold or offered
for sale for use on recreational boats. As previously described, we
propose to incorporate both ANSI/CAN/UL 12402-4 and ANSI/CAN/UL 12402-5
with respect to the approval of PFDs. Both these standards require that
a PFD include an informational placard in a pictographic format
containing specific information on PFD performance, selection,
approval, and maintenance, as well as general water safety information.
To permit the placard to be used in place of the currently required
pamphlet, the Coast Guard is proposing to add the term ``placard'' to
33 CFR 181.701-702. We also propose to remove 33 CFR 181.703, which
requires that placards conform with UL 1123, and would add text to 33
CFR 181.702 specifying that a pamphlet or placard must meet the
requirements in the applicable subpart of 46 CFR part 160 or be
accepted by the Commandant. All currently approved PFDs have pamphlets
or placards that have been accepted by the Commandant. Removing 33 CFR
181.703 would eliminate all references to UL 1123 in this subpart, so
we would remove 33 CFR 181.4, which incorporates that standard, as
well. Finally, we propose to remove the separate requirements for
hybrid and inflatable PFDs in 33 CFR 181.704 and 181.705, respectively,
and include requirements for all PFDs in 33 CFR 181.702.
7. Amend the Existing Regulatory Text To Make Editorial Corrections and
Increase Clarity
We propose to update the introductory IBR text, in accordance with
current practice, in 46 CFR 160.055, 160.060, 160.064, and 160.076. We
propose to amend table 28.110 to replace ``Do'' (meaning ``ditto'')
with the actual text to clarify the requirements in plain language, and
to remove references to type codes from the table without modifying the
intent or application of the requirements. We further propose to remove
reference to approval series 160.177 in 46 CFR 108, 133 and 199,
because this unused approval series does not exist, and to remove
outdated provisions allowing cork and balsa wood lifejackets until
March 11, 1999, from 46 CFR 117 and 180. Finally, we are proposing to
consistently use the term ``lifejacket'' by amending instances of
``life jacket'' from two words to one.
V. Incorporation by Reference
Material proposed for IBR appears in 46 CFR 160.045, 160.055,
160.060, 160.064, 160.076, 160.255, 160.264, and 160.276. The standards
proposed for IBR are summarized in section IV, paragraphs (1) through
(3), of this preamble. They are:
(1) ANSI/CAN/UL 9595:2021, Standard for Factory Follow-Up on
Personal Flotation Devices (PFDs), First Edition, June 4, 2020
(including revisions through September 9, 2021) (``ANSI/CAN/UL
9595''). This standard specifies the basic elements of a production
inspection program for various types of PFDs.
(2) ANSI/CAN/UL 12402-4:2020, Standard for Personal Flotation
Devices--Part 4: Lifejackets, Performance Level 100--Safety
Requirements, First Edition, July 9, 2020 (``ANSI/CAN/UL 12402-4'').
This standard specifies safety requirements for Level 100
lifejackets for use by adults, children, and infants.
(3) ANSI/CAN/UL 12402-5:2022, Standard for Personal Flotation
Devices--Part 5: Buoyancy Aids (Level 50)--Safety Requirements,
First Edition, December 31, 2015 (including revisions through
January 27, 2022) (``ANSI/CAN/UL 12402-5''). This standard specifies
safety requirements for Level 50 and Level 70 buoyancy aids for use
by children and adults.
(4) ANSI/UL 1123, Standard for Marine Buoyant Devices, Seventh
Edition, October 1, 2008 (including revisions through November 23,
2020) (``ANSI/UL 1123''). This standard specifies requirements for
marine buoyant devices intended for recreational use.
(5) ANSI/UL 1175, Standard for Buoyant Cushions, Fourth Edition,
April 20, 2007 (including revisions through January 10, 2020)
(``ANSI/UL 1175''). This standard specifies construction,
performance, and markings requirements for inherently buoyant and
inflatable throwable PFDs.
These standards are reasonably available to, and usable by, the
class of persons affected by this proposed rule. PFD manufacturing
firms have access to these standards in their normal course of
business. These standards are
[[Page 21021]]
available for free digital viewing with the creation of a free account
at https://shopulstandards.com. Copies of the material are also
available for purchase from the publishers listed in 46 CFR 160.045,
160.055, 160.060, 160.064, 160.076, 160.255, 160.264, and 160.276. In
addition, any person may view the standards at a Coast Guard facility,
by making arrangements with the person in the FOR FURTHER INFORMATION
CONTACT section of this preamble. Before publishing a final rule, we
will submit this material to the Director of the Federal Register for
approval of the IBR. We are also accepting comments on whether you use
the substance of these standards, or if certain standards can be simply
referenced where we no longer need to incorporate the full text of the
reference.
VI. Regulatory Analyses
We developed this proposed rule after considering numerous statutes
and Executive orders related to rulemaking. We have prepared a full
regulatory analysis (RA) based on these statutes and Executive orders
and have placed it in the docket; a summary of our analysis follows.
A. Regulatory Planning and Review
Executive Orders 12866 (``Regulatory Planning and Review'') and
13563 (``Improving Regulation and Regulatory Review'') direct agencies
to assess the costs and benefits of available regulatory alternatives
and, if regulation is necessary, to select regulatory approaches that
maximize net benefits (including potential economic, environmental,
public health and safety effects, distributive impacts, and equity).
Executive Order 13563 emphasizes the importance of quantifying both
costs and benefits, of reducing costs, of harmonizing rules, and of
promoting flexibility.
The Office of Management and Budget (OMB) has not designated this
proposed rule a significant regulatory action under section 3(f) of
Executive Order 12866. OMB has not reviewed this proposed rule. A
regulatory analysis (RA) is available in the docket and a summary
follows. Table 1 summarizes the impacts of this rulemaking.
Table 1--Summary of Impacts of the Proposed Rule
------------------------------------------------------------------------
Category Summary
------------------------------------------------------------------------
Applicability.......................... IBR of ANSI/CAN/UL 9595, ANSI/
CAN/UL 12402-5, and ANSI/CAN/
UL 12402-4.
------------------------------------------------------------------------
Affected Population.................... 2 recognized independent
laboratories (1 U.S. and 1
foreign), 57 PFD manufacturing
firms (37 U.S. and 20
foreign), the Coast Guard,
recreational vessel operators,
and commercial vessel
operators.
------------------------------------------------------------------------
Costs to U.S. Firms ($2019, 7% discount 10-year total: $1,401,108.
rate).
Annualized: $199,486.
------------------------------------------------------------------------
Costs to Foreign Firms ($2019, 7% 10-year total: $340,229.
discount rate).
Annualized: $48,441.
------------------------------------------------------------------------
Total Costs ($2019, 7% discount rate).. 10-year total: $1,741,338.
Annualized: $247,927.
------------------------------------------------------------------------
Cost Savings to U.S. Firms ($2019, 7% 10-year total: $5,841,460.
discount rate).
Annualized: $831,693.
------------------------------------------------------------------------
Cost Savings to Foreign Firms ($2019, 10-year total: $1,453,901.
7% discount rate).
Annualized: $207,003.
------------------------------------------------------------------------
Cost Savings to the U.S. Government 10-year total: $27,414.
($2019, 7% discount rate).
Annualized: $3,903.
------------------------------------------------------------------------
Total Cost Savings to All Entities 10-year total: $7,322,776.
($2019, 7% discount rate).
Annualized: $1,042,599.
------------------------------------------------------------------------
Net Cost Savings to U.S. Firms ($2019, 10-year total: $18,405,217.
7% discount rate).
Annualized: $2,620,489.
------------------------------------------------------------------------
Net Cost Savings to Foreign Firms 10-year total: $4,401,743.
($2019, 7% discount rate).
Annualized: $626,709.
------------------------------------------------------------------------
Net Cost Savings to the U.S. Government 10-year total: $22,806,961.
($2019, 7% discount rate).
Annualized: $3,247,198.
------------------------------------------------------------------------
Net Cost Savings to All Entities 10-year total: $4,440,352.
($2019, 7% discount rate).
Annualized: $632,206.
------------------------------------------------------------------------
Unquantified Benefits.................. The newer performance-based
standards would allow for the
development of more innovative
PFD designs that might better
meet boaters' needs. New PFD
designs that may be more form
fitting, in addition to the
requirement that Level 50
devices be worn to count for
carriage, could lead to higher
PFD wear rates and additional
lives saved from drowning.
Placards are cheaper to
produce than pamphlets and
provide pictorial
instructions, understandable
by non-English reading
populations.
------------------------------------------------------------------------
[[Page 21022]]
The Coast Guard proposes to harmonize its approval process for PFDs
with that of Canada, resulting in cost savings from eliminating
duplicative requirements. The proposed rule would introduce harmonized
performance standards instead of design standards for PFDs, allowing
manufacturers the opportunity to produce more innovative equipment that
meets the approval requirements of both Canada and the United States.
The proposed rule would amend PFD approval and follow-up program
requirements by incorporating three new binational standards into
regulations, amend PFD carriage requirements to allow for the use of
equipment approved to the new standards, and remove obsolete equipment
approval requirements. The proposed performance-based standards are
more current and intended to replace the legacy design standards. The
proposed amendments would streamline the process for approval of PFDs
and allow manufacturers the opportunity to produce more innovative
equipment that meets the approval requirements of Canada and the United
States, while reducing the burden for manufacturers in the approval
process and follow-up program.
Specifically, the Coast Guard proposes to incorporate by reference
the following binational industry consensus standards:
1. ANSI/CAN/UL 12402-4. This binational standard specifies the
safety requirements for lifejackets that provide face-up flotation for
use in sheltered or calm water, where users may have to wait for
rescue. A lifejacket meeting the requirements of ANSI/CAN/UL 12402-4
provides an equivalent level of safety to a lifejacket currently
approved under 46 CFR subpart 160.055.
2. ANSI/CAN/UL 12402-5. This binational standard specifies the
safety requirements for buoyancy aids used in sheltered waters with
help and rescue nearby. A PFD meeting the requirements of ANSI/CAN/UL
12402-5 provides an equivalent level of safety as a PFD currently
approved under 46 CFR 160.064 or 160.076.
3. ANSI/CAN/UL 9595. This binational standard covers the basic
elements of a production inspection program for various types of PFDs,
and formalizes and modifies current industry standards.
Additionally, the Coast Guard proposes to incorporate two national
standards (ANSI/UL/1123 and ANSI/UL/1175) and to amend numerous CFR
parts to remove obsolete PFD design standards and update carriage
requirements to include PFDs approved to the new proposed subparts. As
mentioned earlier, ANSI/UL/1123 and ANSI/UL/1175 are both currently in
use as a matter of policy and are being incorporated by reference for
the sake of clarity, so we do not estimate any costs or benefits from
their incorporation by reference into the CFR. Similarly, we do not
anticipate any quantifiable costs or benefits from the removal of
obsolete design standards, as these design standards are not currently
in use.
Affected Population
To determine the affected population of the rule, it is first
necessary to describe the economic impacts from this proposed rule. The
economic impacts would stem from the following proposed provisions:
(1) The IBR of ANSI/CAN/UL 12402-4 in 46 CFR 160.255 to replace the
design requirements in 46 CFR 160.055.
(2) The IBR of ANSI/CAN/UL 12402-5 in 46 CFR 160.264 and 160.276 to
replace the design standards in 46 CFR 160.064, 160.076, and 160.077.
(3) The IBR of ANSI/CAN/UL 9595 for follow-up service into the PFD
approval requirements of existing subparts 46 CFR 160.055, 160.060,
160.064, 160.076 and new proposed subparts of 46 CFR 160.045, 160.255,
160.264, and 160.276.
(4) The proposed edits to 33 CFR 181 subpart G, which would permit
manufacturers of all PFDs to provide placards instead of information
pamphlets.
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\7\ The Coast Guard lists all approved products on the Coast
Guard Maritime Information Exchange website, https://cgmix.uscg.mil/
.
\8\ We used the headquarters location of a firm's parent
company, as indicated on the company website, to determine whether a
firm was U.S. or foreign.
---------------------------------------------------------------------------
These four provisions would affect PFD manufacturers, the two
recognized independent laboratories, and the Coast Guard. Before we
present the affected population for each of these provisions, we
present the overall PFD manufacturing firm population.
As of 2021, there are over 800 models of PFDs approved by the Coast
Guard, manufactured by 57 separate manufacturing firms worldwide.\7\
Based on a review of publicly available information across the 57
manufacturing firms, the Coast Guard estimates that 37 are U.S. firms
and 20 are foreign firms. Market share and production volumes are not
equal across the firms.\8\
[[Page 21023]]
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 3.20 1.80
-----------------------------------------------
Total....................................................... 100 80.70 19.30
----------------------------------------------------------------------------------------------------------------
The first provision, the IBR of ANSI/CAN/UL 12402-4, would affect
three populations:
(1) PFD manufacturers that would seek approval to manufacture
devices meeting the requirements of ANSI/CAN/UL 12402-4;
(2) The two recognized independent laboratories that would review
and certify these devices; and
(3) The Coast Guard, which would correspond with the recognized
independent laboratories and manufacturers on device approval.
In table 3, we list the number of PFD manufacturing firms that
would be affected by ANSI/CAN/UL 12402-4. We estimate that each of the
top 13 firms would produce ANSI/CAN/UL 12402-4 devices or components of
those devices at 2 facilities each and firms outside of the top 13
firms would produce ANSI/CAN/UL 12402-4 devices at 1 facility each.\9\
---------------------------------------------------------------------------
\9\ The PFD manufacturing firm does not necessarily own the
facilities where its products are produced. Instead, the facility
may be producing PFDs on contract for the PFD manufacturing firm.
Additionally, much production for U.S. firms occurs at overseas
facilities. We call these ``U.S. Associated Facilities'' not because
they are in the United States but because they have a longstanding
relationship with U.S. firms, while ``Foreign Facilities'' have
longstanding relationships with foreign firms.
Table 3--Manufacturing Firms and Facilities Impacted by ANSI/CAN/UL 12402-4
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. associated Foreign
Firm ownership U.S. firms Foreign firms facilities facilities Total facilities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Firms in top 13................................................... 5 3 10 6 16
All other firms................................................... 4 2 4 2 6
-------------------------------------------------------------------------------------
Total facilities.............................................. 9 5 14 8 22
--------------------------------------------------------------------------------------------------------------------------------------------------------
In the second provision, by incorporating by reference ANSI/CAN/UL
12402-5, the Coast Guard would introduce new categories for youth
inflatables and Level 50 PFDs for approval. Permitting youth
inflatables and Level 50 devices would affect three populations:
(1) PFD manufacturers that would seek Coast Guard approval to
produce youth inflatables or Level 50 devices;
(2) The two recognized independent laboratories that would review
and certify youth inflatables and Level 50 devices; and
(3) The boating public that would purchase youth inflatables or
Level 50 devices instead of Level 70 or Type III devices, because youth
inflatables and Level 50 devices are likely to be more form-fitting
than Level 70 or Type III devices.
In the third provision, the Coast Guard intends to incorporate by
reference ANSI/CAN/UL 9595 covering production inspections and
inspection frequency into multiple newly proposed and existing subparts
in Title 46, as listed in table 4.
Table 4--PFDs Impacted by ANSI/CAN/UL 9595
------------------------------------------------------------------------
Proposed or
Subpart PFD type existing subpart
------------------------------------------------------------------------
160.045....................... Throwable PFDs....... Proposed.
160.255....................... Level 100 PFDs....... Proposed.
160.264....................... Inherently Buoyant Proposed.
Level 50 and Level
70 PFDs.
160.276....................... Inflatable Level 50 Proposed.
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 C is assigned to
facilities with a minimally compliant QMS. The requirements for Process
Rating C are equivalent to the current minimum requirements. Process
Rating B is assigned to facilities with a good QMS, and Process Rating
A is reserved for facilities that have demonstrated a superior QMS.
Because Process Rating C is equivalent to current industry practice,
the affected population for the IBR of ANSI/CAN/UL 9595 would be
[[Page 21024]]
any PFD manufacturer producing a device approved under one of the
subparts listed in table 4 and eligible to gain a Process Rating of A
or B.
In table 5, we estimate the market share likely to be at Process
Rating A, B, or C and whether they are foreign or domestic firms.\10\
Because a QMS system is expensive to set up, industry stakeholders
informed the Coast Guard that firms are not expected to develop a QMS
solely to secure the cost savings of ANSI/CAN/UL 9595. However, a
number of firms have already established QMS systems at their
facilities because of other benefits, such as production consistency
and quality control. The firms that have already established a QMS
system would experience net cost savings from the proposed IBR of ANSI/
CAN/UL 9595. As a result, we estimate the process rating distribution
recorded in table 5.
---------------------------------------------------------------------------
\10\ The process rating applies to a facility owned by a PFD
manufacturing firm. The lowest process rating is C; if manufacturers
seek a higher process rating of A or B, then an independent
laboratory must certify that each facility owned by a manufacturing
firm meets the standard of the higher rating, which is determined
through an audit of a facility. A PFD manufacturing firm incurs the
cost of a higher process rating at each facility. A PFD
manufacturing firm who currently has a QMS (at least partially in
place) would be able to seek a higher process rating, A or B, for
each facility it owns (process rating C is the current baseline or
default rating and represents the current inspection volume at
facilities). A separate QMS inspection or audit is necessary for
this to occur. A higher process rating would result in a reduction
in the inspection volume at facilities, which would save PFD
manufacturing firms money.
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, would affect all firms manufacturing PFDs
approved to any of the categories in table 6 that list placards as
permitted under the proposed rule.
Table 6--Device Category and Permitted Instruction Types
------------------------------------------------------------------------
Types of
instructions Types of
Device category allowed by the instructions
proposed 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.
------------------------------------------------------------------------
ANSI/CAN/UL 12402-4
Costs
There are two sources of costs from this provision: (1) independent
laboratories would need to train their staff to these new standards and
(2) manufacturing firms that intend to sell in only one market (the
United States or Canada) would experience additional costs due to an
increase in the cost of testing according to ANSI/CAN/UL 12402-4 when
compared to the cost of testing to the legacy standards.\11\
---------------------------------------------------------------------------
\11\ 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 proposed IBR of
ANSI/CAN/UL 12402-4 to U.S. firms in table 7. These costs would include
$25,000 paid by independent laboratories in the first year to develop
the instructions and manuals on how to conduct the new ANSI/CAN/UL
12402-4 testing and the estimated $1,406 per year manufacturers would
spend on the more expensive ANSI/CAN/UL 12402-4 certification as
opposed to the legacy certification.\12\
---------------------------------------------------------------------------
\12\ We estimate the cost of Level 100 testing and approval to
be about $44,280 and we estimate the cost for the new Type I
approval to be about $40,000. The Coast Guard estimates 0.45 new
approvals annually for products intended for sale exclusively in the
United States. Therefore, the total additional cost to manufacturers
for the more expensive Level 100 certification would be about $1,926
($4,280 x 0.45). There are currently 51 products approved as Type I
devices under 46 CFR part 160.055, of which 37 (73 percent) are
produced by U.S. PFD firms and 14 (27 percent) are produced by
foreign PFD firms. Therefore, we estimate the cost to U.S. PFD firms
for the new UL 12402-4 approval would be about $1,406 annually
($1,926 x 0.73). We estimate the cost to foreign PFD firms would be
about $520 ($1,926 x 0.27) annually.
[[Page 21025]]
Table 7--Estimated Costs to U.S. Firms for Level 100 Devices Under Standard ANSI/CAN/UL 12402-4
[2019 dollars, 10-year period of analysis]
----------------------------------------------------------------------------------------------------------------
Total Discounted costs
Year undiscounted -------------------------------
costs 7% 3%
----------------------------------------------------------------------------------------------------------------
1............................................................... $26,406 $24,678 $25,637
2............................................................... 1,406 1,228 1,325
3............................................................... 1,406 1,148 1,287
4............................................................... 1,406 1,073 1,249
5............................................................... 1,406 1,002 1,213
6............................................................... 1,406 937 1,177
7............................................................... 1,406 876 1,143
8............................................................... 1,406 818 1,110
9............................................................... 1,406 765 1,078
10.............................................................. 1,406 715 1,046
-----------------------------------------------
Total....................................................... 39,060 33,240 36,265
-----------------------------------------------
Annualized.................................................. .............. $4,733 $4,251
----------------------------------------------------------------------------------------------------------------
We present the 10-year total costs to foreign firms from the
proposed IBR of ANSI/CAN/UL 12402-4 in table 8. Foreign firms would
only experience the additional approval costs of $520 per year.
Table 8--Estimated Costs to Foreign Firms for Level 100 Devices Under Standard ANSI/CAN/UL 12402-4
[2019 dollars, 10-year period of analysis]
----------------------------------------------------------------------------------------------------------------
Total Discounted costs
Year undiscounted -------------------------------
costs 7% 3%
----------------------------------------------------------------------------------------------------------------
1............................................................... $520 $486 $505
2............................................................... 520 454 490
3............................................................... 520 424 476
4............................................................... 520 397 462
5............................................................... 520 371 449
6............................................................... 520 347 436
7............................................................... 520 324 423
8............................................................... 520 303 411
9............................................................... 520 283 399
10.............................................................. 520 264 387
-----------------------------------------------
Total....................................................... 5,200 3,652 4,436
-----------------------------------------------
Annualized.................................................. .............. 520 520
----------------------------------------------------------------------------------------------------------------
We present the 10-year total costs to U.S. and foreign firms from
the proposed IBR of ANSI/CAN/UL 12402-4 in table 9.
Table 9--Estimated Total Cost to All Firms for Level 100 Devices Under Standard ANSI/CAN/UL 12402-4
[2019 dollars, 10-year period of analysis]
----------------------------------------------------------------------------------------------------------------
Total Discounted costs
Year undiscounted -------------------------------
costs 7% 3%
----------------------------------------------------------------------------------------------------------------
1............................................................... $26,926 $25,164 $26,142
2............................................................... 1,926 1,682 1,815
3............................................................... 1,926 1,572 1,763
4............................................................... 1,926 1,469 1,711
5............................................................... 1,926 1,373 1,661
6............................................................... 1,926 1,283 1,613
7............................................................... 1,926 1,199 1,566
8............................................................... 1,926 1,121 1,520
9............................................................... 1,926 1,048 1,476
10.............................................................. 1,926 979 1,433
-----------------------------------------------
Total....................................................... 44,260 36,892 40,701
-----------------------------------------------
Annualized.................................................. .............. 5,253 4,771
----------------------------------------------------------------------------------------------------------------
[[Page 21026]]
Cost Savings
By adopting ANSI/CAN/UL 12402-4, the Coast Guard would be able to
harmonize commercial PFD requirements of the United States with those
of Transport Canada. Harmonization of commercial PFD standards would
lead to cost savings for PFD manufacturing firms through less expensive
approval requirements and less frequent ongoing facility inspections.
Additionally, as a performance-based standard ANSI/CAN/UL 12402-4
would allow for more innovative designs than the current standards and
regulations. The newer performance-based standards would allow for the
development of more innovative PFD designs that might better meet
boaters' needs. The adoption of a performance-based standard would
spare the Coast Guard from making the equivalency determinations
frequently necessary when using the current prescriptive requirements.
Consequently, the Coast Guard would experience time savings from
reducing the review time of new device applications during the approval
process.
In total, we estimate three sources of quantifiable benefits in the
form of cost savings associated with the proposed IBR of ANSI/CAN/UL
12402-4:
(1) The Coast Guard would spend less time reviewing approval
applications and making equivalency determinations for the approval of
innovative PFDs because ANSI/CAN/UL 12402-4 is a performance-based
rather than prescriptive standard and would allow more innovative
designs to meet the standard;
(2) All firms that would apply for approval in both Canadian and
United States markets would save the difference between one
certification to ANSI/CAN/UL 12402-4 and separate United States and
Canadian certifications to legacy standards; and
(3) Manufacturing facilities producing devices meeting the
requirements of ANSI/CAN/UL 12402-4 for the United States and Canadian
markets could be inspected just once for both United States and
Canadian approval instead of the current requirement to be inspected
twice, once for United States approval and once for Canadian approval.
We summarize the total quantified benefits for the cost savings of
the proposed IBR of ANSI/CAN/UL 12402-4 by reporting the annual
undiscounted cost savings in table 10.
Table 10--Estimated Annual Cost Savings of ANSI/CAN/UL 12402-4 to the
Industry and the U.S. Government
[2019 Dollars]
------------------------------------------------------------------------
Cost savings Cost savings
Annual cost savings item to U.S. to foreign
entities entities
------------------------------------------------------------------------
Value of Coast Guard time saved......... $3,903 $0
Canadian and United States approval 23,551 8,711
savings................................
Billed facility inspection savings...... 13,129 7,502
Quality manager's time saved............ 3,054 1,182
-------------------------------
Total............................... 43,637 17,395
------------------------------------------------------------------------
In table 11 and table 12, we record the 10-year cost savings from
the proposed adoption of ANSI/CAN/UL 12402-4 to U.S. and foreign firms,
separately. In table 13, we record the total 10-year cost savings from
this proposed provision to the U.S. government.
Table 11--Estimated Cost Savings to U.S. Firms From ANSI/CAN/UL 12402-4
[2019 Dollars, 10-year period of analysis]
----------------------------------------------------------------------------------------------------------------
Total Discounted cost savings
Year undiscounted -------------------------------
cost savings 7% 3%
----------------------------------------------------------------------------------------------------------------
1............................................................... $39,734 $37,135 $38,577
2............................................................... 39,734 34,705 37,453
3............................................................... 39,734 32,435 36,362
4............................................................... 39,734 30,313 35,303
5............................................................... 39,734 28,330 34,275
6............................................................... 39,734 26,476 33,277
7............................................................... 39,734 24,744 32,307
8............................................................... 39,734 23,126 31,366
9............................................................... 39,734 21,613 30,453
10.............................................................. 39,734 20,199 29,566
-----------------------------------------------
Total....................................................... 397,340 279,075 338,939
-----------------------------------------------
Annualized.................................................. .............. 39,734 39,734
----------------------------------------------------------------------------------------------------------------
[[Page 21027]]
Table 12--Estimated Cost Savings to Foreign Firms From Adopting ANSI/CAN/UL 12402-4
[2019 Dollars, 10-year period of analysis]
----------------------------------------------------------------------------------------------------------------
Total Discounted cost savings
Year undiscounted -------------------------------
cost savings 7% 3%
----------------------------------------------------------------------------------------------------------------
1............................................................... $17,395 $16,257 $16,888
2............................................................... 17,395 15,193 16,396
3............................................................... 17,395 14,200 15,919
4............................................................... 17,395 13,271 15,455
5............................................................... 17,395 12,402 15,005
6............................................................... 17,395 11,591 14,568
7............................................................... 17,395 10,833 14,144
8............................................................... 17,395 10,124 13,732
9............................................................... 17,395 9,462 13,332
10.............................................................. 17,395 8,843 12,944
-----------------------------------------------
Total....................................................... 173,950 122,175 148,383
-----------------------------------------------
Annualized.................................................. .............. 17,395 17,395
----------------------------------------------------------------------------------------------------------------
Table 13--Estimated Cost Savings to the United States Government of ANSI/CAN/UL 12402-4
[2019 Dollars, 10-year period of analysis]
----------------------------------------------------------------------------------------------------------------
Total Discounted cost savings
Year undiscounted -------------------------------
cost savings 7% 3%
----------------------------------------------------------------------------------------------------------------
1............................................................... $3,903 $3,648 $3,789
2............................................................... 3,903 3,409 3,679
3............................................................... 3,903 3,186 3,572
4............................................................... 3,903 2,978 3,468
5............................................................... 3,903 2,783 3,367
6............................................................... 3,903 2,601 3,269
7............................................................... 3,903 2,431 3,174
8............................................................... 3,903 2,272 3,081
9............................................................... 3,903 2,123 2,991
10.............................................................. 3,903 1,984 2,904
-----------------------------------------------
Total....................................................... 39,032 27,414 33,295
-----------------------------------------------
Annualized.................................................. .............. 3,903 3,903
----------------------------------------------------------------------------------------------------------------
In table 14, we record the total discounted, 10-year cost savings
to the U.S. and foreign PFD industry for the ANSI/CAN/UL 12402-4
portion of this proposed rule. We estimate this proposed provision
would save the U.S. and foreign PFD industry about $57,129 annually and
produce cost savings for the industry of about $401,250 over a 10-year
period of analysis using a 7-percent discount rate.
Table 14--Total Estimated Cost Savings to Industry of the Proposed Rule for ANSI/CAN/UL 12402-4
[2019 Dollars, 10-year period of analysis]
----------------------------------------------------------------------------------------------------------------
Total Discounted cost savings
Year undiscounted -------------------------------
cost savings 7% 3%
----------------------------------------------------------------------------------------------------------------
1............................................................... $57,129 $53,392 $55,465
2............................................................... 57,129 49,899 53,850
3............................................................... 57,129 46,634 52,281
4............................................................... 57,129 43,583 50,758
5............................................................... 57,129 40,732 49,280
6............................................................... 57,129 38,067 47,845
7............................................................... 57,129 35,577 46,451
8............................................................... 57,129 33,250 45,098
9............................................................... 57,129 31,074 43,785
10.............................................................. 57,129 29,041 42,509
-----------------------------------------------
Total....................................................... 571,290 401,250 487,322
-----------------------------------------------
Annualized.................................................. .............. 57,129 57,129
----------------------------------------------------------------------------------------------------------------
[[Page 21028]]
ANSI/CAN/UL 12402-5
Costs
The PFD industry would also incur an increase in costs from this
proposed rule because, based on consultation with industry experts, we
estimate this rule would increase the PFD market by 5 percent (meaning
manufacturing firms would seek new device approvals and produce more
devices).\13\ The Coast Guard requests public comment on the
possibility that this rule would increase the PFD market by 5 percent.
We estimate the costs of this proposed provision as the costs of the
additional device approvals and the costs of the additional production
inspections for the greater volume of production that we estimate this
rule would generate.\14\
---------------------------------------------------------------------------
\13\ As part of our discussion with PFD manufacturing firms, we
asked their representatives whether the introduction of Level 50
devices would lead to a net growth in the PFD market (inclusive of
substitution out of existing types of products). Manufacturing firm
representatives stated that they would expect the PFD market would
grow by about 5 percent from this provision. We interpret the 5
percent growth as a one-time growth in the level of manufacturing
spread over a 2-year period.
\14\ We estimate the additional production inspections based on
the current production inspection requirements, and we estimate the
reduction in these inspections through the proposed incorporation by
reference of ANSI/CAN/UL 9595 in its associated section.
---------------------------------------------------------------------------
We present in table 15, table 16, and table 17 the discounted costs
of introducing Level 50 devices over the 10-year period of analysis to
U.S. firms, foreign firms, and all firms, respectively. The tables
include the estimated costs of Level 50 devices approved and inspected
under the current inspections regime. In Year 1, undiscounted costs
would only be the costs of Level 50 approval for manufacturers, or
$521,751 for U.S. manufacturers and $124,781 for foreign manufacturers.
For Year 2, the undiscounted costs would be the costs of Level 50
approvals to manufacturers ($521,751 for U.S. firms and $124,781 for
foreign firms) plus the cost of inspections ($29,325 for U.S. firms and
$6,516 for foreign firms), for a total of about $551,076 ($521,751 +
$29,325) to U.S. firms and $131,297 ($124,781 + $6,516) to foreign
firms. In Years 3-10, the costs would be the cost of inspections of
$71,682 ($58,650 for U.S. firms and $13,032 for foreign firms). The
estimated 10-year cost discounted at 7 percent would be $1,274,842 or
$181,509 annualized for U.S. firms, and the 10-year cost discounted at
7 percent would be $299,267 or $42,609 annualized for foreign firms.
Table 15--Estimated Costs to U.S. Firms From Introducing Level 50 Devices
[2019 Dollars, 10-year period of analysis]
----------------------------------------------------------------------------------------------------------------
Total Discounted costs
Year undiscounted -------------------------------
costs 7% 3%
----------------------------------------------------------------------------------------------------------------
1............................................................... $521,751 $487,618 $506,554
2............................................................... 551,076 481,331 519,442
3............................................................... 58,650 47,876 53,673
4............................................................... 58,650 44,744 52,110
5............................................................... 58,650 41,817 50,592
6............................................................... 58,650 39,081 49,118
7............................................................... 58,650 36,524 47,688
8............................................................... 58,650 34,135 46,299
9............................................................... 58,650 31,902 44,950
10.............................................................. 58,650 29,815 43,641
-----------------------------------------------
Total....................................................... 1,542,027 1,274,842 1,414,068
-----------------------------------------------
Annualized.................................................. .............. 181,509 165,772
----------------------------------------------------------------------------------------------------------------
Table 16--Estimated Costs to Foreign Firms From the Introduction of Level 50 Devices
[2019 Dollars, 10-year period of analysis]
----------------------------------------------------------------------------------------------------------------
Total Discounted costs
Year undiscounted -------------------------------
costs 7% 3%
----------------------------------------------------------------------------------------------------------------
1............................................................... $124,781 $116,618 $121,147
2............................................................... 131,297 114,680 123,760
3............................................................... 13,032 10,638 11,926
4............................................................... 13,032 9,942 11,579
5............................................................... 13,032 9,292 11,242
6............................................................... 13,032 8,684 10,914
7............................................................... 13,032 8,116 10,596
8............................................................... 13,032 7,585 10,288
9............................................................... 13,032 7,089 9,988
10.............................................................. 13,032 6,625 9,697
-----------------------------------------------
Total....................................................... 360,334 299,267 331,136
-----------------------------------------------
Annualized.................................................. .............. 42,609 38,819
----------------------------------------------------------------------------------------------------------------
[[Page 21029]]
Table 17--Total Estimated Costs to PFD Manufacturers From the Introduction of Level 50 Devices
[2019 Dollars, 10-year period of analysis]
----------------------------------------------------------------------------------------------------------------
Total Discounted costs
Year undiscounted -------------------------------
costs 7% 3%
----------------------------------------------------------------------------------------------------------------
1............................................................... $646,532 $604,236 $627,701
2............................................................... 682,373 596,011 643,202
3............................................................... 71,682 58,514 65,599
4............................................................... 71,682 54,686 63,689
5............................................................... 71,682 51,108 61,834
6............................................................... 71,682 47,765 60,033
7............................................................... 71,682 44,640 58,284
8............................................................... 71,682 41,720 56,586
9............................................................... 71,682 38,990 54,938
10.............................................................. 71,682 36,439 53,338
-----------------------------------------------
Total....................................................... 1,902,361 1,574,109 1,745,204
-----------------------------------------------
Annualized.................................................. .............. 224,118 204,591
----------------------------------------------------------------------------------------------------------------
Qualitative Benefits of ANSI/CAN/UL 12402-5
The Coast Guard believes that the proposed introduction of Level 50
devices coupled with the requirement to wear them if they are to count
for the purposes of PFD carriage requirements may lead to an
unquantifiable increase in PFD wear rates among recreational boaters
and thereby potentially decrease the rate of drowning. The Coast Guard
requests public comment on whether Level 50 devices could lead to an
increase in PFD wear rates among recreational boaters. Drowning is the
leading cause of death in recreational boating accidents, accounting
for 79 percent of all recreational boating casualties where we know the
cause of death.\15\ Of those who drowned, 86 percent were not wearing a
lifejacket. Wearing a lifejacket is one of the best means available of
preventing accidental drowning in recreational boating. Unfortunately,
recreational boaters only wear lifejackets about 24 percent of the
time.\16\
---------------------------------------------------------------------------
\15\ United States Coast Guard, ``2019 Recreational Boating
Statistics.'' https://uscgboating.org/library/accident-statistics/Recreational-Boating-Statistics-2019.pdf.
\16\ United States Coast Guard, ``2019 Life Jacket Wear Rate
Observation Study.'' https://uscgboating.org/library/national-live-jacket-wear-study/2019-Life-Jacket-Wear-Rate-Report.pdf.
---------------------------------------------------------------------------
Level 50 devices are likely to be slimmer, lighter in weight, and
more comfortable to wear than current Type III and Level 70 devices.
Additionally, the Coast Guard would require recreational boaters to
wear Level 50 devices to count towards PFD carriage requirements.
Individuals who purchase Level 50 devices would be more likely to wear
PFDs than similar individuals who purchase bulkier Level 70 or Type III
devices without a requirement that they be worn for the purposes of
carriage. The National Institutes of Health (NIH) conducted a
literature review, and among other factors, found discomfort to be
negatively associated with lifejacket wear [NIH, 2018].\17\ It is the
Coast Guard's view that PFDs worn are more effective than PFDs carried
on board if a man overboard situation occurs. As a result, it is
possible that the public would be safer due to recreational boaters
wearing a greater number of PFDs while boating.
---------------------------------------------------------------------------
\17\ We cited this review from the NIH earlier in the preamble
in footnote number 2. Readers should reference that footnote for a
link to this article and other articles by the NIH for more
information on PFD usage.
---------------------------------------------------------------------------
Since the Level 50 devices provide a lower level of buoyancy than
Level 70 devices, a direct comparison is not possible. However, the
view of the subject matter experts in the Coast Guard's Office of
Boating Safety is that the wearing of Level 50 PFDs by recreational
boaters and the general boating public would improve safety on the
water. Recreational boaters fail to wear lifejackets 76 percent of the
time, leaving themselves vulnerable to drowning. The Coast Guard
believes that by offering recreational boaters an additional choice of
a Level 50 PFD, which is required to be worn, more recreational boaters
will choose to wear their lifejacket while engaged in boating
activities. A lifejacket that is worn by the user is more effective
than a lifejacket stowed on the boat.
ANSI/CAN/UL 9595
The third proposed change incorporates by reference the consensus
standard ANSI/CAN/UL 9595 to cover follow-up inspections and inspection
frequency for Coast Guard approved PFDs. Currently, when a
manufacturing firm produces a Coast Guard approved PFD there is a
required follow-up inspection regime to ensure that the devices
continue to meet the specifications under which the Coast Guard
approved them. Although the Coast Guard has not previously published a
substantive minimum requirement for what constitutes a follow-up
inspections regime, we set out general requirements in 46 CFR 159, 46
CFR 160.064-4, and 46 CFR 160.076-29. The Coast Guard reviews each
recognized independent laboratory's follow-up services program to
ensure compliance with these regulations.
Incorporating by reference ANSI/CAN/UL 9595 would provide a few key
benefits to the regulated public and the testing laboratories. First,
ANSI/CAN/UL 9595 is one standard to ensure consistency across all
accepted and recognized independent laboratories. Second, ANSI/CAN/UL
9595 is a standard that would be widely available to the industry and
transparently clarifies guidance on what constitutes a follow-up
inspection regime. Third, and most importantly, ANSI/CAN/UL 9595
establishes a rating system for each facility, which would result in
cost savings for the firms manufacturing at facilities with a good or
superior QMS.
Costs
There are three cost items associated with the proposed adoption of
ANSI/CAN/UL 9595. These costs are based on input from subject matter
experts from the PFD industry on how ANSI/CAN/UL 9595 is likely to be
implemented:
(1) The two recognized independent laboratories would need to train
their staff to implement ANSI/CAN/UL 9595;
(2) Manufacturing firms could request a special inspection in the
first year to certify their QMS at a given facility
[[Page 21030]]
meets the requirements for Process Rating of A or B. We expect the top
13 firms to request this certification across all 27 facilities at
which they manufacture. This special inspection would be expected to be
in addition to the regular production inspections required for Process
Rating C; and
(3) After the first year where the QMS inspection would be
supplemental to standard inspections, the QMS inspection could replace
one of the mandatory inspections, but could cost more than a standard
inspection at the top 13 firms with 27 facilities.
We estimate the 10-year discounted cost for inspections under this
proposed provision that are associated with U.S. firms would be
approximately $93,027, or $13,245 annualized using a 7-percent discount
rate. We estimate the total 10-year discounted cost for inspections
that are associated with foreign firms would be approximately $37,310,
or $3,000 annualized using a 7-percent discount rate. In total, we
estimate the 10-year discounted costs from ANSI/CAN/UL 9595 would be
$130,337 or $18,557 annualized using a 7-percent discount rate. We
present these amounts in table 18, table 19, and table 20.
Table 18--Estimated QMS Inspection Costs to U.S. Firms From ANSI/CAN/UL 9595
[2019 Dollars, 10-year period of analysis]
----------------------------------------------------------------------------------------------------------------
Total Discounted costs
Year undiscounted -------------------------------
costs 7% 3%
----------------------------------------------------------------------------------------------------------------
1............................................................... $53,118 $49,643 $51,571
2............................................................... 7,125 6,223 6,716
3............................................................... 7,125 5,816 6,520
4............................................................... 7,125 5,436 6,330
5............................................................... 7,125 5,080 6,146
6............................................................... 7,125 4,748 5,967
7............................................................... 7,125 4,437 5,793
8............................................................... 7,125 4,147 5,625
9............................................................... 7,125 3,876 5,461
10.............................................................. 7,125 3,622 5,302
-----------------------------------------------
Total....................................................... 117,243 93,027 105,431
-----------------------------------------------
Annualized.................................................. .............. 13,245 12,360
----------------------------------------------------------------------------------------------------------------
Table 19--Estimated QMS Inspection Costs to Foreign Firms From ANSI/CAN/UL 9595
[2019 Dollars, 10-year period of analysis]
----------------------------------------------------------------------------------------------------------------
Total Discounted costs
Year undiscounted -------------------------------
costs 7% 3%
----------------------------------------------------------------------------------------------------------------
1............................................................... $20,376 $19,043 $19,783
2............................................................... 3,000 2,620 2,828
3............................................................... 3,000 2,449 2,745
4............................................................... 3,000 2,289 2,665
5............................................................... 3,000 2,139 2,588
6............................................................... 3,000 1,999 2,512
7............................................................... 3,000 1,868 2,439
8............................................................... 3,000 1,746 2,368
9............................................................... 3,000 1,632 2,299
10.............................................................. 3,000 1,525 2,232
-----------------------------------------------
Total....................................................... 47,376 37,310 42,461
-----------------------------------------------
Annualized.................................................. .............. 5,312 4,978
----------------------------------------------------------------------------------------------------------------
Table 20--Total Estimated QMS Inspection Costs for ANSI/CAN/UL 9595
[2019 Dollars, 10-year period of analysis]
----------------------------------------------------------------------------------------------------------------
Total Discounted costs
Year undiscounted -------------------------------
costs 7% 3%
----------------------------------------------------------------------------------------------------------------
1............................................................... $73,494 $68,686 $71,353
2............................................................... 10,125 8,844 9,544
3............................................................... 10,125 8,265 9,266
4............................................................... 10,125 7,724 8,996
5............................................................... 10,125 7,219 8,734
6............................................................... 10,125 6,747 8,480
7............................................................... 10,125 6,305 8,233
8............................................................... 10,125 5,893 7,993
9............................................................... 10,125 5,507 7,760
[[Page 21031]]
10.............................................................. 10,125 5,147 7,534
-----------------------------------------------
Total....................................................... 164,619 130,337 147,892
-----------------------------------------------
Annualized.................................................. .............. 18,557 17,337
----------------------------------------------------------------------------------------------------------------
Cost Savings
The proposed IBR of ANSI/CAN/UL 9595 would generate benefits in the
form of cost savings for PFD manufacturing firms who have a QMS in
place. Manufacturers with an audited QMS would be able to secure a
higher Process Rating, which in turn, would reduce the frequency of
production inspections for PFDs based upon their higher Process Rating.
We estimate this proposed provision would generate benefits in the
form of cost savings for U.S. firms of $5,562,385, or $791,959
annualized, over a 10-year period of analysis using a 7-percent
discount rate, and we similarly estimate cost savings of $1,331,726, or
$189,608 annualized, to foreign firms over a 10-year period of analysis
discounted at 7 percent. In total, we estimate $6,894,111, or $981,566
annualized, in cost savings to all firms under this proposed provision
using a 10-year period of analysis and a 7-percent discount rate. We
present these 10-year cost savings to U.S., foreign, and both U.S. and
foreign firms in table 21, table 22, and table 23, respectively.
Table 21--Estimated Cost Savings to U.S. Firms From ANSI/CAN/UL 9595
[2019 Dollars, 10-year period of analysis]
----------------------------------------------------------------------------------------------------------------
Total Discounted cost savings
Year undiscounted -------------------------------
cost savings 7% 3%
----------------------------------------------------------------------------------------------------------------
1............................................................... $0 $0 $0
2............................................................... 897,438 783,857 845,921
3............................................................... 916,206 747,897 838,458
4............................................................... 916,206 698,969 814,037
5............................................................... 916,206 653,242 790,327
6............................................................... 916,206 610,506 767,308
7............................................................... 916,206 570,567 744,959
8............................................................... 916,206 533,240 723,261
9............................................................... 916,206 498,355 702,195
10.............................................................. 916,206 465,752 681,743
-----------------------------------------------
Total....................................................... 8,227,082 5,562,385 6,908,209
-----------------------------------------------
Annualized.................................................. .............. 791,959 809,853
----------------------------------------------------------------------------------------------------------------
Table 22--Estimated Cost Savings to Foreign Firms From ANSI/CAN/UL 9595
[2019 Dollars, 10-year period of analysis]
----------------------------------------------------------------------------------------------------------------
Total Discounted cost savings
Year undiscounted -------------------------------
cost savings 7% 3%
----------------------------------------------------------------------------------------------------------------
1............................................................... $0 $0 $0
2............................................................... 214,989 187,780 202,648
3............................................................... 219,333 179,041 200,721
4............................................................... 219,333 167,328 194,875
5............................................................... 219,333 156,382 189,199
6............................................................... 219,333 146,151 183,688
7............................................................... 219,333 136,590 178,338
8............................................................... 219,333 127,654 173,144
9............................................................... 219,333 119,303 168,101
10.............................................................. 219,333 111,498 163,204
-----------------------------------------------
Total....................................................... 1,969,655 1,331,726 1,653,917
-----------------------------------------------
Annualized.................................................. .............. 189,608 193,890
----------------------------------------------------------------------------------------------------------------
[[Page 21032]]
Table 23--Estimated Cost Savings to All Firms From ANSI/CAN/UL 9595
[2019 Dollars, 10-year period of analysis]
----------------------------------------------------------------------------------------------------------------
Total Discounted costs savings
Year undiscounted -------------------------------
cost savings 7% 3%
----------------------------------------------------------------------------------------------------------------
1............................................................... $0 $0 $0
2............................................................... 1,112,427 971,637 1,048,569
3............................................................... 1,135,539 926,938 1,039,179
4............................................................... 1,135,539 866,297 1,008,912
5............................................................... 1,135,539 809,623 979,526
6............................................................... 1,135,539 756,657 950,996
7............................................................... 1,135,539 707,156 923,297
8............................................................... 1,135,539 660,894 896,405
9............................................................... 1,135,539 617,658 870,296
10.............................................................. 1,135,539 577,250 844,948
-----------------------------------------------
Total....................................................... 10,196,737 6,894,111 8,562,126
-----------------------------------------------
Annualized.................................................. .............. 981,566 1,003,742
----------------------------------------------------------------------------------------------------------------
Placards in Lieu of Information Pamphlets
The fourth change in the proposed rule comes from details contained
within ANSI/CAN/UL 12402-4 and ANSI/CAN/UL 12402-5. These standards
specify requirements for a placard to be attached to all devices
certified to those standards. The placard provides information on PFDs'
performance, selection, and approval, warnings, maintenance, and
general water safety information in a pictographic format. This
proposed rule would amend 33 CFR 181 to permit manufacturing firms to
use a placard in lieu of the informational pamphlet.
Costs
For the convenience of the reader, table 24 reproduces table 6 from
the Affected Population section to list the various types of PFDs
impacted by this rule, and whether they would be required to use
placards to covey safety instructions or whether they could use either
placards or information pamphlets.\18\
---------------------------------------------------------------------------
\18\ Current marking requirements require a pamphlet, while the
proposed new marking requirement would be for a placard or pamphlet.
Because these placards and pamphlets are both produced in factories,
the Coast Guard estimates that it takes the same amount of time to
produce and include either a pamphlet or a placard with a newly
manufactured PFD for sale. As a result, we do not estimate there
would be any changes in the PRA burden brought on by the switch from
pamphlets to placards.
Table 24--Device Category and Permitted Instruction Types
------------------------------------------------------------------------
Types of
instructions Types of
Device category allowed by the instructions
proposed 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.
------------------------------------------------------------------------
As shown in table 24 above, the proposed changes in instruction
information would either apply to PFD categories not yet produced or
permit an additional compliance option. No devices would have fewer
options for instruction materials than under current regulations. As a
result, we estimate there would be no additional costs from replacing
safety information pamphlets with placards because firms could either
continue their current activities or produce placards instead.
Unquantified Benefits
There are two sources of unquantified benefits from the proposed
requirement for the use of placards on new device categories and the
proposed permitting of placard use on existing device categories. The
first source of unquantified benefits would occur because a placard is
likely less expensive to produce than an information pamphlet. A
representative from the PFD manufacturing industry told us that the
placard would likely be around $0.05 cheaper to produce than the
information pamphlet because the placard would contain fewer materials
than the information pamphlet. However, we could not find any data on
the costs to produce information pamphlets and the costs to produce
placards, so we cannot determine the relative size of this cost
savings. We believe based on the full discussion that the $0.05
estimate is a rough approximation of the fact that placards are
slightly less expensive than information pamphlets but ultimately about
the same price. Additionally, we have no way of estimating how large a
share of current production would switch from producing information
pamphlets to placards, as placards would not be required. Due to these
factors, we did not produce a quantitative estimate of the cost savings
due to placards.
The second unquantified benefit would come from the fact that
placards use pictorial images to communicate safety information, while
information
[[Page 21033]]
pamphlets use English-language text. Pictorial information is superior
to text at communicating information to non-English-reading audiences.
We do not have a way of quantifying this benefit, but would like to
note that approximately 21 percent of the U.S. population has a ``low''
level of English literacy. For those populations, pictorial information
may be better than text-based information.\19\
---------------------------------------------------------------------------
\19\ U.S. Department of Education, ``Data Point: Adult Literacy
in the United States'' (July 2019). https://nces.ed.gov/pubs2019/2019179.pdf.
---------------------------------------------------------------------------
Total Costs
We display the total costs from this proposed rule to U.S.
entities, foreign entities, and both U.S. and foreign entities using a
10-year period of analysis discounted at 7 percent in table 25, table
26, and table 27, respectively.
Table 25--Estimated Costs for U.S. Firms
[2019 Dollars, 10-year period of analysis]
----------------------------------------------------------------------------------------------------------------
Total Discounted costs
Year undiscounted -------------------------------
costs 7% 3%
----------------------------------------------------------------------------------------------------------------
1............................................................... $601,275 $561,939 $583,762
2............................................................... 559,607 488,782 527,483
3............................................................... 67,181 54,840 61,480
4............................................................... 67,181 51,252 59,689
5............................................................... 67,181 47,899 57,951
6............................................................... 67,181 44,766 56,263
7............................................................... 67,181 41,837 54,624
8............................................................... 67,181 39,100 53,033
9............................................................... 67,181 36,542 51,489
10.............................................................. 67,181 34,151 49,989
-----------------------------------------------
Total....................................................... 1,698,330 1,401,108 1,555,764
-----------------------------------------------
Annualized.................................................. .............. 199,486 182,383
----------------------------------------------------------------------------------------------------------------
Table 26--Estimated Costs for Foreign Firms
[2019 Dollars, 10-year period of analysis]
----------------------------------------------------------------------------------------------------------------
Total Discounted costs
Year undiscounted -------------------------------
costs 7% 3%
----------------------------------------------------------------------------------------------------------------
1............................................................... $145,677 $136,147 $141,434
2............................................................... 134,817 117,754 127,078
3............................................................... 16,552 13,511 15,147
4............................................................... 16,552 12,627 14,706
5............................................................... 16,552 11,801 14,278
6............................................................... 16,552 11,029 13,862
7............................................................... 16,552 10,308 13,458
8............................................................... 16,552 9,633 13,066
9............................................................... 16,552 9,003 12,686
10.............................................................. 16,552 8,414 12,316
-----------------------------------------------
Total....................................................... 412,910 340,229 378,032
-----------------------------------------------
Annualized.................................................. .............. 48,441 44,317
----------------------------------------------------------------------------------------------------------------
Table 27--Total Estimated Costs for U.S. and Foreign Firms
[2019 Dollars, 10-year period of analysis]
----------------------------------------------------------------------------------------------------------------
Total Discounted costs
Year undiscounted -------------------------------
costs 7% 3%
----------------------------------------------------------------------------------------------------------------
1............................................................... $746,952 $698,086 $725,196
2............................................................... 694,424 606,537 654,561
3............................................................... 83,733 68,351 76,628
4............................................................... 83,733 63,880 74,396
5............................................................... 83,733 59,700 72,229
6............................................................... 83,733 55,795 70,125
7............................................................... 83,733 52,145 68,083
8............................................................... 83,733 48,733 66,100
9............................................................... 83,733 45,545 64,174
[[Page 21034]]
10.............................................................. 83,733 42,566 62,305
-----------------------------------------------
Total....................................................... 2,111,240 1,741,338 1,933,796
-----------------------------------------------
Annualized.................................................. .............. 247,927 226,700
----------------------------------------------------------------------------------------------------------------
Total Cost Savings
We display the total cost savings from this proposed rule to U.S.
firms, the U.S. government, foreign firms, and all firms using a 10-
year period of analysis discounted at 7 percent in table 28, table 29,
table 30, and table 31, respectively.
Table 28--Total Estimated Cost Savings to U.S. Firms
[2019 Dollars, 10-year period of analysis]
----------------------------------------------------------------------------------------------------------------
Total Discounted costs savings
Year undiscounted -------------------------------
cost savings 7% 3%
----------------------------------------------------------------------------------------------------------------
1............................................................... $39,734 $37,135 $38,577
2............................................................... 937,172 818,562 883,374
3............................................................... 955,940 780,331 874,820
4............................................................... 955,940 729,282 849,340
5............................................................... 955,940 681,572 824,602
6............................................................... 955,940 636,983 800,584
7............................................................... 955,940 595,311 777,266
8............................................................... 955,940 556,366 754,628
9............................................................... 955,940 519,968 732,648
10.............................................................. 955,940 485,951 711,309
-----------------------------------------------
Total....................................................... 8,624,422 5,841,460 7,247,148
-----------------------------------------------
Annualized.................................................. .............. 831,693 849,587
----------------------------------------------------------------------------------------------------------------
Table 29--Total Estimated Cost Savings to Foreign Firms
[2019 Dollars, 10-year period of analysis]
----------------------------------------------------------------------------------------------------------------
Total Discounted costs savings
Year undiscounted -------------------------------
cost savings 7% 3%
----------------------------------------------------------------------------------------------------------------
1............................................................... $17,395 $16,257 $16,888
2............................................................... 232,384 202,973 219,044
3............................................................... 236,728 193,241 216,640
4............................................................... 236,728 180,599 210,330
5............................................................... 236,728 168,784 204,204
6............................................................... 236,728 157,742 198,256
7............................................................... 236,728 147,422 192,482
8............................................................... 236,728 137,778 186,875
9............................................................... 236,728 128,764 181,432
10.............................................................. 236,728 120,341 176,148
-----------------------------------------------
Total....................................................... 2,143,605 1,453,901 1,802,300
-----------------------------------------------
Annualized.................................................. .............. 207,003 211,285
----------------------------------------------------------------------------------------------------------------
Table 30--Total Estimated Cost Savings to the United States Government
[2019 Dollars, 10-year period of analysis]
----------------------------------------------------------------------------------------------------------------
Total Discounted costs savings
Year undiscounted -------------------------------
cost savings 7% 3%
----------------------------------------------------------------------------------------------------------------
1............................................................... $3,903 $3,648 $3,789
2............................................................... 3,903 3,409 3,679
3............................................................... 3,903 3,186 3,572
4............................................................... 3,903 2,978 3,468
[[Page 21035]]
5............................................................... 3,903 2,783 3,367
6............................................................... 3,903 2,601 3,269
7............................................................... 3,903 2,431 3,174
8............................................................... 3,903 2,272 3,081
9............................................................... 3,903 2,123 2,991
10.............................................................. 3,903 1,984 2,904
-----------------------------------------------
Total....................................................... 39,032 27,414 33,295
-----------------------------------------------
Annualized.................................................. .............. 3,903 3,903
----------------------------------------------------------------------------------------------------------------
Table 31--Total Estimated Cost Savings to U.S. and Foreign Manufacturing Firms and the U.S. Government
[2019 Dollars, 10-year period of analysis]
----------------------------------------------------------------------------------------------------------------
Total Discounted costs savings
Year undiscounted -------------------------------
cost savings 7% 3%
----------------------------------------------------------------------------------------------------------------
1............................................................... $61,032 $57,039 $59,255
2............................................................... 1,173,459 1,024,945 1,106,098
3............................................................... 1,196,571 976,758 1,095,032
4............................................................... 1,196,571 912,858 1,063,138
5............................................................... 1,196,571 853,139 1,032,173
6............................................................... 1,196,571 797,326 1,002,109
7............................................................... 1,196,571 745,164 972,922
8............................................................... 1,196,571 696,415 944,584
9............................................................... 1,196,571 650,855 917,072
10.............................................................. 1,196,571 608,276 890,361
-----------------------------------------------
Total....................................................... 10,807,059 7,322,776 9,082,743
-----------------------------------------------
Annualized.................................................. .............. 1,042,599 1,064,775
----------------------------------------------------------------------------------------------------------------
Net Cost Savings
We display the total net cost savings from this proposed rule to
U.S. firms, the U.S. government, foreign firms, and all entities using
a 10-year period of analysis discounted at 7 percent in table 32, table
33, table 34, and table 35, respectively.
Table 32--Total Estimated Net Cost Savings to U.S. Firms
[2019 Dollars, 10-year period of analysis]
----------------------------------------------------------------------------------------------------------------
Net Net discounted costs savings
Year undiscounted -------------------------------
cost savings 7% 3%
----------------------------------------------------------------------------------------------------------------
1............................................................... -$561,541 -$524,805 -$545,185
2............................................................... 377,565 329,780 355,891
3............................................................... 888,759 725,492 813,340
4............................................................... 888,759 678,030 789,651
5............................................................... 888,759 633,673 766,651
6............................................................... 888,759 592,217 744,321
7............................................................... 888,759 553,474 722,642
8............................................................... 888,759 517,266 701,594
9............................................................... 888,759 483,426 681,159
10.............................................................. 888,759 451,800 661,320
-----------------------------------------------
Total....................................................... 6,926,092 4,440,352 5,691,384
-----------------------------------------------
Annualized.................................................. .............. 632,206 667,204
----------------------------------------------------------------------------------------------------------------
[[Page 21036]]
Table 33--Total Estimated Net Cost Savings to Foreign Firms
[2019 Dollars, 10-year period of analysis]
----------------------------------------------------------------------------------------------------------------
Net Net discounted costs savings
Year undiscounted -------------------------------
cost savings 7% 3%
----------------------------------------------------------------------------------------------------------------
1............................................................... -$128,282 -$119,890 -$124,546
2............................................................... 97,567 85,219 91,966
3............................................................... 220,176 179,729 201,492
4............................................................... 220,176 167,971 195,624
5............................................................... 220,176 156,983 189,926
6............................................................... 220,176 146,713 184,394
7............................................................... 220,176 137,115 179,023
8............................................................... 220,176 128,145 173,809
9............................................................... 220,176 119,761 168,747
10.............................................................. 220,176 111,926 163,832
-----------------------------------------------
Total....................................................... 1,730,695 1,113,672 1,424,268
-----------------------------------------------
Annualized.................................................. .............. 158,562 166,968
----------------------------------------------------------------------------------------------------------------
Table 34--Total Estimated Cost Savings to the United States Government
[2019 Dollars, 10-year period of analysis]
----------------------------------------------------------------------------------------------------------------
Net Net discounted costs savings
Year undiscounted -------------------------------
cost savings 7% 3%
----------------------------------------------------------------------------------------------------------------
1............................................................... $3,903 $3,648 $3,789
2............................................................... 3,903 3,409 3,679
3............................................................... 3,903 3,186 3,572
4............................................................... 3,903 2,978 3,468
5............................................................... 3,903 2,783 3,367
6............................................................... 3,903 2,601 3,269
7............................................................... 3,903 2,431 3,174
8............................................................... 3,903 2,272 3,081
9............................................................... 3,903 2,123 2,991
10.............................................................. 3,903 1,984 2,904
-----------------------------------------------
Total....................................................... 39,032 27,414 33,295
-----------------------------------------------
Annualized.................................................. .............. 3,903 3,903
----------------------------------------------------------------------------------------------------------------
Table 35--Total Estimated Net Cost Savings to All Entities
[2019 Dollars, 10-year period of analysis]
----------------------------------------------------------------------------------------------------------------
Net Net discounted costs savings
Year undiscounted -------------------------------
cost savings 7% 3%
----------------------------------------------------------------------------------------------------------------
1............................................................... -$685,920 -$641,047 -$665,942
2............................................................... 479,035 418,408 451,536
3............................................................... 1,112,838 908,407 1,018,404
4............................................................... 1,112,838 848,979 988,742
5............................................................... 1,112,838 793,438 959,944
6............................................................... 1,112,838 741,531 931,984
7............................................................... 1,112,838 693,020 904,839
8............................................................... 1,112,838 647,682 878,485
9............................................................... 1,112,838 605,310 852,898
10.............................................................. 1,112,838 565,710 828,056
-----------------------------------------------
Total....................................................... 8,695,819 5,581,438 7,148,947
-----------------------------------------------
Annualized.................................................. .............. 794,671 838,075
----------------------------------------------------------------------------------------------------------------
[[Page 21037]]
Alternatives
We identified three alternatives to the current proposed rule:
(1) Incorporate ANSI/CAN/UL 12402-5 for the approval of Level 70
PFDs only, prohibiting the approval of Level 50 PFDs;
(2) Require placards for existing Type I, II, and III PFDs instead
of providing the option to continue the use of informational pamphlets;
and
(3) Adopt ANSI/CAN/UL 12402-4 and ANSI/CAN/UL 12402-5 by policy.
Alternative 1: Incorporate ANSI/CAN/UL 12402-5 for Level 70 PFDs
only.
We considered an alternative that would incorporate ANSI/CAN/UL
12402-5, but limit approval to Level 70 PFDs only. Level 50 PFDs would
not be eligible for Coast Guard approval and would not meet carriage
requirements on any vessel. If the Coast Guard were to choose this
alternative, the market for Level 50 devices would not be viable
because Level 50 devices would no longer meet carriage requirements. We
therefore expect there would be no benefits from a new market as the
market would not exist. The expected qualitative benefit of increased
wear-rates associated with more comfortable and innovative Level 50
PFDs would be lost with this alternative. We would also be restricting
recreational boaters to one category of PFD when Level 50 PFDs could
better suit their purpose. As a result, we rejected this alternative
because we expect wear rates and therefore benefits would be lower.
Alternative 2: Require Placards Instead of the Option of Placards or
Pamphlets
Under this proposed rule, we require that only new Level 50, 70,
and 100 devices use placards. We considered the alternative of
requiring that PFD manufacturers use placards instead of information
pamphlets for all existing PFDs. While we observe that the cost of
producing a placard is generally less than the cost of producing an
information pamphlet, we also observe that some manufacturers may have
already printed pamphlets or may not choose to use placards. As a
result, we rejected this alternative.
Alternative 3: Adopt ANSI/CAN/UL 12402-4 and ANSI/CAN/UL 12402-5 by
Policy
Another alternative we considered would be to adopt ANSI/CAN/UL
12402-4 and ANSI/CAN/UL 12402-5 by policy instead of incorporating them
by reference into the CFR. Under 46 CFR 159.005-7(c), the Coast Guard
has the authority to approve an item of equipment that does not meet
all the requirements of 46 CFR 160.055 if it has equivalent performance
characteristics. The Coast Guard has already used this authority to
partially adopt ANSI/CAN/UL 12402-4 and ANSI/CAN/UL 12402-5 by policy.
Because this authority is limited to the approval of equipment with
equivalent performance characteristics, we cannot fully adopt these
standards by policy. In particular, Level 50 PFDs, youth inflatable
PFDs, and inflatable Level 100 PFDs could not be approved by policy
because they are not equivalent to any current Coast Guard standards.
For that reason, we rejected this alternative.
B. Small Entities
Under the Regulatory Flexibility Act (RFA), 5 United States Code
(U.S.C.) 601-612, we have prepared this Initial Regulatory Flexibility
Analysis (IRFA) that examines the impacts of the proposed rule on small
entities.
Per the RFA, a small entity may be a small independent business,
defined as one independently owned and operated, organized for profit,
and not dominant in its field under the Small Business Act (5 U.S.C.
632); a small not-for-profit organization, defined as any not-for-
profit enterprise which is independently owned and operated and is not
dominant in its field; or a small governmental jurisdiction, defined as
a locality with fewer than 50,000 people.
Section 603(b) of the RFA prescribes the content of the IRFA, which
addresses the following:
(1) A description of the reasons why action by the agency is being
considered;
(2) A succinct statement of the objectives of, and legal basis for,
the proposed rule;
(3) A description of and, where feasible, an estimate of the number
of small entities to which the proposed rule will apply;
(4) A description of the projected reporting, recordkeeping, and
other compliance requirements of the proposed rule, including an
estimate of the classes of small entities that will be subject to the
requirement and the type of professional skills necessary for
preparation of the report or record;
(5) An identification, to the extent practicable, of all relevant
Federal rules that may duplicate, overlap, or conflict with the
proposed rule; and
(6) A description of any significant alternatives to the rule that
accomplish the stated objectives of applicable statutes and that
minimize any significant economic impact of the proposed rule on small
entities.
1. A Description of the Reasons Why Action by the Agency Is Being
Considered
The Coast Guard proposes to amend the lifejacket approval
requirements and follow-up program requirements by incorporating three
new binational standards. At the same time, the Coast Guard proposes to
amend lifejacket and PFD carriage requirements to allow for the use of
equipment approved to the new standards, and to remove obsolete
equipment approval requirements. The new standards are intended to
replace the legacy standards. The proposed amendments will streamline
the process for approval of PFDs and allow manufacturers the
opportunity to produce equipment that meets the approval requirements
of both Canada and the United States, while reducing the burden for
manufacturers in both the approval process and follow-up program.
2. A Succinct Statement of the Objective of, and Legal Basis for, the
Proposed Rule
This proposed rule would harmonize PFD approval standards with
those used in Canada, lead to net cost savings for PFD manufacturers,
and introduce a new type of PFD that may better meet the needs of some
recreational boaters.
This proposed rule is discretionary and not issued because of a
statutory mandate. The Coast Guard will use its existing rulemaking
authority provided under Title 46, U.S. Code, sections 3306(a), 4102(a)
and (b), 4302(a) and (c), and 4502(a) and (c)(2)(B).
Title 46 U.S.C. 3306 provides the Coast Guard with the general
authority to prescribe regulations for the design, construction,
performance, testing, carriage, use, and inspection of lifesaving
equipment on commercial and recreational vessels. Title 46 U.S.C. 4102
and 4302 provide more specific authority to prescribe regulations about
life preservers and other life saving devices on uninspected and
recreational vessels, respectively.
3. A Description--and, Where Feasible, an Estimate of the Number--of
Small Entities to Which the Proposed Rule Will Apply
This proposed rule has four major provisions:
(1) It would incorporate by reference ANSI/CAN/UL 12402-4,
replacing Type I device approval with Level 100 device approval.
(2) It would incorporate by reference ANSI/CAN/UL 12402-5,
introducing new Level 50 device approvals.
(3) It would incorporate by reference ANSI/CAN/UL 9595, setting new
[[Page 21038]]
standards for follow-on production inspections.
(4) It would permit the use of placards in lieu of instruction
pamphlets.
Across these four provisions, we estimate that this proposed rule
would directly affect two Coast Guard recognized laboratories and 57
PFD manufacturers.
We researched these two Coast Guard recognized laboratories and 57
PFD manufacturers to determine if they are U.S. companies or foreign
companies based on the location of their parent company's headquarters.
We found one Coast Guard recognized laboratory to be a U.S. company and
one to be a foreign company. We found 37 of the 57 PFD manufacturers to
be U.S. companies and 20 to be foreign companies. We then researched
each of these 38 U.S. companies (1 testing laboratory and 37 PFD
manufacturers) to determine its North American Industry Classification
System (NAICS) code and its size standard using the Small Business
Administration's (SBA) size standard table. Next, we reviewed each U.S.
parent company's revenue or employee information to determine whether
the company would be small or not small according to SBA size
standards. We present the results of our research in table 36. We found
the U.S. Coast Guard recognized laboratory to be small, and of the 37
U.S. manufacturers, we found 30 of them to be small entities according
to SBA size standards; we did not find any U.S. small entities to be
small governmental jurisdictions.
Table 36--Number of Small Entities Affected by the Proposed Rule
----------------------------------------------------------------------------------------------------------------
Size
NAICS code NAICS code and industry Size standard type standard Number of U.S. Number of
type used companies small entities
----------------------------------------------------------------------------------------------------------------
314910............ Textile Bag and Canvas Employees........... 500 1 1
Mills.
314999............ All Other Miscellaneous Revenue............. $8.0 2 2
Store Retailers (except
Tobacco Stores).
315280............ Other Cut and Sew Employees........... 750 1 1
Apparel Manufacturing.
315990............ Apparel Accessories and Employees........... 500 1 1
Other Apparel
Manufacturing.
326199............ All Other Plastics Employees........... 750 2 0
Product Manufacturing.
326299............ All Other Rubber Product Employees........... 500 1 1
Manufacturing.
327120............ Clay Building Material Employees........... 750 1 1
and Refractories
Manufacturing.
336612............ Boat Building........... Employees........... 1,000 2 2
339920............ Sporting and Athletic Employees........... 750 4 3
Goods Manufacturing.
339999............ All Other Miscellaneous Employees........... 500 1 1
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 Stores.. Revenue............. $41.5 1 0
448150............ Clothing Accessories Revenue............. $16.5 2 1
Stores.
451110............ Sporting Goods Stores... Revenue............. $16.5 2 2
452319............ All Other General Revenue............. $35.0 1 1
Merchandise Stores.
453930............ Manufactured (Mobile) Revenue............. $16.5 1 0
Home Dealers.
541380............ Testing Laboratories.... Revenue............. $16.5 1 0
541870............ Advertising Material Revenue............. $16.5 1 1
Distribution Services.
561990............ All Other Support Revenue............. $12.0 1 1
Services.
713930............ Marinas................. Revenue............. $8.0 1 1
Unknown........... Unknown................. Unknown............. Unknown 5 5
--------------------------------
38 30
----------------------------------------------------------------------------------------------------------------
Each proposed provision would affect a different subset of the 30
small entities from above and have a different distribution of costs,
cost savings, and transfers across those small entities. We will
discuss each proposed provision separately below and then summarize
each provision's impacts.
Provision 1: Incorporation by Reference of ANSI/CAN/UL 12402-4
The first proposed provision, the IBR of ANSI/CAN/UL 12402-4, would
affect seven small entities, six of which have known revenues. The
first provision would result in costs to PFD manufacturing firms that
are small entities that would intend to sell Level 100 devices in only
one market (the United States or Canada). Firms wishing to sell Level
100 devices in both United States and Canadian markets would no longer
conduct duplicative approvals and facility inspections, leading to cost
savings.
Whether small entities would or would not experience cost savings
depends on whether each small entity would prefer to sell their device
in only the United States or Canada or in both markets. The Coast Guard
does not know which small entities would prefer a cheaper set of tests
with only the ability to sell in one market and which would prefer a
more expensive set of tests with the ability to sell in both markets.
We therefore compare both the costs and cost savings estimates to each
small entity.
In the RA, we estimate the Level 100 approval would be $4,280 more
expensive than the current Type I approval. While in the RA we estimate
that testing laboratories would receive an application for approval to
Level 100 standards 0.45 times per year, each small entity would
experience this cost only when they submit a new application. Each
small entity would likely apply for an approval once they develop a new
device. The Coast Guard cannot ascertain when each small entity might
submit a new application, so instead we retain the cost of $4,280 as an
estimate of a one-time (initial year cost) per small entity cost of
ANSI/CAN/UL 12402-4.
We estimate the cost savings for small entities that wish to sell
in two markets would be $35,720 per new Level 100 approval, $4,746 per
revision of an existing approval with testing, and $1,172 per revision
of an existing approval without testing. As with costs of ANSI/CAN/UL
12402-4, each small entity would experience the cost savings only when
it submits each application. The Coast Guard does not know when small
entities might seek new approvals or revisions in the future, so we
estimate
[[Page 21039]]
these as one-time cost savings to small entities from ANSI/CAN/UL
12402-4. Specifically, we estimate each small entity would experience a
one-time total cost savings of $41,638 for each approval, which is the
sum of the Level 100 approvals and revisions to approvals with or
without testing ($35,720 + $4,746 + $1,172). Each of these seven small
entities would also experience an ongoing (annual) cost savings of
$1,155.92 from reduced facility inspection frequency.\20\
---------------------------------------------------------------------------
\20\ Facility inspections last four hours and include the billed
cost of the inspector's time, or $234.45, and the opportunity cost
of a Quality Manager's time, or $54.53 per hour as a loaded weighted
average. ($234.45 + $54.53) x 4 = $1,155.92. Readers should refer to
the section of the RA discussing the ANSI/CAN/UL 12402-4 standard.
---------------------------------------------------------------------------
Provision 2: Incorporation by Reference of ANSI/CAN/UL 12402-5
Incorporating by reference ANSI/CAN/UL 12402-5 would permit small
entities to seek Coast Guard approval to produce and sell Level 50
devices. The Coast Guard has not previously approved these devices. We
estimate that this provision would affect all 30 small entities, 24 of
which have known revenues.
In the RA, we estimate that the introduction of Level 50 devices
would most likely result in a 5-percent growth in the North American
PFD market. The growth in the market would be composed of new types of
PFDs. We assume the 5-percent growth in the market would also be a
proxy for the growth in the number of approved devices (for a growth of
38 device approvals). The initial approvals would represent a one-time
(initial year) cost to small entities. Small entities would also
experience an annual cost of additional production inspections based on
the volume of Level 50 PFDs produced.
We estimate a new Level 50 device approval would cost a small
entity about $34,028. We do not know which small entities would seek
Coast Guard approval for a Level 50 device or how many devices for
which each small entity might seek approval. As a result, we treat each
small entity as seeking approval for one Level 50 device costing
$34,028. This would be a one-time (initial year) cost to small
entities.
Production and revenue are not distributed equally across the small
entities that produce PFDs for the North American market. Instead, some
small entities produce vastly more PFDs than others. In the RA, we
estimate the market share of the 13 largest firms to be collectively
about 95 percent, and we estimate the remaining 44 firms' market share
collectively to be about 5 percent. We do not know the relative market
share of the 44 firms, so we divide the 5 percent equally across the 44
firms. Therefore, we treat each of the 44 firms as accounting for
roughly about 0.11 percent of the PFD market.\21\ For the 30 small
entities that would use the ANSI/CAN/UL 12402-5 standard, 22 of them
are in the set of 44 firms composing 5 percent of the market, and we
assume each has a market share of 0.11 percent. Based on conversations
with PFD manufacturing executives, we estimate 5 of the 30 firms have a
market share of 2.5 percent each, 1 has a market share of 7.5 percent,
1 has a market share of 15 percent, and 1 has a market share of 25
percent.\22\ We could not find revenue data for six small entities.
---------------------------------------------------------------------------
\21\ We divided 5 percent (or 0.05) by 44 firms to obtain 0.11
percent of the market for each one.
\22\ For more details on how we calculated market share, see the
initial regulatory analysis in the docket.
---------------------------------------------------------------------------
In the RA, we estimate that the annual cost of production
inspections across the whole industry would be $71,682. Because we do
not know which small entities would seek Level 50 approval, we estimate
the additional costs from production inspections from Level 50 device
sales for each small entity by multiplying each small entity's market
share by the total costs. For example, if we use a small entity that
has a market share of 0.11 percent, then we would estimate the small
entity's additional production inspection costs would be about $78.85
($71,682 x 0.0011, rounded) annually.
Provision 3: Incorporation by Reference of ANSI/CAN/UL 9595
Incorporating ANSI/CAN/UL 9595 by reference would establish
production testing standards for the PFD manufacturing industry. ANSI/
CAN/UL 9595 would lead to reductions in testing frequency for PFD
manufacturing entities with a QMS in place. We estimate that eight
small entities would be affected by this provision, seven of which have
known revenue.
Small entities would experience one-time costs of an initial QMS
inspection, and they would experience ongoing costs because a QMS
inspection is more expensive than the facility inspection it would
replace in years after the first year. We estimate that each small
entity has two facilities with the largest small entity having three
facilities, and QMS inspection costs would occur per facility. We
estimated 7 of the firms in the top 13 are small entities, including
the top firm. In the RA, we estimate that the total costs to U.S. firms
for the ANSI/CAN/UL 9595 standard would be about $53,118 for 19
facilities. Because we do not know where each small entity's facilities
are located, to estimate each small entity's one-time costs, we
multiply $53,118 by each small entity's share of the 19 facilities
yielding $5,591.37 (2 / 19 x $53,118) for all but the largest small
entity and $8,387.05 (3 / 19 x $53,118) for the largest small entity.
We estimate annual costs would be about $375 per facility, which is the
difference between eight hours of billed QMS inspector time and eight
hours of a regular inspector's time. The largest small entity has three
facilities, so would experience $1,125 ($375 x 3) in additional costs.
All the other small entities have two facilities, and they would
experience about $750 ($375 x 2) in annual costs. In table 37, we
present the costs per small entity from the IBR of ANSI/CAN/UL 9595.
Table 37--Costs per Small Entity From ANSI/CAN/UL 9595
----------------------------------------------------------------------------------------------------------------
Number of Total one-time
Entity type facilities costs Annual costs
----------------------------------------------------------------------------------------------------------------
The largest..................................................... 3 $8,387.05 $1,125
All others...................................................... 2 5,591.37 750
----------------------------------------------------------------------------------------------------------------
The small entities that would achieve a higher process rating
according to the ANSI/CAN/UL 9595 standard would also experience annual
cost savings based on each small entity's market share and the rigor of
the QMS system that would be in place. As mentioned previously, we
estimate that only the top 13 firms would experience savings from ANSI/
CAN/UL 9595, and we estimate 7 of those firms are small entities.
[[Page 21040]]
Cost savings would be different for each of the seven small
entities. To estimate the cost savings per small entity, we need to
estimate the number of reductions in inspections per small entity and
then multiply by $2,346 ($1,876 of billed inspector time and $470 of
weighted average quality manager loaded wages). To calculate the
reductions in inspections for each small entity, we take the share of
current inspections for each small entity and then estimate the number
of inspections that would take place under Process Rating A or B. Next,
we subtract the reduced inspection frequency per small entity from the
current inspection frequency yielding a reduction in inspection
frequency for current production. In the RA, we also estimate cost
savings from reduced inspection frequency on Level 50 devices that
entities do not yet produce. In the RA, we estimate that U.S. firms
would experience 16 fewer inspections on Level 50 devices. We then
multiply the 16 inspections by each small entity's share of reduction
in current inspections.
For example, assume that a small entity had a 10 percent market
share, half of which would be at Process Rating A and half of which
would be at Process Rating B. We first would take the total number of
current inspections on U.S. firms (587) and multiply by the small
entity's market share relative to the total affected U.S. market share,
or 10 percent / 77.5 percent x 587, yielding 76 rounded. Then we would
derive the reduced number of inspections at B and the reduced number of
inspections at A by multiplying the reduced inspection frequency at B
(194) by the share of the small entity's Process Rating at B relative
to all other U.S. firms at B, or 5 percent / 51 percent, yielding 19
rounded. To estimate the reduced inspection frequency at A, we take the
number of facilities at A (one) and multiply by two, accounting for the
number of inspections that would occur once the facility is at Process
Rating A. Next, we add to it the multiplication of the number of
commercial PFD production inspections at A (7) and the small entity's
relative share of production at A, or 5 percent / 26.5 percent,
yielding 3 rounded (2x1 + 7x5 percent / 26.5 percent). Taken together
the small entity's reduced inspection frequency would be 22 (19 + 3)
meaning the small entity would experience 54 fewer production
inspections annually (76-22). To calculate the number of reduced Level
50 inspections, we take the small entity's share of U.S. firm
inspection reduction (54 / 376) and multiply by the 16 total reduction
in inspections, yielding 2 rounded. We add the reduction in Level 50
inspections (2) and the reduction in current inspections (54) together
and multiply by the cost of each inspection ($2,346) yielding $131,376
([2 + 54] x $2,346) or the small entity's annual cost savings from
reduced inspection frequency. We perform this process for each of the
eight small entities. We record these calculations in table 38; the
results are rounded.
Table 38--Cost Savings for a Representative Small Entity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Current Total
Total market share Market share Market share inspection Inspection Inspection inspection Reduced level Total cost
at B at A frequency frequency at B frequency at A reduction 50 inspections savings
A B = A / 2 C = A / 2 D = 587 x A / E = 194 x B / F = (2 x 1 + 7 G = D-E-F H = G / 376 x (G + H) x
77.5% 51% x C / 26.5%) 16 $2,346
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
10%............................................................. 5% 5% 76 19 3 54 2 $131,376
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Provision 4: Replacement of Information Pamphlets With Placards
We did not predict any costs or cost savings from this provision,
so we do not project any impact on small entities. We summarize the
number of small entities affected, cost impacts, cost savings impacts,
and transfers per provision in table 39.
Table 39--Number of Affected Small Entities, Costs, and Cost Savings per Provision
----------------------------------------------------------------------------------------------------------------
PFD manufacturing
Provision population affected Costs Cost savings
----------------------------------------------------------------------------------------------------------------
ANSI/CAN/UL 12402-4............... 7 small entities of One-time testing to Level One-time testing to Level
the 30; 6 small 100 would cost $4,280 100 would be $35,720
entities with known more than testing to less than testing to
revenues. Legacy Type I standards Type I standards for
for entities wishing to entities wishing to sell
sell in only Canada or in both the United
the United States. States and Canada. Small
entities would also save
costs from cheaper
revisions with and
without testing, $4,746
and $1,172 respectively.
Together, small entities
would save $41,638.
Small entities would
also experience
$1,155.92 in annual cost
savings from reduced
facility inspections.
ANSI/CAN/UL 12402-5............... 30 small entities, 24 One-time (initial year) No estimated cost savings
small entities with testing to Level 50 for these small
known revenues. standards would cost entities.
about $34,028. Additional
ongoing costs from
inspections would be
between $78.85 and
$17,920.50 based on each
small entity's market
share (small entities
with larger market shares
would experience greater
costs).
[[Page 21041]]
ANSI/CAN/UL 9595.................. 8 small entities, 7 One-time (initial year) Small entities would save
small entities with cost from an additional through reduced
known revenues. QMS inspection of about inspection frequencies
$8,387.05 for the largest based on each small
small entity based on entity's market share
three facilities and and each small entity's
$5,591.37 for all other QMS in place. We
small entities with two estimate these 8 small
facilities. entities would
Ongoing (annual) costs experience between
would result from a QMS $21,114 and $229,908 in
inspection and would be savings based on their
more than a regular market share and QMS
inspection. We estimate ratings per year.
ongoing costs to be about
$375 per facility or
$1,125 for the largest
small entity with three
facilities and $750 for
each other small entity
with two facilities.
Information Pamphlets............. 30 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 40. We report the estimated overall net
cost savings revenue impact per small entity of this proposed rule
across all provisions from total costs in table 41.
Table 40--Range of Impacts per Entity
----------------------------------------------------------------------------------------------------------------
One-time impacts Ongoing impacts
---------------------------------------------------------------
Lowest per Highest per Lowest per Highest per
entity entity entity entity
----------------------------------------------------------------------------------------------------------------
Cost............................................ $34,028.00 $46,695.05 $78.85 $60,683.50
Cost Savings.................................... .............. 41,638.00 .............. 231,063.92
Net Cost Savings................................ (39,619.37) 3,330.00 (40,560.93) 170,380.42
----------------------------------------------------------------------------------------------------------------
Table 41--Percentage of Estimated Revenue Impact on Small Entities From Overall Impact (Net Cost Savings) of
This Proposed Rule
----------------------------------------------------------------------------------------------------------------
One-time net cost savings Ongoing net cost savings
---------------------------------------------------------------
Portion of Portion of
% Revenue impact Small entities small entities Small entities small entities
with known with known with known with known
revenue revenue revenue revenue
----------------------------------------------------------------------------------------------------------------
<1%............................................. 17 71 20 83
1-3%............................................ 2 8 2 8
>3%............................................. 5 21 2 8
----------------------------------------------------------------------------------------------------------------
4. A Description of the Projected Reporting, Recordkeeping, and Other
Compliance Requirements of the Proposed Rule, Including an Estimate of
the Classes of Small Entities Which Will Be Subject to the Requirements
and the Type of Professional Skills Necessary for Preparation of the
Report or Record
This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3520.
5. An Identification, to the Extent Practicable, of All Relevant
Federal Rules That May Duplicate, Overlap, or Conflict With the
Proposed Rule
There are no relevant Federal rules that may duplicate, overlap, or
conflict with this NPRM.
6. A Description of Any Significant Alternatives to the Rule Which
Accomplish the Stated Objectives of Applicable Statutes and Which
Minimize any Significant Economic Impact of the Proposed Rule on Small
Entities
The Coast Guard identified three alternatives:
(1) Incorporate ANSI/CAN/UL 12402-5 for the approval of Level 70
PFDs only, prohibiting the approval of Level 50 PFDs;
(2) Require placards instead of permitting either placards or
pamphlets; and
(3) Adopt ANSI/CAN/UL 12402-4 and ANSI/CAN/UL 12402-5 by policy.
Alternative 1: Incorporate by Reference ANSI/CAN/UL 12402-5 for Level
70 PFDs Only
Under the first alternative, we could have chosen to incorporate
ANSI/CAN/UL 12402-5, but limit approval to Level 70 PFDs only. Level 50
PFDs would not be eligible for Coast Guard approval and would not meet
carriage requirements on any vessel. If the Coast Guard chose this
alternative, the market for Level 50 devices would not be viable
because
[[Page 21042]]
Level 50 devices would no longer partially substitute for Level 70 or
Type III devices. Small entities would be unable to sell these new
devices and would not experience a positive revenue impact from this
alternative.
As a result, we rejected this alternative because it does not
maximize small entities' revenue.
Alternative 2: Require Placards Instead of Permitting Either Placards
or Pamphlets
We considered the alternative of requiring that PFD manufacturers
use placards instead of their choice of either placards or information
pamphlets for the mandatory PFD instructional materials. While the cost
of producing placards is generally less than the costs of producing
information pamphlets, some manufacturers may not be ready to switch to
producing placards. As such, if we required that manufacturers use
placards, we could place undue burden on small entities in the PFD
industry by requiring that they acquire new equipment to produce
placards. We do not know how large these costs could be, but small
entities would experience greater compliance costs. As a result, we
ultimately rejected this alternative.
Alternative 3: Adopt ANSI/CAN/UL 12402-4 and ANSI/CAN/UL 12402-5 by
Policy
Another alternative that we considered would be to adopt ANSI/CAN/
UL 12402-4 and ANSI/CAN/UL 12402-5 by policy instead of incorporating
them by reference in the regulations. Under 46 CFR 159.005-7(c), the
Coast Guard has the authority to approve an item of equipment that does
not meet all the requirements of 46 CFR 160.055 if it has equivalent
performance characteristics. The Coast Guard has used this authority to
partially adopt ANSI/CAN/UL 12402-4 and ANSI/CAN/UL 12402-5 by policy.
However, because this authority is limited to the approval of equipment
with equivalent performance characteristics, we cannot fully adopt
these standards by policy. Namely, Level 50 PFDs, youth inflatable
PFDs, and inflatable Level 100 PFDs cannot be approved by policy. As a
result, small entities would not receive the additional revenue from
the sale of Level 50 devices or the cost savings on Level 100
inflatable device approvals as compared to Type I device approvals. For
these reasons, we rejected this alternative.
7. Conclusion
We are interested in the potential impacts from this rule on small
businesses and we request public comment on these potential impacts. If
you think that this rule will have a significant economic impact on
you, your business, or your organization, please submit a comment to
the docket at the address under the Public Participation and Request
for Comments section of this preamble. In your comment, explain why,
how, and to what degree you think this rule will have an economic
impact on you.
C. Assistance for Small Entities
Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996, Public Law 104-121, we want to assist small
entities in understanding this proposed rule so that they can better
evaluate its effects on them and participate in the rulemaking. If the
proposed rule would affect your small business, organization, or
governmental jurisdiction and you have questions concerning its
provisions or options for compliance, please call or email the person
in the FOR FURTHER INFORMATION CONTACT section of this proposed rule.
The Coast Guard will not retaliate against small entities that question
or complain about this proposed rule or any policy or action of the
Coast Guard.
Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247).
D. Collection of Information
This proposed rule would call for no new collection of information
under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3520.
E. Federalism
A rule has implications for federalism under Executive Order 13132
(Federalism) if it has a substantial direct effect on States, on the
relationship between the National Government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this proposed rule under Executive Order
13132 and have determined that it is consistent with the fundamental
federalism principles and preemption requirements described in
Executive Order 13132. Our analysis follows.
It is well settled that States may not regulate in categories
reserved for regulation by the Coast Guard. It is also well settled
that all the categories covered in 46 U.S.C. 3306, 3703, 7101, and 8101
(design, construction, alteration, repair, maintenance, operation,
equipping, personnel qualification, and manning of vessels), as well as
the reporting of casualties and any other category in which Congress
intended the Coast Guard to be the sole source of a vessel's
obligations, are within the field foreclosed from regulation by the
States. See the Supreme Court's decision in United States v. Locke and
Intertanko v. Locke, 529 U.S. 89, 120 S.Ct. 1135 (2000). The statutory
authorities upon which this rulemaking is based--46 U.S.C. 3306(a),
4102(a), 4302(a), and 4502(a) and (c)(2)(B)--all generally preempt
State and local law. Therefore, because the States may not regulate
within these categories, this rule is consistent with the fundamental
federalism principles and preemption requirements described in
Executive Order 13132.
F. Unfunded Mandates
The Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1531 0336; 1538,
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100 million (adjusted for
inflation) or more in any one year. Although this proposed rule would
not result in such an expenditure, we do discuss the effects of this
proposed rule elsewhere in this preamble.
G. Taking of Private Property
This proposed rule would not cause a taking of private property or
otherwise have taking implications under Executive Order 12630
(Governmental Actions and Interference with Constitutionally Protected
Property Rights).
H. Civil Justice Reform
This proposed rule meets applicable standards in sections 3(a) and
3(b)(2) of Executive Order 12988, (Civil Justice Reform), to minimize
litigation, eliminate ambiguity, and reduce burden.
I. Protection of Children
We have analyzed this proposed rule under Executive Order 13045
(Protection of Children from Environmental Health Risks and Safety
Risks). This proposed rule is not an economically significant rule and
would
[[Page 21043]]
not create an environmental risk to health or risk to safety that might
disproportionately affect children.
J. Indian Tribal Governments
This proposed rule does not have tribal implications under
Executive Order 13175 (Consultation and Coordination with Indian Tribal
Governments), because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.
K. Energy Effects
We have analyzed this proposed rule under Executive Order 13211
(Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use). We have determined that it is not a
``significant energy action'' under that order because it is not a
``significant regulatory action'' under Executive Order 12866 and is
not likely to have a significant adverse effect on the supply,
distribution, or use of energy.
L. Technical Standards
The National Technology Transfer and Advancement Act, codified as a
note to 15 U.S.C. 272, directs agencies to use voluntary consensus
standards in their regulatory activities unless the agency provides
Congress, through OMB, with an explanation of why using these standards
would be inconsistent with applicable law or otherwise impractical.
Voluntary consensus standards are technical standards (such as
specifications of materials, performance, design, or operation; test
methods; sampling procedures; and related management systems practices)
that are developed or adopted by voluntary consensus standards bodies.
This proposed rule uses the following voluntary consensus
standards:
ANSI/CAN/UL 9595, Standard for Buoyant Cushions, Fourth
Edition, April 20, 2007 (including revisions through January 10, 2020).
ANSI/CAN/UL 12402-4, Standard for Personal Flotation
Devices--Part 4: Lifejackets, Performance Level 100--Safety
Requirements, First Edition, July 9, 2020.
ANSI/CAN/UL 12402-5, Standard for Personal Flotation
Devices--Part 5: Buoyancy Aids (Level 50)--Safety Requirements, First
Edition, December 31, 2015 (including revisions through January 27,
2022).
ANSI/UL 1123, Standard for Marine Buoyant Devices, Seventh
Edition, October 1, 2008 (including revisions through November 23,
2020).
ANSI/UL 1175, Standard for Buoyant Cushions, Fourth
Edition, April 20, 2007 (including revisions through January 10, 2020).
The proposed sections that reference these standards and the
locations where these standards are available are listed in 46 CFR
160.045-5, 160.055-5, 160.060-5, 160.064-5, 160.076-5, 160.255-5,
160.264-5, and 160.276-5.
M. Environment
We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01, Rev. 1, associated implementing
instructions, and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made
a preliminary determination that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. A preliminary Record of Environmental
Consideration supporting this determination is available in the docket.
For instructions on locating the docket, see the ADDRESSES section of
this preamble. This proposed rule would be categorically excluded under
paragraph L52 of Appendix A, Table 1 of DHS Instruction Manual 023-01-
001-01, Rev. 1. Paragraph L52 pertains to regulations concerning vessel
operation safety standards.
This proposed rule involves approval requirements and follow-up
program requirements for lifejackets. We seek any comments or
information that may lead to the discovery of a significant
environmental impact from this proposed rule.
List of Subjects
33 CFR Part 181
Incorporation by reference, Labeling, Marine safety, Reporting and
recordkeeping requirements.
46 CFR Part 25
Fire prevention, Marine safety, Reporting and recordkeeping
requirements.
46 CFR Part 28
Alaska, Fire prevention, Fishing vessels, Marine safety,
Occupational safety and health, Reporting and recordkeeping
requirements, Seamen.
46 CFR Part 108
Fire prevention, Marine safety, Occupational safety and health, Oil
and gas exploration, Vessels.
46 CFR Part 117
Marine safety, Passenger vessels.
46 CFR Part 133
Cargo vessels, Marine safety, Reporting and recordkeeping
requirements.
46 CFR Part 141
Incorporation by reference, Marine safety, Occupational health and
safety, Reporting and recordkeeping requirements, Towing vessels.
46 CFR Part 160
Incorporation by reference, Marine safety, Reporting and
recordkeeping requirements.
46 CFR Part 169
Fire prevention, Marine safety, Reporting and recordkeeping
requirements, Schools, Vessels.
46 CFR Part 180
Marine safety, passenger vessels.
46 CFR Part 199
Cargo vessels, Marine safety, Oil and gas exploration, Passenger
vessels, Reporting and recordkeeping requirements.
For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 181 and 46 CFR parts 25, 28, 108, 117, 133, 141,
160, 169, 180, and 199 as follows:
Title 33--Navigation and Navigable Waters
PART 181--MANUFACTURER REQUIREMENTS
0
1. The authority citation for part 181 is revised to read as follows:
Authority: 46 U.S.C. 4302; DHS Delegation 00170.1, Revision No.
01.2, paragraph (II)(92)(a).
0
2. Revise the title of Subpart G to read as follows:
Subpart G--Instruction Pamphlet or Placard for Personal Flotation
Devices
Sec. 181.4 [Removed and Reserved]
0
3. Remove and reserve Sec. 181.4.
Sec. 181.701 [Amended]
0
4. Amend Sec. 181.701 by adding the words ``Coast Guard approved''
after the word ``all''.
0
5. Revise Sec. 181.702 to read as follows:
[[Page 21044]]
Sec. 181.702 Information pamphlet or placard: requirement to furnish.
(a) Each manufacturer of a Coast Guard approved personal flotation
device (PFD) must furnish with each PFD that is sold or offered for
sale for use on a recreational boat, an information pamphlet or placard
accepted by the Commandant (CG-ENG-4) or meeting the requirements in
the applicable subpart of 46 CFR part 160.
(b) No person may sell or offer for sale for use on a recreational
boat, a Coast Guard approved PFD unless an information pamphlet or
placard required by this section is attached in such a way that it can
be read prior to purchase.
Sec. 181.703 [Removed]
0
6. Remove Sec. 181.703.
Sec. 181.704 [Removed]
0
7. Remove Sec. 181.704.
Sec. 181.705 [Removed]
0
8. Remove Sec. 181.705.
Title 46--Shipping
PART 25--REQUIREMENTS
0
9. The authority citation for part 25 is revised to read as follows:
Authority: 33 U.S.C. 1903(b); 46 U.S.C. 2103, 3306, 4102, 4302;
DHS Delegation 00170.1, Revision No. 01.2, paragraphs (II)(77),
(92)(a), 92(b).
0
10. Amend Sec. 25.25-5 by:
0
a. Removing in paragraph (b)(2), the text ``or 160.176'' and adding, in
its place, the text ``160.176, or 160.255''; and
0
b. Revising the introductory text to paragraph (c)(2).
The addition and revision read as follows:
Sec. 25.25-5 Life preservers and other lifesaving equipment required.
* * * * *
(c) * * *
(2) On each vessel, regardless of length and regardless of whether
carrying passengers for hire, a commercial hybrid PFD approved under
former approval series 160.077 prior to [EFFECTIVE DATE OF FINAL RULE],
may be substituted for a PFD approved under approval series 160.055,
160.155, 160.176, or 160.255 if it is in good and serviceable condition
and--
* * * * *
PART 28--REQUIREMENTS FOR COMMERCIAL FISHING INDUSTRY VESSELS
0
11. The authority citation for part 28 is revised to read as follows:
Authority: 46 U.S.C. 3316, 4502, 4505, 4506, 6104, 8103, 10603;
DHS Delegation 00170.1, Revision No. 01.2, paragraph (II)(92)(a).
0
12. Revise Sec. 28.110(a) to read as follows:
Sec. 28.110 Life preservers or other personal flotation devices.
(a) Except as provided by Sec. 28.305 of this chapter, each vessel
must be equipped with at least one immersion suit, exposure suit, or
wearable personal flotation device of the proper size for each
individual on board as specified in Table 1 to Sec. 28.110(a) and part
25, subpart 25.25 of this chapter. Notwithstanding the provisions of
paragraphs (c) and (d) of Sec. 25.25-1 of this chapter, each
commercial fishing industry vessel propelled by sail, and each manned
barge employed in commercial fishing activities, must meet the
requirements of this paragraph.
Table 1 to Sec. 28.110--Personal Flotation Devices and Immersion Suits
----------------------------------------------------------------------------------------------------------------
Applicable waters Vessel type Devices required Other regulations
----------------------------------------------------------------------------------------------------------------
Seaward of the Boundary Line and Documented Vessel...... Immersion suit or 28.135; 25.25-9(a);
North of 32 [deg]N or South of 32 exposure suit. 25.25-13; 25.25-15.
[deg]S; and Lake Superior.
Coastal Waters on the West Coast of All vessels............ Immersion suit or 28.135; 25.25-9(a);
the United States north of Point exposure suit. 25.25-13; 25.25-15.
Reyes, CA; Beyond Coastal Waters,
cold water; and Lake Superior.
All other waters (Includes all Great 40 feet (12.2 meters) Wearable PFD approved 28.135; 25.25-5(e);
Lakes except Lake Superior). or more in length. under approval series 25.25-5(f); 25.25-
160.055, 160.155, or 9(a); 25.25-13; 25.25-
160.176, or 160.255 15.
immersion suit, or
exposure suit \1\.
Less than 40 feet (12.2 Wearable PFD approved 28.135; 25.25-5(e);
meters) in length. under subchapter Q of 25.25-5(f); 25.25-
this chapter immersion 9(a); 25.25-13; 25.25-
suit, or exposure 15.
suit\1\.
----------------------------------------------------------------------------------------------------------------
\1\ A commercial hybrid approved under former approval series 160.077 prior to [EFFECTIVE DATE OF FINAL RULE]
may be substituted for a PFD approved under approval series 160.055, 160.155, 160.176, or 160.255 if it is in
good and serviceable condition, used in accordance with the conditions marked on the PFD and in the owner's
manual, and labeled for use on commercial vessels.
PART 108--DESIGN AND EQUIPMENT
0
13. The authority citation for part 108 is revised to read as follows:
Authority: 43 U.S.C. 1333; 46 U.S.C. 3102, 3306; DHS Delegation
00170.1, Revision No. 01-2, paragraph (II)(92)(a).
Sec. 108.580 [Amended]
0
14. Amend Sec. 108.580(b) introductory text by removing the text ``,
160.176 or 160.177'' and replace it with the text ``or 160.176''.
PART 117--LIFESAVING EQUIPMENT AND ARRANGEMENTS
0
15. The authority citation of part 117 is revised to read as follows:
Authority: 46 U.S.C. 2103, 3306; E.O. 12234, 45 FR 58801, 3
CFR, 1980 Comp., p.277; DHS Delegation 00170.1, Revision No. 01.2,
paragraph (II)(92)(a).
0
16. Amend Sec. 117.71 by:
0
a. Revising the section heading and paragraph (c);
0
b. Removing paragraph (d); and
0
c. Redesignating paragraph (e) as paragraph (d).
The revisions read as follows:
[[Page 21045]]
Sec. 117.71 Lifejackets.
* * * * *
(c) Each lifejacket must be approved under approval series
Sec. Sec. 160.002, 160.005, 160.055, 160.155, 160.176, or 160.255 in
subchapter Q of this chapter, or other standard specified by the
Commandant. An inflatable lifejacket approved under approval series
160.255 must include a full back-up inflation chamber.
* * * * *
0
17. Amend Sec. 117.72 by revising the section heading and paragraphs
(b) and (d) to read as follows:
Sec. 117.72 Personal flotation devices carried in addition to
lifejackets.
* * * * *
(b) Wearable PFDs approved in accordance with Sec. Sec. 160.064,
160.076, 160.264, or 160.276 in subchapter Q of this chapter, or other
standard specified by the Commandant, may be carried as additional
equipment.
* * * * *
(d) A commercial hybrid PFD approved under former approval series
160.077 prior to [EFFECTIVE DATE OF FINAL RULE] may be carried as
additional equipment for use by persons working near or over the water
if it is in good and serviceable condition, used in accordance with the
conditions marked on the PFD and in the owner's manual, of the same or
similar design, and has the same method of operation as each other
hybrid PFD carried on board.
PART 133--LIFESAVING SYSTEMS
0
18. The authority citation for part 133 is revised to read as follows:
Authority: 46 U.S.C. 3306, 3307; DHS Delegation 00170.1,
Revision No. 01.2, paragraph (II)(92)(a).
Sec. 133.70 [Amended]
0
19. Amend Sec. 133.70(b) introductory text by removing the text
``160.177'' and adding, in its place, the text ``160.255''.
PART 141--LIFESAVING
0
20. The authority citation for part 141 is revised to read as follows:
Authority: 46 U.S.C. 3103, 3301, 3306, 3308, 3316, 8104, 8904;
33 CFR 1.05; DHS Delegation 00170.1, Revision No. 01.2, paragraph
(II)(92)(a).
Sec. 141.340 [Amended]
0
21. Amend Sec. 141.340 by:
0
a. Removing in paragraph (a), the text ``or 160.176,'' and adding, in
its place, the text ``160.176, or 160.255''; and
0
b. Adding new paragraph (i).
The additions read as follows:
Sec. 141.340 Lifejackets.
* * * * *
(i) Wearable PFDs approved in accordance with Sec. Sec. 160.064,
160.076, 160.264, or 160.276 in subchapter Q of this chapter, or other
standard specified by the Commandant, may be carried as additional
equipment. Additional equipment is not acceptable in lieu of any
portion of the required lifejackets.
PART 160--LIFESAVING EQUIPMENT
0
22. The authority citation for part 160 is revised to read as follows:
Authority: 46 U.S.C. 2103, 3306, 3703 and 4302; E.O. 12234; 45
FR 58801; 3 CFR, 1980 Comp., p. 277; and DHS Delegation 00170.1,
Revision No. 01.2, paragraph (II)(92)(a).
Subpart 160.001 [Removed and Reserved]
0
23. Remove and reserve subpart 160.001, consisting of Sec. Sec.
160.001-1 through 160.001-5.
Subpart 160.002 [Removed and Reserved]
0
24. Remove and reserve subpart 160.002, consisting of Sec. Sec.
160.002-1 through 160.002-7.
Subpart 160.005 [Removed and Reserved]
0
25. Remove and reserve subpart 160.005, consisting of Sec. Sec.
160.005-1 through 160.005-7.
Subpart 160.006 [Removed and Reserved]
0
26. Remove and reserve subpart 160.006, consisting of Sec. 160.006-2.
0
27. Add subpart 160.045, consisting of Sec. Sec. 160.045-1 through
160.045-25, to read as follows:
Subpart 160.045 Recreational Throwable PFDs
Sec. 160.045-1 Scope.
(a) This subpart contains structural and performance standards for
approval of throwable PFDs for use on recreational vessels, as well as
requirements for production follow-up inspections, associated manuals,
information pamphlets or placards, and markings.
(b) Throwable PFDs approved under this subpart may rely entirely on
inherently buoyant material, or rely entirely or partially upon
inflation to achieve the minimum buoyancy.
(c) Throwable PFDs approved under this subpart are intended to meet
the carriage requirements for uninspected commercial vessels under 40
ft (12 m) not carrying passengers for hire and recreational boats, in
accordance with 33 CFR part 175.
Sec. 160.045-3 Definitions.
The following definitions apply to this subpart:
Commandant means the Chief of the Lifesaving and Fire Safety
Standards Division. Address: Commandant (CG-ENG-4), Attn: Lifesaving
and Fire Safety Division, U.S. Coast Guard Stop 7509, 2703 Martin
Luther King Jr. Avenue SE, Washington, DC 20593-7509; email
[email protected].
First quality workmanship means construction that is free from any
defect materially affecting appearance or serviceability.
Recognized laboratory means an independent laboratory accepted by
the Commandant in accordance with 46 CFR subpart 159.010, with a valid
memorandum of understanding in accordance with 46 CFR 159.010-7.
Sec. 160.045-5 Incorporation by reference.
Certain material is incorporated by reference into this part with
the approval of the Director of the Federal Register in accordance with
5 U.S.C. 552(a) and 1 CFR part 51. All approved material is available
for inspection at the Coast Guard Headquarters and at the National
Archives and Records Administration (NARA). Contact Commandant (CG-ENG-
4), Attn: Lifesaving and Fire Safety Division, U.S. Coast Guard Stop
7509, 2703 Martin Luther King Jr. Avenue SE, Washington, DC 20593-7509.
For information on the availability of this material at NARA, visit
www.archives.gov/federal-register/cfr/ibr-locations.html or email:
[email protected]. The material may be obtained from UL, 333
Pfingsten Road, Northbrook, IL 60062-2002; phone 847-272-8800; website:
www.ul.com.
(a) ANSI/CAN/UL 9595:2021, Standard for Factory Follow-Up on
Personal Flotation Devices (PFDs), First Edition, June 4, 2020
(including revisions through September 9, 2021) (``ANSI/CAN/UL 9595'');
IBR approved for Sec. 160.045-15(e).
(b) ANSI/UL 1123, Standard for Marine Buoyant Devices, Seventh
Edition, October 1, 2008 (including revisions through November 23,
2020) (``ANSI/UL 1123''); IBR approved for Sec. Sec. 160.045-7(e);
160.045-13(d).
(c) ANSI/UL 1175, Standard for Buoyant Cushions, Fourth Edition,
April 20, 2007 (including revisions through January 10, 2020) (``ANSI/
UL 1175''); IBR approved for Sec. Sec. 160.045-7(e); 160.045-13(d).
[[Page 21046]]
Sec. 160.045-7 Design, construction, and performance of throwable
PFDs.
(a) General. Every throwable PFD must conform to the requirements
as accepted by the Commandant for listing and labeling by a recognized
laboratory, and must be of such design, materials, and construction as
to meet the requirements specified in this section.
(b) Designs and constructions. Throwable PFDs must not provide
means for adjustment or close fitting to the body. Methods of
construction must provide strengths, with reinforcements where
necessary, to be adequate for the intended use and purpose of the
device.
(c) Materials. All materials used in any device covered by this
subpart must meet the applicable requirements of subpart 164.019 of
this chapter, must be all new materials, must be suitable for the
purpose intended, and must be at least equivalent to corresponding
materials specified for standard buoyant cushions. Hardware or
fastenings must be of sufficient strength for the purpose of the device
and must be of inherently corrosion-resistant material, such as
stainless steel, brass, bronze, certain plastics, etc. Decorative
platings of any thickness are permissible. Fabrics, coated fabrics,
tapes, and webbing must be either mildew-resistant or treated for
mildew resistance. Buoyancy provided by inherently buoyant material
must not be dependent upon loose, granulated material.
(d) Standard construction. A standard foam cushion that is designed
to be thrown must be 2 inches or more in thickness and must have 225 or
more square inches of top surface area.
(e) Nonstandard construction. A nonstandard throwable PFD must meet
the requirements in ANSI/UL 1123 or ANSI/UL 1175 (both incorporated by
reference, see Sec. 160.045-5) and any additional requirements that
the Commandant may prescribe to approve unique or novel designs.
(f) Buoyancy. (1) Ring life buoys must have 16\1/2\ pounds or more
of buoyancy.
(2) Foam cushions must have 18 pounds or more of buoyancy.
(3) A device other than those standard devices specified in
paragraph (f)(1) or (2) of this section must have 20 pounds or more of
buoyancy.
(g) Workmanship. Throwable PFDs must be of first quality
workmanship and must be free from any defects materially affecting
their appearance or serviceability.
Sec. 160.045-9 Approval procedures for throwable PFDs.
(a) Each application for approval of a throwable PFD must be
submitted directly to a Coast Guard recognized laboratory.
(b) The recognized laboratory must determine if a throwable PFD
with novel design features requires a preliminary review by the Coast
Guard prior to testing. Submissions requiring preliminary review must
be sent to [email protected], and must include a full description
and drawings. Pictures, samples, and preliminary test results may also
be submitted.
Sec. 160.045-11 Recognized laboratory.
(a) The approval inspections and tests required by Sec. 160.045-
13, and production inspections, tests, and quality control required by
Sec. 160.045-15, must be conducted by an independent laboratory
recognized by the Coast Guard under 46 CFR subpart 159.010 to perform
such functions. A list of recognized independent laboratories is
available from the Commandant and online at https://cgmix.uscg.mil.
(b) The same laboratory that performs the approval tests must also
perform production oversight unless the employees of the laboratory
performing production oversight receive training and support equal to
that of the laboratory that performed the approval testing, as
determined by the Commandant.
Sec. 160.045-13 Approval inspections and tests.
(a) Each throwable PFD must be certified by a recognized laboratory
as meeting the requirements of this subpart. Approval tests must be
conducted or supervised by a recognized laboratory using PFDs
constructed in accordance with the plans and specifications submitted
with the application for approval.
(b) Each throwable PFD design must be visually examined for
compliance with the construction and performance requirements of this
subpart.
(c) Standard PFDs must be submerged in fresh water for 24 or more
continuous hours. The measured buoyancy after the 24 hours of
submersion must be the buoyancy specified in Sec. 160.045-7(f).
(d) Non-standard throwable PFDs must be subjected to approval tests
specified in ANSI/UL 1123 or ANSI/UL 1175 (both incorporated by
reference, see Sec. 160.045-5) or another test program accepted by the
Commandant. Approval tests must be conducted or supervised by a
recognized laboratory using throwable PFDs constructed in accordance
with the plans and specifications submitted with the application for
approval.
(e) The Commandant may prescribe additional tests for approval of
novel or unique designs.
Sec. 160.045-15 Production inspections, tests, and quality control of
throwable PFDs.
(a) Manufacturer's inspection and tests. Manufacturers of approved
throwable PFDs must maintain quality control of the materials used,
manufacturing methods and the finished product to meet the applicable
requirements, and make sufficient inspections and tests of
representative samples and components produced to maintain the quality
of the finished product. Records of tests conducted by the manufacturer
and records of materials, including affidavits by suppliers that
applicable requirements are met, must be made available to the
recognized laboratory inspector or to the Coast Guard marine inspector,
or both, for review upon request.
(b) Laboratory inspections and tests. The laboratory inspector will
conduct examinations, inspections, and tests for listed and labeled
devices, as required by the recognized laboratory, at the place of
manufacture or other location at the option of the laboratory.
(c) Test facilities. The laboratory inspector, or the Coast Guard
marine inspector assigned by the Commander of the District in which the
factory is located, or both, must be admitted to any place in the
factory where work is being done on listed and labeled products. Either
or both inspectors may take samples of parts or materials entering
construction or final assemblies, for further examinations,
inspections, or tests. The manufacturer must provide a suitable place
and the apparatus necessary for the performance of the tests done at
the place of manufacture.
(d) Additional tests, etc. Unannounced examinations, tests, and
inspections of samples obtained either directly from the manufacturer
or through commercial channels may be made to determine the suitability
of a product for listing and labeling, or to determine conformance of a
labeled product to the applicable requirements. These may be conducted
by the recognized laboratory or by the United States Coast Guard.
(e) Follow-up program. A follow-up program in accordance with ANSI/
CAN/UL 9595 (incorporated by reference, see Sec. 160.045-5) meets the
requirements of this section.
Sec. 160.045-17 Marking and Labeling.
(a) Each throwable PFD must be marked in accordance with the
[[Page 21047]]
recognized laboratory's listing and labeling requirements in accordance
with Sec. 160.045-3(a). At a minimum, all labels must include--
(1) Size information, as appropriate;
(2) The Coast Guard approval number;
(3) Manufacturer's contact information;
(4) Model name/number;
(5) Lot number, manufacturer date; and
(6) Any limitations or restrictions on approval or special
instructions for use.
(b) Marking must be of a type that will be durable and legible for
the expected life of the device.
(c) The Commandant may prescribe additional marking requirements
for special purpose devices or unique or novel designs.
Sec. 160.045-21 PFD manuals.
(a) An owner's manual must be provided with each fully or partially
inflatable throwable PFD sold or offered for sale. The text of each
manual is reviewed with the application for approval.
(b) The Commandant may prescribe additional information in the
manual for special purpose devices or unique or novel designs.
(c) Additional information, instructions, or illustrations may be
included in the owner's manual if there is no contradiction to the
required information.
Sec. 160.045-23 Procedure for approval of design or material change.
(a) The manufacturer must submit any proposed changes in design,
material, or construction to the recognized laboratory for approval
before changing throwable PFD production methods.
(b) Determinations of equivalence of design, construction, and
materials may be made only by the Commandant or a designated
representative.
Sec. 160.045-25 Suspension or termination of approval.
As provided in 46 CFR 159.005-15, the Commandant may suspend or
terminate the approval of a throwable PFD if the manufacturer fails to
comply with this subpart or the recognized laboratory's accepted
procedures or requirements.
Subpart 160.047 [Removed and Reserved]
0
28. Remove and reserve subpart 160.047, consisting of Sec. Sec.
160.047-1 through 160.047-7.
Subpart 160.048 [Removed and Reserved]
0
29. Remove and reserve subpart 160.048, consisting of Sec. Sec.
160.048-1 through 160.048-8.
Subpart 160.052 [Removed and Reserved]
0
30. Remove and reserve subpart 160.052, consisting of Sec. Sec.
160.052-1 through 160.052-9.
Subpart 160.055--Life Preservers, Unicellular Plastic Foam, Adult
and Child, for Merchant Vessels
0
31. Revise Sec. 160.055-1 to read as follows:
Sec. 160.055-1 Scope.
(a) This subpart contains requirements for production follow-up
inspections for life preservers approved under this subpart prior to
[EFFECTIVE DATE OF FINAL RULE].
(b) Life preservers approved under this subpart rely upon
inherently buoyant material to achieve the minimum buoyancy.
(c) Life preservers approved under this subpart are intended to
meet the carriage requirements for wearable PFDs for uninspected
passenger vessels, uninspected commercial vessels over 40 ft (12m), and
for inspected vessels.
(d) Each life preserver specified in this subpart is a:
(1) Standard, bib type, vinyl dip coated:
(i) Model 62, adult (for persons weighing over 90 pounds); or
(ii) Model 66, child (for persons weighing less than 90 pounds); or
(2) Standard, bib type, cloth covered;
(i) Model 63, adult (for persons weighing over 90 pounds); or
(ii) Model 67, child (for persons weighing less than 90 pounds); or
(3) Nonstandard, shaped type:
(i) Model,\1\ adult (for persons weighing over 90 pounds); or
(ii) Model,\1\ child (for persons weighing less than 90 pounds).
\1\ A model designation for each nonstandard life preserver is
to be assigned by the manufacturer. That designation must be
different from any standard lifesaving device designation.
Sec. 160.055-2 [Removed and Reserved]
0
32. Remove and reserve Sec. 160.055-2.
0
33. Revise Sec. 160.055-3 to read as follows:
Sec. 160.055-3 Definitions.
The following definitions apply to this subpart:
Commandant means the Chief of the Lifesaving and Fire Safety
Standards Division. Address: Commandant (CG-ENG-4), Attn: Lifesaving
and Fire Safety Division, U.S. Coast Guard Stop 7509, 2703 Martin
Luther King Jr. Avenue SE, Washington, DC 20593-7509; email
[email protected].
First quality workmanship means construction that is free from any
defect materially affecting appearance or serviceability.
Inspector means a recognized laboratory representative assigned to
perform, supervise, or oversee the duties described in Sec. 160.255-15
or any Coast Guard representative performing duties related to the
approval.
Recognized laboratory means an independent laboratory accepted by
the Commandant in accordance with 46 CFR 159.010, with a valid
memorandum of understanding in accordance with 46 CFR 159.010-7.
Sec. 160.055-4 [Removed and Reserved]
0
34. Remove and reserve Sec. 160.055-4.
0
35. Revise Sec. 160.055-5 to read as follows:
Sec. 160.055-5 Incorporation by reference.
Certain material is incorporated by reference into this part with
the approval of the Director of the Federal Register in accordance with
5 U.S.C. 552(a) and 1 CFR part 51. All approved material is available
for inspection at the Coast Guard Headquarters and at the National
Archives and Records Administration (NARA). Contact Commandant (CG-ENG-
4), Attn: Lifesaving and Fire Safety Division, U.S. Coast Guard Stop
7509, 2703 Martin Luther King Jr. Avenue SE, Washington, DC 20593-7509.
For information on the availability of this material at NARA, visit
www.archives.gov/federal-register/cfr/ibr-locations.html or email:
[email protected]. The material may be obtained from UL, 333
Pfingsten Road, Northbrook, IL 60062-2002 phone (847) 272-8800;
website: www.ul.com.
(a) ANSI/CAN/UL 9595:2021, Standard for Factory Follow-Up on
Personal Flotation Devices (PFDs), First Edition, June 4, 2020
(including revisions through September 9, 2021) (``ANSI/CAN/UL 9595'');
IBR approved for Sec. 160.055-15(a).
(b) [Reserved]
Sec. 160.055-6 [Removed and Reserved]
0
36. Remove and reserve Sec. 160.055-6.
Sec. 160.055-7 [Removed and Reserved]
0
37. Remove and reserve Sec. 160.055-7.
Sec. 160.055-8 [Removed and Reserved]
0
38. Remove and reserve Sec. 160.055-8.
Sec. 160.055-9 [Removed and Reserved]
0
39. Remove and reserve Sec. 160.055-9.
[[Page 21048]]
0
40. Add Sec. 160.055-11 to read as follows:
Sec. 160.055-11 Independent laboratory.
The production inspections, tests, and quality control required by
this subpart must be conducted by an independent laboratory accepted by
the Coast Guard under 46 CFR subpart 159.010 to perform such functions.
A list of accepted independent laboratories is available from the
Commandant and online at https://cgmix.uscg.mil.
0
41. Add Sec. 160.055-15 to read as follows:
Sec. 160.055-15 Production inspections, tests, and quality control of
life preservers.
(a) General. Production tests and inspections must be conducted in
accordance with this section, subpart 159.007 of this chapter, and the
independent laboratory's procedures for production inspections and
tests as accepted by the Commandant. The Commandant may prescribe
additional production tests and inspections necessary to maintain
quality control and to monitor compliance with the requirements of this
subchapter. A follow-up program in accordance with ANSI/CAN/UL 9595
(incorporated by reference, see Sec. 160.055-5), meets the
requirements of this subpart.
(b) Oversight. In addition to responsibilities set out in part 159
of this chapter and the accepted laboratory procedures for production
inspections and tests, each manufacturer of a life preserver and each
laboratory inspector must comply with the following, as applicable:
(1) Manufacturer. Each manufacturer must--
(i) perform all tests and examinations necessary to show compliance
with this subpart on each lot before any inspector's tests and
inspection of the lot;
(ii) follow established procedures for maintaining quality control
of the materials used, manufacturing operations, and the finished
product; and
(iii) allow an inspector to take samples of completed units or of
component materials for tests required by this subpart and for tests
relating to the safety of the design.
(2) Laboratory. An inspector from the accepted laboratory must
oversee production in accordance with the laboratory's procedures for
production inspections and tests accepted by the Commandant. During
production oversight, the inspector must not perform or supervise any
production test or inspection unless--
(i) the manufacturer has a valid approval certificate; and
(ii) the inspector has first observed the manufacturer's production
methods and any revisions to those methods.
(3) At least quarterly, the inspector must check the manufacturer's
compliance with the company's quality control procedures, examine the
manufacturer's required records, and observe the manufacturer perform
each of the required production tests.
(c) Test facilities. The manufacturer must provide a suitable place
and apparatus for conducting the tests and inspections necessary to
determine compliance of life preservers with this subpart. The
manufacturer must provide means to secure any test that is not
continuously observed, such as the 48-hour buoyancy test. The
manufacturer must have the calibration of all test equipment checked in
accordance with the test equipment manufacturer's recommendation and
interval but not less than at least once every year.
(d) Lots. A lot must not consist of more than 1000 life preservers.
A lot number must be assigned to each group of life preservers
produced. Lots must be numbered serially. A new lot must be started
whenever any change in materials or a revision to a production method
is made, and whenever any substantial discontinuity in the production
process occurs. The lot number assigned, along with the approval
number, must enable the PFD manufacturer to determine the supplier's
identifying information for the component lot.
(e) Samples. (1) From each lot of life preservers, manufacturers
must randomly select a number of samples from completed units at least
equal to the applicable number required by table 1 to Sec. 160.055-
15(e)(1) for buoyancy testing. Additional samples must be selected for
any tests, examinations, and inspections required by the laboratory's
production inspections and tests procedures.
Table 1 to Sec. 160.055-15(e)(1)--Sampling for Buoyancy Tests
------------------------------------------------------------------------
Number of
life
Lot size preservers
in sample
------------------------------------------------------------------------
100 and under.............................................. 1
101 to 200................................................. 2
201 to 300................................................. 3
301 to 500................................................. 4
501 to 750................................................. 6
751 to 1,000............................................... 8
------------------------------------------------------------------------
(2) For a lot succeeding one from which any sample life preserver
failed the buoyancy test, the sample must consist of not less than ten
specimen life preservers to be tested for buoyancy in accordance with
paragraph (f) of this section.
(f) Buoyancy test. The buoyancy of the life preservers must be
determined by measuring the upward force exerted by the individual
submerged unit. The buoyancy measurement must be made at the end of the
48 hours of submersion, during which period the pad inserts must not be
disturbed.
(g) Buoyancy required. The buoyant pad inserts from Model 3 adult
life preservers must provide not less than 25 pounds buoyancy in fresh
water, and the pads from Model 5 child life preservers must provide not
less than 16.5 pounds buoyancy.
(h) Lot inspection. On each lot, the laboratory inspector must
perform a final lot inspection to be satisfied that the life preservers
meet this subpart. Each lot must demonstrate--
(1) first quality workmanship;
(2) that the general arrangement and attachment of all components,
such as body straps, closures, tie tapes, and drawstrings, are as
specified in the approved plans and specifications;
(3) compliance with the marking requirements; and
(4) the information pamphlet or placard specified in 33 CFR part
181 subpart G, if required, is securely attached to the device, with
the PFD selection information visible and accessible prior to purchase.
(i) Lot acceptance. When the independent laboratory has determined
that the life preservers in the lot are of a type officially approved
in the name of the company, and that such life preservers meet the
requirements of this subpart, they must be plainly marked in waterproof
ink with the independent laboratory's name or identifying mark.
(j) Lot rejection. Each nonconforming unit must be rejected. If
three or more nonconforming units are rejected for the same kind of
defect, lot inspection must be discontinued and the lot rejected. The
inspector must discontinue lot inspection and reject the lot if
examination of individual units or the records for the lot shows
noncompliance with either this subchapter or the laboratory's or the
manufacturer's quality control procedures. A rejected unit or lot may
be resubmitted for testing and inspection if the manufacturer first
removes and destroys each defective unit or, if authorized by the
laboratory, reworks the unit or lot to correct the defect. A rejected
lot or rejected unit must not be sold or offered for sale under the
representation that it meets this subpart or that it is Coast Guard
approved.
[[Page 21049]]
0
42. Add Sec. 160.055-19 to read as follows:
Sec. 160.055-19 Pamphlet or placard.
Each life preserver sold or offered for sale for use on
recreational boats must be provided with a pamphlet or placard that a
prospective purchaser can read prior to purchase, as specified in 33
CFR part 181 subpart G.
0
43. Add Sec. 160.055-23 to read as follows:
Sec. 160.055-23 Procedure for approval of design or material change.
(a) The manufacturer must submit any proposed changes in design,
material, or construction to [email protected] for approval before
changing life preserver production methods.
(b) Only the Commandant or a designated representative may make
determinations of equivalence of design, construction, and materials.
0
44. Add Sec. 160.055-25 to read as follows:
Sec. 160.055-25 Suspension or termination of approval.
As provided in 46 CFR 159.005-15, the Commandant may suspend or
terminate the approval if the manufacturer fails to comply with this
subpart or the recognized laboratory's accepted procedures or
requirements.
Subpart 160.060--Specification for a Buoyant Vest, Unicellular
Polyethylene Foam, Adult and Child
0
45. Revise Sec. 160.060-1 to read as follows:
Sec. 160.060-1 Scope.
(a) This subpart contains requirements for production follow-up
inspections for buoyant vests approved under this subpart prior to
[EFFECTIVE DATE OF FINAL RULE].
(b) Buoyant vests approved under this subpart rely upon inherently
buoyant material to achieve the minimum buoyancy.
(c) Buoyant vests approved under this subpart are intended to meet
the carriage requirements for wearable PFDs for uninspected passenger
vessels, uninspected commercial vessels over 40 ft (12m), and for
inspected vessels.
(d) Each buoyant vest specified in this subpart is a standard
model:
(1) Standard:
(i) Model AY, adult (for persons weighing over 90 pounds); or
(ii) Model CYM, child, medium (for children weighing from 50 to 90
pounds); or
(iii) Model CYS, child, small (for children weighing less than 50
pounds).
(2) Nonstandard:
(i) Model,\1\ adult (for persons weighing over 90 pounds); or
(ii) Model,\1\ child, medium (for persons weighing from 50 to 90
pounds); or
(iii) Model,\1\ child, small (for persons weighing less than 50
pounds).
\1\A model designation for a nonstandard vest is to be assigned
by the individual manufactured and must be different from any
standard vest.
Sec. 160.060-2 [Removed and Reserved]
0
46. Remove and reserve Sec. 160.060-2.
0
47. Revise Sec. 160.060-3 to read as follows:
Sec. 160.060-3 Definitions.
The following definitions apply to this subpart:
Commandant means the Chief of the Lifesaving and Fire Safety
Standards Division. Address: Commandant (CG-ENG-4), Attn: Lifesaving
and Fire Safety Division, U.S. Coast Guard Stop 7509, 2703 Martin
Luther King Jr. Avenue SE, Washington, DC 20593-7509; email
[email protected].
First quality workmanship means construction that is free from any
defect materially affecting appearance or serviceability.
Inspector means a recognized laboratory representative assigned to
perform, supervise, or oversee the duties described in Sec. 160.255-15
or any Coast Guard representative performing duties related to the
approval.
Recognized laboratory means an independent laboratory accepted by
the Commandant in accordance with 46 CFR subpart 159.010, with a valid
memorandum of understanding in accordance with 46 CFR 159.010-7.
Sec. 160.060-3a [Removed and Reserved]
0
48. Remove and reserve Sec. 160.060-3a.
Sec. 160.060-4 [Removed and Reserved]
0
49. Remove and reserve Sec. 160.060-4.
0
50. Revise Sec. 160.060-5 to read as follows:
Sec. 160.060-5 Incorporation by reference.
Certain material is incorporated by reference into this part with
the approval of the Director of the Federal Register in accordance with
5 U.S.C. 552(a) and 1 CFR part 51. All approved material is available
for inspection at the Coast Guard Headquarters and at the National
Archives and Records Administration (NARA). Contact Commandant (CG-ENG-
4), Attn: Lifesaving and Fire Safety Division, U.S. Coast Guard Stop
7509, 2703 Martin Luther King Jr. Avenue SE, Washington, DC 20593-7509.
For information on the availability of this material at NARA, visit
www.archives.gov/federal-register/cfr/ibr-locations.html or email:
[email protected]. The material may be obtained from UL, 333
Pfingsten Road, Northbrook, IL 60062-2002; phone (847) 272-8800;
website: www.ul.com.
(a) ANSI/CAN/UL 9595:2021, Standard for Factory Follow-Up on
Personal Flotation Devices (PFDs), First Edition, June 4, 2020
(including revisions through September 9, 2021) (``ANSI/CAN/UL 9595'');
IBR approved for Sec. 160.060-15(h).
(b) [Reserved]
Sec. 160.060-6 [Removed and Reserved]
0
51. Remove and reserve Sec. 160.060-6.
Sec. 160.060-7 [Removed and Reserved]
0
52. Remove and reserve Sec. 160.060-7.
Sec. 160.060-8 [Removed and Reserved]
0
53. Remove and reserve Sec. 160.060-8.
Sec. 160.060-9 [Removed and Reserved]
0
54. Remove and reserve Sec. 160.060-9.
0
55. Add Sec. 160.060-11 to read as follows:
Sec. 160.060-11 Independent laboratory.
(a) The production inspections, tests, and quality control required
by this subpart must be conducted by an independent laboratory
recognized by the Coast Guard under 46 CFR 159.010 to perform such
functions. A list of recognized independent laboratories is available
from the Commandant and online at https://cgmix.uscg.mil.
(b) The same laboratory that performs the approval tests must also
perform production oversight unless the employees of the laboratory
performing production oversight receive training and support equal to
that of the laboratory that performed the approval testing, as
determined by the Commandant.
0
56. Add Sec. 160.060-15 to read as follows:
Sec. 160.060-15 Production inspections, tests, and quality control.
(a) General. Manufacturers of listed and labeled buoyant vests
must--
(1) Maintain quality control of the materials used, the
manufacturing methods, and the finished product to meet the applicable
requirements of this subpart by conducting sufficient inspections and
tests of representative samples and components produced;
(2) Make available to the recognized laboratory inspector or the
Coast Guard inspector, upon request, records of tests conducted by the
manufacturer and records of materials used during production of the
device, including affidavits by suppliers; and
(3) Permit any examination, inspection, or test required by the
[[Page 21050]]
recognized laboratory or the Coast Guard for a produced listed and
labeled device, either at the place of manufacture or some other
location.
(b) Lot size and sampling.
(1) A lot must consist of 500 buoyant vests or fewer;
(2) A new lot begins after any change or modification in materials
used or manufacturing methods employed;
(3) The manufacturer of the buoyant vests must notify the
recognized laboratory when a lot is ready for inspection;
(4) The manufacturer must select samples in accordance with the
requirements in Table 1 to Sec. 160.060-15(b)(4) from each lot of
buoyant vests to be tested for buoyancy in accordance with paragraph
(e) of this section; and
Table 1 to Sec. 160.060-15(b)(4)--Sample for Buoyancy Tests
------------------------------------------------------------------------
Number of
Lot size vests in
sample
------------------------------------------------------------------------
100 and under.............................................. 1
101 to 200................................................. 2
201 to 300................................................. 3
301 to 500................................................. 4
------------------------------------------------------------------------
(5) If a sample vest fails the buoyancy test, the sample from the
next succeeding lot must consist of 10 specimen vests or more to be
tested for buoyancy in accordance with paragraph (e) of this section.
(c) Additional compliance tests. An inspector may conduct an
examination, test, and inspection of a buoyant device obtained from the
manufacturer or through commercial channels to determine the
suitability of the device for listing and labeling, or to determine its
conformance to applicable requirements.
(d) Test facilities. The manufacturer must admit the inspector to
any part of the premises at the place of manufacture of a listed and
labeled device to--
(1) Examine, inspect, or test a sample of a part or a material that
is included in the construction of the device; and
(2) Conduct any examination, inspection, or test in a suitable
place and with appropriate apparatus provided by the manufacturer.
(e) Buoyancy.
(1) Buoyancy test method. Remove the buoyant inserts from the
vests. Securely attach the spring scale in a position directly over the
test tank. Suspend the weighted wire basket from the scale in such a
manner that the basket can be weighed while it is completely under
water. In order to measure the actual buoyancy provided by the inserts,
the underwater weight of the empty basket must exceed the buoyancy of
the inserts. To obtain the buoyancy of the inserts, proceed as follows:
(i) Weigh the empty wire basket under water.
(ii) Place the inserts inside the basket and submerge it so that
the top of the basket is at least 2 inches below the surface of the
water. Allow the inserts to remain submerged for 24 hours. The tank
must be locked or sealed during this 24-hour submergence period. It is
important that after the inserts have once been submerged they remain
submerged for the duration of the test, and at no time during the
course of the test removed from the tank or otherwise exposed to air.
(iii) After the 24-hour submergence period, unlock or unseal the
tank and weigh the wire basket with the inserts inside while both are
still under water.
(iv) The buoyancy is computed as paragraph (e)(1)(i) of this
section minus paragraph (e)(1)(iii) of this section.
(2) Buoyancy required. The buoyant inserts from adult size buoyant
vests must provide not less than 151 2044;2 pounds of buoyancy in fresh
water; the inserts from the child medium size buoyant vests must
provide not less than 11 pounds buoyancy; and the inserts from the
child small size buoyant vests must provide not less than 7 pounds
buoyancy.
(f) Body strap test. The complete body strap assembly, including
hardware must be tested for strength by attaching the D-ring to a
suitable support such that the assembly hangs vertically its full
length. A weight of 150 pounds for an adult size and 115 pounds for a
child size must be attached to the other end on the snap hook for 10
minutes. The specified weight must not break or excessively distort the
body strap assembly.
(g) Additional approval tests for nonstandard vests. Tests in
addition to those required by this section may be conducted by the
inspector for a nonstandard vest to determine performance equivalence
to a standard vest. Such additional tests may include determining
performance in water, suitability of materials, donning time, ease of
adjustment, and similar equivalency tests. Costs for any additional
tests must be assumed by the manufacturer.
(h) Follow-up program. A follow-up program in accordance with ANSI/
CAN/UL 9595 (incorporated by reference, see Sec. 160.060-5) meets the
requirements of this section.
0
57. Add Sec. 160.060-19 to read as follows:
Sec. 160.060-19 Pamphlet or placard.
Each buoyant vest sold or offered for sale for use on recreational
boats must be provided with a pamphlet or placard that a prospective
purchaser can read prior to purchase, as specified in 33 CFR part 181
subpart G.
0
58. Add Sec. 160.060-23 to read as follows:
Sec. 160.060-23 Procedure for approval of design or material change.
(a) The manufacturer must submit any proposed changes in design,
material, or construction to [email protected] for approval before
changing PFD production methods.
(b) Only the Commandant or a designated representative may make
determinations of equivalence of design, construction, and materials.
0
59. Add Sec. 160.060-25 to read as follows:
Sec. 160.060-25 Suspension or termination of approval.
As provided in 46 CFR 159.005-15, the Commandant may suspend or
terminate the approval if the manufacturer fails to comply with this
subpart or the recognized laboratory's accepted procedures or
requirements.
Subpart 160.064--Marine Buoyant Devices
0
60. Revise Sec. 160.064-1 to read as follows:
Sec. 160.064-1 Scope.
(a) This subpart contains requirements for production follow-up
inspections for wearable PFDs and throwable PFDs approved under this
subpart prior to [EFFECTIVE DATE OF FINAL RULE].
(b) PFDs approved under this subpart are intended to meet the
carriage requirements for PFDs for uninspected commercial vessels under
40 ft (12m) not carrying passengers for hire and recreational boats, in
accordance with 33 CFR 175 and 46 CFR 25.25.
(c) PFDs covered by this subpart are of two general types: those
intended to be worn on the body and those intended to be thrown.
Sec. 160.064-2 [Removed and Reserved]
0
61. Remove and reserve Sec. 160.064-2.
0
62. Revise Sec. 160.064-3 to read as follows:
Sec. 160.064-3 Definitions.
The following definitions apply to this subpart:
Commandant means the Chief of the Lifesaving and Fire Safety
Standards Division. Address: Commandant (CG-ENG-4), Attn: Lifesaving
and Fire Safety
[[Page 21051]]
Division, U.S. Coast Guard Stop 7509, 2703 Martin Luther King Jr.
Avenue SE, Washington, DC 20593-7509; email [email protected].
First class workmanship means construction that is free from any
defect materially affecting appearance or serviceability.
Inspector means a recognized laboratory representative assigned to
perform, supervise, or oversee the duties described in Sec. 160.264-15
or any Coast Guard representative performing duties related to the
approval.
Recognized laboratory means an independent laboratory accepted by
the Commandant in accordance with 46 CFR subpart 159.010, with a valid
memorandum of understanding in accordance with 46 CFR 159.010-7.
Sec. 160.064-4 [Removed and Reserved]
0
63. Remove and reserve Sec. 160.064-4.
0
64. Add Sec. 160.064-5 to read as follows:
Sec. 160.064-5 Incorporation by reference.
Certain material is incorporated by reference into this part with
the approval of the Director of the Federal Register in accordance with
5 U.S.C. 552(a) and 1 CFR part 51. All approved material is available
for inspection at the Coast Guard Headquarters and at the National
Archives and Records Administration (NARA). Contact Commandant (CG-ENG-
4), Attn: Lifesaving and Fire Safety Division, U.S. Coast Guard Stop
7509, 2703 Martin Luther King Jr. Avenue SE, Washington, DC 20593-7509.
For information on the availability of this material at NARA, visit
www.archives.gov/federal-register/cfr/ibr-locations.html or email:
[email protected]. The material may be obtained from UL, 333
Pfingsten Road, Northbrook, IL 60062-2002; phone (847) 272-8800;
website: www.ul.com.
(a) ANSI/CAN/UL 9595:2021, Standard for Factory Follow-Up on
Personal Flotation Devices (PFDs), First Edition, June 4, 2020
(including revisions through September 9, 2021) (``ANSI/CAN/UL 9595'');
IBR approved for Sec. 160.064-15(e).
(b) [Reserved]
Sec. 160.064-6 [Removed and Reserved]
0
65. Remove and reserve Sec. 160.064-6.
Sec. 160.064-7 [Removed and Reserved]
0
66. Remove and reserve Sec. 160.064-7.
0
67. Add Sec. 160.064-11 to read as follows:
Sec. 160.064-11 Recognized laboratory.
(a) The production inspections, tests, and quality control required
by this subpart must be conducted by an independent laboratory
recognized by the Coast Guard under 46 CFR subpart 159.010 to perform
such functions. A list of recognized independent laboratories is
available from the Commandant and online at https://cgmix.uscg.mil.
(b) The same laboratory that performs the approval tests must also
perform production oversight unless the employees of the laboratory
performing production oversight receive training and support equal to
that of the laboratory that performed the approval testing, as
determined by the Commandant.
0
68. Add Sec. 160.064-15 to read as follows:
Sec. 160.064-15 Production inspections, tests, and quality control of
PFDs.
(a) Manufacturer's inspection and tests. Manufacturers of approved
PFDs must maintain quality control of the materials used, manufacturing
methods, and the finished product to meet the applicable requirements,
and make sufficient inspections and tests of representative samples and
components produced to maintain the quality of the finished product.
Records of tests conducted by the manufacturer and records of
materials, including affidavits by suppliers that applicable
requirements are met, must be made available to the recognized
laboratory inspector or to the Coast Guard marine inspector, or both,
for review upon request.
(b) Laboratory inspections and tests. The laboratory inspector will
conduct examinations, inspections, and tests for listed and labeled
devices, as required by the recognized laboratory, at the place of
manufacture or other location at the option of the laboratory.
(c) Test facilities. The laboratory inspector, or the Coast Guard
marine inspector assigned by the Commander of the District in which the
factory is located, or both, must be admitted to any place in the
factory where work is being done on listed and labeled products. Either
or both inspectors may take samples of parts or materials entering
construction or final assemblies, for further examinations,
inspections, or tests. The manufacturer must provide a suitable place
and the apparatus necessary for the performance of the tests done at
the place of manufacture.
(d) Additional tests, etc. Unannounced examinations, tests, and
inspections of samples obtained either directly from the manufacturer
or through commercial channels may be made to determine the suitability
of a product for listing and labeling, or to determine conformance of a
labeled product to the applicable requirements. These may be conducted
by the recognized laboratory or the United States Coast Guard.
(e) Follow-up program. A follow-up program in accordance with ANSI/
CAN/UL 9595 (incorporated by reference, see Sec. 160.064-5) meets the
requirements of this section.
0
69. Add Sec. 160.064-23 to read as follows:
Sec. 160.064-23 Procedure for approval of design or material change.
(a) The manufacturer must submit any proposed changes in design,
material, or construction to the recognized laboratory for approval
before changing PFD production methods.
(b) Determinations of equivalence of design, construction, and
materials must be made only by the Commandant or a designated
representative.
0
70. Add Sec. 160.064-25 to read as follows:
Sec. 160.064-25 Suspension or termination of approval.
As provided in 46 CFR 159.005-15, the Commandant may suspend or
terminate the approval of a PFD design if the manufacturer fails to
comply with this subpart or the recognized laboratory's accepted
procedures or requirements.
Subpart 160.076--Inflatable Recreational Personal Flotation Devices
0
71. Revise Sec. 160.076-1 to read as follows:
Sec. 160.076-1 Scope.
(a) This subpart contains requirements for production follow-up
inspections for inflatable recreational personal flotation devices
(PFDs) approved prior to [EFFECTIVE DATE OF FINAL RULE].
(b) Inflatable PFDs approved under this subpart rely partially or
entirely upon inflation for buoyancy.
0
72. Revise Sec. 160.076-5 to read as follows:
Sec. 160.076-5 Incorporation by reference.
Certain material is incorporated by reference into this part with
the approval of the Director of the Federal Register in accordance with
5 U.S.C. 552(a) and 1 CFR part 51. All approved material is available
for inspection at the Coast Guard Headquarters and at the National
Archives and Records Administration (NARA). Contact Commandant (CG-ENG-
4), Attn: Lifesaving and Fire Safety Division, U.S. Coast Guard Stop
7509, 2703 Martin
[[Page 21052]]
Luther King Jr. Avenue SE, Washington, DC 20593-7509. For information
on the availability of this material at NARA, visit www.archives.gov/federal-register/cfr/ibr-locations.html or email:
[email protected]. The material may be obtained from UL, 333
Pfingsten Road, Northbrook, IL 60062-2002; phone (847) 272-8800
website: www.ul.com.
(a) ANSI/CAN/UL 9595:2021, Standard for Factory Follow-Up on
Personal Flotation Devices (PFDs), First Edition, June 4, 2020
(including revisions through September 9, 2021) (``ANSI/CAN/UL 9595'');
IBR approved for Sec. 160.076-29(a).
(b) [Reserved].
Sec. 160.076-11 [Removed and Reserved]
0
73. Remove and reserve Sec. 160.076-11.
Sec. 160.076-13 [Removed and Reserved]
0
74. Remove and reserve Sec. 160.076-13.
Sec. 160.076-21 [Removed and Reserved]
0
75. Remove and reserve Sec. 160.076-21.
Sec. 160.076-23 [Removed and Reserved]
0
76. Remove and reserve Sec. 160.076-23.
Sec. 160.076-25 [Removed and Reserved]
0
77. Remove and reserve Sec. 160.076-25.
0
78. Amend Sec. 160.076-29 by:
0
a. Revising the first sentence of paragraph (a);
0
b. Removing in paragraph (c)(1)(i), the text ``Except as provided in
paragraph (e)(2) of this section, perform'' and adding, in its place,
the text ``Perform'';
0
c. Removing paragraphs (c)(5), (6), (e)(3) through (5), (f), and (g);
and
0
d. Redesignating paragraph (h) as paragraph (f).
The revisions read as follows:
Sec. 160.076-29 Production oversight.
(a) Production tests and inspections must be conducted in
accordance with ANSI/CAN/UL 9595 (incorporated by reference, see Sec.
160.076-5) or an alternative follow-up procedure accepted by the
Commandant. * * *
* * * * *
Sec. 160.76-31 [Amended]
0
79. Amend Sec. 160.076-31 by:
0
a. Removing in paragraph (a), the text ``Sec. 160.076-29(e)'' and
adding, in its place, the words ``the sampling plan accepted by the
Commandant'';
0
b. Removing in paragraph (b)(1), the text ``in paragraphs (c)(2)
through (c)(8) of this section'' and adding, in its place, the words
``specified in the follow-up program accepted by the Commandant'';
0
c. Removing in paragraph (b)(2), the text ``in paragraphs (c)(4)
through (c)(8) of this section'' and adding, in its place, the words
``specified in the follow-up program accepted by the Commandant'';
0
d. Removing paragraph (c);
0
e. Redesignating paragraphs (d) and (e) as (c) and (d); and
0
f. Removing the second sentence of redesignated paragraph (c)(1).
Sec. 160.76-33 [Amended]
0
80. Amend Sec. 160.076-33 by removing and reserving paragraph (b)(6).
0
81. Revise Sec. 160.076-35 to read as follows:
Sec. 160.076-35 Information pamphlet or placard.
A pamphlet or placard accepted by the Commandant must be attached
to each inflatable PFD sold or offered for sale in such a way that a
prospective purchaser can read the pamphlet prior to purchase. The
pamphlet or placard text and layout must be submitted to the Commandant
for approval. The text must be printed in each pamphlet or placard
exactly as approved by the Commandant. Additional information,
instructions, or illustrations must not be included within the approved
text and layout. Sample pamphlet text and layout may be obtained by
contacting the Commandant. This pamphlet or placard may be combined
with the manual required by Sec. 160.076-37 if PFD selection and
warning information is provided on the PFD packaging in such a way that
it remains visible until purchase.
0
82. Revise Sec. 160.076-37 to read as follows:
Sec. 160.076-37 Owner's manual.
(a) General. The manufacturer must provide an owner's manual with
each inflatable PFD sold or offered for sale.
(b) Manual contents. The manual must contain the information as
approved by the Commandant. If the PFD is conditionally approved, an
explanation of the meaning of and reasons for the approval conditions
must be included.
Sec. 160.076-39 [Amended]
0
83. In the introductory text to Sec. 160.076-39, removing the text
``specified in UL 1180 (incorporated by reference, see Sec. 160.076-
11)'' and adding, in its place, the words ``approved by the
Commandant''.
Subpart 160.077 [Removed and Reserved]
0
84. Remove and reserve subpart 160.077, consisting of Sec. Sec.
160.077-1 through 160.077-31.
0
85. Add subpart 160.255, consisting of Sec. Sec. 160.255-1 through
160.255-27, to read as follows:
Subpart 160.255--Commercial Lifejackets
Sec. 160.255-1 Scope.
(a) This subpart contains structural and performance standards for
approval of Level 100 lifejackets, as well as requirements for
production follow-up inspections, markings, information placards, and
associated manuals.
(b) Lifejackets approved under this subpart must rely upon
inherently buoyant material, inflation, or a combination to achieve the
minimum buoyancy.
(c) Lifejackets approved under this subpart are intended to meet
the carriage requirements for wearable PFDs for uninspected passenger
vessels, uninspected commercial vessels over 40 ft (12m) and for
inspected vessels.
Sec. 160.255-3 Definitions.
The following definitions apply to this subpart:
Commandant means the Chief of the Lifesaving and Fire Safety
Standards Division. Address: Commandant (CG-ENG-4), Attn: Lifesaving
and Fire Safety Division, U.S. Coast Guard Stop 7509, 2703 Martin
Luther King Jr. Avenue SE, Washington, DC 20593-7509; email
[email protected].
First quality workmanship means construction that is free from any
defect materially affecting appearance or serviceability.
Inspector means a recognized laboratory representative assigned to
perform, supervise, or oversee the duties described in Sec. 160.255-15
or any Coast Guard representative performing duties related to the
approval.
Recognized laboratory means an independent laboratory accepted by
the Commandant in accordance with 46 CFR subpart 159.010, with a valid
memorandum of understanding in accordance with 46 CFR 159.010-7.
Sec. 160.255-5 Incorporation by reference.
Certain material is incorporated by reference into this part with
the approval of the Director of the Federal Register in accordance with
5 U.S.C. 552(a) and 1 CFR part 51. All approved material is available
for inspection at the Coast Guard Headquarters and at the National
Archives and Records Administration (NARA). Contact Commandant (CG-ENG-
4), Attn: Lifesaving and Fire Safety Division, U.S. Coast Guard Stop
7509, 2703 Martin Luther King Jr. Avenue SE, Washington, DC 20593-7509.
For information on the availability of this material at NARA, visit
www.archives.gov/federal-register/cfr/ibr-locations.html or email:
[email protected]. The material
[[Page 21053]]
may be obtained from UL, 333 Pfingsten Road, Northbrook, IL 60062-2002;
phone (847) 272-8800; website: www.ul.com.
(a) ANSI/CAN/UL 9595:2021, Standard for Factory Follow-Up on
Personal Flotation Devices (PFDs), First Edition, June 4, 2020
(including revisions through September 9, 2021) (``ANSI/CAN/UL 9595'');
IBR approved for Sec. 160.255-15(a).
(b) ANSI/CAN/UL 12402-4:2020, Standard for Personal Flotation
Devices--Part 4: Lifejackets, Performance Level 100--Safety
Requirements, First Edition, July 9, 2020 (``ANSI/CAN/UL 12402-4'');
IBR approved for Sec. Sec. 160.255-7(a); 160.255-13(a) and (b);
160.255-17(a); 160.255-19; 160.255-21(a).
Sec. 160.255-7 Design, construction, and performance of lifejackets.
(a) Each Level 100 lifejacket design must--
(1) Meet the requirements in ANSI/CAN/UL 12402-4 (incorporated by
reference, see Sec. 160.255-5) for a Level 100 device, and the
requirements of this subpart; and
(2) For novel or unique designs, meet any additional requirements
that the Commandant may prescribe.
(b) Lifejackets must be of first quality workmanship and must be
free from any defects materially affecting their appearance or
serviceability.
(c) Lifejackets must not provide means intended for fastening or
securing the device to a boat.
Sec. 160.255-9 Approval procedures for lifejackets.
(a) Each application for approval of a Level 100 lifejacket must be
submitted directly to a Coast Guard recognized laboratory.
(b) The recognized laboratory must determine if a lifejacket with
novel design features requires a preliminary review by the Coast Guard
prior to testing. Submissions requiring preliminary review must be sent
to [email protected], and must include a full description and
drawings. Pictures, samples, and preliminary test results may also be
submitted.
Sec. 160.255-11 Recognized laboratory.
(a) The approval inspections and tests, production inspections,
tests, and quality control required by this subpart must be conducted
by an independent laboratory recognized by the Coast Guard under 46 CFR
subpart 159.010 to perform such functions. A list of recognized
independent laboratories is available from the Commandant and online at
https://cgmix.uscg.mil.
(b) The same laboratory that performs the approval tests must also
perform production oversight unless the employees of the laboratory
performing production oversight receive training and support equal to
that of the laboratory that performed the approval testing, as
determined by the Commandant.
Sec. 160.255-13 Approval inspections and tests.
(a) Each lifejacket must be certified by a recognized laboratory as
meeting the requirements of ANSI/CAN/UL 12402-4 (incorporated by
reference, see Sec. 160.255-5). Approval tests specified in ANSI/CAN/
UL 12402-4 must be conducted or supervised by a recognized laboratory
using prototype lifejackets constructed in accordance with the plans
and specifications submitted with the application for approval.
(b) Each lifejacket design must be visually examined for compliance
with the construction and performance requirements of this subpart and
ANSI/CAN/UL 12402-4 (incorporated by reference, see Sec. 160.255-5).
(c) The Commandant may prescribe additional tests for approval of
novel or unique designs.
Sec. 160.255-15 Production inspections, tests, and quality control of
lifejackets.
(a) General. Production tests and inspections must be conducted in
accordance with ANSI/CAN/UL 9595 (incorporated by reference, see Sec.
160.255-5), or an alternative follow-up procedure accepted by the
Commandant. To maintain approval, the manufacturer must be in good
standing under an accepted follow-up procedure.
(b) Manufacturer's inspection and tests. Manufacturers of approved
lifejackets must maintain quality control of the materials used,
manufacturing methods, and the finished product so as to meet the
applicable requirements, and make sufficient inspections and tests of
representative samples and components produced to maintain the quality
of the finished product. Records of tests conducted by the manufacturer
and records of materials, including affidavits by suppliers that
applicable requirements are met, must be made available to the
recognized laboratory inspector or to the Coast Guard marine inspector,
or both, for review upon request.
(c) Laboratory inspections and tests. The laboratory inspector will
conduct examinations, inspections, and tests for listed and labeled
devices, as required by the recognized laboratory, at the place of
manufacture or other location at the option of the laboratory.
(d) Test facilities. The inspector must be admitted to any place in
the factory where work is being done on listed and labeled products,
and the inspector may take samples of parts or materials entering
construction or final assemblies, for further examinations,
inspections, or tests. The manufacturer must provide a suitable place
and the apparatus necessary for the performance of the tests done at
the place of manufacture.
(e) Additional tests, etc. Unannounced examinations, tests, and
inspections of samples obtained either directly from the manufacturer
or through commercial channels may be made to determine the suitability
of a product for listing and labeling, or to determine conformance of a
labeled product to the applicable requirements. These may be conducted
by the recognized laboratory or the United States Coast Guard.
Sec. 160.255-17 Marking and Labeling.
(a) Each lifejacket must be marked with the appropriate label as
specified in Figure 6DV of ANSI/CAN/UL 12402-4 (incorporated by
reference, see Sec. 160.255-5).
(b) The Commandant may prescribe additional marking requirements
for special purpose devices or unique or novel designs.
Sec. 160.255-19 Placard.
Each lifejacket sold or offered for sale must be provided with a
placard that a prospective purchaser can read prior to purchase, as
specified in Figure 8DV.1.1a and Figure 8DV.1.1b, Choose the Device You
Will Want to Wear, of ANSI/CAN/UL 12402-4 (incorporated by reference,
see Sec. 160.255-5). The required placard text must be printed exactly
as set out in ANSI/CAN/UL 12402-4, unless otherwise approved by the
Commandant.
Sec. 160.255-21 Lifejacket manuals.
(a) An owner's manual in accordance with Figure 7DV of ANSI/CAN/UL
12402-4 (incorporated by reference, see Sec. 160.255-5), must be
provided with each inflatable lifejacket sold or offered for sale. The
text of each manual is reviewed with the application for approval.
(b) The Commandant may prescribe additional information in the
manual for special purpose devices or unique or novel designs.
(c) Additional information, instructions, or illustrations may be
included in the owner's manual if there is no contradiction to the
required information.
[[Page 21054]]
Sec. 160.255-23 Procedure for approval of design or material change.
(a) The manufacturer must submit any proposed changes in design,
material, or construction to the recognized laboratory for approval
before changing lifejacket production methods.
(b) Determinations of equivalence of design, construction, and
materials must be made only by the Commandant or a designated
representative.
Sec. 160.255-25 Suspension or termination of approval.
As provided in 46 CFR 159.005-15, the Commandant may suspend or
terminate the approval of a lifejacket design if the manufacturer fails
to comply with this subpart or the recognized laboratory's accepted
procedures or requirements.
Sec. 160.255-27 Servicing for fully and partially inflatable
lifejackets.
(a) General. Each lifejacket that relies fully or partially on
inflation and is approved under this subchapter must be serviced at
approved facilities at 12-month intervals according to this section.
(1) Each manufacturer of an approved inflatable lifejacket must
provide one or more Coast Guard-approved facilities for servicing those
lifejackets. The manufacturer must notify the Commandant whenever an
approved facility under its organization no longer provides servicing
of a lifejacket make and model listed in the guidelines required by
paragraph (d) of this section.
(2) Each manufacturer of an approved inflatable lifejacket must
make replacement parts available to Coast Guard-approved independent
servicing facilities.
(b) Servicing facilities. Each Coast Guard-approved servicing
facility must meet the requirements of this paragraph and paragraph (d)
of this section to receive and keep its approval for each make and
model of lifejacket. Approval is obtained according to Sec. 160.255-
5(c) of this part.
(1) Each servicing facility must conduct lifejacket servicing
according to its servicing guidelines and follow the procedures in the
service manual required by this section.
(2) Each servicing facility must have a suitable site for servicing
that must be clean, well lit, free from excessive dust, drafts, and
strong sunlight, and have appropriate temperature and humidity control
as specified in the service manual.
(3) Each servicing facility must have the appropriate service,
repair, and test equipment and spare parts for performing required
tests and repairs.
(4) Each servicing facility must have a current manufacturer's
service manual for each make and model of lifejacket serviced.
(5) A servicing facility may have more than one servicing site
provided that each site meets the requirements of paragraph (b)(2) of
this section.
(6) Each servicing facility must be inspected at intervals not
exceeding six months by an accepted independent laboratory, and a
report of the inspections must be submitted to the Commandant at least
annually. The report must contain enough information to show compliance
with paragraphs (b)(1) through (4) of this section and paragraph (d) of
this section. Where a facility uses more than one site the report must
show compliance at each site at least biennially.
(c) Service manual. (1) Each manufacturer of an approved inflatable
lifejacket must prepare a service manual for the lifejacket. The
service manual must be approved by the Commandant according to Sec.
160.176-5(b) of this part.
(2) The manufacturer must make the service manual, service manual
revisions, and service bulletins available to each approved servicing
facility.
(3) Each service manual must contain the following:
(i) Detailed procedures for inspecting, servicing, and repackaging
the lifejacket;
(ii) A list of approved replacement parts and materials to be used
for servicing and repairs, if any;
(iii) A requirement to mark the date and servicing facility name on
each lifejacket serviced;
(iv) Frequency of servicing; and
(v) Any specific restrictions or special procedures prescribed by
the Coast Guard or manufacturer.
(4) Each service manual revision and service bulletin which
authorizes the modification of a lifejacket, or which affects a
requirement under this subpart, must be approved by the Commandant.
Other revisions and service bulletins are not required to be approved,
but a copy of each must be sent to the Commandant when it is issued. At
least once each year, the manufacturer must provide to the Commandant
and to each servicing facility approved to service its lifejackets a
bulletin listing each service manual revision and bulletin in effect.
(d) Servicing facilities guidelines. Each servicing facility must
have written guidelines that include the following:
(1) Identification of each make and model of lifejacket that may be
serviced by the facility as well as the manual and revision to be used
for servicing;
(2) Identification of the person, by title or position, who is
responsible for the servicing program;
(3) Training and qualifications of servicing technicians;
(4) Provisions for the facility to retain a copy of its current
letter of approval from the Coast Guard at each site; and
(5) Requirements to--
(i) Ensure each inflatable lifejacket serviced under its Coast
Guard approval is serviced in accordance with the manufacturer's
service manual;
(ii) Keep servicing technicians informed of each approved servicing
manual revision and bulletin and ensure servicing technicians
understand each change and new technique related to the lifejackets
serviced by the facility;
(iii) Calibrate each pressure gauge, weighing scale, and
mechanically operated barometer at intervals of not more than one year;
(iv) Ensure each inflatable lifejacket serviced under the
facility's Coast Guard approval is serviced by or under the supervision
of a servicing technician who meets the requirements of paragraph
(d)(3) of this section;
(v) Specify each make and model of lifejacket the facility is
approved to service when it represents itself as approved by the U.S.
Coast Guard; and
(vi) Not service any lifejacket for a U.S. registered commercial
vessel, unless it is approved by the U.S. Coast Guard to service the
make and model of lifejacket.
(e) Servicing records. Each servicing facility must maintain
records of all completed servicing. These records must be retained for
at least 5 years after they are made, be made available to any Coast
Guard representative and independent laboratory inspector upon request,
and include at least the following:
(1) Date of servicing, number of lifejackets serviced, lot
identification, approval number, and test results data for the
lifejackets serviced;
(2) Identification of the person conducting the servicing;
(3) Identity of the vessel receiving the serviced lifejackets; and
(4) Date of return to the vessel.
0
86. Add new subpart 160.264, consisting of Sec. Sec. 160.264-1 through
160.264-25, to read as follows:
Subpart 160.264--Wearable Recreational Personal Flotation Devices
(PFDs)
Sec. 160.264-1 Scope.
(a) This subpart contains structural and performance standards for
approval of Level 50 and Level 70 inherently buoyant personal flotation
devices
[[Page 21055]]
(PFDs), as well as requirements for production follow-up inspections,
markings, information placards, and associated manuals.
(b) PFDs approved under this subpart rely entirely upon inherently
buoyant material to achieve the minimum buoyancy.
(c) PFDs approved under this subpart are intended to meet the
carriage requirements for wearable PFDs for uninspected commercial
vessels under 40 ft (12m) not carrying passengers for hire and
recreational boats, in accordance with 33 CFR part 175 and 46 CFR
25.25.
Sec. 160.264-3 Definitions.
The following definitions apply to this subpart:
Commandant means the Chief of the Lifesaving and Fire Safety
Standards Division. Address: Commandant (CG-ENG-4), Attn: Lifesaving
and Fire Safety Division, U.S. Coast Guard Stop 7509, 2703 Martin
Luther King Jr. Avenue SE, Washington, DC 20593.-7509; email
[email protected].
First quality workmanship means construction that is free from any
defect materially affecting appearance or serviceability.
Inspector means a recognized laboratory representative assigned to
perform, supervise, or oversee the duties described in Sec. 160.264-15
or any Coast Guard representative performing duties related to the
approval.
Recognized laboratory means an independent laboratory accepted by
the Commandant in accordance with 46 CFR subpart 159.010, with a valid
memorandum of understanding in accordance with 46 CFR 159.010-7.
Sec. 160.264-5 Incorporation by reference.
Certain material is incorporated by reference into this part with
the approval of the Director of the Federal Register in accordance with
5 U.S.C. 552(a) and 1 CFR part 51. All approved material is available
for inspection at the Coast Guard Headquarters and at the National
Archives and Records Administration (NARA). Contact Commandant (CG-ENG-
4), Attn: Lifesaving and Fire Safety Division, U.S. Coast Guard Stop
7509, 2703 Martin Luther King Jr. Avenue SE, Washington, DC 20593-7509.
For information on the availability of this material at NARA, visit
www.archives.gov/federal-register/cfr/ibr-locations.html or email:
[email protected]. The material may be obtained from UL, 333
Pfingsten Road, Northbrook, IL 60062-2002; phone (847) 272-8800;
website: www.ul.com.
(a) ANSI/CAN/UL 9595:2021, Standard for Factory Follow-Up on
Personal Flotation Devices (PFDs), First Edition, June 4, 2020
(including revisions through September 9, 2021) (``ANSI/CAN/UL 9595'');
IBR approved for Sec. 160.264-15(a).
(b) ANSI/CAN/UL 12402-5:2022, Standard for Personal Flotation
Devices--Part 5: Buoyancy Aids (Level 50)--Safety Requirements, First
Edition, December 31, 2015 (including revisions through January 27,
2022) (``ANSI/CAN/UL 12402-5''); IBR approved for Sec. Sec. 160.264-
7(a) and (b); 160.264-13(a) and (b); 160.264-17(a); 160.264-19;
160.264-21(a).
Sec. 160.264-7 Design, construction, and performance of PFDs.
(a) Each Level 70 PFD design must--
(1) Meet the requirements in ANSI/CAN/UL 12402-5 (incorporated by
reference, see Sec. 160.264-5) for a Level 70 device; and
(2) For novel or unique designs, meet any additional requirements
that the Commandant may prescribe.
(b) Each Level 50 PFD design must--
(1) Meet the requirements in ANSI/CAN/UL 12402-5 (incorporated by
reference, see Sec. 160.264-5) for a Level 50 device;
(2) Be marked to indicate that the device must be worn to be
counted as equipment required by vessels meeting USCG regulations; and
(3) For novel or unique designs, meet any additional requirements
that the Commandant may prescribe.
(c) Buoyancy is to be provided by inherently buoyant material and
not depend on loose, granulated material, gas compartments, or
inflation.
(d) PFDs must be of first quality workmanship and must be free from
any defects materially affecting their appearance or serviceability.
(e) PFDs must not provide means intended for fastening or securing
the device to a boat.
Sec. 160.264-9 Approval procedures for PFDs.
(a) Each application for approval of a Level 50 or Level 70 PFD
must be submitted directly to a Coast Guard recognized laboratory.
(b) The recognized laboratory must determine if a PFD with novel
design features requires a preliminary review by the Coast Guard prior
to testing. Submissions requiring preliminary review must be sent to
[email protected], and must include a full description and
drawings. Pictures, samples, and preliminary test results may also be
submitted.
Sec. 160.264-11 Recognized laboratory.
(a) The approval inspections and tests, production inspections,
tests, and quality control required by this subpart must be conducted
by an independent laboratory recognized by the Coast Guard under 46 CFR
subpart 159.010 to perform such functions. A list of recognized
independent laboratories is available from the Commandant and online at
https://cgmix.uscg.mil.
(b) Production oversight must be performed by the same laboratory
that performs the approval tests unless, as determined by the
Commandant, the employees of the laboratory performing production
oversight receive training and support equal to that of the laboratory
that performed the approval testing.
Sec. 160.264-13 Approval inspections and tests.
(a) Each PFD must be certified by a recognized laboratory as
meeting the requirements of ANSI/CAN/UL 12402-5 (incorporated by
reference, see Sec. 160.264-5) for an inherently buoyant Level 50 or
Level 70 PFD. Approval tests specified in ANSI/CAN/UL 12402-5 must be
conducted or supervised by a recognized laboratory using PFDs
constructed in accordance with the plans and specifications submitted
with the application for approval.
(b) Each PFD design must be visually examined for compliance with
the construction and performance requirements of this subpart and ANSI/
CAN/UL 12402-5 (incorporated by reference, see Sec. 160.264-5).
(c) The Commandant may prescribe additional tests for approval of
novel or unique designs.
Sec. 160.264-15 Production inspections, tests, and quality control of
PFDs.
(a) General. Production tests and inspections must be conducted in
accordance with ANSI/CAN/UL 9595 (incorporated by reference, see Sec.
160.264-5) or an alternative follow-up procedure accepted by the
Commandant. To maintain approval, the manufacturer must be in good
standing under an accepted follow-up procedure.
(b) Manufacturer's inspection and tests. Manufacturers of approved
PFDs must maintain quality control of the materials used, manufacturing
methods, and the finished product to meet the applicable requirements,
and make sufficient inspections and tests of representative samples and
components produced to maintain the quality of the finished product.
Records of tests conducted by the manufacturer and records of
materials, including affidavits by suppliers that applicable
[[Page 21056]]
requirements are met, must be made available to the recognized
laboratory inspector or to the Coast Guard marine inspector, or both,
for review upon request.
(c) Laboratory inspections and tests. The laboratory inspector will
conduct examinations, inspections, and tests for listed and labeled
devices, as required by the recognized laboratory, at the place of
manufacture or other location at the option of the laboratory.
(d) Test facilities. The laboratory inspector, or the Coast Guard
marine inspector assigned by the Commander of the District in which the
factory is located, or both, must be admitted to any place in the
factory where work is being done on listed and labeled products. Either
or both inspectors may take samples of parts or materials entering
construction or final assemblies, for further examinations,
inspections, or tests. The manufacturer must provide a suitable place
and the apparatus necessary for the performance of the tests done at
the place of manufacture.
(e) Additional tests, etc. Unannounced examinations, tests, and
inspections of samples obtained either directly from the manufacturer
or through commercial channels may be made to determine the suitability
of a product for listing and labeling, or to determine conformance of a
labeled product to the applicable requirements. These may be conducted
by the recognized laboratory or the United States Coast Guard.
Sec. 160.264-17 Marking and Labeling.
(a) Each PFD must be marked with the appropriate label as specified
in Figure 6DV of ANSI/CAN/UL 12402-5 (incorporated by reference, see
Sec. 160.264-5).
(b) The Commandant may prescribe additional marking requirements
for special purpose devices or unique or novel designs.
Sec. 160.264-19 Placard.
Each PFD sold or offered for sale must be provided with a placard
that a prospective purchaser can read prior to purchase, as specified
in Figure 8DV.1.1a and Figure 8DV.1.1b, Choose the Device You Will Want
to Wear, of ANSI/CAN/UL 12402-5 (incorporated by reference, see Sec.
160.264-5). The required placard text must be printed exactly as set
out in ANSI/CAN/UL 12402-5.
Sec. 160.264-21 PFD manuals.
(a) An owner's manual in accordance with Figure 7DV of ANSI/CAN/UL
12402-5 (incorporated by reference, see Sec. 160.264-5), may be
provided with each inherently buoyant PFD sold or offered for sale. The
text of each manual is reviewed with the application for approval.
(b) The Commandant may prescribe additional information in the
manual for special purpose devices or unique or novel designs.
(c) Additional information, instructions, or illustrations may be
included in the owner's manual if there is no contradiction to the
required information.
Sec. 160.264-23 Procedure for approval of design or material change.
(a) The manufacturer must submit any proposed changes in design,
material, or construction to the recognized laboratory for approval
before changing PFD production methods.
(b) Determinations of equivalence of design, construction, and
materials must be made only by the Commandant or a designated
representative.
Sec. 160.264-25 Suspension or termination of approval.
As provided in 46 CFR 159.005-15, the Commandant may suspend or
terminate the approval of a PFD design if the manufacturer fails to
comply with this subpart or the recognized laboratory's accepted
procedures or requirements.
0
87. Add subpart 160.276, consisting of Sec. Sec. 160.276-1 through
160.276-25, to read as follows:
Subpart 160.276--Wearable Recreational Inflatable Personal
Flotation Devices
Sec. 160.276-1 Scope.
(a) This subpart contains structural and performance standards for
approval of Level 50 and Level 70 inflatable recreational personal
flotation devices (PFDs), as well as requirements for production
follow-up inspections, associated manuals, information placards, and
markings.
(b) Inflatable PFDs approved under this subpart rely entirely or
partially upon inflation to achieve the minimum buoyancy.
(c) PFDs approved under this subpart are intended to meet the
carriage requirements for uninspected commercial vessels under 40 ft
(12m) not carrying passengers for hire and recreational boats, in
accordance with 33 CFR part 175 and 46 CFR 25.25.
Sec. 160.276-3 Definitions.
The following definitions apply to this subpart:
Commandant means the Chief of the Lifesaving and Fire Safety
Standards Division. Address: Commandant (CG-ENG-4), Attn: Lifesaving
and Fire Safety Division, U.S. Coast Guard Stop 7509, 2703 Martin
Luther King Jr. Avenue SE, Washington, DC 20593-7509; email
[email protected].
First quality workmanship means construction that is free from any
defect materially affecting appearance or serviceability.
Inspector means a recognized laboratory representative assigned to
perform, supervise, or oversee the duties described in Sec. 160.276-15
or any Coast Guard representative performing duties related to the
approval.
Recognized laboratory means an independent laboratory accepted by
the Commandant in accordance with 46 CFR 159.010, with a valid
memorandum of understanding in accordance with 46 CFR 159.010-7.
Sec. 160.276-5 Incorporation by reference.
Certain material is incorporated by reference into this part with
the approval of the Director of the Federal Register in accordance with
5 U.S.C. 552(a) and 1 CFR part 51. All approved material is available
for inspection at the Coast Guard Headquarters and at the National
Archives and Records Administration (NARA). Contact Commandant (CG-ENG-
4), Attn: Lifesaving and Fire Safety Division, U.S. Coast Guard Stop
7509, 2703 Martin Luther King Jr. Avenue SE, Washington, DC 20593-7509.
For information on the availability of this material at NARA, visit
www.archives.gov/federal-register/cfr/ibr-locations.html or email:
[email protected]. The material may be obtained from UL, 333
Pfingsten Road, Northbrook, IL 60062-2022; phone (847) 272-8800;
website: www.ul.com.
(a1) ANSI/CAN/UL 9595:2021, Standard for Factory Follow-Up on
Personal Flotation Devices (PFDs), First Edition, June 4, 2020
(including revisions through September 9, 2021) (``ANSI/CAN/UL 9595'');
IBR approved for Sec. 160.276-15(a).
(b) ANSI/CAN/UL 12402-5:2022, Standard for Personal Flotation
Devices--Part 5: Buoyancy Aids (Level 50)--Safety Requirements, First
Edition, December 31, 2015 (including revisions through January 27,
2022) (``ANSI/CAN/UL 12402-5''); IBR approved for Sec. Sec. 160.276-
7(a) and (b); 160.276-13(a) and (b); 160.276-17(a) and (b); 160.276-19;
160.276-21(a).
Sec. 160.276-7 Design, construction, and performance of inflatable
PFDs.
(a) Each Level 70 inflatable PFD design must--
[[Page 21057]]
(1) Meet the requirements in ANSI/CAN/UL 12402-5 (incorporated by
reference, see Sec. 160.276-5) for a Level 70 device; and
(2) For novel or unique designs, meet any additional requirements
that the Commandant may prescribe.
(b) Each Level 50 inflatable PFD design must--
(1) Meet the requirements in ANSI/CAN/UL 12402-5 (incorporated by
reference, see Sec. 160.276-5) for a Level 50 device;
(2) Be marked to indicate that the device must be worn to be
counted as equipment required by vessels meeting USCG regulations; and
(3) For novel or unique designs, meet any additional requirements
that the Commandant may prescribe.
(c) Buoyancy is to be provided by inflation, or a combination of
inherently buoyant material and inflation.
(d) PFDs must be of first quality workmanship and must be free from
any defects materially affecting their appearance or serviceability.
(e) PFDs must not provide means intended for fastening or securing
the device to a boat.
Sec. 160.276-9 Approval procedures for PFDs.
(a) Each application for approval of a Level 50 or Level 70 PFD
must be submitted directly to a Coast Guard recognized laboratory.
(b) The recognized laboratory must determine if a PFD with novel
design features requires a preliminary review by the Coast Guard prior
to testing. Submissions requiring preliminary review must be sent to
[email protected], and must include a full description and
drawings. Pictures, samples, and preliminary test results may also be
submitted.
Sec. 160.276-11 Recognized laboratory.
(a) The approval inspections and tests and production inspections,
tests, and quality control required by this subpart must be conducted
by an independent laboratory recognized by the Coast Guard under 46 CFR
subpart 159.010 to perform such functions. A list of recognized
independent laboratories is available from the Commandant and online at
https://cgmix.uscg.mil.
(b) The same laboratory that performs the approval tests must also
perform production oversight unless the employees of the laboratory
performing production oversight receive training and support equal to
that of the laboratory that performed the approval testing, as
determined by the Commandant.
Sec. 160.276-13 Approval inspections and tests.
(a) Each PFD must be certified by a recognized laboratory as
meeting the requirements of ANSI/CAN/UL 12402-5 (incorporated by
reference, see Sec. 160.276-5) for an inflatable Level 50 or Level 70
PFD. Approval tests specified in ANSI/CAN/UL 12402-5 must be conducted
or supervised by a recognized laboratory using PFDs constructed in
accordance with the plans and specifications submitted with the
application for approval.
(b) Each PFD design must be visually examined for compliance with
the construction and performance requirements of this subpart and ANSI/
CAN/UL 12402-5 (incorporated by reference, see Sec. 160.276-5).
(c) The Commandant may prescribe additional tests for approval of
novel or unique designs.
Sec. 160.276-15 Production inspections, tests, and quality control of
PFDs.
(a) General. Production tests and inspections must be conducted in
accordance with ANSI/CAN/UL 9595 (incorporated by reference, see Sec.
160.276-5) or an alternative follow-up procedure accepted by the
Commandant. To maintain approval, the manufacturer must be in good
standing under an approved follow-up procedure.
(b) Manufacturer's inspection and tests. Manufacturers of approved
PFDs must maintain quality control of the materials used, manufacturing
methods, and the finished product to meet the applicable requirements,
and make sufficient inspections and tests of representative samples and
components produced to maintain the quality of the finished product.
Records of tests conducted by the manufacturer and records of
materials, including affidavits by suppliers that applicable
requirements are met, must be made available to the recognized
laboratory inspector or to the Coast Guard marine inspector, or both,
for review upon request.
(c) Laboratory inspections and tests. The laboratory inspector will
conduct examinations, inspections, and tests for listed and labeled
devices, as required by the recognized laboratory, at the place of
manufacture or other location at the option of the laboratory.
(d) Test facilities. The laboratory inspector, or the Coast Guard
marine inspector assigned by the Commander of the District in which the
factory is located, or both, must be admitted to any place in the
factory where work is being done on listed and labeled products. Either
or both inspectors may take samples of parts or materials entering
construction or final assemblies, for further examinations,
inspections, or tests. The manufacturer must provide a suitable place
and the apparatus necessary for the performance of the tests done at
the place of manufacture.
(e) Additional tests, etc. Unannounced examinations, tests, and
inspections of samples obtained either directly from the manufacturer
or through commercial channels may be made to determine the suitability
of a product for listing and labeling, or to determine conformance of a
labeled product to the applicable requirements. These may be conducted
by the recognized laboratory or the United States Coast Guard.
Sec. 160.276-17 Marking and Labeling.
(a) Each inflatable PFD must be marked as specified in Figure 6DV
of ANSI/CAN/UL 12402-5 (incorporated by reference, see Sec. 160.276-
5).
(b) In addition to the information required by ANSI/CAN/UL 12402-5,
Figure 6DV, each Level 50 inflatable PFD must be marked with a
statement that the device must be worn to be counted as equipment
required by vessels meeting USCG regulations; and
(c) The Commandant may prescribe additional marking requirements
for special purpose devices or unique or novel designs.
Sec. 160.276-19 Placard.
Each inflatable PFD sold or offered for sale must be provided with
a placard that a prospective purchaser can read prior to purchase, as
specified in Figure 8DV.1.1a and Figure 8DV.1.1b, Choose the Device You
Will Want to Wear, of ANSI/CAN/UL 12402-5 (incorporated by reference,
see Sec. 160.276-5). The required placard text must be printed exactly
as set out in ANSI/CAN/UL 12402-5.
Sec. 160.276-21 PFD manuals.
(a) An owner's manual in accordance with Figure 7DV of ANSI/CAN/UL
12402-5 (incorporated by reference, see Sec. 160.276-5), must be
provided with each inflatable PFD sold or offered for sale. The text of
each manual is reviewed with the application for approval.
(b) The Commandant may prescribe additional information in the
manual for special purpose devices or unique or novel designs.
(c) Additional information, instructions, or illustrations may be
included in the owner's manual if there is no contradiction to the
required information.
[[Page 21058]]
Sec. 160.276-23 Procedure for approval of design or material change.
(a) The manufacturer must submit any proposed changes in design,
material, or construction to the recognized laboratory for approval
before changing PFD production methods.
(b) Determinations of equivalence of design, construction, and
materials must be made only by the Commandant or a designated
representative.
Sec. 160.276-25 Suspension or termination of approval.
As provided in 46 CFR 159.005-15, the Commandant may suspend or
terminate the approval of an inflatable PFD design if the manufacturer
fails to comply with this subpart or the recognized laboratory's
accepted procedures or requirements.
PART 169--SAILING SCHOOL VESSELS
0
88. The authority citation for part 169 is revised to read as follows:
Authority: 33 U.S.C. 1321(j); 46 U.S.C. 3306, 6101; Pub. L.
103-206, 107 Stat. 2439; E.O. 11735, 38 FR 21243, 3 CFR, 1971-1975
Comp., p. 793; DHS Delegation 00170.1, Revision No. 01.2, paragraph
(II)(92)(a); Sec. 169.117 also issued under the authority of 44
U.S.C. 3507.
Sec. 169.539 [Amended]
0
89. Amend Sec. 169.539 by:
0
a. Removing in paragraph (a), the text ``160.055, 160.002, or
160.005'', and adding in its place the text ``160.002, 160.005,
160.055, or 160.255,'';
0
b. Removing in paragraph (b), the text ``or 160.077'', and adding in
its place the text ``, 160.077, or 160.264''; and
0
c. Removing in paragraph (c), the text ``160.064'', and adding in its
place the text ``160.064 or 160.264''.
PART 180--LIFESAVING EQUIPMENT AND ARRANGEMENTS
0
90. The authority citation for part 180 is revised to read as follows:
Authority: 46 U.S.C. 2104, 3306; E.O. 12234, 45 FR 58801, 3
CFR, 1980 Comp., p. 277; DHS Delegation 00170.1, Revision No. 01.2,
paragraph (II)(92)(a).
0
91. Amend Sec. 180.71 by:
0
a. Revising the section heading and paragraph (c);
0
b. Removing paragraph (d); and
0
c. Redesignating paragraph (e) as paragraph (d).
The revisions read as follows:
Sec. 180.71 Lifejackets.
* * * * *
(c) Each lifejacket must be approved under approval series 160.002,
160.005, 160.055, 160.115, 160.176, or 160.255 in subchapter Q of this
chapter, or other standard specified by the Commandant. An inflatable
lifejacket approved under approval series 160.255 must include a full
back-up inflation chamber.
* * * * *
0
92. Amend Sec. 180.72 by:
0
a. Revising the section heading;
0
b. Removing in paragraph (a), the words ``life jackets'' wherever they
appear and adding, in their place, the word ``lifejackets''; and
0
c. Revising paragraphs (b) and (d).
The revisions read as follows:
Sec. 180.72 Personal flotation devices carried in addition to
lifejackets.
* * * * *
(b) Wearable marine buoyant devices approved in accordance with
Sec. 160.064, 160.076, 160.264, or 160.276 in subchapter Q of this
chapter, or other standard specified by the Commandant, may be carried
as additional equipment.
* * * * *
(d) A commercial hybrid approved under former approval series
160.077 prior to [EFFECTIVE DATE OF FINAL RULE] may be carried as
additional equipment for use by persons working near or over the water
if it is in good and serviceable condition, used in accordance with the
conditions marked on the PFD and in the owner's manual, and of the same
or similar design and has the same method of operation as each other
hybrid PFD carried on board.
PART 199--LIFESAVING SYSTEMS FOR CERTAIN INSPECTED VESSELS
0
93. The authority citation for part 199 is revised to read as follows:
Authority: 46 U.S.C. 3306, 3703; Pub. L. 103-206, 107 Stat.
2439; DHS Delegation 00170.1, Revision No. 01.2, paragraph
(II)(92)(a).
Sec. 199.70 [Amended]
0
94. Amend Sec. 199.70(b) introductory text by removing the text ``,
160.176 or 160.177'', and adding, in its place, the text ``or
160.176''.
Sec. 199.620 [Amended]
0
95. Revise Sec. 199.620(c) to read as follows:
Sec. 199.620 Alternatives for all vessels in a specified service.
* * * * *
(c) Lifejackets approval series. As an alternative to a lifejacket
meeting the approval requirements in Sec. 199.70, vessels may carry a
lifejacket approved under approval series 160.002, 160.005, 160.055, or
160.077, or 160.255. An inflatable lifejacket approved under approval
series 160.255 must include a full back-up inflation chamber.
* * * * *
Dated: March 24, 2023.
W.R. Arguin,
Rear Admiral, U.S. Coast Guard, Assistant Commandant for Prevention
Policy.
[FR Doc. 2023-06504 Filed 4-6-23; 8:45 am]
BILLING CODE 9110-04-P