```

[Federal Register Volume 89, Number 224 (Wednesday, November 20, 2024)]
[Proposed Rules]
[Pages 91586-91617]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-25446]

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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: Notice of proposed rulemaking.

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SUMMARY: The Consumer Product Safety Improvement Act of 2008 (CPSIA) 
mandates that ASTM F963 shall be a mandatory toy safety standard. This 
toy safety standard sets forth only minimal labeling requirements for 
aquatic toys such as neck floats. The U.S. Consumer Product Safety 
Commission (CPSC or Commission) proposes to establish new performance 
and revised labeling requirements to address potentially deadly hazards 
associated with neck floats. The Commission also proposes to amend 
CPSC's list of notice of requirements (NORs) to include neck floats.

DATES: Submit comments by January 21, 2025. Submit comments related to 
the Paperwork Reduction Act aspects of the marking, labeling, and 
instructional literature requirements by January 21, 2025

ADDRESSES: Submit all comments, identified by Docket No. CPSC-2024- 
0039, by any of the following methods:

[[Page 91587]]

    Electronic Submissions: Submit electronic comments to the Federal 
eRulemaking Portal at: https://www.regulations.gov. Follow the 
instructions for submitting comments. Do not submit through this 
website: confidential business information, trade secret information, 
or other sensitive or protected information that you do not want to be 
available to the public. CPSC typically does not accept comments 
submitted by email, except as described below.
    Mail/Hand Delivery/Courier/Confidential Written Submissions: CPSC 
encourages you to submit electronic comments by using the Federal 
eRulemaking Portal. You may, however, submit comments by mail, hand 
delivery, or courier to: Office of the Secretary, Consumer Product 
Safety Commission, 4330 East-West Highway, Bethesda, MD 20814; 
telephone: (301) 504-7479. If you wish to submit confidential business 
information, trade secret information, or other sensitive or protected 
information that you do not want to be available to the public, you may 
submit such comments by mail, hand delivery, or courier, or you may 
email them to: [email protected].
    Instructions: All submissions must include the agency name and 
docket number. CPSC may post all comments without change, including any 
personal identifiers, contact information, or other personal 
information provided, to https://www.regulations.gov. Do not submit 
through this website: Confidential business information, trade secret 
information, or other sensitive or protected information that you do 
not want to be available to the public. If you wish to submit such 
information, please submit it according to the instructions for mail/
hand delivery/courier/confidential written submissions.
    Docket: For access to the docket to read background documents or 
comments received, go to: https://www.regulations.gov, and insert the 
docket number, CPSC-2024-0039, into the ``Search'' box, and follow the 
prompts.

FOR FURTHER INFORMATION CONTACT: Zachary 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

    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 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 and 16 CFR part 1250 contain requirements for a 
category of toys known as ``aquatic toys.'' Section 3.1.4 of ASTM F963-
23 defines an aquatic toy as an ``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.
    Section 5.4 of ASTM F963-23 (which is an element of the mandatory 
standard pursuant to CPSIA section 106 and 16 CFR part 1250) contains 
labeling requirements for ``aquatic toys,'' which include neck floats. 
The ASTM requirements are intended to communicate to the consumer that 
an aquatic toy is not a lifesaving device and to warn against leaving a 
child unattended while using the flotation device. However, as 
discussed in section IV of this preamble, ASTM F963-23 does not 
establish adequate requirements specific to neck floats because it does 
not include any performance requirements for these toys. Incident data, 
described in section III of this preamble, demonstrate that children 
have suffered drowning injuries and deaths associated with the use of 
neck floats. Accordingly, as described in section IV of this preamble, 
neck floats that comply with the labeling requirements in ASTM F963-23 
still pose safety hazards.
    This notice of proposed rulemaking (NPR) under section 106 of the 
CPSIA proposes additional requirements in part 1250 to establish a 
mandatory standard for neck floats which includes performance 
requirements and improved warning labels. CPSC proposes to define a 
``neck float'' 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), 
and 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.'' Further, this NPR 
proposes revising the title of part 1250 from ``Safety Standard 
Mandating ASTM F963 for Toys'' to ``Safety Standards for Toys,'' to 
reflect the inclusion of additional proposed requirements that are not 
included in the existing requirements in ASTM F963.3 4
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    \3\ On October 23, 2024, the Commission voted (5-0) to publish 
this NPR.
    \4\ On September 9, 2024, the Commission published an NPR to 
establish a mandatory standard for water beads, under Section 106(a) 
of the Consumer Product Safety Improvement Act of 2008 (CPSIA). 
Safety Standard for Toys: Requirements for Water Beads, 89 FR 73024. 
This NPR also proposed to revise the title of part 1250 from 
``Safety Standard Mandating ASTM F963 for Toys'' to ``Safety 
Standards for Toys.''
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    The Commission is authorized to issue this NPR 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. 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 existing the existing 
standards if the Commission determines that more stringent standards 
would further reduce the risk of injury associated with such toys. 
Consistent with the consultation requirement in section 106(d)(1) of 
the CPSIA, staff has worked with the ASTM F15.22 subcommittee task 
group since 2009 to update the toy standard. In addition, since August 
2021, CPSC staff has been corresponding with the relevant ASTM 
Subcommittee and task group to discuss hazards associated with neck 
floats, including by sharing incident data

[[Page 91588]]

associated with neck floats as well as staff's recommendation to 
develop performance requirements to address the hazards identified in 
the incident data.
    Building on staff's continued collaboration with ASTM and in 
consideration of the incident data, the Commission is issuing this NPR 
to address four identified hazard patterns associated with neck floats 
that are not adequately addressed by the current mandatory standard 
provision addressing aquatic toys. Specifically, the Commission 
proposes to address the following known hazards: (1) children slipping 
through the product due to deflation or underinflation; (2) children 
slipping through the product for reasons other than deflation or 
underinflation; (3) children slipping through the product due to a 
restraint system failure; and (4) children submerging in water without 
slipping through the product. Each of these hazard patterns presents a 
risk of drowning. The Commission proposes adding performance 
requirements to part 1250 to address these risks. The NPR also proposes 
revising labeling requirements for neck floats under part 1250, 
including mandating warnings on products and instructional literature. 
Lastly, the Commission is proposing 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).
    This NPR provides an overview of staff's assessment and analysis, 
and it includes the Commission's basis for issuing the proposed rule. 
For the reasons explained here, the Commission preliminarily determines 
that the proposed neck float requirements comply with section 106 of 
the CPSIA because they are more stringent than the current requirements 
in ASTM F963-23, 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. The Commission seeks comments on these 
issues.

II. Description of Toys Within the Scope of the Rule

    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,\5\ this 
design is intended to allow the child to float and play in water when a 
child is incapable of floating on their own.
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    \5\ Section 3.1.4, in the definition of ``Latex balloon,'' of 
ASTM F963-23 includes a list of toys that are used in aquatic 
activities such as rafts, water wings, swim rings, or other similar 
items.
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    Neck floats are available as both inflatable and 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 efforts from the caregiver to ensure that it floats.
    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, where 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 with direct parental supervision. 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.
    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 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. In this NPR's proposed rule, the Commission defines a 
``neck float'' 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 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 proposed definition of 
``neck float'' in Sec.  1250.5(b), are outside the scope of this rule. 
Life-saving flotation devices regulated by the 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

    The incidents and hazard patterns associated with neck floats are 
based on CPSC's Consumer Product Safety Risk Management System 
(CPSRMS). CPSRMS includes data primarily from three groups of sources: 
incident reports, death certificates, and in-depth follow-up 
investigation reports (IDIs). A large portion of CPSRMS consists of 
incident reports from consumer complaints, media reports, medical 
examiner or coroner reports, retailer or manufacturer reports (incident 
reports received from a retailer or manufacturer involving a product 
they sell or make), safety advocacy groups, law firms, and federal, 
state, or local authorities, among others. It also contains death 
certificates that CPSC purchases from all 50 states, based on selected 
external cause of death codes (ICD-10). The third major component of 
CPSRMS is the collection of in-depth follow-up investigation reports. 
The CPSRMS incidents identified for neck floats occurred from January 
1, 2019, through January 25, 2024; however, the National Electronic 
Injury Surveillance System (NEISS) database contained no incident 
reports during that time period referencing neck floats.
    From January 2019 through January 2024, staff identified 115 
incidents in CPSRMS associated with the use of neck floats. Two of 
these incidents resulted in a fatality, two incidents led to 
hospitalization, five incidents led to

[[Page 91589]]

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 only 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.

A. Overview of Neck Float Hazards

    Based on staff's assessment of the incident data reported in CPSRMS 
and publicly available consumer-uploaded pictures and videos of the 
product in use, the Commission determines that neck floats pose a risk 
of drowning that can result in severe injury or death because of 
slipping through a neck float or being submerged in the water while 
using a neck float.
    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. 
In most drowning incidents, consciousness is lost after approximately 
two minutes, and irreversible brain damage occurs within four to six 
minutes. Survival without neurological impairment after five minutes is 
highly unlikely. Rapid initiation of CPR, which helps increase 
ventilation and oxygen delivery to the brain, will increase the chance 
for survival and/or optimal medical outcomes (Fields, 1992), such as in 
CPSC's IDI 230317CCC3554. Victims who survive anoxic episodes, such as 
in IDI 210114HCC1250, may need prolonged specialized care, including 
occupational and physical therapy, and can face lifelong disabilities 
(e.g., learning, language, and memory) that impact their life and those 
who care for them. Victims who cannot be resuscitated at the scene, are 
resuscitated with weak breathing and heart rhythm, or are transported 
in critical condition, will most likely suffer severe neurological 
impairment that may lead to organ failure and death as described in 
IDIs 200915HFE0001 and 190711CCC2487. Prolonged submersion in water for 
more than five to ten minutes usually leads to poorer prognosis or a 
fatal drowning.
    During the drowning process, a victim experiences respiratory 
distress impairment because of submersion or immersion in liquid in the 
victim's airway (Van Beeck et al., 2005). The drowning process begins 
either when the child's mouth and/or nose goes below the surface of the 
water (submersion) or when water splashes over the face (immersion). In 
most of the incidents, neck floats posed a risk of drowning because of 
a child's head slipping through the product with submersion of the 
mouth and nose. Seventy-seven incidents reported submersion of a 
child's airway (nose and/or mouth) in water either full (76 incidents) 
or partial (one incident), 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 
mouth. Because infants generally cannot self-rescue, 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.
    When water enters the airway of the drowning victim, the victim 
will attempt to spit out, cough up as a reflex response, or swallow the 
water, often inhaling more water involuntarily (Szpilman et al., 2012; 
Orlowski et al, 1989; Grmec et al., 2009). Incident reports describe 
choking, coughing, water ingestion, vomiting, and spitting up water. 
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. Submersion durations were reported 
ranging from immediate rescue, where caregivers immediately pulled the 
child out of the water before the victim suffered any apparent 
injuries, to several minutes where the caregiver was not nearby or in 
the same room as the child. Water aspiration to the lungs and water 
ingestion can happen with very brief submersions. If the child is not 
rescued, the aspiration of water continues.
    When large amounts of fluid are aspirated into the lungs, there is 
drastic mechanical impairment of gaseous exchange and lung function 
when the aspirated water destroys the pulmonary surfactant and disrupts 
the alveolar-capillary membranes. This injury to the lung leads to 
pulmonary edema, decreased lung compliance, and decreased exchange of 
oxygen and carbon dioxide. Incidents in which a victim is minimally 
symptomatic typically resolve without sustaining serious injuries or 
requiring continued medical treatment, but swallowing or aspirating 
significant amounts of water can require medical attention or 
observation, especially for very young infants because of the risk of 
lung injury, hyponatremia,\6\ hypokalemia,\7\ or other types of 
electrolyte imbalance.
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    \6\ Hyponatremia is a low concentration of sodium in the blood, 
which can cause neurological and metabolic problems.
    \7\ Hypokalemia is a low concentration of potassium in the 
blood, which can cause neurological and metabolic problems.
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    In four incidents, caregivers performed medical treatment at home 
(IDIs 220714CCC1021, 230629CAA1660, 210826CCC3606, 220714CCC3164). In 
two of those four incidents, caregivers intervened to resuscitate an 
infant that was not breathing after being pulled from the water (one 
report of CPR, IDI 220714CCC1021, and one report of back thumps, 
I2360082A). In nine incidents, caregivers sought medical attention by 
going to an emergency department (IDIs 230720CCC1766, 210826CCC1826, 
210901CCC3625, and reports Y227C309G and Y2170991A), calling 911 (IDI 
210910CCC1030), calling a nurse/medical helpline (IDIs 230317CCC3555 
and 210901CCC1904), or by visiting an urgent care (IDI 210910CCC1029)). 
The two incidents reporting injuries that required hospital admission 
(IDIs 230317CCC3554 and 210114HCC1250) and the two fatalities (IDIs 
200915HFE0001 and 190711CCC2487) occurred in a home bathtub with the 
infant being submerged for an unknown length of time.

B. Incident Data 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 fit the child for the duration 
of use such that the child does not slip through the product's center 
opening to the extent that their mouth and nose become submerged in 
water.\8\ Staff examined the available incident data, incident and 
exemplar samples of inflatable and inherently buoyant child neck 
floats, and publicly available consumer-uploaded photos and videos 
demonstrating use of neck floats. Based on this information staff 
identified four hazard patterns associated with the risk of drowning: 
(1) slip-through not associated with inflation; (2) slip-through 
associated with inflation; (3) slip-through associated with restraint

[[Page 91590]]

system failure; and (4) submersion without slip-through.\9\
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    \8\ The risk for partial slip-through poses the risk of 
aspiration of water through the mouth even if the nose is not 
submerged.
    \9\ 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
    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. 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. The 
other seven incidents involved a caregiver's immediate rescue which 
prevented submersion. Where reported, victims ranged in age from 17 
days old to 8 months old. One fatal incident, IDI 200915HFE0001, 
involved the drowning of a 6-month-old female child using a neck float, 
who was unattended for an unknown amount of time in a bathtub. Upon 
returning, the mother found the neck float on the surface of the water, 
and the child was submerged in the tub, unresponsive. Subsequently, the 
child was hospitalized in critical condition and succumbed to her 
injuries six days later.
    It is common for neck floats to rely solely on the size of the 
center opening being smaller than the size of a child's head to prevent 
the child's mouth and/or nose from submerging in water. Neck floats are 
typically marketed for a wide range of ages and weights. Anthropometric 
data provided by the World Health Organization (WHO),10 11 
Centers for Disease Control and Prevention (CDC),\12\ and other 
researchers (e.g., Schneider et al., 1986), demonstrate a large 
variability in weight, head, and neck dimensions for children, 
particularly head dimensions for children between the ages of 0 and 12 
months. In addition, children's head weight data in the voluntary 
standard for childcare articles, CEN/TR 13387-1, Child care articles--
General safety guidelines--Part 1: Safety philosophy and safety 
assessment, shows appreciable growth over the years, particularly 
between 0 and 12 months.\13\ This variability in sizes and weights 
increases the possibility of an ill-fitting neck float and increases 
the risk of a child slipping through the neck float.
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    \10\ See WHO growth charts for girls and boys ages 0 to 24 
months: https://www.cdc.gov/growthcharts/who/girls_length_weight.htm 
and https://www.cdc.gov/growthcharts/who/boys_length_weight.htm.
    \11\ See ``WHO child growth standards: head circumference-for-
age, arm circumference-for-age, triceps skinfold-for-age and 
subscapular skinfold-for-age: methods and development''; https://www.who.int/publications/i/item/9789241547185.
    \12\ See ``Anthropometric Reference Data for Children and 
Adults: United States, 2015-2018,'' U.S. Department of Health and 
Human Services, Centers for Disease Control and Prevention, https://www.cdc.gov/nchs/data/series/sr_03/sr03-046-508.pdf.
    \13\ See CEN/TR 13387-1:2018, Child care articles--General 
safety guidelines--Part 1: Safety philosophy and safety assessment: 
https://standards.iteh.ai/catalog/standards/cen/586a9a9d-14b2-4626-bae4-4e13a80ce111/cen-tr-13387-1-2018.
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    Furthermore, a child's body weight and head mass will not 
necessarily correspond to their head, face, and neck dimensions. For 
instance, infants who have especially smaller dimensions, such as those 
who were born pre-term or those with developmental delays or other 
conditions that affect head size or shape, may have typical weights for 
their ages but their smaller cephalometry \14\ predisposes them to a 
higher risk of slip-through.\15\ Additionally, children's heads and 
faces are not uniformly spherical and are somewhat malleable. This can 
contribute to the risk of the child's head slipping through the neck 
float and will vary from child to child. In evaluating the incident 
data, staff observed that for incidents with known victim information 
and known product age and weight labeling, all victims had ages and 
weights consistent with the manufacturer-recommended guidance. 
Therefore, it is reasonably foreseeable that caregivers are likely to 
select and use neck floats marketed as appropriately sized for their 
child that may nonetheless be too large or too loose for their child.
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    \14\ The measurement and study of the proportions of the head 
and face, especially during development and growth.
    \15\ See ``Corrected Age for Preemies,'' American Academy of 
Pediatrics, https://www.healthychildren.org/English/ages-stages/baby/preemie/Pages/Corrected-Age-For-Preemies.aspx; ``NICU Family 
Information Packet, Appx. B, Growth,'' Agency for Healthcare 
Research and Quality, https://www.ahrq.gov/patient-safety/settings/hospital/resource/nicu/packet/apb3.html; Fenton Preterm Growth 
Charts https://live-ucalgary.ucalgary.ca/resource/preterm-growth-chart/preterm-growth-chart.
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    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 product, wiggle 
their bodies, kick their legs, flail their arms, and even push up on 
the front underside of their product. These and other actions can 
separate the discontinuous ends, deform the center 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. Figure 1 exemplifies 
children wearing neck floats and kicking off the tub floor, leaning 
back to the point that the tops of their heads are submerged, and 
pushing up on the front underside of the neck floats, as captured in a 
consumer's online video of twins wearing neck floats in a bathtub.

[[Page 91591]]

[GRAPHIC] [TIFF OMITTED] TP20NO24.092

    Neck float designs may include features intended to reduce the 
likelihood of slip-throughs. For example, some neck floats include a 
chin rest, which is intended to keep the child's mouth and nose from 
being submerged during use. However, many incidents involving 
submersions due-to slip-through involved neck floats designed with chin 
rests. Incident data and consumer videos of use show that children may 
lean and tilt their heads such that their chin bypasses the chin rest; 
they may twist their head in the product such that their chin is no 
longer supported by the chin rest; or their changes in direction or 
body position can cause the product to rotate during use. For example, 
IDI 210824HCC1797 indicates that the victim was using a neck float with 
a chin rest for approximately 10 minutes, when ``the victim turned his 
head to the right and suddenly the victim's head slipped through the 
neck opening.'' In addition, incident data, such as fatal case IDI 
200915HFE0001, demonstrate that caregivers may put neck floats on their 
children backwards, or otherwise without placing the child's chin on 
the chin rest, resulting in the child slipping through the center 
opening. Therefore, as shown in the incident data, a chin rest does not 
adequately prevent the submersion hazard.
    Incident reports show it is common for children to wear neck floats 
in water shallow enough for them to sit or lay in a reclined position, 
yet still deep enough to allow their mouth and/or nose submerge and 
pose a drowning hazard. For example, IDI 220714CCC3164 reports that the 
victim was in a bathtub with only approximately 5 inches of water when 
the victim was suddenly and fully submerged in the water. If children 
can push/kick off the floor or sides of the body of water, they are 
more likely to arch their heads back and separate the discontinuous 
ends of the neck float causing an expansion of the center opening, 
making it more likely for the child's mouth and/or nose to slip into 
the water. They may also have better leverage to lift the front 
underside of the product upward and over their face, as shown in Figure 
1, resulting in the mouth and nose submerging in water. Where water 
depth was reported, most incidents (81 of 83) indicated the product was 
used in shallow water such as a bathtub or kiddie pool.
    If there are obstacles such as tub walls, then it is easier for the 
product to be partially or fully held in place. If the product is 
immobilized and the child twists their head, then their chin may no 
longer be supported by a chin rest, making it more likely for their 
mouth and nose to slip into the water. If they twist enough that they 
face the discontinuous ends of the product, then the greater space and 
separation afforded by the discontinuous ends may make it easier for 
their mouth and nose to slip into the water. Additionally, if the 
product is immobilized and the child pushes off other surfaces into the 
discontinuous ends, they may generate force sufficient to expand the 
center opening and slip through the product. The University of Michigan 
Transportation Research Institute (UMTRI) conducted child strength 
research for CPSC, which demonstrated a wide range of two-foot seated 
push forces for children ages 6-47 months, such as children in the 6-8 
month range at the 95th percentile generating up to 128.8 N (29 pound-
force), and children in the 36-47 month range at the 95th percentile 
generating up to 547.3 N (123 pound-force).\16\ Another study found 
that fetal kick force reached 47 N (10.6 pound-force) at between 20 and 
30 weeks of gestation, demonstrating that newborns can generate at 
least this amount of force or greater (Verbruggen et al., 2018).
---------------------------------------------------------------------------

    \16\ See UMTRI (2023) child strength reports, ``Child Strength 
Measures: Children 6 through 23 Months Old,'' and ``Child Strength 
Measures: Children 24 through 71 Months Old,'' available at https://www.cpsc.gov/content/Child-Strength-Measures-Children-6-through-23-Months-Old and https://www.cpsc.gov/content/Child-Strength-Measures-Children-24-through-71-Months-Old.
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    The neck float can also be held in place by pressing up against 
other children in close proximity. Numerous incident reports and 
publicly available consumer-uploaded photos demonstrate that some 
children wear neck floats in confined spaces with siblings, even with 
siblings who are also wearing neck floats. For example, IDI 
210901CCC1899, which involved slip-through, indicates that triplets 
wore infant neck floats in the same bathtub at the same time when the 
victim suddenly slipped through the product and went underwater for 2 
to 10 seconds. Cases like this can result in a very confined space with 
the floats bumping into each other and even overlapping.
    Caregivers are unlikely to understand how these environmental 
variables, such as shallow water and confined spaces, can contribute to 
the risk of slip-through by enabling the child to twist their head in 
the product and exert forces that expand the center opening. It is 
reasonably foreseeable that they will mistake such environments as 
providing an increased level of safety, security, and comfort by making 
the water

[[Page 91592]]

experience more controllable compared to a standard pool. As detailed 
further below, they may also underestimate the risk of drowning in 
shallow water, further affording them a false sense of security.
    The slipperiness of the neck float's material, exposure of the neck 
float to lubricants, and motion 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. Many neck floats 
are marketed for use when bathing children. Several reports describe 
the use of soap and shampoo with the product. For example, IDI 
210901CCC1906 reports that the caregiver applied soap to the victim's 
head, and the soap made the victim's head and neck slippery, causing 
the victim's head to slip through the opening and submerge under the 
water. In reviewing products sold online and publicly available 
consumer-uploaded photos, staff observed that it is common for neck 
floats to be used in soapy environments (Figure 2).
[GRAPHIC] [TIFF OMITTED] TP20NO24.093

2. Slip-Through Associated With Inflation
    In 54 incidents, children slipped through or had the potential to 
slip through because the neck floats were more pliable or compressible 
at lower pressure levels or deflated during use. Thirty-three victims 
actually 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.). In one incident of a slip-through, 
it was intentionally underinflated.
    Neck floats that are initially fully inflated also can deflate over 
time or during use, such as from air escaping through holes, tears, or 
open air valves. Neck floats can be underinflated at the time the child 
begins to use the product due to numerous reasons, such as the 
caregiver's perception that the product is uncomfortably snug or the 
caregiver not realizing that air escaped from the product since the 
last time it was inflated.
    Where reported, victims ranged in age from 28 days old to 10 months 
old. Two drowning injuries (IDIs 230317CCC3554 and 210114HCC1250) and 
one drowning death (IDI 190711CCC2487) were reported in this category 
and involved leaks or deflation during use.
    There are unique risks of submersion for inflatable neck floats 
because they can be compressible and deform unevenly during use, vary 
in the amount of inflation prior to use, and may lose air during use. 
Manufacturers typically recommend that neck floats are ``fully'' 
inflated when used; however, full inflation is difficult for consumers 
to estimate. Variability in inflation prior to and during use can 
impact product performance. The inflatable neck float's dependence on 
air to take shape means their dimensions vary by the amount of 
inflation and renders them compressible and unevenly deformable, 
especially if the product has discontinuous ends. Lower levels of 
inflation result in greater deformability and can allow the 
discontinuous ends to separate and expand the size of the center 
opening (Figure 3).

[[Page 91593]]

[GRAPHIC] [TIFF OMITTED] TP20NO24.094

a. Deflation During Use
    Fifty-two CPSRMS incidents involved holes, tears, or other leaks in 
neck floats at the time of the incident. For example, IDI 190711CCC2487 
describes a fatal incident involving a 4-month-old male infant who was 
reportedly unattended for approximately 5 minutes in a bathtub wearing 
an inflatable neck float. He was found unresponsive floating face down 
without the neck float. The neck float was still secured in a closed 
position by both a Velcro strap and a buckle but appeared to be losing 
air. Another example, IDI 230317CCC3554, describes an injury to a 10-
month-old male who was unattended for 5 minutes or less in a neck float 
in a bathtub. The child was found limp and cyanotic \17\ with his face 
underwater, and the neck float was found to be partially deflated due 
to a leak in the seam.
---------------------------------------------------------------------------

    \17\ Cyanotic refers to a bluish discoloration of the skin 
resulting from poor circulation or inadequate oxygenation of the 
blood.
---------------------------------------------------------------------------

    Some incidents involved tears, as in IDI 210901CCC1899, which 
describes a 3-month-old infant slipping through the neck float that had 
a tear near the safety clip and IDI 210826CCC3605, which describes a 2-
month-old male who slipped through a product after it began to deflate 
due to a leak directly under the chin strap portion of the product. 
Several incidents, such as IDI 160512CBB2587, involved neck floats 
deflating during use due to problems with the air valve, such as the 
valve either opening or not being fully closed.
    Manufacturers' instructions often direct caregivers to check the 
product for tears, holes, valve issues, and other sources of leaks 
prior to each use of inflatable neck floats. However, instructions to 
perform these checks can be unclear and ineffective and, as a result, 
leaks may go undetected or develop after an inspection. It can be 
particularly difficult to find small leaks or tears, especially along 
seams. For example, IDI 220714CCC3155 indicates that after the product 
deflated during use, the caregiver performed the manufacturer-
instructed inspection for leaks and did not observe any air coming out 
of the product. The caregiver continued to use the product with a 6-
month-old child and the product deflated further, resulting in the 
child going ``underwater [for] approximately 5 seconds.'' In another 
example, IDI 220714CCC1014 indicates that the caregiver tested the neck 
float for leaks and could not find any, yet the product deflated 
resulting in the child slipping through.
    Incident data also show that caregivers are unlikely to perform a 
leak check prior to every use of the product. For example, IDI 
230720CCC1767 indicates the caregiver performed the manufacturer-
instructed leak test prior to the first use of the product, but not 
thereafter--contrary to the manufacturer's instructions--and the 
product deflated during use after being used ``at least 10 times before 
the incident occurred.'' Leak checks require time and effort, and 
studies have shown that even small inconveniences can have a 
substantial negative effect on behavioral compliance with safety 
measures (Riley, 2006). Further, the neck floats that staff observed in 
incident data and on the market are simple and familiar in assembly and 
use, and they are marketed to keep children, even newborns, afloat in 
bathtubs and other bodies of water. These factors make it likely that 
consumers will overestimate the capabilities of the product, 
underestimate the importance of the checks, and underappreciate the 
nature and likelihood of the submersion hazard (Inaba et al., 2004; 
Woodson et al., 1992). This underappreciation of risk is especially 
likely after the caregiver has seen their child and/or other children 
(e.g., through online marketing and endorsements of neck floats) use 
the product safely without submersion (Godfrey & Allender, 1994; 
Vredenburgh & Zackowitz, 2006; Ayres et al., 1989). As shown in the 
incident reports, it is common for caregivers to leave the product 
inflated between uses, and neither reinflate the product nor perform 
leak checks, prior to each use of the product. For example, IDI 
210908CCC1983 indicates the product was inflated once and never re-
inflated, despite being used several times.
    Some incident reports, moreover, demonstrate that caregivers have 
continued to use neck floats despite being aware of leaks because they 
believed the leak was slow and perceived no hazard in continued use.

[[Page 91594]]

For example, IDI 210908CCC1982 indicated that the consumer was aware of 
a leak and ``would simply re-inflate it and continue with the bath'' 
until the day her child slipped through the product. Caregivers delay 
or even forego replacing neck floats with slow leaks for a myriad of 
reasons, such as underestimating the risk of slip-through and avoiding 
the practical burdens (e.g., expense and time) of finding a 
replacement.
b. Underinflation
    Even without an air leak, neck floats are likely to be used at 
lower levels of inflation that compromise the products' fit and 
increase the likelihood of an infant slipping through. Neck float 
manufacturers often direct caregivers to ``fully'' inflate the products 
prior to use; however, as mentioned above, full inflation is likely to 
be interpreted differently from person-to-person. Consumers also vary 
in their capability to inflate neck floats and retain the air pressure 
as they switch from inflating it to closing the valve(s). Slip-through 
can occur at any level of inflation, but the risk is greater with lower 
inflation pressures. In examining neck float samples, staff observed 
that neck floats can take shape at as little as 0.1 pounds per square 
inch gauge (PSIG). Various factors (e.g., motion) can cause the center 
opening to expand, and consumers are likely to underappreciate the risk 
posed by these factors. Staff observed in product samples and incident 
reports that neck floats can feel secure around a child's neck and 
appear as though the child's head cannot pass through the center 
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. For example, IDI 210910CCC1030 
indicates that the product felt ``quite tight,'' yet the victim still 
slipped through the product without observable deflation.
    Additionally, 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. Intentional underinflation has been reported even for neck 
floats that have warnings against underinflation. For example, IDI 
220714CCC3162 indicated that the caregiver intentionally underinflated 
the neck float 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.
3. Slip-Though Associated With Restraint System Failures
    A restraint system is an interconnecting component, whether 
adjustable or not, that is integral to a neck float and is intended to 
hold the occupant in a fixed position relative to the neck float. Staff 
observed that latches, buckles, or Velcro straps are commonly used to 
bind the discontinuous ends of neck floats together during use, and 
keep the product wrapped securely and tightly around the child's neck. 
Failure of the restraint system is likely to result in the child's 
mouth and nose being submerged in water, whether from disconnecting 
entirely or simply loosening during use. According to report Y227Q815A, 
a 7-month-old infant slipped out of the product due to a latch/
restraint failure: ``the strap needs to be glued to the other side 
otherwise it opens.'' 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.
    The locations of the latches may also be a significant factor, 
though repositioning the location of the latches alone is not enough to 
prevent slip-through. As shown in Figure 3, some neck floats with 
discontinuous ends have the latches located far from the child's neck, 
affording greater separation of the part of the discontinuous ends 
closer to the child, where separation is most dangerous for center 
opening expansion.
4. Submersion Without Slip-Through
    Children can be submerged in water while wearing neck floats 
without slip-through or fastening and restraint system failures, 
putting them at risk of drowning. Where reported, victims ranged in age 
from 3 to 6 months old. 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 Y217O989B, a child leaned back and flipped in the product. As 
discussed above, it is common for children wearing neck floats to 
exhibit a wide range of body positions and movements.
    Additionally, at least one incident, IDI 220714CCC3158, involved an 
infant being pulled down into the water by an inflatable neck float 
that filled with water: ``The neck float made a popping sound and began 
to accumulate water, pulling the infant down into the water.'' This 
incident demonstrates another serious risk posed by inflatable neck 
floats, as numerous cases cite leaks in the products, and leaks can 
result in the product filling with water and weighing the child down. 
No injuries or deaths were reported in this category.

C. Availability of Incident Data

    Upon publication of this NPR in the Federal Register, staff will 
make available for review and comment the CPSRMS incident reports 
relied upon and discussed in the NPR, to the extent allowed by 
applicable law, along with the associated IDIs. The data can be 
obtained by submitting a request to: https://forms.office.com/g/10Cqtd8JP6. You will then receive a website link to access the data at 
the email address you provided. If you do not receive a link within two 
business days, please contact [email protected].

D. Recalls

    In July 2015, the Commission's Office of Compliance conducted one 
recall of a neck float product. Table 1 below summarizes the recall, 
notes the recall date, the firm involved, hazard, the approximate 
number of units affected, number of reported incidents/injuries, and 
the press release number.

[[Page 91595]]

[GRAPHIC] [TIFF OMITTED] TP20NO24.095

IV. Review of Voluntary Standards
---------------------------------------------------------------------------

    \18\ Otteroo Corp Recalls Inflatable Baby Floats [verbar] 
CPSC.gov.
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A. Standard Consumer Safety Specification for Toy Safety, ASTM F963-23

    ASTM F963 includes performance requirements and test methods for 
toys, as well as requirements for warning labels and instructional 
literature, to reduce or prevent injury to children or death of 
children from mechanical, chemical, and other hazards associated with 
toy use. Toys must comply with this standard pursuant to 16 CFR part 
1250. Similar to other ASTM standards, ASTM F963 contains the following 
sections: scope, terminology, referenced documents, safety 
requirements, labeling requirements, instructional literature, 
producer's markings, test methods, and additional sections appropriate 
for toys, such as age grading and flammability testing of certain types 
of toys. Since passage of the CPSIA in 2008, the voluntary standard has 
been revised five times: ASTM F963-08, ASTM F963-11, ASTM F963-16, ASTM 
F963-17, and ASTM F963-23. Pursuant to the update procedures in section 
106 of the CPSIA, the Commission has accepted the sequential revisions 
as the mandatory standard. 15 U.S.C. 2056b(g); 16 CFR part 1250.
    Neck floats are subject to the labeling requirements in section 5.4 
of ASTM F963-23 for aquatic toys. This standard requires that aquatic 
toys and their packaging include 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.'' As 
detailed in section V.B. of this preamble, for the proposed 
requirements for marking, labeling, and instructional literature in 
this NPR, staff assesses that the warning requirements specified in 
section 5.4 of ASTM F963-23 are inadequate for neck floats because they 
do not address the hidden hazards specifically associated with these 
products, such as the risk of center opening expansion during use, the 
risk of drowning in very shallow water, and the risk of death 
associated with partial slip-through. Many of the reported incidents 
involved neck floats compliant with the labeling requirements specified 
in ASTM F963-23, thereby demonstrating that the existing labeling 
requirements are insufficient to address the hazards.
    ASTM F963-23 does not establish any performance requirements for 
aquatic toys, including neck floats. 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.
    Incident data described in section III of this preamble demonstrate 
weaknesses in the current ASTM toy standard. Therefore, the Commission 
preliminarily determines that ASTM F963 fails to adequately address 
children slipping through neck floats or being submerged into water and 
fails to provide the highest level of safety feasible. Accordingly, the 
Commission proposes more stringent performance and labeling 
requirements that further reduce the risk of injury associated with 
neck floats and provide the highest level of safety for such products 
that is feasible.

B. Other Relevant Standards

    The U.S. Coast Guard uses ANSI/CAN/UL 12402-5, Personal Flotation 
Devices--Part 5: Buoyancy Aids (Level 50)--Safety Requirements, and 
ANSI/CAN/UL 12402-9, Personal Flotation Devices--Part 9: Test Methods 
to evaluate level 50 Personal Floatation Devices (PFD's) 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 and ANSI/CAN/UL 12402-9 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, 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, 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, are 
intended to introduce an ``active'' user

[[Page 91596]]

to the range of swimming motions. Class C swimming aids, covered by BS 
EN 13138-2, 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 most closely align 
with the target users of neck float products within the scope of this 
NPR. However, BS EN ISO 13138 classifies floatation 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 for Class B 
devices, including buoyancy testing, align with the test methods for 
their respective counterparts in ANSI/CAN/UL 12402 although the exact 
performance requirements differ. The risk management factors and tests 
of both ANSI/CAN/UL 12402 and BS EN ISO 13138-1 may address many of the 
hazards identified in section III of this preamble and are universal in 
application. However, to address the identified hazards associated with 
neck floats, the performance requirements and test methods will require 
modifications, discussed in more detail in section V of this preamble.

V. NPR Description of Proposed Provisions and Justifications

    Based on incident data described in section III of this preamble 
and staff's engineering, health sciences, and human factors 
assessments, the NPR proposes creating a new Sec.  1250.5 to 16 CFR 
part 1250, Safety Standard Mandating ASTM F963 for Toys, with more 
stringent requirements by adding performance and labeling requirements 
for neck floats 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. Further, this NPR proposes revising the 
title of part 1250 from Safety Standard Mandating ASTM F963 for Toys to 
``Safety Standard for Toys,'' to reflect the inclusion of proposed 
requirements that do not incorporate by reference existing requirements 
in the ASTM F963 voluntary standard.
    To address the risk of injury described in section III of this 
preamble, this NPR proposes to add a definition for ``neck float'' 
discussed in section II of this preamble and to add new performance 
requirements and replace existing labeling requirements for neck float. 
The NPR proposes to add test requirements for conditioning, buoyancy, 
fastening systems, restraining systems, and neck opening and to update 
marking, labeling and literature requirements. The additional 
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. This 
section of the preamble describes the proposed additions in Sec.  
1250.5.

A. Performance Requirements To Address Drowning Hazards

    Because ASTM F963-23 does not establish any performance 
requirements for aquatic toys, including neck floats, it fails to 
adequately address children slipping through neck floats or being 
submerged into water and does not provide the highest level of safety 
for such products that is feasible.
1. Conditioning Procedure
    The NPR proposes conditioning requirements for neck floats prior to 
conducting any other tests under the proposed rule in Sec.  
1250.5(c)(1). The purpose of a conditioning procedure is to simulate 
the conditions in which the product may be stored or used. This helps 
to ensure that the product is tested under realistic circumstances. The 
proposed conditioning procedure involves subjecting the neck float to 
various stressors based on foreseeable use environments, which include 
exposure to cold, hot, and room temperature, exposure to chlorinated 
salt water, and exposure to ultraviolet (UV) light. All inflatable neck 
floats subject to the proposed rule should be deflated for the proposed 
testing requirements in the conditioning procedure.
a. Exposure to Varying Temperatures
    Temperature changes can introduce both short- and long-term impacts 
on any material. For plastics and polymer chains, short-term effects 
can include expansion or contraction of objects' shape, as well as 
softening of the material. Long-term exposure may result in 
deformation, or thermal degradation leading to cracking or 
breaking.\19\ These material changes are typically associated with 
exposure to high temperature, as can be expected when the neck float is 
used for bathing purposes or is stored outside with other swim toys; 
however, transitioning between cold storage to hot use may also 
exacerbate the mechanical degradation.
---------------------------------------------------------------------------

    \19\ Shawn. ``Temperature Considerations in Plastic 
Thermoforming Material Selection.'' Productive Plastics Inc, 27 
June. 2021, www.productiveplastics.com/temperature-considerations-plastic-thermoforming-material-selection.
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    Section 5.5.4.1 of ANSI/CAN/UL 12402-9:2022 includes a 
``Temperature cycling test'' for inflatable PFDs. The temperature 
cycling test 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.
    The Commission proposes to incorporate this test method from 
section 5.5.4.1 of ANSI/CAN/UL 12402-9:2022, for both inflatable and 
inherently buoyant neck floats, with modifications, in the proposed 
rule under Sec.  1250.5(c)(1). ANSI/CAN/UL 12401-9:2022 contains 
separate requirements for inherently buoyant PFDs that includes steps 
to fully open the devices to simulate donning and check for damage. 
However, as discussed in Section II of this preamble, the design of 
inherently buoyant neck floats does not typically include extraneous 
moving parts that require additional ``opening'' steps beyond being 
secured around the child's neck. Therefore, CPSC proposes to apply the 
thermal conditioning procedure in section 5.5.4.1 of ANSI/CAN/UL 12402-
9:2022 to both inflatable and inherently buoyant neck floats.
    BS EN ISO 13138-1 also recommends temperature conditioning for 
swimming aids, with a hot temperature set point of 60  2 
[deg]C (140  4 [deg]F) and cold temperature set point of -
10  2 [deg]C (14  4 [deg]F). Since it is not 
reasonable to expect that a neck float will be stored or operated in 
temperatures low enough to warrant conditioning to -30  2 
[deg]C as recommended by section 5.5.4.1 of ANSI/CAN/UL 12409-9:2022, 
the NPR proposes to increase the temperature set point of the cold 
extreme from -30  2 [deg]C (-22  4 [deg]F) up 
to -10  2 [deg]C (14  4 [deg]F) based on the 
cold temperature recommended by BS EN ISO 13138-1 for comparable 
swimming devices.
    Additionally, rather than repeat thermal conditioning for two, 8-
hour alternating cycles, the NPR proposes to condition neck floats for 
a single 8-hour

[[Page 91597]]

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)). The 
NPR proposes to reduce the number of thermal cycles required in section 
5.5.4.1 of ANSI/CAN/UL 12402-9:2022 to more accurately reflect the use 
and storage conditions of neck floats in comparison to those of PFDs. 
Unlike PFDs, neck floats are not expected to be stored nor operated 
within the same extreme conditions expected of a life-saving device. 
The 24-hour requirement to hold the neck float at room temperature is 
sufficient to ensure that the hot and cold temperature exposures do not 
interfere with the remaining two conditioning requirements for neck 
floats (i.e., chlorinated salt water and UV exposure).
b. Exposure to Chlorinated Salt Water
    Exposure to chlorine environments, as may be expected of a pool, 
can result in an adverse chemical reaction with a plastic or polymer 
chain if the material has not been carefully selected for, or prepared 
with, suitable chemical resistance.\20\ To address this, the proposed 
rule requires conditioning for exposure to chlorinated salt water to 
simulate the use of a neck float in a pool.
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    \20\ Chemical Resistance Chart for Plastics--an In-Depth Look at 
Chemical and Acid Resistant Plastics [bond] a&C Plastics. 
www.acplasticsinc.com/informationcenter/r/a-chemical-resistance-guide-for-plastics.
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    To condition for exposure to chlorinated salt water, section 6.1 of 
BS EN ISO 13138-1:2021 requires the swimming aids to be submerged in a 
chlorinated saltwater solution. Staff recommends adopting similar 
procedures to account for exposure to various use locations of neck 
floats, which may include chemically treated bodies of water such as 
pools. Accordingly, the NPR proposes to require that a neck float 
should be submerged in a chlorinated saltwater solution. The solution 
should be prepared by dissolving 32 g \21\ of sodium chloride (NaCl) in 
one liter of aqueous solution containing 2 ppm chlorine at pH 7.0-
7.8.\22\ The neck float should 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.
---------------------------------------------------------------------------

    \21\ Giovanisci, Matt. ``How Much Salt to Add to Your Pool (Easy 
Pool Salt Calculation).'' Swim University, 8 July 2024, 
www.swimuniversity.com/how-much-pool-salt.
    \22\ Home Pool and Hot Tub Water Treatment and Testing.'' 
Healthy Swimming, 10 May 2024, www.cdc.gov/healthy-swimming/about/home-pool-and-hot-tub-water-treatment-and-testing.html?CDC_AAref_Val=https://www.cdc.gov/healthywater/swimming/residential/disinfection-testing.html.
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c. Exposure to Ultraviolet Light
    UV light can cause degradation of plastics and polymer chains 
through a photochemical effect.\23\ Over continued exposure, plastics 
may weaken, begin to look discolored, take on a chalky appearance, or 
become brittle to the touch.\24\
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    \23\ What Does UV Radiation Actually Do to Degrade Plastics? 
[bond] U.S. Plastic Corp. 11 Dec. 2009, www.usplastic.com/knowledgebase/article.aspx?contentkey=858.
    \24\ ``UV And Its Effect on Plastics: An Overview.'' Essentra 
Components U.S., 23 Jan. 2019, www.essentracomponents.com/en-us/news/manufacturing/injection-molding/uv-and-its-effect-on-plastics-an-overview.
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    Section 4.2.1.1-4.2.1.4 of ANSI APSP ICC-16 (2017), American 
National Standard for Suction Outlet Fitting Assemblies (SOFA) for Use 
in Pools, Spas and Hot Tubs, includes the ``Ultraviolet Light Exposure 
Tests'' test method for exposure to ultraviolet light (UV). 16 CFR part 
1450. Based on the test method requirements in section 4.2.1.1-4.2.1.4 
of ANSI APSP ICC-16, a product is required to be exposed to UV light 
under one of the four UV exposure conditioning methods, selected per 
the discretion of the evaluator, incorporated here:
    (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) 1000 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 X 2.1 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).'' 
\25\
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    \25\ 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.
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    In Sec.  1250.5(c)(1), the Commission proposes to incorporate 
sections 4.2.1.1-4.2.1.4 of ANSI APSP ICC-16 to simulate UV light 
exposure. This provision accounts for sun exposure during use of neck 
floats, which may include outdoor use and temporary or primary outdoor 
storage conditions.
2. Minimum Buoyancy Requirements
    In Sec.  1250.5(c)(2) the Commission proposes minimum buoyancy 
requirements to prevent unintentional submergence. Specifically, the 
Commission is proposing to require that all neck floats 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.\26\ Additionally, the Commission 
proposes to require inherently buoyant neck floats to not lose more 
than 5 percent of their initial buoyancy after being submerged for a 
24-hour period.
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    \26\ 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.
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    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 2 based on the neck float's maximum 
recommended user age, whichever is greater.

[[Page 91598]]

[GRAPHIC] [TIFF OMITTED] TP20NO24.096

    Section 5.5.9.2 of ANSI/CAN/UL 12402-9:2022 requires the use of a 
weighted cage with a calibrated load cell \28\ to submerge a swimming 
device in a tank of fresh water, with its upper surface at a depth of 
100mm to 150mm below the water surface without touching any sides of 
the tank. In addition, the product must be secured within the cage such 
that both it and the cage always remain approximately horizontal and 
level. The test method requires the submerged weight of the cage be 1.1 
times the expected buoyancy value of the swimming device to ensure 
there is sufficient load to fully submerge the weighted cage system 
when combined with the swimming device.
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    \27\ 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).
    \28\ The calibrated load cell is used to record the cage weight 
measurements, with and without the product.
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    The procedure in section 5.5.9.3 of ANSI/CAN/UL 12402-9 directs 
that the cage should be suspended in the water tank at a temperature of 
(20  5) [deg]C. First, the weight of the immersed cage with 
the product should be recorded, as A. Next, the weighted cage and 
product should remain immersed for 24 hours, and the weight shall be 
re-recorded as B. Lastly, the product should be removed from the cage 
and the weight of the immersed cage alone, without the product, should 
be recorded as C. Section 5.5.9.4 of ANSI/CAN/UL 12402-9 explains that 
the initial buoyancy is determined by deducting A from C, and the final 
buoyancy is taken by deducting B from C. The buoyancy loss is taken by 
deducting the final buoyancy from the initial buoyancy.
    The Commission proposes to incorporate this test method from 
sections 5.5.9.2-5.5.9.4 of ANSI/CAN/UL 12402-9:2022, with 
modifications, in the proposed rule to determine the minimum buoyancy 
for all neck floats, under Sec.  1250.5(c)(2). 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 NPR, however, proposes 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. It is foreseeable that a consumer could use the 
neck float while inflated to only 0.1 PSIG--even if that is below the 
proper operating pressure--because the float may appear to be in the 
proper shape and functional at this inflation level. An internal 
pressure of 0.1 PSIG is the lowest foreseeable operating pressure for 
neck floats, and therefore performance requirements that depend on 
inflation pressure (such as buoyancy) should be evaluated at that 
lowest limit. During experimental testing, staff found at least four 
sample inflatable neck floats (representing two distinct make/models) 
met the requirements of this NPR's proposed buoyancy test when inflated 
to 0.1 PSIG internal pressure.
    This NPR proposes to evaluate the minimum required buoyancy of the 
neck float as a function of its intended user weight. Requiring the 
upward buoyancy to be equal or greater than 30 percent of the expected 
weight capacity is based on applying 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.\29\ Using three as the 
safety factor is based on performance requirements in ASTM F963 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, 
which requires the test load to be three times the weight indicated by 
Table 7 in ASTM F963 or three times the manufacturer's stated weight 
capacity, whichever is greater. In this instance, staff equates ASTM 
F963's requirement for ride-on-toys to bear three times the dry-land 
weight of a child to the proposed buoyancy requirement that neck floats 
bear three times the in-water weight of a child.
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    \29\ Water cancels about 90 percent of a human's body weight. 
DNP, Darcy Reber Aprn, C.N.P. ``Aquatic Exercise: Gentle on Your 
Bones, Joints, Muscles.'' Mayo Clinic Health System, 9 Apr. 2024, 
https://www.mayoclinichealthsystem.org/hometown-health/speaking-of-health/aquatic-exercise-gentle-on-your-bones-joints-and-muscles.
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    In addition, the Commission proposes that inherently buoyant neck 
floats must demonstrate no more than a 5 percent loss of buoyancy after 
being submerged for 24 hours to ensure that inherently buoyant 
materials do not absorb enough water such that the product's ability to 
float properly is adversely impacted. The 5 percent loss is based on 
the staff's analysis of other relevant standards. Both ANSI/CAN/UL 
12402-9 and BS EN 13138-1 evaluate the buoyancy of flotation devices 
after a 24-hour submergence period to determine how much buoyancy is 
lost. BS EN 13138-1 requires inherently buoyant swimming aids to lose 
no more than 10 percent of their initial buoyancy, while ANSI/CAN/UL 
12402-9 requires PFDs to lose no more than 5 percent. The Commission 
preliminarily determines that the 5 percent loss metric is the more 
stringent of those two standards and is more appropriate to achieve the 
highest level of safety that is feasible.
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 proposes in Sec.  1250.5(c)(3) requirements for the release 
mode of the fastening mechanism, and overall mechanical integrity of 
restraint systems. A

[[Page 91599]]

fastening mechanism, such as a buckle, on a neck float serve as a 
restraint system because it secures and holds the child in place during 
use. The requirements proposed 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 as seen in Y227Q815A.
a. Fastening Mechanism
    Section 5.4.2 of BS EN 13138-1:2021, Fastening Systems, requires 
parts of a swimming device used to attach the swimming device to the 
body or to connect any other functional components to have at least two 
simultaneous or sequential actions for release to prevent unintended 
opening. Alternatively, the standard allows for a single action release 
if it requires at least 50 N to open. The standard further directs that 
this testing must be performed in accordance with Annex C of BS EN 
13138-1:2021, Procedure for testing the security of the pressure 
release of buckles without double action (simultaneous/sequential) 
release. Annex C specifies that the buckle used to secure a swimming 
device should be positioned and loaded with 5 N on a plain, rigid 
surface. For single release, mechanisms, a force of 50 N is required to 
be applied at point 3, perpendicular to the release mechanisms of the 
buckle.
    Section 4.13.1.2 of ASTM F963-23 also includes requirements for 
latching and locking mechanisms, which require either a double-action 
locking device with two distinct and separate actions to release, or a 
single-action locking device that requires a minimum force of 45 N to 
open. There are similar provisions in other ASTM standards for 
children's products that incorporate restraint straps, such as section 
6.4.7 of ASTM F833-21, Standard Consumer Safety Performance 
Specification for Carriages and Strollers. 16 CFR part 1227. Based on 
these comparable restraint system requirements, the Commission proposes 
to require 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. A minimum of 50 N to release is the 
greatest minimum force requirement for single-action release mechanisms 
in the applicable standards, and therefore ensures the highest level of 
safety.
    Unlike in ASTM F963-23, which allows the double-action release 
mechanism to use two separate actions to release, the NPR proposes to 
require two distinct, but simultaneous actions to release. Two 
simultaneous actions, such as depressing and twisting the cap of a 
medicine bottle open, are considered more difficult for a child in the 
age range considered by this NPR (0-4 years) to perform without 
assistance. Because there are no performance requirements for double-
action release system, allowing the double-action release system to 
utilize sequential actions where each action can be performed one-at-a-
time would be equivalent to allowing the neck float to rely on two 
unverified single-action release systems for fastening to the user.
b. Restraint System Mechanical Integrity
    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. 16 CFR part 1227. Additionally, the standard requires that any 
anchorages must remain attached without separating from their 
attachment points during testing. The standard also requires that the 
restraint system may not move more than 2 inches (51 mm) when tested in 
accordance with section 7.5.2.8. Section 7.5.1, Restraining System 
Integrity Test Method, 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 directs that force should be applied gradually within 5 
seconds and maintained for an added 10 seconds, which should be 
repeated a total of 5 times with a 5 second maximum time interval 
between tests for each attachment point on the restraint system. The 
standard further requires that, after testing, the Civil Aeronautical 
Medical Institute (CAMI) dummy, required for this test, should not be 
fully released.
    As noted in section III, the confined space of a bathtub 
environment provides the neck float occupant with possible surfaces to 
kick, pull, push, twist themselves off, or otherwise struggle against 
the surfaces of the bathtub. To account for this expected elevated 
force, the Commission proposes to incorporate section 6.4.4 and 7.5.1 
of ASTM F833-21, 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 Method. The 
CAMI dummy and section 7.5.2 testing have been omitted from the 
proposed restraint system requirements because the seat-based retention 
tests are incompatible with the neck float retention method. Instead, 
the NPR will address occupant retention through the proposed neck 
opening requirements in section V.A.4.
    The Commission has considered a potential requirement for neck 
floats to incorporate a secondary attachment system as a backup in the 
event the primary neck opening securement fails. CPSC staff, however, 
have identified a risk that a child could partially slip through the 
neck opening and be supported by the secondary system with their mouth 
below the waterline, creating a drowning hazard without a notable 
visual change to alert the caregiver to the danger. The addition of the 
secondary attachment system also may convey to the caregiver the 
incorrect impression that there can be no possibility for the child to 
slip through the product. The Commission requests comments on a 
secondary attachment system for neck floats to address hazards 
associated with use the of neck floats.
4. Neck Opening Test Requirements
    To address the hazard of a child slipping-through a neck float, the 
Commission proposes requirements for the neck opening on a neck float 
under Sec.  1250.5(c)(4). To meet the proposed requirement, the neck 
opening of the neck float must not admit the passage of a specified 
head probe when subjected to a specified dynamic movement, in 
accordance with the proposed test method. Currently, there are no 
existing standards or test methods developed to ensure that an aquatic 
toy such as a neck float will not pose a risk of drowning because of 
slip-throughs during its use. As a result, staff developed a test and 
test method to accommodate this need.
    Under the proposed neck opening test, first the neck opening of the 
neck float is saturated with a soapy solution to simulate use in a 
bathtub or with a slippery substance such as sunscreen. Second, the 
specified head probe is be weighted to a specific mass (M1) and 
positioned in the neck float. Next, a hanging weight of another 
specific mass (M2) is suspended below the head probe at a specified 
distance (L) of the specified head probe (see Table 3 for details on 
M1, M2 and L for various user-age categories). Finally, the hanging 
weight is 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 4. The hanging weight must be allowed to move freely 
for 30 seconds in this manner. After 30 seconds have

[[Page 91600]]

passed, the hanging weight is brought up again to a 90-degree 
displacement angle and then released so that it swings side-to-side 
relative to the neck float's user and allowed to move 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.
BILLING CODE 6355-01-P
[GRAPHIC] [TIFF OMITTED] TP20NO24.097

BILLING CODE 6355-01-C
    This dynamic test method was selected to account for the variety of 
movements children using this product have been reported to engage in, 
including kicking, back and belly floating, twisting, and pushing off 
of bathtub or pool walls and floors. The number of swing cycles, 
direction, and duration have been determined based on the CPSRMS 
incidents which contained many reported the incident occurring within 
10 minutes of use. Based on this, the minimum number of dynamic swing 
cycles in the proposed test is set at ten swings and reflects the child 
shifting their body weight at least one time every minute. This 
approximation is considered a conservative estimate of a child's 
expected activity over the 10 minute duration. The proposal to 
alternate directions between front-to-back and side-to-side accounts 
for multi-direction movements. The 90 degree starting swing angle and 
30 second swing cycle reflect the shift in body weight, from the 
child's transition from floating on their back or belly to one where 
their legs are positioned below them.
    The proposed test for neck opening is required to be repeated for 
both the smallest and largest head probe in the neck float's 
recommended user range to ensure that the neck float adequately retains 
the occupant by preventing the occupant from slipping fully through the 
neck opening. Evaluating the neck float using the smallest specified 
head probe ensures the neck opening is not large enough, or cannot 
expand to become large enough during use, to allow the smallest 
foreseeable occupant to slip fully through it. Evaluating the neck 
float using the largest specified

[[Page 91601]]

head probe ensures the neck float can adequately support the forces 
generated by the largest foreseeable occupant such that they cannot 
fully slip through it, as well. If a neck float uses an adjustable 
fastening mechanism then the evaluation of both probes is performed at 
the largest, or loosest, possible size setting.
    As discussed in section III, some reports indicated that caregivers 
loosened or intentionally deflated a neck float because they believed 
it was too tight around their child's neck (IDIs 220714CCC3162 and 
180403CCC1583). To ensure that a neck float achieves the highest-
possible level of safety, the proposed test therefore includes testing 
the smallest recommended child using a product at the loosest available 
setting. If the neck float utilizes inflatable components, those 
components must be inflated to an internal pressure of 0.1  
0.01 PSIG for the duration of this test. The internal air pressure 
specified by this test method has been discussed at length in the 
section V.A.2 of this preamble.
    As part of this test, the Commission proposes including the soapy 
water solution as described in ``Baby Wash Test Solution'' from section 
7.4.1.5 of ASTM F1967-19 Standard Consumer Safety Specification for 
Infant Bath Seats in the proposed rule for neck floats under Sec.  
1250.5. 16 CFR part 1215. ASTM F1967 requires the use of an established 
baby wash solution mix to evaluate the stability of infant bath seats 
under the same onerous soapy conditions. Incidents discussed in section 
III of this preamble support that neck floats may be used in soapy 
water solutions. Therefore, to achieve the highest-level of safety that 
is feasible, a test sample must be saturated with soap to simulate the 
most slippery foreseeable use condition to evaluate the neck float's 
ability to prevent the user from slipping through the neck float.
    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 3. 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.
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    \30\ See BSI Standards Publication. ``Child Care Articles--
General Safety Guidelines--Part 1: Safety Philosophy and Safety 
Assessment.'' 2018. BSI Standards Publication, report, 2018.
    \31\ 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.
    \32\ See Schneider et al., 1986).
    [GRAPHIC] [TIFF OMITTED] TP20NO24.098
    
    Dimensions of the four specified head probes, depicted in Figure 5, 
are based on available anthropometric data (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 91602]]

[GRAPHIC] [TIFF OMITTED] TP20NO24.099

[[Page 91603]]

[GRAPHIC] [TIFF OMITTED] TP20NO24.100

BILLING CODE 6355-01-C
    The four head probes represent children of various ages. Probe A is 
used to test products intended for children from 0 up to 3 months old, 
Probe B covers products for children up to 6 months old, Probe C covers 
products for children up to 18 months old, and Probe D covers products 
for children up to 48 months old. CPSC staff established these subsets 
based on the change in overall rate of growth of the head from 0-48 
months, which generally develops and grows more rapidly until around 7-
9 months. All dimensions used for the head probes represent the 5th 
percentile measurement of the specified age range for that probe. Where 
a probe is designated for use to evaluate multiple age ranges, the 
smallest 5th percentile measurement for that span has been selected.
    Staff note that the maximum neck circumference of a 43-48-month-old 
(10.2 in.) is smaller than the minimum head circumference of a 0-3-
month-old (14.6 in.). Based on these measurements, a neck float 
intended to accommodate the neck of a 48-month-old should still be 
expected to prevent the head of a 3-month-old from slipping through it. 
If the head probe can slip through the neck opening then that means the 
neck opening is either large enough, or can expand during use to be 
large enough, to allow that child's head to fully slip through the neck 
opening and submerge underwater. Staff assess this slip through metric 
to be a conservative representation of the slip through event.
    To simulate foreseeable use stresses on neck floats during use, 
each head probe is weighted to mass M1 and using a hanging weight of 
mass M2 positioned at distance L during the evaluation. Mass M1 
represents the 95th percentile weight of a child's head, alone, for the 
specified age range. Mass M2 has been selected as 20 percent of the 
95th percentile weight of the user in the specified age range. As noted 
in section V.A.2, the average human bears 10 percent of their dry-land 
weight when submerged up to their necks. The hanging weight used in 
this assessment is double the expected amount, or 20 percent of the 
dry-land weight for that user, to incorporate an appropriate factor of 
safety. Distance L has been determined as half of the 95th percentile 
stature of the user in the specified age range. This choice is made to 
approximate the position of the hanging mass at roughly the user's 
center of mass. Distance L includes the length between the narrowest 
and widest circumferences of probe to account for that distance as 
being the length of the user's head, as described in the paragraphs 
above.
    The four hazard patterns addressed in this NPR may not be 
exhaustive of the hazards associated with this product category. For 
example, the United States Food and Drug Administration (FDA) has 
warned about the risk of death due to suffocation, strain, and injury 
to a baby's neck.\33\ Accordingly, the Commission is seeking comment on 
whether it should strengthen these performance requirements to address 
other hazards, or whether it should promulgate alternative performance 
requirements.
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    \33\ See U.S. Food & Drug Admin., Do Not Use Baby Neck Floats 
Due to the Risk of Death or Injury: FDA Safety Communication (June 
28, 2022), available at https://www.fda.gov/medical-devices/safety-communications/do-not-use-baby-neck-floats-due-risk-death-or-injury-fda-safety-communication.
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B. Marking, Labeling, and Instructional Literature Requirements

    Section 5.4 of the ASTM F963-23 requires aquatic toys, such as neck 
floats, and their packaging to have a warning that states: ``This is 
not a lifesaving device. Do not leave child unattended while device is 
in use.'' The incidents discussed in section III of this preamble 
reflect that the existing safety messaging by way of marking, labeling, 
and instructional literature has had limited effectiveness for 
preventing the submersion hazard associated with neck floats. Indeed, 
it is reasonably foreseeable that caregivers will disregard warnings 
and instructions for neck floats and fail to adhere to them for each 
use. Many of the reported incidents involved products that not only met 
but exceeded the existing ASTM F963-23 requirements. Safety messaging 
has inherent weaknesses compared to designing the hazard out of a 
product or guarding consumers from the hazard (Laughery & Wogalter, 
2011), and it cannot, alone, adequately address the specific identified 
hazards from neck floats. 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.34 35 Further, warnings and instructional literature 
depend on persuading the consumer to change their behavior to avoid a 
hazard, and various factors can impede the effectiveness of these 
mediums. Conversely, the requirements for safety

[[Page 91604]]

messaging can be improved to increase the likelihood of consumers 
seeing, reading, remembering, and heeding the warnings and 
instructions, and better support the Commission's proposed performance 
requirements. Accordingly, the Commission proposes in Sec.  1250.5(d) 
to require the following marking, labeling, and instructional 
literature requirements for all products within the scope of the NPR 
and seeks comment on the format, location, and content requirements of 
the proposed warnings.
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    \34\ 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.
    \35\ See CDC on drowning facts: Drowning Facts [verbar] Drowning 
Prevention [verbar] CDC; accessed on March 20, 2024.
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1. Product and Package Marking and Labeling
    The primary U.S. voluntary consensus standard for product safety 
signs and labels, ANSI/NEMA Z535.4, American National Standard for 
Product Safety Signs and Labels,\36\ recommends that on-product 
warnings include content that addresses the following three elements:
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    \36\ ANSI Z535.4, American National Standard for Product Safety 
Signs and Labels is the primary U.S. voluntary consensus standard 
for the design, application, use, and placement of on-product 
warning labels when developing or assessing the adequacy of warning 
labels.
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     a description of the hazard;
     information about the consequences of exposure to the 
hazard; and
     instructions regarding appropriate hazard-avoidance 
behaviors.
    Providing more explicit or detailed information in a warning has 
been found to increase warning effectiveness (Laughery & Smith, 2006) 
by increasing the perception of injury severity and perceived hazard 
(DeJoy, 1999). Vividness of message content has been found to increase 
message salience by triggering motivation to act in consideration of 
the warning (Murray-Johnson & Witte, 2003). Accordingly, the Commission 
proposes, in Sec.  1250.5(d)(1), that the products within scope of the 
rule, and their retail packaging, contain the warning message shown in 
Figure 6, including the use of bolding and the formatting of the text, 
the safety alert symbol, and the signal word, in the order presented.
[GRAPHIC] [TIFF OMITTED] TP20NO24.101

    The portion, ``[specify lower bound for age],'' is to be filled 
with the lowest age intended for use of the product and in bold font. 
The portion, ``[specify upper bound for age],'' is to be filled with 
the highest age intended for use of the product and in bold font. The 
portion, ``[specify lower bound for weight],'' is to 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],'' is to 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 are to 
be omitted from the label in each case above.
a. Content
    In developing the proposed message panel, among other sources, 
staff considered the available incident data, reasonably foreseeable 
use, warnings required for ``Aquatic Toys'' per ASTM F963, warnings 
recommended and required by other standards and bodies, and 
recommendations and requirements specified in ANSI/NEMA Z535.4. 
Additionally, the Commission considers that consumers are less likely 
to read, heed, and remember safety messaging if they feel overwhelmed 
by the volume and/or depth of the information. The Commission 
encourages manufacturers to include additional product-specific 
warnings where necessary; however, such warnings shall neither 
contradict nor confuse the intended meaning of the required warnings.
    The statement, ``THIS PRODUCT DOES NOT PREVENT DROWNING,'' begins 
the message panel by articulating clearly that children can still drown 
even though they use the product. Each letter in this statement shall 
be bold and capitalized to strengthen the statement and attract the 
consumer's attention to the warning label. If the consumer reads 
nothing else, this statement may challenge some consumers' perception 
that the product will necessarily keep the child's mouth and nose above 
the water. This perception of safety is dangerous because it may lead 
consumers to provide inadequate supervision of the child using the 
product in water. This language is required by the Australian 
Competition & Consumer Commission (ACCC) for floatation aids as 
specified in the Australian standard, AS/NZS 1900:2014, Flotation aids 
for water

[[Page 91605]]

familiarization and swimming tuition.\37\ Similar language is required 
for Aquatic Toys per section 5.4 of ASTM F963-23 (i.e., ``This is not a 
lifesaving device.'') and for infant bath seats per ASTM F1967 (i.e., 
``NOT A SAFETY DEVICE.'').\38\ 16 CFR part 1215. However, the 
Commission preliminarily determines that the statement, ``This is not a 
lifesaving device,'' is not appropriate for the product because the 
proposed warnings better satisfy the intent to communicate that the 
product does not prevent drowning, and to include it in addition to the 
other warnings could dilute the warnings and increase the risk of 
warning exhaustion. Therefore, instead of complying with the warning 
text ``This is not a lifesaving device.'' in section 5.4 of ASTM F963-
23, the Commission proposes to require the language in Figure 6.
---------------------------------------------------------------------------

    \37\ See ACCC web page on ``Swimming & flotation aids'': https:/
/www.productsafety.gov.au/product-safety-laws/safety-standards-bans/
mandatory-standards/swimming-flotation-
aids#:~:text=The%20mandatory%20standard%20contains%20requirements%20t
o%20minimise%20incidences,light%208%20buoyancy%20of%20cellular%20mate
rial%20More%20items; accessed on March 27, 2024.
    \38\ See ASTM F1967, Standard Consumer Safety Specification for 
Infant Bath Seats: https://compass.astm.org/document/?contentCode=ASTM%7CF1967-19%7Cen-US; accessed on March 27, 2024.
---------------------------------------------------------------------------

    The statement, ``Children have died after slipping through neck 
floats,'' may reduce the likelihood of consumers otherwise inferring 
that the life-threatening hazard is just an unlikely potential risk 
rather than a hazard that has occurred and may happen to their child. 
As detailed above in section III, at least 87 incidents involved a 
child's head slipping through, two of which resulted in the child dying 
as a result of drowning. In most cases, the caregiver immediately 
intervened such that the child either did not fully submerge or was 
only submerged briefly. Had the caregiver not been present, these 
incidents could have resulted in the child drowning. Similar language 
is used in numerous other standards, such as for infant bath seats per 
ASTM F1967, infant bathtubs per ASTM F2670, Standard Consumer Safety 
Specification for Infant Bathtubs, and Beach Umbrellas per ASTM F3681, 
Standard Consumer Safety Specification for Beach Umbrellas and Anchor 
Devices.39 40
---------------------------------------------------------------------------

    \39\ See ASTM F2670, Standard Consumer Safety Specification for 
Infant Bath Tubs: https://www.astm.org/f2670-22.html; accessed on 
March 27, 2024. ASTM F2670 on infant bath tubs and F1967 on infant 
bath seats specify that the warning label shall address that babies 
have drowned while using the respective products.
    \40\ See ASTM F3681, Standard Consumer Safety Specification for 
Beach Umbrellas and Anchor Devices: https://www.astm.org/f3681-24.html; accessed on June 12, 2024. ASTM F3681 on beach umbrellas 
specifies that the warning shall state that beach umbrellas have 
killed people.
---------------------------------------------------------------------------

    The statement, ``Neck opening can get bigger during use, even if it 
feels snug,'' addresses the critical and hidden hazard of center 
opening expansion, because consumers are likely to expect that the 
center opening will not permit the child's mouth to go underwater if 
the product is tightly fitted, even though this is possible and has 
occurred in reported incidents (e.g., IDI 210910CCC1030 detailed 
above). Without dispelling this false assumption of safety, the 
consumer is more likely to discredit the warning messages and use the 
product without taking all necessary precautions, particularly if they 
have previously used the product without incident or seen others use 
the product without incident. Of the 21 incident reports that mentioned 
whether the neck float felt snug when placed on the victim at the time 
of the incident, 19 of the incident reports indicated the neck float 
did have a tight fit.
    The statement, ``Your child can drown in as little as 1 inch of 
water,'' communicates an important point that may help maintain the 
consumer's attention and educate them, as they are unlikely to be 
familiar with this fact,\41\ and they are likely to be caught off guard 
by it. It serves an important role by emphasizing that even very 
shallow water can be lethal, which may contradict the consumer's 
expectation of safety associated with using the product in shallow 
water, such as in bathtubs. The statement is also personalized to the 
reader by using the words: ``Your child,'' as opposed to ``a child,'' 
or similar language, which can more easily be disregarded by the 
consumer as not applying directly to the child for whom they are 
responsible.\42\ Other standards, such as ASTM F3681 on beach 
umbrellas, also take the approach of personalized language regarding 
the risk of death.\43\
---------------------------------------------------------------------------

    \41\ For example, see ``Water Safety for Parents'' from John 
Hopkins Medicine: https://www.hopkinsmedicine.org/health/wellness-and-prevention/water-safety-for-parents; accessed on June 13, 2024.
    \42\ ASTM F1967 on infant bath seats specifies the following 
warning regarding supervision using the word ``your'': ``Stay in 
arm's reach of your baby.''
    \43\ ASTM F3681 on beach umbrellas specifies the following 
warning regarding the risk of death, using the word ``you'': ``You 
can be killed too!''
---------------------------------------------------------------------------

    The message panel includes bulleted statements for important 
information about how to avoid the drowning hazard. The statement, 
``Always stay within arm's reach to keep your child's mouth above 
water,'' emphasizes the importance of a caregiver's attentiveness to a 
child while using a neck float to be able to rescue the child 
immediately if their mouth and/or nose submerges. Unattended children 
using neck floats in bathtubs sustained injuries and two reportedly 
died (e.g., IDIs 190711CCC2487 and 200915HFE0001). Again, caregivers 
may develop a false sense of security when using the neck float, 
relaxing their supervision of the child for numerous reasons, such as 
past incident-free experiences, the perception that the neck float is 
too tight for the child to slip through, and the presumption of safety 
associated with the neck float being a consumer product marketed to 
such young ages for the purpose of keeping their mouth and nose above 
the water (Woodson et al., 1992).
    The American Academy of Pediatrics (AAP) has encouraged caregivers 
to use ``touch supervision'' that is, remaining within arm's reach of 
infants and toddlers swimming in pools.\44\ Section 5.4 of ASTM F963--
23 requires a warning statement that addresses the following: ``Do not 
leave child unattended while device is in use.'' Similar juvenile 
product standards, such as ASTM F1967 and ASTM F2670, also support the 
use of statements pertaining to supervision and proximity.\45\ The 
proposed language is stronger for neck floats because it highlights the 
risk of partial slip-through, which is a small movement that requires a 
more attentive caregiver than simply monitoring for a large motion, 
such as the child fully submerging. Further, the personalization via 
``your child'' may help encourage the consumer to see the warning as 
applying to the child for whom they are responsible and increase its 
impact.
---------------------------------------------------------------------------

    \44\ See AAP on drowning and touch supervision. ``A Parent's 
Guide to Water Safety.'' Pediatric Patient Education, 1 Jan. 2021, 
https://doi.org/10.1542/peo_document110.
    \45\ ASTM F1967 on infant bath seats and F2670 on infant bath 
tubs specify the following warning regarding supervision: ``Stay in 
arm's reach of your baby.''
---------------------------------------------------------------------------

    The statements specific to inflatable products, ``Check for leaks 
before each use. Never use with leaks,'' are intended to motivate 
consumers using inflatable neck floats to check for leaks before each 
use and to never use neck floats with leaks. Detailed in section III of 
this preamble, numerous incidents involved products that had leaks. In 
many cases, the consumers did not report testing the product for leaks 
prior to every use, and some cases mentioned that the consumers were 
aware of slow leaks and continued to use the product anyway

[[Page 91606]]

due, in part, to past incident-free experiences and the costs 
associated with having to replace the product. The proposed 
instructional literature requirements, detailed below, complement this 
warning with specific instructions to help the consumer avoid the risks 
of underinflation. The Commission cautions that, while the proposed 
statements may help some consumers prevent submersion associated with 
leaks, most reported incidents involved products with warnings and 
instructions pertaining to leaks.
    Lastly, the statements in brackets pertaining to the child's age 
and weight are intended to help and encourage the consumer to select 
and use the appropriate product for their child; though, as explained 
above, children can vary considerably in the key face, head, and neck 
measurements relevant to slip-through, regardless of their age and 
weight. Discussed below, the Commission proposes instructional 
literature requirements to further aid the consumer in accurately 
taking the necessary measurements. Providing the intended age and 
weight also serves to guide testing of the products to increase the 
safety of the products for the intended and foreseeable end users.
b. Format
    CPSC commonly uses ANSI/NEMA Z535.4 as a reference for warning 
formatting requirements. Human factors experts and warnings literature 
regularly cite ANSI/NEMA Z535.4 when discussing the design and 
evaluation of on-product warning labels and generally consider the ANSI 
Z535 series of requirements as the benchmark and state of the art 
standards against which warning labels should be evaluated for adequacy 
(Vredenburgh & Zackowitz, 2005; Wogalter & Laughery, 2005). 
Furthermore, the scope of ANSI/NEMA Z535.4 is broad enough to encompass 
nearly all consumer products, including children's products and toys 
(Kalsher & Wogalter, 2008).
    Signal words, colors, graphics, and placement all increase 
conspicuity. The salience of a visual warning can be enhanced using 
large and bold print, high contrast, color, borders, pictorial symbols, 
and special effects like flashing lights. Therefore, the NPR proposes 
that the warning label design requirements for children's neck floats 
adopt the current recommendations from ASTM's Ad Hoc Language Task 
Group (Ad Hoc Task Group).\46\ Staff has worked closely with the Ad Hoc 
Task Group to develop warning recommendations that are based largely on 
the ANSI/NEMA Z535.4 requirements. The recommendations provide 
permanent, conspicuous, and consistently formatted warning labels 
across juvenile products. Warnings that meet the recommendations 
address numerous format issues related to capturing consumer attention, 
improving readability, and increasing hazard perception and avoidance 
behavior. Such recommendations include requiring that the proposed 
warnings conform to ANSI/NEMA Z535.4 sections 6.1-6.4, 7.2-7.6.3, and 
8.1, with the following changes to the ANSI standard:
---------------------------------------------------------------------------

    \46\ ASTM Ad Hoc Wording Task Group (Ad Hoc TG) consists of 
members of various durable nursery product voluntary standards 
committees, including CPSC staff. The Ad Hoc TG's purpose is to 
harmonize the wording of common sections (e.g., introduction, scope, 
protective components) and warning label requirements across nursery 
product voluntary standards. The latest version of the Ad Hoc-
approved recommended language is published in the ``Committee 
Documents'' section of the Committee F15 ASTM website.
---------------------------------------------------------------------------

     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'').
    Further, certain text in the message panel must be in bold and in 
capital letters as shown in the example warning label in Figure 6, 
above, to provide emphasis and capture the reader's attention. 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 point 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\'' (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
    Warning research indicates that warning labels with prominent 
placement increase the likelihood of being noticed (Rogers et al., 
2000). Further, warnings that are placed directly on a product and/or 
the packaging have a higher noticeability rate (Wogalter et al., 1987; 
Frantz & Rhoades, 1993) because consumers are more likely to see such 
warnings when first examining the product prior to purchase. ANSI/NEMA 
Z535.4 provides general guidance on the placement of warnings, stating 
that warnings must be placed so they are ``readily visible to the 
intended viewer'' and will ``alert the viewer to the hazard in time to 
take appropriate action.'' \47\ Similarly, both the Ad Hoc Task Group 
and section 5.3.6 of ASTM F963-23 require warnings to be conspicuous. 
Accordingly, the Commission proposes that the warning label identified 
in Figure 6 is positioned conspicuously on the product, such that it is 
visible clearly and, in its entirety, when the product is placed on the 
child.
---------------------------------------------------------------------------

    \47\ American National Standards Institute. (2011). ANSI Z535.4. 
American national standard: Product safety signs and labels. 
Rosslyn, VA: National Electrical Manufacturers Association, Section 
9.1.
---------------------------------------------------------------------------

    For the product's packaging, to ensure that the label is in an area 
of the packaging that stands out and is visible, the Commission 
proposes that the warning label in Figure 6 must be placed in the 
principal display panel, which is defined in ASTM F963 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 Commission proposes to require that instructions are provided 
with all neck float products and that they 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 center 
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

[[Page 91607]]

information, nor be otherwise misleading to the consumer.
    For products with inflatable components, the Commission proposes 
that the instructional literature includes clear directions for testing 
the product for leaks. These directions are important for reducing the 
likelihood of the product losing air during use, as air loss may 
increase the amount deformation and center opening expansion. Absent 
these directions, caregivers are less likely to identify leaks in their 
products prior to the children being submerged in water.
    The Commission assesses that these instructional literature 
requirements support the proposed performance requirements and may help 
some consumers to select, use, and maintain the products safely. 
Instructional literature, however, is likely to have limited 
effectiveness to address this hazard, as consumers using inflatable 
neck floats would need to remember and choose to follow the 
instructions every time they use the product, and it is reasonably 
foreseeable they will forego doing so for the reasons detailed above. 
Most neck floats involved in incidents provided instructional 
literature in the forms of user manuals and on-product labels, and many 
of the products were used contrary to the instructions, resulting in 
the children being submerged in water.

VI. Prohibited Stockpiling

    The Commission is proposing in Sec.  1250.5(e) an anti-stockpiling 
provision to prevent firms from manufacturing or importing large 
quantities of noncompliant neck floats before the rule takes effect and 
seeks comment on this provision. Under this proposal, firms could not 
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.
    Neck float products have characteristics that make them ideal for 
firms seeking to stockpile, such as low inventory costs due to their 
small size (particularly for inflatable products before sale), 
durability, and low costs of production. Additionally, the new 
requirements may cause some firms to exit the market. Exiting firms 
would have an incentive to sell stockpiled neck floats to support the 
costs of switching to manufacturing another product. These firms would 
be relatively unconstrained by reputational concerns surrounding their 
sale of stockpiled non-compliant neck floats after the effective date 
of a final rule. Further, because many neck floats are sold primarily 
or exclusively on manufacturers' or importers' own websites, the 
responsible business practices of retailers that refuse to take 
noncompliant toys into their inventory, even before the effective date 
of a new safety regulation, would have little constraining effect on 
stockpiling by manufacturers and importers themselves. These firms 
could expect to sell their stockpiled noncompliant products even as 
other sellers limit their sales to compliant products.

VII. Feasibility of Proposed Requirements

    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). 
Based on the staff's analysis provided in this NPR, the Commission 
preliminarily determines that the NPR is technically and economically 
feasible, and requests comment on this determination.

A. Technological Feasibility

    A proposed 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 preliminarily concludes that the NPR's 
proposals meet technical feasibility criteria. No new or even emerging 
technology is needed to manufacture a compliant product.
    In addition, 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. Of the testing tools proposed by the NPR, 
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 proposed by the NPR are already 
either included in CPSC mandatory standards or come from other 
previously published external safety standards.

B. Economic Feasibility

    The proposed rule is economically feasible because the cost of 
compliance would not threaten the viability of the industry. CPSC 
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 that, CPSC staff 
assesses, are compliant or readily could be compliant with the proposed 
rule, demonstrates that the proposed rule is economically feasible.

VIII. Incorporation by Reference

    Proposed section 1250.5 would incorporate by reference portions of 
ANSI/CAN/UL 12402-9, ANSI APSP ICC-16, ANSI/NEMA 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. Under 
those regulations, agencies must discuss, in the preamble to a final 
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 of this preamble 
summarizes the provisions of ANSI/CAN/UL 12402-9, ANSI APSP ICC-16, 
ASTM F833-21, ASTM F1967-19 and ANSI/NEMA Z535.4-2023 that the 
Commission proposes to incorporate by reference into proposed Sec.  
1250.5. The standards are reasonably available to interested parties by 
permission of the relevant standards developing organization (SDO) to 
be viewed as a read-only document during the comment period on this 
NPR, at:
    https://www.surveymonkey.com/r/DQVJYMKforANSI/CAN/UL 
12402-9,
    https://codes.iccsafe.org/content/ANSIAPSPICC162017/title-page for ANSI APSP ICC-16,
    https://www.surveymonkey.com/r/DQVJYMKforANSI/NEMA 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.
    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

[[Page 91608]]

Highway, Bethesda, MD 20814, telephone: (301) 504-7479; email: [email protected]. Alternatively, 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, 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, Standard for Personal Flotation Devices--
Part 9: Test Methods, (published February 11, 2021).
    (3) National Electrical Manufacturers Association (NEMA), 1300 17th 
St. N, Arlington, VA 22209; phone: (703) 841-3200; website: 
www.nema.org.
    (i) ANSI/NEMA Z535.4-23, American National Standard for Product 
Safety Signs and Labels (approved December 14, 2023).
    (4) ASTM International (ASTM), 100 Barr Harbor Drive, P.O. 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)

IX. Effective Date

    The Administrative Procedure Act (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). The Commission proposes a 180-day 
effective date for this rule. The rule would apply to all neck floats 
manufactured after the effective date. 15 U.S.C. 2058(g)(1).
    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).\48\ 
Accordingly, to provide time to comply with the rule, to ensure 
adequate lab capacity to test and certify toys, and to spread the cost 
of compliance over a period of months, the Commission proposes to make 
this rule effective 180 days after publication of the final rule in the 
Federal Register.
---------------------------------------------------------------------------

    \48\ Section 14(a)(3) specifies laboratories must have at least 
90 days to implement new third-party testing requirements.
---------------------------------------------------------------------------

    The effective date of 180 days should be sufficient for firms to 
come into compliance, because the proposed tests are consistent with 
testing required in 16 CFR parts 1215, 1227, and 1450. For other 
proposed 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. The Commission invites 
comments, particularly from small businesses, regarding the proposed 
testing and the amount of time needed to come into compliance with a 
final rule.

X. Regulatory Flexibility Act (RFA)

    The RFA requires that agencies review a proposed rule for the 
rule's potential economic impact on small entities, including small 
businesses. Section 603 of the RFA generally requires that agencies 
prepare an initial regulatory flexibility analysis (IRFA) and make the 
analysis available to the public for comment when the agency publishes 
an NPR, unless the rule would not have a significant economic impact on 
substantial number of small entities. 5 U.S.C. 603. The IRFA must 
describe the impact of the proposed rule on small entities and identify 
significant alternatives that accomplish the statutory objectives and 
minimize any significant economic impact of the proposed rule on small 
entities. The IRFA must also contain:
    (1) a description of why action by the agency is being considered;
    (2) a succinct statement of the objectives of, and legal basis for, 
the proposed rule;
    (3) a description of and, where feasible, an estimate of the number 
of small entities to which the proposed rule will apply;
    (4) a description of the projected reporting, recordkeeping and 
other compliance requirements of the proposed rule; and
    (5) an identification to the extent practicable, of all relevant 
Federal rules which may duplicate, overlap or conflict with the 
proposed rule.
    This proposed rule would have a significant economic impact on a 
substantial number of small U.S. entities, 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.

A. Reason for Agency Action, NPR Objectives and Legal Basis

    Section I of this preamble explains why the Commission proposes to 
establish a mandatory rule for neck float and provides a statement of 
the objectives of, and legal basis for, the proposed rule. The proposed 
requirements in the NPR are more stringent than ASTM F963-23, which the 
Commission incorporated into the mandatory rule in 16 CFR part 1250, 
Safety Standard Mandating ASTM F963 for Toys, as described in sections 
IV and V of this preamble. The NPR addresses the known hazards 
presented by neck floats, discussed in section III of this preamble, 
that the current mandatory toy safety standard does not adequately 
address.

B. Small Entities to Which the Rule Will Apply

    Section II of this preamble describes the products within the scope 
of the proposed rule, provides an overview of the market for neck 
floats and the use of these products in the U.S. This section provides 
additional details on the market for products within the scope of the 
rule.
    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. Floatation products can be sold among varying

[[Page 91609]]

retail channels focused on swimming or toddler products. Therefore, the 
NAICS codes listed in this IRFA for retailers, importers, and 
manufacturers are unlikely to be exhaustive.
    Under the U.S. Small Business Administration (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,\49\ 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 6 and Table 7 provide the 
estimated number of small firms by each NAICS code.\50\ CPSC estimates 
that a total of 19 small U.S. manufacturers and importers, and 27,260 
small U.S. retailers, deal in neck floats.
---------------------------------------------------------------------------

    \49\ Census Bureau, 2023. Statistics of US Businesses (SUSB) 
2021. Suitland, MD. Census Bureau.
    \50\ 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] TP20NO24.102

[GRAPHIC] [TIFF OMITTED] TP20NO24.103

    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.

C. Compliance Reporting and Recordkeeping Requirements of the Proposed 
Rule

    The NPR would require manufacturers and importers of neck floats to 
meet performance, warning label, and instructional material 
requirements, and to conduct third-party testing to demonstrate 
compliance. Section V of this preamble describes the performance, 
warning label and instructional material requirements.
    Manufacturers must demonstrate that they have met the performance 
requirements of the rule by providing a children's product certificate. 
As specified in 16 CFR part 1109, suppliers who are not the original 
manufacturer, such as importers, may rely on the

[[Page 91610]]

testing or certification suppliers provide, as long as the requirements 
in part 1109 are met. Manufacturers and importers are required to 
furnish certificates to retailers and distributors (section 14(g)(3) of 
the CPSA). Retailers are not required to third-party test the 
children's products that they sell unless they are also the 
manufacturer or importer. Under section 14 of the CPSA, manufacturers, 
importers, and private labelers of neck float products would be 
required to certify, based on a test of each product by an ISO-
accredited, CPSC-accepted third party conformity assessment body, that 
their products comply with the requirements of the proposed rule. Each 
children's product certificate of compliance must identify the third-
party conformity assessment body that conducted the testing upon which 
the certificate depends.

D. Federal Rules Which May Duplicate, Overlap, or Conflict With the 
Proposed Rule

    CPSC has not identified any other Federal rules that duplicate, 
overlap, or conflict with the proposed rule.

E. Potential Impact on Small Entities

    The Commission expects small firms of inflatable products to incur 
a significant cost from redesign/retooling, and material changes as a 
result of the proposed rule. If the rule is finalized, small 
manufacturers would 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 proposed requirements. 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. The Commission seeks 
comments from small firms stating their annual revenue and estimated 
compliance costs.
    Staff assesses that a large majority of inflatable neck float 
products cannot, as currently constructed, meet the proposed 
requirements of the rule. These products will require redesign, 
retooling and additional components to comply with the proposed rule. 
Major design changes are needed to meet the performance requirements 
related to durability, buoyancy, and the neck opening. 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 proposed 
performance standards without costly modification, while inflatable 
neck floats are likely not to comply with the performance requirements. 
CPSC assumes the observed premium of 20 percent of retail price \51\ 
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 
\52\ and benefits,\53\ is $79.64 per hour.\54\ 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 estimates a range of 
possible redesign costs of $38,227 to $50,970 per firm.\55\
---------------------------------------------------------------------------

    \51\ Non-inflatable neck floats were on average 20 percent more 
than the most popular inflatable neck float.
    \52\ 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.
    \53\ 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).
    \54\ $79.64 per hour = $53.09 wage per hour x 1.50 compensation 
factor.
    \55\ $79.64 per hour x 480 hours (3 months) = $38,227, $79.64 x 
640 hours (4 months) = $50,970.
---------------------------------------------------------------------------

    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 NPR would require 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 proposed rule. The certification of must 
be completed by a third party conformity assessment body. Based on 
quotes from testing laboratories for ASTM F963 testing services, the 
cost of certification testing would range from $130 to $250 per product 
sample. For neck floats, the average number of models per firm is two, 
based on manufacturer websites, which would equate to a testing and 
certification cost range of $260 to $500 per firm.

H. Efforts To Minimize Impact, Alternatives Considered

    The Commission considered four alternatives to the proposed rule 
that could reduce the 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 voluntary 
standard if the Commission determines that more stringent requirements 
would further reduce the risk of injury associated with the product, as 
well as 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(c), (d). 
Given CPSC's statutory mandate, and continuing incidents associated 
with neck float as described in section III of this preamble, the 
Commission has determined that it must address the safety of children 
using neck float to ensure that the risk of drowning is mitigated. 
While failing to promulgate a mandatory standard for neck floats would 
have no direct impact on U.S. small businesses, it would allow

[[Page 91611]]

unsafe products to remain on the market and ignore a known drowning 
hazard to children, with reported fatalities. After preliminarily 
determining that the existing requirements in ASTM F-963 are 
inadequate, in section IV, the Commission is 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
    CPSC could create an information and education campaign to better 
alert parents and caregivers regarding the drowning hazard associated 
with neck floats. 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 have been 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 preliminary 
finds that 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 could adopt BS EN 13138-1:2021 without 
modifications, discussed above in section V, because it has similar 
requirements as the proposed 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 proposed 
requirements. Adopting this alternative would lower the number of firms 
affected by the proposed rule. However, the international standards do 
not include specifications for slip-through hazards associated with 
neck floats. Therefore, 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 could adopt 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 proposed 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, 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.

XI. 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 NPR falls within 
the categorical exclusion.

XII. Paperwork Reduction Act

    This proposed rule for neck floats 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 (44 U.S.C. 3501-3521). In this document, pursuant to 44 
U.S.C. 3507(a)(1)(D), we set 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.
    Title: Safety Standard for Toys: Requirements for Neck Floats.
    Description: As described in section V of this preamble, the 
proposed rule would require new labeling and instructions for neck 
floats toys. The NPR proposes that neck float meet the proposed 
requirements of Sec.  1250.5, which are summarized in section V of this 
preamble.
    Section 5 of ASTM F963-23 contains requirements for marking, 
labeling, and instructional literature of children's toys in general. 
These requirements fall within the definition of ``collection of 
information,'' as defined in 44 U.S.C. 3502(3). CPSC will request an 
OMB control number for the proposed collection.
    Description of Respondents: Persons who manufacture or import neck 
floats.
    Estimated Burden: We estimate the burden of this collection of 
information as follows:
[GRAPHIC] [TIFF OMITTED] TP20NO24.104

    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 1 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 2 hours per response. 
Therefore, the total burden hours for the collection are estimated to 
be 40 hours

[[Page 91612]]

annually (20 responses x 2 hours per response = 40 total burden hours).
    CPSC estimates the hourly compensation for the time required to 
create and update labeling and instructions is $41.76.\56\ 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 
proposed information collection would impose a burden to industry of 40 
hours at a cost of $1,670 annually.
---------------------------------------------------------------------------

    \56\ 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.
---------------------------------------------------------------------------

    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
3507(d), we will submit the information collection requirements of this 
proposed rule to the OMB for review. Interested persons are requested 
to submit comments regarding information collection by January 21, 
2025, (see the ADDRESSES section at the beginning of this notice). 
Pursuant to 44 U.S.C. 3506(c)(2)(A), we invite comments on:
    [ssquf] Whether the collection of information is necessary for the 
proper performance of the CPSC's functions, including whether the 
information will have practical utility;
    [ssquf] The accuracy of the CPSC's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used;
    [ssquf] Ways to enhance the quality, utility, and clarity of the 
information to be collected;
    [ssquf] Ways to reduce the burden of the collection of information 
on respondents, including the use of automated collection techniques, 
when appropriate, and other forms of information technology; and
    [ssquf] The estimated burden hours associated with label 
modification, including any alternative estimates.

XIII. 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 a rule issued under section 106 of the CPSIA takes effect, it will 
preempt in accordance with section 26(a) of the CPSA.

XIV. 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 proposed rule would 
create a new 16 CFR 1250.5 as part of 16 CFR part 1250. If issued as a 
final rule, the proposed rule would be 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 of the NORs issued previously by 
the Commission. To meet the requirement that the Commission issue an 
NOR for the proposed standard, the Commission proposes to add neck 
floats to the list of children's product safety rules for which CPSC 
has issued an NOR.
    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 or 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/.
    Testing laboratories should not be adversely impacted as a result 
of this rule. CPSC expects that laboratories will be able to test to 
this proposed rule in a short time period. Furthermore, no laboratory 
is required to provide testing services. The only laboratories that are 
expected to provide such services are those that anticipate receiving 
sufficient revenue from the mandated testing to justify procuring the 
testing equipment and obtaining accreditation.

XV. Request for Comments

    The Commission requests comments on the proposed rule to promulgate 
a mandatory standard for neck floats under section 106 of the CPSIA. 
During the comment period, ASTM F963-23 is available as a read-only 
document at: http://www.astm.org/cpsc.htm. Comments should be submitted 
in accordance with the instructions in the ADDRESSES section at the 
beginning of this document.
    CPSC requests comments on all aspects of this rulemaking and 
specifically comment on the following topics:

A. Neck Float Definition

    1. The proposed rule defines a ``neck float'' as ``an article, 
whether inflatable or not, that encircles the neck, supports the weight 
of the child by securing around the neck (such as by fastening, 
tightening, or other methods), and 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.'' Should the proposed rule use a different definition of neck 
floats?

B. NPR Scope

    1. Are there any other products that should be included within the 
scope of this NPR as neck floats?
    2. Based on FDA's warning about the risk of death due to 
suffocation, strain, and injury to a baby's neck, should the Commission 
strengthen the proposed performance requirements to address other 
hazards, or should the Commission promulgate alternative performance 
requirements?

C. Proposed Requirements To Address Slip-Through Due to Deflation

    1. Are there any other performance requirements CPSC should 
consider to address the hazards associated with slipping through the 
product as a result of deflation?

[[Page 91613]]

D. Proposed Requirements To Address Slip-Through Without Deflation

    1. Are there any other performance requirements CPSC should 
consider to address the hazards associated with slipping through the 
product without deflation?

E. Proposed Requirements To Address Restraint System Failure

    1. Are there any other performance requirements CPSC should 
consider to address the hazards associated with restraint system 
failures?
    2. Should CPSC consider performance requirements to include 
secondary attachment systems? Please, provide details of any secondary 
attachment system that should be considered.

F. Proposed Requirements To Address Submergence Without Slip-Through

    1. Are there any other performance requirements CPSC should 
consider to address the hazards associated with submergence during the 
use of the product without slipping through?

G. Proposed Test Methods

    1. Does the proposed internal air pressure of 0.1 PSIG adequately 
simulate use conditions to address the hazard associated with 
deflation?
    2. Are the proposed neck opening performance requirements adequate 
to address the hazards associated with slip-through?

H. Proposed Warning Label and Instructional Material Requirements for 
Neck Floats

    1. Are the proposed warnings adequate to address the hazards 
associated with neck floats? Should CPSC consider additional warnings? 
Should other warning formats be considered?
    2. Are the proposed instructional material requirements adequate to 
address the hazards associated with neck floats? Should CPSC consider 
requiring additional information to be provided?

I. Initial Regulatory Flexibility Analysis

    1. Significant impact. Is CPSC's estimated cost of redesign to 
achieve compliance accurate? If not, please provide additional 
information and support for your proposed correction. Also, do the 
estimated costs represent more than one percent of annual revenue for 
individual small U.S. manufacturers and importers?
    2. Testing costs. Will third party testing costs for neck floats 
increase as a result of this requirements in this NPR, and if so, by 
how much? Are test labs currently accredited to test for ASTM F963-23 
equipped to test neck floats in accordance with this proposal?
    3. Effective date of 180 days. How much time is required to come 
into compliance with a final rule (including product compliance and 
third-party testing)? Please provide supporting data with your comment, 
particularly from small businesses.
    4. Anti-Stockpiling Provision. Should CPSC finalize with the anti-
stockpiling provision as proposed, or is it not unnecessary for neck 
floats? If an anti-stockpiling provision is included, are there any 
changes that should be included? Please provide supporting data with 
your comment, particularly from small businesses.
    5. Alternatives to reduce the impact on small businesses. Are there 
any alternatives to the rule that could reduce the impact on small 
businesses without reducing safety? Please provide supporting data with 
your comment, particularly addressing small businesses.

J. Feasibility

    1. Are the proposed requirements in this NPR feasible, both 
technically and economically?
    2. What would be the total cost to industry of implementing this 
rule? Please be specific about labor and/or materials costs to redesign 
products, and costs of third-party testing.
    3. Will complying with this rule increase the costs of production 
or the retail price of neck floats? Why? By how much?

XVI. References

Thomas J. Ayres, Madeline M. Gross, Christine T. Wood, Donald P. 
Horst, Roman R. Beyer, & Neil J. Robinson, What is a warning and 
when will it work?, 33 Proceedings of the Human Factors Society 
Annual Meeting, 426-430 (1989).
Dave M. DeJoy, Motivation, in Warnings and Risk Communication 221-
243. (Michael S. Wogalter, David M. Dejoy, & Kenneth R. Laughery 
eds, Philadelphia: Taylor & Francis 1999).
Alan I. Fields, Near-drowning in the pediatric population. 8 Crit. 
Care Clin., 113-129 (1992).
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.
J.P. Frantz & T.P. Rhoades, A Task-Analytic Approach to the Temporal 
and Spatial Placement of Product Warnings. 35 Human Factors: The 
Journal of the Human Factors and Ergonomics Society, 719-730 (1993).
Sandra S. Godfrey & Laurel Allender (1994). Warning Messages: Will 
the consumer bother to look? In Human Factors Perspectives on 
Warnings 53-57. (K.R., Wogalter, M.S. Young, S. Laughery, eds. 
1994).
Stefek Grmec, Matej Strnad, & Dejan Podgorsek, Comparison of the 
characteristics and outcome among patients suffering from out-of-
hospital primary cardiac arrest and drowning victims in cardiac 
arrest, 2 Int. J. Emerg. Med. 7-12 (2009).
Kay Inaba, Suart O. Parsons, & Robert J. Smillie. Guidelines for 
developing instructions, (Boca Raton, FL: CRC Press. 2004).
Kalsher, M.J., & Wogalter, M.S. (2008). Warnings: Hazard Control 
Methods for Caregivers and Children. In R. Lueder & V.J.B. Rice 
(Eds.), Ergonomics for Children: Designing Products and Places for 
Toddlers to Teens (pp. 509-539). New York: Taylor & Francis; Rice, 
V.J.B. (2012). Designing for Children. In G. Salvendy (Ed.), 
Handbook of Human Factors and Ergonomics (4th ed.) (pp. 1472--1483). 
Hoboken, NJ: Wiley.
Laughery, K.R., & Wogalter, M.S. (2011). The Hazard Control 
Hierarchy and its Utility in Safety Decisions about Consumer 
Products. In W. Karwowski, M.M. Soares, & N.A. Stanton (Eds.), Human 
Factors and Ergonomics in Consumer Product Design: Uses and 
Applications (pp. 33-39). Boca Raton, FL: CRC Press; Williams, D.J., 
& Noyes, J.M. (2011). Reducing the Risk to Consumers: Implications 
for Designing Safe Consumer Products. In W. Karwowski, M.M. Soares, 
& N.A. Stanton (Eds.), Human Factors and Ergonomics in Consumer 
Product Design: Uses and Applications (pp. 3-21). Boca Raton, FL: 
CRC Press; Vredenburgh, A.G., & Zackowitz, I.B. (2006). 
Expectations. In M.S. Wogalter (Ed.), Handbook of warnings (pp. 345-
354). Mahwah, NJ: Lawrence Erlbaum Associates.
Kem Laughery Sr. & D.P. Smith, Explicit Information in Warnings, In 
Handbook of Warnings 419-428. (M.S. Wogalter Ed., Mahwah, NJ: 
Lawrence Erlbaum Associates 2006).
L. Murray-Johnson & K. Witte. Looking Toward the Future: Health 
Message Design Strategies, in Handbook of Health Communication 473-
495, (T.L. Thompson, A. Dorsey, K.I. Miller, & R. Parrott Eds., New 
York: Routledge 2003).
J.P. Orlowski JP, M.M. Abulleil, & J.M. Phillips. The hemodynamic 
and cardiovascular effects of near-drowning in hypotonic, isotonic, 
or hypertonic solutions. 18 Ann Emerg Med 1044-9 (1989).
D.M. Riley (2006). Beliefs, attitudes, and motivation, In Handbook 
of Warnings 289-300. (M.S. Wogalter Ed., Mahwah, NJ: Lawrence 
Erlbaum Associates 2006).
W.A. Rogers, N. Lamson, & G.K. Rousseau, Warning research: An 
integrative perspective, 42 Human Factors 102-130 (2000).
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.

[[Page 91614]]

David Szpilman, Joost J.L. Bierens, Anothony J. Handley, & James P. 
Orlowski, Drowning, 22 N Engl. J. Med. 2101-10 (2012). doi: 10.1056/
NEJMra1013317.
E.F. van Beeck, C.M. Branche, D. Szpilman D, J.H. Modell, J.J. 
Bierens. A new definition of drowning: towards documentation and 
prevention of a global public health problem. 11 Bull World Health 
Organ 853-6 (2005). PMID: 16302042 PMCID: PMC2626470.
Stefaan W. Verbruggen, Bernhard Kainz, Susan C. Shelmerdine, Joseph 
V. Hajnal, Mary A. Rutherford, Owen J. Arthurs, Andrew T.M. 
Phillips, & Niamh C. Nowlan, Stresses and strains on the human fetal 
skeleton during development, 15 Journal of The Royal Society 
Interface 138 (2018). https://doi.org/10.1098/rsif.2017.0593.
A.G. Vredenburgh, & I.B. Zackowitz, Human Factors Issues to be 
Considered by Product Liability Experts, in Handbook of Human 
Factors in Litigation (Y.I. Noy & W. Karwowski Eds., Boca Raton, FL: 
CRC Press 2005).
A.G. Vredenburgh & I.B. Zackowitz, Expectations, In Handbook of 
Warnings 345-354. (M.S. Wogalter Ed., Mahwah, NJ: Lawrence Erlbaum 
Associates 2006).
Michael S. Wogalter, Sandra S. Godfrey, Gail A. Fontenelle, David R. 
Desaulniers, Pamela R. Rothstein, & Kenneth R. Laughery. 
Effectiveness of warnings. 5 Human Factors 599-612 (1987).
Michael S. Wogalter & Kenneth R. Laughery, Effectiveness of Consumer 
Product Warnings: Design and Forensic Considerations, in Handbook of 
Human Factors in Litigation (Y.I. Noy & W. Karwowski Eds., Boca 
Raton, FL: CRC Press 2005).

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 proposes 
to amend 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 is revised to read as follows:

    Authority: 15 U.S.C. 2063.

0
2. Amend Sec.  1112.15 by adding paragraph (b)(32)(ii)(LL) 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) * * *
    (ii) * * *
    (LL) 16 CFR part 1250.5, Requirements for Neck Floats.
* * * * *
0
3. The title of part 1250 is revised to read as follows:

PART 1250--SAFETY STANDARD FOR TOYS

0
4. Revise the heading to part 1250 to read as set forth above.
0
5. The authority citation for part 1250 is revised to read as follows:

    Authority: 15 U.S.C. 2056b.

0
6. Revise Sec.  1250.1 to read as follows:

Sec.  1250.1  Scope

    This part establishes a consumer product safety standard for toys.
0
7. 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.  1250.1 and Sec.  1250.2.
    (b) Definitions. In addition to the definitions incorporated by 
reference in Sec.  1250.2(a), 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 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 general 
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, with modifications provided in 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), 
with the modifications provided in this section, prior to any testing 
in accordance with paragraphs (2)-(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 (5,00.1) min.'' shall be removed from section 5.5.4.1 of ANSI/CAN/UL 
12402-9:2022.
    (iv) The words ``1. Twelve new cover/grates'' shall be removed and 
replaced with ``Neck floats'' in section 4.2.1 of ANSI APSP ICC-16.
    (v) The words ``and 4.2.15 through 4.2.17'' shall be removed in 
section 4.2.1 of ANSI APSP ICC-16.
    (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:

[[Page 91615]]

    (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 paragraph (c)(2) 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)(i)--Expected Weight Capacity
----------------------------------------------------------------------------------------------------------------
                               Age of child                                    Weight in kg       Weight in lb
----------------------------------------------------------------------------------------------------------------
0-3 months................................................................                7.7               17.0
4-6 months................................................................                9.5               21.0
7-9 months................................................................               10.6               23.4
10-12 months..............................................................               11.5               25.4
1 up to 2 years...........................................................               17.6               38.8
2 up to 3 years...........................................................               23.2               51.2
3 up to 4 years...........................................................               23.7               52.3
----------------------------------------------------------------------------------------------------------------

    (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 ANSICAN/UL 
12402-9.
    (v) Remove the last two paragraphs ``The water temperature . . . 
immersion period'' from section 5.5.9.3 of ANSI/CAN/UL 12402-9.
    (vi) Remove the last paragraph ``The water temperature . . . and 
pressure conditions'' from section 5.5.9.4 of ANSI/CAN/UL 12402-9.
    (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, with the following 
additions and exclusions:
    (i) The sentence ``At the . . . 2 in. (51 mm).'' of section 6.4.4 
of ASTM F833-21 shall be removed.
    (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) Test method. 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.
    (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 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 paragraph (c)(4) 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.

                               Table 2 to Paragraph (c)(4)(ii)--Neck Opening Test
----------------------------------------------------------------------------------------------------------------
                                         Age range       Head probe mass    Hanging weight M2
       Head probe designation             (months)           M1  (kg)             (lbs)         Distance L  (in)
----------------------------------------------------------------------------------------------------------------
A..................................                0-3                1.5                 3.4              12.45
B..................................                4-6                  2                 4.2               13.8
C..................................                7-9                2.2                4.68              14.65
                                                 10-12                2.4                5.08               15.6
                                                 13-18                2.6                7.76              16.55
D..................................              19-24                2.8                7.76              17.55
                                                 25-30                  3               10.24              18.75
                                                 31-36                  3               10.24               19.4
                                                 37-42                3.2               10.46              20.45
                                                 43-48                3.2               10.46               21.3
----------------------------------------------------------------------------------------------------------------

    (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

[[Page 91616]]

alternating swing cycles shall occur consecutively.
    (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 1 to paragraph 
(d)(1)(i).

Figure 1 to Paragraph (d)(1)(i)--Warning for Neck Floats and Packaging
[GRAPHIC] [TIFF OMITTED] TP20NO24.105

    (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 incorporated by reference in Sec.  1250.2(a) and in a 
distinct color contrasting to the background on which it appears.
    (iv) The warnings shall conform to ANSI/NEMA Z535.4-2023, 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/NEMA Z535.4-
2023 replace the word ``should'' with the word ``shall.''
    (B) In section 7.6.3 of ANSI/NEMA Z535.4-2023, replace the phrase 
``should (when feasible)'' with the word ``shall.''
    (C) In section X of ANSI/NEMA 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 figures 3 and 
4 to paragraph (d)(1)(ii). 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 inflatable neck floats, 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 [DATE OF PUBLICATION OF FINAL RULE] 
and [EFFECTIVE DATE OF FINAL RULE] 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 [DATE OF PUBLICATION OF THE FINAL 
RULE].
    (f) Incorporation by reference. Certain material is incorporated by 
reference into this section 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 material is available for 
inspection at the Consumer Product

[[Page 91617]]

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:
    (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, American National Standard for Suction Outlet 
Fitting Assemblies (SOFA) for Use in Pools, Spas, and Hot Tubs, 
(approved August 18, 2017).
    (ii) [Reserved]
    (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, Standard for Personal Flotation Devices--
Part 9: Test Methods, (published February 11, 2021).
    (ii) [Reserved]
    (3) National Electrical Manufacturers Association (NEMA), 1300 17th 
St. N, Arlington, VA 22209; phone: (703) 841-3200; website: 
www.nema.org.
    (i) ANSI/NEMA Z535.4-23, American National Standard for Product 
Safety Signs and Labels (approved December 14, 2023).
    (ii) [Reserved]
    (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).

Alberta E. Mills,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2024-25446 Filed 11-19-24; 8:45 am]
 BILLING CODE 6355-01-P
```