[Federal Register Volume 90, Number 238 (Monday, December 15, 2025)]
[Rules and Regulations]
[Pages 58096-58139]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-22827]
[[Page 58095]]
Vol. 90
Monday,
No. 238
December 15, 2025
Part II
Consumer Product Safety Commission
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16 CFR Parts 1112 and 1250
Mandatory Toy Safety Standards: Requirements for Neck Floats; Final
Rule
Federal Register / Vol. 90, No. 238 / Monday, December 15, 2025 /
Rules and Regulations
[[Page 58096]]
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Parts 1112 and 1250
[CPSC Docket No. CPSC-2024-0039]
Mandatory Toy Safety Standards: Requirements for Neck Floats
AGENCY: Consumer Product Safety Commission.
ACTION: Final rule.
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SUMMARY: Section 106(a) of the Consumer Product Safety Improvement Act
of 2008 (CPSIA) mandates that ASTM F963 shall be a mandatory toy safety
standard. ASTM F963-23, however, does not establish specific
performance requirements for aquatic toys, such as neck floats. The
U.S. Consumer Product Safety Commission (CPSC or Commission) is issuing
this final rule establishing additional performance requirements
specifically for neck floats and revised labeling requirements for neck
floats to address fatal hazards associated with neck floats. The
Commission is also amending CPSC's list of notice of requirements
(NORs) to include neck floats.
DATES: This rule will become effective June 15, 2026. The incorporation
by reference of the publication listed in this rule is approved by the
Director of the Federal Register as of June 15, 2026.
The incorporation by reference of certain other material listed in
this rule was approved for use by the Director of the Federal Register
as of April 20, 2024.
FOR FURTHER INFORMATION CONTACT:
Carol Afflerbach, Compliance Officer, Office of Compliance,
Consumer Product Safety Commission, 4330 East West Highway, Bethesda,
MD 20814-4408, telephone: 301-743-8595; email: [email protected].
Zachary R. Goldstein, Project Manager, Division of Mechanical
Engineering, Directorate for Laboratory Sciences, Consumer Product
Safety Commission, 5 Research Place, Rockville, MD 20850; telephone:
301-987-2472; email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background and Statutory Authority
A. Background
Section 106(a) of the Consumer Product Safety Improvement Act of
2008 (CPSIA) made ASTM International's (ASTM) voluntary standard for
toys, ASTM F963-07, Standard Consumer Safety Specification for Toy
Safety (except sections 4.2 and Annex 4), a mandatory safety standard
for toys beginning 180 days after the enactment date of the CPSIA. 15
U.S.C. 2056b(a). The CPSIA states that ASTM F963 shall be considered a
consumer product safety standard issued by the Commission under section
9 of the Consumer Product Safety Act (CPSA; 15 U.S.C. 2058). Since
2009, CPSC has enforced ASTM F963 as a mandatory standard for
toys.1 2 In 2017, the Commission codified the mandatory toy
standard in 16 CFR part 1250, Safety Standard Mandating ASTM F963 for
Toys, and incorporated by reference the newly revised ASTM standard at
that time, ASTM F963-16. 82 FR 8989 (Feb. 2, 2017). Most recently, on
January 18, 2024, the Commission updated part 1250 to incorporate by
reference a 2023 revision, ASTM F963-23. 89 FR 3344.
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\1\ Since the CPSIA's enactment in 2008, ASTM has revised F963
five times: ASTM F963-08, ASTM F963-11, ASTM F963-16, ASTM F963-17,
and ASTM F963-23 (approved August 1, 2023).
\2\ Section 3.1.92 of ASTM F963-23 defines a toy as: ``Any
object designed, manufactured, or marketed as a plaything for
children under 14 years of age.''
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ASTM F963-23 includes requirements for toys, including but not
limited to a category of toys known as ``aquatic toys.'' Section 3.1.4
of ASTM F963-23 defines an aquatic toy as ``an article, whether
inflatable or not, intended to bear the mass of a child and used as an
instrument of play in shallow water. This does not include bath toys,
beach balls, and United States Coast Guard-approved life saving
devices.'' 16 CFR part 1250.
ASTM F963-23 includes generally applicable performance requirements
for all toys, such as flammability and toxicology (lead, phthalates,
etc.). The mandatory standard also includes specific performance
requirements for some toys, including pacifiers (4.20), teethers and
teething toys (4.22), rattles (4.23), and squeeze toys (4.24), among
others. The standard, however, does not include any specific
performance requirements for aquatic toys or neck floats.
The standard also contains generally applicable marking and
labeling requirements for all toys for warning labels, instructional
literature, and packaging. In addition, for aquatic toys, the standard
includes, in section 5.4, specific labeling requirements that apply to
aquatic toys like neck floats and their packaging.
The labeling requirements are intended to communicate to the
consumer that an aquatic toy is not a lifesaving device and to warn
caregivers against leaving a child unattended while using the aquatic
toy. More specifically, it requires aquatic toys, and their packaging,
carry a safety label that at minimum includes the following, or
equivalent, text: ``This is not a lifesaving device. Do not leave child
unattended while device is in use.'' It also requires ``no advertising
copy or graphics shall state or imply that the child will be safe with
such a toy if left unsupervised.'' The Commission determined that
warning requirements specified in section 5.4 of ASTM F963-23 are
inadequate for neck floats because they do not adequately address the
hidden hazards specifically associated with these products, such as the
risk of neck opening expansion during use, the risk of drowning in very
shallow water, and the risk of death associated with partial or full
slip-through.
As noted above, ASTM F963-23 does not establish adequate
requirements specific to neck floats because it does not include
specific performance requirements that take an aquatic environment and
associated hazards into consideration for these toys. For example,
rattles and pacifiers account for the expected use scenario that
infants may attempt to put them in their mouths, and to address this,
ASTM F963-23 establishes a performance requirement in sections 4.20 and
4.23 that they must not pass through the Pacifier Test Fixture and
Rattle Test Fixture, respectively, to mitigate the possible choking or
impaction hazard associated with that use. In comparison, for aquatic
toys, there are no requirements to adequately address foreseeable use
hazards such as those identified for neck floats in this rule. For
example, even though aquatic toys are defined as ``intended to bear the
mass of a child,'' there are no buoyancy performance requirements in
ASTM F963-23 to evaluate whether an aquatic toy can adequately perform
that duty.
On November 20, 2024, the Commission issued a Notice of Proposed
Rulemaking (NPR) to address hazards associated with neck floats.
Incident data, discussed in the NPR (and described in section III of
this preamble), demonstrated that children have suffered drowning
injuries and deaths associated with the use of neck floats. The NPR
included a proposed definition of ``neck floats'' and performance
requirements that included requirements for conditioning, buoyancy,
restraining systems, and the neck opening. The NPR proposed to amend
existing marking, labeling, and instructional literature requirements.
The NPR also stated that it would revise the title of part 1250 from
``Safety Standard Mandating ASTM F963 for Toys'' to ``Safety Standards
for Toys,'' to reflect the inclusion of additional
[[Page 58097]]
requirements that are not included in the existing requirements in ASTM
F963-23. The Commission received 145 public comments on the NPR.
B. Statutory Authority and Voluntary Standards Activity
The Commission is authorized to issue this final rule pursuant to
both sections 106(c) and (d) of the CPSIA. 15 U.S.C. 2056b(c) and (d).
Section 106(c) requires the Commission to periodically review and
revise its mandatory toy safety standards to ensure that such standards
provide the highest level of safety for toys that is feasible. 15
U.S.C. 2056b(c). Section 106(d) further requires the Commission to
examine and assess the effectiveness of its mandatory toy safety
standards in protecting children from safety hazards, and then to
promulgate consumer product safety standards that are more stringent
than the existing requirements if the Commission determines that the
more stringent standards would further reduce the risk of injury
associated with such toys. Id. at 2056b(d). Consistent with the
consultation requirement in section 106(d)(1) of the CPSIA, staff have
worked with the ASTM F15.22 Subcommittee since 2009 to update the toy
standard. In August 2021, CPSC staff corresponded with the ASTM
Subcommittee and task group to discuss hazards associated with neck
floats, including sharing incident data associated with neck floats and
staff's recommendation to develop performance requirements to address
the hazards identified in the incident data.
In December 2024, ASTM held an exploratory meeting to determine if
there was interest from its members and stakeholders in designating a
subcommittee for work developing a standard for buoyancy aids for
children. Following an organizational meeting in January 2025, ASTM
designated the F15.07 subcommittee to develop the draft standard. CPSC
staff attended both the exploratory and organizational meetings.
CPSC staff have been involved with the F15.07 subcommittee meetings
since its inception and participates in its two task groups that focus
on performance requirements and warning labels. At these meetings,
staff recommended that the subcommittee consider the requirements
proposed in the NPR as the baseline for their draft. The subcommittee
is also considering performance requirements not discussed in the NPR,
such as seam strength, puncture resistance, and protrusions, among
others. The F15.07 subcommittee's work is in the drafting phase and
there have been no balloted draft performance requirements to date.
C. Notice of Proposed Rulemaking (NPR)
On November 20, 2024, the Commission published an NPR to address
hazards associated with neck floats that are not adequately addressed
by the current mandatory standard provisions for aquatic toys, such as
neck floats. The scope of the NPR included ``neck floats,'' defined as
``an article, whether inflatable or not, that encircles the neck,
supports the weight of the child by being secured around the neck (such
as by fastening, tightening, or other methods), is used as an
instrument of play in water environments including sinks, baths,
paddling pools and swimming pools, and is intended for use by children
up to and including 4 years of age.'' Neck floats are typically
available as either inflatable or inherently buoyant (non-inflatable)
products, though it's foreseeable that they may also be constructed
using a combination of both inflatable and inherently buoyant
components. The scope of the NPR excluded products not defined as neck
floats within the proposed rule and U.S. Coast Guard-regulated life-
saving devices.
The proposed neck float requirements included performance
requirements and labeling and instructional literature requirements to
address the following hazards associated with the use of a neck float:
(1) children slipping through the product for reasons associated
with inflation, which includes deflation and underinflation;
(2) children slipping through the product for reasons not
associated with inflation;
(3) children slipping through the product due to a restraint system
failure; and
(4) children submerging in water without slipping through the
product.
In the NPR, the Commission also proposed to amend its regulation at
16 CFR 1112 to add ``neck floats'' to the list of products that require
third-party testing as a basis for certification.
D. Final Rule Overview
Pursuant to section 106 of the CPSIA, the Commission is issuing a
mandatory standard for neck floats, with requirements that are more
stringent than the current requirements in ASTM F963-23, that would
further reduce the risk of injury associated with neck floats and would
achieve the highest level of safety that is feasible for such
products.\3\ 15 U.S.C. 2056b. In this final rule, the Commission
addresses the four types of hazards described in the NPR. Each of these
hazard patterns presents a risk of drowning. The Commission is adding
performance requirements to part 1250 of the CFR to address these
risks. The Commission is also revising labeling requirements for neck
floats under part 1250, including mandating warnings on products and
instructional literature. Lastly, the Commission is issuing a
stockpiling prohibition under part 1250 for neck floats pursuant to
section 9(g)(2) of the CPSA. 15 U.S.C. 2058(9)(g)(2).
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\3\ On August 21, 2025, the Commission voted (2-0) to publish
this final rule.
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However, based on public comments received on the NPR and staff's
analysis, and as discussed in more detail in sections V and VI of this
preamble, the Commission is finalizing this rule with the following
clarifications and changes to the proposed rule:
1. The rule retains the proposed temperature conditioning without
further modification, but clarifies an error in the description of the
temperature conditioning requirement which incorrectly stated the cold
temperature boundary as -30 [deg]C instead of -10 [deg]C.
2. The regulatory text of the proposed rule erroneously proposed
modifications to a portion of section 4.2.1 of ANSI/APSP/ICC-16 2017,
American National Standard for Suction Outlet Fitting Assemblies
(SOFA), that was not intended to be incorporated by reference in this
final rule. Both the proposed rule and final rule only incorporate by
reference sections 4.2.1.1-4.2.1.4 of ANSI/APSP/ICC-16 2017. Reference
to those unincorporated sections, previously Sec. 1250.5(c)(1)(iv) and
(v) in the proposed rule, have been removed.
3. The UV conditioning methods will remain as proposed, however the
total length of conditioning time required by those methods will be
reduced from the proposed 720 hours to 180 hours using methods (a) and
(b), from the proposed 1000 hours to 250 hours using method (c), and
from the proposed 750 hours to 188 hours using method (d) from sections
4.2.1.1-4.2.1.4 of ANSI/APSP/ICC-16 2017 in Sec. 1250.5(c)(1)(iv) to
better reflect foreseeable outdoor use conditions of neck floats.
4. In the neck opening test procedure, the length of distance L,
which represents the location of the occupant's Center of Gravity (CG)
and is used to determine the position of the hanging weight used, is
shortened to better
[[Page 58098]]
reflect the CG location in the bodies of young children. Also, in the
neck opening test, the mass of the hanging weight is reduced for select
age ranges to more accurately represent growth transitions. The revised
values are included in Table 2.
5. The head probe drawings and dimensions presented as Figure 5 and
Table 4 in section V of the NPR were inadvertently not included in the
proposed regulatory text for the rule. They have been added to the
regulatory text in Sec. 1250.5(c)(4)(vii) as Figure 1 and Table 3.
6. To prevent any confusion concerning applicable requirements for
neck floats in ASTM F963-23, the final rule revises the text in Sec.
1250.5(c) by replacing ``any general requirements'' with ``any
applicable performance requirements.''
II. Description of Toys Within the Scope of the Rule
The scope of the final rule includes all neck floats, as defined in
Sec. 1250.5(b) as ``an article, whether inflatable or not, that
encircles the neck, supports the weight of the child by being secured
around the neck (such as by fastening, tightening, or other methods),
is used as an instrument of play in water environments including sinks,
baths, paddling pools and swimming pools, and is intended for use by
children up to and including 4 years of age.''
Section 3.1.92 of ASTM F963-23 defines a ``toy'' as ``any object
designed, manufactured, or marketed as a plaything for children under
14 years of age.'' Section 3.1.4 of ASTM F963-23 defines an ``aquatic
toy'' as ``an article, whether inflatable or not, intended to bear the
mass of a child and used as an instrument of play in shallow water.
This does not include bath toys, beach balls, and United States Coast
Guard-approved life saving devices.'' Neck floats are subject to the
mandatory toy standard as an aquatic toy because they are instruments
of play that are designed to allow a child to play in water, including
shallow water.
Neck floats are aquatic toys that are typically ring-shaped tubes
with discontinuous ends that wrap around a child's neck. This placement
is intended to allow the child's head to float above the water while
supporting their body. As is the case with other aquatic toys,\4\ this
design is intended to allow the child to float and play in water.
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\4\ For example, section 3.1.47 of ASTM F963-23 includes a list
of examples of toys used in aquatic activities which include
``rafts, water wings, swim rings, or other similar items.''
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Neck floats are available as both inflatable and inherently buoyant
(non-inflatable) products. Inflatable variants rely on air to provide
buoyancy and are generally packaged and distributed while deflated.
Caregivers must inflate the neck float prior to their initial use and
are generally advised to check and re-inflate the neck float prior to
subsequent uses as well. Inflatable neck floats have not typically been
sold with an air pump and are generally intended to be inflated by
mouth. In contrast, an inherently buoyant neck float likely does not
require any additional effort from the caregiver to ensure that it
floats.
Commission staff's market research indicates that inflatable neck
floats are primarily composed of plastic sheeting, typically polyvinyl
chloride (PVC) plastic, held together through a process known as PVC
welding. This manufacturing process fuses the plastic sheeting together
by applying heat that melts the individual sheets (Foreman, 2024). The
restraint systems of these neck floats also appear to be joined to the
product using PVC welding. Non-inflatable or inherently buoyant neck
floats are generally composed of two components: a buoyant internal
ring made of open- or closed-cell foam that provides the neck float's
shape and flotation, and a fabric cover that encases the foam,
typically secured with a zipper. The restraint systems are stitched
into the fabric cover.
Neck floats are advertised for use by infants and toddlers based on
minimum/maximum weight and suggested age ranges to identify appropriate
product sizes. Most retailers advertise the products for children 0 to
6 months for small sizes, 6 to 18 months for medium sizes, and 2 to 5
years for large sizes. The products generally are marketed for use in
bathtubs and pools. Retail prices for neck float products intended for
children typically range from $10 to $60 depending on material type and
art design, with inherently buoyant products being more expensive than
inflatable products.
Neck floats include: (1) inflatable neck floats; (2) inherently
buoyant (non-inflatable) neck floats; and (3) neck floats that use a
combination of inflatable and inherently buoyant components. All other
products that are not neck floats, under the definition of ``neck
float'' in Sec. 1250.5(b), are outside the scope of this rule. Life-
saving flotation devices regulated by the U.S. Coast Guard, including
those that attach to the neck of a user, are also outside the scope of
this rule.
III. Incident Data and Hazard Patterns
In the NPR, the Commission identified 115 incidents in Consumer
Product Safety Risk Management System (CPSRMS) \5\ associated with the
use of neck floats between January 2019 and January 2024. Two of these
incidents resulted in a fatality, two incidents led to hospitalization,
five incidents led to emergency department (ED) treatment, and one
incident led to care by a medical professional. The remaining 105
incidents identified in CPSRMS noted home care, possible but uncertain
medical treatment, or the level of care was not reported. In many of
the non-fatal incidents, drowning appears to have been averted due to
quick action by a caregiver to rescue the infant. Of the reported
incidents that indicate a child's age, children's ages range from 17
days to 12 months old. Where specified, most incidents occurred in home
bathtubs, though some reports indicated use in pools. The National
Electronic Injury Surveillance System (NEISS) \6\ database contained no
incident reports during that time period referencing neck floats.
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\5\ CPSRMS is the epidemiological database that houses all
anecdotal reports of incidents received by CPSC, ``external cause''-
based death certificates purchased by CPSC, all in-depth
investigations of these anecdotal reports, as well as investigations
of select National Electronic Injury Surveillance System (NEISS)
reported injuries. CPSRMS documents include hotline reports, online
reports, news reports, medical examiner's reports, death
certificates, retailer/manufacturer reports, and documents sent by
state and local authorities, among others.
\6\ NEISS is a statistically valid surveillance system for
collecting injury data. NEISS is based on a nationally
representative probability sample of hospitals in the U.S. and its
territories. Each participating NEISS hospital reports patient
information for every emergency department visit associated with a
consumer product or a poisoning to a child younger than five years
of age. The total number of product-related hospital emergency
department visits nationwide can be estimated from the sample of
cases reported in the NEISS. See https://www.cpsc.gov/Research--Statistics/NEISS-Injury-Data.
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A. Neck Float Hazards
Based on staff's assessment of the incident data reported in CPSRMS
and other information discussed in the NPR, and publicly available
consumer-uploaded pictures and videos of the product in use, the
Commission determines that neck floats pose a risk of drowning or
severe injury caused by children slipping through a neck float or being
submerged underwater while using a neck float.
As described in the NPR, drowning is a multiphase process of
pathophysiological changes (e.g., asphyxia, electrolyte imbalance,
blood volume changes, alterations in respiration) that results in death
if not interrupted. Seventy-seven incidents reported either full (76
incidents) or partial (one incident) submersion of a
[[Page 58099]]
child's airway (nose and/or mouth) in water after slipping through the
product. Additionally, 87 incidents reported a child's head slipping
through the neck hole of the product. Three incidents report turning,
rotating, or flipping in the product, leading to the submersion of the
nose and/or mouth. Because infants generally cannot self-rescue, every
slip-through or submersion incident has the potential to result in
drowning injury or death, if caregivers do not intervene to quickly
pull the infant from the water.
The Commission is aware that in four incidents, caregivers
performed medical treatment at home. In two of the four incidents,
caregivers intervened to rescue and assist an infant that was not
breathing after being pulled from the water (one report of CPR, and one
report of back thumps). In nine incidents, caregivers sought medical
attention by going to an emergency department, calling 911, calling a
nurse/medical helpline, or by visiting an urgent care. The two
incidents reporting injuries that required hospital admission, and the
two fatalities, occurred in a home bathtub. During these incidents, the
victim was submerged for an unknown length of time.
B. Incident Data and Hazard Patterns
A neck float's ability to keep the child's mouth and/or nose above
the water depends on the product's capability to remain buoyant and
upright during use, and its ability to secure the child in the intended
use position for the duration of use such that the child does not slip
through the product's neck opening and become submerged underwater.\7\
The Commission is aware of four hazard patterns associated with the
risk of drowning:
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\7\ The risk for partial slip-through poses the risk of
aspiration of water through the mouth even if the nose is not
submerged.
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(1) slip-through not associated with inflation;
(2) slip-through associated with inflation;
(3) slip-through associated with restraint system failure; and
(4) submersion without slip-through.\8\
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\8\ There is not enough information in reports for four
incidents to associate them with one of the four hazard patterns.
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1. Slip-Through Not Associated With Inflation
The Commission is aware of 52 reported incidents which involved an
infant slipping through the product despite the neck float showing no
signs of deflation, underinflation, or any other reported product
issues. Forty-four of these incidents reported a child's mouth and/or
nose submerging under the water, posing a risk of drowning or otherwise
aspirating water. Slip-through still occurred in the other seven
incidents; however, the caregiver's immediate intervention prevented
submersion. Where reported, victims ranged in age from 17 days old to 8
months old. One fatal incident involved the drowning of a 6-month-old
female child using a neck float, who was left unattended for an unknown
amount of time in a bathtub.
As discussed in the NPR, several factors can lead to an infant
slipping through the product despite the neck float showing no signs of
deflation, underinflation, or any other reported product issues. Neck
floats are typically marketed for a wide range of ages and weights, and
this variability in sizes and weights increases the possibility of an
ill-fitting neck float causing the child to slip through the neck
opening. Even if a neck float appears to fit a child securely, the
child's position and activity can cause them to slip through the
product. Incident data and publicly available consumer-uploaded content
of children in neck floats demonstrate that children are likely to tilt
their head forward and rearward, tuck their chin, bite the chin rest,
twist their head in the product, wiggle their bodies, kick their legs,
flail their arms, and even push up on the front underside of their
product, which can separate the discontinuous ends, deform the neck
opening, or otherwise alter the fit of the neck float on the child,
resulting in the child's mouth and nose sliding into the water.
2. Slip-Through Associated With Inflation
The Commission is aware of 54 incidents where children slipped
through or had the potential to slip through the neck opening because
the neck floats were more pliable or compressible at lower pressure
levels or deflated during use. Fifty-two of these incidents, including
one fatality, involved holes, tears, or other leaks in neck floats at
the time of the incident resulting in product deflation. Thirty-three
victims slipped through the product. The rest were at risk of slipping
through the product because of issues pertaining to inflation (hole,
tear, unknown deflation type, etc.). For example, IDI 220714CCC3162
indicates the product was intentionally underinflated because the
caregiver believed the victim would have been uncomfortable if it was
fully inflated. Where reported, victims ranged in age from 28 days old
to 10 months old. Two drowning injuries and one drowning death were
reported in this category.
3. Slip-Through Associated With Restraint System Failure
The Commission is aware of one incident involving a 7-month-old
infant, who slipped out of a neck float due to a latch/restraint
failure. Specifically, in the report for this incident, Y227Q815A, the
caregiver indicated that there was an issue with the ``clear plastic by
the buckle'' that caused the victim's head to slip through the neck
opening, and that the ``strap needs to be glued to the other side
otherwise it opens.''
4. Submersion Without Slip-Through
The Commission is aware of at least three incidents where children,
ranging in age from 3 months to 6 months old, either tilted, rotated,
and/or flipped such that their faces contacted the water while wearing
neck floats without slipping through the neck float and without having
a fastening or restraint system failure, putting them at risk of
drowning. No injuries or deaths were reported in this category.
IV. Voluntary Standards
A. Review of Voluntary Standards Development
For aquatic toys such as neck floats, ASTM F963-23 only specifies
minimal labeling requirements and does not establish specific
performance requirements for aquatic toys, including neck floats,
beyond the general performance requirements all toys must comply with,
as applicable.
In the past, ASTM attempted to develop additional requirements for
aquatic toys and CPSC staff participated in these efforts. In August
2022, the ASTM F15.22 subcommittee developed a dedicated aquatic toy
revision task group to develop a draft ballot with performance
requirements for aquatic toys. There have been no balloted draft
requirements to date, however. Since publication of the NPR in November
2024, on December 2, 2024, ASTM held an exploratory call to determine
whether there was interest from its members to designate a subcommittee
dedicated to drafting the proposed voluntary standard. On January 13,
2025, ASTM held an organizational call to discuss the scope of the
prospective standard and proposed definitions for products falling
within that scope. On February 27, 2025, CPSC was alerted that ASTM
Committee F15 established a new subcommittee on buoyancy aids for
children, F15.07, to develop a draft standard for buoyancy aids,
including neck floats.
[[Page 58100]]
The F15.07 subcommittee had its first meeting on March 27, 2025,
and created two task groups: one for performance requirements and one
for warnings/labels. These task groups have met monthly since then. The
subcommittee scheduled a second meeting on June 24, 2025, to discuss
both task groups' progress. CPSC staff have participated in all
subcommittee and task group meetings since the exploratory call in
December 2024. The task groups have also considered how other existing
standards address products similar to the subject of the draft
voluntary standard. CPSC staff recommended the task groups consider the
requirements proposed in the NPR.
The F15.07 subcommittee is still in the process of developing its
draft voluntary standard. There have been no balloted draft
requirements to date, nor is CPSC aware of an expected schedule for a
future ballot on draft requirements. Voluntary standards development is
an iterative process, and there is no set minimum time limit within
which a draft standard must be completed for consideration by the
subcommittee.
B. Other Relevant Standards
The U.S. Coast Guard uses ANSI/CAN/UL 12402-5:2022, Personal
Flotation Devices--Part 5: Buoyancy Aids (Level 50)--Safety
Requirements, and ANSI/CAN/UL 12402-9:2022, Personal Flotation
Devices--Part 9: Test Methods, to evaluate level 50 Personal Flotation
Devices (PFDs) such as life vests. Some PFDs utilize flotation devices
located around the user's collar, similar to neck floats. PFDs are
classified into levels based on intended use conditions, including calm
versus stormy water and relative closeness to possible rescue, such as
at the beach versus offshore, with level 50 being the least stringent.
These factors are not comparable or relevant to the use of neck floats
in a pool or bathtub environment. ANSI/CAN/UL 12402-5:2022 does
classify possible PFD users into four categories based on weight, with
``Infant PFDs'' being intended for users weighing less than 15 kg (33
lbs.). However, certain performance requirement metrics for level 50
PFDs are listed as ``not allowed'' for the infant class. For these
reasons, ANSI/CAN/UL 12402-5:2022 and ANSI/CAN/UL 12402-9:2022 are not
appropriate to apply to regulate neck floats, without sufficient
modification, to adapt its otherwise universal test methods with
acceptance criteria suited for the infant class.
BS EN ISO 13138:2021, Buoyant aids for swimming instruction, is a
multi-part standards collection for the European Union's (EU) three
swimming aid classifications. Class A swimming aids such as swim seats,
covered by BS EN ISO 13138-3:2021, are intended to be used by children
up to 36 months as a ``passive'' user to introduce them to the in-water
environment. Class B swimming aids, covered by BS EN ISO 13138-1:2021,
are intended to introduce an ``active'' user to the range of swimming
motions. Class C swimming aids, covered by BS EN 13138-2:2021, are
products held in the hands or by the body and are intended to aid
``active'' users with improving specific aspects of swimming strokes.
Class C swimming aids are intended for use by advanced swimmers, or
even adult beginners.
Class A devices as defined by BS EN ISO 13138:2021 most closely
align with the target users of neck float products within the scope of
this rule. However, BS EN ISO 13138:2021 classifies flotation products
that attach at the neck as Class B devices. Most of the general
performance requirements in BS EN ISO 13138-1:2021 and 13138-3:2021 and
the associated test methods across the two standards are largely
identical, with some exceptions. Many of the unique tests for Class A
devices in BS EN 13138-3:2021 do not apply to neck floats because Class
A devices are swim seats. Tests for Class A products are not
appropriate for neck floats because these flotation devices are placed
and attached at the waistline versus at the neck for Class B flotation
devices.
Additionally, test methods in BS EN ISO 13138-1:2021 for Class B
devices, including buoyancy testing, align with the test methods for
their respective counterparts in ANSI/CAN/UL 12402: 2022, although the
exact performance requirements differ. The risk management factors and
tests of both ANSI/CAN/UL 12402:2022 and BS EN ISO 13138-1:2021 may
address many of the hazards identified in section III of this preamble
and are universal in application. However, to adequately address the
identified hazards associated with neck floats, the performance
requirements and test methods will require modifications, as discussed
in more detail in section VI of this preamble.
V. Response to Comments
The Commission received 145 comments on the NPR during the comment
period. Comments can be accessed by searching for docket number CPSC-
2024-0039 at http://www.regulations.gov.
Commenters included industry members, consumer advocacy groups,
physical therapists, and consumers. A manufacturer, Otteroo, submitted
comments and divided its comments into 85 separate submissions, so 85
of the 145 comments were from Otteroo. Several comments were submitted
on behalf of multiple parties, such as joint submissions from Consumer
Reports, Safe Infant Sleep, and the U.S. Public Interest Group.
Three comments expressed direct support for the NPR, while six
other comments expressed agreement that neck floats required
regulation, but disagreed with the approach taken by the NPR. Seventy-
eight comments were generally against the proposal, 27 did not express
an opinion on the proposal itself, and 25 suggested changes to the
proposal without indicating whether they were for or against it. Six
comments were determined to be out of scope.
All comments fell into eight broad categories: (1) scope of the
rule; (2) hazards and incident data; (3) recalls; (4) voluntary
standards; (5) performance requirements; (6) marking and labeling
requirements; (7) prohibited stockpiling; and (8) regulatory
alternatives. The comments are summarized and addressed below,
organized by category. Public comments related to small business issues
are discussed in section XII of this preamble.
A. Scope of the Rule
1. Neck Floats
Comments: The Commission received 27 comments from consumers, a
professional engineer, two former lifeguards/swim instructors, Consumer
Federation of America, Safe Infant Sleep, U.S. Public Interest Research
Group, US Drowning Research Alliance, the Toy Association (TA) and
Otteroo discussing the classification of neck floats as toys under the
mandatory toy standard, which incorporates ASTM F963-23. Some
commenters stated that neck floats should not be considered a toy. For
instance, a consumer asserted that neck floats do not meet the
definition of a ``toy'' in ASTM F963-23. The same consumer argued that
Congress did not authorize CPSC to change the definition of ``toy'' or
an ``aquatic toy'' in ASTM F963-23 by claiming that it is inherent in
the definition of ``aquatic toy'' that for an item to be an
``instrument of play,'' it needs to provide play value. In addition,
Otteroo, a neck float manufacturer, stated that other international
bodies such as the EU do not consider neck floats to be toys. Otteroo
asserted that neck floats are not marketed as playthings and are not an
instrument of play because their primary purpose is as a buoyancy aid
even if the user may
[[Page 58101]]
engage in play and experience joy while wearing the neck float.
The TA asserted that the Commission referred to neck floats as non-
toy items in past statements. TA noted: (i) a warning issued by CPSC in
November 2022 where an Otteroo product was described as an infant
flotation ring; (ii) a Commissioner's statement about this warning
which also discussed how new parents should be informed before buying
baby products generally; (iii) communication by the CPSC Small Business
Ombudsman telling a manufacturer that neck floats are not toys; and
(iv) previous communication with CPSC staff also indicated that it was
not a toy. TA also claimed that third-party labs agree that neck floats
are not toys.
The Commission also received comments suggesting that neck floats
should be classified as non-toy products based on other uses. Some
commenters provided alternative classifications such as flotation
devices, medical devices, and bathing aids. A consumer stated that a
neck float is not a toy and should be considered as an aid or a device
because the user is strapped in and unable to escape without support.
The Consumer Federation of America, Safe Infant Sleep, and the U.S.
Public Interest Research Group stated that caregivers use neck floats
as safety devices, not for amusement. Otteroo also commented that
classifying neck floats as toys ignores possible medical and functional
uses of neck floats and requested that the definition of neck floats
should be revised to account for these possible uses.
Response: The Commission considers a neck float to be an ``aquatic
toy,'' as defined in ASTM F963-23, and a ``toy'' subject to the
mandatory toy standard. ``Toy'' as defined in section 3.1.92 of ASTM
F963-23 is ``any object designed, manufactured, or marketed as a
plaything for children under 14 years of age.'' The term ``plaything''
used in the definition of ``toy'' is not defined in ASTM F963-23. In
addition, contrary to the commenter's assertion, the term ``play
value'' is not a requirement in the standard's definition of ``toy'' or
``aquatic toy.'' ASTM F963-23, however, in section 1.4 is explicit
about excluding articles ``not primarily of play value'' such as
finished materials from model kits. Also in section 1.4, ASTM F963-23
specifically excludes items such as ``constant air inflatables,'' but
no other inflatables or any aquatic toys are specifically excluded.
ASTM F963-23 does contain specific definitions for certain types of
toys, including aquatic toys. ``Aquatic toys'' as defined in section
3.1.4 of ASTM F963-23 is ``an article, whether inflatable or not,
intended to bear the mass of a child and used as an instrument of play
in shallow water . . .'' (Emphasis added). This is not unusual in ASTM
F963-23, as the standard provides definitions for other specific types
of toys, subject to the mandatory toy standard, such as: battery-
operated toy (3.1.11); close-to-the-ear toy (3.1.14); hand-held toy
(3.1.37); large and bulky toy (3.1.46); latex ballon (3.1.47);
magnetic/electrical experimental set (3.1.49); projectile toy with
stored energy (3.1.64); push or pull toy (3.1.69), rattle (3.1.70);
soft-filled toy/stuffed toy (3.1.82); squeeze toy (3.1.85); tabletop,
floor, or crib toy (3.1.89); teether (3.1.91); toy chest (3.1.93); toy
seat (3.1.94); and yo yo elastic tether toy (3.1.95). All the
definitions of these toys contain a description of the specific toy and
their function and intended use. This is also the case for the
definition of aquatic toy, which describes the toy (inflatable or
uninflatable article), function (to bear the mass of a child) and use
(as an instrument of play in shallow water).
Neck floats meet the definition of an aquatic toy in the standard
because they are ``article[s]'' that are available as ``inflatable or
not'' and are ``intended to bear the mass of a child'' and are ``used
as an instrument of play in shallow water.'' Neck floats are included
within the broader definition of an ``aquatic toy'' in the standard and
thus are toys as defined in ASTM F963-23. Moreover, the definition of
latex balloon in ASTM F963-23 lists examples of toys used in an aquatic
environment which includes ``rafts, water wings, swim rings, and other
similar items.'' Neck floats are comparable to these listed items
because they are commonly designed, marketed, intended, and used to
provide buoyancy for play and amusement in water. This means that neck
floats are used to keep a child afloat (avoid sinking, not life-saving)
to allow them to play in the water, which is similar to other aquatic
toys such as water wings and swim rings.
In addition, although the Commission's mandatory toy standard
already includes aquatic toys such as neck floats within the scope of
the standard, the Commission is not limited to promulgating safety
standards only for toys within ASTM F963's existing standards. Rather,
Congress mandated that the Commission also ``take into account other
children's product safety rules,'' promulgate standards that are more
stringent than existing standards to further reduce the risk of injury,
and ensure that its mandatory toy safety rules ``provide the highest
level of safety for such products that is feasible.'' 15 U.S.C.
2056b(b)(c).
Furthermore, contrary to Otteroo's assertion that neck floats are
not marketed as playthings, Otteroo's own marketing and customer
reviews shared on its web pages and social media demonstrate that
Otteroo has marketed their products as toys for water play, calling
them ``water toys'' and highlighting ``guided water play'' under their
``Otteroo Activities'' tab (Figure 1).9 10
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\9\ https://otteroo.com/pages/is-it-safe?srsltid=AfmBOopkWsZ7LuzxF9zoosxgdnEe3cfDS74D0Q9sfhFVfIxC6xM2Rzo8
.
\10\ https://otteroo.com/pages/activities.
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BILLING CODE 6355-01-P
[[Page 58102]]
[GRAPHIC] [TIFF OMITTED] TR15DE25.013
Otteroo also posted a blog post on its website, ``How Early Water
Play Can Support Your Baby's Development,'' which describes its product
as useful for playing in the water and having fun, and states: ``Your
baby will be having such a good time exploring and enjoying his or her
newfound freedom that you'll forget that the time with Otteroo playing
in the water is so good for your kiddie, too!'' \11\ In another blog
post (Figure 2), ``Why Baby Neck Floats are NOT Potential Death
Traps,'' Otteroo clarifies that its neck float products are not life-
saving devices and not swimming-aids; instead, the manufacturer
clarifies that its ``Baby neck floaties are a bath (and pool) toy.''
---------------------------------------------------------------------------
\11\ https://otteroo.com/blogs/stories/how-early-water-play-can-support-your-baby-s-development?srsltid=AfmBOoovvxQr4eSpg4T5i1XjIAVGHs-8OnmSJ4wPQ-VgVaHkFdZgnWio.
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[[Page 58103]]
[GRAPHIC] [TIFF OMITTED] TR15DE25.014
In addition, on Otteroo's YouTube page, the company shares an
interview with Julie Forbes, who Otteroo says is their ``Otteroo mom.''
\12\ In the interview, Ms. Forbes describes Otteroo neck floats as
``for most babies, this is a fun toy. It gets them comfortable in the
water. They can enjoy water play.'' Otteroo's YouTube channel also
spotlights a video of children smiling and wearing neck floats in the
water and asks whether the babies are having fun because of water
play.\13\ Otteroo also shares customer reviews of its product, where
consumers share descriptions and pictures of their children using neck
floats and having fun, playing in and enjoying the water (Figure
3).\14\
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\12\ https://otteroo.com/blogs/stories/who-s-our-otteroo-mom?srsltid=AfmBOopKXymLrDjeI_TY_gNSs9nqt28_qciTK-uxqrRH6f9AZABRWTzJ.
\13\ https://www.youtube.com/@otteroobaby.
\14\ https://otteroo.com/collections/all.
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[[Page 58104]]
[GRAPHIC] [TIFF OMITTED] TR15DE25.015
There are also others who advertise neck floats as toys for water
play,\15\ show children playing in water \16\ (Figure 4), and their
neck floats are designed for enjoyment in water \17\ (Figure 5).
---------------------------------------------------------------------------
\15\ https://www.touchoftrending.com/products/the-baby-swimming-neck-float-safe-ring?variant=42550320-bea5-48ad-be20-e95c9c883b53&msclkid=4ccb18595d02137fdee77036abb2ab13&utm_source=bing&utm_medium=cpc&utm_campaign=Touch0916&utm_term=4581115211270450&utm_content=Ad%20group%20%231.
\16\ https://verniershop.com/products/baby-floating-neck-ring?utm_medium=cpc&utm_source=bing&utm_campaign=Bing+Shopping&msclkid=c6d124bf8b56162364044cd07de6be13&variant=42462911627334.
\17\ https://ozerty-usa.com/products/baby-floating-neck-ring?variant=48142874509605&ref=BINGMANUALALL&msclkid=f45c80595bf615a05596e836ad466e32.
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[[Page 58105]]
[GRAPHIC] [TIFF OMITTED] TR15DE25.016
BILLING CODE 6355-01-C
In addition, the mandatory toy standard does not exclude products
that are toys because a user is strapped in and unable to escape
without assistance. Also, while regulatory approaches of other
entities, such as the EU, may be informative to CPSC, the Commission is
not subject to or limited by regulatory frameworks based on EU laws and
policy.
In response to TA's comments attributing certain statements to
CPSC, the Commission clarifies:
(1) A CPSC warning described the product as an ``infant flotation
ring'' which is similar to a swim ring in the toy standard; regardless
the notice did not classify how the product was regulated and merely
provided a description of the product.
(2) The statement issued by a Commissioner discussed baby products
in general, cautioning parents to be wary of their claims. The
statement did not claim that neck floats are not toys.
(3) Third-party labs' opinions regarding a legal interpretation of
the Commission's regulations are not relevant/controlling.
(4) The commenter's claim about communication with the CPSC staff
and the office of the Small Business Ombudsman (SBO) about the
product's determination premanufacturing is not supported by any
evidence or context. In addition, guidance provided by the
[[Page 58106]]
SBO or staff is considered non-binding.\18\
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\18\ Consumer Product Safety Commission, ``Small Business
Ombudsman Mission,'' Oct. 2014, available at: https://www.cpsc.gov/s3fs-public/pdfs/blk_pdf_SBOmissionFinal3.pdf.
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2. Other Products
Comments: The Commission received seven comments from Otteroo
regarding the decision to propose rulemaking for neck floats. Otteroo
stated that there are other consumer products that have resulted in
drowning deaths and injuries including pools, bathtubs, and buckets.
Otteroo questioned why CPSC is disproportionately focusing on neck
floats, despite a letter to ASTM in 2021 which included incident
reports for a range of other inflatable bather products, including four
fatalities attributed to non-neck float consumer products. Otteroo
questioned why the NPR only concerned neck floats and requested CPSC to
address all forms of inflatable products instead of just neck floats.
Otteroo also requested CPSC to clarify its position on other consumer
products, such as bathtubs, buckets, and car seats that are also
involved in incident reports of injury or death due to consumer misuse
or neglect, and to explain why the Commission allegedly is focusing on
neck floats despite Otteroo's assertion that data point to a lack of
supervision as the primary risk factor, not the product design.
Response: Other consumer products are out of scope for this
rulemaking. The Commission's decision to promulgate a safety standard
for neck floats is based on hazards identified in the incident data and
staff's expertise and assessment to support that a more stringent
standard will further reduce the risk of injury and will provide the
highest level of safety for such products that is feasible. Data
requests made by ASTM or other groups do not determine the focus of
rulemaking, and the Commission's decision to pursue rulemaking
regarding neck floats is not an indication that other product areas are
not of concern to the agency, nor an indication that rulemaking will
not be considered for other consumer products.
The incident data shared with ASTM in 2021 contained 26 total cases
concerning ``inflatable infant bather products'' used in bathtubs and
pools. In that letter, staff stated that they believed the products in
question met the definition of an aquatic toy from section 3.1.4 of
ASTM F963-19. Contrary to the assertions from the comment, that data
included six fatalities across all 26 reported incidents and the
majority (four) of those fatalities were attributed to neck float use.
CPSC does not dismiss the impact and importance of proper
supervision around water environments, and stresses that caregivers
must maintain proper supervision around those environments as expressed
in the labeling requirements in this final rule. However, relying on
caregiver intervention to prevent an ongoing incident from resulting in
catastrophic injury or death is not a valid alternative to performance
requirements that can reduce the risk of those incidents occurring.
CPSC staff's assessment of incident data in the NPR supports the
Commission's determination that the primary risks associated with neck
float use, including slip-through, restraint system failure, and
submergence without slip-through, can be reduced through the
performance and warnings/labeling requirements of this final rule.
3. Other Uses
Comments: Twenty-four commenters including consumers, Tender Ones
Therapy Services, Inc., a professional engineer, a pediatric physical
therapist, two former lifeguards/swim instructors, a clinic employee,
Consumer Reports, Safe Infant Sleep, the U.S. Public Interest Research
Group, Consumer Federation of America, U.S. Drowning Research Alliance,
and Otteroo discussed possible medical/therapeutic uses of neck floats
and U.S. Food and Drug Administration's (FDA) activities regarding neck
floats. Some commenters stated their belief that neck floats have
medical/therapeutic benefits and uses, or they are primarily
manufactured to attain those benefits. Otteroo asserted that these
possible medical benefits were not considered by the Commission and
detailed their efforts with FDA to pursue a De Novo application to
classify neck floats as a medical device. Some commenters noted a
previous FDA publication warning against the use of neck floats as they
may pose a risk to infants. Otteroo commented that the FDA warning
should be removed because it is ``outdated.''
Response: Medical or therapeutic uses of neck floats that are FDA-
regulated medical devices are not within the scope of this rulemaking.
Any neck floats that are medical devices under 15 U.S.C. 2052(a)(5)(H)
are not subject to this rule.
The FDA has previously issued a warning against the use of neck
floats on June 28, 2022, advising against their use with babies for
water therapy interventions, especially with babies who have
developmental delays or special needs such as spina bifida, spinal
muscular atrophy (SMA) type 1, Down syndrome, or cerebral palsy,
stating the use of these products can lead to death or serious injury.
The warning further states: ``Recently, the FDA became aware of
companies marketing neck floats for use as a water therapy tool without
FDA clearance or approval. The FDA has communicated our concerns about
these promotional materials to these companies and will continue to
monitor promotional materials and claims for these devices.'' CPSC
requested comments on the NPR regarding this FDA warning, as it is
considered relevant to the discussion of neck float safety.
B. Hazards and Incident Data
1. Toy Hazards
Comments: Three consumers, a professional engineer, Swim Safety
Education, Consumer Reports, Consumer Federation of America, U.S.
Drowning Alliance, Otteroo, and the TA expressed concerns that
classifying neck floats as toys may trivialize the hazards by creating
a false sense of security for consumers. TA further elaborated that
``characterizing infant neck floats as toys sends a message that these
are primarily children's products and safe for children, like other
children's `toys,' rather than properly emphasizing the unique risks
and how the product should be safely used, i.e., only under direct and
full-on supervision of an adult, and constant vigilance. Consumers may
hear `toy' and lower their guard towards drowning risk.'' Other
commenters explained that even if considered an ``aquatic toy,'' it is
plausible that a neck float's resemblance to a life-saving device
creates a false sense of security that may cause caregivers to lower
their guard towards the drowning risk. Swim Safety Education proposed
creating a distinct category of attaching/wearable floats to prevent
trivializing safety concerns.
Response: The Commission disagrees that categorizing neck floats as
toys trivializes the submersion hazards associated with them. These
products are already marketed and sold as toys. Otteroo neck floats,
for example, have been marketed as a ``fun toy'' used for ``playing in
the water,'' as described above. Additionally, Congress recognized that
toys may present a risk of injury or death to children and directed
CPSC to address that risk via rulemaking. 15 U.S.C. 2056b.
It is well-documented that toys and other recreational products
intended for children can pose serious, even life-threatening hazards.
The Commission's mandatory toy standard and the ASTM
[[Page 58107]]
F963 toy standard are designed to reduce the likelihood of death and
serious injury associated with toys, including toys used in aquatic
activities like rafts, water wings, and swim rings. Neck floats that
are designed and marketed to keep a child's mouth and nose above the
water without the child having to perform an action, such as tread
water or hold onto the product, are especially likely to be seen by
caregivers as a method of keeping children floating above water, even
if they are toys or have warnings indicating they are not life-saving
devices.
CPSC agrees that the resemblance of neck floats to products
intended as life-saving devices, particularly the design and marketing
of these products, creates a false sense of security for caregivers.
The toy standard regulates against risks/hazards, but the product is
still a toy. Thus, the final rule incorporates performance and labeling
requirements to emphasize the unique risks and promote safe use.
2. Slip-Through Hazard
Comments: Otteroo requested CPSC to provide empirical evidence,
such as a human factors study or data analysis, to support the
assertion in the NPR that ``neck floats can feel secure around a
child's neck and appear as though the child's head cannot pass through
the neck opening, yet, during use, whether from deflation, the child's
activity, or both, the child's head does slip through the product such
that their mouth and nose become submerged;'' and the claim that ``some
caregivers intentionally inflate neck floats to air pressures that
leave space around a child's neck to address their perception of
discomfort for their child, not appreciating that the likelihood of
slip-through increases as the product's inflation level decreases.''
Response: In developing this rule, CPSC staff examined various
child neck floats on the market, including those most frequently cited
in incidents involving children slipping through the neck opening.
Staff tested neck floats by placing the products around the necks of
anthropometrically accurate infant and toddler dolls in and out of
water to evaluate the likelihood and relevant circumstances for slip-
through to occur. This examination included varying Pounds-per-Square-
Inch-Guage (PSIG) pressure amounts. Staff observed that the neck floats
could feel sufficiently snug to prevent the dolls' heads from slipping
through the neck opening, whether fully or partially inflated, yet, due
to various reasonably foreseeable circumstances, such as the
application of lubricants like soapy water (e.g., IDI 210901CCC1906
indicates the victim had a ``heavy lather'' of soap on their head and
their head slipped through the neck opening because their head and neck
were slippery), deflation during use (e.g., IDI 220714CCC3155 indicates
the incident unit deflated during use due to a hole that the caregiver
identified via a bubble test following the slip-through incident), and
body movements like pushing up on the front underside of the product
while leaning back, such as seen in Figure 6, could cause the neck
opening to deform and expand to the point that the child's mouth and/or
nose slip underwater. The Commission also notes that Otteroo has
recognized that if a neck float deflates during use, such as from a
leak, the child can slip through it: ``Otteroo [(the neck float)] won't
hold its shape if a leak develops and your baby can slip through.''
\19\
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\19\ Otteroo, ``So, is Otteroo safe?,'' at https://otteroo.com/pages/is-it-safe?srsltid=AfmBOopkWsZ7LuzxF9zoosxgdnEe3cfDS74D0Q9sfhFVfIxC6xM2Rzo8
.
[GRAPHIC] [TIFF OMITTED] TR15DE25.017
Numerous incident reports describe incident units having a tight
fit when placed on the victims, yet slip-through occurred nonetheless
(e.g., IDI 210910CCC1030 indicates the incident unit was ``fully
inflated'' and felt ``quite tight,'' yet the victim's head slipped
through the neck opening). Additionally, as explained in the NPR, some
slip-throughs involved neck floats that caregivers had intentionally
underinflated, due to their perception that the victims were
uncomfortable when the neck floats were fully inflated (e.g., IDI
220714CCC3162 indicates the caregiver intentionally underinflated the
incident unit because she was ``worried about the product being too
tight around the victim's neck''). Inflatable neck floats typically do
not have other means for adjustability of the fit around the child's
neck beyond the amount of inflation, so it is reasonably foreseeable
that caregivers seeking to adjust the fit would intentionally
underinflate the product. Slip-through due to inadequate inflation may
also be unintentional in nature, as there is no clear metric for users
to determine what ``full inflation'' means, and overinflation may
result in the product bursting.
[[Page 58108]]
3. Restraint System Failure
Comments: Otteroo requested CPSC to remove the hazard pattern for
``Slip-Through Associated With Restraint System Failures'' and its
associated test requirements from the final rule unless it can produce
a human factors study or usability testing. Otteroo stated that the
only incident data cited in conjunction with the restraint system
hazard pattern shows a manufacturing defect, not a design failure, and
there are no incidents to support fasteners becoming undone that would
support the need for such requirements. Otteroo added that given the
age range of the product, the only way the fasteners could come undone
is through caregiver action, and such user error can only be addressed
through education and warnings, not through additional product
requirements. Lastly, Otteroo claimed that the mitigation strategy of
clear warnings emphasizing close supervision was employed successfully
in this hazard pattern.
Response: The integrity of the fasteners, including their
connection to each other and to the product, can be affected by user
weights, sizes, and actions, such as children pushing up on the floats,
kicking, and thrashing. Failure of the fastener/restraint system,
whether from disconnecting entirely or simply loosening during use, is
likely to result in the child's mouth and nose being submerged in
water, and the requirements in the rule are intended to address both
design and manufacturing defects that similarly pose a drowning hazard
to children. Requiring fastener and restraint system performance
requirements is a standard practice in safety standards concerning
infant-used products where applicable, such as in section 6.4 of ASTM
F833-21 for carriages and strollers, which was, in part, incorporated
by reference in this final rule. Therefore, the Commission will not
remove the hazard pattern and associated test requirements from the
rule.
4. Incident Data
Comments: Otteroo asserted that in CPSC's description of IDI
230317CCC3554 in the NPR contradicts the details contained in the
report. Otteroo claimed that the report did not note that any injury or
treatment was received for the submersion incident. Otteroo also
asserted that CPSC inaccurately claimed that this incident resulted in
an injury that required hospital admission.
Response: According to the narrative in IDI 230317CCC3554, the
``child was found limp and cyanotic with his face underwater,''
caregivers administered CPR, and the child subsequently required
hospitalization. This is consistent with the description in the reports
associated with IDI 230317CCC3554. Incidents in which a victim is
minimally symptomatic typically resolve without sustaining serious
injuries or requiring continued medical treatment, but incidents where
a victim swallows or aspirates significant amounts of water requires
medical attention or observation.
Comments: Otteroo commented that CPSC attributed the incident in
IDI 230720CCC1797 to the ``slip-through not associated with inflation''
hazard pattern. Otteroo stated that CPSC implied that there is a design
defect in the neck float's chin rest. Otteroo noted that in this
incident, the caregiver did not perform a bubble test to check for
leaks. Otteroo suggested that the neck float may have had an undetected
leak and asserted that a chin rest does not function to prevent slip-
throughs. Otteroo requested that the CPSC remove the reference to this
IDI from the rule to avoid presenting what Otteroo characterizes as
unsupported conclusions that unfairly mischaracterize the product.
Response: As explained in the NPR, IDI 210824HCC1797 indicates the
victim's head slipped through the neck opening as he turned his head.
There was no indication that the product had deflated at the moment of
slip-through. Therefore, the Commission is not removing IDI
230720CCC1797. The NPR does not cite this case as evidence of a design
defect in the incident unit's chin rest; rather, the NPR cites this
case as evidence that, while the chin rest may help reduce the
likelihood of slip-through, it does not prevent slip-through, as
evidenced by the fact that the majority of incident units had
pronounced chin rests. Otteroo argued that the chin rest does not
function to prevent slip-through; however, chin rests are intended to
support the child's chin above the water, making it more difficult for
their mouth to go underwater. The chin rest also provides a visual
indication of how the neck float is intended to be oriented, as slip-
through is much more likely to occur if the child's face is against the
discontinuous ends, which can separate and deform more easily than the
other sides of the neck opening. One adverse consequence of this design
is that consumers are more likely to mistakenly believe the child's
head cannot pass through the neck opening because their chin is
supported; however, deformation of the neck opening and the child
twisting or tilting their head can negate this benefit of the chin
rest.
Comments: Otteroo asserted that CPSC incorrectly determined that a
neck float was associated with the incident in IDI 200915HFE0001
because a police report stated that the caregiver initially told the
police on the scene that the infant was placed in a bath seat after
using a neck float. Otteroo further argued that there was no conclusive
evidence that a neck float was being worn by an infant at the time of
the incident in IDI 200915HFE0001.
Response: In the Maine state police report associated with
200915HFE0001, the victim was wearing a neck float at the time of the
incident. The police report indicated the caregiver specified that a
bath seat was placed in the bath after she found the infant non-
responsive. She further explained that she put the bath seat in the tub
because she was scared and did not want her mother to be mad at her for
what happened. The police report also described the caregiver
explaining that she placed the victim in the neck float and recorded
videos of the victim using it prior to his drowning. Maine's Office of
Child and Family Services assessment narrative and a Maine state police
audio interview with the victim's mother contained in the IDI
corroborates this narrative.
Comments: Otteroo requested that IDIs 210826CCC1826, 210901CCC3625,
210910CCC1030, 210901CCC1904, 210910CCC1029, 220714CCC3164,
230317CCC3555, and 230720CCC1766 and incident Y227C309G be removed from
the rule or revised to reflect the full context of the incidents,
including the caregiver's attentiveness and absence of any injuries,
because the severity of the incident is allegedly misrepresented and
Otteroo asserts that CPSC failed to acknowledge the effectiveness of
close supervision as a risk mitigation strategy.
Response: The incident data relied upon for the analysis in the NPR
accurately describes the severity of the incidents in the referenced
IDIs. None of these incidents resulted in an injury, and the NPR did
not describe these incidents as injuries. Instead, the NPR describes
the actions that caregivers took, including seeking medical attention
or providing home care following the incident. In IDI 220714CCC3164,
caregivers provided treatment at home, as described in the NPR. In IDIs
210826CCC1826, 210901CCC3625, and 230720CCC1766 and incident Y227C309G,
caregivers sought medical attention by going to an emergency
department. In IDI 210910CCC1029, caregivers visited an
[[Page 58109]]
urgent care. Caregivers called 911 in IDI 210910CCC1030 and a nurse/
medical helpline in IDIs 230317CCC3555 and 210901CCC1904. As discussed
in the NPR, every slip through or submersion incident has the potential
to be a drowning, resulting in injury or death, if caregivers do not
intervene quickly to pull the infant from the water. Based on this
information, the Commission is not removing or revising the specified
IDIs and Y227C309G.
Comments: Otteroo asserted that the conclusion that the infants in
IDIs 2108826CCC3606 and 220714CCC3164 received medical treatment is not
supported by the facts. Otteroo also stated that the conclusion that
``the caregivers intervened to resuscitate an infant'' in incident
I2360082A is an exaggeration of the events described and requested that
the phrase ``caregivers intervened to resuscitate the infant'' be
removed from the rule.
Response: The Commission disagrees that the IDIs 2108826CCC3606 and
220714CCC2164 mischaracterize the care the infants received. The NPR
clearly stated that in both incidents no medical attention was sought
from medical professionals, and no injuries were reported. The
Commission, however, agrees with the commenters that the phrase
``caregivers intervened to resuscitate an infant'' may not accurately
reflect the scenario in the incident and clarifies that caregivers
intervened to rescue and assist the infant.
Comments: Otteroo stated that in IDI 220714CCC3155, CPSC
intentionally combined details from two separate incidents to create a
misleading narrative that proper inspections and the bubble test are
ineffective. Otteroo requested the removal of IDI 210901CCC1899 from
the rule because it is used twice in the NPR as an exemplar incident,
once to discuss environmental factors such as confined spaces and again
to discuss product tears.
Response: CPSC staff examined all available incident data
associated with inflatable neck floats. In the case of IDI
220714CCC3155, this includes multiple incidents reported by a consumer
that are associated with the same product. Some incidents, such as IDI
210901CCC1899, document multiple risk factors that resulted in an
incident. These incidents are relevant to the Commission's
determination that neck floats pose a risk of drowning, and so the
Commission is not removing the IDIs.
Comments: Otteroo requested the removal, or a revision with full
context, of IDI 210901CCC1906, used as an example of how lubricants
make neck floats more slippery because the incident description omits
that the caregiver identified a leak near the product chin rest.
Otteroo asserted that soapy water is a common and expected use case for
neck floats and requested that the CPSC remove references to soapy
water in the NPR and eliminate its associated testing in the neck
opening performance requirement because these elements lack sufficient
evidence and risk imposing unnecessary regulatory burdens that do not
align with the identified root causes of incidents.
Response: The Commission is not removing references to soapy water
in the NPR or eliminating its associated testing requirements. The
Commission concludes that many neck floats are marketed for use when
bathing children and the slipperiness of the neck float's material and
exposure of the neck float to lubricants can allow the product to slide
more easily against the child's skin, increasing the likelihood of the
child twisting and slipping through the product during use.
Comments: Otteroo requested CPSC to revise its inclusion of IDI
220714CCC1014 in its current form, to ensure all possible contributing
factors (such as underinflation) are investigated before drawing
conclusions, and to acknowledge the critical role of caregiver
supervision in the incident. Otteroo also commented that although IDI
220714CCC3162 is an example of an underinflation incident where the
caregiver intentionally underinflated the neck float, it is important
to note that the caregiver was present and closely supervising the
infant throughout the incident, demonstrating caregiver attentiveness
to mitigate risk in that case. Additionally, Otteroo stated that
caregivers will reinflate as they did in IDI 210908CCC1982 or reglue
the clear plastic near the buckle as they did in Y227Q815A of a neck
float instead of seeking a replacement and that caregivers will
continue to use the product, demonstrating that caregiver supervision
is effective in maintaining safety even when product issues such as
deflation arise.
Response: The Commission disagrees with the commenter regarding the
conclusions related to IDI 220714CCC1014. In this incident report, the
victim's caregiver performed a bubble test after inflating the product
by mouth and did not observe any visible leaks, yet the neck float
deflated. Therefore, it is unlikely, based on the investigation, that
the caregiver underinflated the product.
Regarding the role of caregiver supervision in IDIs 220714CCC1014,
220714CCC3162, and 210908CCC1982 and incident Y227Q815A, every slip-
through or submersion incident has the potential to be a drowning,
resulting in injury or death, if caregivers do not intervene to quickly
pull the infant from the water. Drowning statistics and water safety
campaigns have shown that caregiver supervision can be imperfect and
insufficient to avoid drowning hazards, and many children drown every
year.20 21 Caregiver supervision should not be relied on to
prevent injuries and death when product issues arise such as deflation
and restraint/buckle issues. In fact, the labeling requirements in the
rule acknowledge that caregiver supervision is imperfect and these
requirements are intended, along with the other requirements of the
rule, to mitigate the drowning hazard. Therefore, the Commission
declines to remove or revise the IDIs to clarify caregiver
attentiveness or supervision.
---------------------------------------------------------------------------
\20\ See AAP on drowning: https://www.aap.org/en/patient-care/early-childhood/early-childhood-health-and-development/safe-environments/drowning/; accessed on March 20, 2024.
\21\ See CDC on drowning facts: Drowning Facts [verbar] Drowning
Prevention [verbar] CDC; accessed on March 20, 2024.
---------------------------------------------------------------------------
Comments: Otteroo disagreed with CPSC's categorization of IDIs
220714CCC3166 and 220714CCC3156 and incident Y217O989B as submersion
for children ``tilting, rotating, or flipping such that their face
contacted the water.'' Instead, Otteroo claimed that these incidents
did not involve slip-throughs in the neck float or restraint system
failures and therefore should not be considered submersion events.
Otteroo stated that the incident IDIs demonstrate the effectiveness of
close supervision as a reliable mitigation strategy. Specifically,
Otteroo suggested that the incident in IDI 220714CCC3156 should be
categorized under the hazard pattern for ``Slip-Through Associated With
Inflation'' rather than ``Submersion Without Slip-Through'' because
water was found in a chamber of the neck float following the incident
by the caregiver and suggested removal of IDIs 220714CCC3156 and
220714CCC3166.
Response: Children can be submerged in water while wearing neck
floats without slip-through or fastener and restraint system failures,
putting them at risk of drowning. In at least three incidents, children
reportedly tilted, rotated, and/or flipped in the neck float such that
their faces contacted the water. In IDI 220714CCC3166, the child tilted
forward and ingested water; in IDI 220714CCC3156, the child was able to
rotate his body such that his face was in contact with water; and in
report
[[Page 58110]]
Y217O989B, a child leaned back and flipped in the product. These are
considered submersion events because the victim was able to contact the
water with their face, posing a drowning risk. Additionally, IDI
220714CCC3156 should not be moved to the hazard pattern ``Slip-Through
Associated With Inflation'' because, in this submersion without slip-
through incident, the victim did not slip through the product and
therefore does not fit that hazard pattern.
Comments: Otteroo commented that because very little information
was made available to CPSC by the police regarding IDI 210114HCC1250,
it is impossible for CPSC to conclude that the incident was a result of
a product malfunction or leaking or deflation. Otteroo stated that CPSC
only had access to a general description of the neck float product
found on their own website and knowledge of the items in the bathroom
at the time of the investigation. As a result, Otteroo concluded that
CPSC's determinations were not supported by evidence.
Response: The information contained in IDI documents was made
available to the public by CPSC, to the extent allowable by applicable
law. Some records associated with CPSC incident data contain
confidential and sensitive information that requires redaction prior to
public access, as is the case with IDI 210114HCC1250.
The documents associated with IDI 210114HCC1250 released alongside
the NPR state that at the time of the original IDI review date, March
1, 2021, CPSC investigators had access to limited information provided
primarily by a health care professional. However, the IDI also notes
that there were three addendums to the initial report, during which
additional information requests concerning this incident were collected
and processed. This includes access to police reports, medical records,
and the child abuse investigative report, among other documents. The
determination that this incident involved an infant slipping through a
neck float product, and that this slip-through incident was associated
with product deflation during use, was made after reviewing all
documents and data concerning this incident and was not limited to only
the initial CPSC incident report filed in 2021. Images from the report
show a deflated neck float at the scene which corroborates this
narrative.
5. Swimming Position
Comments: A former swim instructor/lifeguard and the Great Lakes
Surf Rescue Project commented that neck floats present a drowning risk
to children because neck floats put children in a vertical position and
condition children to assume that position, even when the product is
removed, and give a false sense of swimming ability to children. These
commenters asserted that children must unlearn the vertical position
and relearn proper horizontal positioning necessary for swimming. In
addition, the Great Lakes Surf Rescue Project expressed concerns that
caregivers believe neck floats will prevent their children from
submerging and do not recognize the slip through hazard. A consumer
requested CPSC to conduct research on neck floats to understand child
psychology and their use and misuse.
Response: The requirements in this final rule are based on incident
data and staff's analysis. Staff did not identify the hazard pattern
described by the commenters. CPSC is not aware of data to support the
claim that the use of neck floats will condition children to assume the
vertical body position in water, even if the neck float is removed,
increasing the likelihood of drowning. The Commission agrees that
children accustomed to neck floats may develop a false sense of
confidence in their ability to float/swim; however, this can be said of
any product on which children rely to keep them afloat, particularly
those that do not depend on the child's activity to remain afloat. The
rule reduces the likelihood of drowning associated with neck floats
based on the known hazard patterns. The rule also contains warnings
that explain the drowning risk associated with neck floats to
consumers, which can further educate consumers on water safety. Staff
will, however, continue to monitor incident reports concerning neck
floats in the future, and the Commission may propose additional
requirements or modify existing requirements to respond to new hazard
patterns identified by that data.
6. Diving Reflex
Comments: Otteroo commented on IDI 220714CCC1021, which described
an incident where an infant slipped through a neck float and was not
immediately breathing when rescued from the submersion incident,
stating that infants have a diving reflex that is present until six
months of age that functions as a protective mechanism that allows
infants to hold their breath underwater. Otteroo stated that it is
crucial for CPSC to contextualize incidents such as this consistent
with natural infant physiology and to avoid overstating the risk
without sufficient evidence. Otteroo argued that temporary submersion
with immediate retrieval does not present significant harm.
Response: The Commission disagrees with the commenter that
temporary submersion with immediate retrieval does not present a
significant risk of harm. Every slip-through or submersion incident has
the potential to be a drowning, resulting in injury or death, if
caregivers do not intervene to quickly pull the infant from the water.
The infant diving reflex should not be relied upon to prevent drowning.
Although this reflex is highly prevalent in the first year of life, the
reflex is not present in every infant and at every infant age.\22\
Aspirating significant amounts of water can require medical attention
or observation, especially for very young infants because of the risk
of lung injury. The risk of injury is dependent on the duration of
submersion and amount of water that enters the lungs, as well as the
immediacy of rescue and resuscitation efforts.
---------------------------------------------------------------------------
\22\ Pedroso FS, Riesgo RS, Gatiboni T, Rotta NT. The diving
reflex in healthy infants in the first year of life. J Child Neurol.
2012 Feb;27(2):168-71. doi: 10.1177/0883073811415269. Epub 2011 Aug
31. PMID: 21881008.
---------------------------------------------------------------------------
C. Recalls
Comments: The Commission received a comment from Otteroo regarding
previous recall action of its neck float product and questioned why
CPSC expressed safety concerns for neck floats despite previously
``approving its launch.'' Otteroo requested CPSC re-establish open
communication with it to develop safety measures.
Response: The hazard pattern identified in the recall concerned the
seam leaking air and deflation of Otteroo's product, which presented a
risk of drowning. This particular hazard was addressed in the
Corrective Action Plan (CAP) \23\ in 2014, which included the terms of
the remedial action agreed upon between the firm, Otteroo, and CPSC.
CPSC does not approve or certify any market product either through pre-
market testing or otherwise. The commenter is likely referring to the
aforementioned CAP, which does not constitute a blanket-approval of
their products. A CAP is a voluntary measure agreed to by a firm and
does not prohibit the Commission from acting
[[Page 58111]]
under CPSIA section 106 to address a risk of injury presented by toys.
---------------------------------------------------------------------------
\23\ The term ``corrective action plan'' (CAP) generally
includes any type of remedial action taken by a firm. A CAP could,
for example, provide for the return of a product to the manufacturer
or retailer for a cash refund or a replacement product; for the
repair of a product; and/or for public notice of the hazard. A CAP
may include multiple measures that are necessary to protect
consumers. The Commission staff refer to corrective actions as
``recalls'' because the public and media more readily recognize and
respond to that description.
---------------------------------------------------------------------------
Moreover, in this rule, the Commission is addressing other hazards
associated with all neck floats (not just Otteroo's product), which
include slip-through associated with inflation or otherwise, restraint
system failures, and submersion without slip-through.
Concerning Otteroo's request for communication with CPSC,
Commission staff have continued to participate in voluntary standards
activities with Otteroo. Otteroo also has participated in the public
comment process of this rulemaking and the Commission has considered
Otteroo's comments in developing this final rule.
D. Voluntary Standards
1. Voluntary Standard Development
Comments: The Commission received comments from one consumer,
Otteroo, and TA regarding CPSC's involvement with ASTM. Otteroo
asserted that CPSC is ignoring ASTM activity and refusing to
acknowledge their efforts and alleged that CPSC is choosing to move
forward without considering ASTM's input. The consumer encouraged
continued participation in ASTM's effort, including the recently formed
F15.07 subcommittee on buoyancy aids for children. TA recommended CPSC
pause work related to the NPR on neck floats and invest resources in
the ASTM effort to develop the Buoyancy Aids for Children safety
standard.
In addition, the Commission received comments from Otteroo
questioning whether CPSC expects ASTM to adopt similar requirements to
CPSC's proposal for other buoyancy aids, asserting it would be a
challenge due to inconsistences with international standards such as
AS/NZS 1900:2014, Flotation Aids for Water Familiarization and Swimming
Tuition, and EN 13138-1:2021. The commenters requested CPSC consider
aligning with established international standards to reduce regulatory
burden.
Response: Section IV of this preamble and the NPR provide a
detailed description of CPSC's participation in the ASTM activities
concerning buoyancy aids and toys, including neck floats. The ASTM
F15.07 subcommittee was established in January 2025, after the NPR was
published in November 2024. In December 2024, staff attended an
exploratory call discussing whether ASTM should establish a designated
subcommittee for buoyancy aids. Staff also participated in the first
official F15.07 subcommittee meeting, which was held on March, 24,
2025. Staff will continue to participate in this subcommittee's efforts
to develop a safety standard for buoyancy aids for children. At this
time, ASTM does not have a standard that adequately addresses the risks
identified for neck floats. Accordingly, to prevent future deaths and
injuries associated with neck floats based on the hazards addressed in
this final rule, the Commission will not pause its efforts in reducing
these risks to wait for ASTM. Once a final standard is published by
ASTM, the Commission may consider it in a future action.
CPSC staff recommended to the F15.07 subcommittee that the
subcommittee consider the requirements from the NPR in their draft
standard for buoyancy aids for children. Ultimately, however, CPSC is
not responsible for the final decisions that ASTM and its members make
regarding their safety standards. Otteroo did not provide information
to support their claim that adopting international standards that
currently do not apply to aquatic toys such as neck floats would reduce
regulatory burden, and the Commission has assessed that current
voluntary standards do not sufficiently address the risk of injury.
2. Incorporation by Reference
Comments: The Commission received comments from Otteroo regarding
the agency's incorporation by reference of existing standards. Otteroo
stated that referencing non-toy standards contradicts the toy
determination. Otteroo questioned why the Commission did not adopt EN
13138-1:2021, requested further clarification on how ANSI/CAN/UL 12402-
9:2022 or ANSI/APSP/ICC-16 2017 was determined to be relevant to neck
floats, and urged the Commission to reassess the applicability of the
standards that are incorporated by reference. Consumer Reports, Safe
Infant Sleep and the U.S. Public Interest Research Group commented in
support of the NPR's assessment of the standards that are incorporated
by reference.
Response: Incorporating standards by reference that are not
specific to the subject product is a routine practice and fully
complies with legal requirements. The Commission appreciates the work
of voluntary standards committees. Although the Commission assesses
that existing standards do not adequately address slip-through hazards
associated with neck floats, the Commission determined that some parts
of the existing standards EN 13138-1:2021, ANSI/CAN/UL 12402-9:2022 and
ANSI/APSP/ICC-16 2017 were relevant to support the performance
requirements to address the safety hazards for neck floats. For
instance, as discussed in the NPR, although the requirements from the
multi-part standards series used by the EU for swimming aids, EN
13138:2021 parts 1-3, are intended for swimming instruction and are not
comparable to neck float use, the Commission based the requirements for
restraint system, specifically for the fastening mechanism, on these
standards.
As discussed in the NPR, ANSI/CAN/UL 12402-9:2022 includes test
methods that apply to personal flotation devices located around the
user's collar, similar to where neck floats are located on infants. The
test method in ANSI/CAN/UL 12402-9:2022 applies to level 50 PFDs, which
are the most stringent and meant to apply to PFDs used in stormy waters
offshore. For this reason, the Commission is incorporating this
standard, with modifications, for the thermal conditioning requirement
in Sec. 1250.5(c)(i) to account for the use of neck floats in a pool
or bathtub environment.
For the buoyancy requirement, the Commission considered both ANSI/
CAN/UL 12402-9:2022 and BS EN 13138-1:2021 to evaluate the buoyancy of
flotation devices after a 24-hour submergence period to determine how
much buoyancy is lost. As discussed in the NPR, ultimately the
Commission is incorporating ANSI/CAN/UL 12402-9:2022 because it
includes a 5 percent loss metric, compared to a 10 percent loss metric
in BS EN 13138-1:2021, which is the more stringent of those two
standards and determined to be more appropriate to achieve the highest
level of safety that is feasible and to reduce the risk of injury and
death associated with neck floats.
The Commission is incorporating ANSI/APSP/ICC-16 2017 by reference
for UV conditioning requirement to account for sun exposure during use
of neck floats, which may include outdoor use and temporary or primary
outdoor storage conditions. The test method in ANSI/APSP/ICC-16 2017
applies to a Suction Outlet Fitting Assembly (SOFA) that is designed to
be used in pools, spas, and hot tubs, and includes all components such
as the cover, grate, adapters, supports, riser rings, and fasteners, to
account for the UV exposure of SOFA to ensure its safe and proper
functionality in aquatic environments. As discussed in section VI of
this preamble, the Commission is modifying this requirement to better
align with the expected UV exposure of a neck float.
3. Publicly Available Standards
Comments: Center of Individual Rights (CIR) asserted that the NPR
[[Page 58112]]
violates statutory and constitutional guarantees regarding the public's
right to access the law. The commenter stated that the agency's
exercise of its federal authority exceeds the industry consensus that
the agency ordinarily follows, at the expense of one company, Otteroo.
CIR also commented that the public comment period closed on the
incoming administration's first business day and therefore disregarded
potential implications for this rulemaking based on the change.
The commenter asserted that the proposed rule exercises
unconstitutionally delegated power because Congress designated ASTM
with the primary responsibility of creating binding legal obligations
for affected industries and delegated future lawmaking power with the
mandatory update provision of the CPSIA. CIR argued that in the
proposed rule, the Commission takes some of this power back arbitrarily
by creating new and extra obligations for one disfavored industry,
removing lawmaking even further away from Congressional control.
CIR also argued that the incorporation by reference of standards
set by private organizations is unlawful because it violates Freedom of
Information Act (FOIA) and the Administrative Procedures Act (APA) and
its requirement to ``make available to the public'' all ``substantive
rules of general applicability adopted as authorized by law,'' 5 U.S.C.
552(a)(1)(D), and because it hides binding law behind a paywall in
violation of principles of due process and fair notice.
Response: Under the CPSIA, Congress stated that the Commission
shall promulgate more stringent requirements than those in the
mandatory toy rule, ASTM F963, if the Commission determines that more
stringent standards would further reduce the risk of injury of such
toys. 15 U.S.C. 2056b(b)(2). In addition, the Commission is also
directed to periodically review and revise the mandatory toy standard
to ensure that such rules provide the highest level of safety for such
products that is feasible. Id. 2056b(c).
This final rule establishes requirements for neck floats. The rule
is not specific to Otteroo, as there are other manufactures of neck
floats (e.g., Mambobaby).
In accordance with Office of the Federal Register (OFR)
regulations, 1 CFR part 51, when the Commission proposes or finalizes a
rule which includes private standards by incorporating them by
reference, these standards are reasonably available to the public as
described in section X of this preamble. This process complies with all
statutory and constitutional requirements.
The Commission voted to approve the NPR with a 60-day comment
deadline, on October 23, 2024. The OFR determines the publication date
for the NPR after the Commission submits it to the OFR. The NPR was
published on November 20, 2024, in the Federal Register. As a result,
the comment deadline was designated to be January 21, 2025, which was
after Inauguration Day.
E. Performance Requirements
1. ASTM F963 Requirements
Comments: TA commented that the statements in the NPR that ASTM
F963-23 only has labeling requirements, in section 5.4, for aquatic
toys is erroneous and asserted that aquatic toys must still comply with
all other applicable sections of ASTM F963-23. In addition, TA
commented that, even though it is true, it is irrelevant to state that
there are no specific performance requirements for aquatic toys in ASTM
F963-23 because neck floats are not toys subject to ASTM F963-23.
Response: Based on some of the language used in the NPR, it may
appear as though the NPR is stating that ASTM F963-23 only includes
labeling requirements for aquatic toys. For example, in the NPR, the
first summary of the Commission's assessment of the existing
requirements stated that ``ASTM F963-23 does not establish adequate
requirements specific to neck floats because it does not include any
performance requirements for these toys.'' There are two other
instances where the NPR stated that ``ASTM F963-23 does not establish
any performance requirements for aquatic toys, including neck floats.''
In both cases, it was tied to specific concerns for aquatic toys. In
the first instance, the statement was followed by a discussion of the
ASTM F15.22 subcommittee's development of a dedicated aquatic toy
revision task group to develop a draft ballot with performance
requirements for aquatic toys. The second time, the statement was
followed by the inadequacy of the ASTM F963-23 to address children
slipping through neck floats or being submerged into water. However,
both in the NPR and in this final rule, in Sec. 1250.5(a), it
specifies that section 1250.5, Requirements for Neck Floats, adds
requirements for neck floats in addition to the requirements in
Sec. Sec. 1250.1 and 1250.2, which are the other applicable
performance requirements in ASTM F963-23 that apply to all toys (such
as lead and flammability requirements). Therefore, to clarify, ASTM
F963-23 contains certain performance requirements and labeling
requirements for all toys, including aquatic toys, as discussed in more
detail in section I of this preamble. In addition, ASTM F963-23
contains specific labeling requirements for aquatic toys but does not
contain specific performance requirements for aquatic toys. The NPR
referred to the performance requirements applicable to all toys as
``general requirements'' in Sec. 1250.5(c). To prevent any confusion
about applicable requirements for neck floats in ASTM F963-23, the
final rule revises the text in Sec. 1250.5(c) by replacing ``any
general requirements'' with ``any applicable performance requirements''
to state: ``In addition to any applicable performance requirements from
Sec. 1250.1 or Sec. 1250.2, all neck floats within the scope of the
rule must meet the performance requirements in this section to reduce
the risk of children drowning while using a neck float.'' [Emphasis
added].
2. Necessity of Performance Standards
Comments: The Commission received comments from Otteroo requesting
the rationale, justification, or evidence that the proposed
requirements are necessary for improving the safety of neck floats.
Response: In the NPR, the Commission provided its rationale for
each proposed performance requirement, which was based on staff's
analysis of incident data and staff's assessment regarding the
effectiveness of existing standards or guidelines to address the
hazards identified in the incident data. The Commission is adopting the
requirements proposed in the NPR for the reasons discussed in the NPR
and in this document, with the changes discussed in section VI of this
preamble.
3. New Hazards
Comments: Consumer Federation of America, Safe Infant Sleep, and
U.S. Public Interest Research Group expressed concern that the proposed
performance requirements may make neck floats more dangerous by
introducing new hazards such as strangulation. These commenters
asserted that no performance requirement is sufficient to mitigate the
risks because the demographic of neck floats users is too vulnerable.
Response: The Commission assesses that the final rule's performance
requirements will reduce the risk of injury and will not pose a
strangulation hazard. To develop the test methods in
[[Page 58113]]
the final rule, staff reviewed available anthropometric data, including
head and neck measurements, and found that the neck opening of neck
floats can accommodate very large necks while still being small enough
to prevent very small heads from slipping through the neck opening. For
example, as explained in the NPR, the maximum neck circumference of a
43-to-48-month-old (10.2 in.) is smaller than the minimum head
circumference of a 0-to-3-month-old (14.6 in.). While neck floats wrap
round the neck, neck floats do not retain the occupant within the float
by compressing or tightening around the neck. Instead, the inner edge
of the float supports the chin and the back of the head, which keeps
the child's head above water.
Neck floats will not be able to meet the requirements of the final
rule by simply shrinking the diameter of the float's neck opening. The
required test evaluates the neck opening with probes sized to the 5th
percentile head and neck measurements in their respective age classes.
A neck float that relies purely on geometry to prevent one of these
head probes from slipping through it during dynamic testing would
necessarily be too small for the remaining 95 percent of end users.
Therefore, to meet the requirements of the final rule, manufacturers
need to eliminate or reduce the capability of the neck opening to
unintentionally expand and deform enough to cause slip-through.
Moreover, although staff assessed that the performance requirements
do not pose a strangulation hazard, staff also assessed that even if a
product posed such a hazard, caregivers are likely to (1) understand
that an overly-tight neck float is hazardous for a child's respiration
and blood flow, (2) recognize the symptoms of decreased respiration and
blood flow, and (3) intervene in the event of sustained pressure on the
neck sufficient to cause harm. Compression of the neck region leading
to sustained pressure on the neck in an area close to the carotid
arteries can cause unconsciousness in 10-15 seconds, and death within
2-3 minutes. Caregivers are likely to be present when the product is
initially donned and remove a dangerously tight neck float before harm
is caused by compression of the neck. Strangulation due to compression
of the neck has not been identified as a hazard pattern in current
incident data. On the contrary, as noted in the NPR, incident data
indicate that caregivers are generally aware of the product's fit
around their child's neck. Where sizing of the product was a concern,
caregivers erred towards oversizing the product for their child,
ultimately increasing the risk of slip-through, due to perceived
``discomfort.''
4. Feasibility
Comments: The Commission received comments from Otteroo that
discussed the inherent wear-and-tear risks of any inflatable product.
Otteroo questioned whether it is feasible to apply the proposed
performance requirements to other inflatables and whether the
requirements apply to other inflatables.
Response: Based on incident data and staff's analysis, the
Commission is finalizing a safety standard for neck floats to address
the identified hazards in section III of this preamble. Other
inflatable products are not included within the scope of this
rulemaking. However, the Commission regularly assesses incident data
and may take future action for other inflatable products if hazard
patterns necessitate such action. The feasibility of this rule with
respect to neck floats is discussed in section IX of this preamble.
5. Conditioning Requirements
Comments: Otteroo and one consumer submitted comments on the
proposed conditioning requirements. Both commenters objected to the
temperature and UV requirements stating that they should not apply to a
product like neck floats because they allegedly are meant for indoor
use. Otteroo stated that in international standards relevant to neck
floats, such as EN 13138-1:2021 and AS/NZS 1900:2014, there are no
``unrealistic'' requirements for conditioning for cold temperatures and
UV exposure. These commenters suggested aligning the proposed
requirements with the international standards by replacing the proposed
requirements with the requirements in the referenced standards, which
would requiring removing the UV requirement in the final rule. Otteroo
also stated the 720-hour UV exposure test designed for spa and pool
outlets exposed to prolonged sunlight in outdoor pools is irrelevant to
neck floats because they are typically used indoors or other controlled
environments and not stored outdoors. The commenter also added that the
-10 [deg]C requirement, derived from the USCG approved PFD standard, is
unnecessary because neck floats are not intended for extreme open water
conditions. Otteroo also stated that long-term temperature degradation
is a minimal concern for neck floats intended to be used in more
controlled environments, in comparison to PFDs. Otteroo suggested
either removing the cold storage consideration or modifying the range
of consideration for temperature condition to 20-40 C. Otteroo also
pointed out there were inconsistencies between the temperature range
the NPR references from EN 13138-1:2021 with -10 2 [deg]C
as the cold conditioning temperature and what the NPR proposes with -30
2 [deg]C as the cold range temperature.
Response: Incident data show that neck floats are used in both
indoor and outdoor environments. They may be used and stored outdoors
near pools (such as on pool decks, in outdoor sheds or in storage
boxes) exposing them to outdoor temperatures and UV radiation. At least
four incidents reported in the NPR detail neck float use in outdoor
settings including kiddie pools and community pools. In addition,
product marketing and publicly available consumer-uploaded pictures and
videos of the product in use demonstrate neck floats being used in
outdoor settings, including on Otteroo's website.\24\ As explained in
the NPR, conditioning procedures related to cold temperatures and UV
exposure are meant to simulate outdoor elements including temperature
changes and UV exposure due to foreseeable outdoor use and/or storage.
Therefore, to ensure that the product is tested under realistic
circumstances, the requirement to condition for cold temperature and UV
exposure is retained in the final rule.
---------------------------------------------------------------------------
\24\ For example, one firm markets its neck floats with videos
showing use in outdoor pools. See, e.g., Summer lovin', Otteroo
babies havin' a blast at https://www.youtube.com/watch?v=5P-PJGh2Ak8; Otteroo Neck Float for Babies: Bath & Pool Time Fun,
https://www.youtube.com/watch?v=dbd9UvFkDA0; Otteroo Babies Having
Fun in the Pool!, https://www.youtube.com/watch?v=bPv3mChIUD4.
---------------------------------------------------------------------------
In the final rule, however, the Commission is revising the UV
exposure to account for the expected UV exposure of a neck float. The
NPR proposed to incorporate by reference four UV conditioning methods
for neck floats in accordance with sections 4.2.1.1-4.2.1.4 of ANSI/
APSP/ICC-16 2017, which governs pool and spa drain covers. While
outdoor pool and spa drain covers are expected to be exposed to
sunlight even while the pool itself is closed due to seasonal use, neck
floats may foreseeably see outdoor use only while seasonal weather
permits typical pool access. While the effects of accelerated
weathering compared to actual outdoor exposure are dependent on the UV
source and material being evaluated, staff understand that the duration
of those four methods roughly correlates to daily year-round exposure
because it applies to fixed components, in outdoor pools and spas, that
are immovable once installed. Therefore,
[[Page 58114]]
the Commission will reduce the real-time estimate of these conditioning
methods from approximately 12 months down to approximately three
months. Three months has been selected as the new UV benchmark to
represent outdoor sun exposure for only a single season rather than the
full year and is intended to reflect outdoor neck float use during the
summer months when many outdoor pools are typically open for use.
Accordingly, in this final rule, the total duration of exposure in each
of the four methods is reduced by 75 percent from the proposed 720
hours to 180 hours using methods (a) and (b), from the proposed 1000
hours to 250 hours using method (c), and from the proposed 750 hours to
188 hours using method (d) in section 4.2.1.1-4.2.1.4 of ANSI/APSP/ICC-
16 2017. Additionally, staff assess that the typical age and weight
recommendations for neck float use provided by manufacturers generally
restrict their potential use by any single child to roughly one year,
rendering repeated year-long UV weathering of neck floats unnecessary
to simulate their expected real-world use.
The concerns raised by the commenters with regard to temperature
conditioning requirements are misplaced because the Commission
accounted for the difference between PFDs and neck floats, as discussed
in the NPR. The Commission proposed to incorporate ANSI/CAN/UL 12401-
9:2022, with modifications to cold temperature thresholds. Section
5.5.5.1 of ANSI/CAN/UL 12401-9:2022 requires alternate exposure to hot
temperature at 60 2 [deg]C (140 4 [deg]F) for
8 hours, then to cold temperature at -30 2 [deg]C (-22
4 [deg]F) for 8 hours, repeated for two complete cycles.
As discussed in the NPR, EN ISO 13138-1:2021, also recommends
conditioning with a hot temperature of 60 2 [deg]C (140
4 [deg]F). Otteroo incorrectly stated that EN 13138-1:2021
does not have cold temperature conditioning requirements. Moreover, the
Commission proposed to modify the cold temperature requirement
referenced in ANSI/CAN/UL 12401-9:2022 by replacing it with the cold
temperature set point in EN ISO 13138-1:2021 at -10 2
[deg]C. This modification was based on the Commission's reasoning that
it is unlikely that a neck float will be stored in the lower
temperature requirement of -30 2 [deg]C. Therefore, the
conditioning requirements for hot and cold temperature are aligned with
an international standard, EN 1313801-1:2021, as requested by the
commenter.
Lastly, the Commission had proposed to modify the conditioning time
in ANSI/CAN/UL 12402-9:2022 to only one 8-hour conditioning period at
each temperature point instead of two 8-hour cycles, in recognition
that neck floats generally are not exposed to the same extreme
conditions that PFDs may be expected to operate in. In addition, the
commenter's claim that long-term thermal degradation is a minimal
concern for neck floats was not supported by data or other cited
evidence. In the NPR, the Commission details the effect of temperature
on plastics as a basis for this requirement. Accordingly, the
Commission is finalizing the temperature conditioning requirements
based on an international standard, as proposed with the noted
modifications to account for the difference between PFDs and neck
floats.
There is a discrepancy in the NPR noted by Otteroo that is
clarified in this final rule. Though the description of the proposed
requirement and the proposed regulatory text from the NPR align with
the requirement discussed above for this final rule, an error in
section V of the NPR incorrectly described the cold temperature
requirement as -30 2 [deg]C instead of -10 2
[deg]C.
6. Minimum Buoyancy Requirement
Comments: The Commission received comments from Otteroo on the
proposed buoyancy requirements. Otteroo stated that the requirement for
all neck floats to demonstrate a minimum upward buoyancy equal to or
greater than 30 percent of the expected weight capacity of a neck float
will lead to over-designed products that are impractical and cost-
prohibitive, particularly for small businesses and consumers. Otteroo
asserted that the 30 percent body mass is erroneously based on data for
adults that are incomparable to infants because infant heads account
for 25 percent of their weight while the other 75 percent is more
buoyant than an adult due to higher water content. Otteroo also
requested justification for the safety factor of three applied to the
10 percent body weight specification, stating that the proposed
requirement exceeds what is required from international standards for
similar products such as EN 13138-1:2021.
Otteroo further questioned why the internal pressure of 0.1 0.01 PSIG for this test was more stringent than the internal
pressure required for PFDs, 4.0 0.1 kPa (0.58
0.016 PSIG), under ANSI/CAN/UL 12402-9:2022. Otteroo requested studies/
data to justify the requirement of the proposed PSIG for neck floats.
Response: The Commission disagrees with the suggestion that
products will necessarily become overdesigned and more expensive.
Currently, neck floats that meet the requirements of the final rule
already are available on the market, including the 30 percent minimum
upward buoyancy when inflated at 0.1 PSIG.
As discussed in the NPR, the 30 percent minimum buoyancy is based
on multiplying a safety factor of three to 10 percent, which is the
approximate body weight, on average, a human bears while submerged to
their neck in water. Testing protocol for juvenile products and toys
typically requires a safety factor of three times the recommended
user's weight to account for variations such as user weight and size,
product manufacturing, and real-world conditions. For example,
performance requirements in ASTM F963-23 for toys intending to bear the
weight of a child, such as the overload testing of ride-on toys and toy
seats in section 8.28 of ASTM F963-23, requires the test load to be
three times the weight indicated by Table 7 in ASTM F963-23 or three
times the manufacturer's stated weight capacity, whichever is greater.
This safety factor is particularly important where a safety standard is
addressing a risk of infant death and where Congress required the
Commission to set a standard at ``the highest level of safety . . .
feasible.'' 15 U.S.C. 2056b(c).
The commenter did not provide any data or sources for the
suggestion that an infant's head is equal to 25 percent of its body
weight. Due to this, staff are unable to determine if the ratio
suggested by the commenter reflects the minimum, maximum, or average
head-to-body ratio; therefore, staff maintain that the 30 percent
minimum requirement, as explained in NPR and in response here, is more
appropriate metric to use in this buoyancy evaluation.
International standards suggested by the commenter, such as EN
13138-1:2021, are intended for swimming aids for swimming instruction.
Use of a swimming aid for swimming instruction suggests the capacity of
the user to possess and further develop the ability to swim, and a
device intended to foster that ability would be one designed to assist
the user but not bear their full weight in a water environment so that
the user may develop the strength and technique to do so on their own,
unassisted. Neck floats, however, generally are used by infants that do
not possess the capacity to swim on their own. The minimum buoyancy
requirement of this final rule, which is based on the child weight data
provided in Table 1 in section VI of this preamble, ranges from 22.7-
69.8 N at the youngest and eldest extremes of the
[[Page 58115]]
age spectrum within the scope of this final rule. It is intentionally
greater than the requirements of standards such as EN 13138-1:2021,
which ranges from 20-25 N for collar swimming aids over the same age
spectrum, to account for this difference between swimming aids and
aquatic toys and to adequately provide for the safety of neck float
users.
The Commission is requiring inflatables to be evaluated at 0.1 PSIG
due to the slip-through associated with inflation hazard pattern
established by incident data. This hazard pattern demonstrates the
capacity for neck floats to be used, even under caregiver supervision,
to such degree that the child slips through the neck opening on their
own before the neck float becomes deflated enough to sink with the
occupant, as depicted in incident data discussed in section III of this
preamble. To account for this reasonably foreseeable use and hazard
pattern, the inflation pressure is less than what would otherwise be
considered ``fully inflated,'' but high enough for the neck float to
pass visual inspection by a caregiver so that it appears to retain the
expected shape and maintain expected functionality. The inflation
pressure of 0.1 PSIG is the limit at which the Commission determined
that it is reasonably foreseeable that a caregiver will continue
allowing their child to use the neck float, despite the increased slip-
through risk posed by the reduced internal inflation pressure. As
described in the NPR, staff confirmed through testing that, even when
inflated to only 0.1 PSIG, there are neck floats currently on the
market that meet this 30 percent buoyancy requirement in this final
rule.
7. Restraint System Requirements
Comments: Otteroo provided comments on the proposed restraint
system requirements asserting that only user error on the part of the
caregiver is responsible for incidents involving the restraint system
because infants cannot be expected to unlatch themselves. This
manufacturer suggested that this hazard can only be addressed through
education and warnings rather than performance requirements for
restraint systems. Otteroo further requested that the hazard pattern
associated with restraint system failures and the associated testing
requirements should be removed in the final rule, unless the Commission
provides a human factors study or usability testing to support its
claim that the location of latches may afford greater separation enough
to require restraint system testing. Otteroo claimed that, without this
empirical evidence, the requirement imposes an undue financial burden
on manufacturers without addressing a demonstrated risk or improving
safety outcomes.
Response: As discussed in the NPR, the requirements for restraint
systems are intended to reduce the likelihood of an unintentional
release of a fastener mechanism during use, and to reduce the
likelihood of component failures in a restraint system and detachment
from the neck float. The purpose of requiring release mechanisms to
have either a double-action release system with two distinct, but
simultaneous actions to release, or a single-action release system that
requires a minimum of 50 N to release is to reduce the risk of the
fastener system unintentionally being released during use. While it is
true that the infant using the neck float interacting with the fastener
system is a factor that could contribute to the fastener system's
unintentional release, these performance requirements are not intended
to only prevent that single, explicit interaction. Rather than
preventing any one specific cause of unintended release, the
requirements of this rule increase the reliability that fastener
systems will only be released when the caregiver explicitly wants to
release it because the risk of other sources of unintentional release,
including but not limited to infant interaction with the fastener
system, are sufficiently reduced through the final rule's performance
requirement.
The Commission explained in the NPR that the location of the
restraint system on the product directly impacts the neck opening's
ability to expand because the fastener system used to connect the
discontinuous ends of the neck float together is logically the only
physical component keeping them connected. If that fastener system
fails, whether by unintentional release or by physical separation from
the neck float, then there will be no other physical components to
prevent the two ends from separating, which may lead to the neck
opening widening during use and the occupant slipping through as a
result. In addition, the Commission explained in the NPR that the
location of latches of a restraint system on a neck float can be a
significant factor because they can contribute to a slip-through if the
discontinuous ends have the latches located far from the child's neck
and affording greater separation of the part on the discontinuous ends
closer to the child, where separation is most dangerous for neck
opening expansion.
Furthermore, as discussed in the NPR, compressibility/deformability
of inflatable neck floats introduces a unique slip-through risk because
it can cause the size and shape of the neck opening to change during
use as is demonstrated in Figure 7. In this figure, it is physically
evident that the latching system of the neck float directly impacts the
extent of separation the neck opening experiences due to the
deformation of the inflatable neck float.
[[Page 58116]]
[GRAPHIC] [TIFF OMITTED] TR15DE25.018
Staff note that the requirements concerning fasteners, in
isolation, are not expected to impose a significant economic effect on
firms. Neck float products with fasteners currently available for sale
at online US retailers are listed at very similar or identical prices
as products without fasteners. Staff note that this indicates fasteners
do not impose undue financial burden on manufacturers. As discussed in
the NPR, other standards impose requirements for fastener safety,
including EN 13138-1:2021, which has similar requirements for fastener
systems on swimming aids; ASTM F963-23, which has similar requirements
on locking devices for folding mechanisms intended to prevent
unexpected or sudden movement; and other ASTM standards concerning
children's products that make use of fastener systems, such as ASTM
F833-21 for carriages and strollers, which also have similar fastener
system requirements intended to prevent unintentional release. The
requirements of this final rule may be considered typical regarding
fastener system unintentional release prevention, and by that measure
should not be considered an undue financial burden on the manufacturer
to address this hazard as a standard practice.
8. Secondary Attachment System
Comment: The American Academy of Pediatrics (AAP) commented to
agree with CPSC staff's assessment against establishing requirements
for a secondary attachment system.
Response: In the NPR, the Commission considered and ultimately
rejected a potential requirement for neck floats to incorporate a
secondary attachment system as a backup in the event the primary neck
opening securement fails. The Commission agrees with the commenter and
will not be finalizing a requirement for a secondary attachment system
based on the concerns expressed in the NPR.
9. Neck Opening Test
Comments: The Commission received comments from Otteroo regarding
the proposed neck opening test requirements. Otteroo stated that the
proposed probes are not anatomically correct, are too rigid, and do not
mimic infant anatomy. Otteroo also asserted that the probe weights
should be completely on top of the float rather than partially within
the neck opening as proposed. Otteroo requested that CPSC design better
test probes to account for anatomy and weight distribution. Otteroo
also asserted that the proposed test method does not properly simulate
real-world-use conditions and ignores the impact that water properties
such as viscosity may have because the proposed test is conducted in
the air and recommended that it be performed in water instead. Otteroo
further asserted that the test incorrectly assumes forces acting on the
neck opening are uniform and consistent and does not take dynamic
motion of the occupant such as kicking, flailing, or twisting into
account, requesting the procedure be modified to account for those
motions. Otteroo claimed that the Center of Gravity (CG) of an infant
is higher on their body relative to an adult, thus the proposed length
L, used to designate the position of the body's CG, is too long, and it
should be closer to the neck than the waist. Otteroo asserted that
soapy water is irrelevant to the scenario and lacks evidence to support
its inclusion, requesting its removal from the procedure. Otteroo also
asserted that underinflation is irrelevant to the scenario with minimal
evidence to support it increases slip-through risks, requesting its
removal from the procedure. Otteroo suggested consulting with others
(biomechanics experts, pediatric specialists, water safety
professionals) to develop a more accurate test protocol.
Otteroo requested the basis for using language such as ``not
proprietary'' and ``reasonably sourced'' to describe the neck probes
used in the neck opening test in the NPR, as pertains to technological
feasibility.
Response: The probes are anatomically accurate in their
representation of users of neck floats. As described in the NPR, the
dimensions of the probes were selected based on the minimum and maximum
circumferences of a 5th percentile child's body beginning from the neck
and moving up past the crown according to available anthropometric
[[Page 58117]]
data (Schneider et al., 1986). Those dimensions reflect the narrowest
and widest dimensions of a child's head according to the age range of
the probe, and are by staff's assessment the minimum dimensions that
must be considered when evaluating a neck float for slip-through
hazards. Staff also assess the placement of the probe in the neck float
during testing and recommended weight distribution to be an accurate
representation of real-world use because the weight of a child's head
is naturally distributed within the head, as the probe is intended to
reflect, and because seating the narrow end of the probe, representing
a child's neck, into the neck opening imitates the neck float's
attachment to a child as the neck opening wraps around the neck while
the head sits atop it.
In addition, the Commission disagrees that probes are ``too
rigid.'' The requirement being evaluated in this test method is whether
the neck opening can expand during use such that a child will slip-
through and be submerged underwater. This test method proposes to use
rigid probes that always maintain the critical dimensions of the neck/
head of the neck float's user during the evaluation to that end. There
are other instances of rigid body probes being utilized to evaluate a
toy's interaction with a human user, too, such as the head probe used
to evaluate entanglement hazards related to cords and elastics in
section 4.14 of ASTM F963-23.
As discussed in the NPR, and by the commenter, infant movement can
be erratic. In developing this test method, CPSC considered the various
movements an infant could make, which may include but is not limited to
kicking, twisting, or flailing. The pendulum motion described in the
NPR simulated that randomness in a way that could be replicated by
other testing labs. The initial swing of the pendulum, which imparts
the most force on the probe, simulates a sudden burst of energy such as
that created by flailing and gradually decreases with each swing back-
and-forth. Subsequent back-and-forth swings simulate rhythmic repeated
motion, as may be expected of kicking in water, and the free swing of
that pendulum develops a rotating element to introduce some effects of
twisting. Because the Commission already accounted for the movements
suggested by the commenter, the test method for the neck opening test
is being finalized as proposed in the final rule.
The Commission acknowledges that the higher viscosity of water
compared to air would introduce a new variable to the neck opening
test, a dampening force that would reduce the movement caused by the
swinging pendulum weight (referred to as M2 in the test method). This
would reduce the magnitude of the moment that a swing creates on the
probe and cause that weight to come to a rest more quickly compared to
its performance in air because the pendulum loses more kinetic energy
fighting against the greater drag force acting on it while moving
underwater compared to in the air. It is explicitly because of this
effect water viscosity would have on the test that staff recommended
the test be conducted in air, so that the swinging pendulum continues
to provide mechanical stimulus as described above without becoming
overdamped by water and slowing to an immediate stop upon release. To
reflect performance in a water environment, the test method requires
the M2 swinging weight to represent the in-water weight of the child's
body, to be determined as a fraction of the total body weight,
specifically 20 percent of the dry-land weight of the maximum intended
occupant according to the manufacturer's recommended use instructions,
to account for the buoyant effects water has on the human body.
After considering the comment regarding the location of the user's
CG based on length L, the Commission agrees that the distance for L
proposed in the NPR, which was determined as half of the 95th
percentile stature of the neck float's user, was too long. The center
of mass for a human is generally situated in the body's torso, though
it may skew closer to the chest or stomach depending on an individual's
body composition. The commenter notes that the distribution of weight
for infants and young children, particularly in the legs, is different
than that for adults, and that the CG location defined by length L
should be higher for infants to reflect this. Based on further analysis
and testing by staff, the Commission will require, in the final rule,
that the distance L shall be determined by applying the 50th percentile
location of the CG to the 95th percentile standing height of the user
in the specified age range. Using this measurement when determining the
CG will position the CG distance, measured from the top of the head,
closer to the chest-line of the user. This change will reduce the
length of L, as depicted in Figure 8, and ultimately reduce the
magnitude of the moment acting on the probe caused by the swinging
pendulum.
BILLING CODE 6355-01-P
[[Page 58118]]
[GRAPHIC] [TIFF OMITTED] TR15DE25.019
BILLING CODE 6355-01-C
The inclusion of a soap solution is based on the incident data
verifying its involvement as a contributing factor to a slip-through
event and as a foreseeable element of general neck float use in a
bathtub. The Commission received several comments from consumers on
neck float use specifically in the context of bathing an infant. In
addition, firms such as Otteroo market their products for use in
bathtubs, in addition to pools.
[[Page 58119]]
This further verifies the foreseeable association of soapy water and
neck float use. Soapy water introduces a lubricant that would increase
the likelihood of a slip-through scenario, and based on its foreseeable
use, staff do not agree that its impact should be removed from
consideration in the test method. Accordingly, the Commission is not
removing this requirement.
The rationale for the 0.1 PSIG inflation factor is discussed at
length earlier in this same section of the preamble. Accordingly, based
on the explanations provided above, the Commission is not removing the
requirement to deflate to 0.1 PSIG.
The neck opening test was developed, including revisions in the
final rule, with expert staff in CPSC divisions including Engineering
Sciences/Laboratory Sciences Mechanical, Human Factors, Health
Sciences, and CPSC's machinist.
Otteroo requested the basis for using the language such as ``not
proprietary'' and ``reasonably sourced'' to describe the neck probes
used in the neck opening test in the NPR. In the discussion regarding
technological feasibility, the NPR explained that though testing
laboratories may need to procure additional equipment to accommodate
the conditioning, buoyancy, and neck opening requirements, the tools
required for those test methods are not proprietary or exclusive items
and may be reasonably sourced from commercial providers. With regard to
test probes for the neck opening test, the NPR and the final rule
acknowledge that head probes are unique; however, the probes required
to be used for the neck opening test are not protected under any
registered trade name and the dimensions have been fully provided in a
public setting at no cost to the reader, and therefore are not
proprietary. The basis for using the reasonably sourced language
includes the lack of specialty items designated for the probe's
fabrication. The Commission is not requiring that the test probes be
fabricated using difficult/expensive to acquire materials, or even to
be created using specific machining processes that require special
expertise or equipment to perform. CPSC used a 3D printer for the neck
probes using a commercially available machine with commercially
available filament.
F. Marking and Labeling Requirements
1. Supervision
Comments: The Commission received 46 comments that discussed
whether encouraging caregiver supervision of children in and around
water is an adequate solution to prevent drowning associated with neck
floats. Otteroo and some consumers expressed that supervision is an
effective risk mitigation strategy for the slip-through and other
submersion hazards. They pointed to incident reports to highlight cases
in which caregivers prevented death or serious injury by quickly
retrieving their children to prevent them from drowning after slipping
through a neck float. They also stated that the fatal incidents were
caused by caregivers leaving their children unattended and suggested
that constant caregiver supervision could have prevented the deaths.
Consumer Reports, Consumer Federation of America, Safe Infant
Sleep, the U.S. Public Interest Research Group, and some consumers
expressed that relying on supervision without performance requirements
is not an effective risk mitigation strategy for the slip-through and
other submersion hazards. These commenters stated that neck floats
exhibit a clear hazard based on the incident reports, including
fatalities where children drowned while wearing the product, and cases
where children would have drowned without immediate caregiver
intervention. They also stated that product marketing of neck floats as
safe and trusted can give caregivers a false sense of security. They
also commented that drowning and other harm from the child's mouth and
nose submerging in water can occur very quickly and because early signs
of distress may not be noticeable to caregivers (even in the same
room), caregivers may be delayed in rescuing children who are incapable
of self-rescue.
Response: Encouraging supervision of children in and around water
is not an adequate solution to prevent drowning associated with neck
floats. The Commission agrees with commenters who expressed that
relying on supervision without performance requirement is not an
effective risk mitigation strategy for the slip-through and other
submersion hazards. Such a strategy also would not ``ensure . . . the
highest level of safety for such products that is feasible.'' 15 U.S.C.
2056b(c). The Commission also agrees with commenters that it is common
sense to supervise children in and around water, especially those who
cannot swim. Yet, drowning remains a leading cause of death for
children globally. There has been a persistent gap between caregivers
knowing they should supervise children in and around water and
practicing active, touch supervision. Lapses in adequate supervision
are especially common when children are in shallow water and/or wearing
a flotation device.
The Commission assesses it is reasonably foreseeable that
caregivers will relax their supervision of children using neck floats,
whether remaining in the same room/space and performing other or
simultaneous activities, or even leaving the child unattended for brief
periods. As commenters explained, there are myriad reasons why
caregivers relax their supervision of children wearing neck floats. The
NPR detailed numerous reasons why caregivers overestimate the
capabilities of neck floats and underappreciate the nature and
likelihood of children submerging underwater during the use of neck
floats, such as:
Neck floats are marketed and commonly recognized as
effective at keeping children's upper airways above water so they can
safely interact, play, and be bathed in water.
The products are typically effective at keeping children
afloat without the child needing to do anything. Caregivers are likely
to judge the product to be safe and reliable after observing past
incident-free use of the product by their children and others.
Neck floats often appear to be secure around the child's
neck, and may have design elements like a chin rest, which can make it
seem like the child's head cannot pass through the neck opening even
though it can.
The environment does not appear to be dangerous or
uncontrolled, such as confined spaces with shallow water (e.g., a
bathtub with only several inches of water).
The incident data demonstrate patterns in children's upper airways
suddenly and unexpectedly submerging in water while using neck floats,
typically due to the product's neck opening deforming and expanding
during use in ways that caregivers are likely to overlook and
underestimate.
As commenters explained, hazardous, even life-threatening outcomes,
may result even when caregivers are in the same room as children using
neck floats in and around water. Children, especially infants,
generally cannot self-rescue in a drowning scenario, so every slip-
through or submersion incident has the potential to be a drowning,
resulting in injury or death if caregivers do not quickly rescue the
child. Water aspiration into the lungs and water ingestion can happen
even with very brief submersions, and distracted caregivers may not
hear and notice that the child is drowning because the act of drowning
can be silent or otherwise not
[[Page 58120]]
stand out from typical use of the product.\25\
---------------------------------------------------------------------------
\25\ McCall JD, Sternard BT. Drowning: Clinical Management. 2023
Aug 8. In: StatPearls [internet]. Treasure Island (FL): StatPearls
Publishing; 2025 Jan-. PMID: 28613583.
---------------------------------------------------------------------------
2. Checking for Leaks
Comments: Otteroo asserted that leaks are an inevitability of
inflatable products, and that consumers should be responsible for
checking the products for leaks prior to each use. Otteroo acknowledged
that CPSC claims this is not a realistic expectation for consumers.
Otteroo stated that the potential for leaks is not a design defect, and
that the solution is caregiver supervision of children wearing neck
floats. Otteroo also asserted that NPR claims that ``incident data
shows that caregivers are unlikely to perform a leak check prior to
every use of the product'' suggests that preventing leaks falls solely
on the manufacturer and inflatable products must never experience wear
and tear that could lead to leaks.
Response: The Commission agrees with Otteroo that wear and tear and
the potential for leaks are risks associated with inflatable products,
including but not limited to neck floats. For this rule, based on
incident data, the Commission is particularly concerned about the
incidents involving child neck floats because these products are
intended for vulnerable populations who depend on the products to keep
from submerging their mouth and nose underwater, and who cannot self-
rescue in the event of submersion. As discussed in the response above
and in the NPR, the Commission explains the multitude of reasons why
simply instructing consumers to supervise their children better is not
a reasonable and adequate solution, such as caregivers getting a false
sense of security in the products, children's false sense of confidence
in/around water, and because signs of drowning can be imperceptible or
mistaken for continued playing.
Fifty-two reported incidents involved an infant slipping through
the product despite the neck float showing no signs of deflation,
underinflation, or any other reported product issues. Even if a neck
float appears to fit a child securely, that is, around a child's neck
with little to no extra space, the child's position and activity can
cause them to slip through the product. Incident data and publicly
available consumer-uploaded content of children in neck floats
demonstrate that children will use neck floats on their back, on their
chest, on their side, and while sitting or standing, and are likely to
tilt their head forward and rearward, tuck their chin, bite the chin
rest, twist their head in the neck float, wiggle their bodies, kick
their legs, flail their arms, and even push up on the front underside
of the neck float. These and other actions can separate the
discontinuous ends, deform the neck opening, or otherwise alter the fit
of the neck float on the child, resulting in the child's mouth and nose
sliding into the water.
3. Effectiveness of Warnings
Comments: The Commission received 16 comments on the warning
requirements for neck floats. Otteroo claimed that clear warnings that
address the need for constant supervision are adequately effective
without performance requirements in preventing deaths and serious
injuries that could result from the use of neck floats. Otteroo claimed
that existing labeling practices are sufficient without having to
comply with new labeling requirements and pointed to other standards,
such as EN 13138-1:2021, which address ``common-sense safety measures,
such as warnings about drowning risks and the necessity for
supervision.'' Otteroo questioned the effectiveness and appropriateness
of the proposed warnings. Otteroo further questioned why CPSC
recommends warnings and instructional literature if it considers safety
messaging to be ineffective.
Consumer Federation of America, Safe Infant Sleep, U.S. Public
Interest Research Group, and a consumer supported the warning language
in the proposed rule as increasing the safety of neck floats by
communicating the hazards and how to avoid the hazards. However,
Consumer Reports, Safe Infant Sleep, the U.S. Public Interest Research
Group, and Consumer Federation of America argued that even improved
warnings are not sufficient to mitigate the risks for various reasons,
such as follows: the illusion of safety created by the products,
marketing as safe and trusted, drowning can occur very quickly,
inability to self-rescue, and early signs of distress may not be
noticeable to caregivers, even if the children and caregivers are in
the same room.
Responses: Otteroo references EN 13138-1:2021, which requires
warnings for certain buoyancy/swimming devices. In particular, these
warnings include that the product will not protect against drowning,
that all air chambers must be fully inflated, and that constant
supervision must be provided while the product is used. The vast
majority of products involved in reported neck float incidents had on-
product warnings and warnings in instructional literature, which
directed caregivers to always supervise their children, to check for
leaks, and other relevant guidance. Yet, numerous incidents have
occurred and demonstrate that caregivers did not always follow these
warnings (e.g., IDI 210908CCC1983 indicates the caregiver read the
incident unit's warnings and instructional literature but did not
perform any bubble tests). As discussed in CPSC's above response
regarding supervision, caregivers are likely to have a false sense of
security that neck floats will keep their children's mouth and nose
above the water during use, and children are likely to develop a false
sense of confidence in and around water.
Warnings for neck floats have inherent weaknesses, as their success
requires the uphill battle of overcoming caregiver underappreciation of
the risk and severity of injury. The effectiveness of warnings for neck
floats depends on caregivers reading them, understanding them,
remembering them, and heeding them every time the neck floats are used.
Warnings for neck floats are unlikely to be universally effective, but
strong warnings are likely to inform and convince some consumers about
the hazards, and the Commission is finalizing warnings that are
complementary to performance requirements, which aim to reduce the
likelihood of sudden and unexpected submersion by improving the safety
of the products' design. The warnings will increase the likelihood of
caregivers being informed about the hazards and how to avoid the
hazards, but the best way to prevent drowning is to have performance
requirements that prevent an infant from slipping through the product
and that do not rely on constant supervision and intervention to
prevent infant death.
The Commission concludes that the warnings required by the final
rule are necessary to address the submersion hazards associated with
child neck floats. The language in the warnings aims to attract
attention to the hazards by using vivid and personalized, yet concise,
language to identify the risks and motivate positive behavioral change
to avoid the risks. The warnings explain that children have died from
slipping through neck floats. This is to communicate to caregivers who
read the warnings that children drowning while using a neck float is
not simply a theoretical hazard, but an outcome that has tragically
occurred and may occur again.
The warnings explain that the neck opening can expand during use
even if
[[Page 58121]]
it feels snug. This is because incident data demonstrate that
caregivers thought their neck floats were too tight around their
children's necks to permit the children's heads to slip through, and
yet their heads slipped through, nonetheless. CPSC staff examined neck
floats and concurred with this perception that the snugness makes it
seem like a child's head cannot pass through the opening without the
neck float being unclipped or deflated, yet reasonably foreseeable
circumstances (as discussed in previous responses to comments in this
section of the preamble) can result in the child's head slipping
through.
The warnings explain that children can drown in as little as 1 inch
of water. This is to emphasize the importance of watching children even
when it seems like there would not be enough water to cause a risk of
drowning. Similarly, the warnings include statements to provide touch
supervision with emphasis that the caregivers need to be attentive to
keep their children's mouths above the water. This emphasis highlights
the potential that the neck float will not always keep the child from
drowning.
For products with inflatable components, the warnings include
statements to check for leaks and to not use the product with leaks
(the proposed instructional literature requirements include explaining
how to check for leaks). While the incident data demonstrate cases in
which caregivers did not perform the leak tests as instructed, some of
the involved caregivers did indicate that they performed the tests
appropriately, therefore, these warnings are still important and are
likely to be more effective given the strong language in the other
required warnings. Lastly, the warnings include specifying intended
user ages and weights so caregivers know for whom the products were
designed.
Additional warnings may be necessary for certain products, and the
rule supports neck floats including additional warnings not specified
by this final rule as long as the additional warnings neither confuse
nor conflict with the required language to be addressed in the
warnings.
G. Prohibited Stockpiling
Comment: The Commission received a comment from Otteroo regarding
the proposal to prohibit stockpiling. Otteroo asserted that the NPR
negatively portrays manufacturers, includes claims regarding reputation
that are unfounded, and does not provide evidence that stockpiling or
other irresponsible behavior would occur. Otteroo further asserted that
small businesses do not have the resources to stockpile the products
and requested that the speculative language be removed.
Response: The language used in the NPR highlights the Commission's
concerns regarding potential manufacturers circumventing the purpose of
the safety standard for neck floats. It is not directed at any specific
business entity. Additionally, the commenter states that small
businesses do not have the resources to stockpile products; therefore,
such businesses will be unaffected by a stockpiling requirement.
H. Regulatory Alternatives
1. Education
Comments: The Commission received comments from Otteroo and Great
Lakes Surf Rescue Project that opined on the subject of public
education for safe use of neck floats. Great Lakes Surf Rescue Project
asserted that regulation and education were the solutions to addressing
the hazards. Otteroo recommended there should be public education
efforts that emphasize the importance of providing constant supervision
when the child is using the product in or around water. Great Lakes
Surf Rescue Project recommended explaining to caregivers that flotation
aids can result in various concerns, such as false sense of security,
getting children accustomed to the ``drowning position'' (vertical in
water with the head tipped back and no purposeful movements for the
arms and legs), and leading children who cannot swim to enter bodies of
water without flotation aids.
Response: There have been numerous public awareness raising
campaigns over the past decades to reduce instances of childhood
drowning, and CPSC has participated in such efforts.\26\ CPSC continues
to support these efforts; however, childhood drowning remains a leading
cause of death for children despite these many attempts at public
education, including recommendations for active and touch supervision.
As discussed in previous responses to comments in this section of the
preamble, it is reasonably foreseeable that caregivers will not provide
adequate supervision, particularly for neck floats. Therefore, the
Commission is issuing a final rule that includes performance
requirements and mandatory safety messaging to reduce the risk and
severity of the submersion hazards for neck floats.
---------------------------------------------------------------------------
\26\ For example, see The National Pool Safely Campaign to
Reduce Drowning and Entrapment Injuries: http://www.PoolSafely.gov.
---------------------------------------------------------------------------
2. ASTM Standard for Flotation Products
Comments: The Commission received 10 comments from consumers, two
former lifeguards, a clinic employee, US Drowning Research Alliance,
and Otteroo expressing support for creating a separate safety standard
or regulation dedicated to flotation products for children in general,
including but not limited to neck floats, with specific guidance for
``attaching and wearable flotation products.''
Response: The scope of this rulemaking is limited to neck floats.
Accordingly, the Commission is finalizing a safety standard for neck
floats. Regarding safety standards to address flotation devices more
broadly, as discussed in previous responses to comments in this section
of the preamble, CPSC staff continue to participate in the ASTM
designated subcommittee F15.07 as it develops a potential standard for
buoyancy aids for children.
3. Ban
Comments: The Commission received comments from consumers and
consumer groups regarding a ban on neck floats. The Consumer Federation
of America, Safe Infant Sleep and U.S. Public Interest Research Group
asserted that no amount of regulation would be sufficient to address
all hazards associated with neck floats and that neck floats must be
banned. A consumer recommended a ban and referenced California's ban on
wearable personal flotation devices that are not approved by the U.S.
Coast Guard. American Academy of Pediatrics, Consumer Reports, Safe
Infant Sleep, and the U.S. Public Interest Research Group voiced their
preference for a ban on neck floats and their desire to pursue one in
the future in addition to suggesting that CPSC consider acting on the
matter as a rule under CPSIA section 104 (15 U.S.C. 2056a) for infant
and toddler products. Those commenters, however, stated that they would
support the proposed rulemaking effort for the time being. One consumer
commenter agreed that neck floats required regulation and described
them as inherently hazardous products. This commenter, however,
expressed uncertainty about reducing the risk associated with neck
floats to an acceptable level by the proposed requirements.
Response: The Commission determines that a ban on neck floats is
not necessary based on incident data, staff's engineering, health
sciences, and
[[Page 58122]]
human factors assessments. The requirements of the final rule, in Sec.
1250.5, for neck floats have been assessed to reduce the risk of injury
associated with neck floats and provide the highest level of safety for
such products that is feasible.
VI. Description of the Final Rule for Neck Floats
Based on the comments received on the NPR and staff's engineering
and human factors assessments, the final rule establishes new
requirements in Sec. 1250.5 to 16 CFR part 1250, Safety Standard
Mandating ASTM F963 for Toys, to better address known hazards
associated with neck floats and to provide the highest level of safety
for such products that is feasible.
To address the risk of injury described in section III of this
preamble, in Sec. 1250.5(b), this final rule includes a definition for
``neck float'' discussed in section II of this preamble, adds new
performance requirements, and revises existing labeling requirements
for neck floats. More specifically, the final rule includes test
requirements for conditioning, buoyancy, fastening systems, restraining
systems, and neck openings, and revised marking, labeling and
literature requirements. These requirements are more stringent than the
existing requirements in part 1250 to further reduce the risk of injury
associated with neck floats and to provide the highest level of safety
for such products that is feasible to address child drownings
associated with neck floats. Below, we summarize the requirements in
the final safety standard, including changes from the NPR.
A. Performance Requirements To Address Drowning Hazards
Because ASTM F963-23 does not establish specific performance
requirements for aquatic toys, including neck floats, the Commission
determines that it fails to adequately address children slipping
through neck floats or otherwise being submerged into water and does
not provide the highest level of safety for such products that is
feasible.
1. Conditioning Procedure
The final rule requires neck floats to undergo a conditioning
procedure prior to conducting any other tests under section
1250.5(c)(1), which includes thermal, chlorinated salt water, and
ultraviolet (UV) light exposure, in this order. In response to public
comments, the Commission is revising the conditioning requirements for
UV exposure, as discussed below. All inflatable neck floats subject to
the final rule are required to be deflated for all of the testing
requirements in the conditioning procedure.
a. Exposure to Varying Temperatures
Section 1250.5(c)(1) of the final rule incorporates by reference
section 5.5.4.1 of ANSI/CAN/UL 12402-9:2022, Temperature cycling test,
for both inflatable and inherently buoyant neck floats, with three
modifications. The final rule excludes the separate requirement in
ANSI/CAN/UL 12401-9:2022 to fully open inherently buoyant PFDs. Another
modification is based on adjusting exposure to cold temperatures from -
30 2 [deg]C to -10 2 [deg]C (14
4 [deg]F). The last modification reduces the thermal conditioning for a
single 8-hour period at both temperature extremes (60 2
[deg]C and -30 2 [deg]C) followed by a 24-hour period at
room temperature (20 2 [deg]C (68 4 [deg]F)).
b. Exposure to Chlorinated Salt Water
Section 1250.5(c)(2) of the final rule requires that a neck float
should be submerged in a chlorinated saltwater solution, after
completing thermal conditioning in accordance with Sec. 1250.5(c)(1).
The solution is required to be prepared by dissolving 32 grams \27\ of
sodium chloride (NaCl) in one liter of aqueous solution containing 2
ppm chlorine at pH 7.0-7.8.\28\ The neck float is required to be
submerged in the necessary volume of the prepared chlorinated saltwater
solution, in darkness and at room temperature (20 2 [deg]C
(68 4 [deg]F)) for 8 hours.
---------------------------------------------------------------------------
\27\ Giovanisci, Matt. ``How Much Salt to Add to Your Pool (Easy
Pool Salt Calculation).'' Swim University, 8 July 2024, http://www.swimuniversity.com/how-much-pool-salt.
\28\ Home Pool and Hot Tub Water Treatment and Testing.''
Healthy Swimming, 10 May 2024, http://www.cdc.gov/healthy-swimming/about/home-pool-and-hot-tub-water-treatment-and-testing.html.
---------------------------------------------------------------------------
c. Exposure to Ultraviolet Light
In Sec. 1250.5(c)(1), for exposure to UV light, the final rule
incorporates by reference sections 4.2.1.1-4.2.1.4 of ANSI/APSP/ICC-16
2017 with some changes from the proposed rule. The requirements in
section 4.2.1.1-4.2.1.4 of ANSI/APSP/ICC-16 2017 include the
``Ultraviolet Light Exposure Tests'' selected per the discretion of the
evaluator:
``(a) 720 hours of twin enclosed carbon-arc (ASTM G153, Table X1.1
Cycle 1 except the Black Panel Temperature shall be 50[deg] C); or
(b) 720 hours of twin enclosed carbon-arc (ASTM G153, a programmed
cycle of 20 minutes consisting of a 17-minute light exposure and a 3-
minute exposure to water spray with light shall be used with a black-
panel temperature of 63 3 [deg]C); or
(c) 1,000 hours of xenon-arc (ASTM G155, Table X3.1 Cycle 1 except
the Black Panel Temperature should be 50 [deg]C); or
(d) 750 hours of fluorescent (ASTM G154, Table X2.1 Cycle 1 except
the 8-hour UV shall be at a Black Panel Temperature of 50 [deg]C and
the 4-hour condensation Black Panel Temperature shall be 40 [deg]C).''
\29\
---------------------------------------------------------------------------
\29\ American National Standards Institute (ANSI) and
Association of Pool & Spa Professionals. American National Standard
for Suction Outlet Fitting Assemblies (SOFA) for Use in Pools, Spas,
and Hot Tubs. American National Standards Institute (ANSI), 18 Aug.
2017, APSP.org.
---------------------------------------------------------------------------
In response to public comments, the Commission is revising the UV
exposure to more conservatively account for the expected UV exposure of
a neck float. Accordingly, in the final rule, the total duration of
exposure in each of the four methods is reduced by 75 percent from the
proposed 720 hours to 180 hours using methods (a) and (b), from the
proposed 1000 hours to 250 hours using method (c), and from the
proposed 750 hours to 188 hours using method (d) from sections 4.2.1.1-
4.2.1.4 of ANSI/APSP/ICC-16 2017. Additionally, the NPR erroneously
proposed modifications to a portion of section 4.2.1 of ANSI/APSP/ICC-
16 2017 that was not intended to be incorporated by reference in this
final rule. Both the NPR and the final rule only incorporate by
reference section 4.2.1.1-4.2.1.4 of ANSI/APSP/ICC-16 2017. Reference
to those unincorporated sections, previously Sec. 1250.5(c)(1)(iv) and
(v) in the NPR, have been removed.
2. Minimum Buoyancy Requirements
In Sec. 1250.5(c)(2) the Commission is finalizing minimum buoyancy
requirements to prevent unintentional submergence. Specifically, the
final rule requires all neck floats to demonstrate a minimum upward
buoyancy equal to or greater than 30 percent of the expected weight
capacity of the neck float, which will ensure that a neck float is
buoyant during use.\30\ Additionally, the final rule will require
inherently buoyant neck floats to not lose more than 5 percent of their
initial buoyancy after being submerged for a 24-hour period.
---------------------------------------------------------------------------
\30\ Buoyancy is a property of the object's density, and for
inflatables is achieved by increasing the float's volume by blowing
it up, without substantially affecting the float's mass.
---------------------------------------------------------------------------
The expected weight capacity, as defined in Sec. 1250.5(b), will
be determined as the neck float's maximum recommended user weight, or
the weight provided in Table 1 based on the
[[Page 58123]]
neck float's maximum recommended user age, whichever is greater.
---------------------------------------------------------------------------
\31\ See CDC ``Data Table for Boys Length-for-age and Weight-
for-age Charts'': https://www.cdc.gov/growthcharts/who/boys_length_weight.htm, for ages 0 to 12 months (weights by month).
See CDC ``Anthropometric Reference Data for Children and Adults:
United States, 2015-2018'': https://www.cdc.gov/nchs/data/series/sr_03/sr03-046-508.pdf, for ages 2 to 4 years (weight by years).
[GRAPHIC] [TIFF OMITTED] TR15DE25.020
The Commission is incorporating by reference the test method from
sections 5.5.9.2-5.5.9.4 of ANSI/CAN/UL 12402-9:2022, with
modifications, in the final rule to determine the minimum buoyancy for
all neck floats. Section 5.5.9.3 of ANSI/CAN/UL 12402-9:2022 requires a
swimming device to be inflated to the pressure provided by its primary
means of inflation, or to 4.0 0.1 kPa (0.58
0.016 PSIG), whichever is less, if it contains inflatable components.
This final rule, however, requires that any neck float utilizing
inflatable components must be inflated to the lower internal air
pressure of 0.1 0.01 PSIG for the duration of this test.
3. Restraint Systems
To reduce the likelihood of a restraint system failure on a neck
float, which can result in a child slipping through the product, the
Commission finalizes in Sec. 1250.5(c)(3) requirements for the release
mode of the fastening mechanism, and overall mechanical integrity of
restraint systems.
The final rule requires the release mechanism of neck float
fasteners to have either a double-action release system with two
distinct, but simultaneous actions to release, or a single-action
release system that requires a minimum of 50 N to release.
Additionally, the Commission is incorporating by reference section
6.4.4, Restraining System, and 7.5.1, Restraining System Integrity Test
Method, of ASTM F833-21 in the final rule, with modifications to omit
both the CAMI dummy evaluation following testing, and any evaluation to
section 7.5.2 of ASTM F833-21, Restraining System occupant Retention
Test. Section 6.4.4 of ASTM F833-21 requires that a restraint system
and any closure mechanisms such as buckles must not part or slip more
than 1 inch (25 mm) when tested in accordance with section 7.5 of ASTM
F833-21. Additionally, the standard requires that any anchorages must
remain attached without separating from their attachment points during
testing. Section 7.5.1 of ASTM F833-21 specifies the testing method for
this requirement, which includes applying a force of 200 N (45 lbf) to
a single attachment point on the restraining system. Specifically, the
standard requires that force is applied gradually within 5 seconds and
maintained for an added 10 seconds, and repeated a total of five times
with a 5 second maximum time interval between tests for each attachment
point on the restraint system.
4. Neck Opening Test Requirements
To address the hazard of a child slipping through a neck float, the
Commission is finalizing requirements for the neck opening on a neck
float under Sec. 1250.5(c)(4). To meet the requirement, the neck
opening of the neck float must not admit the passage of a specified
head probe (Figure 10) when subjected to a specified dynamic movement.
The final rule requires that, prior to conducting the test, any
adjustable restraint straps on the neck float must be set at the
loosest (largest) setting possible, and any inflatable components of
the neck float must be inflated to an internal air pressure of 0.1
0.01 PSIG.
The neck opening of the neck float shall be saturated with a soapy
solution, prepared according to section 7.4.1.5 of ASTM F1967-19,
Standard Consumer Safety Specification for Infant Bath Seats, for
``Baby Wash Test Solution'' incorporated by reference in the final
rule. Next, a specified head probe of specific mass (M1) should be
positioned in the neck opening and a hanging weight of specific mass
(M2) shall be suspended below the head probe at a distance (L),
relative to the head probe (see Table 2 for details on M1, M2 and L for
various user-age categories).
The hanging weight shall then be brought up to a 90-degree
displacement angle and released such that it is swung front-to-back
relative to the neck float's user as shown in Figure 9. The hanging
weight must be allowed to move freely for 30 seconds in this manner.
After 30 seconds have passed, the hanging weight shall be brought up
again to a 90-degree displacement angle, this time so that it swings
side-to-side relative to the neck float's user and released to swing
freely for 30 seconds in this manner. This alternating pattern is
repeated for up to a total of ten swinging cycles, five front-to-back
and five side-to-side, or until the head probe fully slips through the
neck opening.
BILLING CODE 6355-01-P
[[Page 58124]]
[GRAPHIC] [TIFF OMITTED] TR15DE25.021
BILLING CODE 6355-01-C
The choice of specified head probe, mass M1, mass M2, and length L
is based on the manufacturer's recommended user age range, in
conjunction with Table 2. If the recommended user age falls between two
ranges, then the lower range shall be used to determine the smallest
probe and associated testing conditions, and the higher range shall be
used to determine the largest probe and associated testing conditions.
[[Page 58125]]
[GRAPHIC] [TIFF OMITTED] TR15DE25.022
Dimensions of the head probe shall comply with the values given in
Table 3. Section A-A of Figure 10 demonstrates that the head probe may
be hollow for the purposes of adding mass M1; however, it is not a
requirement of the probe.
---------------------------------------------------------------------------
\32\ See BSI Standards Publication. ``Child Care Articles--
General Safety Guidelines--Part 1: Safety Philosophy and Safety
Assessment.'' 2018. BSI Standards Publication, report, 2018.
\33\ Values here are 20 percent of respective 95th percentile
weights provided by CDC ``Data Table for Boys Length-for-age and
Weight-for-age Charts'': https://www.cdc.gov/growthcharts/who/boys_length_weight.htm, for ages 0 to 12 months. See CDC
``Anthropometric Reference Data for Children and Adults: United
States, 2015-2018'': https://www.cdc.gov/nchs/data/series/sr_03/sr03-046-508.pdf, for ages 2 to 4 years.
\34\ See Schneider et al., 1986).
---------------------------------------------------------------------------
The narrowest end of the probe is an ellipse whose semi-major axis
corresponds to the neck depth, and whose semi-minor axis corresponds to
the neck breadth. The widest end of the probe is an ellipse whose semi-
major axis corresponds to the head length, and whose semi-minor axis
corresponds to the head breadth on the plane passing through the point
of greatest protrusion on the forehead and the point of greatest
protrusion on the back of the head. The distance between the narrowest
and widest circumferences on the probe is equal to the height of the
head.
BILLING CODE 6355-01-P
[[Page 58126]]
[GRAPHIC] [TIFF OMITTED] TR15DE25.023
[[Page 58127]]
[GRAPHIC] [TIFF OMITTED] TR15DE25.024
BILLING CODE 6355-01-C
C. Marking, Labeling, and Instructional Literature Requirements
The final rule includes marking, labeling, and instructional
literature requirements, as proposed in the NPR. As detailed in the NPR
and discussed above in responses to comments on the NPR, the marking,
labeling, and instructional literature requirements increase the
likelihood of caregivers being informed about the hazards and how to
avoid the hazards.
1. Warning Label
The final rule requires, in Sec. 1250.5(d)(1), that instead of
complying with the warning text of section 5.4 of ASTM F963-23, neck
floats and their packaging must include the safety alert symbol, signal
word, and word message as shown in Figure 11. The warnings are required
to be in the English language, in a distinct color contrasting its
background, conspicuous, and permanent on the principal display panel
as defined in section 3.1.62 of the ASTM F963-23 incorporated by
reference in Sec. 1250.10.
[GRAPHIC] [TIFF OMITTED] TR15DE25.025
a. Content
The beginning statement, ``THIS PRODUCT DOES NOT PREVENT
DROWNING,'' clearly articulates that children can still drown even
though they use the product, and is bold and capitalized to attract the
consumer's attention. The portion, ``[specify lower bound for age],''
should be filled with the lowest age intended for use of the product
and in bold font. The portion, ``[specify upper bound for age],''
should be filled with the highest age intended for use of the product
and in bold font. The portion, ``[specify lower bound for weight],''
should be filled with the minimum intended weight in pounds for use of
the product and in bold font. The portion, ``[specify upper bound for
weight],'' should be filled with the maximum intended weight in pounds
for use of the product and in bold font. The portion, ``{Check for
leaks before each use. Never use with leaks.{time} ,'' is only required
and appropriate for child neck floats with inflatable components. The
brackets should be omitted from the label in each case above.
[[Page 58128]]
b. Format
For formatting, the final rule incorporates by reference sections
6.1-6.4, 7.2-7.6.3, and 8.1 of ANSI Z535.4-2023, with the following
changes:
For enforceability, in sections 6.2.2, 7.3, 7.5, and
8.1.2, replace the word ``should'' with ``shall;''
Also, for enforceability, in section 7.6.3, replace the
phrase ``should (when feasible)'' with the word ``shall;'' and
To allow greater production flexibility without affecting
the efficacy of the warnings, strike the word ``safety'' when used
immediately before a color (e.g., replace ``safety white'' with
``white'').
The signal word, ``WARNING,'' must appear in sans serif letters in
upper case only and be at least \1/8\ inch (3.2 mm) in height and be
center or left aligned. The height of the exclamation mark inside the
safety alert symbol, an exclamation mark in a triangle, as shown in the
example warnings must be at least half the height of the triangle and
be centered vertically inside the triangle. The message panel text
capital letters cannot be less than \1/16\ inch (1.6 mm) and the
message panel text shall be center or left aligned and appear in sans
serif letters. The text in each column should be arranged in list or
outline format, with precautionary (hazard avoidance) statements
preceded by bullet points. Precautionary statements must be separated
by bullet points if paragraph formatting is used.
c. Placement
Consistent with the recommendations of the Ad Hoc Task Group and
requirements in section 5.3.6 of ASTM F963-23, the final rule requires
that the warning label identified in Figure 11 is positioned
conspicuously on the product, such that it is visible clearly and, in
its entirety, when the product is placed on the child. In addition, for
the product's packaging, to ensure that the label is in an area of the
packaging that stands out and is visible, the warning label in Figure
11 must be placed in the principal display panel, which is defined in
section 3.1.62 of ASTM F963-23 as ``the display panel for a retail
package or container, bin, or vending machine that is most likely to be
displayed, shown, presented, or examined under normal or customary
conditions of display for retail sale.''
2. Instructional Literature
The final rule includes requirements for the instructional
literature for all neck floats. The instructional literature must be
easy to read and understand, and shall be in the English language, at a
minimum, consistent with the Ad Hoc recommended language under Sec.
1250.5(d)(2). These instructions must be printed on the product and
provided separately, such as a user manual, and include information on
assembly, installation, maintenance, cleaning, and use, where
applicable. The instructions must explain how to check for adequate fit
of the product to prevent the child from slipping through the neck
opening. Instructional literature provided with the product, but not
printed on the product, must include all warnings specified above in
section 1 on content. Any instructions provided in addition to those
required in this section must neither contradict nor confuse the
meaning of the required information, nor be otherwise misleading to the
consumer. For products with inflatable components, the instructional
literature must include clear directions for testing the product for
leaks prior to each use.
D. Severability
If any requirements in the final rule are stayed or determined to
be invalid by a court, the Commission intends that the remaining
requirements in the rule will continue in effect and finds that the
individual requirements in the rule each independently promote the
safety of infants. This applies to all provisions adopted as part of
the safety standard for neck floats under section 106 of the CPSIA, to
reflect the Commission's intent that part 1250 be given its greatest
effect.
VII. Prohibited Stockpiling
The Commission is finalizing Sec. 1250.5(e) to prohibit any
manufacturer of neck floats from stockpiling their products towards
circumventing the purpose of this rule, as discussed in the NPR. 15
U.S.C. 2058(g)(2). More specifically, firms cannot manufacture or
import noncompliant products in a given month more than a rate of 105
percent of the base period. The base period is the average monthly
manufacturing or import volume within the last 13 months of production
that immediately precedes the month of promulgation of the final rule.
VIII. Amendment to 16 CFR part 1112 To Include Notice of Requirements
for Safety Standard for Toys: Requirements for Neck Floats
Products subject to a consumer product safety rule under the CPSA,
or to a similar rule, ban, standard, or regulation under any other act
enforced by the Commission, must be certified as complying with all
applicable CPSC-enforced requirements. 15 U.S.C. 2063(a). Certification
of children's products subject to a children's product safety rule must
be based on testing conducted by a CPSC-accepted third party conformity
assessment body. 15 U.S.C. 2063(a)(2). The Commission must publish an
NOR for the accreditation of testing laboratories as third party
conformity assessment bodies to assess conformity with a children's
product safety rule. 15 U.S.C. 2063(a)(3). This rule for neck floats is
a children's product safety rule that requires an issuance of an NOR.
The Commission's rules, at 16 CFR part 1112, establish requirements
for accreditation of third-party conformity assessment bodies to test
for conformance with a children's product safety rule in accordance
with section 14(a)(2) of the CPSA. Part 1112 also lists the NORs that
the CPSC has published. In the NPR, the Commission proposed to amend
part 1112 to include the Safety Standard for Toys: Requirements for
Neck Float in the list of children's product safety rules for which the
CPSC has issued NORs. Section 16 CFR 1112.15(a)(57) is being finalized
as proposed in the NPR.
Laboratories applying for acceptance as a CPSC-accepted third party
conformity assessment body to test to the new Safety Standard for Toys:
Requirements for Neck Floats are required to meet the third-party
conformity assessment body accreditation requirements in part 1112.
When a laboratory meets the requirements as a CPSC-accepted third party
conformity assessment body, the laboratory can apply to the CPSC to
have the Safety Standard for Toys: Requirements for Neck Floats
included in its scope of accreditation as reflected on the CPSC website
at: www.cpsc.gov/labsearch.
IX. Feasibility of the Final Rule
Pursuant to section 106(c) of the CPSIA, Congress directed the
Commission to ``periodically review and revise the rules set forth
under this section to ensure that such rules provide the highest level
of safety for such products that is feasible.'' 15 U.S.C. 2056b(c). The
Commission's statutory obligation is to ensure that toys have the
highest level of safety that the producers are capable of achieving,
considering technological and economic ability. Based on staff's
analysis provided in this NPR and the responses to comments in the
final rule, the Commission determines that the final rule is
technically and economically feasible.
[[Page 58129]]
A. Technological Feasibility
A rule is technically feasible if it is capable of being done. For
example, compliant products might already be on the market; or the
technology to comply with the requirements might be commercially
available; or existing products could be made compliant; or alternative
practices, best practices, or operational changes would allow
manufacturers to comply. See, e.g., 15 U.S.C. 1278a(d) (discussing lead
limits). The Commission determines that the requirements of this final
rule meet technical feasibility criteria. No new or even emerging
technology is needed to manufacture a compliant product.
In addition, although testing laboratories may need to procure
additional equipment to accommodate the conditioning, buoyancy, and
neck opening requirements, the tools required for those test methods
are not proprietary or exclusive items and may be reasonably sourced
from commercial providers, see section V in this preamble for further
explanation. Of the testing tools required by this final rule, only the
specified head probes are unique; however, staff were able to fabricate
those probes using commercially available resources. Additionally, many
of the test methods in the final rule are already either included in
CPSC mandatory standards or come from other previously published
external safety standards.
B. Economic Feasibility
The Commission determines that the final rule is economically
feasible because the cost of compliance would not threaten the
viability of the industry. Based on staff's analysis, the Commission
expects a significant economic effect on firms supplying inflatable
neck floats and a de minimis impact on firms supplying inherently
buoyant neck floats, which are more easily made compliant with the
rule. The availability of inherently buoyant products, which are
compliant or can be readily made compliant, with the final rule
demonstrates that the final rule is economically feasible.
X. Incorporation by Reference
Section 1250.5 incorporates by reference portions of ANSI/CAN/UL
12402-9:2022, ANSI/APSP/ICC-16 2017, ANSI Z535.4-2023, ASTM F833-21 and
ASTM F1967-19. The Office of the Federal Register (OFR) has regulations
concerning incorporation by reference. 1 CFR part 51. For a final rule,
agencies must discuss, in the preamble to the rule, ways in which the
material the agency incorporates by reference is reasonably available
to interested parties and how interested parties can obtain the
material. In addition, the preamble to the final rule must summarize
the material. 1 CFR 51.5(b)(3).
In accordance with the OFR regulations, section V and VI of this
preamble summarizes the provisions of ANSI/CAN/UL 12402-9:2022, ANSI/
APSP/ICC-16 2017, ASTM F833-21, ASTM F1967-19 and ANSI Z535.4-2023 that
the Commission is incorporating by reference into Sec. 1250.5. ANSI/
CAN/UL 12402-9:2022, ANSI/APSP/ICC-16 2017, ASTM F833-21, ASTM F1967-19
and ANSI Z535.4-2023 are copyrighted. Before the effective date of this
rule, you can view a copy of the standards at:
https://www.surveymonkey.com/r/DQVJYMKforANSI/CAN/UL
12402-9:2022,
https://codes.iccsafe.org/content/ANSIAPSPICC162017/title-pageforANSI/APSP/ICC-16 2017,
https://www.surveymonkey.com/r/DQVJYMK for ANSI Z535.4-
2023,
https://www.astm.org/products-services/reading-room.html
for ASTM F833-21, and
https://www.astm.org/products-services/reading-room.html
for ASTM F1967-19.
Once the rule becomes effective, these standards can be viewed free
of charge as a read-only document at:
https://asc.ansi.org/User/Login.aspx#bfor ANSI/CAN/UL
12402-9:2022
https://codes.iccsafe.org/content/ANSIAPSPICC162017/title-pageforANSI/APSP/ICC-16 2017,
https://ibr.ansi.org/Standards/nema.aspx for ANSI Z535.4-
2023,
https://www.astm.org/products-services/reading-room.html
for ASTM F833-21, and
https://www.astm.org/products-services/reading-room.html
for ASTM F1967-19.
To download or print the standards, interested parties can purchase
copies from the following sources:
(1) Pool and Hot Tub Alliance (PHTA), 1650 King Street, Suite 602,
Alexandria, VA 22314; phone: (703) 838-0083; website: www.phta.org.
(i) ANSI/APSP/ICC-16 2017, American National Standard for Suction
Outlet Fitting Assemblies (SOFA) for Use in Pools, Spas, and Hot Tubs,
(approved August 18, 2017).
(2) Underwriters Laboratories (UL), 1250 Connecticut Avenue NW,
Suite 520, Washington, DC 20036; phone: (202) 296-7840; website:
www.ul.com.
(i) ANSI/CAN/UL 12402-9:2022, Standard for Personal Flotation
Devices--Part 9: Test Methods, (dated January 18, 2022).
(3) National Electrical Manufacturers Association (NEMA), 1300 17th
St. N, Arlington, VA 22209; phone: (703) 841-3200; website:
www.nema.org.
(i) ANSI Z535.4-23, American National Standard for Product Safety
Signs and Labels (approved December 14, 2023).
(4) ASTM International (ASTM), 100 Barr Harbor Drive, PO Box C700,
West Conshohocken, PA 19428-2959; phone: (610) 832-9585; website:
www.astm.org.
(i) ASTM F833-21, Standard Consumer Safety Performance
Specification for Carriages and Strollers, (approved June 15, 2021).
(ii) ASTM F1967-19, Standard Consumer Safety Specification for
Infant Bath Seats, (approved May 1, 2019).
ASTM F963-23 is referenced in the amendatory text of this document
and was previously approved for 16 CFR 1250.10.
Alternatively, interested parties can also schedule an appointment
to inspect a copy of the standards at CPSC's Office of the Secretary,
U.S. Consumer Product Safety Commission, 4330 East-West Highway,
Bethesda, MD 20814, telephone: (301) 504-7479; email: [email protected].
XI. Effective Date
The APA generally requires that the effective date of a rule be at
least 30 days after publication of the final rule. 5 U.S.C. 553(d). In
the NPR, the Commission proposed and is now finalizing an effective
date of 180 days after the publication of the final rule. The rule
applies to all neck floats manufactured after the effective date. 15
U.S.C. 2058(g)(1).
As stated in the NPR, some neck floats may already comply with the
proposed requirements; however, most neck floats would need to be
redesigned, manufacturing equipment may need to be retooled, and all
neck floats would require third-party testing to the new requirements.
15 U.S.C. 2063(a)(3).\35\ The changes in the final rule do not change
the assessment that some neck floats may already comply with the
finalized requirements. To provide time to comply with the rule for
those neck floats that will require redesigning to comply, to ensure
adequate lab capacity to test and certify toys, and to spread the cost
of compliance over a period of months, the Commission is finalizing the
rule with a 180-day effective date
[[Page 58130]]
after publication of the final rule in the Federal Register.
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\35\ Section 14(a)(3) of the CPSA specifies laboratories must
have at least 90 days to implement new third-party testing
requirements.
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The Commission determines that the effective date of 180 days is
sufficient for firms to come into compliance, because the tests are
consistent with testing required in 16 CFR parts 1215, 1227, and 1450.
For other tests that are based on ANSI/CAN/UL 12402-9:2022, no unique
tools will be required. For the neck opening testing, staff were able
to fabricate head probes within a reasonable time using commercially
available resources. Accordingly, CPSC expects that these laboratories
are competent to conduct the required testing and obtain their
International Organization for Standardization (ISO) accreditation and
CPSC-acceptance updated in the normal course.
XII. Regulatory Flexibility Act (RFA)
The Regulatory Flexibility Act generally requires an agency to
prepare a final regulatory flexibility analysis (FRFA), for a final
rule, that describes the impact the rule would have on small
businesses. 5 U.S.C. 604(a). The FRFA must contain:
1. a statement of the need for, and objectives of, the rule;
2. a statement of the significant issues raised by the public
comments in response to the initial regulatory flexibility analysis, a
statement of the assessment of the agency of such issues, and a
statement of any changes made in the proposed rule as a result of such
comments;
3. the response of the agency to any comments filed by the Chief
Counsel for Advocacy of the Small Business Administration (SBA) in
response to the proposed rule, and a detailed statement of any change
made to the proposed rule in the final rule as a result of the
comments;
4. a description of and an estimate of the number of small entities
to which the rule will apply or an explanation of why no such estimate
is available;
5. a description of the projected reporting, recordkeeping and
other compliance requirements of the rule, including an estimate of the
classes of small entities which will be subject to the requirement and
the type of professional skills necessary for preparation of the report
or record; and
6. a description of the steps the agency has taken to minimize the
significant economic impact on small entities consistent with the
stated objectives of applicable statutes, including a statement of the
factual, policy, and legal reasons for selecting the alternative
adopted in the final rule and why each one of the other significant
alternatives to the rule considered by the agency which affect the
impact on small entities was rejected.
Id. This final rule will have a significant economic impact on a
substantial number of small U.S. entities operating within the affected
market, primarily from redesign costs in the first year that the final
rule would be effective. A significant impact would occur for small
companies whose products do not meet the proposed requirements. Staff
prepared an IRFA for this rulemaking that was provided in the preamble
of the NPR. The FRFA is provided below.
A. Need for and Objectives of This Rule
The objective of the final rule is to reduce the risk of injury and
death associated with neck floats, as discussed in section III of this
preamble. A detailed analysis of the objectives and statutory basis for
the rule is set forth in section I of the preamble. As discussed in
section VI of this preamble, the rule sets mandatory requirements for
neck floats to address the slip-through hazards and drowning risks
associated with these products and adds neck floats to the list of
products for which an NOR is required.
B. Issues Raised by Public Comments Concerning Impact on Small
Entities; Changes in Response to Those Comments
Two commenters expressed concerns related to the economic impact of
the proposed rule. One commenter submitted multiple comments with
concerns about undue burden to small businesses and third-party testing
costs. Commenters submitted quotes from a CPSC-accredited lab
indicating the initial cost of testing will be higher than CPSC
estimates.
The Commission agrees that the potential burden of the rule on
small businesses in the affected markets will be significant. Burden
estimates generated by CPSC meet and exceed the threshold for a
significant economic effect on a substantial number of small businesses
operating in this space. Regarding the testing cost estimates, CPSC
staff find the estimates provided by the commenter to be reasonable
given the requirements. Staff note that variations in price quotes for
services from labs are common; however, to avoid an underestimate of
these costs, CPSC has revised its burden estimate to incorporate the
commenter's quote.
Another commenter expressed concerns related to the burden on small
firms from the neck opening test probe, as the commenter believes
accredited labs may be unwilling to perform the necessary testing. The
commenter asked for an expected cost estimate for a lab to perform the
test.
Quotes received from accredited labs and discussions of similar
requirements for other product types indicate laboratories' willingness
to perform numerous testing protocols of varying types. Creating
fixtures, probes, mounts, and tools to perform these protocols is a
normal part of testing labs' business models. Prices for these services
will vary between labs. Testing services for neck floats may be higher
than other products, as the product is rather obscure. Quotes for
individual test services provided by another commenter indicate small
businesses could have to pay close to $2,000 for an individual test.
C. Issues Raised by the Staff of the Small Business Administration's
Chief Counsel for the Office of Advocacy
The U.S. Small Business Administration's (SBA) Office of Advocacy
did not submit any public comments on the NPR.
D. Description and Estimate of Number of Small Entities Affected
Small entities subject to this rule include small businesses that
supply neck floats to the U.S. market, which includes manufacturers and
importers. The North American Industry Classification System (NAICS)
defines product codes for U.S. firms. Firms that manufacture neck
floats may be categorized under various NAICS product codes. Most of
these firms likely fall under NAICS code such as 339930 Doll, Toy, and
Game Manufacturing, 326190 Other Plastics Product Manufacturing, and
326199 All Other Plastic Product Manufacturing. Importers of these
products could also vary among different NAICS codes, with a majority
of the firms categorized under NAICS codes as wholesalers: 423920 Toy
and Hobby Goods and Supplies Merchant Wholesalers, and 424610 Plastics
Materials and Basic Forms and Shapes Merchant Wholesalers.
Currently, unlike inherently buoyant neck floats, the inflatable
versions of these products are not available for purchase through
larger retailers and retailers with physical store locations. Retailers
of neck floats fall under NAICS codes 459120 Hobby, Toy, and Game
Stores, 452210 Department Stores, 452310 General Merchandise Stores
Including Warehouse Clubs and Supercenters, and 454390 Other Direct
Selling establishments. Flotation products can be sold among varying
retail channels focused on swimming or toddler products. Therefore, the
NAICS codes listed in this FRFA for retailers,
[[Page 58131]]
importers, and manufacturers are unlikely to be exhaustive.
Under the SBA guidelines, a manufacturer, importer, and retailer of
neck float products is categorized as ``small'' based on the SBA's size
thresholds associated with the NAICS code. SBA uses the number of
employees to determine whether a manufacturer or importer is a small
business while SBA uses annual revenues to consider retailers. Based on
2021 Statistics of U.S. Businesses (SUSB) data,\36\ and a review of
publicly available data on annual revenues, CPSC estimated the number
of firms classified as small for the most relevant NAICS codes. Table 4
and Table 5 provide the estimated number of small firms by each NAICS
code.\37\ CPSC estimates that a total of 19 small U.S. manufacturers
and importers, and 27,260 small U.S. retailers, deal in neck floats.
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\36\ Census Bureau, 2023. Statistics of US Businesses (SUSB)
2021. Suitland, MD. Census Bureau.
\37\ Some discrepancies exist between the published SBA size
standard NAICS code and the SUSB code. Staff used the code
description to match the size standard to the correct value.
Retailer size determination is made using 2017 SUSB data by applying
the ratio of firms that meet the standard to the 2021 data values.
[GRAPHIC] [TIFF OMITTED] TR15DE25.026
[GRAPHIC] [TIFF OMITTED] TR15DE25.027
The data indicated that all the manufacturers/importers of these
products are considered to be small businesses. CPSC assesses that the
total size of this market likely does not exceed $5 million in
aggregate.
E. Compliance, Reporting and Recordkeeping Requirements of the Rule
The final rule will require manufacturers and importers of neck
floats to meet performance, warning label, and instructional literature
requirements, and to conduct third-party testing to demonstrate
compliance. Section VI of this preamble describes the performance,
warning label and instructional literature requirements.
[[Page 58132]]
Small manufacturers will incur one-time costs related to redesign,
retooling, testing, labeling/literature updates and ongoing
certification costs to comply with the rule for product lines that
currently do not meet the requirements of the final rule. Generally,
CPSC considers an impact to be potentially significant if it exceeds 1
percent of a firm's revenue. Based on the aforementioned costs, CPSC
expects approximately 19 small firms to incur a cost that exceeds 1
percent of the annual revenue of the firm.
Staff assess that a large majority of inflatable neck float
products do not, as currently constructed, meet the requirements of the
final rule. These products will require redesigning, retooling, and
additional components to comply with the final rule. Major design
changes are needed to meet the performance requirements related to
durability, buoyancy, and the neck opening test. The Commission
anticipates that design and/or material changes, which may include
modifying the shape of the neck float or modifying the structure by
transitioning between or combining inherently buoyant and inflatable
flotation components, would be required to the entirety of the product.
The potential product costs are therefore the incremental cost for the
material change and the one-time labor cost to perform the redesign and
retooling. Inherently buoyant neck floats are expected to incur
significantly lower costs.
CPSC estimates that the incremental costs of the material change to
be $6 per product based on a comparison of retail prices of inflatable
neck floats with non-inflatable neck floats. This assumes that most
inherently buoyant neck floats are likely to meet the performance
standards without costly modification, while inflatable neck floats are
likely not to comply with the performance requirements without
modification. CPSC assumes the observed premium of 20 percent of retail
price \38\ for non-inflatables represents the incremental cost of
material between the types. CPSC estimates a range of 3 to 4 months of
labor by a material engineer would be required for neck float redesign.
Data from the Bureau of Labor Statistics (BLS) indicates that the
average full hourly compensation rate of a material engineer, which
includes wages \39\ and benefits,\40\ is $79.64 per hour.\41\ Because
neck float designs are very similar across product models and firms,
CPSC assesses that firms would be able to incorporate design changes
across all products lines that the manufacturer offers without
additional effort required for each product line. CPSC staff estimate a
range of possible redesign costs of $38,227 to $50,970 per firm.\42\
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\38\ Non-inflatable neck floats were on average 20 percent more
than the most popular inflatable neck float.
\39\ The mean hourly wage of a material engineer is $53.09 per
hour as of May 2023 according to BLS. https://www.bls.gov/oes/current/oes172131.htm.
\40\ The ratio of full compensation to wages for someone in
Professional and related occupations in the Manufacturing industry
is 1.50 ($68.47 compensation per hour / $45.60 wage per hour) as of
December 2023. Table 4. Private industry workers by occupational and
industry group--2023 Q04 Results (bls.gov).
\41\ $79.64 per hour = $53.09 wage per hour x 1.50 compensation
factor.
\42\ $79.64 per hour x 480 hours (3 months) = $38,227, $79.64 x
640 hours (4 months) = $50,970.
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Some additional costs might be incurred related to updating and/or
adding labels/literature. Generally, the costs associated with
modifying or adding warning labels or instructional literature are low
on a per unit basis because manufacturers of these products are already
required to provide labels with their product. Nearly every
manufacturer also provides some literature with their product. A one-
time update is expected to be less than $0.01 in cost per product sold.
Therefore, CPSC expects the incremental cost related to the labeling
and instructional literature provisions to be de minimis.
F. Third-Party Testing Costs
The final rule requires manufacturers and importers of neck floats
to comply with performance requirements and demonstrate compliance by
required third-party testing. As specified in 16 CFR part 1109,
entities that are not manufacturers of children's products, such as
importers, may rely on the certificate of compliance provided by
others.
Neck float manufacturers could incur some additional costs for
certifying compliance with the final rule. The certification of
compliance must be completed by a third-party conformity assessment
body. Based on a comment to the NPR, CPSC is revising the cost of
certification testing for all requirements from a range of $130 to $250
per product sample to approximately $2,767 per product sample. As a
result, with the two models per firm as the average, the testing and
certification cost is $5,534 per firm.
G. Efforts To Minimize Impact, Alternatives Considered
The Commission considered four alternatives to minimize the
significant economic impact on small entities: (1) not establishing a
mandatory standard for neck floats, (2) establishing an information and
education campaign for neck floats, (3) incorporating existing
international standards without modification, and (4) setting a later
effective date.
1. Not Establishing a Mandatory Standard
Section 106 of the CPSIA requires CPSC to promulgate toy safety
standards that are ``more stringent than'' the applicable mandatory
standard, ASTM F-963, if the Commission determines that more stringent
requirements would further reduce the risk of injury associated with
the product. 15 U.S.C. 2056b(c). Section 106 also requires CPSC to
periodically review and revise the rules set forth under section 106 to
ensure that such rules provide the highest level of safety for such
products that is feasible. 15 U.S.C. 2056b(d). Given CPSC's statutory
mandate, and continuing incidents associated with neck float as
described in section III of this preamble, the Commission determines
that it must address the safety of children using neck floats to
mitigate the risk of drowning. While failing to promulgate a mandatory
standard for neck floats would have no direct impact on U.S. small
businesses, it would allow unsafe products to remain on the market and
ignore a known drowning hazard to children, with reported fatalities.
The Commission determines that the existing requirements in ASTM F963-
23 are inadequate, as discussed in section IV of this preamble, and is
therefore moving forward with this rulemaking to comply with its
statutory mandate and prioritize the safety of children by mitigating
potential child slip-throughs and submergence in water associated with
the use of neck floats.
2. Information and Education Campaign
The Commission considered creating an information and education
campaign to better alert parents and caregivers regarding the drowning
hazard associated with neck floats, see section V in this preamble.
This would require consumer outreach efforts like advertising and
marketing related to the hazards. This alternative could be implemented
independent of regulatory action. Although information campaigns may be
helpful, there were deaths associated with these products while CPSC
was conducting extensive drowning prevention educational campaigns.
This demonstrates that information and education alone are inadequate
to address the drowning hazard associated with neck floats. Therefore,
the Commission finds that
[[Page 58133]]
while information campaigns might be helpful, performance standards
would be more effective in preventing deaths associated with the use of
neck floats.
3. Incorporate BS EN 13138-1:2021 Without Modifications
The Commission considered adopting BS EN 13138-1:2021 without
modifications, discussed in section IV of this preamble, because it has
similar requirements as the final rule. Some neck float products
currently available in the U.S. are advertised as meeting these
requirements, and as a result, these products would be unaffected by
the requirements in the final rule. Adopting this alternative would
reduce the number of firms subject to the rule. However, the
international standard does not include specifications for slip-through
hazards associated with neck floats. As a result, the Commission
determines that this alternative is unlikely to prevent drowning
related injuries to children who may slip through neck floats.
4. Later Effective Date
To reduce burden on small businesses, the Commission considered
adopting an effective date later than 180 days after Federal Register
publication, to spread the cost of compliance over a longer period.
Although some neck floats already comply with most of the requirements,
most neck floats (primarily inflatable neck floats) would need to be
redesigned, and all neck floats would require third-party testing to
the new requirements. In this case, as described above, the Commission
determines that 180 days is reasonable for firms to comply with the
rule, and many labs are already CPSC-accepted to conduct the same or
similar testing and products expected to already be compliant are
currently available for purchase.
H. Impact on Small Manufacturers
Generally, CPSC considers an impact to be potentially significant
if it exceeds 1 percent of a firm's revenue. Staff assess that small
manufacturers/importers would incur costs from redesign, retooling,
additional components, testing and labeling to comply with the final
rule. Staff estimate these costs will greatly exceed the 1 percent
threshold and will impact nearly all small manufacturers/importers
identified. Manufacturers and importers of inflatable neck floats are
expected to have at least a 5 percent impact. Staff have determined
that a substantial number of neck float manufacturers/importers would
be impacted by the final rule. Therefore, the final rule will have a
significant impact on a substantial number of small firms operating in
this market.
XIII. Environmental Considerations
The Commission's regulations address whether the agency is required
to prepare an environmental assessment or an environmental impact
statement. Under these regulations, certain categories of CPSC actions
normally have ``little or no potential for affecting the human
environment,'' and therefore do not require an environmental assessment
or an environmental impact statement. Safety standards providing
performance and labeling requirements for consumer products come under
this categorical exclusion. 16 CFR 1021.5(c)(1). The final rule for
neck floats falls within the categorical exclusion.
XIV. Paperwork Reduction Act
This rule contains information collection requirements that are
subject to public comment and review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA; 44 U.S.C.
3501-3521). In this document, pursuant to 44 U.S.C. 3507(a)(1)(D), CPSC
sets forth:
Title for the collection of information;
Summary of the collection of information;
Brief description of the need for the information and the
proposed use of the information;
Description of the likely respondents and proposed
frequency of response to the collection of information;
Estimate of the burden that shall result from the
collection of information; and
Notice that comments may be submitted to the OMB.
The preamble to the NPR discussed the information collection burden
of the rule and specifically requested comments on the accuracy of
CPSC's estimates. 89 FR 91586. The estimated burden of this collection
of information is unchanged from the NPR. CPSC did not receive any
comments regarding the information collection burden in the NPR through
OMB. OMB has assigned control number 3041-0211 for this collection of
information.
Title: Mandatory Toy Safety Standard: Requirements for Neck Floats.
Description: The final rule requires each neck float within the
scope of the rule to meet the rule's new performance and labeling in
Sec. 1250.5, which are summarized in section VI of this preamble.
Specifically, the rule includes marking, labeling, and instructions
literature requirements for neck floats toys. These requirements fall
within the definition of ``collection of information,'' as defined in
44 U.S.C. 3502(3).
Description of Respondents: Persons who manufacture or import neck
floats.
Estimated Burden: CPSC estimates the burden of this collection of
information as cited in Table 6.
[GRAPHIC] [TIFF OMITTED] TR15DE25.028
This estimate is based on the following: CPSC estimates there are
20 suppliers that would respond to this collection annually, and that
the majority of these entities would be considered small businesses.
CPSC assumes that on average each respondent that reports annually
would respond once, as product models for neck floats are brought to
market and new labeling and instruction materials are created, for a
total of 20 responses annually (20 respondents x 1 responses per year).
CPSC assumes that on average it will take one hour for each respondent
to create the required label and one hour for them to create the
required instructions, for an average response burden of two hours per
response. Therefore, the total burden hours for the collection are
estimated to be 40 hours annually (20 responses x 2 hours per response
= 40 total burden hours).
[[Page 58134]]
CPSC estimates the hourly compensation for the time required to
create and update labeling and instructions is $41.76.\43\ Therefore,
the estimated annual cost of the burden requirements is $1,670 ($41.76
per hour x 40 hours = $1,670.40). No operating, maintenance, or capital
costs are associated with the collection. Based on this analysis, the
information collection would impose a burden to industry of 40 hours at
a cost of $1,670 annually. In compliance with the Paperwork Reduction
Act of 1995 (44 U.S.C. 3507(d), CPSC has submitted the information
collection requirements of this final rule to OMB. Recordkeeping burden
for certification and testing is accounted for under OMB Control Number
3041-0159, Third Party Testing of Children's Products.
---------------------------------------------------------------------------
\43\ U.S. Bureau of Labor Statistics, ``Employer Costs for
Employee Compensation,'' March 2024, Table 4, total compensation for
all sales and office workers in goods-producing private industries:
https://www.bls.gov/news.release/archives/ecec_06182024.htm.
---------------------------------------------------------------------------
XV. Certification and Notice of Requirements
Section 14(a) of the CPSA imposes the requirement that products
subject to a consumer product safety rule under the CPSA, or to a
similar rule, ban, standard, or regulation under any other act enforced
by the Commission, must be certified as complying with all applicable
CPSC-enforced requirements. 15 U.S.C. 2063(a). Section 14(a)(2) of the
CPSA requires that certification of children's products subject to a
children's product safety rule be based on testing conducted by a CPSC-
accepted third party conformity assessment body. Section 14(a)(3) of
the CPSA requires the Commission to publish an NOR for the
accreditation of third-party conformity assessment bodies (or
laboratories) to assess conformity with a children's product safety
rule to which a children's product is subject. The final rule creates a
new 16 CFR 1250.5 as part of 16 CFR part 1250 that is a children's
product safety rule that requires the issuance of a NOR.
16 CFR part 1112 establishes requirements for accreditation of
third-party conformity assessment bodies to test for conformity with a
children's product safety rule in accordance with section 14(a)(2) of
the CPSA. Part 1112 also codifies all the NORs issued previously by the
Commission. Accordingly, the Commission is amending part 1112 to add
neck floats to the list of NORs.
Testing laboratories applying for acceptance as a CPSC-accepted
third-party conformity assessment body to test to the standard for neck
floats would be required to meet the third-party conformity assessment
body accreditation requirements in part 1112. When a laboratory meets
the requirements as a CPSC-accepted third-party conformity assessment
body, the laboratory can apply to CPSC to have 16 CFR 1250.5, Safety
Standard for Toys: Requirements for Neck Floats, included within the
laboratory's scope of accreditation of CPSC safety rules listed for the
laboratory on the CPSC website at: https://www.cpsc.gov/cgi-bin/labsearch/.
XVI. Preemption
Section 26(a) of the CPSA, 15 U.S.C. 2075(a), states that when a
consumer product safety standard is in effect and applies to a product,
no state or political subdivision of a state may either establish or
continue in effect a standard or regulation that prescribes
requirements for the performance, composition, contents, design,
finish, construction, packaging, or labeling of such product dealing
with the same risk of injury unless the state requirement is identical
to the federal standard. Section 106(f) of the CPSIA deems rules issued
under that provision ``consumer product safety standards.'' Therefore,
once this final rule is issued under section 106 of the CPSIA takes
effect, it will have a preemptive effect in accordance with section
26(a) of the CPSA.
XVII. Congressional Review Act and Executive Order 12866
Pursuant to the Congressional Review Act (CRA; 5 U.S.C. 801-808)
and Executive Order (E.O.) 12866, OIRA has determined that this rule
does not qualify as a ``major rule,'' as defined in 5 U.S.C. 804(2),
and is not a significant regulatory action as defined under section
2(f) of E.O. 12866. To comply with the CRA, CPSC will submit the
required information to each House of Congress and the Comptroller
General.
XVIII. References
Foreman, Jim. ``How to Make Inflatables (With Vinyl Welding)--Vinyl
Technology.'' Vinyl Technology, 12 June 2024,
www.vinyltechnology.com/blog/how-to-make-inflatable-products-vinyl-welding.
L.W. Schneider et al., U.S. Consumer Prod. Safety Comm'n. Size and
Shape of the Head and Neck from Birth to Four Years (Report No.
UMTRI-86-2). (1986). https://deepblue.lib.umich.edu/handle/2027.42/114.
List of Subjects
16 CFR Part 1112
Administrative practice and procedure, Audit, Consumer protection,
Reporting and recordkeeping requirements, Third-party conformity
assessment body.
16 CFR Part 1250
Consumer protection, Incorporation by reference, Infants and
children, Labeling, Law enforcement, Toys.
For the reasons discussed in the preamble, the Commission amends 16
CFR parts 1112 and 1250 as follows:
PART 1112--REQUIREMENTS PERTAINING TO THIRD PARTY CONFORMITY
ASSESSMENT BODIES
0
1. The authority citation for part 1112 continues to read as follows:
Authority: 15 U.S.C. 2063.
0
2. Amend Sec. 1112.15 by adding paragraph (b)(32)(v) to read as
follows:
Sec. 1112.15 When can a third party conformity assessment body apply
for CPSC acceptance for a particular CPSC rule and/or test method?
* * * * *
(b) * * *
(32) * * *
(v) 16 CFR 1250.5, Requirements for neck floats.
* * * * *
PART 1250--SAFETY STANDARD FOR TOYS
0
3. The authority citation for part 1250 continues to read as follows:
Authority: 15 U.S.C. 2056b.
0
4. Add Sec. 1250.5 to read as follows:
Sec. 1250.5 Requirements for neck floats.
(a) Scope and purpose. This section establishes performance and
labeling requirements for neck floats to reduce the risk of children
drowning while using a neck float. The provisions of this part are
intended to address the risk of injury and death to children from neck
float hazards. This section adds requirements for neck float in
addition to the requirements of Sec. Sec. 1250.1 and 1250.2.
(b) Definitions. In addition to the definitions in ASTM F963-23
(incorporated by reference, see Sec. 1250.10), the following
definitions apply for the purposes of this section:
Expected weight capacity means the maximum weight capacity the neck
float is rated for, per the manufacturer's recommended use
instructions.
Neck float means an article, whether inflatable or not, that
encircles the neck, supports the weight of the child by being secured
around the neck (such as by fastening, tightening, or other methods),
is used as an instrument of play in water environments including
[[Page 58135]]
sinks, baths, paddling pools, and swimming pools, and is intended for
use by children up to and including 4 years of age in water
environments including sinks, baths, paddling pools, and swimming
pools.
Restraint system means interconnecting components, whether
adjustable or not, that are integral to a neck float and are intended
to hold the occupant in position relative to the neck float. A
restraint system uses fastening mechanisms, such as buckles or Velcro
straps, to secure together.
(c) Performance requirements. In addition to any applicable
performance requirements from Sec. 1250.1 or Sec. 1250.2, all neck
floats within the scope of the rule must meet the performance
requirements in this section to reduce the risk of children drowning
while using a neck float.
(1) Conditioning procedure. Neck floats shall undergo thermal
conditioning in accordance with section 5.5.4.1 of ANSI/CAN/UL 12402-
9:2022 (incorporated by reference, see Sec. 1250.10), with
modifications provided in paragraphs (c)(1)(i) through (iii) of this
section. Following thermal conditioning, a neck float shall undergo
exposure conditioning in a chlorinated saltwater bath. The chlorinated
saltwater bath shall be prepared by dissolving 32 grams of sodium
chloride (NaCl) in 1 liter of aqueous solution containing 2 ppm
chlorine at pH 7.0-7.8. The necessary volume of solution at those
concentrations shall be prepared to fully submerge the neck float, in
darkness and at room temperature (20 2[deg]C (68 4 [deg]F)) for 8 hours. Lastly, the neck float shall undergo
ultraviolet light exposure conditioning in accordance with sections
4.2.1.1-4.2.1.4 of ANSI/APSP/ICC-16 2017 (incorporated by reference,
see Sec. 1250.10), with the modifications provided in paragraph
(c)(1)(iv) of this section, prior to any testing in accordance with
paragraphs (c)(2) through (4) of this section. Any inflatable
component(s), if applicable, of the neck float shall be deflated during
the conditioning procedure.
(i) The words ``Inflatable PFDs'' shall be removed and replaced
with ``Neck floats'' in section 5.5.4.1 of ANSI/CAN/UL 12402-9:2022.
(ii) The cold temperature ``-30 2[deg]C'' shall be
removed and replace with ``-10 2[deg]C'' in section
5.5.4.1 of ANSI/CAN/UL 12402-9:2022.
(iii) The words ``for two complete cycles,'' and the paragraph
after item b) ``Inflatable PFDs, shall be . . . inflated for (5,0
0.1) min.'' shall be removed from section 5.5.4.1 of ANSI/
CAN/UL 12402-9:2022.
(iv) The exposure duration for each UV conditioning methods shall
be reduced from 720 hours to 180 hours using methods (a) and (b), from
1000 hours to 250 hours using method (c), and from 750 hours to 188
hours using method (d) from sections 4.2.1.1-4.2.1.4 of ANSI APSP ICC-
16 2017.
(2) Minimum buoyancy requirements. Neck floats shall demonstrate a
minimum upward buoyancy equal to or greater than 30 percent the
expected weight capacity of the neck float, and neck floats utilizing
inherently buoyant components shall lose no more than 5 percent of
their initial buoyancy, when tested in accordance with sections
5.5.9.2-5.5.9.4 of ANSI/CAN/UL 12402-9:2022 with the following
additions and exclusions:
(i) The words ``PFD'' shall be removed and replaced with ``neck
float.''
(ii) The weight of the cage shall be equal to 1.1 times the
expected weight capacity of the neck float, which shall be determined
based on either the maximum weight capacity according to the
manufacturer's recommended user weight, or the weight given by table 1
to this paragraph (c)(2)(ii) according to the manufacturer's
recommended user age, whichever is greater. If the manufacturer's
recommended user age falls between two age range options, the older
range shall be used.
Table 1 to Paragraph (c)(2)(ii)--Expected Weight Capacity
------------------------------------------------------------------------
Weight, lbs.
Age of child (kg.)
------------------------------------------------------------------------
0-3 months.............................................. 17.0 (7.7)
4-6 months.............................................. 21.0 (9.5)
7-9 months.............................................. 23.4 (10.6)
10-12 months............................................ 25.4 (11.5)
1 up to 2 years......................................... 38.8 (17.6)
2 up to 3 years......................................... 51.2 (23.2)
3 up to 4 years......................................... 52.3 (23.7)
------------------------------------------------------------------------
(iii) The sentence ``If the PFD contains inflatable . . . whichever
is less'' shall be removed from the first paragraph of section 5.5.9.3
of ANSI/CAN/UL 12402-9:2022. In its place, the following sentence shall
be added to the beginning of that section: ``Any inflatable
component(s), if applicable, of the neck float shall be inflated to an
internal air pressure of 0.1 0.01 PSIG.''
(iv) Add ``If the neck float contains inherently buoyant
components'' to the beginning of the third paragraph (``The assembly
shall remain . . . recorded as B'') of section 5.5.9.3 of ANSI/CAN/UL
12402-9:2022.
(v) Remove the last two paragraphs ``The water temperature . . .
immersion period'' from section 5.5.9.3 of ANSI/CAN/UL 12402-9:2022.
(vi) Remove the last paragraph ``The water temperature . . . and
pressure conditions'' from section 5.5.9.4 of ANSI/CAN/UL 12402-9:2022.
(3) Restraint system requirements. All restraint systems used to
attach the neck float to the body or to connect components of the neck
float together shall require the release of the fastening mechanism to
have either a double-action release system that requires two distinct,
but simultaneous actions to release, or a single-action release system
that requires a minimum of 50 N to release. The restraint system shall
also comply with the requirements of section 6.4.4 when tested in
accordance with section 7.5.1 of ASTM F833-21 (incorporated by
reference, see Sec. 1250.10), with the following exclusions:
(i) The sentence ``At the . . . 2 in. (51 mm).'' of section 6.4.4
of ASTM F833-21 shall be removed.
(ii) [Reserved]
(4) Neck opening test requirement. The neck opening of the neck
float shall not admit the passage of a specified head probe when tested
in accordance with the following test procedure:
(i) The neck float shall be placed on an elevated platform and
positioned directly above and centered about a circular opening in that
platform large enough to allow the head probes to fall fully through
it. The surfaces of the neck float shall be saturated with baby wash
solution, prepared in accordance with section 7.4.1.5 of ASTM F1967-19
(incorporated by reference, see Sec. 1250.10).
(ii) If the neck float includes adjustable restraint straps, then
all applicable head probes shall be evaluated at the loosest (largest)
setting.
(iii) Any inflatable components of the neck float shall be inflated
to an internal air pressure of 0.1 0.01 PSIG.
(iv) A specified head probe, as described in paragraph (c)(4)(vii)
of this section, shall then be weighted to mass M1 and positioned in
the neck opening. A hanging weight of mass M2 shall then be suspended
below the head probe at distance L, where L includes the length between
the narrowest and widest circumference of the specified head probe. The
choice of specified head probe, mass M1, mass M2, and distance L shall
be determined using table 2 to this paragraph (c)(4)(iv) based on the
manufacturer's recommended youngest and oldest user age. If the
manufacturer's recommended user age falls between two age range
options, the younger or older range shall be considered, as is
appropriate.
[[Page 58136]]
Table 2 to Paragraph (c)(4)(iv)--Neck Opening Test
----------------------------------------------------------------------------------------------------------------
Head probe
Head probe designation Age range mass M1, lbs. Hanging weight Distance L,
(months) (kg.) M2, lbs. (kg.) in. (cm.)
----------------------------------------------------------------------------------------------------------------
A............................................... 0-3 3.3 (1.5) 3.4 (1.6) 10.0 (25.4)
B............................................... 4-6 4.4 (2.0) 4.2 (1.9) 11.5 (29.2)
C............................................... 7-9 4.9 (2.2) 4.7 (2.1) 12.0 (30.5)
10-12 5.3 (2.4) 5.1 (2.3) 13.0 (33.0)
13-18 5.7 (2.6) 7.5 (3.4) 13.75 (34.9)
D............................................... 19-24 6.2 (2.8) 7.8 (3.5) 15.25 (38.7)
25-30 6.6 (3.0) 7.8 (3.5) 15.0 (38.1)
31-36 6.6 (3.0) 10.2 (4.6) 16.0 (40.6)
37-42 7.1 (3.2) 10.2 (4.6) 16.75 (42.6)
43-48 7.1 (3.2) 10.5 (4.8) 17.0 (43.2)
----------------------------------------------------------------------------------------------------------------
(v) If the neck float's recommended age range could apply to two or
more head probes this procedure will be conducted first using the
smallest applicable head probe, then repeated using the largest
applicable head probe.
(vi) The hanging weight shall be swung for a total of ten 30-second
cycles by raising the hanging weight to a 90-degree angle and releasing
it. Alternate between a front-to-back swinging direction interval and
side-to side interval, relative to the intended position of the neck
float user. The 10 alternating swing cycles shall occur consecutively.
(vii) Head probes shall be constructed in accordance with figure 1
and table 3 to this paragraph (c)(4)(vii). Section A-A in figure 1 to
this paragraph (c)(4)(vii) demonstrates that the head probe may be
hollow for the purposes of adding mass M1, however it is not a
requirement of the probe.
BILLING CODE 6355-01-P
[[Page 58137]]
[GRAPHIC] [TIFF OMITTED] TR15DE25.029
BILLING CODE 6355-01-C
Table 3 to Paragraph (c)(4)(vii)--Head Probe Dimensions
--------------------------------------------------------------------------------------------------------------------------------------------------------
R1 (head breadth/ R2 (head length/ R3 (neck breadth/ R4 (neck depth/ H LI>(head
Probe designation 2), in. 2), in. 2), in. 2), in. height), in.
--------------------------------------------------------------------------------------------------------------------------------------------------------
A........................................................ 1.85 2.50 0.90 0.85 4.60
B........................................................ 2.05 2.80 0.95 0.80 4.90
C........................................................ 2.20 2.95 1.10 1.00 5.20
D........................................................ 2.35 3.20 1.20 1.00 6.10
--------------------------------------------------------------------------------------------------------------------------------------------------------
(d) Labeling requirements. All neck floats and the packaging of
neck floats must meet the marking, labeling, and instructional
literature requirements in this section to reduce the risk of children
drowning while using a neck float.
(1) Requirements for marking and labeling. (i) Instead of complying
with the warning text of section 5.4 of ASTM F963-23, neck floats and
the packaging of neck floats must include the safety alert symbol,
signal word, and word message as shown in figure 2 to this paragraph
(d)(1)(i).
[[Page 58138]]
[GRAPHIC] [TIFF OMITTED] TR15DE25.030
(ii) The warnings shall be in the English language at a minimum.
(iii) The warnings shall be conspicuous and permanent on the
principal display panel as defined in section 3.1.62 of the version of
ASTM F963-23 and in a distinct color contrasting to the background on
which it appears.
(iv) The warnings shall conform to ANSI Z535.4-2023 (incorporated
by reference, see Sec. 1250.10), sections 6.1-6.4, 7.2-7.6.3, and 8.1,
with the following changes:
(A) In sections 6.2.2, 7.3, 7.5, and 8.1.2, of ANSI Z535.4-2023
replace the word ``should'' with the word ``shall.''
(B) In section 7.6.3 of ANSI Z535.4-2023, replace the phrase
``should (when feasible)'' with the word ``shall.''
(C) In ANSI Z535.4-2023, strike the word ``safety'' when used
immediately before a color (for example, replace safety white'' with
``white'').
(v) Certain text in the message panel must be in bold and in
capital letters as shown in the example warning labels in figure 2 to
paragraph (d)(1)(i) of this section. Text must use black lettering on a
white background or white lettering on a black background.
(vi) The message panel text shall appear in sans serif letters and
be center or left aligned. Text with precautionary (hazard avoidance)
statements shall be preceded by bullet points.
(vii) Multiple precautionary statements shall be separated by
bullet points if paragraph formatting is used.
(viii) The safety alert symbol ! and the signal word ``WARNING''
shall appear in sans serif letters and be at least 1/8'' (3.2mm) high
and be center or left aligned. The remainder of the text shall be in
characters whose upper case shall be at least 1/16'' (1.6mm) high.
(ix) The safety alert symbol, an exclamation mark in a triangle,
when used with the signal word, must precede the signal word. The base
of the safety alert symbol must be on the same horizontal line as the
base of the letters of the signal word. The height of the safety alert
symbol must equal or exceed the signal word letter height. The
exclamation mark must be at least half the size of the triangle
centered vertically.
(x) The warning contained within {{time} ``Check for leaks before
use. Never use with leaks.'' is only required for neck floats utilizing
inflatable components.
(2) Requirements for instructional literature. Instructions shall
have the same warning labels that must appear on the product and
provided separately, as a user manual, with similar formatting
requirements, but without the need to be in color. However, the signal
word and safety alert symbol shall contrast with the background of the
signal word panel, and the warnings shall contrast with the background
of the instructional literature. The instructions shall include
information on assembly, installation, maintenance, cleaning and use,
where applicable. The instructions shall explain how to check for
adequate fit of the neck float around the child's neck to prevent
slipping through the center opening. For neck floats utilizing
inflatable components, the instructions shall include clear directions
for testing the neck float for leaks. Any additional instructions
provided, that are not required, shall neither contradict nor confuse
the meaning of the requirements.
(e) Prohibited stockpiling--(1) Prohibited acts. Manufacturers and
importers of neck floats shall not manufacture or import neck floats
that do not comply with the requirements of this part between December
15, 2025, and June 15, 2026, at a rate that is greater than 105 percent
of the rate at which they manufactured or imported neck floats during
the base period for the manufacturer or importer.
(2) Base period. The base period for neck floats is the average
monthly manufacturing or import volume within the last 13 months of
production immediately preceding December 15, 2025.
0
5. Revise and republish Sec. 1250.10 to read as follows:
Sec. 1250.10 Incorporation by reference.
Certain material is incorporated by reference into this part with
the approval of the Director of the Federal Register in accordance with
5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by
reference (IBR) material is available for inspection at the U.S.
Consumer Product Safety Commission and at the National Archives and
Records Administration (NARA). Contact the U.S. Consumer Product Safety
Commission at: Office of the Secretary, U.S. Consumer Product Safety
Commission, 4330 East West Highway, Bethesda, MD 20814; telephone (301)
504-7479, email [email protected]. For information on the availability
of this material at NARA, visit www.archives.gov/federal-register/cfr/ibr-locations or email [email protected]. The material may be
obtained from the following sources:
(a) ASTM International: 100 Barr Harbor Drive, P.O. Box C700, West
Conshohocken, PA 19428-2959; telephone (610) 832-9585; www.astm.org.
(1) ASTM F833-21, Standard Consumer Safety Performance
[[Page 58139]]
Specification for Carriages and Strollers, approved June 15, 2021; into
Sec. 1250.5(c).
(2) ASTM F963-23, Standard Consumer Safety Specification for Toy
Safety, approved on August 1, 2023; into Sec. Sec. 1250.2(a),
1250.4(b) and (d), 1250.5(b) and (d).
(3) ASTM F1967-19, Standard Consumer Safety Specification for
Infant Bath Seats, approved May 1, 2019; into Sec. 1250.5(c).
(b) National Electrical Manufacturers Association (NEMA): 1300
North 17th Street, Suite 900, Rosslyn, Virginia 22209; (703) 841-3200;
www.nema.org.
(1) ANSI Z535.4-2023, American National Standard for Product Safety
Signs and Labels (approved December 14, 2023); into Sec. Sec.
1250.4(d) and 1250.5(d).
(2) [Reserved]
(c) Pool and Hot Tub Alliance (PHTA), 1650 King Street, Suite 602,
Alexandria, VA 22314; phone: (703) 838-0083; website: www.phta.org.
(1) ANSI/APSP/ICC-16 2017, American National Standard for Suction
Outlet Fitting Assemblies (SOFA) for Use in Pools, Spas and Hot Tubs,
approved August 18, 2017 ; into Sec. 1250.5(c).
(2) [Reserved]
(d) Underwriters Laboratories (UL), 1250 Connecticut Avenue NW,
Suite 520, Washington, DC 20036; phone: (202) 296-7840; website:
www.ul.com.
(1) ANSI/CAN/UL 12402-9:2022, Standard for Safety for Personal
Flotation Devices--Part 9: Test Methods, First Edition, dated January
18, 2022; into Sec. 1250.5(c).
(2) [Reserved]
Alberta E. Mills,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2025-22827 Filed 12-12-25; 8:45 am]
BILLING CODE 6355-01-P