[Federal Register Volume 89, Number 174 (Monday, September 9, 2024)]
[Proposed Rules]
[Pages 73024-73050]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19286]
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Parts 1112 and 1250
[CPSC Docket No. CPSC-2024-0027]
Safety Standard for Toys: Requirements for Water Beads
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
safety standard sets forth requirements for water bead toys and toys
that contain water beads. The U.S. Consumer Product Safety Commission
(CPSC) proposes to establish additional performance and labeling
requirements for these products. The Commission also proposes to amend
CPSC's list of notice of requirements (NORs) to include water bead toys
and toys that contain water beads.
DATES: Submit comments by November 8, 2024.
ADDRESSES: Submit all comments, identified by Docket No. CPSC-2024-
0027, by any of the following methods:
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-2024-0027, into the ``Search'' box, and follow the
prompts.
FOR FURTHER INFORMATION CONTACT: Matthew Kresse, Project Manager,
Division of Mechanical Engineering, Directorate for Laboratory
Sciences, Consumer Product Safety Commission, 5 Research Place,
Rockville, MD 20850; Telephone 301-987-2222; 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 section 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 (15 U.S.C. 2058). Since 2009, CPSC
has enforced ASTM F963 as a mandatory standard for toys.1 2
In 2017, the Commission established 16 CFR part 1250, Safety Standard
Mandating ASTM F963 for Toys, and it 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 2009, 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 3.1.91 of ASTM F963-23 (Toy): ``Any object designed,
manufactured, or marketed as a plaything for children under 14 years
of age.''
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Section 4.40 of ASTM F963-23 includes requirements for toys,
including but not limited to water beads, that are made of ``Expanding
Materials.'' \3\ However, the requirements currently in ASTM F963-23
for this category of toys appear insufficient to address all known
water bead hazards. Potential hazards for ``Expanding Materials'' in
general include gastrointestinal tract blockage if a child ingests a
product comprised of expanding materials. Hazard mitigation provisions
in ASTM F963-23 include performance requirements, but do not include
warnings or instructional literature specifically tailored to the
[[Page 73025]]
``Expanding Materials'' requirements. While sections 5, 6, and 7 of
ASTM F963-23 provide ``Labeling Requirements,'' ``Instructional
Literature'' requirements, and ``Producer's Markings'' requirements
generally for toys under the standard, none of these requirements is
directed to water beads specifically. Thus, the generalized warnings
and instructional literature requirements do not address all known
hazards.
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\3\ Under ASTM F963, ``Expanding Materials'' are defined as
``any material used in a toy which expands greater than 50% in any
dimension from its as-received state.''
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Incident data, described in section III of this preamble,
demonstrate that children ingest water beads, aspirate and choke on
them, or insert them into the nose or ear, and subsequently suffer
injury or death. Staff's testing of water beads, described in section
IV of this preamble, further demonstrates that tested water beads that
pass the performance requirements in ASTM F963-23 can still pose safety
hazards. Accordingly, this notice of proposed rulemaking (NPR) under
section 106 of the CPSIA proposes additional requirements in part 1250
to establish mandatory requirements specifically for water beads.\4\
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 ASTM
F963.5 6
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\4\ https://www.cpsc.gov/content/FY-2024-Operating-Plan.
\5\ On August 21, 2024, the Commission voted unanimously (5-0)
to publish this NPR.
\6\ The information in this proposed rule is based in part on
information and analysis in the July 31, 2024 Memorandum, Staff's
Draft Proposed Rule for Safety Standard for Toys: Requirements for
Water Beads, available at: https://www.bing.com/ck/a?!&&p=fcf3dff1c5f81972JmltdHM9MTcyNDI4NDgwMCZpZ3VpZD0wMDlhOTVlYi01OTI3LTYwZDYtMzEzYy04MTY1NTg2ODYxNGMmaW5zaWQ9NTIwNA&ptn=3&ver=2&hsh=3&fclid=009a95eb592760d6313c81655868614c&psq=Staff%e2%80%99s+Draft+Proposed+Rule+for+Safety+Standard+for+Toys%3a+Requirements+for+Water+Beads&u=a1aHR0cHM6Ly93d3cuY3BzYy5nb3YvczNmcy1wdWJsaWMvTm90aWNlLW9mLVByb3Bvc2VkLVJ1bGVtYWtpbmctUmVxdWlyZW1lbnRzLWZvci1XYXRlci1CZWFkcy5wZGY_VmVyc2lvbklkPTNreHZnemVNcElSSEphS1Eza25BNEczNnFWWjZFeVNp&ntb=1.
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The Commission is authorized to issue this NPR pursuant to both
section 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 it must promulgate consumer
product safety rules that are more stringent than the existing
standards if the Commission determinates 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 and discuss hazards
associated with water beads. This consultation, including sharing
staff's assessment of hazards and suggested additional performance and
labeling requirements, continued through revision and publication of
ASTM F963-23.
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 water beads
that are not adequately addressed by the current mandatory standard
provisions addressing Expanding Materials: (1) ingestion of water
beads, (2) insertion of water beads into the nose or ear, (3)
aspiration due to water beads, and (4) choking due to water beads. The
Commission proposes adding additional performance requirements to part
1250 to better address these risks. The NPR also proposes establishing
acrylamide level limits for water beads, which may contain this toxic
chemical, and implementing new testing for water beads under part 1250
to limit acrylamide in water beads in response to toxicity hazards when
they enter the body. Finally, the Commission proposes labeling
requirements for water beads under part 1250, including mandating
warnings on products and instructional literature within scope of the
rule.
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 water bead 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 and death
associated with products within the scope of the NPR, and would provide
the highest level of safety that is feasible for such products. The
Commission seeks comment on these issues.
II. The Product
A. Description of the Product
Water beads are various shaped, multi-colored or clear beads
composed of water absorbing polymers, such as polyacrylamides and
polyacrylates, which expand when soaked in liquid such as water. When
first purchased, water beads are small and dehydrated, typically no
larger than 7.0 mm diameter. The beads are often sold in large quantity
packages that may contain up to thousands of beads (depending on
original size) in one package. While in the dehydrated state, with all
water content removed, water beads are typically either hard, solid
beads, or soft-gelled beads. Water beads are designed to be soaked in
water, which allows the beads to absorb the water and expand. After
being soaked in water for periods as short as a few hours for smaller
water beads or two to three days for larger water beads, water beads
multiply in size, as demonstrated in Figure 1. Some water beads can
expand, for example, from 2.0 mm diameter in their dehydrated state to
16.0 mm diameter when fully expanded (shown on the left in Figure 1),
or from 7.0 mm diameter in the dehydrated state to 50.0 mm diameter
when fully expanded (shown on the right in Figure 1). Thus, water beads
have the potential to expand up to 800 percent of their original size.
Once expanded, water beads remain moist even if removed from water but
do not appear to have any adhesive properties that would cause them to
stick together. When broken apart by hand or squeezing, expanded water
beads tend to break into small, fragmented pieces (shown in Figure 2).
[[Page 73026]]
[GRAPHIC] [TIFF OMITTED] TP09SE24.008
Water beads are often sold in bulk or as part of other children's
toys, such as experiment kits and sensory kits, or can be contained
within toy squeeze balls or stress balls. Some water beads are not
marketed as children's toys and are outside of the scope of this
proposed rule.
As noted, CPSC currently regulates water beads under section 4.40
of ASTM F963-23, Expanding Materials, and 16 CFR 1250.2(a). ASTM F963-
23 does not define the term ``water beads,'' but it defines an
``Expanding Material'' in section 3.1.28 as ``any material used in a
toy which expands greater than 50% in any dimension from its as-
received state when tested in accordance with 8.30.'' Section 8.30
directs that the toy must be submerged in deionized water maintained at
37 [deg]C 2 [deg]C for a duration of 72 hours, with the
toy dimensions measured at 6-, 24-, 48- and 72-hour intervals in order
to determine if the toy is an expanding material. CPSC proposes
establishing a definition for ``water bead(s)'' under part 1250 as
``various shaped, water absorbent polymers, such as, but not limited to
polyacrylamides and polyacrylates, which expand when soaked in water.''
CPSC proposes to incorporate ASTM's process for conditioning water bead
in the proposed rule test procedures.
B. Scope of Products Within the NPR
This NPR would apply both to water bead toys and toys that contain
water beads. A toy is ``any object designed, manufactured, or marketed
as a plaything for children under 14 years of age.'' 16 CFR 1250.2(a);
section 3.1.92 of ASTM F963-23. Water bead toys therefore are water
beads marketed as a plaything for children under 14 years of age
(consistent with the definition of a ``toy'' in 16 CFR 1250.2(a)),
while toys that contain water beads are toys that encompass water beads
within the toy and the water beads are not intended to be accessed,
such as a squeeze ball (Figure 5). Commonly, water beads are included
in a variety of toy products, such as toy experiment kits (Figure 3),
toy sensory kits (Figure 4), toy squeeze/sensory balls filled with
water beads (Figure 5), and toy water pellet guns designed to shoot
water bead projectiles (Figure 6). Each product would be subject to the
proposed rule and would need to meet the requirements of a final rule.
[[Page 73027]]
[GRAPHIC] [TIFF OMITTED] TP09SE24.009
Examples of products outside of the scope of this proposed rule are
water beads that are not toys or are not contained in toys and are for
various non-toy uses, such as water beads used for decorative purposes
(e.g., placement in candle holders), in vases or gardens for plant
hydration, as air freshener products or deodorizers for cat litter, and
in first-aid cold packs.
[[Page 73028]]
III. Incident Data and Hazard Patterns
CPSC staff searched two CPSC-maintained databases to identify
incidents and hazard patterns associated with water beads: the Consumer
Product Safety Risk Management System (CPSRMS) \7\ and the National
Electronic Injury Surveillance System (NEISS).8 9 Due to
data availability, the CPSRMS incidents occurred between January 1,
2017, and December 31, 2023, while the NEISS incidents occurred between
January 1, 2017, and December 31, 2022.
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\7\ CPSRMS includes data primarily from three groups of sources:
incident reports, death certificates, and in-depth follow-up
investigation reports. 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. Based on the incident reports, death
certificates, or NEISS injury reports, CPSC field staff conduct in-
depth investigations (on-site, telephone, or online) of incidents,
deaths, and injuries, which are then stored in CPSRMS.
\8\ NEISS is the source of the injury estimates; it is a
statistically valid injury surveillance system. NEISS injury data
are gathered from emergency departments of a sample of hospitals,
with 24-hour emergency departments and at least six beds, selected
as a probability sample of all U.S. hospitals. The surveillance data
gathered from the sample hospitals enable CPSC to make timely
national estimates of the number of injuries associated with
specific consumer products.
\9\ CPSC staff performed multiple searches consisting of a
combination of product codes and narrative or manufacturer/model
keyword searches to find water bead incidents. Staff extracted data
coded under 1381 (Toys, not elsewhere classified), 1395 (Toys, not
specified), 1413 (Greenhouse supplies or gardening supplies
[excluding plant stands, tools, hoses, sprayers and chemicals]),
1616 (Jewelry [excluding watches]), 1682 (Hair curlers, curling
irons, clips & hairpins), 5016 (Balls, other or not specified), 5020
(Pretend electronics, tools, housewares, and appliances), 9101 (No
clerical coding--retailer report), and 9102 (No clerical coding--
retailer report).
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A. CPSRMS Data
From 2017 through 2023, CPSC identified 64 incidents in CPSRMS
associated with the use of water beads. One incident resulted in a
fatality, while 27 incidents led to hospitalization; 15 incidents led
to emergency department (ED) treatment; and seven incidents led to care
by a medical professional. The remaining 14 incident reports noted
possible but uncertain medical treatment, or the level of care was
unreported. Of the reported incidents that indicate a child's age,
children's ages range from 9 months old to 11 years old, with one
incident involving a 22-year-old woman with special needs. Staff
identified the following incident data hazard patterns.
1. Ingestion
In 52 reported incidents, a child ingested or likely ingested at
least one water bead.\10\ Of those reports, 47 incidents involved a
child ingesting at least one water bead, while five incidents involved
a likely ingestion. Where reported, children between the ages of 9
months old and 5 years old ingested or likely ingested the water beads.
Incidents included one death, 23 hospitalizations, 12 ED treatments,
four visits to a medical professional, and 12 instances where the level
of care was uncertain. The fatality involved a child swallowing at
least one water bead. Specifically, in CPSC In-Depth Investigation
(IDI) \11\ 230727CBB1846, a 10-month-old female was discovered
unresponsive after consuming at least one water bead. The medical
examiner determined that the child died from complications after a
water bead expanded and caused a small intestine obstruction.\12\
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\10\ In several cases where a child likely ingested water beads,
a caregiver saw a child put a water bead in his or her mouth, yet
the presumably ingested water bead was not found. The water bead
could have passed naturally, or the child never swallowed the water
bead. Still, medical intervention had been sought in some incidents.
\11\ IDIs are CPSC-generated investigation summaries of events
surrounding product-related injuries or incidents. Based on victim/
witness interviews, the reports provide details about incident
sequence, human behavior, and product involvement.
\12\ Water bead obstruction was measured to be ``approximately
2.8 x 2.8 x 2.8 cm [or 28 x 28 x 28 mm].''
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In 22 reported incidents, an ingested water bead caused a bowel
obstruction because the water bead expanded to a size that did not
naturally pass through the gastrointestinal tract. After ingestion,
water beads do not remain in the stomach for an extended period, which
limits the potential for the water bead to expand in the stomach. Water
beads can expand fully once they pass from the stomach and into the
small intestine because water beads remain in the small intestine for a
longer period and are able to absorb liquid like the water in which
they are designed to absorb and expand. After expansion, water beads
can become too large to pass from the small intestine to the large
intestine and instead form a bowel obstruction.
Swallowing a water bead presents different hazards than swallowing
a smooth, solid object such as a marble because an object like a marble
will not grow after being swallowed. Marbles and other smooth, solid
objects can frequently also be located and identified by x-ray due to
their density, unlike water beads, as discussed further below. Once
located, marbles can be removed endoscopically if reported early
enough, especially if they appear to be too large to pass through the
stomach or the remainder of the digestive track, whereas water beads
can remain small within the stomach and then grow larger, then causing
a small bowel obstruction.
Vomiting and coughing are commonly reported initial symptoms that
occur after a water bead is first ingested.\13\ Lethargy, distress,
dehydration, loss of appetite, fever, fatigue, and abdominal pain are
also reported when an expanded water bead blocks the small intestine.
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\13\ Forrester MB. Pediatric Orbeez Ingestions Reported to Texas
Poison Centers. Pediatr Emerg Care. 2019 Jun;35(6):426-427. doi:
10.1097/PEC.0000000000001227. PMID: 28697162.
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Medical providers may misdiagnose water bead ingestion symptoms
because the symptoms are ambiguous and may be attributable to medical
conditions or sources other than water bead ingestion, such as
gastrointestinal illness. Further, caregivers may be unaware a child
ingested a water bead and, therefore, are unable to report the
ingestion. Children commonly visit medical care providers multiple
times before diagnosis of a water bead ingestion. For example, in IDI
220511HCC3859, a 14-month-old female was initially diagnosed with
gastrointestinal illness after episodes of vomiting. The child was
taken first to a pediatrician and then to a local ED where she was
treated with intravenous fluids and released. Only after the child was
taken to a second ED once her condition worsened was it discovered that
she had ingested a water bead.\14\
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\14\ Size of expanded water bead not provided. Samples of the
product showed full expansion being between 45 mm and 50 mm in
diameter.
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In some cases, small water beads pass naturally, as can be the case
when other small foreign objects are ingested, such as coins and small
toy parts.\15\ For example, in IDI 230707CBB1698, a 3-year-old female
ingested approximately 1,200 small water beads (approximately 1
tablespoon before expansion). The child successfully passed all water
beads through her digestive system with the aid of a mineral oil
enema.\16\
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\15\ Mehmeto[gbreve]lu F. A Retrospective 10-Year Analysis of
Water Absorbent Bead Ingestion in Children. Emerg Med Int. 2018 May
6;2018:5910527. doi: 10.1155/2018/5910527. PMID: 29854461; PMCID:
PMC5960561.
\16\ Size of expanded water beads not provided. However, samples
of the product that staff collected for testing shows full expansion
being between 9.32 mm and 15.20 mm in diameter.
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Medical providers may also not know that ingested water beads can
cause
[[Page 73029]]
bowel obstructions. Therefore, although a medical provider is aware
that a child ingested a water bead, they may send a patient home to
digest or naturally pass the water bead, not knowing that may be
impossible and the ingestion may result in injury or death. Water beads
that do not pass naturally through the digestive tract can sometimes be
removed by endoscopy or colonoscopy. However, such medical procedures
routinely require sedation or general anesthesia, which carry risks of
side effects and complications. For example, in IDI 230613CBB1591, a 2-
year-old male swallowed at least two water beads and was examined and
released from an ED without intervention. The child was later admitted
to a different hospital where a water bead was removed via endoscopy.
The child required a third hospital visit to remove a second water bead
via colonoscopy.\17\
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\17\ Size of expanded water beads not provided.
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Water beads that do not pass naturally or cannot be removed can
result in small bowel obstructions. Children experiencing a small bowel
obstruction have required invasive exploratory laparotomy with small
intestine enterotomy \18\ under general anesthesia to remove any
ingested water beads. For example, in IDI 170802CCC3140, a 13-month-old
female became ill after ingesting a water bead. The water bead expanded
in her small intestine, causing a blockage. She was transported to a
hospital where the water bead was surgically removed under general
anesthesia with an exploratory laparotomy and enterotomy.\19\
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\18\ An exploratory laparotomy is a general surgical operation
where a surgeon opens the abdomen and examines the abdominal organs.
This is coupled with a small intestine enterotomy, which is a
surgical incision to the intestine wall to remove the foreign body.
\19\ Size of expanded water bead not provided. Samples of the
product that staff collected for testing shows full expansion being
between 13.0 mm and 17.50 mm in diameter.
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A delay between the time a caregiver or medical provider discovers
that a child has ingested a water bead and when the child receives
appropriate medical treatment may increase the risk of severe injury or
death. Prompt recognition that a child has ingested a water bead
enables swift medical treatment and removal of the water bead before
the water bead expands, causing gastrointestinal blockages. However,
due to the small size of individual water beads, caregivers may not
know that a child has swallowed a water bead, so early intervention may
not be possible. Even after a child begins to receive medical care,
medical providers may have difficulty locating an ingested water bead
inside the body because water beads are radiolucent.\20\ Radiolucent
water beads are not easily identified using routine x-ray radiography
because they are not dense, appearing dark or black and almost entirely
transparent when the x-ray beam passes through the bead. Incident data
and medical literature report children requiring serial x-rays,
computer tomography (CT) scans, and ultrasounds to accurately diagnose
a water bead bowel obstruction.\21\
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\20\ Radiolucent is defined as being transparent to x-rays.
\21\ Kim HB, Kim YB, Ko Y, Choi YJ, Lee J, Kim JH. A case of
ingested water beads diagnosed with point-of-care ultrasound. Clin
Exp Emerg Med. 2020 Dec;7(4):330-333. doi: 10.15441/ceem.20.041.
Epub 2020 Dec 31. PMID: 33440112; PMCID: PMC7808832.
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Other possible medical outcomes that can occur from a child
ingesting water beads include surgery site infection, sepsis, extended
hospital stays, and follow up surgeries. For example:
In IDI 221107CFE0002, a 9-month-old child required five
surgeries to remove the small bowel obstruction and treat complications
from the initial surgery.\22\
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\22\ The IDI confirms that ``[m]edical imaging revealed a 2.4 cm
[or 24 mm] foreign object blockage.''
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In IDI 220701HFE0002, a 14-month-old child required a
second surgery and a small bowel resection at the site of the previous
enterotomy after the initial surgery failed to remove all ingested
water beads.\23\
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\23\ Size of expanded water beads not provided.
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When reviewing the incident data and conducting laboratory testing,
CPSC staff has not identified evidence of water beads sticking together
once fully expanded within the gastrointestinal tract to form a
congealed water bead mass that is more difficult to pass than
individual beads. In an effort to diligently address all potential
water bead ingestion hazards, though, CPSC is requesting comment on
whether any toy water bead products present adhesive properties that
would allow water beads to stick together.
2. Ear Insertion
CPSRMS contains five reports of victims presenting with water beads
in the ear canal. All five of the incidents required medical
intervention, while two of the five incidents required hospitalization.
When reported, children's ages ranged from 3 years old to 9 years old.
One incident involved a 22-year-old woman with special needs.
Ear canal insertions are not uncommon for healthcare providers to
treat in hospital EDs. Common inserted objects include plastic beads,
small toy parts, pebbles, and pieces of food. Many such cases are
evaluated, then treated with irrigation or suction of the ear canal, or
using surgical instrumentation, such as forceps or hooks.\24\ However,
it is uniquely challenging to remove water beads from the ear
canal.\25\ For example, water beads should not be removed using
irrigation because exposure to water may cause the beads to expand.
Medical providers may attempt to remove water beads with tools, but
water beads can break during a removal attempt or if a removal attempt
fails. Under those circumstances, surgery under sedation or general
anesthesia may be necessary to remove water bead fragments. Further,
because water beads are radiolucent (i.e., transparent to x-rays) and
thus difficult for medical providers to locate and identify,
confirmation that a water bead is in the ear canal before attempting
removal is difficult. Although medical providers can typically see that
something is in the ear canal, x-ray or other imaging technology such
as a CT scan are often used to attempt to confirm the object in the ear
canal is in fact a water bead, as opposed to a cyst or other object.
Because water beads can be difficult to identify on x-rays and the
symptoms are ambiguous, cases of insertions into the ear canal have
been misdiagnosed as ear infections and treated with topical
antibiotics, which can lead to enlargement of the bead and further
damage to the ear canal. For similar reasons regarding enlargement,
irrigation efforts should be avoided.
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\24\ Lotterman S, Sohal M. Ear Foreign Body Removal. [Updated
2022 Nov 28]. In: StatPearls [internet]. Treasure Island (FL):
StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK459136/; Svider PF, Vong A, Sheyn A,
et al. What are we putting in our ears? a consumer product analysis
of aural foreign bodies. Laryngoscope. 2015;125(3):709-714.
doi:10.1002/lary.24935.PubMedGoogle ScholarCrossref.
\25\ Ramgopal S, Ramprasad V, Manole M, Maguire R. Expansile
Superabsorbent Polymer Ball Foreign Body in the Ear. The Journal of
Emergency Medicine, ISSN: 0736-4679, Vol: 56, Issue: 6, Page: e115-
e117. 2019; Sterling M, Murnick J, Mudd P. Destructive Otologic
Foreign Body: Dangers of the Expanding Bead. JAMA Otolaryngol Head
Neck Surg. 2016;142(9):919-920. doi:10.1001/jamaoto.2016.1870;
Zalzal HG, Ryan M, Reilly B, Mudd P. Managing the Destructive
Foreign Body: Water Beads in the Ear (A Case Series) and Literature
Review. Annals of Otology, Rhinology & Laryngology.
2023;132(9):1090-1095. doi:10.1177/00034894221133768.
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Early diagnosis of a suspected water bead insertion is critical for
a good health outcome because water beads are highly damaging when they
expand into middle ear structures.\26\ Young children or patients with
certain special needs may not be able to communicate well
[[Page 73030]]
enough to explain that a water bead is lodged in their ear, which leads
to delayed diagnosis and a poor treatment outcome. For example, in
I2410042A, a 22-year-old female with special needs visited multiple
healthcare facilities before diagnosis of a water bead ear
insertion.\27\ Once a water bead expands into the middle ear structure,
children can experience ear pain, damage to ear structures, and hearing
loss. For example, in IDI 210421HCC1751, a 5-year-old female's ear drum
was injured after a water bead expanded in her ear canal.\28\
Similarly, a case report identifies a 4-year-old female who sustained a
small ear drum perforation. The perforation was subsequently repaired
during a follow up operation.\29\
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\26\ The middle ear is the portion of the ear that is
responsible for transferring acoustic energy to the inner ear.
\27\ Size of expanded water bead not provided.
\28\ Size of expanded water bead not provided.
\29\ Ramgopal S, Ramprasad V, Manole M, Maguire R. Expansile
Superabsorbent Polymer Ball Foreign Body in the Ear. The Journal of
Emergency Medicine, ISSN: 0736-4679, Vol: 56, Issue: 6, Page: e115-
e117. 2019.
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Long-term or permanent hearing loss is possible after a water bead
is inserted into the ear canal. For example, in IDI 230613CBB1590, a 3-
year-old female reported ear pain for several days. She was initially
presumed to have an ear infection and was treated with antibiotics.
Thereafter, she began having seizures and was hospitalized. A water
bead was removed from her middle ear after it expanded and ruptured the
right ear drum.\30\ The child experienced ongoing seizures, hearing
loss, and ear pain at least 14 months after the incident. Another case
report describes a 10-year-old female who suffered permanent hearing
loss after a water bead remained in her ear canal for at least 10
weeks.\31\
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\30\ The IDI confirms that the ``[g]randmother described the
extracted water bead as being the size of a pea.''
\31\ Schulze SL, Kerschner J, Beste D. Pediatric external
auditory canal foreign bodies: a review of 698 cases. Otolaryngol
Head Neck Surg. 2002 Jul;127(1):73-8. doi: 10.1067/mhn.2002.126724.
PMID: 12161734.
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3. Nose Insertion
Four injury incident reports identify children presenting with
water beads in the nasal passage. One incident involved a required
hospitalization. When a child's age was reported, ages ranged from 3
years old to 11 years old.
Water beads can cause severe tissue damage to the nasal mucosa \32\
if left in the nasal cavity for prolonged periods of time, such as days
or weeks.\33\ While it is not uncommon for children to insert foreign
bodies into nasal cavities, children may display significant symptoms
from water beads that are not experienced after inserting other
objects, such as pieces of food, into the nose. Water bead nasal cavity
insertion symptoms include nasal congestion, bleeding, fever, runny
nose, and nasal swelling. Because these symptoms can be related to many
other causes, caregivers or doctors may not realize that they are due
to water beads.
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\32\ The tissue that lines the nasal cavity.
\33\ Han S, Chen Y, Xian X, Teng Y. BMC Pediatrics (2021) 21:273
https://doi.org/10.1186/s12887-021-02740-x.
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While it may be possible to remove a water bead from a nasal cavity
without professional medical intervention or for a water bead to pass
naturally, children may still experience symptoms and negative side
effects after water beads expand in the nose. For example, in
I18C0277A, a 3-year-old male was eventually able to blow out a water
bead that had been in his nose for up to two weeks.\34\ The child had
not told his parents he had inserted the water bead into his nose, but
the parents later described the child as having had a nosebleed,
trouble sleeping, congestion, a small tear in the nasal cavity, and a
low-grade fever lasting three days.
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\34\ Size of expanded water bead not provided.
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Some water bead nose insertions require medical intervention to
remove the water bead, sometimes using nasal endoscopy under general
anesthesia or sedation.\35\ For example, in IDI 180104CBB1236, a 4-
year-old male was placed under general anesthesia at a local hospital
and underwent a nasal endoscopy. The child inserted an unknown number
of water beads into his nose. He was successful in blowing out most of
the water beads, but a nasal endoscopy revealed a single water bead in
the nasal passages. Removal was unsuccessful due to bleeding, so the
child was placed under general anesthesia to remove the remaining water
bead.\36\
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\35\ Id.
\36\ Size of expanded water bead not provided.
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4. Aspiration
Aspiration is the entry of a foreign body, excess saliva, food, or
stomach contents from the upper respiratory tract into the lower
respiratory tract, which includes the trachea, bronchi, bronchioles,
and lungs. Two reported incidents of aspiration involved a child
swallowing and inhaling a water bead that then entered and blocked the
child's airway. One incident required ED treatment and the other
required hospitalization.
Sudden inhalation of small objects can cause aspiration into the
respiratory tract.\37\ Depending on the object's size, aspirated
foreign bodies tend to pass through the trachea and bronchi mainstream
and lodge in areas of the tracheobronchial tree.\38\ If a water bead
becomes lodged in a child's upper airway, particularly after expansion,
the child may experience airway obstruction or acute respiratory
distress, which may be fatal. Examples of aspirations include:
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\37\ Abdulmajid, O., Ebeid, A.M, Motaweh, M.M., Kleibo, I.S.
Aspirated foreign bodies in the tracheobronchial tree. Thorax
31:365-640, 1976; Aytac, A. Ikizler, C. Inhalation of foreign bodies
in children. J. Thoracic & Cardiovasc. Surgery 74(1):145-151, 1977;
Blazer, S. Naveh, Y., Friedman, A. Foreign body in the airway--a
review of 200 cases. Am. J. Diseases of Children 134(1):68-71, 1980;
Cohen, S.R., Herbert, W.I. Lewis, G.B. Geller, K.A. Foreign bodies
in the airway--five-year retrospective study with special reference
to management. Ann. Otol. 89:437-442, 1980.
\38\ The tracheobronial tree is composed of the trachea, the
bronchi, and the bronchioles that transport air from the environment
to the lungs for gas exchange.
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In I2310047A, a 20-month-old male aspirated a water bead,
which obstructed his airway, necessitating medical intervention.\39\
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\39\ Size of expanded water bead not provided.
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In IDI 201130CCC3196, an 18-month-old male aspirated water
beads, which led to an airway obstruction. The child was admitted to
the hospital for a bronchoscopy \40\ under general anesthesia, where
several water beads were removed from his airway.\41\
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\40\ A bronchoscopy is an endoscopic technique to visualize the
inside of the airways for diagnostic and therapeutic purposes.
\41\ IDI included a photo of an expanded water bead from the toy
alongside a dime coin to reflect the bead's approximate size. While
the expanded sizes of the removed beads are unknown, the mother
provided a photo of before and after expansion in water. The photo
shows an expanded bead with a diameter about the size of a dime, and
much larger than an unexpanded bead next to it. As discussed in
section IV of this preamble below, limiting the expansion potential
of water bead toys to no more than 50 percent of the original size
will help reduce damage from aspiration.
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When a child aspirates a water bead, the initial symptoms range
from minor initial choking spells, coughing, or wheezing, to
unconsciousness as the water bead obstructs more of the airway for a
longer period of time, resulting in the child being unable to breathe
and transmit oxygen to the brain. Death versus injury to the child
after a water bead aspiration is dependent upon the degree of bronchial
obstruction and the time interval between inhalation and extraction of
the water bead. Early diagnosis of water bead aspiration allows for a
greater likelihood of successful removal and better potential treatment
outcome because the water bead may not have yet expanded. Because water
beads are radiolucent, they can be difficult to locate within the body
and thus difficult to remove,
[[Page 73031]]
particularly when the airway obstruction is not complete.
5. Choking
One reported incident identified that a child had choked on a water
bead. Choking occurs when a foreign body fully or partially obstructs
the airway to compromise oxygen supply to the lungs.\42\ Physical
characteristics of objects that pose a choking hazard include, for
example, large size, round shape, and smooth texture.
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\42\ Baker, S.P. Childhood asphyxiation by choking or
suffocation. JAMA 244(12):1343-1346, 1980.
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The hazard pattern for choking does not depend upon expansion after
the water bead enters the body. Caregivers commonly place water beads
in water for prolonged periods of time so the beads can fully expand in
advance of a child's playtime. For example, in IDI 180104CBB1236, the
child's father placed a number of water beads in water so that they
``would grow and be ready to use in the morning.'' Children may then
attempt to swallow the expanded beads. Large, expanded water beads pose
a significant choking hazard because they are spherical objects, which
can easily roll to the back of the throat and form an air-tight seal
with the elastic lining of the airway, thereby causing a complete
blockage of the air way and inability to breath.\43\ The throat muscles
can contract and tightly grip a water bead, which can make removal
difficult without medical intervention. If an object completely
obstructs the airway at or above the level of the trachea, the rapid
loss of oxygen to body tissues can cause irreversible brain damage or
death within minutes. If the airway is not completely blocked, the gag
reflex will force the object to the back of the throat (the opposite of
swallowing) and the cough reflex will bring in air to force the object
from the airway in response to choking.
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\43\ Chang DT, Abdo K, Bhatt JM, Huoh KC, Pham NS, Ahuja GS.
Persistence of choking injuries in children. Int J Pediatr
Otorhinolaryngol. 2021 May;144:110685. doi: 10.1016/
j.ijporl.2021.110685. Epub 2021 Mar 21. PMID: 33819896; Hayes NM,
Chidekel A. Pediatric choking. Del Med J. 2004 Sep;76(9):335-40.
PMID: 15510972.
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B. National Injury Estimates From NEISS
Based on NEISS data, CPSC estimates 6,300 injuries (sample size =
250, coefficient of variation = 0.27) related to water beads were
treated in U.S. hospital EDs over the six-year period from 2017 through
2022.\44\ Of the 250 sample NEISS cases, none were fatal. About 42
percent of the estimated injuries involved children ages 2 through 4
years old, while about 15 percent of the estimated injuries involved
children under the age of 2 years old. The youngest child was 7 months
old. Forty-one (41) percent of those injured were male, while 59
percent were female. Regarding patient disposition, 95 percent were
treated at the hospital ED and released; 3 percent were held for
observation; 2 percent were admitted for hospitalization; and less than
1 percent left the hospital without care. The following hazard patterns
were identified:
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\44\ The estimated injuries for this NPR are less than the
estimate presented in the public guidance on water beads that can be
found on the Commission's website at https://www.cpsc.gov/Safety-
Education/Safety-Education-Centers/Water-Beads-Information-
Center#:~:text=CPSC%20urges%20parents%20and%20caregivers,
seek%20medical%20treatment%20right%20away. The difference is mainly
due to the NPR excluding incidents with hazard patterns related to
rashes or other allergic reactions and incidents involving water
bead gel blaster projectiles, which commonly involve eye injury and
some of which may not involve children's toys in the scope of this
proposed rule.
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Ingestion (48 percent): the reports stated that the child
ingested or swallowed a water bead, possibly ingested a water bead, or
had put a water bead in his or her mouth. In all sample cases, the
youngest child was 7 months old. Three (3) percent of all estimated
injuries due to water bead ingestion involved hospitalizations.
Ear insertion (36 percent): the reports stated that the
child either inserted a water bead into their ear or presented with a
water bead stuck in the ear with uncertainty as to how the water bead
became inserted. In all sample cases, the child was between the ages of
two and 15 years old.
Nose insertion (15 percent): the reports stated that the
child either inserted the water bead into their nose or presented with
the water bead stuck in the nose with uncertainty as to how the water
bead became inserted. In all sample cases, the child was between the
ages of two and 10 years old.
Other (<1 percent): the remaining reports identified one
injury from aspiration and one from eye insertion.
C. Overview of Hazards in Relation to Child Supervision and Behavior
Water bead ingestion, nasal and ear insertion, choking and
aspiration can occur in seconds. Many incidents are not witnessed
because the caregiver was not directly looking at the child when the
ingestion, insertion, initial choking or aspiration occurred. Research
indicates that toddlers and preschoolers (ages 2 years old through 5
years old) are out of view of a supervisor for about 20 percent of
their awake time at home and are not within visual or hearing range for
about 4 percent of awake time at home.\45\ A study of 100 parents found
that the mean amount of time parents were willing to leave a child
unsupervised in low-risk areas, such as a living room, was six minutes
before the child was old enough to crawl and four minutes after the
child was old enough to crawl, before the child was 2 years old.\46\
Consumers reasonably may not know water beads are hazardous,
particularly because they are marketed for children's play.
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\45\ Morrongiello, B. A., Corbett, M., McCourt, M., & Johnston,
N. (2006). Understanding unintentional injury-risk in young children
I. The nature and scope of caregiver supervision of children at
home. Journal of Pediatric Psychology, 31(6): 529-539.
\46\ Garzon, D.L., Lee, Dr. R.K., and Homan, S.M. (2007)
``There's No Place Like Home: A Preliminary Study of Toddler
Unintentional Injury.'' Journal of Pediatric Nursing, 22, 368--375.
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Research demonstrates that infants and toddlers are likely to mouth
objects within reach. Mouthing of non-food items is a normal part of
children's exploratory behavior that contributes to incidents of
choking and poisoning.\47\ This behavior is part of the reason for the
ban on small parts for toys intended for children younger than 3 years
of age, for example, and the mandatory small-parts warning for toys and
games intended for children ages 3 years old to 6 years old. 16 CFR
part 1501. Mouthing non-food items tends to decrease as a child's age
increases; however, it is not uncommon for children over the age of 3
years old to experience choking or ingestion episodes with objects
other than food.\48\ Children are prone to ingest or insert small,
smooth, colorful objects, like water beads or toy parts.\49\
Unintentional foreign body ingestion is a leading causes for nonfatal
ED visits in children younger than 9 years old.\50\
[[Page 73032]]
Management and treatment for childhood accidental ingestion is well
documented in pediatric medical literature.\51\
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\47\ Tulve, N., Suggs, J., McCurdy, T., Cohen-Hubal, E., & Moya,
J. (2002). Frequency of mouthing behavior in young children. Journal
of Exposure Analysis and Environmental Epidemiology. 12, 259-264.
\48\ A-Kader. (2010) Foreign body ingestion: children like to
put objects in their mouth. World J Pediatrics, Vol 6 No 4 .
November 15, 2010. www.wjpch.com; Orsagh-Yentis D, McAdams RJ,
Roberts KJ, et al. (2019). Foreign-Body Ingestions of Young Children
Treated in US Emergency Departments: 1995-2015. Pediatrics.
143(5):e20181988; Reilly, J. (1992, Fall). Airway Foreign Bodies:
Update and Analysis. Int Anesthesiol Clin.30(4):49-55; Altman, A.,
Ozanne-Smith, J. (1997). Non-fatal asphyxiation and foreign body
ingestion in children 0-14 years. Injury Prevention. 3:176-182.
\49\ Svider, P.F., Vong, A., Sheyn, A., Bojrab, D.I., Hong, R.
S., Eloy, J.A., and Folbe, A.J. (2015). What are we putting in our
ears? A consumer product analysis of aural foreign bodies. The
Laryngoscope. 125, 709-714; Heim, SW, & Maughan, K.L. (2007).
Foreign Bodies in the ear, nose, and throat. American Academy of
Family Physicians, 76, p.1186-1189.
\50\ Centers for Disease Control and Prevention. Web-based
Injury Statistics Query and Reporting System (WISQARS) [Online].
(2003). National Center for Injury Prevention and Control, Centers
for Disease Control and Prevention. Available from: URL:
www.cdc.gov/ncipc/wisqars. [10/1/2022].
\51\ Kay, M., & Wyllie, R. (2005). Pediatric foreign bodies and
their management. 7(3):212-8; Lee, J.H., (2018) Foreign Body
Ingestion in Children. Clinical Endoscopy, 51:129-136; Kramer et
al., 2015; Conners GP,& Mohseni M. Pediatric Foreign Body Ingestion.
[Updated 2021 Jul 18]. In: StatPearls [internet]. Treasure Island
(FL): StatPearls Publishing; 2022 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK430915/--(accessed 4/12/22) Pediatric
Foreign Body Ingestion--StatPearls--NCBI Bookshelf (nih.gov).
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D. Availability of Incident Data
Upon publication of this NPR in the Federal Register, CPSC staff
will make available for review and comment the CPSRMS and NEISS
incident reports relied upon and discussed in the NPR, to the extent
allowed by applicable law, along with the associated IDIs. The data
will be made available by submitting a request to: https://forms.office.com/g/gSZi1gHic8. 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].
E. Recalls
From December 2012 through March 2024, the Commission's Office of
Compliance and Field Operations conducted five recalls and issued two
unilateral press release warnings \52\ regarding water bead products.
Table 1 below summarizes the seven announcements, including the
announcement date, firm/brand, hazard(s), approximate number of units
affected, number of reported incidents/injuries, and press release
number. The announcements involved one death and five reported
injuries, and affected approximately 166,000 units.
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\52\ A unilateral press release is a product-related safety
warning issued by CPSC that is not issued jointly with a recalling
company.
\53\ When the press release delineates the approximate number of
recalled units, number of incidents, or number of injuries by
country, this summary only includes the reported United States
values.
\54\ https://www.cpsc.gov/Recalls/2012/dunecraft-recalls-water-balz-skulls-orbs-and-flower-toys-due-to-serious-ingestion.
\55\ https://www.cpsc.gov/Recalls/2013/Be-Amazing-Toys-Recalls-Monster-Science-and-Super-Star-Science-Colossal-Water-Balls.
\56\ https://www.cpsc.gov/Recalls/2013/Eco-Novelty-Recalls-Jumbo-Size-and-Jumbo-Multipurpose-Cosmo-Beads-Toys.
\57\ https://www.cpsc.gov/Recalls/2014/Doodlebutt-Recalls-Jelly-BeadZ-Jumbo-BeadZ-and-Magic-Growing-Fruity-Fun-Toys.
\58\ https://www.cpsc.gov/Recalls/2023/Buffalo-Games-Recalls-Chuckle-Roar-Ultimate-Water-Beads-Activity-Kits-Due-to-Serious-Ingestion-Choking-and-Obstruction-Hazards-One-Infant-Death-Reported-Sold-Exclusively-at-Target.
Table 1--Summary of Water Bead Announcements
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Announcement date Firm/brand Hazard affected Number of incidents Press release
units (injuries & deaths) \53\ No.
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December 17, 2012..................... Dunecraft Inc............ Serious Ingestion Hazard...... 94,799 1 incident (1 injury, 0 \54\ 13-071
deaths).
July 31, 2013......................... Be Amazing! Toys......... Serious Ingestion Hazard...... 14,200 None Reported........... \55\ 13-254
September 10, 2013.................... Eco-Novelty Corp......... Serious Ingestion Hazard...... 3,500 None Reported........... \56\ 13-278
December 12, 2013..................... Doodlebutt............... Serious Ingestion Hazard...... 1,500 None Reported........... \57\ 14-056
September 14, 2023.................... Buffalo Games, Inc....... Serious Ingestion, Choking and 52,000 2 incidents (1 injury, 1 \58\ 23-286
Obstruction Hazards. death).
March 19, 2024........................ Jangostor Brand.......... Chemical Toxicity Hazard-- Unknown 2 incidents (2 injuries, \59\ 24-163
Violation of Federal Ban of 0 deaths).
Hazardous Substances.
March 19, 2024........................ Tuladuo Brand............ Chemical Toxicity Hazard-- Unknown 1 incident (1 injury, 0 \60\ 24-162
Violation of Federal Ban of deaths).
Hazardous Substances.
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IV. Review of Voluntary Standards--ASTM F963 and EN 71-1
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\59\ https://www.cpsc.gov/Newsroom/News-Releases/2024/CPSC-Warns-Consumers-to-Immediately-Stop-Using-Jangostor-Water-Beads-Due-to-Chemical-Toxicity-Hazard-Violation-of-Federal-Ban-of-Hazardous-Substances-Sold-on-Amazon-com.
\60\ https://www.cpsc.gov/Newsroom/News-Releases/2024/CPSC-Warns-Consumers-to-Immediately-Stop-Using-Tuladuo-Water-Bead-Sets-Due-to-Chemical-Toxicity-Hazard-Violation-of-Federal-Ban-of-Hazardous-Substances-Sold-on-Amazon-com.
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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.
ASTM F963 defines ``Expanding Materials'' as ``any material used in
a toy which expands greater than 50% in any dimension from its as-
received state.'' Section 4.40 of ASTM F963-23 addresses potential
hazards associated with expanding materials by requiring that toys and
removable components of toys composed of expanding materials which,
first, fit entirely within a small parts cylinder while in the toy's
as-received size condition, then must, after expansion, completely pass
through a 20.0 mm diameter gauge while applying a force of up to 4.5
lbf (pound-force).
Water beads that expand up to 20.0 mm diameter would meet the ASTM
F963-23 ``Expanding Material'' requirements because they would pass
through the gauge, but water beads larger than 20.0 mm diameter would
likely fail the requirements because the water beads would fragment
once force is applied, as described below in more detail. Yet, as
explained in section III of this preamble, incident data show that
water beads both larger and smaller than 20.0 mm diameter are
hazardous.
Another voluntary standard used primarily in the European Union, EN
71-1, Safety of Toys--Part 1: Mechanical and Physical Properties, also
provides requirements for expanding materials. Section 3.24 of EN 71-1
defines an ``expanding material'' as a ``material, the volume of which
expands when exposed to water.'' Section 4.6 of EN 71-1 establishes
performance requirements for expanding materials in toys or components
of toys which fit entirely in a 31.7 mm diameter small parts cylinder,
the same size as CPSC's small parts cylinder reflected in Figure 9
below, and states they shall not expand more than 50 percent in any
dimension when measured after being submerged in demineralized water
for 24, 48 and 72 hours. If the expansion in any dimension is more than
50 percent, then the toy does not comply with the expanding material
requirement. For example, water beads with an unexpanded diameter of
2.0 mm and expand larger than 3.0 mm diameter would pass through the
small parts cylinder in their dehydrated state but expand by more than
50 percent, thus failing the EN 71-1 requirements. Additionally, EN 71-
9, Safety of Toys--
[[Page 73033]]
Part 9: Organic Chemical Compounds--Requirement \61\ provides a test
method and a concentration limit for a potentially hazardous chemical,
called acrylamide, in toys. The EN standard states that the acrylamide
concentration limit has been ``calculated based on long-term licking,
sucking and chewing of toys that are intended or likely to be mouthed
for a significant amount of time. Examples are teethers, rattles and
other hand-held soft plastic toys for young children.''
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\61\ EN 71-9 provides requirements and test methods for organic
chemical compounds, such as acrylamide. Previously cited EN 71-1
provides requirements and test methods for mechanical and physical
properties, such as expansion limits. Both are part of the standard
EN 71.
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Acrylamide limitations in EN 71-9 were developed to address
acrylamide exposure following long-term licking, sucking and chewing of
toys that are intended to be mouthed. In contrast, water bead toys
addressed in this NPR are not intended to be mouthed, nor are they
likely to be mouthed for a significant amount of time. The hazards this
NPR works to address are ingestion, insertion, choking, and aspiration,
not mouthing. Therefore, CPSC staff proposes mandating a different
acrylamide limit and test method, intended to address the hazards
outlined in the NPR, which is discussed in section V of this preamble.
A. Assessment of Current ASTM F963-23 Performance Requirements
The test method for ``Expanding Materials'' described in section
8.30, Expanding Materials--Test Method of ASTM F963-23 requires that an
expanding material, such as a water bead, first be submerged in
deionized water for up to 72 hours in order to reach its largest
expansion size. The product is then tested to check whether, at its
largest expanded size, the water bead can pass through a gauge with a
20.0 mm (+0.0/-0.1 mm) diameter hole, as is seen in Figure 7, when
applying a force of 4.5 lbf (pound-force) to the water bead in the
direction of the hole via a rod having a hemispherical end diameter of
10.0 mm.
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\62\ Reprinted, with permission, from ASTM F963-23 Standard
Consumer Safety Specification for Toy Safety, copyright ASTM
International, 100 Barr Harbor Drive, West Conshohocken, PA 19428. A
copy of the complete standard may be obtained from ASTM
International, www.astm.org. A free, read-only copy of the standard
is available for viewing on the ASTM website at https://www.astm.org/READINGLIBRARY/.
[GRAPHIC] [TIFF OMITTED] TP09SE24.010
CPSC staff assessed the current ASTM test method in section 8.30 of
ASTM F963-23 and found that using a rod to apply force to an expanded
water bead to determine whether the water bead can fit through a test
gauge does not realistically represent the compression forces exerted
on a water bead when it is swallowed. The use of a 10.0 mm diameter rod
to apply a force when conducting the test causes fragmentation of the
water bead (Figure 8), which would be considered a ``pass'' pursuant to
the ASTM test standard. Yet, incident data confirms water beads remain
whole after being swallowed, thus creating a gastrointestinal tract
blockage.\63\ Because the force that the rod exerts can damage the
expanded water bead and cause fragmentation, Commission staff has
assessed that the current ASTM test method is inadequate to effectively
test water beads for an ingestion hazard.
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\63\ Examples include the following IDIs: 230727CBB1846,
230707CBB1698, 230613CBB1591, 170802CCC3140 and 221107CFE0002.
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[[Page 73034]]
[GRAPHIC] [TIFF OMITTED] TP09SE24.011
Staff also analyzed the 20.0 mm (+0.0/-0.1 mm) diameter gauge
specified in section 4.40 of ASTM F963-23 and determined that in light
of incident data demonstrating how ingestion hazards occur, the gauge
diameter should be reduced. The 20.0 mm diameter gauge used in ASTM
F963 was selected based on the dimension of the pyloric sphincter \64\
within the gastrointestinal tract of an 18-month-old child because, at
the time the ``Expanding Materials'' requirements were created, the
pyloric sphincter was thought by the drafters to be the most likely
site where the gastrointestinal blockage would occur. As explained
below, however, objects that can cause a gastrointestinal blockage are
more likely to occur at either the gastric outlet part of the stomach
or the ileocecal valve at the end of the small intestine.\65\
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\64\ The pyloric sphincter is the valve located at the bottom of
the stomach which opens to allow food to pass from stomach to the
small intestine.
\65\ The ileocecal valve is a sphincter muscle situated at the
junction of the ileum (last portion of the small intestine) and the
colon (first portion of the large intestine).
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Water beads, like other foreign bodies and food, do not remain in
the stomach for long. Therefore, water beads generally do not expand
fully in the stomach but pass through the pyloric sphincter and into
the small intestine. Water beads continue to expand in the small
intestine, where they spend more time and are exposed to liquid that
facilitates expansion. After the water beads expand fully in the small
intestine, they are unable to pass through the ileocecal valve and into
the large intestine, therefore causing a gastrointestinal blockage.
CPSC staff evaluated the relevant recent incident data and advises that
because the ileocecal valve is often the site of the gastrointestinal
blockage when a child ingests a water bead, the ileocecal valve is a
more appropriate anatomical structure on which to base the diameter of
the funnel test gauge than the pyloric sphincter. Literature on
ileocecal valve size indicates valve size will vary based on age and
natural variation within the population, 66 67 but the
Commission has not identified reliable authorities providing ileocecal
valve sizes for children between the ages of 9 months old and 3 years
old. Accordingly, as explained in section V below, the Commission has
based this proposed rule on incident data.
---------------------------------------------------------------------------
\66\ Tang SJ, Wu R. Ilececum: A Comprehensive Review. Can J
Gastroenterol Hepatol. 2019 Feb 3;2019:1451835. doi: 10.1155/2019/
1451835. PMID: 30854348; PMCID: PMC6378086.
\67\ Silva AC, Beaty SD, Hara AK, Fletcher JG, Fidler JL, Menias
CO, Johnson CD. Spectrum of normal and abnormal CT appearances of
the ileocecal valve and cecum with endoscopic and surgical
correlation. Radiographics. 2007 Jul-Aug;27(4):1039-54. doi:
10.1148/rg.274065164. PMID: 17620466.
---------------------------------------------------------------------------
Section 4.40 of ASTM F963-23 also requires that ``[t]oys, and
removable components of toys, which fit entirely inside the small parts
cylinder in their as-received condition, and which are composed of an
expanding material, shall completely pass through the gauge when
tested.'' The referenced small parts cylinder is from 16 CFR 1501.4 and
section 4.6.1, Small Objects of ASTM F963-23, which provides general
safety requirements. Under section 4.6.1, toys intended for children
under 36 months of age, ``including removable [components], liberated
components, or fragments of toys[,] shall [not] be small enough without
being compressed to fit entirely within [the small parts cylinder].''
This requirement is to minimize choking, ingestion, or inhalation
hazards. Most water bead products are intended for children older than
36 months of age, however, and therefore are not subject to
requirements in section 4.6.1 of ASTM F963-23.
Finally, to address the potential presence of toxic chemicals in
toys, section 4.3 of ASTM F963-23 requires that all toys must comply
with the Federal Hazardous Substances Act (FHSA) toxicity and hazardous
substances standards. Though there is this generalized FHSA compliance
requirement for all of ASTM F963-23, section 4.40, Expanding Materials
of ASTM F963-23 does not specifically mandate testing for hazardous
chemicals. Water beads are composed of absorbent polymers, which can
contain acrylamide monomer--a chemical that can be hazardous when
ingested.\68\ ASTM F963-23 does not have any test methods or limits for
acrylamide monomer in water beads. Therefore, the current ASTM standard
is inadequate to provide the highest level of safety feasible to ensure
that the chemicals in water beads are non-toxic. Because water beads
containing high levels of acrylamide monomer are toxic, the NPR
proposes to establish content limits and test methods to address the
toxicity hazard.
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\68\ Per the Federal Hazardous Substances Act (FHSA) (16 CFR
1500.3(c)(2)(i)(A)), a substance with a median lethal dose
(LD50) between 50 and 5000 mg/kg in rats is ``toxic'' for
acute toxicity. The reported oral LD50 values for
undiluted acrylamide in rats range from 150 to 413 mg/kg. See ATSDR
Toxicological Profile for Acrylamide, available at https://www.atsdr.cdc.gov/ToxProfiles/tp203.pdf.
---------------------------------------------------------------------------
B. Assessment of Current EN 71-1 Expanding Materials Requirements
The test method for ``Expanding Materials'' described in section
8.14 of EN 71-1 requires that an expanding material, such as a water
bead, that fits entirely in a small parts cylinder first be measured,
using calipers,\69\ to determine its original size in each dimension.
Next, the expanding material must be submerged in demineralized water
for up to 72 hours to reach its largest expansion size. After
expansion, the water bead must be measured again to determine if it has
expanded more than 50 percent of its original size in any dimension. If
the water bead has expanded more than 50 percent, the expanding
material requirements are not met.
---------------------------------------------------------------------------
\69\ An instrument used to measure the dimensions of an object.
---------------------------------------------------------------------------
The Commission preliminarily determines that the current EN 71-1
expanding material requirement is inadequate as a stand-alone
requirement. Staff assesses that an additional maximum size requirement
is
[[Page 73035]]
necessary because as currently written, for example, the standard would
allow for a water bead having a diameter of 9.0 mm to expand to 13.5 mm
diameter. While this expansion would not be more than 50 percent of the
water bead's original size, therefore meeting the EN 71-1 expanding
material requirements, the expanded water bead would likely cause a
gastrointestinal block if a child ingested it. Indeed, as described in
section III of this preamble,\70\ a water bead with 13.0 mm diameter is
known to have caused a gastrointestinal block in a 13-month-old female.
If the only limitation on compliant water beads was that they do not
expand more than 50 percent, the ingestion hazard would still be
present.
---------------------------------------------------------------------------
\70\ IDI 170802CC3140.
---------------------------------------------------------------------------
The 50 percent expansion limit is, however, a beneficial additional
safety provision when combined with staff's proposed diameter limit for
fully expanded beads. In particular, requiring a reduction in the
maximum expansion of water beads reduces the potential damage to inner
ear structures or nasal tissue if a child inserts a water bead into
their ear or nose because more damage occurs when the water beads are
intended to expand to bigger sizes and therefore exert more pressure on
the body parts that contain them. Reducing expansion potential will
also reduce the degree of bronchial obstruction created when a water
bead is aspirated.
C. Assessment of Current ASTM F963-23 Labeling Requirements
Section 5.0, Labeling Requirements of ASTM F963-23 contains general
labeling requirements that apply to toys, including water beads or toys
containing water beads. Still, the requirements in section 5.0 are not
specifically referenced in section 4.40, Expanding Materials. Only
broad warning statements for small part choking hazards and small ball
hazards are required for ``Expanding Materials.'' While the warning
statements address general choking hazards, they do not address or
inform about injuries (e.g., gastrointestinal blockage and nasal tissue
damage) and deaths that have occurred when water beads expand after
being swallowed or inserted.
D. 2024 Proposed Draft Revisions to ASTM F963
On January 22, 2024, and March 25, 2024, CPSC staff met with the
ASTM F15.22 Emerging Hazards Task Group to discuss a possible revision
of ASTM F963 to include specific requirements for water beads. CPSC
staff and ASTM discussed incident information and the ASTM 20.0 mm
diameter test gauge compared to CPSC's proposed funnel test gauge shown
below in Figure 10 and Figure 11. On July 9, 2024, ASTM shared a draft
proposal to revise section 4.40 of ASTM F963-23 to include water bead-
specific requirements. On July 18, 2024, ASTM submitted a ballot for
vote on the proposal, which is available until August 19, 2024.
CPSC staff has reviewed the 2024 draft proposal, finding that it is
inadequate to address all known water bead hazards. In the proposed
revision, the draft would define a water bead as a ``spherical or
spheroid water-absorbent object, intended to expand in size when
immersed in a liquid.'' This draft revision would apply to water beads
intended to be accessible in dehydrated state and water beads in the
expanded state. If the water bead is already expanded, the water bead
would be given time to dehydrate before testing. These draft
requirements would not apply to water beads that are not intended to be
accessible, such as water beads within a squeeze ball.
ASTM's draft performance test proposal requires first measuring the
diameter of a dehydrated water bead and then measuring the maximum
amount of expansion after soaking the water bead in deionized water at
37 [deg]C. If the maximum expansion is greater than 50 percent in
diameter, then the water bead will be placed in a funnel gauge like
that in Figure 10 to determine whether it can pass through the gauge
under a certain external pressure. If the maximum expansion of the
water bead is less than or equal to 50 percent in diameter, no further
testing is required. Based on incident data, the ASTM draft proposes
use of a funnel test gauge with a 12.0 mm diameter (+0.0/-0.1 mm) as a
performance requirement. When attempting to pass an expanded water
bead, the proposed test includes applying a force of 0.1 lbf to the
water bead in the direction of the 12.0 mm diameter hole with a 10.0 mm
diameter rod having a flat end. The ASTM draft states that ``a water
bead material which breaks or loses integrity during this test is
considered to be acceptable,'' and therefore if the fragmented pieces
pass through the funnel, the product still would meet the draft
requirement even if the unbroken water bead was larger than 12.0 mm.
The draft does not include acrylamide limits or revised labeling
requirements.
CPSC staff has reviewed the draft ASTM proposal and finds that a
gauge size of 12.0 mm is inadequate to address known hazards from water
beads. The draft proposes 12.0 mm in consideration of one incident,\71\
which describes a 13-month-old female who was unable to pass a water
bead presumed to be as small as 13.0 mm diameter. However, while staff
knows a 13.0 mm sized bead can cause a blockage in a child, this
incident does not establish the size of the largest water bead that can
safely pass. Further, the draft ASTM requirements leave the potential
for a dehydrated water bead of 13.0 mm diameter capable of expanding to
19.5 mm diameter without requiring testing because the water bead would
not expand to more than 50 percent of its original size. As explained
elsewhere in this preamble, fragmentation of the water bead during
testing is not representative of incident data, and testing of water
beads within toys, such as squeeze balls, appears necessary to address
accessibility incidents. Therefore, while the draft ASTM proposal may
be an improvement beyond the current ``Expanding Materials''
requirements, it would not adequately address known water bead hazards
even if adopted.
---------------------------------------------------------------------------
\71\ IDI 170802CCC3140.
---------------------------------------------------------------------------
V. NPR Description of Proposed Provisions and Justification
Based on incident data described in section III of this preamble
and CPSC staff's engineering, health sciences, and human factors
assessments, the NPR proposes creating a new section 1250.4 to 16 CFR
part 1250, Safety Standard Mandating ASTM F963 for Toys, adding
performance and labeling requirements for water beads to better address
the known water bead hazards and to provide the highest level of safety
feasible for such products. 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.
A. Performance Requirements To Address Ingestion, Choking, Aspiration,
and Insertion Hazards
Under the proposed rule, water beads in the pre-expanded state that
fit entirely inside the small part cylinder from 16 CFR 1501.4 (Figure
9) must then, after full expansion, not grow more than 50 percent in
any dimension and must remain whole while completely passing through
the funnel test gauge depicted in Figure 10 and Figure 11. Instead of
using the rod test in ASTM F963-23, the NPR proposes requiring the
water bead to pass through
[[Page 73036]]
a 9.0 mm (+0.0/-0.1 mm) diameter funnel test gauge under its own weight
to better reflect the lower range of the compression forces a water
bead would experience while passing through a child's gastrointestinal
tract.
In the absence of conclusive anatomical evidence, the Commission
relies on incident data and CPSC staff's analysis to propose that the
funnel test gauge have a 9.0 mm diameter. IDI 170802CCC3140 describes a
13-month-old female who was unable to pass a water bead presumed to
range from 13.0 mm to 17.5 mm diameter. Staff purchased a separate
sample of the same product that the 13-month-old female ingested and
tested the water beads according to the section 4.40 requirements.
After testing, the water beads had a dehydrated, as-received diameter
ranging between 2.0 mm and 2.50 mm. After hydration and expansion, the
size ranged from between 13.0 mm to 17.5 mm diameter. IDI 230707CBB1698
describes a 3-year-old female who ingested but successfully passed
approximately 1,200 water beads. The child successfully passed
approximately 200 of the water beads naturally and then passed the
remaining water beads with the aid of a mineral oil enema. Staff
purchased a separate sample of the same product that the 3-year-old
female ingested and tested the water beads according to the
requirements in section 4.40. After the testing was completed, the
water beads had a dehydrated, as-received diameter ranging between 2.20
mm and 2.40 mm. After hydration and expansion, the diameter of the
water beads ranged from between 9.32 mm and 15.20 mm diameter. Based on
these investigations, the NPR proposes requiring the use of a 9.0 mm
diameter funnel test gauge to ensure the test methods provide the
highest level of safety feasible by limiting the gauge size to the size
of the smallest water bead that was known to pass through the body
without causing an intestinal obstruction.
The proposed 9.0 mm diameter funnel test gauge also would reduce
the hazards associated with water beads that are inserted into
children's noses and ears. While nose and ear insertion incident data
do not indicate the expanded water bead sizes, larger beads can grow
further into the nasal cavity and middle ear, causing severe injuries
and requiring invasive surgery with sedation and/or general anesthesia
to completely remove. The larger water beads are more likely to be
removable only in pieces, as opposed to as a whole, because the bead
has expanded deeper into the nasal cavity or inner ear. Removal of
smaller water beads tends to be less invasive because they can be
removed in one piece by health care professionals, similar to removal
efforts of other inserted small objects, like marbles, toy parts, and
food.
[GRAPHIC] [TIFF OMITTED] TP09SE24.012
[[Page 73037]]
[GRAPHIC] [TIFF OMITTED] TP09SE24.013
The NPR proposes including the ``Expanding Materials'' test method
from section 8.30 of ASTM F963-23, with modifications, in the proposed
rule for water beads under Sec. 1250.4. The NPR proposes conditioning
the water bead or toy containing the water bead at 20 5
[deg]C (68 9 [deg]F) and at a relative humidity of 40-65
percent for a minimum of seven hours prior to the test. This mirrors
the ASTM test method but adds a requirement that if the water bead is
partially expanded, or contained within a toy and partially expanded,
the water bead should be removed and dehydrated before testing. This
simulates the hazard that occurs when a water bead dislodges from the
product and then dehydrates. Pursuant to the ASTM test method, the NPR
proposes that the water bead should next be submerged in a test bath of
deionized water maintained at 37 [deg]C 2 [deg]C (98.6
[deg]F 3.6 [deg]F) for the duration of immersion, without
agitation.\72\ For water beads that exhibit positive buoyancy, the test
requires placing weight(s) with mass just sufficient to achieve
complete submersion on top of the water bead. The test requires that
test labs be careful to minimize contact of the test water bead with
the sides or bottom of the container to minimize any interference with
expansion. To ensure the water bead is fully expanded, the test
requires submersion for 72 hours and to measure the bead's expansion
after 6 hours, 24 hours, 48 hours and then 72 hours. If the greatest
expansion was observed at 72 hours, then the testing should proceed. If
greatest expansion was observed at another time interval, then a new
sample should be conditioned for the time interval when greatest
expansion was observed.
---------------------------------------------------------------------------
\72\ The largest expansion usually occurs in deionized water;
therefore, the water bead can grow to its largest potential in
deionized water when testing the product in a laboratory. This is a
conservative approach, as beads may expand less in digestive fluids.
---------------------------------------------------------------------------
Next, the NPR proposes adding a test step based on the ``Expanding
Materials'' requirement from section 4.6 of EN 71-1, which limits water
bead expansion to no more than 50 percent in any dimension. After the
required period of submersion to reach greatest expansion, the water
bead will be measured with calipers to determine whether it has
expanded more than 50 percent. Setting this expansion limit will
address potential damage to nasal passages and ear cavities, as well as
prevent choking or aspiration hazards by limiting water bead growth.
Thereafter, returning to the ASTM framework but instead of using
the ASTM F963 rod test, the proposed test in the NPR would require
placing the expanded water bead at the top surface of the 9.0 mm
diameter gauge's upper opening (Figure 11) in the orientation least
likely to pass through, and releasing the bead to allow it to travel
[[Page 73038]]
down until it reaches the lower opening, then observing if the expanded
water bead is able to remain whole and completely pass through the
lower opening. By testing to observe if the water bead can completely
pass through the 9.0 mm diameter funnel test gauge without external
force, the test can simulate what occurs in a child's gastrointestinal
tract to determine whether the bead will or will not cause a blockage
in a child's gastrointestinal tract or, specifically, at the child's
ileocecal valve located at the end of the small intestines.
B. Acrylamide Limits and Testing
Water beads are composed of absorbent polymers, such as
polyacrylamide and/or polyacrylate polymers. Polyacrylamide is a
chemical compound composed of acrylamide monomer units linked together.
The polymer form, polyacrylamide, is relatively non-toxic; however,
acrylamide monomer alone can be toxic.\73\ Residual acrylamide monomer
can remain after production of polyacrylamide, which can stay in water
beads after manufacturing. Human exposure to acrylamide monomer is
known to cause negative health effects depending on the amount and
duration of exposure.\74\ Chronic, long-term exposure can adversely
affect the nervous, gastrointestinal, and reproductive systems and is
suspected to be a human carcinogen. Even short-term or one-time
exposures has caused acute negative effects in the nervous system.\75\
---------------------------------------------------------------------------
\73\ Per FHSA (16 CFR 1500.3(c)(2)(i)(A)), a substance with a
median lethal dose (LD50) between 50 and 5000 mg/kg in
rats is ``toxic'' for acute toxicity. The reported oral
LD50 values for undiluted acrylamide in rats range from
150 to 413 mg/kg (source: ATSDR Toxicological Profile for
Acrylamide, available at https://www.atsdr.cdc.gov/ToxProfiles/tp203.pdf).
\74\ ATSDR Toxicological Profile for Acrylamide, available at
https://www.atsdr.cdc.gov/ToxProfiles/tp203.pdf; Internationally
Peer Reviewed Chemical Safety Information (INCHEM) Acrylamide
Review, available at https://inchem.org/documents/pims/chemical/pim652.htm; U.S. Environmental Protection Agency (EPA) Hazard
Summary of Acrylamide, available at https://www.epa.gov/sites/default/files/2016-09/documents/acrylamide.pdf; U.S. FDA Process
Contaminants in Food--acrylamide, available at https://www.fda.gov/food/process-contaminants-food/acrylamide.
\75\ Agency for Toxic Substances and Disease Registry (ATSDR)
Toxicological Profile for Acrylamide, available at https://www.atsdr.cdc.gov/ToxProfiles/tp203.pdf.
---------------------------------------------------------------------------
The United States Food and Drug Administration (FDA) limits the
amount of residual acrylamide monomer allowed in polyacrylamide used in
food production (21 CFR 176.170, 176.180), processing (21 CFR 173.5,
173.10, 173.315), and packaging (21 CFR 176.110). The FDA has also
published guidance on reducing the amount of acrylamide in foods.\76\
Polyacrylamide is commonly used in water and wastewater treatment, and
the EPA limits the amount of acrylamide permitted in drinking
water.\77\
---------------------------------------------------------------------------
\76\ U.S. FDA Guidance for Industry Acrylamide in Foods,
available at https://www.fda.gov/media/87150/download.
\77\ U.S. EPA National Primary Drinking Water Regulations,
available at https://www.epa.gov/ground-water-and-drinking-water/national-primary-drinking-water-regulations.
---------------------------------------------------------------------------
No CPSC mandatory standard sets acrylamide limits for water beads
or any other product; however, toys subject to ASTM F963, including
water beads, are subject to the toxicology safety requirements in
section 4.3.1, Hazardous Substances of ASTM F963-23. Section 4.3.1
stipulates that ``[t]oys or materials used in toys shall conform to the
FHSA and to the regulations promulgated under that act . . . The
regulations define limits for substances that are toxic, corrosive,
[or] an irritant . . . .'' Section 8.2, Testing for Hazardous Substance
Content in ASTM F963-23 directs readers to review the FHSA to determine
whether a product is comprised of hazardous substances. Depending on
exposure, acrylamide could be a hazardous substance per 16 CFR
1500.3(b)(4)(i), which defines a hazardous substance as ``any substance
or mixture of substances which is toxic . . . .'' Per 16 CFR
1500.3(b)(5), the term `toxic' refers to ``any substance (other than a
radioactive substance) which has the capacity to produce personal
injury or illness to man through ingestion, inhalation, or absorption
through any body surface.''
While CPSC does not have incident data reflecting acrylamide
poisoning from water beads,\78\ the presence of acrylamide monomers in
several water bead products that staff tested demonstrates a potential
chemical hazard. CPSC has made efforts to address the potential
chemical hazard outside of rulemaking. For example, in March 2024 CPSC
announced unilateral warnings for two water bead products that
contained levels of acrylamide in violation of the FHSA.\79\ If one of
those water beads was ingested, it could pose a risk of acute toxicity
to children from the acrylamide exposure.
---------------------------------------------------------------------------
\78\ CPSC has not yet received data demonstrating chronic
exposure to acrylamide from water beads.
\79\ https://www.cpsc.gov/Newsroom/News-Releases/2024/CPSC-Warns-Consumers-to-Immediately-Stop-Using-Jangostor-Water-Beads-Due-to-Chemical-Toxicity-Hazard-Violation-of-Federal-Ban-of-Hazardous-Substances-Sold-on-Amazon-com; https://www.cpsc.gov/Newsroom/News-Releases/2024/CPSC-Warns-Consumers-to-Immediately-Stop-Using-Tuladuo-Water-Bead-Sets-Due-to-Chemical-Toxicity-Hazard-Violation-of-Federal-Ban-of-Hazardous-Substances-Sold-on-Amazon-com.
---------------------------------------------------------------------------
Children's possible exposures to acrylamide after ingesting water
beads would likely be a single, infrequent event (possibly including
multiple beads in a single event). Therefore, the exposure scenario
would be acute rather than chronic. The Agency for Toxic Substances and
Disease Registry (ATSDR) \80\ created and published an acute-duration
oral minimal risk level (MRL) of 0.01 mg/kg-day for acrylamide.\81\ The
MRL is an acute exposure level at which an exposed person (including a
child) is unlikely to experience an adverse health effect.
---------------------------------------------------------------------------
\80\ ATSDR is a federal public health agency within the United
States Department of Health and Human Services. More information
about ATSDR is available at https://www.atsdr.cdc.gov.
\81\ ATSDR Toxicological Profile for Acrylamide, available at
https://www.atsdr.cdc.gov/ToxProfiles/tp203.pdf.
---------------------------------------------------------------------------
The Commission proposes that acrylamide limits be set to ensure
that if a child ingests multiple water beads, the child's exposure
levels would not exceed the acute duration oral MRL for children aged 6
months old.\82\ The NPR proposes that the limit be set to 65 [micro]g
acrylamide extractable from 100 small water beads (defined as <4 mm
across the smallest diameter of the bead prior to hydration) or one
large water bead (defined as >=4 mm across the smallest diameter of the
bead prior to hydration). The quantities of small and large beads
assumed to be ingested are based on water bead ingestion incidents and
published case reports. Incident data indicate that children tend to
ingest only one or two large beads. CPSC therefore proposes an exposure
scenario in which a 6-month-old child ingests one large water bead.
---------------------------------------------------------------------------
\82\ Six months is the most sensitive age in this range by
having the lowest body weights, so the proposed limit of extractable
acrylamide from water beads is based on children of this age.
---------------------------------------------------------------------------
Less information is available for incidents of children ingesting
small beads. If small beads do not expand enough after ingestion to
cause a blockage, a child may not receive medical care. However, two
case reports describe a 12-month-old who ingested 12 small water beads
\83\ and a 2-year-old who ingested approximately 100 small beads.\84\ A
review of 21 water bead ingestion cases over a 10-year period
[[Page 73039]]
(2008 to 2017) reported that the number of water beads swallowed ranged
from one to ``a handful.\85\ Although IDI 230707CBB1698 describes a 3-
year-old who ingested approximately 1,200 small water beads, this
scenario appears to be an extreme occurrence. CPSC therefore proposes
for this NPR an exposure scenario in which a 6-month-old child ingests
100 small water beads. The 100 count is within the range of documented
ingestion incidents, and it is consistent with the number of small
beads that staff uses in the acrylamide extraction test method
described below.
---------------------------------------------------------------------------
\83\ Kim HB, Kim YB, Ko Y, Choi YJ, Lee J, Kim JH. A case of
ingested water beads diagnosed with point-of-care ultrasound. Clin
Exp Emerg Med. 2020 Dec;7(4):330-333. doi: 10.15441/ceem.20.041.
Epub 2020 Dec 31. PMID: 33440112; PMCID: PMC7808832.
\84\ Jackson J, Randell KA, Knapp JF. Two Year Old With Water
Bead Ingestion. Pediatr Emerg Care. 2015 Aug;31(8):605-7. doi:
10.1097/PEC.0000000000000520. PMID: 26241717.
\85\ Mehmeto[gbreve]lu F. A Retrospective 10-Year Analysis of
Water Absorbent Bead Ingestion in Children. Emerg Med Int. 2018 May
6;2018:5910527. doi: 10.1155/2018/5910527. PMID: 29854461; PMCID:
PMC5960561.
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An acrylamide exposure limit from ATSDR's acute-duration oral MRL
of 0.01 mg/kg would mean that a child should not be exposed to more
than 0.01 mg of acrylamide for each kg of the child's body weight. When
assessing the appropriate limit, staff used the fifth percentile body
weight for the youngest female child according to the National Center
for Health Statistics.\86\ The fifth percentile body weight of a 6- to
8-month-old female is 6.5 kg. By multiplying the acute-duration oral
MRL by the body weight, staff recommends an exposure limit for
acrylamide from water beads is 0.065 mg, which is equal to 65 [micro]g
of extractable arylamide. The calculation are:
---------------------------------------------------------------------------
\86\ U.S. Centers for Disease Control and Prevention (CDC)
Anthropometric Reference Data for Children and Adults: United
States, 2015-2018, available at https://www.cdc.gov/nchs/data/series/sr_03/sr03-046-508.pdf.
1. Calculate Acrylamide Exposure Limit: 0.01 mg/kg x 6.5 kg = 0.065 mg
2. Convert mg unit to [micro]g: 0.065 mg x 1000 [micro]g/mg = 65
[micro]g
The amount of extractable acrylamide shall be tested in accordance
with the test procedure specified in the proposed 16 CFR
1250.4(c)(2).\87\ The proposed 65 [micro]g acrylamide exposure limit
applies to an assumed ingestion of one large bead (defined as >=4 mm
across the smallest diameter of the bead prior to hydration) or 100
small beads (defined as <4 mm across the smallest diameter of the bead
prior to hydration). Under the proposal, CPSC would consider less than
65 [micro]g acrylamide extractable from water beads safe in children as
young as 6 months old, while water beads containing more than 65
[micro]g pose a risk of acute toxicity. Staff in CPSC's Division of
Chemistry and Directorate for Health Sciences developed a test method
to determine the levels of extractable acrylamide in water beads. The
NPR proposes the following extraction method:
---------------------------------------------------------------------------
\87\ Because the volume of the extraction fluid may be variable,
the 65 [micro]g acrylamide limit is the total mass of acrylamide
extracted in 24 hours and not a concentration.
---------------------------------------------------------------------------
Perform an extraction test on water beads to determine the
amount of acrylamide that leaches from the water beads over a 24-hour
period.
Place dehydrated water beads in a container with pH
neutral deionized water and place the container in a shaker bath that
heats the water beads to 37 [deg]C while shaking them at 30 RPM for 24
hours.
For each water bead product, perform three separate
extraction trials, or repetitions, concurrently to ensure that all
results are reasonably consistent, given any bead-to-bead variation.
For large water beads (defined as >=4 mm across the smallest diameter
of the bead prior to hydration), perform three trials using one large
bead per trial. For small beads (defined as <4 mm across the smallest
diameter of the bead prior to hydration), perform three trials using
100 small beads per trial. If a product contains different sizes of
water beads, perform extraction testing for each size.
Use an appropriate extraction container and volume of
deionized water so that all water beads remain covered by water for the
duration of the extraction period. Because water beads absorb different
volumes of water depending on their size, conduct additional tests
before performing final acrylamide extractions, to determine what
volume of water best allows for full bead growth without unnecessarily
diluting the concentration of extracted acrylamide. Choose containers
that will not compress the water beads at any point during the 24-hour
extraction period. To prevent water evaporation during the extraction,
cover the containers during the extraction.
Following the extraction period, determine the volume of
remaining water for each trial, then analyze the water to determine the
mass of acrylamide present using an instrument that is able to
quantitate acrylamide at levels equal to or less than the proposed
limit. Staff used a liquid chromatography-tandem mass spectrometer (LC-
MS/MS) system,\88\ but other instruments may accurately quantify
acrylamide at levels equal to or less than the proposed limit.
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\88\ LC-MS/MS is an analytical chemistry technique that allows
for the physical separation and subsequent identification and
quantification of analytes of interest within a solution.
---------------------------------------------------------------------------
C. Marking, Labeling, and Instructional Literature Requirements
The ASTM F963-23 standard does not contain marking, warning, or
labeling requirements specifically for water beads. While the standard
provides broad warning requirements under section 5 of ASTM F963-23,
such warnings do not adequately address the hazards associated with
water beads. The Commission proposes requiring the following marking,
labeling, and instructional literature requirements for all products
within scope of the NPR and seeks comment on format, location, and
content requirements of proposed warnings.
1. Packaging and Container Marking and Labeling
Warning about a hazard is a less effective method of addressing the
hazard, contrasted with either designing the hazard out of a product or
guarding consumers from the hazard.\89\ Therefore, when a standard
relies on warnings to address a hazard, it is particularly important
that the warning statements are noticeable, understandable, and
motivational. The primary U.S. voluntary consensus standard for product
safety signs and labels, ANSI Z535.4, American National Standard for
Product Safety Signs and Labels,\90\ recommends that on-product
warnings include content that addresses the following three elements:
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\89\ 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.
\90\ ANSI Z535.4, American National Standard for Product Safety
Signs and Labels is the primary US. voluntary consensus standard for
the design, application, use, and placement of on-product warning
labels when developing or assessing the adequacy of warning labels.
---------------------------------------------------------------------------
a description of the hazard;
information about the consequences of exposure to the
hazard; and
instructions regarding appropriate hazard-avoidance
behaviors.
Providing explicit or detailed information in a warning can
increase its effectiveness \91\ by enhancing perception of injury
severity and perceived hazard.\92\ Vividness of
[[Page 73040]]
message content can increase message salience by triggering motivation
to act in consideration of the warning.\93\
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\91\ Laughery, Sr., K.R., & Smith, D.P. (2006). Explicit
Information in Warnings. In M.S. Wogalter (Ed.), Handbook of
Warnings (pp. 419-428). Mahwah, NJ: Lawrence Erlbaum Associates.
\92\ DeJoy, D.M. (1999). Motivation. In M.S. Wogalter, D.M.
DeJoy, & K.R. Laughery (Eds.), Warnings and Risk Communication (pp.
221-243). Philadelphia: Taylor & Francis.
\93\ Murray-Johnson, L., & Witte, K. (2003). Looking Toward the
Future: Health Message Design Strategies. In T.L. Thompson, A.
Dorsey, K. I. Miller, & R. Parrott (Eds.), Handbook of Health
Communication (pp. 473-495). New York: Routledge.
---------------------------------------------------------------------------
The Commission proposes including the following warnings on water
bead toys and packaging of toys that contain water beads. Specifically,
packaging would be required to include the warning as shown in Figure
12:
[GRAPHIC] [TIFF OMITTED] TP09SE24.014
Packaging of toys with contained water beads, such as squeeze balls
filled with water beads, would be required to include the warnings as
shown in Figure 13:
[GRAPHIC] [TIFF OMITTED] TP09SE24.015
The Commission further proposes that toys containing water beads
that are not individually packaged (e.g., multiple squeeze balls sold
in a bin/box) would be required to have a hangtag or sticker label
affixed on each individual product with the warning shown in Figure 13.
Because CPSC is aware of one death in the U.S. and additional
deaths outside of the U.S.,\94\ both warnings labels state, ``Children
have DIED after swallowing water beads because the beads blocked their
intestines. Your child can die too.'' The purpose of this statement is
to communicate to consumers the consequences of swallowing water beads,
as well as clarify that once a water bead enters the body, water beads
pose a danger by expanding inside the body. The additional statements
advise consumers how to avoid hazards and what to do if the consumer
suspects a child has swallowed or inserted a water bead. The warning
for toys with contained water beads (Figure 13) includes the wording,
``This product contains water beads that grow larger. Discard if beads
are coming out[,]'' to ensure consumers are aware that water beads are
within the toy, and that exposed water beads are hazardous. Incident
data confirm that caregivers may be unaware that toy products purchased
contain hazardous water beads.\95\
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\94\ https://www.consumerreports.org/babies-kids/toys/water-beads-pose-a-serious-safety-risk-to-children-a6431187819/.
\95\ Such as incident 20230601-3657B-2147347238 found on
saferproducts.gov. A 2-year-old child bit into a stress ball and
swallowed the contents requiring medical treatment. The consumer
claims to have been unaware that there were water beads inside.
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When developing or assessing the adequacy of a warning, one must
consider not only the content of a warning, but also its design or
form.\96\ CPSC commonly uses ANSI Z535.4 as a reference for warning
formatting requirements. Human factors experts and warnings literature
regularly cite ANSI Z535.4 when discussing the design and evaluation of
on-product warning labels and generally consider the ANSI Z535 series
of requirements as the state-of-the-art, benchmark standards against
which warning labels should be evaluated for adequacy.\97\ The scope of
ANSI Z535.4 is broad enough to encompass nearly all consumer
[[Page 73041]]
products, including children's products and toys.\98\
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\96\ Laughery, Sr., K.R., & Wogalter, M.S. (2006). The Warning
Expert in Civil Litigation. In M.S. Wogalter (Ed.), Handbook of
Warnings (pp. 605-615). Mahwah, NJ: Lawrence Erlbaum Associates;
Madden, M.S. (1999). The Law Relating to Warnings. In M.S. Wogalter,
D.M. DeJoy, & K.R. Laughery (Eds.), Warnings and Risk Communication
(pp. 315-330). Philadelphia: Taylor & Francis; Madden, M.S. (2006).
The Duty to Warn in Products Liability. In M.S. Wogalter (Ed.),
Handbook of Warnings (pp. 583-588). Mahwah, NJ: Lawrence Erlbaum
Associates.
\97\ Vredenburgh, A.G., & Zackowitz, I.B. (2005). Human Factors
Issues to be Considered by Product Liability Experts. In Y.I. Noy &
W. Karwowski (Eds.), Handbook of Human Factors in Litigation
(Chapter 26). Boca Raton, FL: CRC Press; Wogalter, M.S., & Laughery,
K.R. (2005). Effectiveness of Consumer Product Warnings: Design and
Forensic Considerations. In Y.I. Noy & W. Karwowski (Eds.), Handbook
of Human Factors in Litigation (Chapter 31). Boca Raton, FL: CRC
Press.
\98\ 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.
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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
warning label design requirements for water bead toys and toys
containing water beads that reflect the current recommendations from
ASTM's Ad Hoc Language Task Group (Ad Hoc Task Group).\99\ 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--2023,
American National Standard for Product Safety Signs and Labels,
sections 6.1-6.4, 7.2-7.6.3, and 8.1, with the following changes to the
ANSI standard:
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\99\ 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.
---------------------------------------------------------------------------
In sections 6.2.2, 7.3, 7.5, and 8.1.2, replace the word
``should'' with ``shall;''
In section 7.6.3, replace the phrase ``should (when
feasible)'' with the word ``shall;'' and
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 labels in Figure 12 and
Figure 13, to provide emphasis and capture the reader's attention. The
signal word ``WARNING'' must appear in sans serif letters in upper case
only, 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 must be at least half the height of the triangle and be
centered vertically inside the triangle, as shown in the example
warnings. The message panel text capital letters are no less than \1/
16\'' (1.6mm) \100\ and the message panel text is center- or left-
aligned, in sans serif letters. Consistent with Ad Hoc, the text in
each column should be arranged in list or outline format, with
precautionary statements preceded by bullet points. Precautionary
statements must be separated by bullet points if paragraph formatting
is used.
---------------------------------------------------------------------------
\100\ 1.6mm is the size dimension from the toy standard, 16 CFR
part 1250, Safety Standard Mandating ASTM F963 for Toys, not from
the Ad Hoc Task Group.
---------------------------------------------------------------------------
Warnings that are placed directly on a product and/or the packaging
have a higher noticeability rate \101\ because consumers are more
likely to see such warnings when examining the product prior to
purchase. ANSI Z535.4 provides general guidance on warning placement,
stating that warnings must be ``readily visible to the intended
viewer'' and will ``alert the viewer to the hazard in time to take
appropriate action.'' \102\ Similarly, both the Ad Hoc Task Group and
section 5.3.6 of ASTM F963-23 require conspicuous warnings. The NPR
proposes warning labels be placed on the principal display panel as
defined in section 3.1.62 of ASTM F963-23.
---------------------------------------------------------------------------
\101\ Wogalter, M.S., Godfrey, S.S., Fontenelle, G.A.,
Desaulniers, D.R., Rothstein, P., & Laughery, K.R. (1987).
Effectiveness of warnings. Human Factors 29(5), 599-612; Frantz,
J.P.; Rhoades, T.P. (1993). A Task-Analytic Approach to the Temporal
and Spatial Placement of Product Warnings. Human Factors: The
Journal of the Human Factors and Ergonomics Society, 35(4), pp. 719-
730.
\102\ 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.
---------------------------------------------------------------------------
2. Instructional Literature
Some water bead toys or toys containing water beads provide
instructional literature, such as manuals for use. Instructions or
other literature accompanying a water bead product, when provided,
shall include directions for use, including the relevant warnings from
Figure 12 or Figure 13. The NPR proposes that instructional literature
shall include the same warning labels that the NPR proposes for product
packaging, with similar formatting requirements, though the literature
does not need to be in color.\103\ Still, the Commission proposes that
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.\104\
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\103\ ANSI Z535.6, Product Safety Information in Product
Manuals, Instructions and Other Collateral Materials, allows warning
labels to be black and white whereas the NPR mandates color for
warning labels packaging.
\104\ Ad Hoc section Y.6, Instructional Literature.
---------------------------------------------------------------------------
VI. 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). The
Commission's statutory obligation is to ensure that toys have the
highest level of safety that the producers are capable of achieving,
considering technological and economic ability. Based on 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 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 believes the NPR's proposals meet technical
feasibility criteria. For instance, products currently available on the
market are within the proposed rule's 9.0 mm size limitation, and there
should be multiple means of producing and packaging water bead toys
that expand by less than 50 percent. With respect to demonstrating
compliance, the proposed funnel test gauge test does not require tools,
like a push rod, to determine whether a water bead can pass through the
gauge. Further, several testing tools in the NPR (e.g., a small parts
cylinder) are already included in CPSC mandatory standards or come from
the ASTM F963 standard. Accordingly, much of the technology is already
used when testing to section 4.40 of ASTM F963-23 and is commercially
available.
B. Economic Feasibility
The draft proposed rule is economically feasible because non-
compliant toy products can be redesigned to be compliant, or be
repurposed for non-toy uses. Based on CPSC staff's analysis, the
Commission expects manufacturers would, to comply with the proposed
rule, incur
[[Page 73042]]
material costs to redesign their product and retool their manufacturing
processes to produce a compliant product. Staff expect the redesign and
retooling costs to be significant for small firms involved in the water
bead toy market, with the exception of the labeling requirements, which
are negligible (i.e., less than $0.01 per product). A decline in sales
is expected, as many currently available water bead toys would not be
compliant with the draft proposed rule. However, while the impact of
the proposed rule may be significant, firms could sell compliant water
bead toys or sell non-compliant water beads for non-toy purposes, such
as agricultural purposes.
VII. Incorporation by Reference
Proposed Sec. 1250.4 would incorporate by reference ANSI Z535.4--
2023. The Office of the Federal Register (OFR) has regulations
regarding incorporation by reference. 1 CFR part 51. Under these
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 major provisions of ANSI Z535.4--2023 that the
Commission proposes to incorporate by reference into proposed Sec.
1250.4. The standard itself is reasonably available to interested
parties. By permission of ANSI, the standard can be viewed as a read-
only document during the comment period for this NPR, at: https://ibr.ansi.org/Standards/nema.aspx. Interested parties can also schedule
an appointment to inspect a copy of the standard at CPSC's Office of
the Secretary, U.S. Consumer Product Safety Commission, 4330 East West
Highway, Bethesda, MD 20814, telephone: (301) 504-7479; email: [email protected]. Alternatively, interested parties can purchase a copy of
the standard from ANSI, 1899 L Street NW, 11th Floor, Washington, DC
20036.
VIII. 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 90-day effective
date for this rule. The rule would apply to all water beads
manufactured after the effective date. 15 U.S.C. 2058(g)(1).
Although the NPR proposes to add new requirements, most of the test
methods and test equipment are not unique, in that the current ASTM toy
standard utilizes several similar methods and equipment. For example,
as of July 12, 2024, 81 third-party laboratories were already CPSC-
accepted to test expanding materials as provided in section 4.40 of
ASTM F963-23, as incorporated into part 1250 on January 18, 2024.
Additionally, as of July 12, 2024, 153 third-party laboratories were
CPSC-accepted to test expanding materials as provided in section 4.40
of ASTM F963-17. While these third-party laboratories may not yet be
CPSC-accepted for testing for acrylamide, CPSC expects that these
laboratories are competent to conduct the required testing and can have
their International Organization for Standardization (ISO)
accreditation and CPSC-acceptance updated quickly in the normal course.
Additionally, a 90-day effective date allows the proposed standard to
coincide with the third-party testing requirements for children's
products under section 14(a)(3) of the CPSA, as an NOR date must be no
later than 90 days before such rules or revisions take place. 15 U.S.C.
2063(a)(3). 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.
IX. 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
a substantial number of small entities. 5 U.S.C. 603, 605(b). 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.
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. Third-party testing costs should
not be a new significant cost for most small firms, given suppliers
should already test to the current mandatory standard in part 1250.
A. Reason for Action, NPR Objectives, Product Description, and Market
Description
Section I of this preamble explains why the Commission proposes to
establish a mandatory rule for water bead toys and provides a statement
of the objectives of, and legal basis for, the proposed rule. Section
II of this preamble describes the types of products within the scope of
the NPR, the market for water beads, and the use of water beads in the
U.S. The proposed requirements in the NPR are more stringent than ASTM
F963-23, which the Commission incorporated into the mandatory rule 16
CFR part 1250, Safety Standard Mandating ASTM F963 for Toys, as
described in sections IV and V of this preamble. CPSC staff has not
identified any other Federal rules that duplicate, overlap, or conflict
with the draft proposed rule. The NPR addresses the known hazards
presented by water beads, discussed in section III of this preamble,
that the current rule does not adequately address.
B. Small Entities To Which the Rule Would Apply
Section II of this preamble describes the products within the scope
of the rule and an overview of the market for water beads. This section
provides additional details on the market for products within the scope
of the rule.
CPSC staff has found that a majority of the firms that sell water
bead toys are wholesalers of hobby goods, toys, and plastic
products.\105\ Retailers of water bead toy products are hobby and toy
stores, department stores, and warehouse stores and supercenters.\106\
Some of these products may be sold by convenience stores, but staff
estimates the number of units sold from such stores is negligible.
Water bead toys are
[[Page 73043]]
small, novelty products which can easily be stored and sold in varying
retail channels and, therefore, the described retailers, importers, and
manufacturers are not all inclusive but represent the most prominent
sources for water bead toys.
---------------------------------------------------------------------------
\105\ The North American Industry Classification System (NAICS)
defines product codes for U.S. firms. Firms advertise water bead
products as toys and therefore water beads may be categorized under
many NAICS product codes. These firms could be listed in NAICS code
339930 Doll, Toy, and Game Manufacturing but some may also be listed
in code 326199 All Other Plastic Product Manufacturing. Importers of
these products could also vary among different NAICS codes. A
majority of the firms should be listed in the following NAICS codes
as wholesalers; 423920 Toy and Hobby Goods and Supplies Merchant
Wholesalers, and 424610 Plastics Materials and Basic Forms and
Shapes Merchant Wholesalers.
\106\ Retailers consist of NAICS codes 459120 Hobby, Toy, and
Game Stores, 455110 Department Stores, and 455211 Warehouse Clubs
and Supercenters.
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Currently, over 30 firms supply water bead toys to the U.S. market.
Most of the U.S.-based manufacturers and importers are small companies
based on Small Business Administration (SBA) size standards.\107\ The
SBA size standards for small entities are based on the number of
employees or the annual revenue of the firm, and there is a specific
size standard for each 6-digit North American Industry Classification
Series (NAICS) category.\108\ The U.S. Census Bureau conducts an annual
survey of small businesses in the U.S. and counts how many large and
small businesses are in each NAICS category.\109\ There is no NAICS
category specifically for water bead manufacturing or importing.
Companies that manufacture water bead toy products may be categorized
as doll, toy, and game manufacturing or under the category ``All Other
Plastic Product Manufacturing.'' Importers are generally considered a
type of merchant wholesaler. As seen in the tables below of applicable
NAICS categories, the SBA small entity threshold for manufactures is
generally 150 to 750 employees.
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\107\ Under SBA standards, a manufacturer, importer, and
retailer of a product is categorized as a small entity based on
their associated NAICS code. SBA uses the number of employees to
determine if a manufacturer or importer is a small entity while SBA
uses the amount of annual revenues for retailers.
\108\ The North American Industry Classification System (NAICS)
is the standard used by Federal statistical agencies in classifying
business establishments for the purpose of collecting, analyzing,
and publishing statistical data related to the U.S. business
economy. For more information, see https://www.census.gov/naics/.
Some programs use 6-digit NAICS codes, which provide more specific
information than programs that use more general 3- or 4-digit NAICS
codes.
\109\ https://www.census.gov/programs-surveys/susb/data/tables.html.
Table 2--Estimate of Number of Small Manufacturers and Importers
----------------------------------------------------------------------------------------------------------------
SBA size standard Number of firms that
NAICS code Description for firms (# of meet size standard
employees) (based on SUSB data)
----------------------------------------------------------------------------------------------------------------
339930............................ Doll, Toy, and Game 700 7
Manufacturing.
326199............................ All Other Plastic Product 750 1
Manufacturing.
424610............................ Plastics Materials and Basic 150 4
Forms and Shapes Merchant
Wholesalers.
423920............................ Toy and Hobby Goods and 175 19
Supplies Merchant Wholesalers.
----------------------------------------------------------------------------------------------------------------
Table 3--Estimate of Number of Small Retailers
----------------------------------------------------------------------------------------------------------------
SBA size standard
for firms (annual Number of firms that
NAICS code Description revenue) millions meet size standard
$ (based on SUSB data)
----------------------------------------------------------------------------------------------------------------
452210............................ Department Stores.............. $40.0 15
452310............................ General Merchandise Stores, 47.0 8,006
Including Warehouse Clubs and
Supercenters.
451120............................ Hobby, Toy, and Game Stores.... 35.0 4,660
----------------------------------------------------------------------------------------------------------------
Based on the Census Bureau's 2021 Statistics of U.S. Businesses
(SUSB) data and a review of publicly available data on annual revenues,
staff estimates the number of firms classified as small for the
aforementioned NAICS codes to be seven manufacturers, 23 importers, and
12,681 retailers. These firms could be considered small and supply
water bead products.
C. Compliance, Reporting, Paperwork, and Recordkeeping Requirements of
the Proposed Rule
The proposed rule would require suppliers (manufacturers and
importers) of water bead toys to meet performance, warning label, and
user instruction requirements, and to conduct third-party testing to
demonstrate compliance. This section discusses the reporting and
paperwork requirements. Compliance costs are analyzed in detail in
section IX.E of this preamble.
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 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 water bead products will be required to certify,
based on a test of each product conducted by third-party conformity
assessment body, that their products comply with the requirements of
the proposed rule. Each children's product certificate must identify
the third-party conformity assessment body that conducted the testing
upon which the certificate depends.
D. Potential Impact on Small Entities
Water beads that expand to larger than 9.0 mm or to more than 50
percent greater than their original size in diameter when tested
pursuant to section 8.30, Expanding Materials Test Method of ASTM F963-
23, with modifications proposed in the NPR, would require modification
to meet the proposed rule or be taken off the market. Additionally,
water beads toys that do not meet the proposed acrylamide limit would
require modification or discontinuation.
The Commission assesses it is likely that a substantial number of
firms will incur significant costs from redesign, retooling, loss of
sales, or the purchase and installation of new components. While some
water bead toys are produced at sizes under the proposed maximum water
bead diameter limit of 9.0 mm, CPSC staff has not identified
[[Page 73044]]
water bead products that currently conform to the 50-percent-or-less
growth limitation specified in the proposed rule.
CPSC staff reviewed product descriptions for popular water bead
retail packages and found that most are sold in mixed sizes with water
beads that are both under and over the maximum size limit of the
proposed rule. Staff estimates that water beads over the size limit are
less than 5 percent of the market based on the range of sizes in these
descriptions and an assumed distribution. Staff assesses water beads
over the established limit can easily be replaced with sizes smaller
than the limit to comply with the proposed rule. However, the 50
percent growth limitation requirement is expected to result in all or
nearly all water bead toys needing to be redesigned. Given this
requirement, and the likelihood that all currently available water bead
toys would not be compliant, staff expects some small firms to no
longer package and advertise their products as toys but instead as
agricultural or decorative home products (although firms may be able to
redesign toys with water beads that expand to less than 9.0 mm and/or
be packaged at a size closer to the desired expanded size). Due to the
uncertainty related to redesigning these products, CPSC staff cannot
generate an estimate of the potential costs of the proposed rule. CPSC
staff seeks comment on the number of water beads designated as toys
that currently meet the requirements of the proposed rule, and on the
technical feasibility of the proposed requirements and potential
redesign/retooling costs.
Firms might incur a small one-time additional cost from updating
existing labels and/or adding labels. Generally, the costs associated
with modifying or adding warning labels are low on a per unit basis
because all manufacturers of children's products are already required
to provide labels with their product pursuant to section 14(a)(5) of
the CPSA. The additional costs related to updating labels are less than
$0.01 per unit of product sold, therefore, staff expect the incremental
cost related to the labeling provision to be negligible.
E. Impact on Small Manufacturers
CPSC staff considers 1 percent of revenue to be a ``significant''
economic impact, consistent with other federal government agencies.
Staff expect that small manufacturers would incur significant costs
from redesign, retooling, loss of product sales, and material change to
comply with the proposed rule. However, the labeling costs per product
are negligible (less than $0.01) and would have a de minimis impact on
small firms. Overall, staff assess that a substantial number of small
manufacturing firms will incur a significant cost from the proposed
rule, although sale losses would be mitigated to the extent that
manufacturers repurpose non-compliant water beads for non-toy uses
(e.g., agricultural or decorative).
F. Third-Party Testing Costs
The NPR would require manufacturers and importers of water bead
toys 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.
Water bead manufacturers could incur some additional costs for
certifying compliance with the proposed rule. The certification must be
based on a test of each product performed by a third-party conformity
assessment body. Based on quotes from testing laboratories for ASTM
F963 mechanical services and chemistry testing services, the cost of
certification testing would range from $300 to $500 per product sample.
Some labs currently not performing acrylamide testing in other contexts
may incur retooling costs to perform the necessary testing, which could
result in higher prices per product sample. However, testing of
products is already a requirement and only the incremental increase in
expected price would be considered a cost for the proposed rule. CPSC
staff do not expect a significant price increase for these testing
services as a result of the proposed rule, particularly because they
assess that laboratories tend to price testing by category (i.e.,
chemical testing vs. mechanical testing) and, therefore, such testing
already has a price assigned that likely will not increase.
G. Efforts To Minimize Impact, Alternatives Considered
The Commission considered three alternatives to the proposed rule
that could reduce the impact on small entities: (1) not establishing a
mandatory standard for water beads, (2) establishing an information and
education campaign, or (3) setting a later effective date.
1. Not Establishing a Mandatory Standard
Section 106 of the CPSIA requires CPSC to periodically review and
revise ASTM F963 to ensure that such standards provide the highest
level of safety for such products that is feasible. Given CPSC's
statutory mandate, and continuing incidents associated with water bead
toys as described in section III of this preamble, the Commission has
determined that it must address the safety of children using water bead
toys to ensure that the risks of ingestion and insertion into the body
are mitigated. While failing to promulgate a mandatory standard for
water beads would have no direct impact on U.S. small businesses, it
would allow hazardous products to remain on the market and do nothing
to reduce known hazards associated with water beads. This option might
be selected if it were believed that the risk associated with these
products is acceptable and that agency warning efforts have resulted or
will result in the necessary market changes to address these injuries.
As discussed immediately below, however, that is not the case. In
addition, while there are no direct costs associated with this
alternative, this alternative is unlikely to directly address the fatal
and non-fatal injuries identified from water bead toys.
2. Information and Education Campaign
CPSC could expand its information and education campaigns
concerning the ingestion hazard associated with water bead toys. This
would require consumer outreach efforts like advertising and marketing
related to the hazards. This alternative could be implemented
independent of regulatory action. Public awareness is a crucial
component in making safe purchasing decisions and safely using water
beads. CPSC issued the first warning about ingesting water beads in
2012 with a recall. Since then, there have been many announcements from
government bodies, healthcare professionals and the media.\110\ Given
the continuing
[[Page 73045]]
incidents associated with water beads, CPSC assesses that information
and education campaigns have limited effectiveness in adequately
addressing the hazard. Therefore, the Commission preliminarily finds
that while an information campaign might be helpful, it would be
inadequate to address water bead toy hazards.
---------------------------------------------------------------------------
\110\ Dunecraft Recalls Water Balz, Skulls, Orbs and Flower Toys
Due to Serious Ingestion Hazard [verbar] CPSC.gov (2012) https://www.cpsc.gov/Recalls/2012/dunecraft-recalls-water-balz-skulls-orbs-and-flower-toys-due-to-serious-ingestion; ACCC warns of dangers of
water expanding balls to kids [verbar] ACCC (2015) https://www.accc.gov.au/media-release/accc-warns-of-dangers-of-water-expanding-balls-to-kids; Are Water Beads Toxic?--poisonhelp.org
https://www.poisonhelp.org/2024/03/26/water-beads-toxic/; How High-
Powered Magnetic Toys Can Harm Children--HealthyChildren.org (2023)
https://www.healthychildren.org/English/safety-prevention/at-home/Pages/Dangers-of-Magnetic-Toys-and-Fake-Piercings.aspx?ampnfstatus=401&nftoken=00000000-0000-0000-0000-000000000000&nfstatusdescription=ERROR%252525252525253A%252525252525252BNo%252525252525252Blocal%252525252525252Btoken; Water Beads: A
Danger to Young Children & Can Be Deadly if Swallowed [verbar]
CPSC.gov (2023) https://www.cpsc.gov/Safety-Education/Safety-Guides/Toys-Crafts-Water-Beads/Water-Beads-A-Danger-to-Young-Children-Can-Be-Deadly-if-Swallowed; Water Beads: Harmful if Swallowed, Put in
Ears--HealthyChildren.org (2024) https://www.healthychildren.org/English/safety-prevention/at-home/Pages/Water-Beads-Harmful.aspx?gad_source=1; Water Beads [verbar] CPSC.gov (2024)
https://www.cpsc.gov/Safety-Education/Safety-Education-Centers/Water-Beads-Information-Center?language=en.
---------------------------------------------------------------------------
3. Later Effective Date
The Commission could propose a later effective date that would
reduce the burden on entities of all sizes by allowing more time to
remove products from the market, repackage, and test products. In
addition, testing laboratories need to become accredited to the
proposed rule before any product can be tested to the proposed rule.
Smaller companies are less likely to have the resources to quickly come
into compliance with the proposed rule than larger ones, and a minority
of the small U.S. companies that have products in scope of this
proposed rule have multiple products that do not appear to meet the new
performance requirements. However, the Commission preliminarily finds
that providing a longer effective date would allow the hazards of water
bead toys to be unaddressed for a later period of time resulting in
more deaths and injuries, and thus would unreasonably delay addressing
the ingestion hazard associated with water beads.
X. Environmental Consideration
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.
XI. Paperwork Reduction Act
This proposed rule for water beads 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 Water Beads
Description: As described in section V of this preamble, the
proposed rule would require new labeling for water bead toys. CPSC will
seek a new OMB control number for this rule in the next PRA update for
Third Party Testing of Children's Products. The NPR proposes that water
bead toys meet the proposed requirements of Sec. 1250.4, 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).
Description of Respondents: Persons who manufacture or import water
bead toys or toys that contain water beads.
Estimated Burden: We estimate the burden of this collection of
information as follows:
Table 4--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
Number of Frequency of Total annual Hours per Total burden
Burden type respondents responses responses response hours
----------------------------------------------------------------------------------------------------------------
Labeling and instructions......... 30 1 30 2 60
----------------------------------------------------------------------------------------------------------------
This estimate is based on the following: CPSC estimates there are
30 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 water beads are brought to
market and new labeling and instruction materials are created, for a
total of 30 responses annually (30 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 60 hours annually (30 responses x 2 hours per response = 60 total
burden hours).
CPSC estimates the hourly compensation for the time required to
create and update labeling and instructions is $41.55.\111\ Therefore,
the estimated annual cost of the burden requirements is $2,493 ($41.55
per hour x 60 hours = $2,493). No operating, maintenance, or capital
costs are associated with the collection. Based on this analysis, the
proposed revisions to the standard would impose a burden to industry of
60 hours at a cost of $2,493 annually.
---------------------------------------------------------------------------
\111\ U.S. Bureau of Labor Statistics, ``Employer Costs for
Employee Compensation,'' September 2023, Table 4, total compensation
for all sales and office workers in goods-producing private
industries: https://www.bls.gov/news.release/archives/ecec_12152023.pdf.
---------------------------------------------------------------------------
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C.
chapter 35), CPSC has requested OMB approval of new information
collection and recordkeeping requirements related to this proposed
rule. CPSC invites comments on this new information collection. All
comments received on this information collection will be summarized and
included in the final request for OMB approval. Interested persons are
requested to submit comments regarding information collection by
November 8, 2024 (see the ADDRESSES section at the beginning of
[[Page 73046]]
this notice). Pursuant to 44 U.S.C. 3506(c)(2)(A), we invite comments
on:
Whether the collection of information is necessary for the
proper performance of the CPSC's functions, including whether the
information will have practical utility;
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;
Ways to enhance the quality, utility, and clarity of the
information to be collected;
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
The estimated burden hours to create and update labeling
and instructions, including any alternative estimates.
XII. 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
have preemptive effect in accordance with section 26(a) of the CPSA.
XIII. 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 1250.4 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 an 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 water
beads 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 new standard for
water beads 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 1250.4, Safety Standard for Toys: Requirements for Water Beads,
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. Approximately 67 third-party testing laboratories are
CPSC-accepted to test compliance with ASTM F963-23. CPSC staff expects
that these labs will become accredited and CPSC-accepted to test to
this new standard in the normal course of business. CPSC expects that
these laboratories will be able to test to a new 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.
XIV. Request for Comments
The Commission requests comments on the proposed rule to promulgate
a mandatory standard for water beads 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 requests comment on the following topics:
A. Water Bead Definition
The proposed rule defines ``water bead(s)'' as ``various shaped,
water absorbent polymers, such as, but not limited to polyacrylamides
and polyacrylates, which expand when soaked in water.'' Should the
proposed rule use a different definition of water beads?
B. NPR Scope
1. Which, if any, water pellet guns designed to shoot water bead
projectiles are not children's toys within the scope of the NPR? Please
provide rationale supporting your comment.
2. How, if at all, should color(s) of the water beads factor into
the determination of whether they are toys, and therefore within the
scope of the proposed rule? Please provide support for your
recommendation.
C. Proposed Requirements To Address Ingestion Hazards
1. Are the proposed 9.0 mm diameter funnel test gauge and the 50
percent expansion limit adequate to address the hazards associated with
ingestion of the product? If 9.0 mm diameter is not adequate, what size
is adequate and why? If a 50 percent expansion limit is not adequate,
what expansion limit is adequate and why?
2. Are there any other performance requirements CPSC should
consider to address the hazards associated with water bead ingestion?
D. Proposed Requirements To Address Ear Insertion Hazards
1. Is the proposed 9.0 mm diameter funnel test gauge along with the
50 percent expansion limit adequate to address the hazards associated
with ear insertion? If 9.0 mm diameter is not adequate, what size is
adequate and why? If a 50 percent expansion limit is not adequate, what
percentage is adequate and why?
2. What size dehydrated bead is most attractive to children
regarding the risk of ear insertions and why?
3. Are there any other performance requirements CPSC should
consider to address the hazards associated with ear insertion?
E. Proposed Requirements To Address Nose Insertion Hazards
1. Is the proposed 9.0 mm diameter funnel test gauge along with the
50
[[Page 73047]]
percent expansion limit adequate to address the hazards associated with
nose insertion? If 9.0 mm diameter is not adequate, what size is
adequate and why? If a 50 percent expansion limit is not adequate, what
percentage is adequate and why?
2. What size dehydrated bead is most attractive to children
regarding the risk of nose insertions and why?
3. Are there any other performance requirements CPSC should
consider to address the hazards associated with nose insertion?
F. Proposed Requirements To Address Aspiration Hazards
1. Is the proposed 9.0 mm diameter funnel test gauge along with the
50 percent expansion limit adequate to address the hazards associated
with aspiration of the product? If the 9.0 mm diameter is not adequate,
what size is adequate and why? If a limit of 50 percent expansion is
not adequate, what percentage is adequate and why?
2. Are there any other performance requirements CPSC should
consider to address the hazards associated with water bead aspiration?
G. Water Beads Sticking Together
1. Is there evidence of water beads sticking together or are there
specific water bead products that have tendency to stick together
before, during, or after expansion? If so, please provide further
details.
2. Is there an environment or scenario that has successfully caused
expanded water beads to aggregate with themselves and/or any other
substances, like food or mucus, to cause an obstruction? If so, please
provide details.
H. Proposed Acrylamide Limit and Test Method
1. Is the proposed limit of 65 [mu]g extractable acrylamide monomer
from 100 small water beads or from one large water bead appropriate to
adequately address the hazard of acute toxicity for children who ingest
water beads?
2. The 4.0 mm demarcation between the ``small'' and ``large''
designations for water beads was selected based on CPSC staff's
observations of water bead samples prior to hydration, which tended to
have diameters of equal to or less than 3.0 mm, or equal to or greater
than 5.0 mm. Is another metric or method more appropriate to
distinguish small and large water beads?
3. Is there an alternative, more appropriate, acute oral toxicity
reference value than ATSDR's the acute-duration oral minimal risk level
that is based on valid test methods, relevant health endpoint(s), and
appropriate safety factors?
4. The chosen test value of 100 small water beads when testing for
extractable acrylamide was within the range noted in incident case
reports of children ingesting water beads. Is another test value for
small water beads more appropriate?
5. Is CPSC's acrylamide limit test method sufficient to evaluate
extractable acrylamide in water beads? Are there other tests methods
that CPSC should consider?
I. Proposed Warning Label Requirements for Water Beads
1. Are the proposed warnings adequate to address hazards associated
with water beads? Should other warnings be considered? Should other
warning formats be considered?
2. Regarding the proposed warning for toys that contain water
beads, will consumers know what ``water beads'' are when warned of the
dangers of ``water beads'' that became dislodged from the toy? Is there
another term aside from ``water bead'' that would help consumers better
identify what part of the toy is a water bead?
3. Regarding the proposed warning for toys that contain water
beads, will consumers know what the warning ``Discard if beads are
coming out'' means? Is there another term aside from ``coming out''
that would help consumers understand the warning?
J. Initial Regulatory Flexibility Analysis and Other Topics
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 water beads
increase as a result of the requirements in this NPR, and if so, by how
much? Are test labs that are currently accredited to test for ASTM
F963-23 equipped to use LC-MS-MS to test for acrylamide in water beads?
What other analytical test methods and equipment are appropriate for
quantifying acrylamide content in the levels discussed in the NPR?
3. Effective date. How much time is required to come into
compliance with a final rule (including product compliance and third-
party testing), particularly for small businesses? Please provide
supporting data with your comment.
4. 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.
K. Feasibility
Are the proposed requirements in this NPR feasible, both
technically and economically?
L. Water Bead Manufacturing
Are manufacturers able to limit the growth of water beads to a
specific diameter or specific percentage of growth? If so, what is the
process of adjusting growth potential?
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 1250.4, Requirements for Water Beads.
* * * * *
PART 1250--SAFETY STANDARD FOR TOYS
0
3. Revise the heading of part 1250 to read as set forth above.
0
4. The authority citation for part 1250 is revised to read as follows:
Authority: 15 U.S.C. 2056b.
[[Page 73048]]
0
5. Revise Sec. 1250.1 to read as follows:
Sec. 1250.1 Scope.
This part establishes a consumer product safety standard for toys.
0
6. Add Sec. 1250.4 to read as follows:
Sec. 1250.4 Requirements for water beads.
(a) Scope and purpose. This section establishes performance and
labeling requirements for water bead toys and toys containing water
beads to minimize the risk of children ingesting, inserting,
aspirating, and choking on water beads. The provisions of this part are
intended to eliminate or adequately reduce the risk of injury and death
to children from water bead toy hazards. This section adds requirements
for water bead toys in addition to the requirements of Sec. 1250.2.
(b) Definitions. In addition to the definitions incorporated by
reference in Sec. 1250.2(a), the following definitions apply for
purposes of this section:
Aspiration hazard mean a hazard caused by a child inhaling a water
bead whereby the water bead can become lodged in the respiratory tract
and can potentially cause death or injury.
Choking hazard means a hazard cause by a child attempting to
swallow a water bead whereby the water bead can become lodged in the
throat and can potentially cause death or injury.
Ingestion hazard means a hazard caused by a child swallowing a
water bead whereby the water bead can become lodged in the digestive
tract and can potentially cause death or injury.
Insertion hazard means a hazard caused by a child putting a water
bead in the ear canal or nasal passage of the body and can potentially
cause injury or death.
Water bead means a various shaped water absorbent polymer, such as,
but not limited to, polyacrylamide and polyacrylate, which expands when
soaked in water.
(c) Performance requirements. In addition to the requirements of
Sec. 1250.2, all water bead toys and toys containing water beads
within the scope of the rule must meet the performance requirements in
this section to minimize the risk of children ingesting, inserting,
aspirating, and choking on water beads.
(1) Water beads as received or water beads removed from a toy,
which fit entirely inside the small parts cylinder in their dehydrated
(pre-expanded) state as shown in Figure 1 to paragraph (c)(1) (16 CFR
1501.4) shall not expand more than 50 percent in any dimension and
shall remain whole while also completely passing through the funnel
test gauge as shown in Figure 2 to paragraph (c)(1), under its own
weight after expansion, when tested in accordance with the following
test procedure:
Figure 1 to Paragraph (c)(1)--Small Parts Cylinder.
[GRAPHIC] [TIFF OMITTED] TP09SE24.016
Figure 2 to Paragraph (c)(1)--Funnel Test Gauge. Material:
Polytetrafluorethylene (PTFE).
[GRAPHIC] [TIFF OMITTED] TP09SE24.017
(i) Test method. Condition the water bead or toy containing the
water bead, at 20 5 [deg]C (68 9 [deg]F) and
at a relative humidity of 40-65 percent for a minimum of seven hours
prior to the test.
(ii) If the water bead is partially expanded, or contained within a
toy and partially expanded, remove the water bead for testing and allow
120 hours to dehydrate.
(iii) Measure the bead using calipers to determine the dehydrated
dimensions. If not spherical, measure in all dimensions. When measuring
with calipers, do not compress the bead in a manner that will change
its shape.
(iv) Submerge the water bead under a test bath of deionized water
maintained at 37 2 [deg]C (98.6 3.6 [deg]F)
for the duration of immersion, without agitation. For water beads that
exhibit positive buoyancy, place weight(s) (with mass just sufficient
to achieve complete submersion) atop the water bead. Care should be
taken to minimize contact of the test water bead with the sides or
bottom of the container.
(v) Maintain submersion for 72 hours, measuring the water bead
dimensions at 6 hours, 24 hours, 48 hours and 72 hours duration. If the
greatest expansion was observed at 72 hours of submersion, proceed to
immediately test the expanded water bead. If the greatest expansion was
observed at another time interval, condition and submerge a new water
bead per paragraph (c)(1)(i)-(iv) for the time interval at which the
greatest expansion was observed. Then immediately test the expanded
water bead.
(vi) Remove the expanded water bead and using calipers, calculate
the expansion amount in all dimensions as a percentage of the
dehydrated dimensions and determine whether the bead has expanded more
than 50 percent in any dimension. When measuring with calipers, do not
compress the bead in a manner that will change its expanded shape.
(vii) Place the expanded water bead at the top surface of the
gauge's upper opening in the orientation least likely to pass through,
and release allowing it to travel down until it reaches the lower
opening. The expanded water bead shall remain whole and completely pass
through the lower opening.
(2) Acrylamide Limit Requirements. Water beads shall not have more
than 65 [micro]g acrylamide extractable from 100 small water beads
(defined as <4 mm across the smallest diameter of the bead prior to
hydration) or from one large water bead (defined as >=4 mm across the
smallest diameter of the bead prior to hydration) in the test procedure
described below:
(i) Acrylamide test procedure. To determine the amount of
extractable acrylamide in water beads, first place the water beads (one
large water bead or 100 small water beads) as received in a container
with pH neutral deionized water.
(ii) Situate the container(s) in a shaker bath that can heat the
water beads to 37 [deg]C and shake them at a rate of 30 RPM. Leave the
water beads untouched for 24 hours.
(iii) Multiple concurrent trials, or sequential repetitions, must
be performed to ensure that results are reasonably consistent, given
any bead-to-bead variation. For large water beads, perform three trials
with one large bead per trial. For small water beads, perform
[[Page 73049]]
three trials with 100 small beads per trial.
(iv) Use an extraction container and volume of deionized water so
that all water beads remain covered by water for the duration of the
extraction period. Because water beads absorb water differently
depending on their various sizes, additional tests may need to be
conducted before starting the extractions to determine a volume of
water that allows for full growth and coverage of the water beads
without unnecessarily diluting the concentration of extracted
acrylamide. Select containers that will not compress the water beads at
any point during the 24-hour extraction period.
(v) Cover the containers to prevent evaporation of the water during
the extraction.
(vi) Following the extraction, determine the volume of remaining
water for each trial. Analyze the remaining water to determine the mass
of acrylamide present using an instrument that can quantitate
acrylamide at levels equal to or less than the limit.
(d) Labeling requirements. All water bead toys and packaging of
toys containing water beads within the scope of the rule must meet the
marking, labeling, and instructional literature requirements in this
section to minimize the risk of children ingesting, inserting,
aspirating, and choking on water beads.
(1) Requirements for Marking and Labeling. (i) Water bead toys,
packaging of water bead toys, and the container of water beads, if
provided, must include the safety alert symbol, signal word, and word
message as shown in Figure 3 to paragraph (d)(1)(i).
Figure 3 to Paragraph (d)(1)(i)--Warning for Water Bead Toys and
Packaging.
[GRAPHIC] [TIFF OMITTED] TP09SE24.018
(ii) Products with contained water beads, such as balls filled with
water beads, and the packaging must include the safety alert symbol,
signal word, and word message as shown in Figure 4 to paragraph
(d)(1)(ii):
Figure 4 to Paragraph (d)(1)(ii)--Toys That Contain Water Beads.
[GRAPHIC] [TIFF OMITTED] TP09SE24.019
(iii) Products with contained water beads that do not have
packaging must have a hangtag or sticker label with the full warnings.
Multiple products sold in a package or bin must be individually labeled
with a hangtag or sticker.
(iv) The warnings shall be in the English language at a minimum.
(v) 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.
(vi) The warnings shall conform to ANSI 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 Z535.4-2023
replace the word ``should'' with the word ``shall.''
(B) In section 7.6.3 of ANSI Z535.4-2023, replace the phrase
``should (when feasible)'' with the word ``shall.''
(C) In section X of ANSI Z535.4-2023, strike the word ``safety''
when used immediately before a color (for example, replace safety
white'' with ``white'').
(vii) 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.
(viii) 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.
(ix) Multiple precautionary statements shall be separated by bullet
points if paragraph formatting is used.
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(xi) 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.
(2) Requirements for Instructional Literature. Instructions shall
have the same warning labels that must appear on the product packaging,
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.
(e) Incorporation by reference. The Director of the Federal
Register approves the incorporation by reference of ANSI Z535.4-23,
American National Standard for Product Safety Signs and Labels
(approved December 14, 2023) in paragraph (d) of this section in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. This material is
available for inspection at the U.S. Consumer Product Safety Commission
and at the National Archives and Records Administration (NARA). Contact
the U.S. Consumer Product Safety Commission at: the 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, email [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html. A free, read-only copy of the standard
is available for viewing on the ANSI website at https://ibr.ansi.org/Standards/nema.aspx. You may also obtain a copy from American National
Standards Institute (ANSI), 1899 L Street NW, 11th Floor, Washington,
DC 20036, www.ansi.org.
Alberta E. Mills,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2024-19286 Filed 9-6-24; 8:45 am]
BILLING CODE 6355-01-P